(23 days)
The Smith & Nephew TwinFix Ti Quick T is indicated for use as a suture anchor to facilitate percutaneous or endoscopic soft tissue procedures. The Smith & Nephew Suture Anchor is indicated for shoulder, foot, ankle, elbow, knee, wrist and hand. Examples of such procedures include: Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tendonesis, and deltoid repairs. Foot and Ankle: Hallux Valgus repairs, medial or lateral instability repairs/reconstructions, achilles tendon repairs/reconstructions, midfoot reconstructions, and metatarsal ligament/tendon repairs/reconstructions. Elbow, Wrist and Hand: Scapholunate ligament reconstructions, ulner or radial collateral ligament reconstructions, tennis elbow repair, and biceps tendon reattachment. Knee: Extra-capsular repairs: medial collateral ligament, lateral ligament, and posterior oblique ligament. Iliotibial band tendonesis, and patellar realignment and tendon repairs, including vastus medialis obliquous advancement.
The Smith & Nephew TwinFix Ti Quick T is a sterile single use anchor system which is designed to anchor suture to bone for the reattachment of soft tissue.
The provided text is a 510(k) summary for the Smith & Nephew TwinFix Ti Quick T, a suture anchor device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than presenting a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI would.
Therefore, the information requested about acceptance criteria, device performance, study design, sample sizes, expert involvement, and ground truth establishment, is not present in this document because it describes a regulatory submission for a medical device that achieves clearance through substantial equivalence, not through a performance study against predefined acceptance criteria for AI or diagnostic accuracy.
Here's an explanation of why the requested information cannot be extracted from this specific document:
- Type of Device: The Smith & Nephew TwinFix Ti Quick T is a suture anchor, a physical medical device. It is not an AI/ML algorithm or a diagnostic tool that produces outputs like classifications, segmentations, or risk scores that would be evaluated against diagnostic performance metrics (e.g., sensitivity, specificity, AUC).
- Regulatory Pathway: The document describes a 510(k) premarket notification. This pathway typically demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device. This often involves comparing technological characteristics (material, design, intended use, sterilization, etc.), rather than conducting large-scale clinical performance studies with acceptance criteria in the way AI/diagnostic devices do.
- Absence of Performance Data: The 510(k) summary explicitly states its purpose is to show "substantial equivalence in design, function, and intended use" to the predicate device K020159. It does not include any sections detailing:
- Specific acceptance criteria (e.g., "sensitivity must be > 90%").
- Reported device performance metrics (e.g., "achieved 92% sensitivity").
- Any form of clinical study or data analysis against a ground truth.
- Details about test sets, training sets, expert adjudication, or MRMC studies.
In summary, the provided document does not contain the information required to populate the requested table and answer the study-related questions for an AI/diagnostic algorithm because it pertains to a different type of medical device and regulatory clearance pathway.
§ 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.