(73 days)
Permacol™ is indicated for use to provide soft tissue repair or reinforcement in plastic and reconstructive surgery of the face and head.
Permacol™ tissue is intended for use as a soft tissue patch to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue in plastic and reconstructive surgery of the face and head.
Permacol™ consists of a sterile, tough, off-white, moist, flexible, fibrous flat sheet comprised of acellular crosslinked porcine dermal collagen and elastin. Each impermeable inner pack contains a small quantity of saline to maintain its moistness and flexibility. The product is available in thicknesses of 0.5-1.5 mm and dimensions of 0.8 x 0.8 to 4 x 6 inches.
The provided 510(k) summary for Permacol™ Crosslinked Porcine Dermal Collagen Surgical Mesh does not contain the information requested regarding acceptance criteria or a study proving the device meets said criteria.
The document is a premarket notification for a Class II medical device, essentially asserting its substantial equivalence to previously cleared predicate devices. It focuses on:
- Device Identification and Classification: Naming the device, its sponsor, and its classification.
- Predicate Devices: Listing similar devices already on the market.
- Intended Use: Stating the purpose of the device (soft tissue repair/reinforcement in plastic and reconstructive surgery of the face and head).
- Technological Characteristics: Describing the material, form, and how it is used.
- Summary Basis for Substantial Equivalence: Arguing that the new device is sufficiently similar to existing ones and does not raise new questions of safety or effectiveness. This is the core of a 510(k) submission.
The information about specific acceptance criteria, performance data from a study, sample sizes, expert involvement, ground truth, or comparative effectiveness studies (MRMC) is typically not included in a 510(k) summary. These details would be part of a more extensive submission to the FDA, which is not publicly available in this format, or would appear in a full study report.
Therefore, for each of your requested points, the answer based solely on the provided text is:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "these differences do not raise any new questions of safety or effectiveness, as confirmed by preclinical and clinical evaluation," but does not give specific criteria or performance metrics.
- Sample sizes used for the test set and the data provenance: Not provided. The document mentions "preclinical and clinical evaluation" in a general sense but gives no details on studies, test sets, or data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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: Not applicable. This document describes a surgical mesh, not an AI-assisted diagnostic or imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithmic device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not provided.
- The sample size for the training set: Not applicable (not an AI/ML device) and not provided if referring to a general study.
- How the ground truth for the training set was established: Not applicable and not provided.
§ 878.3300 Surgical mesh.
(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.