(94 days)
The updated ACE-Fischer® External Fixation System is indicated for open and closed long bone fracture fixation to include tensioned wire fixation of periarticular fractures, arthrodesis, limb lengthening, osteotomy, reconstruction, non-unions, pseudoarthrosis, correction of bony or soft tissue defects and deformities.
The updated ACE-Fischer® External Fixation System is a highly versatile frame that can be constructed for applications ranging from simple fractures to complex reconstruction. This modular system can be configured for many different applications.
The provided text is a 510(k) summary for the DePuy ACE-Fischer External Fixation System and does not contain information about acceptance criteria, device performance, or a study proving that the device meets acceptance criteria. The submission is for a medical device (external fixation system) and typically, for such devices, "acceptance criteria" and "device performance" are mechanical or structural properties tested through bench testing, rather than an AI-based system.
Therefore, many of the requested fields cannot be answered based on the provided document.
However, I can extract what is available regarding the type of study conducted:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated (likely mechanical/structural integrity standards for external fixation systems) | Equivalence confirmed through bench testing. |
(Note: The document states "Equivalence was confirmed through bench testing," implying that the device's performance, as measured by bench tests, was found to be comparable or "substantially equivalent" to the predicate device. However, the specific acceptance criteria (e.g., tensile strength, fatigue life) or the quantitative performance results are not detailed in this summary.)
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified.
- Data Provenance: Not applicable. The study involved "bench testing" of the physical device, not analysis of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable. This was a physical device bench test, not an expert-driven ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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:
- No. This is a medical device for bone fixation, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For "bench testing," the "ground truth" would be the established engineering and biomechanical standards or the performance of the predicate device. The document does not specify the exact nature of these standards.
8. The sample size for the training set:
- Not applicable. This is a physical medical device, not an AI model.
9. How the ground truth for the training set was established:
- Not applicable.
In summary, the provided document focuses on regulatory approval (510(k)) based on substantial equivalence for a physical medical device. It mentions "bench testing" as the method to confirm equivalence but does not delve into the specifics of the test setup, acceptance criteria, or quantitative results that would be expected for an AI system's performance evaluation.
§ 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.