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The Arthrosurface Bone Screws (2.0-3.0 mm solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fixation for bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, and wrist.

The Arthrosurface Bone Screws (3.5 mm and larger, solid and cannulated) are intended to be used as stand-alone bone screws for internal bone fractures, fusions, osteotomies, and non-unions in the ankle, foot, hand, wrist, shoulder, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, femur, and fibula.

The Arthrosurface Bone Screws have diameters ranging from 2.0 mm to 4.0 mm and lengths ranging from 8 mm to 50 mm. The screws are either partially or fully threaded, solid or cannulated, self-tapping or self-drilling and are manufactured from implant grade stainless steel or titanium alloy. Depending on their size, these bone screws are intended to be used for different indications for use.

Here's a breakdown of the acceptance criteria and the study information based on the provided FDA 510(k) summary for the Arthrosurface Bone Screws:

It's important to note that this document is a 510(k) Premarket Notification summary, which focuses on demonstrating substantial equivalence to existing devices, rather than proving a new device meets specific, novel acceptance criteria through a clinical trial. Therefore, the "study" described is primarily non-clinical testing to show equivalence in performance and safety.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of a 510(k) for bone screws, the "acceptance criteria" are generally derived from recognized industry standards for mechanical performance and safety, and the "reported device performance" are the results demonstrating compliance with these standards.

Note: The document states "demonstrated that the Arthrosurface Bone Screws are substantially equivalent to the predicate devices" and "The safety and effectiveness... is adequately supported by the substantial equivalence and performance testing information," implying that the device met the established criteria within these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify the exact number of screws or tests performed for each non-clinical test (torque, pullout, LAL). It typically refers to "the Arthrosurface Bone Screws" as a general product line being tested.
• Data Provenance: The data is generated from non-clinical laboratory testing conducted by the manufacturer, Arthrosurface, Inc. The location of the testing is not specified beyond the company's address in Franklin, Massachusetts. This is prospective testing conducted specifically for the 510(k) submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This section is not applicable in the context of this 510(k) submission for bone screws.

• Ground truth is typically established through expert consensus or clinical outcomes for diagnostic or AI-driven devices. For implantable mechanical devices like bone screws, "ground truth" is determined by objective physical and chemical testing against established engineering and biocompatibility standards (e.g., ASTM, USP). There are no human experts "establishing ground truth" in the way one would for image interpretation.

4. Adjudication Method for the Test Set

This section is not applicable. As described above, the "test set" involves physical and chemical property measurements against predefined international standards, not subjective assessments requiring adjudication among human experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done.

• MRMC studies are typically used for diagnostic devices (e.g., imaging AI) to compare the performance of human readers with and without AI assistance. This device is a mechanical bone fixation fastener, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this concept is not applicable.

• This question pertains to AI/software as a medical device (SaMD). The Arthrosurface Bone Screw is a physical implantable device. There is no "algorithm" or standalone software performance to evaluate in this context.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical performance testing is based on:

• Established engineering standards: Specifically, ASTM F543 for mechanical properties (torque to failure, insertion/removal torque, axial pullout force).
• Biocompatibility and sterility standards: United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices, and AAMI ST72:2002/R2010, Bacterial Endotoxins-Test Methodologies.

8. The Sample Size for the Training Set

This section is not applicable.

• There is no "training set" in the context of a 510(k) submission for a mechanical bone screw. Training sets are used for machine learning algorithms.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable for the same reason as point 8.

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Intended for the treatment of fracture fixation, osteotomies (ex. Akin, Chevron, Scarf, Weil), reconstruction, revision surgery and arthrodesis of small bones in the upper and lower extremities.

The Arthrosurface Bone Screws have a diameter of 2.0/2.7 mm and are made available in lengths varying from 8 mm to 24 mm with 2 mm increments. The bone screws have a snap-off feature and are designed to work with a powered wire driver, and are manufactured from implant grade stainless steel or titanium allov.

The provided text describes a 510(k) premarket notification for Arthrosurface Bone Screws and does not contain information about acceptance criteria or a study proving device performance in the context of an AI/ML medical device.

The document is a traditional 510(k) submission for a physical medical device (bone screws), where substantial equivalence to a predicate device is demonstrated through comparisons of indications, materials, and non-clinical tests like a pyrogenicity test. It does not mention any AI/ML components, comparative effectiveness studies (MRMC), standalone algorithm performance, or the involvement of experts for establishing ground truth as would be relevant for AI/ML devices.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving device performance as it pertains to AI/ML devices from this text.

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