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The INSTANT-VIEW plus Multi-Drug of Abuse Urine Test - Simple Cup (OTC Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone. These assays may yield positive results when barbiturates, benzodiazepines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The INSTANT-VIEW plus Multi-Drug Urine Test - Simple Cup (Prescription Use) device is a rapid, qualitative immunoassay device for the detection of one or more drugs or metabolites at the designated cutoff concentrations in human urine. The device can detect up to 13 drugs or their metabolites: Amphetamines, Barbiturates, Buprenorphine, Benzodiazepines, Cocaine, Methamphetamine, Methadone, Phencyclidine, Tricyclic Antidepressants, Cannabinoids, MDMA, Morphine, Oxycodone. These assays may yield positive results when barbiturates, benzodiazenines, or tricyclic antidepressants are ingested at or above therapeutic doses. There are no uniformly recognized cutoff levels for barbiturates, benzodiazepines, or tricyclic antidepressants in urine. The assays are not intended to distinguish between prescription use or abuse of these drugs. This device provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

These devices are one-step lateral flow chromatographic immunoassays consisting of any combination of one (1) to thirteen (13) individual test strip(s). Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document describes two types of performance studies: a "precision" study (analytical performance) and a "lay user study" (user performance for OTC use). The acceptance criteria for the precision study appear to be implicit in the results, suggesting that all negative samples below a certain threshold should be negative, and all positive samples above a certain threshold should be positive. For the lay user study, the acceptance criteria are for the interpretation of results by the lay users, implicitly aiming for high agreement with the expected result.

Analytical Performance (Precision Study - Example for Amphetamines)

Lay User Study Performance (Example for Amphetamines)

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

• Analytical/Precision Study Test Set:

  • For each of the 13 analytes, there were 9 different concentration levels tested.
  • For each concentration level, 50 samples were tested per Lot (Neg/Pos).
  • There were 3 Lots, for a total of 150 tests per concentration level per analyte.
  • Total tests per analyte: 9 concentrations * 50 samples/conc/lot * 3 lots = 1350 tests.
  • Total tests across all 13 analytes: 1350 tests/analyte * 13 analytes = 17,550 tests.
  • Data Provenance: Not explicitly stated, but typically these types of precision studies are conducted in a controlled laboratory setting (e.g., by the manufacturer). It is a retrospective analysis of device performance under controlled conditions.

• Lay User Study Test Set:

  • For each analyte, various concentrations at 0%, 75%, 125%, and 150% of the cutoff were tested.
  • The number of samples varied per concentration level per analyte. For example, for Amphetamines, there were 350 samples at 0%, 10 at 75%, 10 at 125%, and 30 at 150%. This totals 400 samples for Amphetamines.
  • Since there were 13 analytes, this would suggest a very large number of total tests if each participant tested all analytes. However, the text states "each participant was provided one (1) package insert, one (1) blind labeled test solution, and one (1) test device. Test solutions were randomly picked for participants, one for each." This implies each participant (total 400) tested one specific drug concentration. Therefore, the overall sample size for the lay user study is 400 participants/tests.
  • Data Provenance: The study was conducted with 400 human participants with "diverse educational backgrounds and ranged in age from 18 to >60." This is prospective data collection with human subjects. The country of origin is not explicitly stated, but given it's an FDA submission, it's typically in the US or in a country following similar regulatory standards.

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

• Analytical/Precision Study: The ground truth for the test concentrations (e.g., 0 ng/mL, 250 ng/mL, cutoff, etc.) is established by laboratory standards and precise dilution methods, not by human experts. The concentrations were precisely prepared.
• Lay User Study: Similar to the analytical study, the ground truth for these samples was based on the known, prepared concentrations of the drug within the test solutions. No human experts were used to establish the ground truth; it was based on the controlled spiking of urine samples.

4. Adjudication Method for the Test Set

• Analytical/Precision Study: No adjudication method involving multiple readers is mentioned. The results were recorded as Neg/Pos based on the device's output and presumably read by the operators performing the tests.
• Lay User Study: No formal adjudication method is mentioned. Each participant performed one test and reported their result. The study assessed how well the individual lay users interpreted the result, rather than having multiple readers interpret the same result for adjudication.

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

• No MRMC comparative effectiveness study was done. This device is a rapid, qualitative immunoassay for drug detection, and the studies performed focus on its analytical performance and lay user interpretability, not on reader improvement with AI assistance. The device itself is not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• This device is not an AI algorithm. It is a chemical immunoassay device. The results are visually read by a human. Therefore, a "standalone" algorithmic performance study without human-in-the-loop is not applicable in the context of AI. However, the "precision study" can be considered a standalone performance assessment of the device's chemical reactions, irrespective of user interpretation (though a human still reads the lines).

7. Type of Ground Truth Used

• Analytical/Precision Study: The ground truth was based on known, precisely prepared drug concentrations in the urine matrix. This is a form of "spiked" samples, where the true concentration is known by the experimenters.
• Lay User Study: The ground truth was also based on known, precisely prepared drug concentrations in the test solutions given to participants.

8. Sample Size for the Training Set

• This device is not an AI/ML algorithm that requires a training set. It is a chemical immunoassay. Therefore, the concept of a "training set" is not applicable.

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

• Not applicable, as there is no training set for this type of device.

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The Instant-view-plus™ Immunochemical Fecal Occult Blood Test is a qualitative immunoassay for detection of Fecal Occult Blood. It is intended for professional and over the counter use.

This device is a Driven Flow™ chromatographic immunoassay consisting of a test strip housed in a plastic cassette.

Here's a breakdown of the acceptance criteria and study information for the Instant-view-plus™ Immunochemical Fecal Occult Blood Test, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the performance demonstrated in the various studies, particularly the precision/reproducibility and method comparison studies. The goal is to show substantial equivalence to predicate devices, meaning the device performs as well as or better than already approved devices.

The tables below compile the key performance metrics provided:

• Positive Percent Agreement: 100% (492/492) (99.3%, 100%)
• Negative Percent Agreement: 99% (404/408) (97.5%, 99.7%) |
  | | | Reproducibility (Lot Variability):
• Lot 1: Pos. 100%, Neg. 98.6%
• Lot 2: Pos. 100%, Neg. 97%
• Lot 3: Pos. 100%, Neg. 96.4% |
  | | | Reproducibility (Day Variability):
• Day 1: Pos. 100%, Neg. 95.1%
• Day 2: Pos. 100%, Neg. 89%
• Day 3: Pos. 100%, Neg. 98.6%
• Day 4: Pos. 100%, Neg. 95.4%
• Day 5: Pos. 100%, Neg. 96.8% |
  | | | Reproducibility (Site Variability):
• Site 1: Pos. 100%, Neg. 97.1%
• Site 2: Pos. 100%, Neg. 97.4%
• Site 3: Pos. 100%, Neg. 96.7% |
  | Assay Cut-off | Clearly defined sensitivity/specificity around cut-off | 50 ng/ml (human hemoglobin in fecal sample mixed with detection buffer).
  At 50 ng/ml: Positive % = 55%, Negative % = 45%
  At 60 ng/ml: Positive % = 100%, Negative % = 0% |
  | Method Comparison (vs. Predicate) | Acceptable Overall, Positive, and Negative Percent Agreement | Combined Sites:
• Overall Percent Agreement: 97.7% (95.2%, 99.1%)
• Positive Percent Agreement: 96.0% (90.2%, 98.9%)
• Negative Percent Agreement: 98.5% (95.6%, 99.7%) |
  | Prozone Effect | No significant prozone effect | No prozone effect observed up to 500,000 ng/mL |
  | Analytical Specificity (Hb variants) | Equivalent recognition of Hb variants | Equivalently recognizes HbA, HbS, and HbC |
  | Cross-Reactivity (Animal Hb) | No significant cross-reactivity | No significant cross-reactivity with tested animal hemoglobins (beef, chicken, fish, horse, goat, rabbit, pig, horseradish peroxidase, sheep) |
  | Interfering Substances (Vegetables) | No significant interference | No significant interference from tested vegetable extracts (broccoli, cantaloupe, cauliflower, parsnip, red radish, turnip) |
  | Interfering Supplements (Iron, Ascorbate) | No significant interference | No significant interference from iron and sodium L-ascorbate |
  | Interference from Toilet Water | No significant interference | No significant interference from samples collected in toilet water |
  | Stability (Accelerated/Real Time) | Defined shelf-life | stable for 24 months at 8-23°C |

Study Details:

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

• Precision/Reproducibility (Repeatability): 6 concentrations (0, 25, 50, 55, 500 ng/ml). 50 replicates per concentration (total of 300 tests per lot). Data provenance is in-house by trained laboratory professionals. This implies retrospective testing of prepared samples.
• Precision/Reproducibility (Reproducibility): 9 concentrations (0, 25, 50, 60, 60 [repeated], 500 ng/ml). 14 replicates for each sample and concentration level. Performed across three intended use sites over a minimum of 5 days. This suggests a prospective data collection design using controlled, spiked samples.
• Prozone Effect Study: 7 concentrations (1,000 to 500,000 ng/ml). 20 aliquots of each concentration. Data provenance is in-house. This is retrospective testing of prepared samples.
• Assay Cut-off Study: 7 concentrations (0, 25, 48, 50, 60, 72, 500 ng/ml). 20 aliquots of each concentration. Data provenance is in-house. This is retrospective testing of prepared samples.
• Method Comparison with Predicate Device: 299 patient samples. Performed at three POC testing sites. Data provenance is not explicitly stated beyond "patient samples" and "POC testing sites," but it implies real-world clinical samples, likely prospective or retrospective from those sites.
• Consumer Study: Concentrations were 0, 25, 50, 60, and 500 ng/ml. "Number of Samples" is consistently "20" (represented as "રત" in the table, clearly a transcription error for 20). Data provenance is in-house using spiked samples. This is retrospective testing of prepared samples.

No specific country of origin for the data is mentioned, but the manufacturer is based in Poway, California, USA, making it highly probable the studies were conducted domestically.

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)

• For the precision/reproducibility, prozone, assay cut-off, analytical specificity, cross-reactivity, and interference studies, the ground truth was established by preparing fecal samples spiked with known concentrations of human hemoglobin or other controlled substances. Therefore, no human experts were needed to establish the ground truth; it was experimentally determined.
• For the method comparison study, the "predicate test Instant-view™ Fecal Occult Blood Rapid Test" results served as the reference standard (comparative ground truth). The predicate device itself would have undergone its own validation based on established ground truth (e.g., clinical diagnosis or pathology). For this specific study, the experts are the operators at the three POC testing sites, but their qualifications are not specified beyond "two operators at each site."
• For the consumer study, similarly, no human experts established a true "ground truth." The comparison was between the new device and the predicate device on spiked samples.

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

• No explicit adjudication method (like 2+1, 3+1 consensus) is described in the provided text for any of the studies involving human interpretation.
• For studies involving spiked samples, the "truth" is the known concentration of hemoglobin or other substances, eliminating the need for adjudication.
• For the method comparison study, the readings of the Instant-view-plus™ were compared directly to the results of the predicate device, not against an expert-adjudicated ground truth.

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 comparative effectiveness study involving AI assistance is mentioned. This device is a rapid immunochemical assay, not an AI-powered diagnostic imaging tool. Human interpretation is involved in reading the lines on the cassette.
• A "method comparison with predicate device" study was performed, which compared the new device's readings to those of a predicate device. This is a comparison between devices, not between human readers with and without AI assistance.
• A "consumer study" was performed, which likely involved lay users or professional users following instructions, but it was to assess the device's performance, not the improvement of human readers with AI.

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

• This device is a standalone test kit that provides a visual readout (presence/absence of lines). Its performance is the algorithm's performance, as the "algorithm" is the biochemical reaction and visual indication. There isn't a separate "human-in-the-loop" vs. "standalone algorithm" distinction in the context of this immunochemical test. The studies evaluate the device's performance directly.

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

• For the precision/reproducibility, prozone, assay cut-off, analytical specificity, cross-reactivity, interfering substances, and stability studies: The ground truth was experimentally determined by preparing Hb-free fecal samples spiked with known, precise concentrations of human hemoglobin, hemoglobin variants, animal hemoglobins, vegetable extracts, or other interfering substances.
• For the method comparison study: The ground truth was the result from the predicate device (Instant-view™ Fecal Occult Blood Rapid Test).
• For the consumer study: The ground truth was again the known concentration of hemoglobin in the spiked samples, used to compare the new device to the predicate.

8. The sample size for the training set

• The provided text describes studies for validation and verification of the device's performance, not the training of an algorithm. Therefore, there is no specific training set identified in the context of machine learning. The "training" for this type of device would involve development and optimization of the immunoassay components, likely using iterative testing, but this is not a formally reported "training set" in the sense of AI.

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

• As there's no identified "training set" for an algorithm in the provided text, this question is not applicable. The device's "ground truth" during its development would have been established through controlled laboratory experiments, optimizing reagent formulations and design to achieve desired sensitivity and specificity.

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The Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use) are rapid, qualitative immunoassays for the detection in human urine of one or more of the cutoff concentrations listed below. These devices will detect up to 13 of the drugs below in any combination. The tests are not intended to distinguish prescription use or abuse of any drugs.

These devices provide only a preliminary analytical test result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Chromatography/mass spectrometry is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling.

Tests for prescription drugs will yield preliminary positive results when these drugs are ingested at or above therapeutic doses. There are no uniformly recognized drug levels for prescription drugs in urine. This multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level.

The Instant View® Multi-Drug Urine Test Cup (Home Use) and the Instant View® Multi-Drug Urine Test Panel (Home Use) are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to thirteen individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during the test regardless of the presence of the drug.

This document describes the performance characteristics and a lay-user study for the Instant-View® Multi-Drug Urine Test Cup (Home Use) and Instant-View® Multi-Drug Urine Test Panel (Home Use).

Here's an analysis of the provided information, structured according to your request:

Acceptance Criteria and Device Performance

The acceptance criteria for this device appear to be tied to the agreement rate of lay users' interpretations compared to GC/MS confirmed results. The performance is reported as the percentage of correctly interpreted results. The implicit acceptance criterion can be inferred from the overall results being "higher than 96%" on average for both device types when considering all concentrations, and 100% agreement at concentrations 150% and above, as well as 50% and below the cutoff. This suggests a high accuracy requirement for lay user interpretation.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not explicitly state pre-defined acceptance criteria values in the form of thresholds (e.g., "must achieve >95% accuracy"). Instead, it presents the results of the study and concludes that "the participants were able to read the results correctly at an average of higher than 96%." Therefore, the reported performance is the demonstrated acceptance of the device's accuracy for lay users.

Given the phrasing and the detailed results, a simplified representation of the demonstrated performance can be derived:

Implicit Acceptance Criteria:

• Average correct interpretation rate for lay users > 96% across all drugs and tested concentrations.
• 100% correct interpretation at concentrations 150% above and 50% below the cutoff. (This was achieved in the study based on the summary).

2. Sample Size and Data Provenance

• Sample Size for Test Set: 400 lay persons.
• Data Provenance: The study was performed at "three intended user sites." The document does not specify the country of origin but implies a domestic (US) setting given the FDA submission context. The study design is prospective, as it involved participants actively testing the devices with prepared blinded samples.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: Not applicable in the context of this specific lay-user study's ground truth.
• Qualifications of Experts: Not applicable. The ground truth for the test set was established by analytical methods, not human expert consensus for interpretation.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. The "ground truth" for the urine samples (presence/absence and concentration of drugs) was established by GC/MS, which is an objective chemical analysis method, not a subjective interpretation requiring adjudication. Lay users then interpreted the device results, and their interpretations were compared to the GC/MS ground truth.

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

• MRMC Study: No, this was not an MRMC comparative effectiveness study in the typical sense of evaluating human readers' performance with and without AI assistance for image interpretation. This was a direct evaluation of lay user interpretation of a rapid diagnostic test.
• Effect Size of Human Reader Improvement: Not applicable, as it was not an AI-assisted interpretation study.

6. Standalone Performance

• Standalone Performance: The study evaluates the human-device interaction for lay users. While the document mentions "analytical test result" and "chemical method" for confirmation, this specific lay-user study's performance data (the tables) represent the accuracy of the lay users' interpretation of the device results compared to the objective ground truth. The device itself (the immunochromatographic test) inherently provides a visual result that humans (lay users) then interpret. Thus, the performance described is the "human-in-the-loop" performance for the intended OTC use. The underlying analytical performance of the immunoassay itself is stated to be "the same as the predicate device," but the detailed performance data provided in the tables are for lay-user interpretation.

7. Type of Ground Truth Used

• Ground Truth: For the test set, the ground truth was established by Chromatography/Mass Spectrometry (GC/MS). The urine samples were "spiked with drugs into drug free-pooled urine specimens" at specific concentrations, and these concentrations were "confirmed by GC/MS."

8. Sample Size for the Training Set

• Training Set Sample Size: The document does not provide information about a separate "training set" in the context of "training" an algorithm or AI. This is a traditional diagnostic device validation, not an AI/ML product. The "training" for the device's development (e.g., optimizing immunoassay reagents) is not detailed in this submission summary.

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" described for an AI/ML algorithm. The "training" that occurs is for the device's internal chemistry and design, which is not elaborated upon as distinct data sets for ground truth establishment.

Summary of the Study Design and Findings:

The study aimed to assess how accurately lay users could interpret the results of the Instant-View® Multi-Drug Urine Test Cup and Panel.

• Participants: 400 lay persons (210 female, 190 male), diverse in education, professional background, and age (18 to >60), with no prior OTC drug test experience.
• Methodology: Participants received package inserts, one test cup, and one test panel. Each participant tested two different blinded urine samples. The samples were prepared at various concentrations (0%, +/- 25%, +/- 50%) relative to the cutoff, and their true concentrations were confirmed by GC/MS.
• Results: The lay users achieved an average correct interpretation rate higher than 96% for both device formats, and 100% accuracy at concentrations 150% above and 50% below the cutoff.
• Conclusion: The study demonstrated that lay users could correctly interpret the device results with high accuracy, supporting the device's suitability for over-the-counter (home) use. The findings indicate effective labelling and ease of use, further supported by participant survey comments that the devices were "very easy to operate" and there were "no difficulties in interpreting the results." The package inserts also had a Flesch-Kincaid reading grade level of 7, indicating appropriate readability for a general audience.

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The Instant View® Multi-Drug of Abuse Urine Test Cup is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific, alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

The Instant View® Multi-Drug of Abuse Urine Test Panel is a rapid, qualitative immunoassay for the detection of one or more of the following drugs in human urine. This device is for over the counter use and may detect any combination of the drugs or drug metabolites at or above the specified cut-off level listed below.
The drug tests will provide a preliminary result only. A more specific. alternative chemical method must be used to obtain a confirmed analytical result. Gas Chromatography/Mass Spectrometry (GC/MS) and High-Performance Liquid Chromatography (HPLC), or the like are the preferred confirmation methods for most drugs in urine. Clinical consideration and professional judgment should be applied to any drug test result, particularly when evaluating preliminary positive results.

The Instant View® Multi-Drug of Abuse Urine Test Cup and the Instant View® Multi-Drug of Abuse Urine Test Panel are one-step lateral flow chromatographic immunoassays. Each device consists of any combination of one to twelve individual test strip(s) for the analyte(s) being tested. Each test strip in the device consists of 1) a conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundycolored band during the test regardless of the presence of the drug.

The provided document is a 510(k) summary for the Instant View® Multi-Drug of Abuse Urine Test Cup and Panel. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, the document does not contain acceptance criteria for device performance or the results of a study proving the device meets acceptance criteria.

The "Acceptance Criteria" for such a device would typically involve sensitivity, specificity, accuracy, and reproducibility in detecting the target drugs at or above specified cutoff levels. The "Study" would then present the results of clinical or laboratory testing to demonstrate that the device performs according to these criteria.

The document states:

• "The performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of this drug of abuse test are the same as the predicate device." This is a claim of equivalence but does not present the actual performance data or acceptance criteria for the current device.

Therefore, I cannot provide the requested information from the provided document. The document primarily focuses on establishing substantial equivalence to a predicate device based on its technology, intended use, and general characteristics, rather than detailing specific performance studies with acceptance criteria for the new device.

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The Drug of Abuse Urine (Cassette/Cup) Test is a rapid qualitative immunoassay for the detection of potential abuse of one or more drugs: Morphine/Opiates, and Oxycodone (see list below). The device is intended for in vitro diagnostic home use.

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

A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to three (3) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a colored band during test regardless of the presence of the drug.

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® Drug of Abuse Urine (Cassette/Cup) Test, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly state numerical acceptance criteria in a table format. Instead, it relies on the established performance characteristics of the predicate devices. The reported device performance is stated to be the same as the individual tests, which were previously 510(k) cleared. While specific numerical performance metrics are not given for the proposed device, the summary implies it meets the performance standards of its predicates.

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

The document does not explicitly state the sample size used for the test set of the proposed device. Instead, it makes a general statement that the "Performance characteristics, such as accuracy, reproducibility, sensitivity and specificity of the multi-drug of abuse test are the same as the individual tests, which have been 510(k) cleared for professional use previously."

The data provenance (country of origin, retrospective/prospective) for the test set is not specified.

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

This information is not provided in the document. The study relies on comparison to predicate devices, but details about how the performance was established for either the predicate or proposed device's test set ground truth are absent.

4. Adjudication Method for the Test Set

The adjudication method for the test set is not specified.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described for this device. This is an immunoassay, not an imaging device typically requiring such studies. The focus is on the device's analytical performance rather than human interpretation of complex images.

6. Standalone Performance Study

Yes, a standalone (algorithm only without human-in-the-loop performance) study was implicitly done for the device. The 510(k) summary focuses entirely on the device's analytical performance, not on how humans interpret its results. It describes the device's technology and states that its performance characteristics (accuracy, reproducibility, sensitivity, and specificity) are the same as the individual tests. This implies direct measurement of the device's output against a known standard.

7. Type of Ground Truth Used

The document implies that the ground truth for establishing the performance of the individual tests (and by extension, the proposed multi-drug device) would involve chemical confirmation using methods like Gas Chromatography/Mass Spectrometry (GC/MS) or Liquid Chromatography/Mass Spectrometry (LC/MS). The "Intended Use" section explicitly states: "A positive result from the device is considered to be a presumptive result and should never be interpreted as final without laboratory confirmation... Gas chromatography/mass spectrometry (GC/MS) or Liquid chromatography/mass spectrometry (LC/MS) is the preferred confirmatory method."

8. Sample Size for the Training Set

The document does not specify the sample size for the training set. It refers to the device using "the same technology and formulations for the detection of the drugs as individual test devices." This suggests that the "training" may have effectively been done on prior individual tests.

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

Similar to the test set, the ground truth for the training set (or the development of the underlying technology for the individual tests) would have been established through chemical confirmation methods, likely GC/MS or LC/MS, to accurately determine the presence and concentration of the target analytes. The document states the proposed device uses "the same technology and formulations" as previously cleared individual tests, implying the ground truth methods were consistent with those used for predicate devices.

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The INSTANT-VIEW Fecal Occult Blood (FOB) Self-Test is a qualitative immunoassay for the detection of Fecal Occult Blood by non-professional, lay individuals as a self-test product. Measurement of FOB is useful as an aid to detect human blood in stool as found in a number of gastrointestinal disorders, e.g. diverticulitis, colitis, polyps and colorectal cancer. It is intended for over the counter use.

Device is a one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with mouse anti-human hemoglobin monoclonal antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti-human hemoglobin antibodies, and the C line is coated with goat anti-mouse IgG antibodies. The proposed device has only cassette format. The cassette is a device that contains a dip-strip in a plastic housing.

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® Fecal Occult Blood (FOB) Self-Test, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Accuracy Study (Spiked Samples): 100 samples. The text states these were "collected in-house" so the provenance details beyond that are not specified, but they were artificially spiked with human hemoglobin - suggesting a controlled laboratory setting rather than patient data.
• Reproducibility Study:
  • POL Sites: Not explicitly stated, but "three Physician's Office Laboratories" were used. The number of tests performed at these sites isn't detailed, only the agreement rate.
  • Medical Laboratory: Not explicitly stated, but "one Medical Laboratory" was used. The number of tests performed isn't detailed.
  • Lay Individuals: 120 professional and non-professional lay individuals.
• Consumer Study: Likely the same 120 individuals mentioned in the reproducibility study for lay users.

The provenance is mixed:

• Accuracy: Likely laboratory-controlled specimens (feces extraction specimens spiked with hemoglobin).
• Reproducibility: Involved external POLs and a Medical Laboratory, and a group of "professional and non-professional lay individuals." The data collection seems prospective for the reproducibility and consumer studies, as individuals were actively performing tests.

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

The document does not explicitly state the number or qualifications of experts used to establish a "ground truth" in the traditional sense for the test set.

• For the Accuracy study, the ground truth was based on the known concentrations of human hemoglobin spiked into the samples. The predicate device (Hemoccult®) was also used for comparison, implying its results (for those concentrations) served as a reference.
• For the Reproducibility study, the "expected results" were used. For the lay user portion, professionals also tested the samples, so their results served as a comparative ground truth.
• For the Consumer study, the "expected results" and "results obtained by professionals" served as the ground truth against which consumer performance was compared.

4. Adjudication Method for the Test Set

The document does not specify a formal adjudication method (like 2+1 or 3+1). For reproducibility and consumer studies, consumer/lay results were compared against "expected results" or "results obtained by professionals," implying a simple comparison rather than a multi-reader adjudication process.

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 device is an in-vitro diagnostic (IVD) self-test, not an AI-assisted diagnostic tool for human readers. Therefore, there's no mention of how human readers improve with AI assistance.

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

This refers to a diagnostic device, not an algorithm. The device itself (the immunoassay) performs the diagnostic function. The "standalone" performance here refers to the device's ability to accurately detect FOB. The accuracy, sensitivity, and specificity studies essentially demonstrate the standalone performance of the device.

7. The Type of Ground Truth Used

• Accuracy: Known concentrations of spiked human hemoglobin. Comparison to a predicate device (Hemoccult®).
• Reproducibility: "Expected results" (likely determined by the manufacturer or expert testing in a controlled environment). For lay users, professional results served as the reference.
• Consumer Study: "Expected results" and "results obtained by professionals."

8. The Sample Size for the Training Set

The document does not mention a "training set" in the context of machine learning or AI. This is a traditional IVD device, not an AI-based one. All sample sizes mentioned pertain to validation/testing or performance evaluation.

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

As there is no mention of a training set, this question is not applicable.

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The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of amphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of cocaine (benzoylecgonine) in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of methamphetamine in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of oxycodone in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The proposed test is for professional and point of care use only.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for health care professional including point of care use.

The proposed test is a lateral flow, one-step immunoassay for the qualitative detection of one or more drugs or drug metabolites in urine specimens. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. The proposed test is for home use.

The Amphetamine (300) test is a qualitative immunoassay for the rapid detection of amphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Cocaine (150) test device is a rapid qualitative immunoassay for the rapid detection of cocaine (benzoylecgonine) from human urine specimens at a cutoff concentration of 150 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Methamphetamine (300) test is a qualitative immunoassay for the rapid detection of methamphetamine from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Oxycodone (100) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 100 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The Oxycodone (300) test is a qualitative immunoassay for the rapid detection of oxycodone from human urine specimens at a cutoff concentration of 300 ng/ml. It is for health care professional use only. This test provides only a preliminary result. A more specific alternate chemical must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. It is for health care professional use. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, tricyclic antilegressant in urine. The malti-drug of absoce wine test device shows the drug was not present at the cutoff level. This test provides only a preliminary result. A more specifical nethod must be used in order to obtain a confirmed analy. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liguid Chromatography (HPLC) is the preferred confirmatory nethod. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

The multi-drug of abuse device is a rapid qualitative immunoassay for screening potential abuse of one or more drugs listed below. The device detects any combination of the drugs or drug metabolites at or above the specified cut-off levels. This test is intended for over-the-counter (OTC) consumer use as the first step in a two step process to provide consumers, including but not limited to concerned parents, with information concerning the presence of the above stated drugs or their metabolites in a urine sample. Information regarding confirmatory testing- the second step in the process, is provided in the package labeling. The BAR, BZD, TCA test will yield preliminary positive results when BAR, BZD, and TCA is ingested at or above therapeutic doses. There are no uniformly recognized drug levels for barbiturate, benzodiazepine, tricyclic antidepressant in urine. The multi-drug of abuse urine test device shows the drug was or was not present at the cutoff level. This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GCMS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-amphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with amphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti- benzoylecgonine (cocaine) antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with benzoylecnine-BTG, and the C line is coated with goat anti-rabbit

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-methamphetamine antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with methamphetamine-BSA, and the C line is coated with goat anti-rabbit IgG antibody.

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody.

This assay is a one-step lateral flow chromatographic immunoassay. The test strip consists of 1) a burgundy-colored conjugate pad containing mouse anti-oxycodone antibodies and rabbit IgG coupled to colloidal gold; and 2) a nitrocellulose membrane containing a Test (T) line and a Control (C) line. The T line is coated with oxycodone-BSA, and the C line is coated with goat anti-rabbit IgG antibody.

A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug.

A one-step lateral flow chromatographic immunoassay. The device consists of any combination between one (1) to twelve (12) individual test strip(s) for the drug(s) being tested. Each test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with the anti-drug antibodies and 2) nitrocellulose membrane containing a test line (T line) coated with the conjugated drug antigen and a control line (C line). The C line serves as an internal quality control of the system and appears as a burgundy-colored band during test regardless of the presence of the drug.

The provided texts describe the acceptance criteria and performance of several in-vitro diagnostic devices for drug abuse testing. It outlines the sensitivity, specificity, accuracy, and reproducibility of tests for Amphetamine, Cocaine, Methamphetamine, Oxycodone (at two different cutoffs), and a Multi-Drug of Abuse Urine Test. The study primarily relies on comparison to GC/MS data for accuracy and general laboratory studies for reproducibility.

Here's a structured breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are generally implied to be "substantially equivalent" to predicate devices, and the performance metrics (sensitivity, specificity, accuracy, reproducibility) are reported. The provided cut-off levels are also part of the performance specification.

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

• Amphetamine (300):
  • Sample Size: 98 clinical confirmed specimens.
  • Data Provenance: Clinical (implicitly from human subjects, country not specified but the manufacturing company is US-based). The studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa, suggesting real-world clinical data. Retrospective based on "clinical confirmed specimens."
• Cocaine (150):
  • Sample Size: 108 clinical confirmed specimens.
  • Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
• Methamphetamine (300):
  • Sample Size: 127 clinical confirmed specimens.
  • Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
• Oxycodone (100):
  • Sample Size: 75 clinical confirmed specimens.
  • Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
• Oxycodone (300):
  • Sample Size: 115 clinical confirmed specimens.
  • Data Provenance: Clinical (implicitly from human subjects, country not specified). Studies were carried out at two Physician's Office Laboratories (POL) and one medical reference laboratory outside Alfa. Retrospective based on "clinical confirmed specimens."
• Multi-Drug of Abuse Urine Test: The performance characteristics (accuracy, reproducibility, sensitivity and specificity) are stated to be "exactly the same as the individual tests, which have been 510(K) cleared previously or are filed in separated sections of this submission." This implies that the sample sizes and provenance for the multi-drug panel are derived from the individual drug tests.

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

The ground truth was established by Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC). These are analytical laboratory methods, not human experts. Therefore, the concept of "number of experts" or "qualifications" for establishing the ground truth as defined in this context is not applicable. The professionals operating these instruments would be trained laboratory personnel.

4. Adjudication Method for the Test Set

The primary "adjudication" for the test results is the comparison against the GC/MS data. This is a direct comparison to a gold standard analytical method, not an expert adjudication process in the traditional sense of multiple human readers. The summary also notes that "Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained," indicating that final clinical decisions would involve human judgment, but the device performance is directly compared to GC/MS.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described as being performed to compare human readers with and without AI assistance. These are standalone in-vitro diagnostic devices (immunoassays), not AI-assisted diagnostic tools for human interpretation. The "Reproducibility" studies involved personnel with diverse educational backgrounds and working experiences, but this was to assess device consistency, not human reader improvement with AI.

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

Yes, the studies described are for the standalone performance of the in-vitro diagnostic devices (the test cassettes/dip-strips themselves). The sensitivity, specificity, and accuracy are reported for the device's ability to detect the targeted substances compared to the GC/MS gold standard, without a human-in-the-loop component influencing the device's measurement. The "professional and point of care use only" and "health care professional use" statements indicate human involvement for interpretation and clinical decision-making, but the performance data presented is for the device's analytical capability.

7. The Type of Ground Truth Used

The type of ground truth used is analytical gold standard comparison, specifically Gas Chromatography/Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) data. This is explicitly stated as the "preferred confirmatory method" to obtain a "confirmed analytical result."

8. The Sample Size for the Training Set

The documents do not explicitly mention a separate "training set" or its sample size. These are immunoassay devices, and the development process would involve formulation, optimization, and validation, rather than a distinct "training set" as understood in machine learning contexts. The clinical confirmed specimens mentioned primarily refer to the test/validation set for assessing performance metrics like accuracy, sensitivity, and specificity against the gold standard.

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

Since a distinct "training set" with established ground truth is not explicitly mentioned or relevant in the context of these in-vitro diagnostic (IVD) immunoassay devices (as opposed to machine learning algorithms), this question is not directly applicable. The device's underlying chemical and immunological principles are pre-determined during its design and manufacturing, rather than "trained" on data.

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The proposed BUP/NBUP Urine Test is a qualitative immunoassay for the rapid detection of buprenorphine and norbuprenorphine from human urine specimens. The test provides only a preliminary result. It is for health care professional use only.

This test provides only a preliminary result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas Chromatography / Mass Spectrometry (GC/MS) or High Performance Liquid Chromatography (HPLC) is the preferred confirmatory method. Clinical consideration and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are obtained.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with Rabbit anti-buprenorphine antibodies and mouse IgG, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with Buprenorphine-BSA, and the C line is coated with goat anti-mouse IgG antibodies.

Here's a breakdown of the acceptance criteria and study information for the INSTANT-VIEW® BUP/NBUP Urine Test, based on the provided document:

Acceptance Criteria and Device Performance

Study Details

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

   • Test Set Size: 94 clinical specimens.
     • 54 specimens were confirmed BUP/NBUP clinical samples.
     • 40 specimens were drug-free clinical samples.
   • Data Provenance: The document does not explicitly state the country of origin. It refers to "clinical specimens," suggesting real-world samples. It does not specify if the data was retrospective or prospective, but the use of "clinical specimens" often implies a retrospective collection for such validation.

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

   • The ground truth was established by HPLC/MS or GC/MS (High-Performance Liquid Chromatography/Mass Spectrometry or Gas Chromatography/Mass Spectrometry), which are analytical gold standard methods, not human experts. Therefore, the concept of "experts" in the traditional sense for establishing ground truth does not directly apply here. These methods are considered highly accurate and serve as the definitive reference.

3. Adjudication method for the test set:

   • Not applicable as the ground truth was established by analytical methods (HPLC/MS or GC/MS), not human interpretation requiring adjudication.

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, this was not an MRMC comparative effectiveness study involving human readers and AI assistance. This device is a qualitative immunoassay for chemical detection, not an AI-assisted diagnostic imaging or interpretation tool.

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

   • Yes, this was a standalone performance study. The device itself performs the detection (algorithm/chemical reaction only), producing a "preliminary positive" or negative result without direct human-in-the-loop performance influencing the result generating mechanism. The "human-in-the-loop" aspect comes in the interpretation of the preliminary result and the need for confirmatory testing.

6. The type of ground truth used:

   • Analytical Gold Standard / Confirmatory Chemical Method: HPLC/MS or GC/MS confirmed results.

7. The sample size for the training set:

   • The document does not explicitly mention a "training set" for the primary performance metrics (sensitivity, specificity, accuracy). Immunoassays typically rely on biochemical reactions rather than machine learning models that require distinct training and test sets in the same way. The 94 clinical specimens are referred to as the "studied" or "test" set for performance evaluation.

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

   • As no explicit "training set" is described in the context of machine learning, this question isn't directly applicable. For the samples used in the performance evaluation, the ground truth was established by HPLC/MS or GC/MS.

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The INSTANT-VIEW Troponin I Test is an immunoassay for the rapid qualitative detection of cardiac troponin I (cTnI) in human whole blood or serum at a cutoff level of 1.5 ng/ml. It provides an aid in the diagnosis of myocardial infarction in emergency room, point-of-care, and hospital setting.

The INSTANT-VIEW Troponin I Test provides a qualitative result rather than information about change in the level of cTnI with single testing. Serial testing should be performed to determine a temporal change in the level of cTnI. If desired, a quantitative method should be used to quantitate the concentration of cTnI. Clinical consideration and professional judgment should be applied when making a diagnosis decision based on this test result.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with anti- Troponin I antibodies, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with anti- Troponin I antibodies, and the C line is coated with goat anti-mouse IgG antibodies.

The proposed device has two formats: Serum Test and Whole Blood/Serum Test. The Serum Test has two sub-formats: Cassette and Dip Strip. The Whole Blood/Serum Test only has the cassette format. A cassette is a device that assembles a dip-strip in a plastic housing. The studies demonstrate all the formats are equivalent.

Acceptance Criteria and Study for INSTANT-VIEW Troponin I Test

This response analyzes the provided 510(k) summary for the INSTANT-VIEW Troponin I Test to extract information about its acceptance criteria and the study conducted to demonstrate its performance.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria are "implied" as they are not explicitly stated with numerical thresholds in the provided document. However, the study results demonstrate high performance that would typically be required for such a device.

2. Sample Size and Data Provenance for Test Set

• Sample Size: 300 clinically confirmed serum specimens (150 positive and 150 negative).
• Data Provenance: Retrospective, as the specimens were "clinically confirmed." The country of origin is not specified.

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

The document does not explicitly state the number of experts used or their specific qualifications for establishing the ground truth of the 300 clinically confirmed serum specimens. The phrase "clinically confirmed" implies that the diagnosis (positive or negative for myocardial infarction) was established through standard clinical practice, likely involving medical professionals (e.g., cardiologists, emergency physicians) and other diagnostic tests, rather than a dedicated panel of experts for this specific study's ground truth.

4. Adjudication Method for the Test Set

The document does not describe an explicit adjudication method (e.g., 2+1, 3+1). The ground truth was based on "clinically confirmed" status, suggesting that the initial clinical diagnosis served as the reference standard without a separate adjudication process described for the study.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or described. The study focused on the standalone performance of the device against clinically confirmed specimens.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance

Yes, a standalone study was performed. The "Sensitivity and Specificity Study" section directly reports the device's performance (sensitivity, specificity, accuracy) when evaluating clinical specimens, indicating its performance without human interpretation influencing the measurement itself. The device is a rapid qualitative immunoassay, where the test strip provides the result.

7. Type of Ground Truth Used (Test Set)

The ground truth for the test set was based on clinical confirmation of myocardial infarction (positive or negative status) using human serum specimens. This is a form of outcomes data/expert diagnosis from clinical practice.

8. Sample Size for the Training Set

The document does not specify a separate training set or its sample size. This type of immunoassay device is often developed and optimized iteratively through laboratory testing rather than traditional machine learning models requiring large, distinct training sets. The "Sensitivity and Specificity Study" likely refers to a validation set after the device's design was finalized.

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

As no explicit training set is mentioned, the method for establishing its ground truth is not described. Device development for this type of immunoassay typically involves using known positive and negative controls and spiked samples to optimize reagent concentrations and test parameters during the R&D phase, rather than a formal "training set" with established clinical ground truth in the same way a software algorithm might.

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The Instant-View H. Pylori Rapid Test is a rapid lateral flow, qualitative immunoassay. It is intended for use at point of care facilities to detect the presence of IgG antibodies specific to Helicobacter pylori (H. pylori) in human blood or serum. It provides an aid in the diagnosis of infection by H. pylori. This test has been evaluated for use with serum specimens of adults, 19 years and older.

A one-step lateral flow chromatographic immunoassay. The test strip in the device consists of 1) a burgundy-colored conjugate pad containing colloidal gold coupled with H. Pylori antigens, and 2) nitrocellulose membrane containing a test line (T line) and a control line (C line). The T line is coated with H. Pylori antigens, and the C line is coated with goat anti-H. Pylori antibodies.

Here's a breakdown of the acceptance criteria and study information for the Instant-View H. pylori Rapid Test based on the provided text:

Acceptance Criteria and Device Performance

Study Information

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

• Test Set Sample Size: 296 clinically confirmed serum specimens (144 positive, 152 negative).
• Data Provenance: Not explicitly stated (e.g., country of origin). The study states "clinically confirmed serum specimens," implying these were from real patient cases. It is retrospective in the sense that the clinical confirmation (ground truth) was already established for these specimens before testing with the Instant-View device.

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):

• The text states "clinically confirmed serum specimens" to establish the ground truth. It does not specify the number or qualifications of experts involved in this clinical confirmation. It implies that standard clinical diagnostic methods were used to determine positive/negative status for H. pylori, but details on the "who" and "how" are not provided.

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

• The text does not describe an adjudication method for establishing the ground truth. It simply refers to "clinically confirmed" specimens.

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 device is a rapid diagnostic immunoassay and does not involve "readers" in the context of imaging or clinical interpretation by multiple experts that would necessitate an MRMC comparative effectiveness study to assess human-AI interaction. Its performance is evaluated objectively against clinical confirmation.

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

• Yes. The reported sensitivity, specificity, and accuracy are for the device's performance alone when interpreting the sample. There is no human interpretation or intervention in the result generation of the test itself, only in applying the test and reading the final visual line. Therefore, this represents the standalone performance of the device.

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

• "Clinically confirmed" positive and negative H. pylori status for serum specimens. This typically refers to confirmation by established laboratory methods (e.g., endoscopy with biopsy and histology, urea breath tests, stool antigen tests, or other validated serological tests) which serves as the "truth" against which the new device is compared. Specific details are not provided.

8. The sample size for the training set:

• The document does not explicitly mention a separate training set for the diagnostic performance evaluation (sensitivity and specificity). For immunoassay devices like this, the 'training' often refers to the internal development and optimization of the assay during the manufacturing process, rather than a distinct dataset used to train an algorithm in the AI sense. The 296 specimens are explicitly referred to as the validation/test set.

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

• As no explicit training set in the context of an algorithm is mentioned for the performance study, this question is not applicable based on the provided text. For the development of the assay itself, internal R&D processes would involve known positive and negative samples, but these are not typically detailed in 510(k) summaries as "training sets."

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