(35 days)
The Fragment Specific fixator is intended for use in adult male and females from skeletal maturity to the geriatric population who have sustained an unstable extra-articular distal radius fracture that cannot be managed by casting, or a 3- or 4-part intra-articular fracture provided the medial fragment is large enough for the insertion of 2 separate 2.5mm - 3.0mm threaded cortical pins. The device can be used in a nonjoint bridging configuration which allows for immediate wrist motion during the fracture healing period of 6-8 weeks. It may alternatively be used in a joint bridging manner to provide ligamentotaxis to obtain and maintain the fracture reduction during the healing period.
The Fragment Specific Fixator is a single use external fixator designed to provide stable fracture fixation in a nonjoint bridging application that does not cross the wrist or in a joint bridging application that obtains and maintains fracture reduction through ligamentotaxis. The lightweight, radiolucent construct attaches to self drilling bone pins to provide secure fracture fixation and to capture fragments.
This is a medical device 510(k) premarket notification for an external fixator, specifically for the treatment of distal radius fractures. The provided document focuses on establishing substantial equivalence to predicate devices and does not contain detailed information about acceptance criteria or specific study results in the format requested for AI/software-based devices.
Therefore, many of the requested sections regarding AI/software performance metrics, sample sizes for test/training sets, expert qualifications, and ground truth establishment cannot be extracted from this document because they are not applicable to this type of device submission.
Here's a breakdown based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not specify quantitative acceptance criteria or detailed device performance metrics in the context of an AI/software study. It states:
| Criterion Type | Acceptance Criteria (Not explicitly stated for AI/software) | Reported Device Performance (Not explicitly stated for AI/software) |
|---|---|---|
| Mechanical Performance | (Implied: Device must meet mechanical integrity and stability requirements typical for external fixators) | "The results of non-clinical (laboratory) performance testing demonstrate that the device is safe and effective." (No specific quantitative values provided in this summary.) |
| Biocompatibility | (Implied: Materials must be biocompatible) | "manufactured from similar materials" to predicate devices (Implied that similar materials are biocompatible) |
| Functional Equivalence | (Implied: Device should perform its intended function of fracture fixation) | "has the same intended use, has similar performance characteristics... and is similar in design to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable / Not provided. This is a mechanical device, not a software or AI device that would have a "test set" in the context of pattern recognition or image analysis. Performance was assessed through non-clinical (laboratory) testing.
- Data Provenance: Not applicable / Not provided in the context of a dataset. Performance data came from "non-clinical (laboratory) performance testing."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth as typically defined for AI/software (e.g., expert consensus on image labels) is not relevant for this mechanical device. The "ground truth" for a mechanical device revolves around engineering specifications, material properties, and mechanical testing standards.
4. Adjudication Method for the Test Set:
- Not applicable. There is no mention of expert adjudication for this mechanical device's performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This is not an AI/software device, and therefore an MRMC study comparing human readers with and without AI assistance is not relevant or mentioned.
6. Standalone (Algorithm Only) Performance Study:
- Not applicable. This is a physical, mechanical device, not an algorithm.
7. Type of Ground Truth Used:
- For mechanical devices, "ground truth" is typically defined by objective engineering measurements, material specifications, and adherence to established mechanical testing standards (e.g., strength, durability, fatigue resistance). The summary states "non-clinical (laboratory) performance testing," implying that such objective measurements were performed.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI/software device that undergoes "training."
9. How the Ground Truth for the Training Set was Established:
- Not applicable. No training set is involved for this type of device.
Key Takeaway from the Document:
The provided 510(k) summary establishes substantial equivalence by demonstrating that the Fragment Specific Fixator has the same intended use, similar performance characteristics, is made from similar materials using similar processes, and has a similar design to two predicate devices: Millennium Medical Technologies, Inc., Wristore Distal Radius Fracture Fixator (K042761) and Howmedica Osteonics Corp., Hoffmann II Micro External Fixation System (K050048). The basis for its safety and effectiveness relies on "non-clinical (laboratory) performance testing."
§ 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.