Search Results

The TenoTac® Soft Tissue Fixation System is intended to be used for soft tissue to bone fixation. Specific indications for the TenoTac® device include:

Foot & Ankle: Medial/lateral repair and reconstruction, mid and forefoot repair, hallux malleus repair and reconstruction, metatarsal ligament/tendon repair and reconstruction including plantar plate attenuation and tear, and the correction of hammer toe, claw toe, mallet toe, crossover toe, floating toe, and any other lesser toe deformities, correction of metatarsophalangeal joint instability due to shortening from interphalangeal fusion, correction of metatarsophalangeal joint instability due to shortening from Weil osteotomy, Achilles tendon repair.

Hand & Wrist: Collateral ligament repair, Scapholunate ligament reconstruction, tendon transfers in phalanx, Volar plate reconstruction.

The TenoTac® Soft Tissue Fixation System is manufactured from titanium alloy (Ti-6Al4V 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.

The provided document is a 510(k) premarket notification from the FDA for a medical device called the "TenoTac® Soft Tissue Fixation System." This type of submission is for demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive new clinical or non-clinical studies.

Therefore, the document explicitly states:

• "Neither clinical or non-clinical testing were necessary to support substantial equivalence of the subject device."

This means that the document does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria in the way you've outlined for performance evaluation of a novel or significantly modified device, especially one involving AI or diagnostic performance.

The 510(k) process primarily relies on demonstrating that the new device has the same intended use and technological characteristics as a predicate device, and that any differences do not raise new questions of safety or effectiveness. For the TenoTac® Soft Tissue Fixation System, the substantial equivalence was based on:

• Same intended use: Soft tissue to bone fixation.
• Same technological characteristics: It is a two-piece titanium tack and sleeve construct inserted on two ends of a bone canal, similar to the predicate TenoTac device. Differences in material and shape compared to a reference device (JuggerKnot) were considered not to raise new questions of safety or effectiveness.

In summary, because this is a 510(k) submission based on substantial equivalence, there is no performance study described that would meet your detailed requirements for acceptance criteria, sample sizes, expert evaluations, or ground truth establishment.

Therefore, I cannot populate the table or answer the specific questions you've asked based on the provided text.

Ask a specific question about this device

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.

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.

Ask a specific question about this device