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MedTrade Product's Antiseptic Barrier Silver Foam Dressings should be used under health care professional direction for the following indications: Pressure ulcers Lower extremity ulcers, including: 1. Venous 2. Arterial Mixed etlology 3. Diabetic ulcers Donor sites

MedTrade Product's Antiseptic Barrier Silver Foam Dressing is an exudate handling system intended for low to moderate exuding wounds. The antibacterial activity acting in the dressing is supported by laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginose, Staphylococcus aureus & Escherichia coli. The island dressing maintains a moist wound environment, which is conducive to optimal wound healing. During use the absorbent island gently expands as it takes up exudate. During use the lesion size may initially increase. This is normal and to be expected prior to wound granulation. Dressings are supplied sterile in single use pouches. Product is gamma irradiated in accordance with the Sterilisation of Health Care Products - Requirements for Validation and Routine Control - Radiation Sterilisation. 30 Edition (ANS/AAMI/SO11137 - 1995) and Microbiological Methods for Gamma Sterilisation (AAMI TIR8-1991) for qualification for Method 1 for dosimetric release with a sterility assurance level of 10 7. Packaging will consist of a single dressing in either a paper / paper / poly pouch, the pouches will then be placed in to a sales carton, with an Instructions For Use Leaflet.

The provided document is a 510(k) premarket notification for a medical device, specifically an Antiseptic Barrier Silver Foam Dressing. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting a new effectiveness study with specific acceptance criteria and performance metrics for the new device.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes for test or training sets, expert consensus details, or MRMC comparative effectiveness studies.

Instead, the submission demonstrates equivalence through a comparison of characteristics with a predicate device.

Here's an analysis of the information available in the document in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable in the traditional sense for a 510(k) submission.
• The document provides a "COMPARATIVE FEATURES" table, which lists characteristics of the proposed device and its predicate (MedTrade Product's Self Adhesive Foam Island Dressing, K993627). This table serves to show that the new device's specifications are similar to those of a device already on the market.
• The document mentions "laboratory testing demonstrating significant antibacterial activity against Pseudomonas aeruginosa, Staphylococcus aureus & Escherichia coli" for the antibacterial activity of the silver in the dressing. This is the closest thing to reported device performance but no specific acceptance criteria (e.g., "X% reduction in bacterial count") or detailed study results are provided within this summary.

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

• Not provided. 510(k) submissions demonstrating substantial equivalence typically do not involve new clinical trials with test sets in the same way a PMA submission would. The "test set" here would implicitly be the data supporting the predicate device or the bench testing data (e.g., antibacterial activity), but no sample sizes are given.
• Data Provenance: The antibacterial activity testing is stated as "laboratory testing." No country of origin is specified for this testing. The information on the predicate device's performance is inherent to its prior clearance and presumably from a variety of sources.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

• Not applicable/Not provided. This type of information relates to clinical studies and expert review for establishing ground truth, which is not described as being part of this 510(k) submission.

4. Adjudication Method for the Test Set:

• Not applicable/Not provided. No clinical test set requiring adjudication is described.

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

• No an MRMC study was done. This is a comparison of human reader performance with and without AI assistance, which is irrelevant for a foam dressing device.

6. Standalone (Algorithm Only) Performance Study:

• No standalone study was done. This concept applies to AI algorithms, not a physical medical device like a wound dressing. The antibacterial activity is a "standalone" performance characteristic of the dressing itself, but it's not an algorithm.

7. Type of Ground Truth Used:

• Not explicitly stated in the context of clinical outcomes for the new device.
  • For the antibacterial claims, the "ground truth" would be established by standard microbiological methods showing inhibition or reduction of bacterial growth.
  • For biocompatibility, the "ground truth" would be the successful completion of ISO/Tripartite guidelines for dermal sensitization, cytotoxicity, acute systemic toxicity, and hemocompatibility/hemolysis.
  • For substantial equivalence, the "ground truth" is the established safety and effectiveness of the predicate device (MedTrade Product's Self Adhesive Foam Island Dressing K993627 and Maersk Medical's Arglaes-AB Antiseptic Barrier Dressing K99080).

8. Sample Size for the Training Set:

• Not applicable/Not provided. Training sets are used for machine learning models, which is not relevant to this device.

9. How the Ground Truth for the Training Set was Established:

• Not applicable/Not provided.

In summary, this 510(k) submission relies on demonstrating substantial equivalence to existing devices through a comparison of design, composition, and function, as well as providing general statements about laboratory testing for specific claims (like antibacterial activity and biocompatibility), rather than presenting a new, full-scale clinical trial with detailed acceptance criteria and performance data as might be found in a PMA submission or for AI/diagnostic devices.

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