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The Ascension Cannulated Screw System is intended for the following:

• Fixation of fractures in long bones
• Fixation of small bones, including those in the foot, patella, ankle, wrist and elbow .
• Arthrodesis of the foot, wrist and elbow
• A Small and long bone osteotomies

The Ascension® Cannulated Screw System consists of various sizes of cannulated screws. The screws are machined, metallic screws with a cannulation that are self-drilling and self-tapping. Each type is offered in a variety of diameters and lengths and is manufactured from stainless steel or titanium. Washers, as well as guide wires, and various orthopedic surgical instruments will be included in the system.

The provided text is a 510(k) summary for the Ascension® Cannulated Screw System, a medical device for bone fixation. It focuses on establishing substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through a dedicated study with the device itself.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert involvement, and ground truth establishment cannot be found in this document because a 510(k) summary for a Class II device like this typically does not require such detailed clinical study data if substantial equivalence can be demonstrated through design, material, and indications comparison with existing devices.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics from a study. For a 510(k), the primary "acceptance criterion" is often demonstrating substantial equivalence to predicate devices in design, materials, and intended use.
• Reported Device Performance: Not reported in terms of clinical outcomes or specific performance metrics from a dedicated study. The document states "similarities in design, materials and indications" as the basis for substantial equivalence.

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/Not Provided. The 510(k) summary does not describe a test set or data from a clinical study for the Ascension device itself.

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/Not Provided. No ground truth establishment is described for a test set of the Ascension device.

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

• Not Applicable/Not Provided. No test set or adjudication process is described.

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/Not Provided. This device is a bone fixation screw, not an AI-assisted diagnostic tool. An MRMC study is irrelevant in this context.

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

• Not Applicable/Not Provided. This is a physical medical device, not an algorithm.

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

• Not Applicable/Not Provided. No ground truth for a performance study is mentioned. The "ground truth" for substantial equivalence would be the established safety and effectiveness of the predicate devices.

8. The sample size for the training set:

• Not Applicable/Not Provided. No training set for an algorithm is mentioned.

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

• Not Applicable/Not Provided. No training set or ground truth establishment for it is mentioned.

Summary of available information:

• Device Name: Ascension® Cannulated Screw System
• Intended Use: Fixation of fractures in long bones; Fixation of small bones (foot, patella, ankle, wrist, elbow); Arthrodesis of the foot, wrist, and elbow; Small and long bone osteotomies.
• Basis of Substantial Equivalence: Similarities in design, materials, and indications to legally marketed predicate devices (K991151, K991197 - Vilex Cannulated Screws; K962823 - Synthes Cannulated Screws; K893512 - DePuy Cannulated Bone Screw; K901616 - Smith & Nephew Cannulated Interference Screw System).

For devices like this, the "study" demonstrating it meets acceptance criteria for FDA clearance is the comparison to predicate devices to show substantial equivalence. The detailed performance metrics, clinical studies, and expert assessments typically associated with software or AI-based devices (as implied by the structure of your questions) are generally not required for these types of 510(k) submissions. Instead, mechanical testing (e.g., tensile strength, fatigue, torque strength) to ensure the device meets engineering specifications and industry standards, and biocompatibility testing, would be performed and submitted as part of the 510(k) package, but these specific results are not detailed in this public summary.

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