(140 days)
OsteoMed Hand Fusion System is intended for use in bone fusion and arthrodesis of phalanges and metacarpals. It is intended for use in trauma, general surgery and reconstructive procedure.
The OsteoMed Hand Fusion System implants are intended for single use only.
The OsteoMed Hand Fusion System consists of plates, fusion screws and surgical instruments. Plates and fusion screws are provided in various sizes. The implants are made of Titanium (ASTM F-67 or ASTM F-136) or Stainless Steel (ASTM F-138 or ASTM F-139).
Surgical instrumentation is provided to facilitate modification, insertion, and removal of implants. These instrüments are made from various grades of stainless steel, anodized aluminum, and/or medical grade polymers.
The OsteoMed Hand Fusion System is a medical device intended for bone fusion and arthrodesis of phalanges and metacarpals. The device's acceptance criteria and subsequent study were based on demonstrating substantial equivalence to predicate devices regarding dimensional and material characteristics, mechanical strength, and pullout strength.
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Plate Strength: Able to withstand equivalent or more load than the predicate device. | Calculations based on cross-sectional area and plate material showed that the Fusion plate is able to withstand more load than the predicate device (OsteoMed Hand Plating System, K090522). |
| Fusion Screw Factor of Safety: Equivalent to the predicate device. | Test results show that the factor of safety (ratio of failure torque to insertion torque) of the Fusion screws is equivalent to the factor of safety of the OsteoMed Headless Screws (K063298). |
| Fusion Screw Pullout Strength: Equivalent to the predicate device. | Test results show the pullout strength of the Fusion screws is equivalent to the pullout strength of the predicate device (OsteoMed Headless Screws, K063298). |
| Plate and Screw Construct: Locking screw engaged with the Fusion plate hole is substantially equivalent to the predicate devices. | Testing of the plate and screw construct showed locking screw engaged with the Fusion plate hole is substantially equivalent to the predicate devices (OsteoMed Hand Plating System, K090522; Synthes Modular Mini Fragment LCP System, K063049; Synthes Stainless Steel Modular Hand System, K030310). |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data or human subjects. The evaluation was based on engineering analyses and mechanical testing. Therefore, the concept of sample size for a test set and data provenance (e.g., country of origin, retrospective/prospective) as typically applied to clinical studies is not applicable here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This section is not applicable. The ground truth was established through engineering calculations and mechanical testing, not through expert consensus on clinical data.
4. Adjudication Method for the Test Set
This section is not applicable as the evaluation was based on engineering analysis and mechanical testing, not on clinical data requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
An MRMC comparative effectiveness study was not done. The submission focuses on device equivalence through engineering analysis and mechanical testing, not on comparing human reader performance with or without AI assistance.
6. Standalone Performance Study (Algorithm Only)
This section is not applicable. The device is a physical implant system, not a software algorithm.
7. Type of Ground Truth Used
The ground truth used for evaluating the OsteoMed Hand Fusion System was based on:
- Engineering principles and calculations: For plate strength comparison.
- Mechanical testing standards and results: For screw factor of safety, screw pullout strength, and plate and screw construct performance.
- The comparison was against established performance characteristics of legally marketed predicate devices.
8. Sample Size for the Training Set
This section is not applicable. The evaluation did not involve a "training set" in the context of machine learning or clinical trials. The device's design and material characteristics were based on established engineering principles for medical implants.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the reasons stated in point 8.
§ 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.