(90 days)
The ALLthread™ Titanium Suture Anchor devices are indicated for use in soft tissue reattachment procedures in the shoulder. Specific indications for the shoulder include: Bankart repair, acromio-clavicular separation, rotator cuff repair, capsule repair or capsulolabral reconstruction, biceps tenodesis, deltoid repair.
The ALLthread Titanium Suture Anchor is a non-resorbable suture anchor used to provide soft tissue fixation to bone during healing.
This document is a 510(k) premarket notification for the ALLthread™ Titanium Suture Anchor, a medical device for soft tissue reattachment, and not a study describing the acceptance criteria and performance of an AI product. Therefore, I cannot extract the requested information. The document focuses on establishing substantial equivalence to predicate devices based on non-clinical testing of mechanical properties and sterility.
Here's why the requested information cannot be found:
- No AI component: The device described is a physical medical implant (suture anchor), not an AI-powered diagnostic or assistive tool.
- Non-clinical testing: The "Summary of Performance Data" details non-clinical tests (cyclic loading, static loading, insertion torque, failure torque, needle attachment strength, suture tensile strength, bacterial endotoxins). These tests assess the physical properties and safety of the anchor itself, not the performance of an algorithm.
- No "acceptance criteria" in the AI sense: The document's closest equivalent to "acceptance criteria" are the performance levels achieved in the non-clinical tests, indicating the device performs "within the intended use" and does "not raise any new risks to device performance." These are not acceptance criteria for an AI model's accuracy, sensitivity, specificity, etc.
- No ground truth, training data, or expert adjudication: Since there's no AI algorithm, there's no concept of ground truth, training set, test set, expert readers, or adjudication methods as they relate to AI performance evaluation.
- No MRMC study: A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is specific to evaluating AI's impact on human performance, which is not applicable here.
§ 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.