(85 days)
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.
§ 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.