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Multi-parameter test strips to measure certain constituents in the urine either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Chemstrip® 5 OB, 7 and 10 MD urine test strips are inert plastic strips to which are attached different reagent pads for determining specific gravity, pH, indication of leukocytes, nitrite, protein, glucose, ketones, urobilinogen, bilirubin, blood and hemoglobin in urine.

The Chemstrip 5 OB test strip is a multi-parameter urinalysis test strip, which measures leukocytes, blood/hemoglobin, nitrite, protein and glucose in the urine.

The Chemstrip 7 test strip is a multi-parameter urinalysis test strip, which measures pH, ketone, leukocytes, blood/hemoglobin, nitrite, protein and glucose in the urine.

The Chemstrip 10 MD test strip is a multi-parameter urinalysis test strip which measures specific gravity, pH, ketones, leukocytes, blood/hemoglobin, nitrite, protein, urobilinogen, bilirubin and glucose in the urine.

The test papers are attached to the strip with a nylon mesh and certain test papers have an inert absorbent paper located between the test area and the strip.

The provided document describes the Roche Diagnostics Chemstrip® 5 OB, Chemstrip® 7, and Chemstrip® 10 MD urine test strips. The acceptance criteria and the study used to establish substantial equivalence are detailed in relation to sensitivity claims.

1. Table of Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for these devices relate to their sensitivity, i.e., the lowest concentration of an analyte that can generally be detected as positive. The study aims to demonstrate that the new Chemstrip® products have comparable sensitivity to the predicate device, the Bayer Multistix® 10 SG.

Note on Differences: There are some discrepancies in the table provided. For instance, the "Blood" sensitivity for the predicate is in mg/dL of hemoglobin, while the new device is in Ery/uL (erythrocytes per microliter), making direct comparison challenging without further conversion. Similarly, Leukocytes are presented as cells/hpf (high power field) for the predicate and Leu/uL for the new device. The predicate device's sensitivity claims are explicitly noted to be for "contrived urine" and state that "lesser concentrations may be detected under certain conditions." The new device's sensitivity is presented as a range and notes "Because of inherent variability in clinical urines, lower levels may be detected under certain conditions."

The Study that Proves the Device Meets Acceptance Criteria:

The document describes a study that generated sensitivity data for the Chemstrip® products.

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

• Sample Size for Test Set: The document states that the sensitivity data was obtained using a "contrived urine pool." It does not specify the number of individual urine samples or patients included in this pool, nor the total number of tests performed.
• Data Provenance: The study was conducted using "contrived urine" and suggests that the data was generated by the manufacturer (Roche Diagnostics Corporation, based in Indianapolis, IN, USA). The document does not explicitly state the country of origin of clinical urine samples if any were used beyond the "contrived urine pool." The study appears to be retrospective in the sense that the data is presented as existing sensitivity values rather than describing a prospective clinical trial.

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

This information is not provided in the document. The ground truth for sensitivity is typically established by precisely preparing analyte concentrations in a controlled matrix (like contrived urine) and verifying these concentrations using a highly accurate reference method. It's not usually established by human expert consensus in this context.

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

This information is not provided in the document. Adjudication methods are generally not applicable to establishing sensitivity for chemical assays using contrived samples.

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 is not applicable to this device. The Chemstrip® products are multi-parameter urine test strips, not an AI-powered diagnostic device. The document mentions use with the Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer, which are automated readers, but no human-in-the-loop AI assistance is described.

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

The device itself is a standalone chemical test strip that can be read visually or with an analyzer. The sensitivity data provided is for the strips used with the Criterion II Urine Analyzer and the Chemstrip 101 Urine Analyzer. This represents the "algorithm only" performance (i.e., the analyzer's interpretation of the strip) for these specific parameters. The document also explicitly states the strips can be read "either visually or by using the Roche Diagnostics Chemstrip 101 Urine Analyzer or Criterion II Urine Analyzer," implying a degree of standalone performance for the strip itself, whether interpreted by an instrument or a human eye.

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

The ground truth for the sensitivity claims was established by using contrived urine pools with known, precisely prepared concentrations of analytes. This is a laboratory-based, analytical ground truth.

8. The sample size for the training set:

This information is not provided in the document. These are chemical test strips, and while there might have been internal development data for optimization, the concept of a "training set" as understood in machine learning (which often requires a large dataset for model training) does not directly apply here. The product's performance is based on the chemical reactions on the pads.

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

This information is not provided and is largely moot due to the nature of the device. For chemical test strips, the "ground truth" during development involves optimizing reagent concentrations and reaction kinetics to achieve desired sensitivity and specificity when exposed to known concentrations of analytes in a controlled environment.

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