(89 days)
AFFINITY - Variable Angle Distal Radius System is indicated for the fixation of simple and complex intra- articular and extra-articular fractures, and for osteotomies of the distal radius in adults.
The device is indicated for fixation of Fractures AO types A2, A3, B1, B3, C1, C2, C3.
The AFFINITY - Variable Angle Distal Radius System is contains a set of titanium plates and screws that are intended to be end-user sterilized. The AFFINITY - Variable Angle Distal Radius System plates are provided in different configurations and are intended to be used in combination with the variable angle drilling guide and the Styloid hole variable angle drill guide to provide the necessary angulation for optimal screw positioning. The system includes Extra-articular plates (intermediate, wide, and narrow), Distal dorso-ulnar and dorso-radial L-plates, Distal ulnar T-plates, and straight Radius styloid plates.
This is a medical device 510(k) summary, not a study of an AI/ML device. Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not applicable.
The document describes the AFFINITY - Variable Angle Distal Radius System, which is a set of titanium plates and screws for fixing fractures and osteotomies of the distal radius. This is a traditional medical device, not an AI/ML product.
Instead of clinical performance, the summary focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device.
Here's a breakdown of the non-clinical testing performed, presented in a table format, though it's important to note this does not align with the AI/ML-specific request for acceptance criteria and device performance:
| Acceptance Criteria (Non-Clinical Test Method) | Reported Device Performance (Test Conclusion) |
|---|---|
| Mechanical Testing of Plates: | |
| ASTM F384-17 (Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices) |
- Annex 1 Static Bend Testing
- Annex 2 Fatigue Bend Testing | Substantial equivalence to predicate device |
| Mechanical Testing of Screws:
ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) - Annex 1 Torsional Properties
- Annex 2 Driving Torque
- Annex 3 Axial Pullout | Substantial equivalence to predicate device |
| Biocompatibility Testing: - ISO 10993-5: Tests for in-vitro cytotoxicity
- ISO 10993-18: Biological Evaluation of Medical Devices - Part 18: Chemical Characterization of Materials.
- XPS investigation for film-forming contaminations
- Detection and Quantification of Bacterial Endotoxins | - no cytotoxic effect
- chemical characterization as per the report
- appropriate surface cleanliness
- no risk of bacterial pyrogenicity |
| Sterilization Testing:
Validating steam sterilization method according to ISO 11737-2:2009, ISO 17665-1:2006, ISO 14161:2009. | The results of the validating steam sterilization method show that the implants, accessories, and models can be sterilized to a SAL of 10-6 using the recommended steam sterilization instructions |
Regarding the specific points requested for an AI/ML device:
- A table of acceptance criteria and the reported device performance: Provided above for non-clinical testing, but not for AI/ML performance.
- Sample size used for the test set and the data provenance: Not applicable as there is no test set for an AI/ML algorithm. The "test set" for this device refers to physical samples used in mechanical and biocompatibility testing.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: No.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No.
- The type of ground truth used: Not applicable. The "ground truth" for this device is established by international standards for material properties, mechanical strength, and biocompatibility.
- The sample size for the training set: Not applicable.
- How the ground truth for the training set was established: Not applicable.
In summary, this document describes a traditional mechanical medical device, not an AI/ML product. The evaluation criteria are based on established engineering and biological standards for such devices, demonstrating substantial equivalence to a predicate device rather than AI/ML performance metrics.
§ 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.