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Endoform® Reconstructive Template 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 or bridging material to obtain the desired surgical outcome.

Endoform Reconstructive Template - Non-Absorbable is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for soft tissue reconstruction. The device design includes thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of Endoform™ Reconstructive Template - Non-Absorbable devices includes lyophilization of single sheets of OFM followed by embroidery with polypropylene. Devices are terminally sterilized by ethylene oxide (EO) sterilization.

This document is an FDA 510(k) premarket notification decision letter for a surgical mesh device, Endoform® Reconstructive Template - Non-Absorbable. It does not describe an AI medical device or a study involving AI. Therefore, it is impossible to answer the questions about acceptance criteria and study proving an AI device meets those criteria based on the provided text.

The document discusses the substantial equivalence of the surgical mesh to a predicate device based on:

• Biocompatibility Data: Additional cytotoxicity testing, toxicological assessment, and viral inactivation assessment were performed.
• Performance Data: Biomechanical testing (uniaxial tensile strength, ball burst strength, suture retention strength) and an in-vivo study in a soft tissue reinforcement model.
• Clinical Data: No clinical data was submitted.

The provided text pertains to a physical medical device (surgical mesh) and its substantial equivalence determination, not an AI/ML medical device. Therefore, the questions about acceptance criteria for an AI device, sample sizes for AI test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for AI models are not applicable to the content of this document.

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Endoform Reconstructive Template is intended for usc 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 or bridging material to obtain the desired surgical outcome.

The Aroa Endoform Reconstructive Template ("ERT") is a surgical mesh manufactured by layering sheets of ovine forestomach matrix (OFM) to create 1- through 10- ply embroidered devices for implant applications as part of soft tissue reconstruction. The device design includes a range of thicknesses from 1- through 10- ply to give a range of strengths as required for a particular implant procedure. The construction of ERT devices includes lyophilization of single sheets of OFM followed by embroidery with polyglycolic acid (PGA). Devices are terminally sterilized by ethylene oxide (EO) sterilization. The device has received FDA clearance (K130547) for sizes up to 200cm2.

This document is a 510(k) premarket notification for a medical device called the "Endoform® Reconstructive Template" (ERT), which is a surgical mesh. The purpose of this notification is to declare that a modified version of the ERT is substantially equivalent to a previously cleared predicate device. The only change proposed is an increase in the maximum device size.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state specific numerical sample sizes for each test set (e.g., how many devices were tested for mechanical strength, endotoxin, etc.). It only broadly refers to "bench testing and validation testing."

• Test Set Sample Size: Not explicitly stated (e.g., number of units tested per bench test).
• Data Provenance: The studies were conducted by Aroa Biosurgery, Limited, which is based in New Zealand. The studies appear to be prospective for the modified device based on the phrase "Performance and validation testing executed based on risk analysis of the proposed change supports the substantial equivalence..."

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

This information is not applicable in this context. The "acceptance criteria" here refer to engineering and manufacturing specifications (e.g., mechanical strength, sterility, dimensions) for a physical medical device. Ground truth, in the context of expert consensus, is typically relevant for diagnostic devices or those requiring human interpretation of results. For this surgical mesh, the "ground truth" is defined by the established engineering standards and specifications.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among multiple human readers or experts when establishing a ground truth, often for image interpretation or clinical diagnosis. Since the "acceptance criteria" for this device are based on objective physical and chemical measurements (bench testing, sterility), there is no human interpretation or adjudication involved in meeting these criteria.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The document explicitly states: "No clinical data was submitted to support the safety and effectiveness of the modified Endoform Reconstructive Template." MRMC studies inherently involve human readers and clinical outcomes.

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

This question is not applicable. A "standalone" performance typically refers to the performance of an algorithm or AI system without human intervention. The Endoform Reconstructive Template is a physical surgical mesh, not an algorithm or AI-powered device.

7. The Type of Ground Truth Used

The "ground truth" (or basis for acceptance) for this device's performance is based on established product specifications, engineering standards, and regulatory requirements. This includes:

• Pre-defined mechanical strength targets.
• Specified endotoxin limits.
• Dimensional tolerances.
• Sterility Assurance Level (SAL) of 10⁻⁶.
• Biocompatibility as demonstrated by the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI models. The Endoform Reconstructive Template is a physical medical device. Its development and testing involve manufacturing processes, material science, and engineering validation, not an AI training paradigm.

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

This information is not applicable for the same reasons as point 8. There is no "training set" in the context of this device's development.

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