Search Results

The Combi Scan 100 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!

The Combi Scan 100 is a small urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!

The provided documentation describes the Combi Scan 100, an automated urine analyzer, and its 510(k) submission for substantial equivalence to a predicate device, the Clinitek 50. However, the document does not contain specific acceptance criteria, a detailed study report demonstrating performance against such criteria, or the methodology used for establishing ground truth or expert adjudication.

The document is a 510(k) summary and an FDA clearance letter, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed performance study with acceptance criteria.

1. Table of Acceptance Criteria and Reported Device Performance:
   This information is not available in the provided text. The document states that "Analyticon has submitted Information that shows the substantial equivalence to the predicative device," but it does not detail the specific performance metrics or acceptance criteria used to establish this equivalence, nor does it present the Combi Scan 100's performance against them in a table.

2. Sample size used for the test set and the data provenance:
   This information is not available in the provided text. The submission summary does not include details on the sample size used for any testing or the provenance of the data (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   This information is not available in the provided text. There is no mention of expert involvement in establishing ground truth for any test sets.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   This information is not available in the provided text. No adjudication method is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   This information is not applicable/not available. The Combi Scan 100 is described as an "Automated Urine Analyzer" that measures urine test strips. It does not appear to be an AI-assisted device designed to improve human reader performance in a diagnostic setting. Therefore, an MRMC comparative effectiveness study involving AI assistance for human readers would not be relevant to this device as described.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
   This information is not explicitly detailed, but the nature of the device suggests standalone performance: "The instrument measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." This implies the device provides direct results without human interpretation of the color changes. Comparison is made to another automated analyzer, the Clinitek 50. The summary itself is focused on device properties and functional equivalence rather than detailed performance studies.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   This information is not available in the provided text. The document does not specify how the ground truth for any performance evaluation was established. For urine analyzers, ground truth typically involves reference laboratory methods or established manual interpretations of test strips.

8. The sample size for the training set:
   This information is not available in the provided text. There is no mention of a "training set" or its size, as this type of device (an automated urine analyzer) typically relies on predefined optical or chemical reaction parameters rather than a machine learning training paradigm.

9. How the ground truth for the training set was established:
   This information is not applicable/not available for the reasons stated above (no mention of a training set or machine learning).

Ask a specific question about this device

The Combi Scan 500 is for use with Combi Screen test strips to determine the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity, urobilinogen. These measurements are used in the evaluation of diabetes, liver diseases, haemolytic diseases, urogenital and kidney disorders or metabolic abnormalities. For professional use only, not for self testing!

The Combi Scan 500 is a medium automated urine test strip analyser for use with Combi Screen test strips to determine one or more of the following parameters from urine: ascorbic acid, bilirubin, blood, glucose, ketones, leucocytes, nitrite, pH, protein, specific gravity. For professional use only!

The provided text describes the Combi Scan 500, an automated urine analyzer, and its 510(k) submission. However, it does not include detailed information about acceptance criteria, specific study designs, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or multi-reader multi-case studies. The document primarily focuses on comparisons to a predicate device and regulatory approval.

Therefore, many of the requested details cannot be extracted from the provided text.

Here's the information that can be extracted, with explicit notes for what is not present:

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

The provided document does not explicitly state specific acceptance criteria (e.g., sensitivity, specificity thresholds) or detailed reported device performance in a quantitative or tabular format. It states the device "measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results." However, it does not quantify what constitutes "meaningful results" or provide performance metrics against such criteria.

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

The document does not provide any information regarding the sample size used for any test set or the data provenance (country of origin, retrospective/prospective).

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 document does not provide any information regarding the number or qualifications of experts used to establish ground truth.

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

The document does not describe any adjudication method.

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

A multi-reader multi-case study was not mentioned or described. The device is an automated urine analyzer, intended to replace or assist in manual reading of test strips, but the document does not focus on human reader performance with or without the device.

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

The Combi Scan 500 is an automated urine analyzer. Its operation, as described ("The instrument measures the color of the light that is reflected from the test pads on the strip... These data are converted into meaningful results"), indicates it is a standalone device that performs measurements without direct human-in-the-loop interpretation during the measurement process. However, the document does not present a specific "standalone performance study" with metrics. It primarily establishes substantial equivalence to a predicate device.

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

The document does not explicitly define the type of ground truth used for any validation studies. Given the nature of a urine analyzer, the ground truth would typically be established by established laboratory methods (e.g., quantitative chemical analysis, microscopic examination of urine sediment, or manual expert reading of the dipsticks by trained personnel). However, this is not stated in the provided text.

8. The sample size for the training set

The document does not provide any information regarding the sample size used for a training set. The Combi Scan 500 is a reflectometric device, and the document doesn't explicitly mention machine learning or AI models requiring "training sets" in the modern sense. It refers to a measurement technology that converts reflected light data into results.

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

Since no training set is described, how its ground truth was established is not provided.

Ask a specific question about this device

Model 10SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, and Leukocytes in urine
Model 11SL: For rapid determination of Bilirubin, Urobilinogen, Ketones, Glucose, Protein, Blood, Nitrite, pH-Value, Specific Gravity, Leukocytes, and Ascorbic Acid in urine.

The urine test strips can be used for the determination of the complete chemical urine status with the parameters: bilirubin, blood, ketones, glucose, leukocytes, nitrite, pH-value, protein, urobilinogen. In addition the specific gravity can be tested. With it early symptoms of three great groups of diseases can be indicated:
Disorders of the carbohydrate metabolism (diabetes)
Illness of the kidney and urinary passages (e.g. infections of urinary passages, tumors, glomerulonephritis, pyelonephritis)
Illness of liver and haemolytic disorders.

The provided text is a 510(k) summary for the Combi-Screen Urine Test Strips. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical study results and acceptance criteria in the same way one might for a novel diagnostic device.

Therefore, the information available is limited regarding explicit acceptance criteria and a structured study proving those criteria are met for the new device. The submission primarily relies on comparison to the predicate device and a general statement about accuracy.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Device Performance

The submission does not explicitly state quantitative acceptance criteria (e.g., specific sensitivity/specificity thresholds, agreement percentages with a gold standard) for each analyte for the Combi-Screen Urine Test Strips. Instead, it relies on demonstrating equivalence to the predicate device and the general statement that "They did not observe any false-negative or false-positive results." This implies that the 'acceptance criteria' are implicitly that the new device performs at least as well as the predicate device and other commercially available strips, without significant errors.

Additional Information (Based on provided text):

1. Sample size used for the test set and the data provenance: The document does not specify the sample size for the test set. The data provenance is not explicitly mentioned (e.g., country of origin), and it's unclear if the study was retrospective or prospective.

2. 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.

3. Adjudication method for the test set: This information is not provided in the document.

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: This device is a manual urine test strip, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance is not applicable and was not performed.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This device is a manual urine test strip that relies on human visual interpretation of color changes. It is not an algorithm-only device. "Standalone" performance in this context would refer to the strip's chemical reaction accuracy rather than an algorithm's.

6. The type of ground truth used: The document states "accuracy study" and comparison to "test strips of the manufacturers: Roche, Dade-Behring, Bayer, Macherey-Nagel." This implies that the ground truth was likely established by comparing the results of the Combi-Screen strips against established, perhaps laboratory-based, methods or other gold-standard urine analysis methods (though not explicitly stated as pathology or outcomes data). The phrase "They did not observe any false-negative or false-positive results" suggests a comparison against known positive and negative samples, or against reference methods.

7. The sample size for the training set: The document does not specify a training set as this is not an AI/machine learning device. The "accuracy study" would typically involve a test set.

8. How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device