(216 days)
The Tenodesis screws are intended for soft tissue reattachment procedures in foot surgery.
The system is indicated for soft tissue reattachment procedures in foot surgery, such as tendon reconstructions and tendon transfers.
The system can be used in adult patients. Additional information is provided in the corresponding surgical techniques.
The Tenodesis screw system is intended for soft tissue reattachment procedures in foot surgery. The screws are made of titanium alloy Ti-6AI-4V (ASTM F136). They are threaded, fully cannulated anchors.
The implants are offered in various sizes. The implants are provided non-sterile and single-use only.
The Tenodesis instruments are non-sterile and reusable.
Based on the provided text, the device in question is a "Tenodesis screw system." This document is a 510(k) submission, which focuses on demonstrating substantial equivalence to pre-existing predicate devices rather than proving performance against specific acceptance criteria in a traditional clinical study format for a novel device. Therefore, many of the requested categories for a study proving acceptance criteria will not be directly applicable or available in this type of submission.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
As this is a 510(k) submission, formal "acceptance criteria" for a novel device performance study are not explicitly stated. Instead, the submission relies on demonstrating substantial equivalence to predicate devices through mechanical testing and biocompatibility.
| Acceptance Criteria Category | Reference/Method | Reported Device Performance |
|---|---|---|
| Intended Use | Comparison to predicate devices (G-Force Tenodesis Screw, Arthrex Tenodesis Screw Family, Arthrex Resorbable Interference Screw) | The Tenodesis screw system has the same intended use for soft tissue reattachment procedures in foot surgery (tendon reconstructions and tendon transfers in adult patients). |
| Technological Characteristics | Comparison to predicate devices regarding design, components, materials, and principles of operation. | The system has similar performance characteristics, is manufactured from similar materials (titanium alloy Ti-6AI-4V), and is similar in design to the selected predicate devices. |
| Biocompatibility | ISO 10993-1 | Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1. All testing passed. |
| Mechanical Properties | Self-tapping performance, driving, torsional properties, and axial pullout strength tests. (Implied comparison to predicate devices, though specific benchmarks are not provided). | Self-tapping performance, driving, torsional properties, and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance. The subject and predicate devices are substantially equivalent. |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes for the mechanical and biocompatibility tests. It states that "Biocompatibility testing on the plates was conducted and evaluated per ISO 10993-1" and "Self-tapping performance, driving, torsional properties and axial pullout strength of the Tenodesis screw system and the predicate devices resulted in similar mechanical properties and performance." The data provenance is from the manufacturer's internal testing as part of the 510(k) submission. No information on country of origin of data or retrospective/prospective status is available for these non-clinical 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. The evaluations (biocompatibility and mechanical properties) rely on established international standards (ISO 10993-1) and direct physical measurements, not expert interpretation of data points that require a "ground truth" established by human experts in the sense of a clinical trial.
4. Adjudication method for the test set
Not applicable, as this is not a human-adjudicated clinical study. The evaluations are based on objective test results against established mechanical and biological performance parameters.
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 is a medical device (screw system), not an AI diagnostic or assistance tool. Therefore, an MRMC study and AI improvement metrics are not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For biocompatibility, the ground truth is compliance with the requirements of ISO 10993-1. For mechanical properties, the "ground truth" is measured physical properties that are comparable to those of the predicate devices, implying that the established performance of the predicate serves as the benchmark. No clinical "ground truth" (pathology, outcomes data) was used or required for this 510(k) submission.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not a machine learning or AI-driven device.
9. How the ground truth for the training set was established
Not applicable, for the same reason as point 8.
§ 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.