(28 days)
The Arthrex CMC Mini TightRope, when used for fixation of bone-to-bone or soft-tissue-tobone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, the Arthrex CMC Mini TightRope is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the suspension of the thumb metacarpal during the healing process of hematoma distraction arthroplasty by providing stabilization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.
The Arthrex CMC Mini TightRope consists of two oblong stainless steel buttons and a single strand of #2 FiberWire.
The provided FDA 510(k) summary is for the Arthrex CMC Mini TightRope, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving performance against specific acceptance criteria through a comprehensive clinical study in the way a diagnostic AI device would.
Therefore, many of the requested categories related to AI device performance evaluation (such as test set sample size, expert ground truth, MRMC studies, training set details) are not applicable to this document or this type of medical device clearance.
However, I can extract the relevant information from the provided text as it pertains to the device's substantial equivalence.
1. A table of acceptance criteria and the reported device performance
The concept of "acceptance criteria" and "reported device performance" in the context of this 510(k) submission relates to demonstrating substantial equivalence to a predicate device, rather than meeting specific quantifiable performance metrics as one might see for a diagnostic tool. The acceptance is that the device is substantially equivalent to the predicate.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated in submission) |
|---|---|
| Intended Use: Device performs as intended for bone-to-bone or soft tissue-to-bone fixation, specifically for CMC joint arthroplasty as an adjunct in suspension of the thumb metacarpal during healing of hematoma distraction arthroplasty by providing stabilization when trapezium is excised due to osteoarthritis. | The Arthrex CMC Mini TightRope is substantially equivalent to the Arthrex Implant System, Mini TightRope (K133275). It performs the same intended use. |
| Technological Characteristics: Similar materials, design, and operating principles to the predicate. | Device consists of two oblong stainless steel buttons and a single strand of #2 FiberWire, similar to the predicate. Differences are considered minor and do not raise questions concerning safety and effectiveness. |
| Safety and Effectiveness: Does not raise new questions of safety and effectiveness compared to the predicate. | "Any differences between the CMC Mini TightRope and this predicate are considered minor and do not raise questions concerning safety and effectiveness." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This is a 510(k) for a medical implant, not a diagnostic device evaluated with a test set of data. The "test" for this device is based on demonstrating substantial equivalence through comparison of design, materials, and intended use with a predicate device, often supported by bench testing (though not detailed here) rather than human subject data sets.
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts/Qualifications: Not applicable. This submission does not involve clinical data requiring expert review for ground truth establishment.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. There is no test set or adjudication process described in this 510(k) summary.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study/Effect Size: Not applicable. This device is a surgical implant, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not applicable. This submission relies on demonstrating substantial equivalence to a predicate device, not on diagnostic accuracy against a ground truth.
8. The sample size for the training set
- Sample Size: Not applicable. There is no training set for a medical implant in this context.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.