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The Reprocessing Products Corporation Test Strips are intended for use in the monitoring of pH in Dialysate and Water.
The Reprocessing Product Corporation (RPC) pH Test Strips are indicated for determining the pH of acid dialysates, bicarbonate dialysates, or water. These Test Strips are indicated for testing acid/bicarbonate dialysates and water.
pH Test Strips are comprised of two different pH ranges:
pH = 6.8-8.5 (K100-0117) is for acid/bicarbonate dialysate, bicarbonate concentrate and water
pH = 0-14 (K100-0104) is for water used to make up dialysate.

Device is semi-quantitative, reagent test strip comprised of a pad impregnated with chemicals which change color upon contact with Dialysate or Water respectively. The pad is attached to a plastic strip for handling.

Here's an analysis of the acceptance criteria and study information for the Reprocessing Products Corporation pH Test Strips, based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state pre-defined acceptance criteria in terms of specific quantitative metrics like sensitivity or accuracy percentages. Instead, the performance is described qualitatively.

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

• Sample Size: The document does not specify a numerical sample size for the test set. It mentions "Reference solutions were used to evaluate pH performance." This implies a series of solutions at various pH levels within the specified ranges, but the exact number is not provided.
• Data Provenance: The document does not explicitly state the country of origin. It can be inferred that the testing was conducted by the manufacturer, Reprocessing Products Corporation, based in Tucson, AZ, USA. The data appears to be prospective, as it describes the evaluation of the product's performance against reference solutions.

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

The document does not mention the use of experts to establish ground truth for the test set. The ground truth appears to be established by the reference solutions themselves, whose pH values are presumably known through independent, calibrated means (e.g., pH meters).

4. Adjudication Method for the Test Set

No adjudication method is described or implied, as the ground truth is established by reference solutions and the device's color changes are matched against these.

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

No MRMC comparative effectiveness study is mentioned. This device is a test strip with a visual color change, not an AI-assisted diagnostic tool that would typically involve human readers interpreting images.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was done. The "Performance" section explicitly states: "The data confirm that the product consistently generates color changes which match the color blocks for the Reference solution pH." This refers to the device's inherent ability to produce accurate results independent of human interpretation or assistance, by visually matching the color to a provided chart.

7. Type of Ground Truth Used

The ground truth used was reference solutions with known pH values. The device's color changes were compared to the color blocks corresponding to these reference pH values.

8. Sample Size for the Training Set

The concept of a "training set" is not applicable here in the context of machine learning. This device is a chemical reagent test strip, not a machine learning algorithm. Its performance is based on chemical reactions, not trained data.

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

As explained above, there is no "training set" in the machine learning sense for this type of device. The chemical formulation of the test strip is designed to react in a specific way to different pH levels, and its performance is evaluated against chemically prepared reference solutions.

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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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