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AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are competitive binding, lateral flow immunochromatographic assays for qualitative and simultaneous detection of Amphetamine, Oxazepam, Cocaine, Cannabinoids, Methamphetamine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxymethamphetamine. Phencyclidine and Methadone in human urine at the cutoff concentrations of.
The tests are intended for over-the-counter and for prescription use.

The AssureTech Panel Dip Tests and AssureTech Quick Cup Tests are immunochromatographic assays that use a lateral flow system for the qualitative detection of Amphetamine, Oxazepam, Cocaine, Marijuana, Methamphetamine, Morphine, Oxycodone, Secobarbital, Buprenorphine, Methylenedioxy-methamphetamine, Phencyclidine and Methadone (target analytes) in human urine. The tests are the first step in a two-step process. The second step is to send the sample for laboratory testing if preliminary positive results are obtained.

The AssureTech Panel Dip Tests comprise two items, a urine collection cup and the dip card with a plastic casing as the lateral flow device. The AssureTech Quick Cup Tests comprise a urine collection cup and a quick cup test with a lateral flow device that will start when the cap is screwed onto cup.

The provided text describes the performance characteristics and acceptance criteria for the AssureTech Panel Dip Tests and AssureTech Quick Cup Tests, which are qualitative drug screening devices.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for qualitative drug tests are typically defined by the performance at and around the cutoff concentration. The data presented shows excellent performance for samples well below and well above the cutoff, with some expected variability around the cutoff.

The tables provide the raw results rather than a single aggregated performance metric (like accuracy, sensitivity, or specificity relative to a cutoff for the entire dataset). However, we can infer the performance based on these results. For samples significantly below the cutoff, the device should consistently report negative results. For samples significantly above the cutoff, it should consistently report positive results. Near the cutoff, there's a transition zone where both positive and negative results are expected, and the reported numbers reflect this.

Let's illustrate with an example for Oxazepam (-25% cutoff, which is 225 ng/mL). The "Panel Dip" table shows for Lot 1: 9-/41+ (9 negative, 41 positive out of 50 samples). This means 41 samples with concentrations at 225 ng/mL were correctly identified as positive (or transitioning to positive). Similarly, for +25% cut off (375 ng/mL), it's 50+/0- (50 positive, 0 negative), indicating consistent positive detection.

Here's a summary table derived from the provided precision data for Oxazepam, Methylenedioxy-methamphetamine, and Morphine, illustrating the device performance relative to the acceptance criteria (consistent results at extremes, transition near cutoff). The "acceptance criteria" for these qualitative tests at different concentration levels are implied by the expected outcome (all negative for greatly reduced concentrations, all positive for greatly increased concentrations, and a mix near the cutoff).

Inferred Acceptance Criteria vs. Reported Performance (from Precision Studies)

Note on Acceptance Criteria: For qualitative tests like these, the acceptance criteria are generally that samples significantly below the cutoff (e.g., -50% to -100% of cutoff) should consistently yield negative results and samples significantly above the cutoff (e.g., +50% to +100% of cutoff) should consistently yield positive results. Around the cutoff (e.g., +/- 25% of cutoff), a mix of positive and negative results is expected, demonstrating the device's ability to discriminate at the threshold. The reported data generally supports this behavior.

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

• Precision Studies (Test Set):

  • For each drug and each concentration point (-100%, -75%, -50%, -25%, +25%, +50%, +75%, +100% cut off), and for each device (Panel Dip, Quick Cup), 50 samples per lot (2 runs per day for 25 days) for 3 lots were tested.
  • Total samples per drug/concentration point/device: 50 samples/lot * 3 lots = 150 samples.
  • Data Provenance: Samples were prepared by spiking drug in negative urine samples, and concentrations were confirmed by LC/MS. "In-house" studies are mentioned for comparison studies, suggesting the data was generated within the company or a collaborating lab. The document does not specify the country of origin of the data or whether the studies were retrospective or prospective, though the precision studies appear prospective due to the controlled spiking and testing regimen.

• Comparison Studies (Test Set):

  • For each drug and each device (Panel Dip, Quick Cup): 80 unaltered clinical samples (40 negative and 40 positive).
  • Data Provenance: "In-house" studies. Samples were "unaltered clinical samples", meaning they were real patient samples, and were blind labeled. The origin (country/retrospective/prospective) is not explicitly stated.

• Lay-user Study (Test Set):

  • For each device format (Panel Dip, Quick Cup): 280 lay persons per device format participated.
  • Urine samples were prepared at various concentrations (-100% Cutoff, -75% Cutoff, -50% Cutoff, -25% Cutoff, +25% Cutoff, +50% Cutoff, +75% Cutoff). The sample count varies for each concentration, but the total across all concentrations sums to 280 (e.g., 20+20+140+20+20+40+20 = 280) for each drug.
  • Data Provenance: "Lay users" at "three intended user sites." The data was generated in a controlled manner (spiking drugs into pooled urine, blind labeling, LC/MS confirmation). The document does not specify country.

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

• Precision Studies: Ground truth was established by LC/MS (Liquid Chromatography/Mass Spectrometry), which is an analytical method used for confirming drug concentrations. This is a highly accurate chemical method, not human expert consensus for visual interpretation.
• Comparison Studies: Ground truth was established by LC/MS results.
• Lay-user Study: Ground truth for sample concentrations was established by LC/MS.

No human experts were used to establish the ground truth in terms of visual interpretation for these studies as the ground truth was based on quantitative chemical analysis.

4. Adjudication Method for the Test Set

• Precision, Comparison, and Lay-user Studies: The ground truth for the spiked samples was determined by LC/MS. For the comparison studies, the "unaltered clinical samples" were also compared to "LC/MS results" as the ground truth.
• In the comparison studies, three laboratory assistants observed the results. The discordant results (where the viewer's result differed from the LC/MS) are listed in tables.
• No explicit "adjudication method" among human viewers (like 2+1 or 3+1 consensus) is described, as the ultimate ground truth was LC/MS. The individual viewer results are presented and compared against this gold standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

• No, a typical MRMC comparative effectiveness study, which usually involves multiple human readers interpreting medical images or data with and without AI assistance to measure improvement, was not performed.
• This device is a qualitative drug screening test, where the result is a visible line (or absence of a line). The "readers" in the "Comparison Studies" are "laboratory assistants" observing these lines, not interpreting complex medical images. The study's focus is on the device's accuracy against a chemical gold standard, not human reader performance improvement with AI.

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

• Yes, for all studies (Precision, Comparison, Lay-user), the device operates in a standalone manner. The "human-in-the-loop" is simply reading the visual indicator (lines) produced by the device, not an "algorithm" making a diagnostic prediction that is then confirmed or refined by a human. The device itself is the "algorithm" in that it performs the chemical assay. The comparison data shows the device's inherent ability to produce the correct qualitative result based on the chemical content, which is then visually interpreted.

7. The Type of Ground Truth Used

• The primary type of ground truth used for all performance evaluations (precision, specificity, interference, comparison, and lay-user studies) was quantitative chemical analysis, specifically Liquid Chromatography/Mass Spectrometry (LC/MS). For the precision studies, concentrations were confirmed by LC/MS, and for the comparison studies, clinical samples were compared to LC/MS results.

8. The Sample Size for the Training Set

• This document describes a 510(k) submission for a diagnostic device. Such devices are typically developed, manufactured, and validated based on established chemical and immunological principles. They do not involve "training sets" in the context of machine learning or AI models.
• The "training" for such devices is in the design, formulation, and manufacturing process to ensure consistent chemical reactivity. There is no explicit "training set" of data points in the same sense as for an AI/ML algorithm.

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

• As stated above, there is no "training set" in the AI/ML sense for this type of device. The "ground truth" for developing the device would involve chemical principles, experimental optimization of reagents and concentrations, and quality control measures during manufacturing. This is a traditional immunoassay, not an AI/ML product.

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AgaMatrix JAZZ Wireless™ Blood Glucose Monitoring System is intended for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ Wireless™ Blood Glucose Meter is intended for use with AgaMatrix JAZZ Blood Glucose Test Strips for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC) ) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix JAZZ Blood Glucose Test Strips are intended for use with AgaMatrix JAZZ Wireless 110 Blood Glucose Meter for the quantitative measurement of glucose in fresh capillary whole blood. Testing is done outside the body (in vitro diagnostic use). It is indicated for use at home (over the counter (OTC)) by persons with diabetes, or in a clinical setting by healthcare professionals, as an aid to monitor the effectiveness of diabetes control.

AgaMatrix WaveSense™ Control Solution is intended for use with the AgaMatrix JAZZ Wireless M Meter and AgaMatrix JAZZ Wireless " Test Strips as a quality control check to verify the accuracy of blood glucose test results.

The AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System which is codeless, includes a meter with batteries, compact carrying case, lancing device, lancets, control solution and owner's booklet. Test Strips and control solution are sold separately.

It is intended for over-the counter home use by diabetics to monitor their blood glucose levels or for use in a clinical setting by healthcare professionals. The system tests fresh capillary whole blood. The meter is a portable, battery-operated instrument.

The modification of Jazz Wireless™ blood glucose system allows users to upload glucose readings from the meter to a blue tooth enabled PC without the use of a USB cable.

The provided document describes a 510(k) summary for the AgaMatrix Jazz Wireless™ Blood Glucose Monitoring System. The modification pertains to the wireless upload of glucose readings; therefore, the core performance of the glucose measurement itself likely relies on previously established data or adherence to recognized standards.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the manufacturer certifies the device complies with ISO 15197:2003 "In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus." This standard outlines performance requirements for blood glucose meters.

While the document states compliance with ISO 15197:2003, it does not provide a specific table of acceptance criteria from ISO 15197 or the detailed reported device performance against those criteria. It merely makes a general declaration of compliance. To fully answer this, the specific ISO 15197:2003 criteria (e.g., accuracy within certain percentage or mg/dL for different glucose ranges) and the AgaMatrix Jazz Wireless™ device's performance data against those criteria would be needed, but they are not included in this document.

What is present in the document:

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

The document states "Based upon the testing and comparison to the predicate device". However, it does not specify the sample size used for the test set, the country of origin of the data, or whether the study was retrospective or prospective.

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

The document does not provide any information regarding the number of experts, their qualifications, or their role in establishing ground truth for any test set. For blood glucose monitoring systems, ground truth is typically established by laboratory reference methods, not expert consensus in the way image analysis or clinical diagnosis might use.

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

The document does not specify any adjudication method for a test set.

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

This device is a blood glucose monitoring system, not an AI-powered diagnostic imaging tool that would typically involve human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this type of device and was not mentioned.

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

The document indicates that the device itself performs the measurement. The "testing" mentioned implies standalone performance studies were conducted to demonstrate compliance with ISO 15197:2003. However, specific details of such standalone testing (e.g., protocol, metrics, results) are not provided, beyond the general statement of compliance.

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

For blood glucose monitoring systems, the ground truth is typically established by laboratory reference methods (e.g., YSI analyzer). The document does not explicitly state the type of ground truth used, but this is the standard practice for demonstrating accuracy of blood glucose meters against a known, highly accurate method.

8. The sample size for the training set

The document does not provide any information about a "training set." This term is typically associated with machine learning or AI algorithms. While the device likely has internal algorithms for glucose measurement, the document does not discuss a separate training phase or associated sample sizes.

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

As no training set is discussed, no information is provided on how its ground truth might have been established.

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