(228 days)
Tornier® BioFiber Scaffold is intended for use where temporary wound support is required to reinforce soft tissues where weakness exists or for the repair of fascial defects that require the addition of a reinforcing or bridging material to obtain the desired surgical result.
Tornier® BioFiber Scaffold is 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® BioFiber Scaffold 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® BioFiber Scaffold is a bi-layer, synthetic absorbable reinforced woven fabric made from poly(4-hydroxybutyrate) fibers. The construction permits the mesh to be cut into anv desired shape or size without unraveling. The device is supplied sterile, for sinqle-patient use for the reinforcement of soft tissue where weakness exists.
This 510(k) summary (K102788) for the Tornier® BioFiber Scaffold does not contain the information needed to answer your questions thoroughly.
The document is a premarket notification for a medical device (surgical mesh) claiming substantial equivalence to previously cleared devices. It focuses on the device's description, intended use, and substantial equivalence to predicates, but does not provide details on specific acceptance criteria, pre-clinical or clinical studies with performance data, or ground truth establishment relevant to the performance of a device like an AI algorithm.
Here's a breakdown of what the document does and does not provide:
What the Document Provides:
- Device Name: Tornier® BioFiber Scaffold
- Classification: Class II, Absorbable Surgical Mesh, Product Code FTL
- Intended Use/Indications: Reinforcement of soft tissues where weakness exists, repair of fascial defects, and reinforcement of rotator cuff, patellar, Achilles, biceps, and quadriceps tendons during tendon repair surgery. It explicitly states it's not for replacement of normal body structures or to provide full mechanical strength.
- Predicate Devices: TephaFLEX™ Surgical Mesh (K070894) and Tornier® Surgical Mesh (K093799).
- Substantial Equivalence Claim: The device is claimed to be "exactly the same device as the Tornier predicate device" and that "scientific evidence of substantial equivalence has been previously submitted to FDA."
What the Document Lacks (and is necessary to answer your questions):
The 510(k) summary is for a physical medical device (surgical mesh), not an AI/algorithm-based device. Therefore, it does not typically involve the types of studies, metrics, or ground truth establishment that would be present for an AI-powered diagnostic or predictive tool.
Specifically, the document does not contain any of the following information requested:
- A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy, F1 score) or quantitative acceptance criteria, as it's not an AI diagnostic.
- Sample size used for the test set and the data provenance: Not applicable, as there's no diagnostic "test set" in the context of this physical mesh.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of human readers improvement with AI vs without AI assistance: Not applicable, as this is not an AI diagnostic device for human readers.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
Conclusion:
This 510(k) document is for a physical surgical mesh and is aimed at demonstrating substantial equivalence to predicates, not at proving the performance of an AI algorithm or diagnostic tool against specific acceptance criteria. Therefore, the requested information regarding AI device performance studies and ground truth establishment is not present in this document.
§ 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.