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The Healstone Accurate ™ Drug of Abuse Urine Test Cup is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (CCMS) is the preferred method confirmation test. For in vitro diagnostic use only.

The Healstone Accurate ™ Drug of Abuse Urine Test Cup Rx is a rapid qualitative immunoassay. The device provides preliminary results for the detection of potential abuse of one or more drugs. This is not a screening device to monitor prescription medication. This drug test cup may contain any combination of the drug tests listed in the table above. This drug tests cup provides only a preliminary result. An alternative laboratory test must be used to confirm the results provided by this drug test. Gas chromatography/mass spectrometry (GC/MS) is the preferred method confirmation test. It is intended for prescription use. For in vitro diagnostic use only.

The Healstone Accurate™ Drug of Abuse Urine Test Cup and Healstone Accurate™ Drug of Abuse Urine Test Cup Rx are rapid, single-use in vitro diagnostic devices. Each test kit contains a test device in one pouch. One pouch contains a test Accurate™ Cup and two desiccants, and a package insert. The Healstone Accurate™ Drug of Abuse Urine Test Cup is intended for over-the-counter use and the Healstone Accurate™ Drug of Abuse Urine Test Cup Rx is intended for prescription use.

The provided text describes the performance characteristics of the "Healstone Accurate™ Drug of Abuse Urine Test Cup" and "Healstone Accurate™ Drug of Abuse Urine Test Cup Rx", but does not specify explicit acceptance criteria in the form of numerical thresholds for sensitivity, specificity, accuracy, or other performance metrics. The tables presented show the reported device performance across various drug tests at different concentrations relative to the cutoff level.

Here's an attempt to extract the information requested, based on what is available in the document:

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, no explicit acceptance criteria are stated in the document. However, the reported performance in both the precision studies and lay-user studies consistently shows a high level of agreement with expected outcomes at concentrations well below and well above the cutoff. At the cutoff concentration, the device exhibits approximately 50% positive and 50% negative results, which is a typical characteristic for qualitative immunoassays designed to detect substances at a specific threshold.

For the precision studies, for concentrations at -100%, -75%, -50% cut off and +50%, +75%, +100% cut off, the results were almost always 100% negative and 100% positive, respectively. For concentrations at -25% cut off, a small number of false positives (1-3 out of 50) were observed across different lots and drugs. For concentrations at +25% cut off, a small number of false negatives (1-3 out of 50) were observed. This indicates that the device has a narrow window around the cutoff where results can be variable, which is expected for such tests.

For the lay-user studies, the agreement percentages for concentrations clearly below (-100%, -75%, -50% cutoff) and clearly above (+50%, +75% cutoff) the cutoff are all 100%. At -25% cutoff, agreement is generally high (85-95% negative). At +25% cutoff, agreement is also high (85-95% positive).

Without explicit acceptance criteria, it's impossible to state whether these results "meet" them. However, they demonstrate consistent performance around the designed cutoff levels.

2. Sample Size and Data Provenance

• Precision Test Set Sample Size: For each drug and each concentration level, 50 tests were performed (2 runs per day for 25 days). This was done for three different lots of test cups. So, for each drug and each concentration, the total number of tests across three lots is 50 * 3 = 150.

• Comparison Studies (Professional Operator) Test Set Sample Size: For each drug, 80 unaltered urine samples were used (40 negative and 40 positive). This was tested by three operators.

• Lay-user Study Test Set Sample Size:

  • Configuration 1 (AMP 1000, MET 1000, MOP 300, COC 300): 140 participants (81 males, 59 females). Each participant tested one blind-labeled test solution. Given that there were 7 concentration levels tested per drug in the table, and 14 drugs are listed for configuration 1, this would imply (20 samples per concentration level, 7 concentration levels, for 14 drugs means) a total of 14 * 7 * 20 = 1960 samples for Configuration 1.
  • Configuration 2 (AMP 500, MET 500, OPI 2000, COC 150): 140 participants (90 males, 50 females). Similar breakdown of sample numbers as Configuration 1.
  • Total participants across both configurations = 280. Total samples tested would be approximately 1960 samples per configuration, totaling around 3920 samples.

• Data Provenance: The document does not specify the country of origin for the data. The studies appear to be prospective as samples were prepared at specific concentrations and then blinded for testing.

3. Number of Experts and Qualifications for Ground Truth

• Comparison Studies (Professional Operator): The ground truth for the comparison studies was established using LC/MS or GC/MS results. These are laboratory-based, highly accurate analytical methods, widely considered the "gold standard" for drug concentration determination. The document does not specify the number of experts (e.g., lab technicians, chemists) that performed or interpreted the LC/MS/GC/MS results, nor their specific qualifications.
• Lay-user Study: The ground truth for the lay-user study was also based on the known concentrations established by LC/MS.

4. Adjudication Method for the Test Set

• Precision Studies: Not applicable. The results are reported directly (number of negative/positive results for the given concentration).
• Comparison Studies (Professional Operator): The results from the test device (Healstone Accurate™) were compared directly against the LC/MS or GC/MS results. Discordant results are noted for each drug and operator. This is a direct comparison rather than an adjudication among human readers.
• Lay-user Study: The lay users read the device results, and these were compared to the known concentrations (ground truth from LC/MS). The document does not describe any adjudication process for lay-user interpretations if they differed from a pre-determined "correct" visual interpretation.

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

• No MRMC comparative effectiveness study was done regarding human readers improving with AI vs without AI assistance. This device is a rapid qualitative immunoassay (a test strip/cup that shows lines), not an AI-powered diagnostic tool requiring human interpretation of AI-generated insights. The "lay-user study" involved human readers (lay individuals) interpreting the device directly, without AI assistance.

6. Standalone (Algorithm Only) Performance Study

• This device is a physical immunoassay test cup, not an algorithm. Therefore, a standalone algorithm-only performance study is not applicable. The performance described is the standalone performance of the physical device.

7. Type of Ground Truth Used

• Precision, Comparison, and Lay-user Studies: The ground truth was established by known concentrations of spiked drugs in urine samples, confirmed by LC/MS or GC/MS (laboratory-based analytical methods). LC/MS and GC/MS are considered definitive methods for identifying and quantifying substances.

8. Sample Size for the Training Set

• This information is not provided in the document. The document describes performance evaluation studies but does not detail the development or training of the immunoassay. Immunoassays are not "trained" in the same way machine learning algorithms are; their performance is inherent to their chemical and biological design.

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

• As mentioned above, information on a "training set" and its ground truth is not provided in this document as it pertains to the development of an immunoassay, not an AI/ML model.

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The hCG One Step Pregnancy Test is an in vitro diagnostic test for the qualitative determination of human chorionic gonadotropin hormone in human urine samples. It is used as an aid in early detection of pregnancy, in some cases as early as five (5) days before the expected period, i.e., as early as six (6) days before the day of the missed period.

The hCG One Step Pregnancy Test is a lateral flow sandwich immunochromatographic assay for the qualitative determination of human chorionic gonadotropin (hCG) in human urine samples.

This report describes the acceptance criteria and the study that proves the device, the hCG One Step Pregnancy Test, meets those criteria.

Note: The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed clinical study report typically associated with AI/ML-based devices. Therefore, some of the requested information, particularly regarding ground truth establishment by experts, adjudication, and MRMC studies, is not explicitly detailed as this device is a qualitative lateral flow immunoassay, not an AI-assisted diagnostic.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are demonstrated through analytical performance studies (Limit of Detection, Precision/Reproducibility, Analytical Specificity) and a comparison study to a legally marketed predicate device.

2. Sample Sizes and Data Provenance

• Test Set Sample Size:
  • Limit of Detection: The panel was created by spiking 30 negative urine samples with hCG. The number of individual test runs was significantly higher, as 3 lots of the device were tested by 3 lab technicians on different days, with randomized, blind-coded panel members. The specific total count of test runs is not provided but is a multiple of 30.
  • Precision/Reproducibility: Twenty replicates of each spiked urine sample (concentrations 0, 5, 7.5, 8.75, 10, 12.5, and 25 mIU/mL) were tested in one day for repeatability. For intermediate precision, 450 replicates per urine sample concentration were tested (10 replicates per operator x 3 operators x 3 lots x 5 nonconsecutive days).
  • Analytical Specificity (Interfering Substances): Five devices were used for testing each interfering substance.
  • Method Comparison: A total of 158 urine samples from 158 subjects.
• Data Provenance:
  • The document does not explicitly state the country of origin for the clinical urine samples.
  • The studies appear to be prospective as per standard FDA premarket notification requirements for device testing. The "urine samples were collected at various times of day in a random fashion" and "masked with a code and randomized by individuals who were not conducting the test," suggesting a structured study design.

3. Number of Experts and Qualifications for Ground Truth

• This information is not explicitly detailed in the document.
• For this type of qualitative immunoassay (pregnancy test), the "ground truth" for the test set is established by the presence or absence of hCG in the urine samples at specified concentrations, verified through the spiking process using traceable hCG standards (5th WHO international Standard) and comparison to a predicate device.
• The interpretation of the device results during testing was performed by "lab technicians" for analytical studies and "professional users" for the comparison study. Their specific qualifications (e.g., years of experience, specific medical background) are not provided, but these roles imply trained personnel capable of accurately performing and interpreting the test. No expert radiologists or similar specialists are required for this device type.

4. Adjudication Method for the Test Set

• Not applicable/Not explicitly stated in the context of expert adjudication.
• For the analytical studies (LOD, Precision), the ground truth is based on the known concentration of hCG in the spiked samples. The device's performance is then measured against this known concentration.
• For the method comparison study, the comparison is made against the results of the legally marketed predicate device. Discrepancies (if any, though 100% concordance was reported) would likely prompt re-evaluation of the sample or test, rather than a formal expert adjudication process as seen in imaging studies. The samples were "masked with a code and randomized by individuals who were not conducting the test," which helps prevent bias in interpretation.

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

• No, an MRMC comparative effectiveness study was not performed. This type of study is typically associated with AI/ML-based diagnostic imaging devices where human readers interpret medical images with and without AI assistance.
• The hCG One Step Pregnancy Test is a qualitative immunoassay, where the result is visually interpreted (presence/absence of a line). The "performance" is about whether the line appears correctly for a given hCG concentration, not about optimizing human interpretation of complex data.
• While multiple operators (lab technicians, professional users) were involved in testing to demonstrate reproducibility and comparability, this is distinct from an MRMC study assessing AI-assisted human reader improvement.

6. Standalone Performance (Algorithm Only)

• Yes, in essence, the device's performance is standalone.
• The hCG One Step Pregnancy Test is a non-AI, non-software-based diagnostic device. Its performance (e.g., sensitivity, specificity, limit of detection) is inherent to its physical and chemical properties and is evaluated directly through the analytical and comparison studies.
• There is no "algorithm only" component separate from the physical test strip and its reagents. The results are based on the immunochromatographic reaction itself.

7. Type of Ground Truth Used

• Analytical Ground Truth (for LOD, Precision, Analytical Specificity): Based on known concentrations of hCG in spiked urine samples, traceable to the 5th WHO international Standard. This is a highly controlled and quantitative ground truth.
• Comparative Ground Truth (for Method Comparison): The results from a legally marketed predicate device (First Response Early Result Pregnancy Test) using the same clinical urine samples. This establishes equivalence to an accepted standard.

8. Sample Size for the Training Set

• Not applicable/Not provided. This device is not an AI/ML device that requires a distinct "training set." Its chemical and biological components are designed and manufactured, not "trained" on data. The studies described are for validation and verification of the finished product's performance.

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

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

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Accurate Multi Panel Drug Urine Test Cup tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine at the cutoff concentrations of:

level /mL /mL /mL /mL z/mL g/mL g/mL /mL g/mL or 2000 ng/mL g/mL g/mL g/mL g/mL g/mL 50 ng/mL

Accurate Multi Panel Drug Urine Test Cup offers any combinations from 2 to 15 drugs of abuse tests but only one cutoff concentration under same drug condition will be included per device. It is for in vitro diagnostic use only.

The tests may yield positive results for the prescription drugs Buprenorphine, Nortriptyline, Oxazepam, Secobarbital, Propoxyphene, and Oxycodone when 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 applied to any drug of abuse test result, particularly in evaluating a preliminary positive result.

The tests provide only preliminary results. To obtain a confirmed analytical result, a more specific alternate chemical method must be used. GC/MS or LC/MS is the recommended confirmatory method.

Accurate® Multi Panel Drug Urine Test Cup are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Buprenorphine, Secobarbital, Oxazepam, Cocaine, 2ethylidene-1,5-dimethyl-3,3-diphenylpyrrolidine, Methamphetamine, Methylenedioxymethamphetamine, Morphine, Methadone, Oxycodone, Phencyclidine, Propoxyphene, Nortriptyline and Marijuana in human urine. Each Accurate® Multi Panel Drug Urine Test Cup device consists of a test cup and a package insert. Each test cup is sealed with desiccant in an aluminum pouch.

This document describes the performance of the "Accurate Multi Panel Drug Urine Test Cup" for detecting various drugs in human urine.

Here's an analysis based on your request:

Acceptance Criteria and Device Performance

The acceptance criteria are implicitly defined by the results of the "Precision" and "Comparison Studies" sections, demonstrating the device's ability to accurately detect drugs at, above, and below specified cutoff concentrations. The core acceptance criterion for qualitative drug tests like this is often high agreement with a confirmed analytical method (LC/MS or GC/MS) and consistent performance around the cutoff.

Here's a table summarizing the reported device performance, based on the precision study results:

Table of Acceptance Criteria (Implicit) and Reported Device Performance (Precision Study: % Agreement for each concentration across 3 lots where 50 positive and 50 negative results would yield 100%)

The precision studies were performed across three different lots of the device. For each drug, the number of positive (+) and negative (-) results are reported out of 50 tests per concentration per lot.
For ease of understanding the acceptance, I interpret the "0-/50+" and "50-/0+" outcomes as 100% agreement for concentrations far from the cutoff (i.e., always negative for significantly below cutoff, and always positive for significantly above cutoff). The critical region is around the cutoff where some variability is expected and defined by the number of discordant results (mix of positive and negative).

The data consistently shows:

• 100% agreement (50-/0+ or 0-/50+) for samples significantly below or above the cutoff (e.g., -50% to -100% cutoff, and +50% to +100% cutoff).
• High agreement (e.g., 47-/3+ or 1-/49+) for samples at -25% and +25% of the cutoff, indicating good performance proximal to the cutoff.
• A 'mixed' result (e.g., 26-/24+ or 22-/28+) at the exact cutoff concentration. This is expected for qualitative tests designed to distinguish around a specified threshold.

Study Details:

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

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

   • Precision Study (Test Set): For each of the 15 drugs, studies were carried out at 9 different concentrations relative to the cutoff (-100%, -75%, -50%, -25%, Cutoff, +25%, +50%, +75%, +100%). For each concentration, tests were performed two runs per day for 25 days across three different lots of the device. This equates to 50 tests per concentration per lot, meaning 150 tests per concentration across all lots per drug. Given 9 concentrations and 15 drugs, the total number of qualitative tests performed in the precision study is 15 drugs * 9 concentrations * 50 tests/concentration/lot * 3 lots = 20,250 individual qualitative test results. The data provenance is not explicitly stated beyond "performed in-house", but implies controlled laboratory conditions. It is retrospective in the sense that the samples were prepared and then tested.
   • Comparison Studies (Test Set): For each drug, 80 unaltered urine samples (40 negative and 40 positive) were "blind labeled" and compared to LC/MS or GC/MS results. This means 80 test samples were used for performance evaluation against ground truth for each drug. As there are 15 drugs, a total of 15 drugs * 80 samples/drug = 1200 samples were analyzed in the comparison study. The provenance for these samples is "unaltered urine samples," implying they were clinical samples, but specific country of origin or whether they were prospectively or retrospectively collected is not mentioned. Given the context of a 510(k) summary, it's typically retrospective analysis of banked samples.
   • Lay-User Study:
     • Configuration 1 (MOP 300): 184 males and 126 females participated. Urine samples were prepared at 8 concentrations (-100%, +/-75%, +/-25% of the cutoff). Each participant received 1 blind-labeled sample. This means 310 participants (samples) were tested for each characteristic (e.g., Cocaine detection). Given that there are multiple drugs in each configuration, and multiple concentrations per drug, the total number of tests in this section is substantial. For Methamphetamine, for example, there are 8 concentrations, implying 8 x 20 = 160 participants were given samples at specific concentrations, with 170 samples being at -50% cutoff for several drugs (potentially pooled data). It's more likely that 310 total participants each tested one device, which covers multiple drugs simultaneously in one cup. The tables presented show results for each drug at various cutoff percentages, with "Number of samples" referring to the number of individual urine samples prepared at that concentration for a given drug. For instance, for Methamphetamine, 20 samples were prepared at -100% cutoff, 20 at -75%cutoff, etc. The "170" in the "-50% Cutoff" row for several drugs is peculiar – it might indicate cumulative samples for those drugs at that specific concentration across the entire study, or a misprint.
     • Configuration 2 (MOP 2000 (OPI)): 178 males and 132 females participated, similar setup.
     • Data provenance for lay-user study is not stated geographically, but it's a simulated environment with prepared urine samples, likely an in-house study.

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

   • For the Precision Study and Comparison Studies, the ground truth was established by "LC/MS or GC/MS results." These are considered highly accurate analytical methods and are the gold standard for confirming drug concentrations in urine. No human experts are explicitly mentioned for establishing ground truth for these analytical methods themselves, as they are instrumental measurements.
   • For the Lay-User Study: The concentrations were confirmed by LC/MS. Again, LC/MS served as the ground truth.

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

   • For the Precision Study: No adjudication method is described; the quantitative LC/MS results serve as the definitive reference. The qualitative results (positive/negative) from the device are simply compared directly.
   • For the Comparison Studies: No adjudication process is explicitly mentioned for the comparison of device results against LC/MS or GC/MS. The LC/MS or GC/MS is the definitive reference against which the device's reading is compared. Discordant results are simply listed.
   • For the Lay-User Study: The "Lay person results" are the outcome of the user's interpretation of the device. These are then compared to the LC/MS confirmed concentration. No adjudication of lay-user interpretation is described.

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 MRMC or AI assistance study was conducted or is applicable here. This device is a rapid, lateral flow immunochromatographic assay, which is a standalone point-of-care test, not an AI-assisted diagnostic tool for Human Readers. Performance is assessed on the device's output itself, or the user's interpretation of that output in the lay-user study.

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

   • Yes, the Precision Study and the Comparison Studies represent "standalone" performance in a laboratory setting, where the device's output (presence/absence of a line) is objectively recorded and compared against the LC/MS/GC/MS ground truth. While human technicians operate the device and record results, the interpretation standard is purely objective based on the chemical reaction. The "discordant results" tables for the comparison studies elaborate on the instances where the device's qualitative result did not match the LC/MS/GC/MS quantitative ground truth.

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

   • The primary ground truth used for all studies (Precision, Comparison, Lay-User) is quantitative analytical results from Liquid Chromatography-Mass Spectrometry (LC/MS) or Gas Chromatography-Mass Spectrometry (GC/MS). These are highly accurate laboratory methods for identifying and quantifying substances in a sample, considered the gold standard for drug testing.

8. The sample size for the training set:

   • This document describes a premarket notification (510(k)) for a medical device that operates based on a well-established biochemical principle (immunochromatography). It is not an AI/ML device that requires a "training set" in the computational sense. The device itself is "trained" during its manufacturing and quality control processes to consistently react at specific cutoff concentrations. The studies described are validation studies to prove the device's performance, not to train it.

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

   • As this is not an AI/ML device, there isn't a "training set" in that context. The device's "training" refers to its design and manufacturing to react precisely to given concentrations, with the LC/MS/GC/MS as the analytical reference used during development and quality control to ensure target specificity and sensitivity.

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