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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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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) is a surqical mesh manufactured by layering sheets of ovine forestomach matrix to create multi-layer configurations of devices sewn together with resorbable Poly(lactic-co-glycolic Acid) ("PLGA") suture for use in plastic and reconstructive surgery. The 2-8 ply devices are available in surface areas up to 434 cm² in various shapes.

This document is a 510(k) Premarket Notification from the FDA for the OviTex PRS (Long-Term Resorbable) surgical mesh. While it discusses the device's characteristics and its comparison to a predicate device, it does not contain information about the acceptance criteria and study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device.

The document indicates that substantial equivalence was not based on an assessment of clinical performance data. Instead, it relies on preclinical, mechanical, and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested points cannot be answered from the provided text.

Here's a breakdown of what can be extracted and what cannot:

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

The document states: "New bench testing included mechanical strength, suture retention, endotoxin, and compliance testing. Results of the testing confirms that the proposed device meets all product specifications." However, it does not provide the specific acceptance criteria (e.g., tensile strength > X N, suture retention > Y N) or the quantitative reported device performance for these tests.

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

• Bench Testing (Mechanical, Suture Retention, Endotoxin, Compliance): The sample sizes for these tests are not provided. Data provenance is not specified beyond "Preclinical testing."
• Biocompatibility Assessment: Not specified.
• Implantation Study: Not specified.

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 is not applicable to the type of studies described (mechanical, biocompatibility, implantation) for a surgical mesh. These studies do not typically involve experts establishing ground truth in the way an AI/ML diagnostic device would for image interpretation.

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

Not applicable for the types of studies described.

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

No, an MRMC study was not done. This device is a surgical mesh, not an AI/ML diagnostic tool.

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

Not applicable. This is not an algorithm or software device.

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

• Bench Testing: Engineering specifications and standardized test methods.
• Biocompatibility: ISO 10993 standards and toxicological risk assessment.
• Implantation Study: Histopathological evaluation of tissue response compared to the predicate, as per ISO 10993-6. This could be considered a form of "pathology" ground truth. The study concluded that the subject device was "classified as a non-irritant" and had "advanced to complete resorption by 78 weeks."

8. The sample size for the training set

Not applicable. This device does not use an AI/ML algorithm that requires a training set.

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

Not applicable.

Summary Table (Limited Information Available from Document):

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