(55 days)
The Omega™ Plus, Omega™ 2, and Omega™ 3 Systems are intended for use in the temporary stabilization of types of fractures of the proximal and distal femur. The subject devices are indicated for fixation of proximal and distal femoral fractures including but not limited to:
- Intracapsular and basal neck fractures including transcervical and subcapital fractures .
- Intertrochanteric fractures .
- Subtrochanteric fractures .
- Supracondylar fractures .
- Intracondylar fractures .
- Osteotomies for patients with diseases or deformities of the hip .
- . Hip arthrodesis
The Omega™ 3 Supracondylar Plate is a compression screw system designed to treat various types of fractures of the distal femur.
The provided text describes a medical device, the Omega™ 3 Supracondylar Plate, and its regulatory review for substantial equivalence. However, it does not contain the specific information requested about acceptance criteria and a study proving the device meets those criteria in the context of device performance metrics (like accuracy, sensitivity, specificity, etc.) for a diagnostic or AI-driven device.
This document is a 510(k) summary for a mechanical orthopedic implant, not a diagnostic device or one that employs AI. Therefore, the types of studies and acceptance criteria typically associated with AI/diagnostic performance (sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies, standalone performance) are not applicable or reported in this document.
Instead, the "study" referred to is mechanical testing demonstrating comparable mechanical properties to predicate devices, and the "acceptance criterion" is achieving substantial equivalence based on these mechanical properties and identical intended use.
Here's a breakdown of the available information based on your request, highlighting what is not present due to the nature of the device:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Comparable mechanical properties to predicate devices (Omega™ Plus System and Omega™ 2 System) | Mechanical testing demonstrated comparable mechanical properties to the predicate components. |
| Same intended use as predicate devices | The subject device shares the same intended use as the predicate devices. |
| Same basic design concepts as predicate devices | The subject device shares the same basic design concepts as the predicate devices. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable/Not provided. This document refers to mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI or diagnostic performance. Sample sizes for mechanical tests are typically specific to the type of test (e.g., number of plates tested for fatigue, bending, etc.), and this detail is not given.
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/Not provided. Ground truth, in the AI/diagnostic sense, is not established for this type of device. The mechanical properties are measured against established engineering standards or comparisons to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable/Not provided. No adjudication method is mentioned as there's no diagnostic or interpretative element to this device's evaluation in the document.
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 mechanical orthopedic implant, not an AI or diagnostic device. An MRMC study is not relevant to its evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant. The concept of "standalone performance" for an algorithm is not relevant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Benchmarking against predicate devices' mechanical properties and established engineering standards. The "ground truth" for this device's evaluation is essentially the performance characteristics of previously cleared, substantially equivalent devices and adherence to relevant material/mechanical standards for orthopedic implants.
8. The sample size for the training set
- Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for AI is involved.
§ 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.