(90 days)
The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation.
Specific indications for the TenoTac® include:
· Foot & Ankle: Medial/lateral reconstruction, mid and forefoot repair, hallux valgus repair, metatarsal ligament/tendon repair or reconstruction, Achilles tendon repair
The TenoTac® Soft Tissue Fixation System is manufactured from titanium alloy (Ti-6Al-4V ELI per ASTM F136) and is comprised of specialized threaded tacks/male implants and associated threaded sleeves/female implants for attaching soft tissue to bone. The tacks and sleeves are available in various sizes and lengths to accommodate different bone sizes.
This document describes a 510(k) premarket notification for the "TenoTac® Soft Tissue Fixation System". The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific performance acceptance criteria for a novel device. Therefore, the information provided does not fully align with the requested format for acceptance criteria and a study proving a device meets those criteria in the context of an AI/algorithm-driven device.
Based on the provided text, here's an attempt to answer the questions in the requested format, acknowledging the limitations due to the nature of a 510(k) for a physical medical device.
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a physical medical device, not an AI/algorithm, "acceptance criteria" here refers to the performance demonstrated to show substantial equivalence to the predicate device. The "reported device performance" is the outcome of the nonclinical testing.
| Acceptance Criteria (Demonstrates Substantial Equivalence via Mechanical Properties) | Reported Device Performance (Summary of Test Results) |
|---|---|
| Mechanical properties equivalent to or better than predicate device (implicitly for soft tissue to bone fixation) | Demonstrated through static pull-apart and static axial pullout testing in bone analog material. |
| Biocompatibility and Pyrogenicity | Bacterial endotoxin testing demonstrated an endotoxin limit of 20 EU/Device. |
2. Sample size used for the test set and the data provenance
The document mentions "All necessary testing has been performed on representative TenoTac® Soft Tissue Fixation System devices." However, it does not specify the sample size for the mechanical or biocompatibility tests.
The data provenance is from nonclinical testing of the TenoTac® Soft Tissue Fixation System, developed by Paragon 28, Inc., in the United States (Englewood, Colorado). It is not retrospective or prospective in the sense of clinical study data, but rather laboratory-based testing of a manufactured product.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable as the ground truth for a physical medical device's mechanical performance is established through calibrated laboratory testing against engineering standards or comparisons to a predicate device, not through expert consensus on diagnostic images or clinical outcomes.
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for expert consensus in clinical or imaging studies to establish ground truth from potentially differing opinions. For a physical device's mechanical testing, the "truth" is derived directly from the physical measurements obtained during the tests.
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 question is not applicable. MRMC studies are specific to evaluating the performance of diagnostic systems (often involving AI) that assist human readers (e.g., radiologists, pathologists). This document is for a physical orthopedic fixation device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. This device is a physical implant, not an algorithm.
7. The type of ground truth used
For the mechanical testing, the "ground truth" implicitly refers to the measured mechanical properties (e.g., tensile strength, pullout force) derived from the static pull-apart and axial pullout tests, and the established safety limits for pyrogenicity. The comparison is made against the performance of the legally marketed predicate device (Zimmer Biomet JuggerKnot™ Soft Anchors device, K110145) to demonstrate substantial equivalence.
8. The sample size for the training set
This question is not applicable. There is no "training set" in the context of a 510(k) for a physical medical device. This term is relevant for machine learning algorithms.
9. How the ground truth for the training set was established
This question is not applicable. See the answer to question 8.
Summary of the Study:
The study referenced is a nonclinical performance evaluation designed to demonstrate substantial equivalence of the TenoTac® Soft Tissue Fixation System to its predicate device, the Zimmer Biomet JuggerKnot™ Soft Anchors device (K110145).
The types of tests performed include:
- Static pull-apart testing: Likely measures the force required to separate the soft tissue from the bone analog material when fixed by the device.
- Static axial pullout testing: Likely measures the force required to pull the device out of the bone analog material.
- Bacterial endotoxin testing: Used the kinetic turbidimetric method to ensure pyrogenicity (endotoxin limit of 20 EU/Device).
The conclusion of the study, as stated in the 510(k) summary, is that "Side-by-side performance testing demonstrates the substantial equivalence of the TenoTac® Soft Tissue Fixation System to the JuggerKnot™ Soft Anchors." The device is considered substantially equivalent based on its indications for use, design, and function, given the results of these nonclinical tests. Clinical data were not deemed necessary to support the safety and effectiveness.
§ 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.