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Endoform™ Reconstructive Template – PLGA is intended for use as a surgical mesh to reinforce and/or repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or abdominal wall defects that require the use of reinforcing material to obtain the desired surgical outcome.

Device Description

Endoform™ Reconstructive Template – PLGA is a surgical mesh comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). The device design includes a range of shapes, sizes, and thicknesses in surface areas up to 400cm², to give a range of strengths as required for a particular implant procedure. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

AI/ML Overview

This FDA 510(k) clearance letter and supporting summary for the Endoform™ Reconstructive Template – PLGA device does not involve artificial intelligence (AI) or machine learning (ML). Therefore, many of the requested elements for AI/ML device validation are not applicable.

The device is a traditional medical device (surgical mesh) and its substantial equivalence is demonstrated through non-clinical performance data and comparison to a predicate device. There is no mention of an algorithm, AI assistance, or human readers.

However, I can extract the information relevant to its acceptance criteria and the study that proves it meets those criteria, based on the provided document.

Acceptance Criteria and Study Proof for Endoform™ Reconstructive Template – PLGA

Since this is a traditional medical device (surgical mesh) and not an AI/ML device, the concept of "acceptance criteria" is related to meeting performance specifications and demonstrating biocompatibility and safety comparable to a predicate device, rather than diagnostic accuracy metrics. The "study" refers to non-clinical testing.

Here's a breakdown based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes the types of tests conducted and the conclusion that the device meets specifications, rather than providing specific numerical acceptance criteria and results in a table format common for AI/ML.

For this device, the "acceptance criteria" are implied by the performance characteristics demonstrated to be "substantially equivalent" to the predicate device and meeting recognized standards.

Acceptance Criteria Category	Description (Implied/Direct)	Reported Device Performance (Summary)
Material Composition	Consistency with ovine-derived extracellular matrix with PLGA reinforcement; comparable to predicate's ovine-derived ECM with PGA.	Comprised of multiple layers of ovine-derived extracellular matrix reinforced with poly(lactic-co-Glycolic) acid (PLGA). "Maintains the same fundamental technological characteristics as the predicate device with respect to material types."
Physical Dimensions	Range of shapes, sizes, and thicknesses for surface areas up to 400cm².	Designs include a range of shapes, sizes, and thicknesses in surface areas up to 400cm². "The subject device is offered in the same range of shapes, sizes, and thicknesses as the predicate device."
Sterilization Method & SAL	Ethylene Oxide sterilization with a Sterility Assurance Level (SAL) of 10⁻⁶.	"Devices are terminally sterilized by ethylene oxide (EO) sterilization." SAL of 10⁻⁶ achieved.
Endotoxin Content	Endotoxin content less than 20 EU/device.	Endotoxin Content:

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