(57 days)
TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction
The TAC-tite™ Suture Anchors are available in 5.5mm and 7.0mm diameters. The TAC-tite™ Suture Anchors are available with a threaded titanium (ASTM F136/ ISO 5832-3) anchor body (that provides a self drilling and self tapping thread). The TAC-tite™ anchor eyelet is designed to accept size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece delivers the preloaded anchor into the bone. The TAC-tite " Suture Anchor will be provided sterile for single use application.
This 510(k) summary (K090128) for the TAC-tite™ Suture Anchor System does not contain details about specific acceptance criteria or a study that proves the device meets such criteria.
The document primarily focuses on establishing "substantial equivalence" of the TAC-tite™ Suture Anchors to a predicate device (reNOVO Suture Anchors, K071520). Substantial equivalence in the FDA 510(k) process means that a new device is as safe and effective as a legally marketed predicate device. This is often demonstrated by showing equivalent intended use, materials, operational principles, and indications for use, rather than through a new, comprehensive performance study with acceptance criteria.
Therefore, most of the information requested in your prompt cannot be extracted from this document, as it describes a different regulatory pathway.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of acceptance criteria and the reported device performance:
- Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, pull-out force thresholds) or present performance data against such criteria. The basis for clearance is "substantial equivalence" to a predicate, not direct performance testing against new acceptance criteria.
2. Sample size used for the test set and the data provenance:
- Cannot be provided. No specific "test set" or associated data (country of origin, retrospective/prospective) for a performance study is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Cannot be provided. This type of information is relevant for studies relying on expert review (e.g., image-based diagnostic devices). This document does not
describe such a study.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Cannot be provided. Not applicable as no such study is 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:
- Cannot be provided. This is a surgical implant; MRMC studies are not relevant. This type of study is typically for diagnostic aids or AI-assisted interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Cannot be provided. Not applicable. The device is a physical surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Cannot be provided. There is no explicit "ground truth" discussed in the context of a performance study for this device within the document. The "truth" for substantial equivalence is implicitly the safety and effectiveness profile of the predicate device.
8. The sample size for the training set:
- Cannot be provided. No training set is mentioned as this is a physical device submission, not an AI or data-driven software submission.
9. How the ground truth for the training set was established:
- Cannot be provided. Not applicable as no training set is mentioned.
Summary regarding acceptance criteria and studies:
The provided 510(k) summary for the TAC-tite™ Suture Anchor System (K090128) asserts substantial equivalence to the reNOVO Suture Anchors (K071520) rather than demonstrating performance against specific, pre-defined acceptance criteria through a new clinical or performance study detailed in this document.
The basis for equivalence is stated as "equivalence in intended use, materials, operational principals, and indications." This is a common pathway for medical device clearance when a suitable predicate device exists. The FDA grants clearance when it determines that the new device is as safe and effective as the legally marketed predicate. The "study" mentioned here is essentially a comparative analysis against the predicate device, not a de novo performance study.
§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.
(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.