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The OsteoCentric Integrated Hip Fastener System is intended to treat stable and unstable intertrochanteric, subtrochanteric, and basilar neck fractures in which a stable medial buttress can be reconstructed.

Device Description

The OsteoCentric Integrated Hip Fastener System is intended for use in internal fixation of femoral neck fractures. The OsteoCentric Integrated Hip Fastem consist of plates and screws in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The devices are provided non-sterile. All implantable devices are manufactured from Stainless Steel per ASTM F138.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "OsteoCentric Integrated Hip Fastener System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with strict acceptance criteria and performance metrics.

Therefore, the document does not contain the kind of information typically requested for AI/ML device studies, such as:

A table of acceptance criteria and reported device performance (in terms of sensitivity, specificity, AUC, etc.)
Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
Number of experts and their qualifications used to establish ground truth
Adjudication method
Multi-reader multi-case (MRMC) comparative effectiveness study
Standalone (algorithm-only) performance
Type of ground truth used (pathology, outcomes data, etc.)
Sample size for the training set
How ground truth for the training set was established

Instead, this document describes an engineering analysis for a mechanical device.

Here's what the document does provide regarding the "study" that proves the device meets the "acceptance criteria" (using these terms loosely in the context of a mechanical device submission):

1. Acceptance Criteria and Reported Device Performance (Mechanical Context):

The acceptance criteria here are implicitly demonstrating substantial equivalence to predicate devices in terms of mechanical properties for the intended use.

Acceptance Criteria (Implicit)	Reported Device Performance (Engineering Analysis Conclusion)
Plate strength and stiffness sufficient for intended use and comparable to predicates.	Plate strength and stiffness was compared by evaluating the material properties and moment of inertia at worst-case locations. The results of the engineering analysis confirmed that the strength, stiffness... of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Screw strength sufficient for intended use and comparable to predicates.	Screw strength was evaluated and compared to the predicates using the material properties, screw types and sizes. The results of the engineering analysis confirmed that the... strength... of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Screw fixation sufficient for intended use and comparable to predicates (e.g., thread profile provides adequate fixation).	Screw fixation was evaluated and compared to predicates using information about the thread profile. The results of the engineering analysis confirmed that the... fixation of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.
Overall mechanical performance equivalent to legally marketed predicate devices.	"The overall technology characteristics and mechanical performance data lead to the conclusion that the OsteoCentric Integrated Hip Fastener System is substantially equivalent to the predicate device." "The results of the engineering analysis confirmed that the strength, stiffness and fixation of the OsteoCentric Integrated Hip Fastener System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
Materials of manufacture (Stainless Steel per ASTM F138) are appropriate and similar to predicates.	Implied by "All implantable devices are manufactured from Stainless Steel per ASTM F138" and "Materials of Manufacture" being identical between subject and predicates.
Similar technological characteristics to predicates (e.g., modular stainless steel bone fixation system with similar interlocking features, plate angulation, lengths, widths, thicknesses, screw sizes, screw lengths).	"The subject and predicate devices have similar technological characteristics and the minor differences do not raise any new issues of safety and effectiveness. Specifically, the following characteristics are identical between the subject and predicates: Indications for Use, Materials of Manufacture." Also, "the subject plating/screw construct is also a modular stainless steel bone fixation system with similar interlocking features, plate angulation, plate lengths, plate widths, plate thicknesses, screw sizes and screw lengths."

2. Sample size used for the test set and the data provenance:

Test Set: No discrete "test set" in the context of an AI/ML algorithm is mentioned. The assessment was based on an "engineering analysis" comparing physical properties and design features of the subject device to predicate devices. This involves material properties, moment of inertia, screw types/sizes, and thread profiles.
Data Provenance: Not applicable in the context of an engineering analysis of mechanical components. The data would come from specifications, material testing standards (e.g., ASTM F138), and design comparisons.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Ground truth for mechanical properties is established through engineering principles, material science, and testing standards, not expert consensus in the medical imaging sense. The submission was prepared by Nathan Wright MS, an Engineer & Regulatory Specialist at Empirical Testing Corp.

4. Adjudication method for the test set:

Not applicable. There was no clinical or interpretative "test set" requiring adjudication.

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 bone fixation device, not an AI/ML diagnostic or assistive tool.

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:

Engineering specifications and standards: The "ground truth" for this device's performance relies on established engineering principles, material science (e.g., Stainless Steel per ASTM F138 specifications), and comparative analysis against the known mechanical properties of legally marketed predicate devices. The aim is to show that the new device's mechanical integrity is equivalent or superior to existing devices for the same indications.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of this type of mechanical device submission.

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

Not applicable.

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