(233 days)
The MICA™ Screw is indicated for fixation of bone fractures or for bone reconstruction. Examples include:
- · Mono or Bi-Cortical osteotomies in the foot or hand
- · Distal or Proximal metatarsal or metacarpal osteotomies
- · Weil osteotomy
- · Fusion of the first metatarsophalangeal joint and interphalangeal joint
- · Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
- · Akin type osteotomy
- · Arthrodesis base first metatarsal cuneiform joint to reposition and stabilize metatarsus varus primus
- Calcaneus/cuboid arthrodesis
- · Talar/navicular arthrodesis
The MICA™ Screws are intended for use in bone reconstruction, osteotomy, arthrodesis, fracture repair, and fracture fixation of bones appropriate for the size of the device. All MICA™ Screws are fully threaded, cannulated screws made from titanium alloy.
The provided document describes the MICA™ Screw System, a medical device for bone fixation, and its substantial equivalence to a predicate device, rather than an AI/ML powered device. Therefore, many of the requested details about acceptance criteria for AI performance and study design for AI models (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance) are not applicable to this document.
However, I can extract the acceptance criteria and performance data for the non-clinical testing performed on the MICA™ Screw System.
1. Table of acceptance criteria and the reported device performance
| Validation and/or Verification Method | Acceptance Value/Criteria | Reported Device Performance |
|---|---|---|
| Torsional Testing: Insertion Torque, Removal Torque, Ultimate Torque | Ultimate Torque must exceed insertion torque and removal torque by a safety factor | Acceptable |
| Engineering Analysis: Axial Pullout Force, Bending Strength | Comparable to the predicate device design | Acceptable |
| Bacterial Endotoxins Testing | ≤20 EU/device | Acceptable |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The testing described is non-clinical, involving mechanical and material properties of the device, not patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the testing is non-clinical and does not involve human experts establishing ground truth for diagnostic or prognostic purposes.
4. Adjudication method for the test set
This information is not applicable as the testing is non-clinical.
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
This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical tests, the "ground truth" or reference standards are engineering specifications, established mechanical test methods, and predefined thresholds for material properties (e.g., specific torque values, force limits, endotoxin levels).
8. The sample size for the training set
This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.
9. How the ground truth for the training set was established
This is not applicable as the document describes a mechanical bone screw system, not an AI/ML powered device.
§ 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.