(72 days)
The V.A.C. GranuFoam Silver Protection Dressing is intended for use with the V.A.C. family of negative pressure wound therapy systems to help promote wound healing. The dressing is an effective barrier to bacterial penetration and may help reduce infection in chronic, acute, traumatic, subacute and dehisced wounds, partial thickness burns, ulcers (such as diabetic, pressure or venous insufficiency), flaps and grafts.
The V.A.C. GranuFoam Silver Protection Dressing is a component of the V.A.C. Therapy System which is an integrated negative pressure wound management system. The dressing is polyurethane foam with a silver coating designed specifically for use with the V.A.C. family of negative pressure wound therapy devices.
The provided documentation describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to a predicate device (K053627). The information primarily focuses on demonstrating equivalence rather than establishing acceptance criteria and performance against novel targets.
Here's an analysis of the provided text in relation to your request:
Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in terms of quantitative performance metrics for a new study. Instead, it demonstrates that the new device has "Same as predicate" or "equivalent results" for certain characteristics.
| Acceptance Criteria (based on predicate equivalence) | Reported Device Performance (New Device) |
|---|---|
| Indications for Use: Should be same as predicate with the addition of venous insufficiency ulcers. | "Same as predicate with the addition of venous insufficiency ulcers, cleared under 510(k) K091585." |
| Dressing composition: Should be same as predicate. | "Same as predicate" |
| Antibacterial activity: Should show equivalent activity against S. aureus, P. aeruginosa, and E. coli as the predicate device. | "Testing has been conducted and the product has been shown to pass these tests with equivalent results." |
Study Details
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated for the antibacterial activity testing. The document mentions "Studies of the antibacterial activity of the predicate device were previously conducted" and then states "testing has been conducted" for the proposed change. It does not provide the sample size of the new testing.
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). However, the nature of the tests (antibacterial activity) suggests laboratory-based testing rather than patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The "ground truth" here relates to the results of antibacterial activity in a laboratory setting, not clinical expert assessment.
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Adjudication method for the test set:
- Not applicable, as the evaluation is based on laboratory test results, not expert review or adjudication.
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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:
- No. This is a medical device (dressing) submission, not an AI software or imaging study.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For antibacterial activity, the ground truth is likely defined by standardized microbiological testing protocols and quantitative measurements of bacterial reduction or inhibition, as compared to the established performance of the predicate device.
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
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How the ground truth for the training set was established:
- Not applicable.
§ 878.4780 Powered suction pump.
(a)
Identification. A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.(b)
Classification. Class II.