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The TITAN 3-D® Wedge System implants are indicated to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the foot and ankle. The TITAN 3-D® Wedge System implants are intended for use with ancillary fixation. The TITAN 3-D® Wedge System implants are not indicated for use in the spine.

The TITAN 3-D® Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

Here's a breakdown of the acceptance criteria and the study details for the TITAN 3-D Wedge System, based on the provided text. Please note that the document is a 510(k) summary for a medical device (an implant for bone fixation), not an AI/software device. Therefore, many of the requested categories related to AI performance, such as expert ground truth, adjudication methods, and MRMC studies, are not applicable.

Device Name: TITAN 3-D® Wedge System

Device Type: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories (Implantable device)

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is an implantable device, the acceptance criteria are not for diagnostic performance (like sensitivity/specificity) but rather for safety and mechanical performance. The document describes performance testing related to MR Safety and mechanical properties.

Note: "Pass" implies that the device met the specified requirements of the respective ASTM standards or verified that the changes did not negatively impact safety or effectiveness.

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

The document does not specify a "test set" in the context of patient data or images. Instead, the testing involves physical samples of the device for mechanical and MR safety testing.

• Sample Size for Testing: Not explicitly stated as a number of devices, but implies testing was performed on representative samples for each test (e.g., multiple wedges for mechanical testing, a representative wedge for MR testing).
• Data Provenance: Not applicable as this refers to physical device testing, not clinical data or images from specific countries.

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

Not applicable. This device is an implant, not a diagnostic AI/software tool. Ground truth for its performance is established through standardized laboratory testing (e.g., ASTM standards) conducted by qualified engineers and technicians, not by expert interpretation of patient data.

4. Adjudication Method for the Test Set

Not applicable. See explanation for #3. Laboratory test results are typically objective measurements against a standard, not subject to subjective adjudication.

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

No. This is an implantable medical device, not an AI-assisted diagnostic tool. MRMC studies are not relevant for its evaluation.

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

Not applicable. This is an implant, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance is based on established engineering principles, material science, and performance standards (e.g., ASTM standards for mechanical properties and MR compatibility). It's scientific measurement and verification against defined criteria, not expert consensus, pathology, or outcomes data in the typical sense of a diagnostic or prognostic study.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/software product that requires a training set.

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

Not applicable. See explanation for #8.

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The TITAN 3-D™ Wedge System implants are intended to be used for internal bone fixation for bone fractures, fusions or osteotomies in the foot and ankle. The TITAN 3-D™ Wedge System implants are use with ancillary fixation. The TITAN3-DTM Wedge System implants are not intended for use in the spine.

The TITAN 3-D™ Wedge System contains a series of titanium alloy implants used for the correction of small bones in the foot. It is offered in varying shapes and sizes to accommodate a variety of small bone applications. The implants are sold sterile.

This document is a 510(k) premarket notification for the TITAN 3-D™ Wedge System, a bone fixation device. It describes the device, its intended use, and its equivalence to predicate devices, but it does not contain acceptance criteria for the performance of an AI/ML powered device, nor does it describe a study proving the device meets such criteria.

The information provided relates to a medical device's regulatory submission, not a study validating an AI/ML algorithm's performance against specific acceptance criteria. Therefore, I cannot extract the requested information from the provided text.

Here's why and what can be extracted:

• Device Type: The TITAN 3-D™ Wedge System is a physical implant (titanium alloy wedges) for internal bone fixation. It is not an AI/ML software or algorithm.
• Performance Data: The document mentions "Performance Data: Static and dynamic compression, and static compression-shear testing was performed following ASTM F2077. Expulsion testing was performed. Abrasion testing per ASTM F1978 was performed. LAL testing for bacterial endotoxins was performed." These are engineering and biocompatibility tests for a physical implant, not a study evaluating an AI algorithm's diagnostic or predictive performance.
• Acceptance Criteria & Reported Performance: Since this is not an AI/ML device, the concept of AI-specific acceptance criteria (like sensitivity, specificity, AUC) and reported AI performance (like 90% sensitivity, 85% specificity) is not applicable here.
• Study Design for AI/ML: All points related to sample size for test sets/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone performance are irrelevant to this document because it's not about an AI/ML device.

In summary, the provided document does not contain the information requested about acceptance criteria and a study proving an AI/ML device meets them. It's a regulatory filing for a physical medical implant.

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