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SteriChek® Bicarb pH Reagent Strips provide a quick convenient means of checking the pH of bicarbonate solution used to prepare dialysate and concentrated bicarbonate solutions used in the preparation of dialysate.

The device is made up of a 0.20 inch square off-white reagent pad that has been chemically treated and affixed to one end of a 3.25 inch by 0.20 inch white opaque polystyrene strip. The reagent pad is activated by exposing it to the sample. The color of the pad is visually compared to a color chart to determine the pH of the bicarbonate solution.

I am sorry, but the provided text does not contain a detailed study proving the device meets acceptance criteria. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive study with specific acceptance criteria and detailed performance metrics.

However, based on the information provided, here's what I can extract and infer:

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

The document implicitly uses performance equivalence to the predicate device as its acceptance criteria.

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

• Sample Size: Not explicitly stated. The document mentions "acid/bicarbonate solutions" and "concentrated bicarbonate solutions" were "prepared," implying a laboratory setting, but the number of samples or data points is not provided.
• Data Provenance: Not explicitly stated. It's safe to assume a laboratory setting for the preparation of solutions, likely within the United States given the submitter's address, but this is an inference. The study appears to be prospective as it involves preparing specific solutions for testing.

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)

Not applicable. The ground truth was established by instrumental measurement.

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

Not applicable. The ground truth was established by instrumental measurement rather than expert adjudication.

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

Not applicable. This device is a reagent strip for visual comparison, not an AI or imaging device involving human readers.

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

This concept is not directly applicable to a reagent strip. The "performance" of the device is its ability to produce a color change accurately reflecting pH, which is then visually interpreted by a human against a color chart. The "algorithm" here is the chemical reaction on the strip. The testing was of this chemical reaction's accuracy against a standard reference method.

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

The ground truth was established using a "standard reference method with calibration based on NIST traceable standard reference material" to determine reference pH values. This is an objective instrumental ground truth.

8. The sample size for the training set

Not applicable. This device is a chemical reagent strip, not a machine learning model that requires a training set.

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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