(82 days)
The OS2®-VP Varisation Staples are indicated for Akin type osteotomies.
The OS2®-VP Varisation Staple is an osteosynthesis staple manufactured from PEEK, a material recognized for its mechanical and radiolucent properties.
Sizes: The OS2®-VP Varisation Staple is available in various angles.
Material: The OS2®-VP Varisation Staple is manufactured from PEEK according to standard ASTM F2026.
Single use: The OS2®-VP Varisation Staple is designed for single use only.
Sterilization: The OS2®-VP Varisation Staple is supplied sterile, using gamma irradiation.
Place of use: The OS2®-VP Varisation Staple is indicated for use in a hospital, or outpatient surgery center where sterile field may be created and maintained.
This document describes the regulatory clearance for the OS2®-VP Varisation Staple, a medical device for fixing foot bones. It is not an AI or software device. Therefore, the information requested about acceptance criteria, efficacy studies, and ground truth in the context of AI/software performance is not applicable to this document.
However, I can extract information related to the device's performance testing for its mechanical properties:
Description of Performance and Acceptance Criteria (Mechanical Testing):
The device's performance was evaluated through mechanical comparison with predicate devices. The claim of "substantial equivalence" is based on these mechanical tests.
The document states: "Performance testing has been evaluated for OS2®-VP Varisation Staple through mechanical comparison with predicate devices, animal and clinical testing being considered not applicable. Mechanical testing was performed according to dedicated protocols based on standard ASTM F564. The results of the testing performed by the test laboratories indicate that the OS2®-VP Varisation Staple performed as expected for each test."
Acceptance Criteria and Reported Device Performance Table:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to dedicated protocols based on standard ASTM F564 | Performed as expected for each test (mechanical testing) |
| Substantial equivalence to predicate mechanical characteristics | OS2®-VP Varisation Staple is similar to the primary predicate device OS2®-V Varisation Staple (K143323) in intended use, design, sizes and principles of operation, and is similar to the reference predicate device In2Bones DUAFIT® Interphalangeal Implant (K132912) in material. |
Information not applicable to this document (as it is not an AI/software device):
- Sample size used for the test set and data provenance (retrospective/prospective)
- Number of experts used to establish ground truth and their qualifications
- Adjudication method for the test set
- Multi-reader multi-case (MRMC) comparative effectiveness study and effect size
- Standalone (algorithm only) performance
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Sample size for the training set
- How ground truth for the training set was established
§ 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.