(30 days)
The KFx Tissue Fixation System (comprised of the KFx Suture Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and Accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromioclavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.
Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.
The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.
The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.
The provided text describes a medical device submission (K080229) for the KFx 5.5mm Suture Lock Bone Screw Anchor. This is a 510(k) Premarket Notification for a modified device, establishing substantial equivalence to a previously cleared predicate device (K072063).
It does not contain any information about a study involving AI or software, or acceptance criteria related to such a study. The document focuses on the mechanical performance and biocompatibility of a physical bone anchor in comparison to a predicate device.
Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided text.
The closest relevant information is:
Acceptance Criteria and Device Performance (Bench Testing):
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe | "Bench test results indicate that the device is safe..." |
| Satisfies functional performance requirements when used as indicated | "...and satisfies functional performance requirements when used as indicated..." |
| Does not raise new issues of safety or effectiveness | "...and do not raise new issues of safety or effectiveness." |
| Substantial equivalence to predicate device (K072063) | "The test results demonstrate that the modified KFx 5.5mm Suture Lock Bone Screw Anchor is substantially equivalent to the currently marketed predicate device." |
Remaining Requested Information (Not Available in the Text):
- Sample sized used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The "ground truth" here is likely mechanical testing standards and biocompatibility standards, not expert clinical interpretation.
- Adjudication method: Not applicable/mentioned for physical device bench testing.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device, not an AI/software.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
- The type of ground truth used: For biocompatibility, it's established standards and data on similar materials. For functional performance, it's likely engineering specifications and comparison to the predicate device's performance.
- The sample size for the training set: Not applicable; there is no "training set" in the context of this physical device submission.
- How the ground truth for the training set was established: Not applicable.
§ 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.