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The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. It is a system which optimally engages the femoral head and permits impaction of bone fracture fragments. The Osteo I-C Humeral Nail System is intended for single use only.

Indications:

Cleared via 510(k)s #K971654, #K971321, #K920037

• Intracapsular fractures of the femoral neck
• Intertrochanteric fractures

Expanded Indication (the subject of this premarket notification)

• Extracapsular fractures of the proximal femur:
  • basal neck fractures
  • trochanteric fractures
  • subtrochanteric fractures

The Osteo Compression Hip Screw System is a proximal fracture fixation system, comprised of compression hip screw plates, lag screws, and a compression screw, which is intended to provide strong and stable internal fixation with minimal soft tissue irritation. Osteo 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 #K971654, #K971321 and #K920037, and remain unchanged from these previous submissions.

The provided 510(k) Premarket Notification for the Osteo Compression Hip Screw System - Expanded Indication does not contain the typical information required to describe acceptance criteria and a study proving device performance as it relates to software or AI/ML-based medical devices.

This submission is for a mechanical medical device (an implantable hip screw system) and therefore the evaluation for its expanded indication focuses on demonstrating substantial equivalence to a predicate device, rather than performance metrics of a diagnostic or predictive algorithm.

Therefore, most of the requested information (items 1-9) about acceptance criteria, study sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this type of device submission.

Here's an explanation based on the content provided:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. Mechanical devices like the Osteo Compression Hip Screw System are not typically evaluated using performance metrics like sensitivity, specificity, or accuracy in the same way software devices are. The "acceptance criteria" for such a device largely revolve around demonstrating substantial equivalence in design, materials, and intended use to a legally marketed predicate device, and ensuring it meets relevant safety and performance standards (e.g., mechanical tests, biocompatibility). The document does not report performance data in the context of clinical outcomes or diagnostic accuracy.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Applicable. There is no "test set" of patient data in the context of evaluating a diagnostic or predictive algorithm. The device is a physical implant. The evaluation is based on engineering principles, materials science, and comparison to a predicate device, not clinical data demonstrating diagnostic performance on a test set.

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. Ground truth, in the context of diagnostic performance, is not established for this type of mechanical device. The "truth" in this context is the safety and effectiveness of the device as an implant, which is assessed through a regulatory pathway of substantial equivalence and adherence to engineering standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As there is no test set for diagnostic performance, there is no adjudication method.

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. An MRMC study is relevant for evaluating the impact of AI/software on human diagnostic performance. This device is a surgical implant and does not involve human "readers" or AI assistance in diagnosis.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a mechanical surgical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not Applicable. Ground truth in the diagnostic sense is not used here. Device safety and effectiveness are established through demonstrating substantial equivalence, mechanical testing, and biocompatibility, not by comparing its "readings" to a ground truth.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

• Not Applicable. No training set exists for this type of device.

Summary of the Provided Information for this Mechanical Device:

The document describes the Osteo Compression Hip Screw System as a proximal fracture fixation system for hip fractures.

• Intended Use: To provide strong and stable internal fixation with minimal soft tissue irritation for various femoral fractures.
• Expanded Indications: The current submission seeks to expand the indications to include extracapsular fractures of the proximal femur (basal neck, trochanteric, and subtrochanteric fractures).
• Predicate Device: Synthes DHS® Dynamic Hip Screw System.
• Basis for Acceptance: The submission relies on demonstrating substantial equivalence in intended use, design, and materials to previously cleared Osteo Compression Hip Screw System components (K971654, K971321, K920037) and to the predicate Synthes DHS® Dynamic Hip Screw System for the expanded indications. The FDA's letter (K982553) confirms this finding of substantial equivalence.
• Safety and Performance: While not explicitly detailed in the provided snippets, for mechanical devices, "acceptance criteria" would typically involve:
  • Material compatibility: Biocompatibility testing to ensure the materials are safe for implantation.
  • Mechanical strength and fatigue testing: To ensure the device can withstand the physiological loads it will be subjected to without failure.
  • Design similarities: Comparison of design features (e.g., screw threads, plate geometry, dimensions) to predicate devices to argue for similar performance and safety profiles.
  • Manufacturing quality: Adherence to Good Manufacturing Practices (GMP) and Quality System Regulation (QS) indicated by the FDA's notice.

The study proving the device meets its "acceptance criteria" in this context is the substantive comparison to predicate devices and established standards, not a clinical study yielding performance metrics against a ground truth as would be done for an AI/ML device.

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