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Genadyne A4-XLR8 Foam Dressing is intended to be used in conjunction with the Genadyne A4 Wound Vacuum System (K082676) to deliver negative pressure wound therapy to the wound. Genadyne A4 Wound Vacuum System is indicated for patients who would benefit from a suction device, particularly as the device may promote wound healing by the removal of excess exudates, infectious material and tissue debris.

A4-XLR8 Foam Dressing is appropriate for use on the following wounds:

• Pressure ulcers
• Diabetic/Neuropathic Ulcers
• Venous insufficiency ulcers
• Traumatic wounds
• Post-operative and dehisced surgical wounds
• Skin flap and grafts

Caution: Federal law restricts this device to sale by or on the order of a physician.

Genadyne A4-XLR8 Foam Dressing is manufactured using a reticulated flexible polyether and polyurethane hydrophobic foam material. The single-use dressing is housed in a Tyvek/Mylar Peel Pouch which is sterilized using EtO.

Genadyne A4-XLR8 Foam Dressing is available in three sizes; 1) small, 2) medium and 3) large.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Genadyne A4-XLR8 Foam Dressing:

The document provided is a 510(k) Summary for a medical device called the "A4-XLR8 Foam Dressing." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical efficacy from scratch. Therefore, the "acceptance criteria" and "study" described are often focused on showing that the new device performs comparably to the predicate device, especially in terms of safety and basic functionality relevant to its intended use.

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text describes bench testing rather than clinical testing with human subjects.

• Sample Size for Bench Testing:
  • For the comparative bench test, the exact number of units of each dressing (Genadyne A4-XLR8 Foam Dressing and Smith & Nephew Renasys F NPWT Foam Dressing) tested is not explicitly stated. It mentions "Genadyne collected data on 3 different conditions," which likely implies multiple measurements or samples for each condition. Without a specific number, it is inferred to be a sufficient sample size for engineering bench testing.
• Data Provenance: The comparative bench test was an in-house study conducted by Genadyne Biotechnologies, Inc. This indicates it was done by the manufacturer, likely in a controlled laboratory setting. No specific country of origin for the data is mentioned beyond "in-house," but the company is located in Great Neck, NY, USA. The nature of the tests (bench tests) means they are prospective experiments designed to evaluate specific physical and chemical properties.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable to this submission. The tests performed are primarily laboratory-based (biocompatibility, chemical residues, physical performance under vacuum). These types of tests establish "ground truth" through adherence to recognized standards (ISO, USP, ASTM) and objective measurements, not through expert human interpretation of medical data (like imaging or pathology).

4. Adjudication Method for the Test Set

This section is not applicable. Since the tests are objective measurements against defined standards or direct comparisons of physical properties (e.g., measuring dimensions, pressure, fluid volume), there is no need for expert adjudication in the way it would be used for clinical interpretations or subjective assessments.

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

This section is not applicable. The device being reviewed is a foam dressing for negative pressure wound therapy, not an AI or imaging diagnostic or assistive device. Therefore, an MRMC study is irrelevant to this product.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This section is not applicable. The device is a physical medical dressing, not an algorithm or an AI system. "Standalone performance" in this context would refer to the dressing's intrinsic properties and performance characteristics as measured in bench tests, which are covered extensively in item 1.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed can be categorized as:

• Objective Measurement against Standards: For biocompatibility tests (L929 MEM Elution, Kligman Maximization, Intracutaneous Injection), endotoxin tests (LAL), sterility-related tests (Bacteriostasis & Fungistasis, Bioburden Validation), and material property tests (Residual EtO/ECh/EG), the ground truth is established by adherence to specified international (ISO) and national (USP, ANSI/AAMI) standards, with results being quantitative measurements or qualitative assessments of compliance.
• Direct Comparative Measurement: For the "Comparative Bench Test," the ground truth is the directly measured performance of the predicate device (Smith & Nephew Renasys F NPWT Foam Dressing Kit). The subject device's performance is then compared to this benchmark to demonstrate "substantial equivalence." This involves objective measurements of dimensions, suction pressures, and fluid removal rates.

8. The Sample Size for the Training Set

This section is not applicable. The device is a passive medical device, not an AI or machine learning system that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

This section is not applicable, as there is no training set for this type of device.

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