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Cutaneous Compression Device for Use in Hemodialysis.

This document is a 510(k) premarket notification for a medical device submitted in 1997. It describes a "Cutaneous Compression Device for Use in Hemodialysis." The purpose of a 510(k) is to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process does not inherently require the same level of detailed performance studies or AI-specific validation metrics that would be expected for a modern AI/ML-driven device.

Therefore, many of the requested items related to AI device performance, sample sizes for training/test sets, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this 1997 submission for a non-AI physical medical device.

I will address the applicable sections based on the provided text.

Acceptance Criteria and Study Details for K964041 - Cutaneous Compression Device for Use in Hemodialysis

This submission is for a physical medical device (Cutaneous Compression Device) and predates the common use of AI/ML in medical devices. The "acceptance criteria" in this context refer to demonstrating substantial equivalence to predicate devices, rather than meeting specific performance metrics of an AI algorithm. Similarly, the "study" referred to is the submission itself and the comparison made, not a clinical trial involving AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a non-AI device focused on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices in terms of safety, effectiveness, and intended use. There are no quantitative performance metrics for "device performance" in the AI sense provided in this summary.

Remaining Questions:

Most of the following questions are related to AI/ML device validation and are not applicable to this submission given its nature and date.

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

• Not Applicable: This is a pre-AI physical device submission. There is no "test set" in the context of an algorithm's performance. The "test" is the comparison to predicate devices based on design and intended use.

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: There is no "ground truth" establishment for an algorithm's performance in this submission. The regulatory ground truth is the FDA's determination of substantial equivalence.

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

• Not Applicable: No test set or expert adjudication process for an AI algorithm's output.

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 not an AI diagnostic or assistance tool, and therefore no MRMC study would be relevant.

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

• Not Applicable: This is a physical device, not an algorithm.

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

• Not Applicable: No ground truth in the context of AI performance is used. Substantial equivalence relies on comparing the device's design, materials, and intended use to legally marketed predicate devices.

8. The sample size for the training set

• Not Applicable: There is no AI algorithm, so no training set exists.

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

• Not Applicable: There is no AI algorithm, so no training set or its ground truth establishment.

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Tape and Bandage, Adhesive

This document (K955270) describes a Class I medical device, a "Cutaneous Compression Device for General Hospital Use," which is essentially an adhesive tape and bandage. As a Class I device, it is exempt from many requirements seen in higher-risk devices.

Based on the provided information, the device is considered substantially equivalent to a predicate device (K951973, a "Cutaneous Compression Device for Hemodialysis"), indicating that its safety and effectiveness have been established by comparison to an already legally marketed device.

Here's an analysis of your requested information based on the provided text:

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

For a Class I device like this, the "acceptance criteria" revolve around demonstrating substantial equivalence to a legally marketed predicate device. This typically means the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. Specific performance metrics are generally not required for Class I devices where substantial equivalence is the primary pathway.

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

• Sample Size for Test Set: Not applicable/Not provided. For Class I devices demonstrating substantial equivalence, formal clinical studies with "test sets" as understood in AI/performance studies are typically not required. The substantial equivalence argument relies on the inherent characteristics of the device and its predicate.
• Data Provenance: Not applicable/Not provided.

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. No "ground truth" establishment by experts, as typically seen in AI/diagnostic device studies, is mentioned or required for this type of device.

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

• Not applicable. There is no mention of a formal adjudication process or test set in the context of this Class I device submission.

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 passive physical compression device, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

• Not applicable. This device is not an algorithm or software. It is a physical medical tape/bandage.

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

• Not applicable. For this Class I device, the "ground truth" (if it could even be conceptualized) is its physical properties and intended use, which are assumed to be safe and effective based on its predicate and general knowledge of such products. No specific "ground truth" labels like pathology or expert consensus are generated.

8. The sample size for the training set

• Not applicable. This device does not involve machine learning or any form of "training set."

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

• Not applicable. (See #8)

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