(29 days)
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
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Shelf Life | Device meets specification through an adequate storage period. (Specific duration not explicitly stated as an acceptance criterion, but the duration tested.) | Real-time shelf life testing confirmed that OviTex PRS LTR meets specification through 18 months of storage. |
| Endotoxin Content | Complies with ISO 10993-7:2008 standards for endotoxin quantification. (Predefined acceptance criteria based on standard). | The results of testing showed that the additional device configurations met the predefined acceptance criteria. |
| Ethylene Oxide Sterilization Residuals | Complies with ISO 10993-7:2008 standards for ethylene oxide sterilization residuals quantification. (Predefined acceptance criteria based on standard). | The results of testing showed that the additional device configurations met the predefined acceptance criteria. |
| Packaging Integrity | The sterile barrier remains unchanged despite the removal of a layer of foil packaging. (Implied acceptance criterion: maintaining sterility). | The sterile barrier is unchanged after the modification. |
| Material/Construction | The new device configurations (25cm diameter circle, 25x30cm oval) maintain the fundamental construction of three layers of decellularized extracellular matrix and embroidery with Poly(lactic co-glycolic Acid) suture, consistent with the predicate device. (Implied acceptance criterion: structural equivalence for new sizes). | The new configurations contain three layers of decellularized extracellular matrix and are embroidered together with Poly(lactic co-glycolic Acid) suture. |
| Overall Substantial Equivalence | The modified device and new configurations are substantially equivalent to the predicate device in terms of safety and effectiveness. (Overall regulatory acceptance criterion). | "Overall, the results of non-clinical testing support a determination of substantial equivalence between and the predicate device." (Note: original phrasing is "between and the predicate device" which implies comparison). |
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.
§ 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.