(90 days)
The Osteo Compression Condyle Screw System is a distal fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues. The Osteo Compression Condyle Screw System is indicated for the following fractures of the distal femur: Intercondylar fractures, Supracondylar fractures, and Unicondylar fractures.
The Osteo Compression Condyle Screw System is a distal femoral fracture fixation system, comprised of compression condyle plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo cancellous and cortical bone screws may be utilized with this system for additional compression and fixation. This system is utilized as an aid to healing, not as a substitute for normal intact tissues.
This document is a 510(k) Premarket Notification summary for the Osteo Compression Condyle Screw System. It seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove specific performance acceptance criteria through a clinical study. Therefore, most of the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance metrics, sample sizes, expert ground truth, and statistical effectiveness studies is not available or applicable in this type of submission.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary "acceptance criterion" for a 510(k) submission is demonstrating substantial equivalence to a legally marketed predicate device. This is achieved by showing that the new device has the same intended use, and the same or similar technological characteristics to the predicate device, or that any differences do not raise new questions of safety and effectiveness.
- Reported Device Performance: The document states: "The Osteo Compression Condyle Screw System is substantially equivalent to the Synthes® Dynamic Condylar Screw System."
- Technological Comparison: The submission explicitly states, "The subject Osteo Compression Condyle Screw System components (compression condyle plates and lag screws) are substantially equivalent in design, materials, and intended use to the predicate devices offered by Synthes in their Dynamic Condylar Screw System."
- Materials: Both the Osteo Compression Condyle Plates and Osteo Lag Screws are fabricated from ASTM F-138 Stainless Steel (Grade 2, 316LVM). This is a common, well-established material for implants.
- Design Characteristics: Specific dimensions and features are provided for the plates (e.g., 25mm barrel length, autocompression holes for 4.5mm cortical screws, 95° barrel angle) and lag screws (e.g., 22mm thread length, 12.5mm thread diameter, cannulated end). The implication is that these design characteristics are comparable to the predicate device.
- Intended Use: The intended uses for distal femoral fractures (Intercondylar, Supracondylar, Unicondylar) are listed and are presumed to be the same as or very similar to the predicate device.
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. This submission is based on demonstrating substantial equivalence through a comparison of design, materials, and intended use to a predicate device, not through a clinical performance study with a "test set" of patients or data in the way a diagnostic AI device would. No patient data or clinical study results are presented.
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. See point 2.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. See point 2.
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
- Not applicable. This device is a mechanical surgical implant, not an AI or diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the established safety and effectiveness of the predicate device (Synthes® Dynamic Condylar Screw System), which has been legally marketed. The submission's goal is to show the new device is sufficiently similar to that known safe and effective predicate.
8. The sample size for the training set
- Not applicable. This is not an AI or machine learning device requiring a training set. The "training" for such a device would be the extensive engineering and material science knowledge applied during its design and manufacturing, based on existing standards and predicate devices.
9. How the ground truth for the training set was established
- Not applicable. See point 8.
In summary, this 510(k) submission is focused on demonstrating substantial equivalence to an existing device rather than presenting a clinical study to prove novel performance criteria. The "acceptance criteria" revolve around matching the characteristics and intended use of the legally marketed predicate device, and the "study" is primarily the detailed technical comparison provided within the submission itself.
§ 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.