(133 days)
Tornier® Surgical Mesh is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of hernia or other fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® Surgical Mesh is also intended for reinforcement of soft tissues, in conjunction with sutures and/or suture anchors during tendon repair surgery; including the reinforcement of rotator cuff, patellar, Achilles, biceps and quadriceps tendons.
Tornier® Surgical Mesh is not intended for use as a replacement for normal body structures or to provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the tendon repair.
Tornier® Surgical Mesh is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into any desired shape or size without unraveling. The device is supplied sterile, for single-patient use for the reinforcement of soft tissue where weakness exists.
The provided text is a 510(k) summary for a medical device (Tornier® Surgical Mesh) and does not describe a study involving acceptance criteria for a device performance evaluation in the manner usually associated with AI/software devices (e.g., sensitivity, specificity, accuracy).
Instead, this document focuses on demonstrating substantial equivalence to legally marketed predicate devices primarily through biocompatibility testing and adherence to specific guidance documents for surgical mesh.
Therefore, many of the requested categories for device performance and study design are not applicable to the information provided in this 510(k) summary. I will address the applicable points based on the available text.
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices regarding intended use and materials. | The sponsor states: "This submission supports the position that the Tornier™ Surgical Mesh System is substantially equivalent to previously cleared devices..." |
| Compliance with biocompatibility standards. | "Substantial equivalence has been demonstrated by conduct of applicable biocompatibility testing as outlined in ISO10993." |
| Adherence to relevant FDA guidance documents for surgical mesh. | "In addition, Tornier has conducted testing consistent with the requirements of the Guidance Document entitled: 'Guidance for the Preparation of a Premarket Notification for a Surgical Mesh' (March 2, 1999)" |
| Materials having an established history of use for similar applications. | "The materials from which the Tornier device is fabricated have an established history of use..." |
| Similar clinical applications as legally marketed devices. | "Tornier, Inc. believes that the information provided establishes that similar legally marketed devices have been used for the same clinical applications as the Tornier™ Surgical Mesh System." (This is an assertion of the sponsor, and the FDA's clearance implies agreement based on the provided evidence). |
| Device performance should be appropriate for its intended use as a temporary support and reinforcement material, not a full replacement for normal body structures or to bear full mechanical strength of tendons. (Implicit in Indications for Use) | The Indications for Use explicitly state these limitations. The device's design (bi-layer, synthetic absorbable woven fabric) and the testing for substantial equivalence supports its role as reinforcement rather than primary mechanical support. |
(Note: This 510(k) is about demonstrating substantial equivalence, not establishing new performance benchmarks for a novel device. The "acceptance criteria" are therefore largely about conforming to existing standards and predicate devices rather than achieving specific numerical performance metrics like those for AI algorithms.)
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The document mentions "applicable biocompatibility testing" and "testing consistent with the requirements of the Guidance Document," but does not detail the specific sample sizes, methodologies, or data provenance (e.g., in vivo/in vitro, animal studies, country of origin) for these tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this type of submission. This 510(k) summary does not involve a study that establishes ground truth based on expert consensus for diagnostic or prognostic purposes, as it is for a surgical mesh device.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable to this type of submission. There is no diagnostic "test set" in the context of expert adjudication for this device.
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 information is not applicable to this submission. An MRMC study is relevant for AI-powered diagnostic/interpretive devices, not for a surgical mesh.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable to this submission. This device is a physical surgical mesh, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the biocompatibility and material testing referenced, the "ground truth" would be established by standardized laboratory testing procedures and scientific consensus on material properties and biological responses (e.g., ISO10993 standards). For demonstrating equivalence of clinical applications, the ground truth is the established clinical use and safety profiles of the predicate devices.
8. The sample size for the training set
This information is not applicable to this submission. There is no concept of a "training set" for a physical surgical mesh device in this context.
9. How the ground truth for the training set was established
This information is not applicable to this submission.
§ 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.