TAPE & BANDAGE, ADHESIVE by ROBERT R. STEVENS

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.

Acceptance Criteria (Implied by Class I and Substantial Equivalence)	Reported Device Performance (Implied)
Same intended use as predicate device	"Cutaneous Compression Device for General Hospital Use" is similar in function to "Cutaneous Compression Device for Hemodialysis" (implied use for localized pressure/wound care).
Similar technological characteristics to predicate device	Assumed to be similar in material, design, and function to the predicate adhesive tape/bandage. The document doesn't detail specific technological characteristics but implies similarity to a basic bandage.
Raises no new questions of safety or effectiveness	Substantial equivalence determination implies no new safety or effectiveness concerns compared to the predicate.

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)

Summary

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K955270

AUG

Summary of Safety and Effectiveness X.

Classification Name:	Tape and Bandage, Adhesive21 C.F.R. § 880.5240 (1994).
Common/Usual Name:	Cutaneous Compression Device for General HospitalUse.
Proprietary Name:	At present, no proprietary name has been chosen for this device.
Establishment Registration:	Mr. Robert R. Stevens has not yet engaged in activities requiring establishment registration. Upon engaging in such activities, an establishment registration will be filed in accordance with the requirements set forth at 21 C.F.R. § 807.20 (1994).
Classification:	Under Section 513 of the Federal Food, Drug, and Cosmetic Act, this device is classified into Class I.
Performance Standards:	As of the date of this Premarket Notification submission, no Performance Standards have been established for this device under Section 514 of the Federal Food, Drug, and Cosmetic Act. As such, no actions have been taken to comply with Section 514 Performance Standards.
Labeling/Promotional Materials:	Proposed labeling is included in this submission.
Substantial Equivalence:	This device is substantially equivalent to the following legally-marketed device ("Predicate Device") in terms of safety, effectiveness, and intended use:Product: Cutaneous Compression Device for HemodialysisManufacturer: Mr. Robert R. Stevens510(k) Number: K951973Substantial Equivalence Date: Class I exempt.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).