(111 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, diabetic ulcers, pressure ulcers, flaps, grafts and partial thickness burns.
The V.A.C. Granufoam Silver Protection dressing is an addition to the V.A.C. 9 product line of dressings designed specifically for use with the V.A.C. 0 Family of negative pressure devices. The V.A.C. GranuFoam Silver Protection dressing is comprised of black, reticulated, polyurethane foam covered with a silver coating.
The provided text describes the V.A.C. GranuFoam Silver Protection Dressing and its substantial equivalence to predicate devices, focusing on its use as an antimicrobial barrier and for negative pressure wound therapy. However, the details required to fill out a comprehensive table of acceptance criteria and a detailed study description for a typical AI/device performance evaluation are not fully present in the document.
Here's an attempt to extract and infer information based on the provided text, and point out where information is missing for a complete response:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Performance Threshold) | Reported Device Performance |
|---|---|
| Antimicrobial Barrier Effectiveness: Substantially equivalent to predicate devices (V.A.C. GranuFoam™ Silver dressing, Johnson & Johnson Silvercel™ Wound dressing) in terms of antibacterial effectiveness. | "Comparative in vitro testing to demonstrate antibacterial effectiveness was conducted on the V.A.C. GranuFoam® Silver Protection dressing, the V.A.C. GranuFoam® Silver dressing and the Johnson & Johnson Silvercel™ Wound dressing." (The specific results or a quantitative comparison demonstrating "equivalence" are not provided.) |
| Compatibility with V.A.C. Negative Pressure Systems: Substantially equivalent to predicate devices (V.A.C. GranuFoam® Silver dressing, V.A.C. GranuFoam® dressing) for use with V.A.C. family of negative pressure devices to promote wound healing including fluid removal. | "Comparative bench testing was conducted to provide evidence of equivalence in physical properties of the three dressings." (Specific physical properties and the results demonstrating "equivalence" are not detailed.) |
| Biocompatibility: Meets GLP testing standards in accordance with ISO-10993. | "Verification of the biocompatibility of the V.A.C. GranuFoam® Silver Protection dressing is based on GLP testing of the gamma-irradiated dressing in accordance with ISO-10993." (Specific test results or a quantitative statement of compliance are not provided.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified for the comparative in vitro or bench testing. The document refers to "testing" and "conducted on the dressings," but doesn't provide numbers of samples or experimental runs.
- Data Provenance: Not explicitly stated (e.g., country of origin). The testing described appears to be laboratory-based ("in vitro testing", "bench testing") rather than involving human subjects. Therefore, a "retrospective or prospective" classification isn't directly applicable in the typical clinical study sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. The studies mentioned (in vitro, bench testing) are not clinical studies involving expert interpretation or "ground truth" establishment in a diagnostic context. They assess material properties and antimicrobial activity.
4. Adjudication method for the test set
- Not applicable. As per point 3, this is not a study where expert adjudication would be relevant.
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
- No. This is a medical device (dressing) submission, not an AI/diagnostic software submission. Therefore, MRMC studies and AI assistance are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- No. This is not an algorithm or AI device.
7. The type of ground truth used
- For Antimicrobial Barrier Effectiveness: The "ground truth" would be established by microbiological laboratory standards and comparison to the known antibacterial performance of the predicate devices. The specific metrics (e.g., zone of inhibition, bacterial log reduction) are not detailed.
- For Compatibility with V.A.C. Negative Pressure Systems: The "ground truth" would be established by engineering specifications and performance characteristics (e.g., fluid handling capacity, tensile strength, pore size) of the predicate devices.
- For Biocompatibility: The "ground truth" is established by the international standard ISO-10993, which outlines methods for evaluating biological responses to medical devices.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. As per point 8, this is not an AI/machine learning device.
§ 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.