(91 days)
The Arthrex Tenodesis Family of screws, made of various metals and polymers which are intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist. Specifically:
- Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder. Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
- Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Foot/Ankle: Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle
- Anterior Cruciate Ligament Repair, Medial Collateral Ligament Knee: Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis
- Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Elbow: Reconstruction
- Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/ wrist
The Arthrex Tenodesis Family of screws are manufactured using a variety of polymers or titanium metal. They are threaded, fully cannulated anchors with a rounded head. The Tenodesis Screws are available with specific instrumentation to aide implantation.
This document describes a 510(k) premarket notification for the Arthrex Tenodesis Family of screws. A 510(k) submission primarily demonstrates substantial equivalence to a predicate device, rather than providing new clinical study data with acceptance criteria for device performance as would be expected for novel devices or those undergoing a PMA.
Therefore, the requested information regarding acceptance criteria, device performance, and study details (like sample size, ground truth, expert involvement, and MRMC studies) for proving the device meets acceptance criteria is not applicable in the context of this 510(k) summary.
A 510(k) submission focuses on demonstrating that the new device has the same intended use and similar technological characteristics to a legally marketed predicate device, or that any differences do not raise new questions of safety or effectiveness. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA)."
Instead of clinical performance acceptance criteria, the "acceptance criteria" here relate to the regulatory requirements for demonstrating substantial equivalence. The "study that proves the device meets the acceptance criteria" is the 510(k) submission itself, which primarily includes comparisons to predicate devices based on materials, design, and intended use.
Here's a breakdown of what can be inferred from the provided text, and where the requested information is not available due to the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria (Regulatory): The primary acceptance criterion for a 510(k) is demonstrating "substantial equivalence" to a predicate device. This is achieved by showing the device has the same intended use and technical characteristics, or if different, that these differences do not raise new questions of safety and effectiveness.
- Reported Device Performance: The document states: "The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices." This is the core "performance" claim in a 510(k) context – that it performs equivalently safely and effectively to the predicates.
| Acceptance Criterion (Regulatory) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to predicate devices. | "The Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The devices, as designed, are as safe and effective as predicate devices." The FDA concurred with this assessment in their letter. |
| Same intended use as predicate devices. | The intended use for the Arthrex Tenodesis Family (fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, foot/ankle, knee, and hand/wrist) is deemed substantially equivalent to predicate devices. |
| Similar technological characteristics to predicate devices. | The description of the device (threaded, fully cannulated anchors with a rounded head, made of polymers or titanium metal) and its use with specific instrumentation implies similar technological characteristics to existing predicate suture anchors/fixation fasteners. The submission argues that any differences do not raise new safety or effectiveness concerns, and material characteristics are well-established. |
| Materials are well characterized and previously used in predicates. | This is explicitly stated: "Furthermore, the materials are well characterized and have been used in predicate devices with similar indications." This supports the safety and effectiveness claim. |
| No new questions of safety or effectiveness raised by differences. | This is the final conclusion made by the manufacturer and accepted by the FDA: "The difference between the Arthrex Bio-Tenodesis Screw, Arthrex Titanium Tenodesis Screws and the predicate devices with similar indications do not raise any questions regarding the safety and effectiveness of the implant." Further, the FDA's approval letter states the device "is substantially equivalent... to legally marketed predicate devices" and "do not require approval of a premarket approval application (PMA)." |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not Applicable. A 510(k) submission typically does not rely on a "test set" of patient data in the way a clinical trial for a novel device would. Instead, it relies on engineering assessments, material characterizations, and comparison to existing predicate devices. No new clinical study data with test sets, patient numbers, or data provenance is mentioned or required for this type of submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. No "test set" or ground truth requiring expert review is described in this 510(k) summary. The "ground truth" for a 510(k) is the established safety and effectiveness of the predicate devices.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. No test set or adjudication method is mentioned.
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 device is a surgical implant (suture anchor), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI assistance are wholly irrelevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. As above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable in the traditional sense. The "ground truth" for a 510(k) lies in the established safety and effectiveness of the identified predicate devices, which have already undergone regulatory scrutiny or have a long history of safe use in the market. The submission argues the new device is comparable to this established "truth."
8. The sample size for the training set
- Not Applicable. No training set for an algorithm is involved.
9. How the ground truth for the training set was established
- Not Applicable. No training set is involved.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.