(62 days)
The SpeedFix Suture Implant with inserter is indicated for use in fixation of soft tissue to bone. Examples of such procedures include:
Shoulder: Bankart Repair, SLAP lesion repair, acromio-clavicular separation, rotator cuff repair, capsule shift/capsule-labral reconstruction, biceps tenodesis and deltoid repair Ankle: Lateral instability, medial instability, Achilles tendon repair/reconstruction and midfoot reconstruction
Foot: Hallux valgus reconstruction
Elbow: Tennis elbow repair, biceps tendon attachment
Knee: Extra-capsular repairs; reattachment of: medial collateral ligament, posterior oblique ligament or joint capsule closure to anterior proximal tibia; extra capsular reconstruction, ITB tenodesis; patellar ligament and tendon avulsions
The SpeedFix Suture System is a bone anchor system with inserter handle designed for specific indications in arthroscopic and orthopedic procedures.
The provided text describes a 510(k) summary for the ArthroCare Corporation SpeedFix Suture System, not a study involving acceptance criteria and device performance in the context of AI or a reader study.
The document states that a "side-by-side comparison bench testing was performed on the proposed and predicate device per the US FDA Guidance Document for Testing Bone Anchors." However, it does not provide details of the acceptance criteria, the specific test results, sample sizes, or the other information requested in the prompt (e.g., data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training sets).
Therefore, based only on the provided text, I cannot complete the requested information. The document focuses on demonstrating substantial equivalence to a predicate device (SpeedFix Suture Implant cleared under K101437) rather than presenting a detailed performance study against defined acceptance criteria in the manner described by the prompt.
The document explicitly states: "The differences between the SpeedFix and the predicate device do not raise any questions regarding the safety and effectiveness of the implant. Furthermore, the materials are well characterized and have been used in predicate devices with similar indications. The proposed device, as designed, is as safe and effective as predicate devices." This indicates a reliance on the predicate device's established safety and effectiveness, supported by bench testing, rather than a de novo performance study against explicit internal acceptance criteria.
§ 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.