Search Results

The Osteo Compression Condyle Screw System is a 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 (#K913269) 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.

Indications Cleared via 510(k) #K971321 and 510(k) #K920037:

• Intercondylar fractures .
• Supracondylar fractures .
• . Unicondylar fractures

Expanded Indications (the subject of this premarket notification):
Fractures of the proximal femur:

• Transverse subtrochanteric fractures .
• . Short oblique subtrochanteric fractures
• . Long oblique subtrochanteric fractures

The Osteo Compression Condyle Screw System is used in the proximal femur in situations which require a more proximal placement of the lag screw in the femoral head, which the 95 degree plate angle accommodates. This allows for the placement of one or more bone screws in the proximal fragment which is intended to result in greater stability in the proximal femur, transmission of load across the fracture site and control of the rotation of the fracture fragment

The Osteo Compression Condyle Screw System is a distal and proximal 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. The design and materials for the Osteo Compression Hip Screw System are determined to be substantially equivalent via 510(k)s #K920037 and remain unchanged from these previous submissions.

The provided text is a 510(k) Premarket Notification Summary for the "Osteo Compression Condyle Screw System - Expanded Indications." This document details the submission of a medical device seeking clearance from the FDA, specifically for expanded indications of use for an existing device.

The fundamental aspect of a 510(k) submission, particularly for devices seeking clearance based on substantial equivalence to predicate devices, is to demonstrate that the new or modified device is as safe and effective as a legally marketed device (the predicate). This demonstration often relies on comparing design, materials, technological characteristics, and intended use, and not typically on extensive clinical trials demonstrating new performance metrics against specific acceptance criteria like those found in studies for novel technologies or drugs.

Therefore, for this specific submission, the traditional "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the sense of a numerical performance metric (e.g., accuracy, sensitivity, specificity) derived from a clinical study with a test set, ground truth established by experts, etc., are not applicable or present in the provided document.

Here's why and what information is available:

• Type of Device: The "Osteo Compression Condyle Screw System" is a bone fixation appliance used in orthopedic surgery to fix fractures. These are mechanical devices.
• Regulatory Pathway: This is a 510(k) submission for expanded indications. This pathway emphasizes substantial equivalence, not de novo clinical effectiveness.
• Focus of the Document: The document focuses on demonstrating that the expanded indications for the device (fractures of the proximal femur) are substantially equivalent to the predicate device (Synthes® Dynamic Condylar Screw System). The previously cleared indications (distal femur fractures) were already deemed substantially equivalent in prior 510(k)s (K971321 and K920037).

What the document does provide in lieu of "acceptance criteria" and performance studies:

The "acceptance criteria" for this type of submission are implicitly related to demonstrating substantial equivalence to the predicate device. This means showing that:

1. Intended Use is the Same or Similar: The device is intended for similar types of femoral fractures.
2. Technological Characteristics are the Same or Similar: The design and materials are the same or similar.
3. Performance is the Same or Similar: While not explicitly detailed with quantitative metrics in this summary, the assumption is that the mechanical performance (stability, fixation strength) for the expanded indications is comparable to existing devices through design comparison.

Based on the provided text, I cannot complete the requested table or sections because the information typically associated with establishing acceptance criteria and performance against a test set (as would be done for AI/diagnostic devices) is not relevant to this 510(k) submission for a mechanical bone fixation device.

Here is a breakdown of why each requested point cannot be answered from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable. The "acceptance criteria" for this submission are a successful demonstration of substantial equivalence to a predicate device, as determined by the FDA. There are no reported numerical performance metrics like sensitivity or accuracy.
2. Sample size used for the test set and the data provenance: Not applicable. No test set or clinical study demonstrating performance metrics for a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No test set or ground truth established by experts for performance evaluation is described.
4. Adjudication method 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: Not applicable. This is a mechanical device, not an AI or diagnostic device that involves human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information relevant to the submission's approval:

• Predicate Device: Synthes® Dynamic Condylar Screw System
• Basis for Substantial Equivalence: Design and materials are substantially equivalent, and the expanded indications regarding proximal femoral fractures are comparable to the intended use of the predicate.
• Result: The FDA determined the device to be substantially equivalent for the expanded indications, allowing it to be marketed.

In conclusion, this document describes a 510(k) clearance for a mechanical medical device based on substantial equivalence, not a performance study against specific acceptance criteria for a diagnostic or AI-driven device.

Ask a specific question about this device

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.

Ask a specific question about this device