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Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories.

Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

For in vitro diagnostic use. For Prescription use.

Hemosure® Accu-Reader™ A100 is an automated immunochemical fecal occult blood test system intended for the qualitative detection of fecal occult blood in human feces by clinical laboratories. Hemosure® Accu-Reader™ A100 is comprised of Hemosure® Accu-Reader™ A100 Reader with Sample Tray, Hemosure Accu-Reader™ A100 Test Cartridge, Sample Collection tube, Hemosure® Accu-Reader™ A100 Control and Hemosure® Accu-Reader™ A100 Calibration Cartridge Kit.

The principle of measurement is an automated sandwich dye conjugate immunoassay that employs a combination of monoclonal antibodies to selectively identify and provide qualitative determination of human hemoglobin in feces. As the test sample flows up through the absorbent device, the labeled antibody-dye conjugate binds to the hemoglobin in the specimen, forming an antibody-antigen complex. This complex binds to anti-hemoglobin antibody in the positive test reaction zone and produces a pink-rose color band. In the absence of hemoglobin, there is no line in the positive test reaction zone. The pink-rose color bands in the control reaction zone demonstrate that the reagents and devices are functioning correctly.

The throughput of the instrument is 100 samples are collected in the sample collection tube "Sample Collection tube". The sample tube and test cartridge are assembled and placed on the sample tray. The instrument positions the plunger station to initiate the test cartridge testing by plunging the sample collection buffer tube into the chamber of the cartridge and thereby piercing its aluminum seal. The test fecal sample buffer is released into the test cartridge and fecal sample buffer will migrate on the enclosed test strip affixed on the test cartridge. Results are read after the tray makes one full rotation, which takes 5 minutes. Immediately after sample reading, the result (positive, negative or invalid) is displayed on the touchscreen and printed on paper whose dispensing slot is situated at the top of the Accu-Reader™ A100.

Here's an analysis of the acceptance criteria and study detailed in the provided document for the Hemosure Accu-Reader A100 device:

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state a single, overarching acceptance criterion as a numerical threshold (e.g., "accuracy > 95%"). Instead, it demonstrates acceptable performance across various studies (precision, cross-reactivity, interference, stability, clinical performance) by consistently achieving high levels of "agreement" and confirming expected results. The primary measure used to show effectiveness, particularly in the clinical method comparison, is the "Overall Percent Agreement (OPA)," "Positive Percent Agreement (PPA)," and "Negative Percent Agreement (NPA)" with a predicate device.

2. Sample Size Used for the Test Set and Data Provenance:

• Clinical Performance Study:

  • Sample Size: A total of 377 clinical fecal samples were used.
  • Data Provenance: The samples were collected from individuals who had previously been screened by colonoscopy. The study was conducted at three different sites, indicating a likely prospective or retrospective multi-center clinical study setup, although the document does not definitively state "prospective" or "retrospective." The samples are human fecal samples. The country of origin is not explicitly stated.

• Other Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity):

  • The test set for each of these studies used 21 replicates for each concentration (spanning various hemoglobin levels, including negative controls, around the cut-off, and high positive).
  • Data Provenance: These studies generally involved contrived or spiked samples (e.g., human hemoglobin, animal hemoglobin, interfering substances spiked into fecal samples). The provenance of the base fecal samples or the location of these analytical studies is not explicitly stated, but they are laboratory-based analytical studies rather than clinical field studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• For the Clinical Performance Study, the ground truth appears to be based on a legally marketed predicate device (OC-Auto Micro FOB Test) and "individuals who had previously been screened by colonoscopy." The document does not specify the number or qualifications of experts (e.g., radiologists, gastroenterologists, pathologists) who established the ground truth from the colonoscopy results. It's implied that the findings from the colonoscopy were used to determine the true positive/negative status for fecal occult blood, which was then compared to the device and predicate.

• For the Analytical Studies (Precision, Cross-Reactivity, Interference, Stability, Analytic Sensitivity), the "ground truth" for the test samples was established by preparing samples with known concentrations of human hemoglobin (or other substances). This is a controlled laboratory setting, so "experts" in the sense of clinical reviewers for ground truth are not applicable here. The known concentrations themselves served as the ground truth.

4. Adjudication Method for the Test Set:

• The document does not describe an explicit adjudication method for the clinical study test set in terms of human expert review. The comparison is made against a "predicate device" and implied "colonoscopy" results.
• For the analytical studies, the "ground truth" was established by the known concentrations of spiked analytes, so adjudication was not necessary.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size:

• No, a standard MRMC comparative effectiveness study, where human readers interpret cases with and without AI assistance to measure improvement, was not conducted.
• This device, the Hemosure Accu-Reader A100, is an automated immunochemical fecal occult blood test system. It is designed for qualitative detection of fecal occult blood in human feces by clinical laboratories, with results read by a camera-based reader and displayed as "positive, negative or invalid." It is an in vitro diagnostic device, not an image interpretation AI system that assists human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply to this type of device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:

• Yes, this was a standalone performance study. The Hemosure Accu-Reader A100 is an automated system. Its "performance characteristics" (precision, analytical sensitivity, cross-reactivity, interference, stability, and clinical comparison to a predicate) reflect the algorithm's performance in analyzing the test cartridge without human intervention in the result interpretation. The reader (machine) identifies and provides qualitative determination of human hemoglobin.

7. The Type of Ground Truth Used:

• For the Clinical Performance Study: The ground truth was based on the performance of a predicate device (OC-Auto Micro FOB Test) and, implicitly, outcomes data from colonoscopy screenings.
• For Analytical Studies (Precision, Prozone, Analytic Sensitivity, Cross-Reactivity, Interfering Substances, Specimen and Shipping Stability, Accelerated and Real-Time Kit Stability): The ground truth was known concentrations of spiked human hemoglobin (or other substances like animal hemoglobin or interfering agents) in fecal samples. These are essentially controlled experimental conditions.

8. The Sample Size for the Training Set:

• The document does not provide information on a training set size. As an in vitro diagnostic device, this typically refers to a specific assay method and an automated reader. While the reader uses digital imaging to analyze lines, it's not described as a deep learning or traditional machine learning system requiring a large "training set" in the common sense for AI algorithms. The system's "training" would be more akin to calibration and optimization of its optical analysis and interpretation logic, rather than iterative learning from a large labeled dataset. The various analytical studies validate its performance but are not explicitly referred to as a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Since a "training set" in the context of an AI algorithm is not explicitly mentioned or implied for this device, the method for establishing its ground truth is not applicable/not provided. The device relies on a pre-defined sandwich dye conjugate immunoassay principle and a calibrated optical system.

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First Sign Multi-Drug Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1.5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Configuration of the First Sign Multi-Drug Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method. For in vitro diagnostic use only.

First Sign Multi-Drug Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2-ethylidene-1,5-dimethyl-3,3diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Configuration of the First Sign Multi-Drug Test Cup can consist of any combination of the above listed drug analytes. The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only.

First Sign Multi-Drug Screen Test Dip Card is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-dipheny|pyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Configuration of the First Sign Multi-Drug Screen Test Dip Card can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only. It is for prescription use.

First Sign Multi-Drug Screen Test Cup is competitive binding, lateral flow immunochromatographic assay for qualitative and simultaneous detection of Amphetamine, Butalbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

Configuration of the First Sign Multi-Drug Screen Test Cup can consist of any combination of the above listed drug analytes.

The test may yield positive results for the prescription drugs Buprenorphine, Oxazepam, Butalbital, Nortriptyline, Propoxyphene and Oxycodone when taken at or above prescribed doses. It is not intended to distinguish between prescription use or abuse of these drugs. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive. The test provides only preliminary test results. A more specific alternative chemical must be used in order to obtain a confirmed analytical result. GC/ MS or LC/MS is the preferred confirmatory method.

For in vitro diagnostic use only. It is for prescription use.

The First Sign Multi-Drug Test Dip Card, First Sign Multi-Drug Test Cup, First Sign Multi-Drug Screen Test Dip Card and First Sign Multi-Drug Screen Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Butalbital, Methadone, Buprenorphine, Phencyclidine, Methylenedioxymethamphetamine, Tricyclic Antidepressants, EDDP and Propoxyphene (target analytes) in human urine. The products are single-use in vitro diagnostic devices. The Dip Card kits contain a Dip Card device, a package insert and a urine cup for sample collection. The Cup kits contain a Cup device, a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

This document describes the performance of the "First Sign Multi-Drug Test Dip Card", "First Sign Multi-Drug Test Cup", "First Sign Multi-Drug Screen Test Dip Card", and "First Sign Multi-Drug Screen Test Cup" for detecting various drugs in human urine. The information provided focuses on the analytical and comparison studies, as clinical studies were deemed "Not applicable".

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a quantitative manner as a pre-defined threshold for device performance (e.g., "accuracy must be >95%"). Instead, it presents the results of performance studies, implicitly demonstrating that the device meets the expected performance for a qualitative drug test. The precision data shows a high degree of correct results at various concentrations relative to the cutoff, and the comparison studies show agreement with LC/MS.

Since explicit acceptance criteria are not provided in the document, the table will present the results as reported, highlighting the percentage of correct results near the cutoff for the "Lay-user study" as a key performance indicator. The precision studies, while not explicitly "acceptance criteria," demonstrate the device's reliability.

Table: Reported Device Performance (Summary from Precision and Lay-User Studies)

2. Sample sizes used for the test set and the data provenance:

• Precision Study Test Set: For Propoxyphene (PPX), 50 tests were performed for each of 9 concentrations (from -100% to +100% cut-off) across 3 lots per device type (Dip Card and Cup). This means 50 tests * 9 concentrations * 3 lots * 2 device types = 2700 individual tests for Propoxyphene. The data for other drugs listed (AMP1000, COC300, THC, BUP, BAR, MOP 300, BZO, MET1000, MOP 2000, MTD, PCP, OXY, EDDP, MDMA, TCA, AMP 500, COC150, MET 500) were reported in previously cleared 510(k) submissions (e.g., K142353, K152551), suggesting similar study designs.
• Comparison Studies (Clinical Samples) Test Set: 80 "unaltered clinical samples" (40 negative and 40 positive) were used for each drug. The document states this was done "for each device," implying this applies to both Dip Card and Cup formats, and for each drug analyte. These samples were "blind labeled."
• Lay-User Study Test Set: 280 lay persons for each device format (Dip Card and Cup). Each participant received 1 blind-labeled sample and 1 device. The urine samples were prepared at 8 concentrations: negative, +/-25%, +/-50%, +/-75%, and -100% of the cutoff. The table for each drug shows 20 samples tested at each of these 8 concentrations. Therefore, for each drug analyte (e.g., AMP 500), 160 samples were tested (20 samples/concentration * 8 concentrations). As there are multiple drugs in each configuration, and multiple configurations, the total number of samples across all drugs and configurations tested by lay users would be substantial (e.g., for Configuration 1 which lists 14 drugs, 14 * 160 = 2240 samples for that configuration).
• Data Provenance: Not explicitly stated in terms of country of origin. The comparison studies used "unaltered clinical samples," suggesting they were collected from human subjects. The precision and lay-user studies used "spiked drug in negative urine samples" or "drug free-pooled urine specimens" with added drugs. The studies appear to be quantitative laboratory performance studies rather than field studies with real patients. The document does not specify if the studies were retrospective or prospective, but the description ("prepared by spiking," "samples were tested," "were performed in-house") suggests prospective laboratory studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Precision Study: "Each drug concentration was confirmed by LC/MS." LC/MS (Liquid Chromatography-Mass Spectrometry) is an analytical gold standard used for precise drug concentration determination. The "person who prepared the samples" was described as doing so "blindly," but there's no mention of "experts" in the context of interpretation, as LC/MS provides a quantitative, objective ground truth.
• Comparison Studies (Clinical Samples): "The samples were blind labeled and compared to LC/MS results." Similar to the precision study, LC/MS serves as the gold standard for ground truth. The "three laboratory assistants" who ran the tests are operators of the device, not experts establishing the ground truth.
• Lay-User Study: "The concentrations of the samples were confirmed by LC/MS." Again, LC/MS is the ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• None. The ground truth in all studies (precision, comparison, lay-user) was established by LC/MS, which is an objective chemical analysis, not a subjective interpretation requiring human adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is an in vitro diagnostic device (IVD) for qualitative detection of drugs in urine. It is a rapid diagnostic test (likely a dip card or cup-based immunoassay), not an AI-assisted diagnostic tool that would involve human "readers" interpreting images or complex data. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• This device is a physical, lateral flow immunochromatographic assay. It does not have an "algorithm" in the sense of software running independently. Its "standalone" performance is represented by the analytical performance (precision, specificity, interference) and the comparison studies against the LC/MS gold standard, where the device's reading (line presence/absence) is directly compared to the LC/MS result. The "lay-user study" involved human interpretation of the device results (visual inspection of lines), which is the intended use, so it's a human-in-the-loop study in that sense, but not an "algorithm-only" study.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The ground truth for all studies was established by LC/MS (Liquid Chromatography-Mass Spectrometry), which is considered a highly accurate and quantitative analytical method for confirming drug concentrations in urine.

8. The sample size for the training set

• This document describes a diagnostic test (immunoassay strip/cup), not an AI/ML device that typically requires a "training set." The device's underlying "knowledge" is built into the chemical reagents and physical design, not learned from data. Therefore, the concept of a "training set" for an algorithm is not applicable to this type of device. The extensive analytical studies serve to characterize its inherent performance.

9. How the ground truth for the training set was established

• As the device is not an AI/ML algorithm requiring a training set, this question is not applicable.

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First Sign® Drug of Abuse Cup Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

First Sign® Drug of Abuse Dip Card Test Marijuana is a qualitative lateral flow immunoassay intended for the detection of Marijuana in human urine at cut-off concentration of 20 ng/mL. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The test is intended for prescription use.

First Sign Multi-Drug Cup Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

First Sign® Multi-Drug Dip Card Test is a qualitative lateral flow immunoassay intended for the detection of Amphetamine, Cocaine, and Methamphetamine in human urine at cut-off concentrations of 500 ng/mL, and 500 ng/mL, respectively. The tests provide only preliminary test results. A more specific alternative method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive. For in vitro diagnostic use only. The tests are intended for over-the-counter use.

First Sign Multi-Drug Cup Test, First Sign Multi-Drug Dip Card Test, First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are lateral flow, immunochromatographic assays. The First Sign Multi-Drug Cup Test and the First Sign Multi-Drug Dip Card Test are for the qualitative detection of Amphetamine, Cocaine, and Methamphetamine in human urine. First Sign Drug of Abuse Cup Test Marijuana, and First Sign Drug of Abuse Dip Card Marijuana are for the qualitative detection of Marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the analytical and user performance of various First Sign® drug tests (Multi-Drug Cup Test, Multi-Drug Dip Card Test, Drug of Abuse Cup Test Marijuana, and Drug of Abuse Dip Card Test Marijuana). These are qualitative lateral flow immunoassays intended for the detection of Amphetamine, Cocaine, Methamphetamine, and Marijuana in human urine. The document does not describe an AI medical device, but rather an in-vitro diagnostic device. Therefore, many of the requested points related to AI/MRMC studies are not applicable.

Here's an attempt to extract relevant information and apply it to the closest possible concepts for an AI device's acceptance criteria and study, based on the provided content:

Device Description:
The devices are lateral flow, immunochromatographic assays for the qualitative detection of Amphetamine, Cocaine, and Methamphetamine (Multi-Drug tests) and Marijuana (Drug of Abuse tests) in human urine. They are single-use in vitro diagnostic devices available in Dip Card or Cup formats.

Acceptance Criteria and Device Performance (Interpreted for a diagnostic device):

The acceptance criteria for these devices would typically be established based on their ability to correctly identify positive and negative samples around the defined cut-off concentrations for each drug. The "Precision" and "Lay-user study" data provide the closest insight into this, demonstrating the device's ability to consistently provide correct results across various concentrations relative to the cut-off.

Since this is a qualitative test (positive/negative), the performance is measured by the percentage of correct results at different concentrations, especially near the cut-off.

Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Breakdown of Requested Information (Applying to this non-AI device where possible):

1. A table of acceptance criteria and the reported device performance:

   • Acceptance Criteria (Inferred): For a qualitative drug test, the acceptance criteria are generally that samples below the cut-off should test negative, and samples at or above the cut-off should test positive, with high accuracy at concentrations away from the cut-off, and acceptable accuracy around the cut-off. Specifically, the data shows an expectation of 100% correct results for samples significantly above or below the cut-off (e.g., +/- 50% to +/- 100%) and a tolerance for some misclassification directly at or very close to the cut-off.
   • Reported Device Performance: See the table above and the detailed "Precision" and "Lay-user study" results within the document (pages 8-20). For instance, in the precision study, samples at the cut-off typically showed a mix of positive and negative results (e.g., 3-/47+ or 2-/48+ out of 50 tests), indicating the expected performance around the threshold. In the lay-user study, performance at +25% cutoff for COC DipCard was 90% correct, and for AMP Cup and MET Cup at +25% cutoff, it was 95% correct, with near-perfect accuracy further from the cutoff.

2. Sample sizes used for the test set and the data provenance:

   • Precision Study:
     • Sample Size: For each drug and each format (e.g., AMP Cup, COC Dip Card), there were 9 concentration levels tested (from -100% to +100% of cut-off). For each concentration, there were 2 runs per day for 25 days, totalling 50 tests per concentration per lot. Since three lots were tested, this amounts to 150 tests per concentration level per drug per format.
     • Data Provenance: Samples were "prepared by spiking drug in negative urine samples." This suggests laboratory-controlled, prospectively prepared samples. The origin of the negative urine samples (e.g., country) is not specified.
   • Method Comparison Studies (Clinical Samples):
     • Sample Size: "80 (40 negative and 40 positive) unaltered clinical samples for each target drug" were used. This means 80 clinical samples per drug per format. (e.g., 80 for AMP Dip Card, 80 for AMP Cup, etc.).
     • Data Provenance: "clinical samples." This implies retrospective (or collected for study), human biological samples. Country of origin is not specified but implied to be in the testing region (likely USA given the FDA submission).
   • Lay-user Study:
     • Sample Size: "320 lay persons testing the devices." Urine samples were prepared at 8 concentration levels.
     • Data Provenance: "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." This indicates laboratory-prepared, prospective samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Ground Truth Establishment:
     • For the Precision Study and Lay-user study, the ground truth was established by the precise concentrations of spiked drugs confirmed by GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is considered the "preferred confirmatory method" and the gold standard for drug detection and quantification in urine.
     • For the Method Comparison Studies, the ground truth for clinical samples was established by GC/MS results.
   • Experts and Qualifications: The document does not mention human experts establishing the ground truth for the test sets. The ground truth relies on the analytical accuracy of GC/MS. The "three different operators" (or "laboratory assistants") mentioned in the Precision and Method Comparison studies were performing the device tests, not establishing the ground truth. No specific qualifications for these operators are provided beyond their role.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • For the analytical and method comparison studies, the results of the device were compared directly to the GC/MS ground truth. There was no human adjudication process described for discrepancies in the test results themselves, as the GC/MS is considered definitive. The "discordant results" tables show instances where the viewer disagreed with GC/MS, but there's no mention of a re-adjudication of the GC/MS reference result itself.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • N/A. This document describes an in-vitro diagnostic device (drug test kit), not an AI medical device. Therefore, no MRMC study involving AI assistance for human readers was conducted or is applicable.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • N/A. This is not an AI algorithm. The device itself is a standalone test kit that provides a visual qualitative result (lines appearing on the dip card/cup). The "lay-user study" demonstrates the performance of the device when interpreted by its intended users (without "human-in-the-loop performance" in the AI sense, but rather human-as-user interpretation). The "Method Comparison Studies" also represent standalone performance, where "viewers" (operators) interpret the device results against a gold standard.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The primary ground truth used for all performance studies was Gas Chromatography/Mass Spectrometry (GC/MS) results, which is an analytical gold standard for quantifying drug concentrations in urine.

8. The sample size for the training set:

   • N/A. This is not a machine learning/AI device, so there is no "training set" in the computational sense. The device's performance is based on its chemical and biological components, not trained data.

9. How the ground truth for the training set was established:

   • N/A. As there is no training set for an AI model, this question is not applicable.

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First Sign Drug of Abuse MDMA Tests are immunoassay tests. The test can detect MDMA in human urine. The cut-off value is 500 ng/mL.. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign Drug of Abuse EDDP Tests are immunoassay tests. The test can detect EDDP in human urine. The cut-off value is 300 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign Drug of Abuse Nortriptyline Tests are immunoassay tests. The test can detect Nortriptyline in human urine. The cut-off value is 1,000 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. If you want to get a confirmed result, you must use a more specific chemical method. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be used when you get any drug of abuse test result. It should be used particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse MDMA Test, First Sign™ Drug of Abuse EDDP Test and First Sign™ Drug of Abuse Nortriptyline Test are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of MDMA, or EDDP or Nortriptyline in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided document describes the performance characteristics of three drug of abuse tests: First Sign® Drug of Abuse MDMA Test, First Sign® Drug of Abuse EDDP Test, and First Sign® Drug of Abuse Nortriptyline Test. These are qualitative immunoassay tests designed to detect specific drugs in human urine.

Here's an analysis of the acceptance criteria and study details:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria thresholds in terms of specific percentages for accuracy, sensitivity, or specificity. However, the performance is reported through various studies, and the implied acceptance criteria are that the device performs reliably at and around the defined cut-off values, and that lay users can operate the device effectively.

Below is a table summarizing the reported device performance, categorized by drug:

First Sign® Drug of Abuse MDMA Test

First Sign® Drug of Abuse EDDP Test

First Sign® Drug of Abuse Nortriptyline Test

2. Sample Size Used for the Test Set and Data Provenance

• Precision Studies:

  • For each drug (MDMA, EDDP, Nortriptyline) and each format (Cup, Dip Card): 9 concentration levels (from -100% cut-off to +100% cut-off).
  • At each concentration level: 50 tests (2 runs/day for 25 days).
  • Total for precision per drug/format: 9 concentrations * 50 tests/concentration = 450 tests.
  • Total for precision across all 3 drugs and 2 formats: 3 * 2 * 450 = 2700 tests.
  • Data Provenance: "Prepared by spiking drug in negative urine samples." This suggests laboratory-controlled samples, likely from a US lab given the FDA submission. Retrospective, as samples were prepared and then tested.

• Cut-off Verification Studies:

  • For each drug and format: 4 concentration levels ( -50% cut-off, cut-off, +25% cut-off, +50% cut-off).
  • Total of 150 samples "equally distributed" meaning approximately 37-38 samples per concentration level. These were tested using three different lots.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Interference and Specificity Studies:

  • The document implies that these were conducted with spiked samples in drug-free urine, testing against three lots of each device for all formats. No specific sample numbers are given for individual interference compounds or cross-reactants, but the method suggests a systematic laboratory study.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Effect of Urine Specific Gravity and Urine pH:

  • Urine samples with varying specific gravity and pH were spiked with target drugs at 25% below and 25% above cut-off levels. Tested using three lots of each device for all formats. No specific sample number provided, but implies a comprehensive set to cover the specified ranges.
  • Data Provenance: Laboratory-controlled samples, likely from a US lab. Retrospective.

• Comparison Studies (Clinical Samples):

  • For each drug and each format: 80 unaltered clinical samples (40 negative, 40 positive).
  • Total for comparison studies across all 3 drugs and 2 formats: 3 * 2 * 80 = 480 clinical samples.
  • Data Provenance: "Unaltered clinical samples" implies real human urine samples from an unspecified source (likely US-based for FDA submission). The study is retrospective, as samples were collected and then tested.

• Lay-User Study:

  • For each drug: 280 lay persons.
  • Each participant tested one blind-labeled urine sample. There were 7 concentration levels tested (-100%, -75%, -50%, -25%, +25%, +50%, +75% of cut-off).
  • For each concentration and format (Dip Card / Cup): 20 samples.
  • Total samples given to lay users per drug: 7 concentrations * 20 samples/concentration * 2 formats = 280 samples. This matches the 280 lay persons.
  • Data Provenance: Laboratory-prepared urine samples (spiked drug into drug-free pooled urine). This is a prospective simulation of real-world use with prepared samples. The study was performed at "three intended user sites". Given the FDA submission, these are likely US sites.

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, Urine SG/pH Studies:

  • The ground truth (drug concentration) for all these studies was established by GC/MS (Gas Chromatography/Mass Spectrometry). This is a highly accurate and widely accepted reference method for drug quantification in toxicology. The document does not specify a separate "expert" for interpreting GC/MS results, as the instrument provides quantitative values which are then used to prepare samples.

• Comparison Studies (Clinical Samples):

  • The ground truth for the 80 clinical samples per drug/format was established by GC/MS results.
  • The device results were interpreted by three different laboratory assistants. Their qualifications are not explicitly stated beyond "laboratory assistants," but it can be inferred they are trained professionals in a laboratory setting.

• Lay-User Study:

  • The ground truth for the prepared urine samples was established by GC/MS to confirm the spiked drug concentrations.
  • No "experts" were used to establish ground truth for how the lay users interpreted the test, as the study's purpose was to evaluate if lay users could correctly interpret the device results against the known (GC/MS confirmed) concentration.

4. Adjudication Method for the Test Set

• Precision Studies, Cut-off Verification, Interference, Specificity, Urine SG/pH Studies: The ground truth used was quantitative GC/MS results, which serves as a definitive reference standard. There's no indication of an adjudication process among multiple readers for these lab-controlled tests; the output of the device (positive/negative line) was compared directly to the GC/MS confirmed concentration.

• Comparison Studies (Clinical Samples): The document mentions "three different laboratory assistants" running the tests and comparing them to GC/MS results. It does not describe an adjudication method (like 2+1 or 3+1) among these three assistants where they would resolve discrepancies in their readings. Instead, individual discrepancies are noted in the "Discordant Results" tables for each viewer. This suggests independent assessment rather than a consensus-seeking or adjudicated process for the readers.

• Lay-User Study: Each lay user interpreted their own test result individually against the known GC/MS confirmed concentration. No adjudication among lay users was described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a typical MRMC comparative effectiveness study was not explicitly conducted as described for AI vs. human readers.
• The comparison studies did involve multiple readers (three laboratory assistants) reviewing clinical cases, which provides some multi-reader data. However, this was a standalone performance evaluation of the device being read by humans, not a comparison of human performance with vs. without AI assistance. The device itself is an immunoassay, not an AI algorithm providing assistance in interpreting complex images or data.
• Therefore, an "effect size of how much human readers improve with AI vs without AI assistance" is not applicable here.

6. Standalone (Algorithm Only) Performance

• Yes, in essence, the "Analytical Performance" section (Precision, Cut-off, Interference, Specificity) represents the standalone performance of the devices. These studies evaluate the intrinsic performance of the immunoassay devices under controlled laboratory conditions, without human interpretation variability, by comparing the device's qualitative output (presence/absence of lines) against known, quantitatively confirmed drug concentrations.
• The "Comparison Studies" with laboratory assistants and "Lay-user studies" then evaluate the human-in-the-loop performance.

7. Type of Ground Truth Used

• All studies (Analytical, Comparison, Lay-User) consistently used Gas Chromatography/Mass Spectrometry (GC/MS) results as the gold standard ground truth.
• GC/MS is a laboratory-based, highly accurate, and quantitative method for identifying and measuring specific substances in a sample, making it a robust ground truth for drug testing.

8. Sample Size for the Training Set

• Not applicable. These are immunoassay devices (lateral flow tests), not machine learning or AI algorithms that require a "training set." The performance characteristics are derived from intrinsic chemical and physical properties, evaluated through these detailed analytical and clinical studies.

9. How the Ground Truth for the Training Set Was Established

• Not applicable, as no training set was used.

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First Sign® Drug of Abuse Buprenorphine Cup Test
First Sign® Drug of Abuse Buprenorphine Dip Card Test
First Sign™ Drug of Abuse Buprenorphine Tests are immunochromatographic assays for the qualitative determination of Buprenorphine, in human urine at cut-off concentration of 10 ng/mL. The tests are available in a Cup format and a Din Card format.

The tests may yield preliminary positive results even when prescription drug Buprenorphine is ingescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Buprenorphine in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign® Drug of Abuse Butalbital Cup Test
First Sign® Drug of Abuse Butalbital Dip Card Test
First Sign™ Drug of Abuse Butalbital Tests are immunochromatographic assays for the qualitative determination of Butalbital in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drug Butalbital is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for Butalbital in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign® Drug of Abuse Morphine Cup Test
First Sign® Drug of Abuse Morphine Dip Card Test
First Sign™ Drug of Abuse Morphine Tests are immunochromatographic assays for the qualitative determination of Morphine in human urine at cut-off concentration of 300 ng/mL. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse Buprenorphine Test, First Sign™ Drug of Abuse Butalbital Test and First Sign™ Drug of Abuse Morphine Test are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Buprenorphine, or Butalbital or Morphine in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of Dip Cards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

Here's a breakdown of the acceptance criteria and study information for the First Sign® Drug of Abuse Buprenorphine, Butalbital, and Morphine tests, based on the provided text:

Acceptance Criteria and Device Performance for Buprenorphine Test

Acceptance Criteria and Device Performance for Butalbital Test

Acceptance Criteria and Device Performance for Morphine Test

Study Details Proving Device Meets Acceptance Criteria:

1. Sample sizes used for the test set and the data provenance:

   • Precision Studies:

     • For each drug (Buprenorphine, Butalbital, Morphine) and each format (Cup, Dip Card), 3 different lots of devices were tested.
     • Each lot was tested with 9 concentrations (e.g., -100% cut-off to +100% cut-off).
     • At each concentration, tests were performed two runs per day for 25 days, by three different operators.
     • This totals to: 3 lots * 9 concentrations * 2 runs/day * 25 days = 1350 tests per operator * 3 operators = 4050 tests per lot. This figure appears to be incorrect considering the "50-/0+" or "3-/47+" reported results which suggest 50 tests per concentration per lot.
     • Given the "50-/0+" format in the tables, it implies 50 tests per concentration per lot. So, for 9 concentrations and 3 lots, this would be 9 * 50 * 3 = 1350 tests for each format (Dip Card/Cup) within the precision study section.
     • Data Provenance: The samples were prepared by "spiking drug in negative urine samples." These were likely laboratory-prepared samples. "Each drug concentration was confirmed by GC/MS."

   • Cut-off Verification:

     • A total of 150 samples (equally distributed at -50%, -25%, cut-off, +25%, +50% concentrations) were tested.
     • Performed using three different lots of each device by three different operators.

   • Interference & Specificity:

     • Samples were prepared by adding potential interfering substances to drug-free urine and to urine containing target drugs at +/- 25% cut-off levels.
     • These urine samples were tested using three lots of each device for all formats. The number of individual samples is not explicitly stated but implies sufficient testing to cover all listed interfering substances and cross-reactants at specified concentrations.

   • Effect of Urine Specific Gravity & pH:

     • Urine samples with varying specific gravity (1.000 to 1.035) and pH (4 to 9) were spiked with target drugs at +/- 25% cut-off levels.
     • These samples were tested using three lots of each device for all formats. The number of individual samples is not explicitly stated.

   • Method Comparison Studies (Clinical Samples):

     • 80 unaltered clinical samples (40 negative and 40 positive) were run for each drug (Buprenorphine, Butalbital, Morphine) and each format (Cup, Dip Card).
     • Data Provenance: "unaltered clinical samples." The country of origin is not specified but implicitly US as this is an FDA submission. These are retrospective given they are "clinical samples" compared to a reference method from what is implied a clinical laboratory setting.

   • Lay-User Study:

     • 280 lay persons tested the devices for each drug (Buprenorphine, Butalbital, Morphine).
     • Urine samples were prepared at negative, +/-75%, +/-50%, +/-25% of the cutoff by spiking drugs into drug-free pooled urine specimens. 7 concentrations were tested, with 20 samples per concentration.
     • This means 7 concentrations * 20 samples = 140 samples were used per drug/format in the lay-user study.
     • Each participant was provided with 1 blind-labeled sample.
     • Data Provenance: Laboratory-prepared spiked urine samples.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • For the Method Comparison Studies, the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) results. This is an analytical method, not human expert interpretation. Therefore, no human experts were used to establish ground truth for this portion in the traditional sense.
   • For Lay-User studies, the "ground truth" for the samples was the known concentration of the spiked drug, confirmed by GC/MS.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Precision, Cut-off, Interference, Specificity, Specific Gravity/pH studies: It's not explicitly stated that an adjudication method was used between readers/operators. For precision, three operators participated, and results were summarized, but no formal adjudication process between them is described.
   • Method Comparison Studies: Three different laboratory assistants ran the tests, and their results were compared to GC/MS. No adjudication method between the assistants is explicitly mentioned.
   • Lay-User Study: Each lay person tested one blind-labeled sample. No adjudication is applicable here as each person provided a single result for their assigned sample.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No MRMC comparative effectiveness study was mentioned. The studies focus on the performance of the device itself (standalone) and its interpretation by users (lay-user study), which is a single-reader, single-case scenario in the context of the device's output. There is no AI component mentioned in the document, so no improvement due to AI assistance can be reported.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • The "First Sign® Drug of Abuse" tests are described as "immunochromatographic assays" and "lateral flow systems," which means they are physical test strips/cups that display visual results (lines). The performance studies (precision, specificity, interference, etc.) directly reflect the standalone analytical performance of these devices, as their reactivity with known concentrations and substances is measured. The "Method Comparison Studies" with laboratory assistants and the "Lay-user studies" do involve human interpretation of these visual results, but the core analytical reaction is standalone.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The primary ground truth used across all analytical performance studies (precision, cut-off, interference, specificity, specific gravity/pH) and method comparison studies was Gas Chromatography/Mass Spectrometry (GC/MS) results for drug concentrations in urine samples. This is considered a gold standard analytical method.
   • For the lay-user study, the "ground truth" was the known spiked concentration in the urine samples, which itself was confirmed by GC/MS.

7. The sample size for the training set:

   • The document does not describe a computational algorithm or AI model that requires a training set. The devices are immunochromatographic assays. Therefore, the concept of a "training set" in the context of machine learning is not applicable here.

8. How the ground truth for the training set was established:

   • As there is no AI/algorithm and thus no "training set," this question is not applicable.

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First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Methadone, Phencyclidine, and Oxycodone in human urine at cut-off concentrations of 300 ng/mL, 25 ng/mL, and 100 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drugs Methadone and Oxycodone are ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There are no uniformly recognized cutoff concentration levels for Methadone and Oxycodone in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Methadone, Phencyclidine, and Oxycodone in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

The provided text describes the performance characteristics and studies for the "First Sign® Drug of Abuse Cup Test" and "First Sign® Drug of Abuse Dip Card Test" for Methadone, Phencyclidine, and Oxycodone.

The acceptance criteria for each drug are implicitly defined by the reported performance, specifically in the precision, cut-off verification, and comparison studies. For instance, in the precision study, at -100% to -25% of the cut-off, all results were expected to be negative, and at +25% to +100% of the cut-off, all results were expected to be positive, with some allowance for variation at the exact cut-off concentration.

Here's a breakdown of the requested information:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a separate table. However, the performance tables demonstrate the device's adherence to the expected behavior around the cut-off concentrations. The "Precision" section's implied criteria are 100% correct negatives for concentrations below -25% of the cut-off, 100% correct positives for concentrations above +25% of the cut-off, and a high percentage of correct results at +/-25% and at the cut-off values. The "Cut-off" section verifies the stated cut-off values.

Table: Acceptance Criteria (Implied from Precision and Cut-off Studies) and Reported Device Performance

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Precision Study:
  • Sample Size: For each drug and each format (Dip Card/Cup), 8 concentrations were tested across 3 lots, with samples run 2 times per day for 25 days by 3 different operators. This is not a simple count of unique clinical samples. It uses spiked samples. Each individual concentration point (e.g., -100% cut-off) had 50 measurements (2 tests/day * 25 days by each of 3 lots, but the values are given as 50-/0+ or 50+/0- for each lot, suggesting 50 replicates per lot at each concentration).
  • Data Provenance: The samples were "prepared by spiking drug in negative samples." The document does not specify the country of origin, but the testing was conducted "in-house." These are prospective, laboratory-prepared samples.
• Cut-off Verification Study:
  • Sample Size: 150 samples ("equally distributed at concentrations of -50% cut-off; cut-off; +25% cut-off; +50% cut-off"). These were tested using three different lots of each device by three different operators.
  • Data Provenance: Similar to precision study, these were laboratory-prepared samples ("spiked drug in negative samples"). No country of origin is specified.
• Comparison Studies (Clinical Samples):
  • Sample Size: 80 "unaltered clinical samples" for each drug (40 negative and 40 positive). This means 80 samples for Methadone, 80 for Phencyclidine, and 80 for Oxycodone, for both Dip Card and Cup formats (though the tables suggest the same samples were likely used for both formats for a given viewer).
  • Data Provenance: "in-house" studies, using "unaltered clinical samples." The origin of these clinical samples is not specified (e.g., country, retrospective/prospective).
• Lay-user Study:
  • Sample Size: 280 lay persons for Methadone, 280 for Phencyclidine, and 280 for Oxycodone devices. Each participant received 1 blind-labeled sample. The samples themselves were prepared at 7 different concentrations, with 20 samples per concentration. This means a total of 140 samples for each drug (7 concentrations * 20 samples/concentration) were tested by the lay-users.
  • Data Provenance: "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." The study was performed "at three intended user sites." No country of origin is specified. These are prospective, laboratory-prepared samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Precision, Cut-off, and Lay-user Studies (Spiked Samples): The ground truth was established by the precise spiking of drugs into negative urine samples at known concentrations, confirmed by GC/MS (Gas Chromatography/Mass Spectrometry). This is an analytical chemistry method, and implicitly, the expertise lies in the laboratory personnel conducting these precise preparations and GC/MS confirmations. No further expert qualifications are provided.
• Comparison Studies (Clinical Samples): The ground truth was established by GC/MS results for each of the 80 unaltered clinical samples per drug. No details on the number or qualifications of the GC/MS experts are provided, but GC/MS is the "preferred confirmatory method" for drug of abuse tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Precision Study: "All sample aliquots were blind-labeled and randomized by the person who prepared samples and did not take part in the sample testing." Tests were performed by "three different operators." The results are aggregated, but no specific adjudication method among operators is explicitly described. It appears each operator's results were simply recorded.
• Cut-off Verification Study: Tested by "three different operators." Similar to precision study, results are aggregated, no specific adjudication is mentioned.
• Comparison Studies: "three different laboratory assistants" ("Viewer A, B, C") tested the samples. The tables show individual viewer results, followed by a list of "Discordant Results." This implies that there wasn't a formal adjudication method (like 2+1 or 3+1) in place to yield a single "device" result, but rather a comparison of each viewer's interpretation against the GC/MS ground truth.
• Lay-user Study: Each "participant was provided with the package insert, 1 blind labeled sample and a device." The results appear to be individual lay person interpretations compared to the GC/MS ground truth, with no inter-lay user adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study involving AI assistance was not done.
• The studies involved human readers (laboratory assistants, lay-users) interpreting the device results, and these devices are immunochromatographic assays (lateral flow tests), not AI software. Therefore, there is no "AI vs without AI assistance" component to these studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

• No, a standalone algorithm-only performance study was not done. The devices are physical tests interpreted by humans (either trained laboratory personnel or lay-users). They do not involve an algorithm separate from human interpretation.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• For all studies (Precision, Cut-off, Comparison, Lay-user), the ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) of the spiked or clinical urine samples. GC/MS is a highly accurate analytical method considered the gold standard for confirming drug concentrations.

8. The sample size for the training set

• The document implies that these studies (precision, cut-off, comparison, lay-user) represent the validation of the device. It does not mention a separate "training set" in the context of machine learning or algorithm development, as this medical device is an immunoassay, not an AI/ML product. The development process for such a test would involve internal R&D and optimization, but the specific term "training set" as used in AI/ML is not applicable here.

9. How the ground truth for the training set was established

• As a traditional immunoassay device, there is no "training set" in the AI/ML sense. The ground truth for the analytical and clinical performance studies was established using GC/MS of urine samples with known (spiked) or confirmed (clinical) drug concentrations.

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First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Oxazepam , Methamphetamine, and Morphine in human urine at cut-off concentrations of 300 ng/mL, and 2000 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests may yield preliminary positive results even when prescription drug Oxazepam is ingested, at prescribed doses; it is not intended to distinguish between prescription use or abuse of this drug. There is no uniformly recognized cutoff concentration level for oxazepam in urine. The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be exercised with any drug of abuse test result, particularly when the preliminary result is positive.

For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of Oxazepam , Methamphetamine , and Morphine in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

Here's an analysis of the acceptance criteria and study detailed in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in terms of specific quantitative benchmarks (e.g., "sensitivity must be >90%"). Instead, it describes performance characteristics and then presents the results of studies to demonstrate that the device performs acceptably. The implied acceptance criterion for these qualitative drug tests is that they generally agree with GC/MS results, especially at and significantly above/below cut-off values.

Based on the provided performance characteristics, here's a summary:

2. Sample Size and Data Provenance (Test Set)

• Sample Size (Trained Professionals, Method Comparison):
  • For each of the three drugs (Oxazepam, Methamphetamine, Morphine) and each format (Dip Card, Cup), 80 clinical samples were used.
  • Total samples for method comparison: 3 drugs * 2 formats * 80 samples/drug/format = 480 samples.
  • Breakdown of 80 samples: 10 Negative, 10 Low Negative, 20 Near Cutoff Negative, 15 Near Cutoff Positive, 25 High Positive.
• Sample Size (Lay User Study):
  • 280 lay persons for Oxazepam devices.
  • 280 lay persons for Methamphetamine devices.
  • 280 lay persons for Morphine devices.
  • Each lay person tested 1 blind labeled sample and a device.
  • Total samples tested by lay users: Roughly 280 samples/drug * 3 drugs = 840 samples.
• Data Provenance (Method Comparison): "unaltered clinical samples" - implies retrospective collection, origin unknown based on the text.
• Data Provenance (Lay User Study): "Urine samples were prepared... by spiking drugs into drug free-pooled urine specimens." This indicates the samples were synthesized or spiked rather than naturally occurring clinical samples, and then blind-labeled.

3. Number of Experts and Qualifications for Ground Truth (Test Set)

• Number of Experts:
  • Method Comparison (Professional User): "three different laboratory assistants for each format of the device." Total of 6 unique readers (3 for dip card, 3 for cup) if they were distinct, or 3 if the same 3 read both formats (the wording "Different set of operators tested each format" in the precision study suggests distinct operators, but here it states "for each format", which could mean the same set of 3 rotated). The data is presented as Viewer A, B, C for each.
  • Lay User Study: 280 lay persons per drug. Not "experts" in the traditional sense, but the intended users.
• Qualifications of Experts: The "three different laboratory assistants" are not further qualified (e.g., radiologist with 10 years of experience).

4. Adjudication Method (Test Set)

• None specified for the professional user readings. The raw results from each "Viewer" (laboratory assistant) are presented individually, and then compared against the GC/MS result. They are not pooled or adjudicated to form a single "device" result.
• For the Lay User Study: There is no "adjudication" between lay users. Each lay user's individual result is recorded and compared to the GC/MS confirmed concentration.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC comparative effectiveness study was done to measure human reader improvement with AI vs. without AI assistance. This device is a standalone qualitative diagnostic test (immunochromatographic assay), not an AI-assisted interpretation tool for human readers.

6. Standalone Performance (Algorithm Only)

• Yes, a standalone performance was done, but it's not an "algorithm" in the typical AI sense. The device itself (the immunochromatographic assay) is designed to provide a result (positive/negative) based on a chemical reaction, which can then be visually interpreted. The precision studies, cut-off studies, interference, specificity, and specific gravity/pH studies all demonstrate the standalone performance of the device without explicit human interpretation variability considered (though a human reads the test line).
• The "Method Comparison" and "Lay-user study" then introduce the human element (laboratory assistants and lay users, respectively) reading these standalone device results.

7. Type of Ground Truth Used (Test Set)

• Gas Chromatography/Mass Spectrometry (GC/MS) was explicitly used as the preferred confirmatory method for establishing ground truth for both the professional method comparison study and for confirming the concentrations of the spiked samples in the lay user study and precision/cut-off studies.

8. Sample Size for the Training Set

• The document describes performance characteristics and equivalence to a predicate device, but does not specify a separate "training set" for the development of the device itself or for any AI/algorithmic component (as there isn't one). The studies described are performance validation studies.

9. How the Ground Truth for the Training Set was Established

• Not applicable as no "training set" is mentioned in the context of device development. The ground truth for all performance evaluation studies (precision, cut-off, method comparison, lay user) was established using GC/MS.

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First Sign™ Drug of Abuse Tests are immunochromatographic assays for the qualitative determination of Amphetamine (d-amphetamine), Cocaine (Benzoylecgonine), and Marijuana (11-nor-A9-THC-9-COOH ) in human urine at cut-off concentrations of 1000 ng/mL, and 50 ng/mL, respectively. The tests are available in a Cup format and a Dip Card format.

The tests provide only preliminary test results. A more specific alternative chemical method must be used in order to obtain a confirmed analytical result. GC/MS is the preferred confirmatory method. Clinical consideration and professional iudgment should be exercised with any drug of abuse test result, particularly when the preliminary result is possive. For in vitro diagnostic use only. The tests are intended for over-the-counter and for prescription use.

First Sign™ Drug of Abuse Tests are immunochromatographic assays. Each assay test is a lateral flow system for the qualitative detection of cocaine, amphetamine, and marijuana in human urine. The products are single-use in vitro diagnostic devices, which come in the formats of DipCards or Cups. Each test kit contains a Test Device (in one of the two formats), a package insert and a urine cup for sample collection. Each test device is sealed with a desiccant in an aluminum pouch.

This document describes the performance characteristics of the First Sign™ Drug of Abuse Dip Card Test and First Sign™ Drug of Abuse Cup Test for Amphetamine, Cocaine, and Marijuana.

Here's an analysis based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" as a set of predefined thresholds. However, the performance is demonstrated through various studies. The primary measure of performance is the ability of the device to correctly identify positive and negative samples relative to a defined cut-off, as confirmed by GC/MS.

For the precision studies, the acceptance criterion implicitly appears to be 100% agreement for samples significantly below (-50%, -75%, -100% cut-off) and significantly above (+50%, +75%, +100% cut-off) the cut-off. For samples near the cut-off, some discordance is expected.

For the comparison studies (against GC/MS), the performance is presented through the number of correct classifications. For the lay-user study, the performance is given as the "percentage of correct results (%)".

Below is a summary of the reported device performance for samples at the cut-off and at +25% and -25% of the cut-off, as these are the most critical regions for accuracy.

Amphetamine (AMP) - Cut-off: 1000 ng/mL (all values are percentage of samples correctly classified)

Cocaine (COC) - Cut-off: 300 ng/mL

Marijuana (THC) - Cut-off: 50 ng/mL

Note: For the precision and lay-user studies, performance at the exact cut-off received mixed results (some negative, some positive), indicating the inherent variability near the detection limit. For the comparison studies, samples were categorized into "Near Cutoff Negative" (between -50% and cut-off) and "Near Cutoff Positive" (between cut-off and +50%), not specifically at the cut-off. Performance percentages for comparison studies are not directly provided in the text and would require calculation from the tables.

2. Sample Size and Data Provenance for Test Set

• Precision Studies:

  • For each drug (AMP, COC, THC) and each format (Dip Card, Cup), 9 different concentrations were tested: -100%, -75%, -50%, -25%, Cut-off, +25%, +50%, +75%, +100% of the cut-off.
  • Each concentration was tested two runs per day for 25 days, using three different lots of the device. This means for each drug/format/concentration, there were 50 tests per lot, totaling 150 tests per concentration. (e.g., 50-/0+ means 50 negative results, 0 positive results).
  • Total tests for precision: 3 drugs * 2 formats * 9 concentrations * 150 tests/concentration = 8100 tests.
  • Data Provenance: "Samples were prepared by spiking drug in negative samples." "Each drug concentration was confirmed by GC/MS." This suggests prospective, laboratory-controlled data using spiked urine samples. The country of origin is not specified but implied to be the location of the manufacturing company (W.H.P.M., Inc., Irwindale, CA).

• Cut-off Verification Study:

  • A total of 150 samples equally distributed at -50% cut-off; -25% cut-off; cut-off; +25% cut-off; +50% cut-off were tested.
  • This implies 5 concentrations * 30 samples/concentration = 150 samples.
  • Data Provenance: Not explicitly stated but likely lab-prepared spiked samples similar to precision studies.

• Comparison Studies (Method Comparison):

  • 80 clinical samples (40 negative and 40 positive) were used for each drug (AMP, COC, THC) and each format (Cup, Dip Card).
  • Total samples for comparison studies: 3 drugs * 2 formats * 80 samples/drug/format = 480 clinical samples.
  • Data Provenance: "Un-altered clinical samples." This suggests retrospective or prospectively collected clinical samples, but without further detail on how they were collected. The country of origin is not specified but implied to be the location of the study (in-house).

• Lay-user Study:

  • 280 lay persons tested the Amphetamine devices.
  • 280 lay persons tested the Cocaine devices.
  • 280 lay persons tested the Marijuana devices.
  • Each participant was given 1 blind labeled sample. These samples were prepared at 7 different concentrations: negative, +/-25%, +/-50%, +/-75%, +/-100% of the cut-off. This suggests that for each drug, 7 concentrations * 20 samples/concentration = 140 samples were prepared. Given 280 lay persons, it implies each person tested one sample, and samples were duplicated for the number of participants.
  • Data Provenance: "Urine samples were prepared at the following concentrations; negative, +/-75%, +/-25% of the cutoff by spiking drugs into drug free-pooled urine specimens. The concentrations of the samples were confirmed by GC/MS." This is prospective, laboratory-prepared spiked urine samples, presented as blind-labeled to the lay users. Country of origin not specified, but study performed "at three intended user sites".

3. Number of Experts and Qualifications for Ground Truth

• Precision, Cut-off, Interference, Specificity, and Effect of Urine Specific Gravity and pH Studies: The ground truth was established by GC/MS (Gas Chromatography/Mass Spectrometry). GC/MS is a laboratory analytical method and does not involve human experts in establishing the "ground truth" concentration of the drugs. These studies were performed by laboratory personnel.
• Comparison Studies (Method Comparison): The ground truth for the 480 clinical samples was also established by GC/MS. These were "compared to GC/MS results," meaning GC/MS served as the reference method (ground truth). The tests themselves were run by "three different laboratory assistants." Their qualifications beyond being "laboratory assistants" are not specified.
• Lay-user Study: The ground truth for the spiked samples was established by GC/MS.

4. Adjudication Method for the Test Set

• Precision, Cut-off, Interference, Specificity, and Effect of Urine Specific Gravity and pH Studies: The data presented are direct results from the devices (negative/positive) for specific concentrations as confirmed by GC/MS. There is no mention of an adjudication method as the results are quantitative and compared against a defined cut-off.
• Comparison Studies: The tests were run by "three different laboratory assistants" (Viewers A, B, C). Each viewer independently provided results (Positive/Negative). The tables present results for each viewer separately. There is no explicit adjudication method (like rule-based consensus, e.g., 2+1, 3+1). Discordant results are noted for individual viewers without a resolution process described for a single, unified "device result."
• Lay-user Study: Each lay person provided individual results. The data aggregates these individual results. There is no adjudication method described for resolving differences between lay users.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study

No. The document presents neither an MRMC study design nor a comparative effectiveness study evaluating human readers with and without AI assistance. The studies involve (1) laboratory personnel interpreting the device, and (2) lay users interpreting the device. There is no AI component mentioned.

6. Standalone (Algorithm Only) Performance

Yes, in essence, the "Analytical Performance" section (Precision, Interference, Specificity, Cut-off, Stability, Effect of Urine Specific Gravity and pH) and the "Comparison Studies" with laboratory assistants can be considered standalone performance of the device without explicit human-in-the-loop assistance influencing the device's detection capabilities. The human element here is about reading and interpreting the visual line on the test, not assisting an underlying algorithm. The device itself is an immunochromatographic assay, which is a chemical/biological-based test, not an AI algorithm.

7. Type of Ground Truth Used

The type of ground truth used across all reported studies (Precision, Cut-off, Comparison, Lay-user) is GC/MS (Gas Chromatography/Mass Spectrometry). This is a laboratory-based, highly accurate chemical method considered the gold standard for drug confirmation in urine. All samples (spiked or clinical) had their drug concentrations confirmed using GC/MS.

8. Sample Size for the Training Set

This document describes a medical device which is an immunochromatographic assay, not an AI/ML-based device. Therefore, there is no "training set" in the context of machine learning algorithms. The performance is based on the chemical reactions and design of the lateral flow assay.

9. How the Ground Truth for the Training Set Was Established

As there is no "training set" for an AI/ML algorithm mentioned, this question is not applicable. The device operates based on antigen-antibody immunochemistry, not learned patterns from data.

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The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine. The tests may be run singly of in combinations of up to six drugs simultaneously. The cut-off concentrations and specific analytes tested for are listed below.

This assay provides only a preliminary test result. A more specific alternate chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method. Clinical and professional judgment must be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

For Professional Use Only.

The First Sign Drug of Abuse Tests are rapid, chromatographic immunoassays for the qualitative detection of drugs-of-abuse in human urine.

Here's an analysis of the provided text, outlining the acceptance criteria and study details for the First Sign™ Drug of Abuse Urine Screening Tests:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this type of device (qualitative drug screening) are typically based on strong agreement with a definitive, confirmatory method. While explicit percentage targets (e.g., "must achieve >95% positive agreement") aren't directly stated as "acceptance criteria" in the submission, the performance characteristics provided demonstrate successful achievement of high agreement rates relative to the gold standard.

Note on Acceptance Criteria: For a 510(k) submission, the "acceptance criteria" are implicitly met when the sponsor demonstrates substantial equivalence to predicate devices, which typically includes performance data that is comparable or superior to the predicate. High positive, negative, and overall agreement rates with a confirmatory method are standard for establishing performance for qualitative drug tests.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: The document does not explicitly state the total sample size (number of urine samples/patients) used for the test set for each drug. It provides percentages (e.g., 97.5% positive agreement), which are derived from a sample, but the raw numbers of positive and negative samples are not given.
• Data Provenance: The document does not specify the country of origin of the data. It mentions that WHPM, Inc. is in El Monte, CA, and WHPM, Bioresearch and Technology Co. Ltd. is in Beijing, China, and that product would be manufactured in both locations. However, where the clinical samples were collected is not stated. The study described is a "clinical evaluation," implying it was prospective or at least involved testing on clinical samples (as opposed to entirely in-silico or simulated data).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable. The ground truth was established by laboratory methods (GC/MS or HPLC), not human experts interpreting the results of the rapid test.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High-Performance Liquid Chromatography (HPLC), which are objective analytical methods, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a rapid, chromatographic immunoassay, not an imaging or interpretive AI device where human readers are involved in the primary result generation. The test provides a direct positive/negative result, not an interpretation of complex data by a human.
• Effect Size of Human Readers with/without AI: Not applicable, as there's no AI component or human interpretation in the workflow described.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Yes, the described performance results are for the device (the immunoassay) operating in a standalone capacity. The comparison is between the immunoassay result and the confirmatory laboratory method. There is no human interpretation or intervention in determining the First Sign test result itself (beyond reading the visible lines, which is standard for such tests).

7. The Type of Ground Truth Used

• Ground Truth Type: The ground truth was established using confirmatory analytical laboratory methods:
  • Gas Chromatography/Mass Spectrometry (GC/MS)
  • High-Performance Liquid Chromatography (HPLC)
    These are considered the gold standard for drug detection and quantification in urine.

8. The Sample Size for the Training Set

• Training Set Sample Size: The document does not mention a training set. This is typical for traditional immunoassay devices based on chemical reactions rather than machine learning algorithms. Immunoassays are "trained" during their development and optimization phases in the lab, but there isn't a distinct "training set" of patient data in the same way there would be for an AI algorithm.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable, as there is no specific "training set" of patient data in the context of an immunoassay. The inherent "ground truth" for developing such a test is the known presence/absence and concentration of analytes in controlled laboratory samples used during R&D.

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The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a test for the qualitative determination of human chorionic gonadotropin (hCG) in urine or serum to aid in the early detection of pregnancy. For Laboratory Professional Use Only.

The WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test is a lateral flow immunoassay intended for the detection of human Chorionic Gonadotropin (hCG) in urine or serum.

Here's a breakdown of the acceptance criteria and study information for the WH Accu Test™ One-Step Urine/Serum Combo Pregnancy Test, based on the provided text:

Acceptance Criteria and Device Performance

Note: The acceptance criterion is inherently defined by the reported device performance in this summary – the goal was 100% agreement with the predicate device, and the device achieved it.

Study Details

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated. The document mentions "A method comparison study" and "100% agreement was observed," but does not specify the number of samples (urine or serum) used in this comparison.
• Data Provenance: Not explicitly stated. The document implies an internal study comparing the WH Accu Test™ to a predicate device, but does not specify the country of origin of the data or whether it was retrospective or prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Number of experts: Not explicitly stated.
• Qualifications of experts: The testing was "done by a person who routinely performs pregnancy tests." Specific qualifications (e.g., years of experience, specific role) are not provided beyond this general statement.

4. Adjudication method for the test set:

• Not applicable/Not explicitly stated. The study involved a direct comparison to a predicate device rather than human adjudication of a novel test result against an existing gold standard.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a point-of-care, in-vitro diagnostic device, not an AI-assisted diagnostic tool for imaging or interpretation that would typically involve MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• This device is inherently a "standalone" test in the sense that the test itself generates the result (color band). The "person who routinely performs pregnancy tests" is likely involved in correctly performing the test and visually interpreting the color bands as per the instructions, rather than providing an independent diagnostic opinion that the device then supports or contradicts. Therefore, no separate "algorithm only" study distinct from the described method comparison was performed or is relevant to this type of device.

7. The type of ground truth used:

• The ground truth was established by comparison to a predicate device: the Acon Laboratories hCG One Step Pregnancy Test (Urine/Serum) [510(k) number: K993065]. The predicate device's results were considered the "truth" against which the new device's performance was measured.

8. The sample size for the training set:

• Not applicable/Not stated. This type of immunoassay device does not typically involve a "training set" in the context of machine learning. The term "training set" usually refers to data used to train an algorithm. For this device, performance is based on its chemical and biological reactions, not a trained algorithm.

9. How the ground truth for the training set was established:

• Not applicable. As noted above, there is no "training set" for this type of device.

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