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DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of glucose in urine. These measurements are used in the screening and diagnosis of glucose metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

DiaScreen® Reagent Strips for Urinalysis are intended for the qualitative and semi-quantitative measurement of ketones in urine. Identification of ketones is used in the qualitative measurement of acidosis or ketosis and for monitoring patients on ketogenic diets and patients with diabetes.

Testing can be done by dipping the Reagent Strips into a specimen container or by holding them directly in the urine stream.

The glucose and ketone strips are intended for both professional and over-the-counter use.

DiaScreen® Reagent Strips for Urinalysis are plastic strips coated with one or more dry reagents. Each reagent is specific for a particular analyte. Reagent areas are spaced along the test strip, with a physical gap between reagent areas. Three configurations are designed for both professional and home use: detecting one or both of the following analytes: glucose, ketone. The dry reagents change color in reaction to the presence, and concentration, of their associated analyte. The strips are read visually against a color chart.

The provided 510(k) summary for the DiaScreen® Reagent Strips for Urinalysis does not contain detailed information about specific acceptance criteria or a comprehensive study report with quantitative data to definitively prove the device meets those criteria.

However, based on the available text, we can infer some aspects and highlight what is missing.

Here's an attempt to answer your questions based on the provided text, along with notes about information that is not available:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified. The document only mentions "Clinical data" and "Testing demonstrated," but provides no numbers for participants or urine samples for any clinical study.
• Data Provenance: Not specified (e.g., country of origin). The study is simply referred to as "Clinical testing." It is implied to be prospective, as it involves home users obtaining results, likely comparing them to professional users.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. The document refers to "professional users," implying healthcare professionals, but their specific titles, years of experience, or training for interpreting these strips are not detailed.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. It is unclear how discrepancies between home user results and professional user results (or any other ground truth) were resolved, or if any formal adjudication process was used.

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

• MRMC Study: No. This device is a visual dipstick test, not an AI-powered diagnostic imaging or interpretation system. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

• Standalone Performance: Not applicable. This is a manual, visually interpreted test strip. There is no "algorithm only" performance to evaluate. The performance is inherently tied to human visual interpretation.

7. The Type of Ground Truth Used

• Type of Ground Truth: The document implies that the ground truth for home user performance was based on the results obtained by "professional users." This suggests a comparison to a referent standard performed by trained personnel, likely using the same DiaScreen® Reagent Strips or a laboratory reference method. However, the exact nature of this "ground truth" (e.g., whether professional user results were cross-referenced with a lab analyzer, pathology, or confirmed clinical outcomes) is not specified.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is not an AI/machine learning device that requires a training set. The device's performance relies on the inherent chemical reactions on the strip and visual interpretation against a color chart.

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

• Training Set Ground Truth: Not applicable, as there is no training set for this type of device.

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The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

The provided document describes the DIASCREEN® Reagent Strip System, focusing on the new leukocyte reagent area. The study aims to demonstrate substantial equivalence to previously approved devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are based on a clinical correlation study comparing the DIASCREEN® Leukocyte Reagent Strips to the Bayer Multistix 10 SG. The performance is reported as the percentage of responses falling within the same color block and within plus or minus one color block compared to the predicate device.

Note: The document implies "substantial equivalence" as the primary acceptance criterion, rather than specific numerical cutoffs. The reported performance demonstrates a strong agreement with the predicate device.

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

• Sample Size for Leucocyte Test (Comparison to Bayer Multistix):
  • Evaluation One: 39 fresh urine samples (for each of the two DIASCREEN® lots tested).
  • Evaluation Two: 279 fresh urine samples.
• Data Provenance: Prospective. Fresh urine samples were obtained at a medical facility for Evaluation One and at two clinical sites for Evaluation Two. The origin country is not explicitly stated, but the contact person and institutions (Wichita State University, Technovations Inc.) suggest the United States.

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

The ground truth for the test set was established by the results obtained from the "510(k) approved" marketed urinalysis strip system, specifically the Bayer Multistix 10 SG Reagent Strips. The readings of the DIASCREEN® strips were then visually compared to the DIASCREEN® color chart, which would presumably be interpreted by trained laboratory personnel.

• No specific "experts" were used to establish a separate ground truth. Instead, the predicate device (Bayer Multistix 10 SG) acted as the reference standard.
• For Evaluation One, the study was under the direction of James Jackson, MT(ASCP) CLS, Ph.D. at Wichita State University Department of Medical Technology. This individual possesses medical technology qualifications.
• For Evaluation Two, the study was conducted under the direction of Myron Rapkin, Technovations Inc. No specific qualifications are listed for this individual in the provided text.

4. Adjudication Method for the Test Set

The adjudication method was a direct comparison between the visual readings of the DIASCREEN® Reagent Strips using their own color chart and the results from the Bayer Multistix 10 SG Reagent Strips. There is no mention of an independent adjudication panel or consensus 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 a manual, visual dip-and-read test strip, not an AI-assisted system.

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

No, a standalone algorithm-only performance study was not done. The device is a visual dip-and-read test strip that requires human interpretation of color changes against a color chart.

7. The Type of Ground Truth Used

The ground truth used was the performance of a legally marketed and "510(k) approved" predicate device: the Bayer Multistix 10 SG Reagent Strips. This is a form of comparative ground truth against another validated diagnostic method rather than an absolute "expert consensus," "pathology," or "outcomes data" ground truth for the condition itself.

8. The Sample Size for the Training Set

The document does not specify a separate "training set" or "validation set" in the context of the clinical evaluation. The reported evaluations appear to be performance studies for verification rather than training a machine learning model. The strips were developed using established chemical reagents and principles.

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

Not applicable, as a discrete training set with explicitly established ground truth (in the AI context) is not described for this type of medical device submission. The device design and reagent compositions were likely developed based on known chemical reactions and prior experience with similar urinalysis strips.

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The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip for semi-quantitative urinalysis. DIASCREEN® Reagent Strips have been developed to allow health care professionals to test semi-quantitatively for patient urine levels of specific gravity. ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart.

The DIASCREEN® Reagent Strip for Urinalysis is a dip-and-read test strip and is intended for use as an in vitro diagnostic aid using urine specimens. The strip contains solid phase reagent areas affixed to a plastic strip and is provided in a dry reagent format.

The strip provides qualitative and semi-quantitative tests for specific gravity, ketones, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen by visual comparison with a color chart for each concentration range. No additional reagents and laboratory equipment are required. The reagent strips are packaged in a plastic vial containing a desiccant. The test strips must be kept tightly capped in the vial to assure reagent reactivity. The directions must be followed exactly and it is necessary to use fresh, well-mixed, uncentrifuged urine for optimal results.

DIASCREEN® Reagent Strips are plastic strips to which are affixed reagent test areas. Several product configurations are included with this submission, but all configurations are limited to one, some or all of the following tests: specific gravity, ketone, glucose, protein, blood, leukocytes, nitrite, pH, bilirubin, and urobilinogen.

The reagent test areas on the DIASCREEN® Reagent Strips are ready to use upon removal from the bottle and the entire reagent strip is disposable after use. The strips are to be read visually, requiring no additional laboratory equipment for testing.

This document describes the DIASCREEN® Reagent Strip System for urinalysis, a dip-and-read test strip for semi-quantitative urinalysis.

1. Table of Acceptance Criteria and Reported Device Performance:

The acceptance criteria are not explicitly stated as numerical targets the device must meet in the provided text. Instead, the study aims to demonstrate substantial equivalence by showing high agreement (within the same color block or within one color block) between the DIASCREEN® Reagent Strips and a legally marketed predicate device (Bayer Multistix 10 SG). The reported device performance is presented as the percentage of agreement.

Here's a table summarizing the performance data, with the understanding that the "acceptance criteria" are implied by the observed high percentages of agreement with the predicate device.

Note: The document also reports cross-lot consistency for DIASCREEN® (Lot 1 vs. Lot 2), showing high agreement (91-100% within the same color block and 100% within 1 color block).

2. Sample Size and Data Provenance:

• Test Set Sample Size: 53 fresh urine samples.
• Data Provenance: The urine samples were obtained from a "mixed patient population" at a "medical facility." The study was conducted in the US at Wichita State University (Kansas), though the manufacturer is based in Korea. The study appears to be prospective, as fresh urine samples were obtained and tested for the evaluation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used for establishing ground truth, nor their specific qualifications beyond the study director, James Jackson MT(ASCP) CLS, Ph.D. While the study director is qualified, it's not indicated if he acted as the sole expert for all ground truth determinations or if additional, similarly qualified personnel were involved in reading the strips and/or performing confirmation tests.

4. Adjudication Method for the Test Set:

The study involved a comparison between the DIASCREEN® Reagent Strips and the Bayer Multistix 10 SG. When data between the two products did not agree within one color block, an "alternate procedure" (confirmation test) was used. This implies an adjudication process where a third, more definitive method resolved discrepancies between the initial two readings.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The study compares the performance of the DIASCREEN® strips to a predicate device and to confirmative tests, not the improvement of human readers with vs. without AI assistance. The device is a visual dip-and-read strip, not an AI-assisted diagnostic tool in the sense of image analysis software.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the sense that the performance of the DIASCREEN® Reagent Strips themselves was evaluated independently against comparator methods and against a predicate device. The results are based on visual comparison with a color chart, which is the intended standalone use of the device. The study evaluates the algorithm of the test strip (i.e., its chemical reactions and color development) and the visual interpretation of results.

7. Type of Ground Truth Used:

The ground truth for the test set was established using a combination of:

• Predicate Device Comparison: Bayer Multistix 10 SG was used as a primary comparator.
• Confirmatory (Reference) Tests: For discrepancies (data not agreeing within one color block between DIASCREEN® and Bayer), specific confirmation tests were employed for each analyte:
  • Specific Gravity: Refractometer
  • Leukocyte: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)
  • pH: pH Meter
  • Blood: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim), Ascorbic Acid Test/Urispec (Henry Schein)
  • Nitrite: Microscopic Evaluation, CHEMSTRIP (Boehringer Mannheim)

8. Sample Size for the Training Set:

The document does not provide information about a "training set" or its sample size. This type of device (visual reagent strip) does not typically involve machine learning or AI models that require specific training sets in the computational sense. The "development" of the strips would involve chemical formulation and calibration, rather than algorithmic training on a dataset.

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

As no "training set" in the context of AI/machine learning is described, there is no information on how its ground truth was established. The "ground truth" for the performance evaluation in this document refers to the established values obtained from the predicate device and the confirmatory reference methods on the test set of urine samples.

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