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PELNAC® Wound Matrix is indicated for the management of wounds including:

• · partial and full-thickness wounds,
• · pressure ulcers,
• · venous ulcers,
• · diabetic ulcers,
• · chronic vascular ulcers,
• · tunneled/undermined wounds,
• · surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound deliscence),
• · trauma wounds (abrasions, lacerations, partial thickness burns and skin tears), and
• · draining wounds.

The device is intended for one-time use.

PELNAC® Wound Matrix is a single layer wound matrix of 100% atelocollagen sponge derived from porcine Achiles tendon that is applied directly to the wound surface. When applied to full-thickness skin defects, PELNAC® Wound Matrix provides a scaffold for cellular invasion and capillary growth. The device is offered in sheet form of various sizes and in two levels of thickness and is provided terminally sterilized by ethylene oxide. PELNAC® Wound Matrix is for single patient use and can only be applied to a patient by a qualified doctor in a professional setting for the management of full-thickness skin defects as described in its product labeling.

The provided document is a 510(k) Premarket Notification for the PELNAC® Wound Matrix. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a study of the device's performance against specific acceptance criteria.

Based on the content, the document does not provide the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Instead, the document details a comparative analysis for substantial equivalence, focusing on:

• Indications for Use: Demonstrating the PELNAC® Wound Matrix has the same indications as the predicate device (AVAGEN Wound Dressing).
• Technological Characteristics: Comparing material composition, construction, mode of action, and other attributes to the predicate and reference devices.
• Non-Clinical Performance Data: Listing the types of non-clinical tests performed (e.g., biocompatibility, sterilization, physical/chemical properties) and stating that results confirmed product specifications were met, leveraging data from a previously cleared device (K191992).

Therefore, I cannot populate the requested table or answer most of the specific questions as the information is not present in the provided text.

Here's why and what can be inferred:

• Acceptance Criteria & Reported Performance: Not explicitly stated as pass/fail criteria for a specific clinical or non-clinical performance study. The document states that "Results confirm that the product specifications for the subject device have been met" for the non-clinical tests, but the specifications themselves or the detailed results are not provided.
• Study Design: No clinical study proving device performance against acceptance criteria is described. The document explicitly states: "Clinical Performance Data: Not applicable to this submission."
• Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance, Ground Truth, Training Set: These are all concepts relevant to a clinical or AI-based performance study, none of which were conducted or are described for this 510(k) submission. The non-clinical tests mentioned (biocompatibility, sterilization, etc.) would have their own sample sizes and testing protocols, but these are not detailed in the summary.

In summary, the provided text describes a 510(k) submission focused on demonstrating substantial equivalence through a comparison of technological characteristics and leveraging existing non-clinical performance data, rather than a de novo study against explicit acceptance criteria.

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