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OviTex PRS (Long-Term Resorbable) is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

OviTex PRS Long-Term Resorbable (OviTex PRS LTR) is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Poly(lactic co-glycolic acid). The device contains bidirectional fenestrations to allow for multidirectional stetch. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

This document is a 510(k) Premarket Notification from the FDA regarding the OviTex PRS (Long-Term Resorbable) surgical mesh. It does not describe an AI medical device or a study proving its performance against acceptance criteria in the way typically seen for AI/ML devices.

However, I can extract information related to acceptance criteria and testing for this non-AI medical device based on the provided text, and structure it in a way that aligns with your request for an AI device, noting where information is not applicable.

Acceptance Criteria and Device Performance for OviTex PRS (Long-Term Resorbable)

The provided document describes a 510(k) submission for a non-AI surgical mesh, OviTex PRS (Long-Term Resorbable). The "acceptance criteria" and "device performance" in this context refer to non-clinical testing to ensure the safety and effectiveness of a modified version of an already cleared device, and not to the performance of an AI algorithm. Therefore, many of the requested fields for AI performance studies are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not explicitly stated for each test. For the "additional device offerings" (25cm diameter circle and 25x30cm oval), tests for endotoxin and ethylene oxide residuals were conducted. The number of units tested is not provided.
• Data Provenance: Not specified, but generally, such non-clinical tests are performed in a laboratory setting by the manufacturer or contracted labs. The data is prospective, generated specifically for this submission.

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

• Not applicable. This is a non-AI medical device; "ground truth" established by human experts is not relevant to the non-clinical tests described (shelf life, endotoxin, etc.). These tests rely on laboratory equipment and standardized methodologies to determine objective measurements against predefined limits.

4. Adjudication Method for the Test Set

• Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or AI performance evaluations involving human interpretation. The tests described are objective, quantitative laboratory tests.

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

• Not applicable. This document pertains to a medical device (surgical mesh), not an AI algorithm, and therefore an MRMC study is not relevant.

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

• Not applicable. This is a medical device, not an AI algorithm.

7. The Type of Ground Truth Used

• For the non-clinical tests (shelf life, endotoxin, ethylene oxide residuals, packaging integrity), the "ground truth" is derived from objective, quantitative measurements against established scientific and regulatory standards (e.g., ISO 10993-7:2008 for biocompatibility tests, internal specifications for shelf life). It's not based on expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic device.

8. The Sample Size for the Training Set

• Not applicable. This is a medical device, not an AI algorithm that requires a training set.

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

• Not applicable. This is a medical device, not an AI algorithm.

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OviTex PRS is for implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair or reinforcement in plastic and reconstructive surgery. The device is supplied sterile and is intended for one-time use.

OviTex PRS is a sterile reinforced tissue matrix composed of biological tissue (ovine extracellular matrix) and Polyglycolic Acid (PGA) or Polypropylene (PP), known as OviTex PRS (STR) (or OviTex PRS Short Term Resorbable) and OviTex PRS PP (or OviTex PRS Permanent), respectively. The device contains unidirectional fenestrations to allow for stretching in a uniaxial direction. The polymer imparts additional structure to the ECM and maintains device integrity through the initial phases of healing. OviTex PRS is provided in various shapes and sizes to suit surgeon preference and nature of the soft tissue repair in plastic and reconstructive surgery. The device may be trimmed to a desired shape to further accommodate an individual patient's requirements.

The provided text is a 510(k) summary for the OviTex PRS surgical mesh. It describes the device, its intended use, and compares it to a legally marketed predicate device (Endoform Restella).

However, this document does not contain information about the acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The OviTex PRS is a surgical mesh, a physical medical device, not an AI/ML software device. Therefore, the requested information regarding AI/ML device performance metrics, sample sizes for test sets, ground truth establishment, expert adjudication, MRMC studies, and training set details are not applicable to this submission.

The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section discusses non-clinical testing related to the physical properties of the mesh (tensile strength, compliance, suture retention) and shelf-life, which are relevant for a physical surgical mesh. This section confirms that the two-layer OviTex PRS (STR) devices meet specifications and that the shelf life extension for OviTex PRS Permanent was validated.

Therefore, I cannot fulfill your request for the specific details of acceptance criteria and AI/ML study results because the provided text pertains to a physical medical device (surgical mesh), not an AI/ML device.

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Ovine Tissue Matrix is intended for use as a surgical mesh to repair soft tissue where weakness exists. Indications for use include the repair of hernias and/or body wall defects which require the use of reinforcing or bridging material to obtain the desired surgical outcome.

The OTM family is comprised of ovine derived extracellular matrix devices combined with polypropylene. The device is individually packaged and supplied sterile in various sizes and thicknesses to address the complexity of the soft tissue repair. The device is designed to perform as a surgical mesh for soft tissue repair while presenting a scaffold to the patient. The device is supplied "ready to use" in a peel pouch, and does not require rehydration or soaking prior to implant.

The provided documentation (K141053) describes the TELA Bio Incorporated Ovine Tissue Matrix (OTM), a surgical mesh. This document is a 510(k) summary, which establishes substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria in a detailed clinical study.

Therefore, many of the requested elements (acceptance criteria table, sample sizes, expert qualifications, adjudication, MRMC study, standalone performance, training set details) are not explicitly present in the provided text, as they are typically found in detailed study reports.

However, based on the information available, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

The document does not provide a table of explicit, quantitative acceptance criteria for each performance metric, nor does it report specific numerical performance results against such criteria. Instead, it states that the device's performance is "acceptable" or "equivalent" to the predicate.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Biomechanical bench, and in vivo performance testing have been conducted," but does not specify the sample sizes for these tests. The provenance of the data (country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document refers to "in vivo study" and "biomechanical bench testing" but does not detail how "ground truth" or performance assessment was established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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 is not applicable. The device is a surgical mesh, not an AI or imaging diagnostic tool that would typically involve human readers or AI assistance in this context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as it's a physical surgical mesh, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For biocompatibility, the ground truth was established by adherence to ISO 10993-1:2009 standards and testing protocols.
For biomechanical testing, the ground truth was defined by comparison to the predicate device and meeting the "requirements for their intended use".
For the "in vivo study," the ground truth for "safety and effectiveness" would likely be based on histopathological evaluation, clinical observations, and potentially macroscopic assessment in the animal model, but this is not explicitly detailed.

8. The sample size for the training set

This is not applicable as the device is a physical product and not an AI algorithm that requires a training set.

9. How the ground truth for the training set was established

This is not applicable for the same reason mentioned above.

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