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The LATITUDE EV™ Total Elbow Arthroplasty system is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthritis and rheumatoid arthritis; correction of functional deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The LATITUDE EV™ Total Elbow Arthroplasty system is intended for cemented use only.

The LATITUDE EVI™ Total Elbow Arthroplasty system is a total elbow prosthesis consisting of a humeral, an ulnar, and an optional radial implant. The LATITUDE EV system is designed to facilitate the reproduction of the natural flexion/extension axis and kinematics of the prosthesis is a semiconstrained prosthesis when it is implanted in an unlinked configuration and becomes a constrained prosthesis when the ulnar cap is used to link the humeral and ulnar implant assemblies. All components are intended for cemented use only.

The provided text is a summary of an FDA 510(k) premarket notification for a medical device called the LATITUDE EV™ Total Elbow Arthroplasty system. This document focuses on the regulatory approval and comparison to predicate devices, and therefore, it does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically concerning AI/algorithm performance.

The document explicitly states: "No clinical studies were performed." This indicates there was no study conducted to assess the performance of the device in a clinical setting in the context of this 510(k) submission. Furthermore, there is no mention of any AI or algorithmic component to the device.

Therefore, I cannot provide the requested information.

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The Tornier Inc. Latitude Elbow Prosthesis is intended for total elbow arthroplasty. Prosthetic replacement with this device may be indicated to relieve severe pain or significant disability following the effects of primary or secondary osteoarthitis and rheumatoid arthritis; correction of functional, deformities; revision procedures where other treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Tornier Inc. Latitude Elbow Prosthesis is intended for cemented use only.

Total Elbow replacement is used to treat a number of clinical conditions such as severe pain or significant disability in degenerative, rheumatic disease of the elbow joint. They are also used in revision procedures where other treatments or devices have failed and treatment of fractures that are unmanageable using other techniques. The usual goal of surgery is to restore the elbow joint to its best working condition and to reduce or eliminate pain. The Tornier Inc. Latitude Elbow Prosthesis is intended to accomplish these goals. The Tornier Inc. Latitude Elbow Prosthesis is intended for use as a cemented total elbow.

The Tornier Inc. Latitude Elbow Prosthesis is a 3-part system consisting of a humeral, an ulnar and a radial component.The humeral implant is modular and consists in the assembly of various sizes of humeral stem and humeral spool in order to better reproduce the functionality of the natural humerus. The prosthesis is a non constrained prosthesis and when it is used with the ulnar cap the prosthesis becomes a constrained prosthesis.

The present device submission corresponds to several changes made to the device cleared in the latest 510k K070787.

This document is a 510(k) premarket notification for the Tornier Inc. Latitude Elbow Prosthesis. It describes modifications to an existing device and demonstrates substantial equivalence to predicate devices through various evaluations.

Here's an analysis of the provided text in relation to your request about acceptance criteria and study details:

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

The provided text does not contain a table of acceptance criteria nor reported device performance in the manner typically associated with clinical performance studies or specific quantitative metrics for AI/ML devices.

Instead, the submission focuses on demonstrating substantial equivalence through various engineering and design-related evaluations rather than clinical performance metrics:

Crucially, this document is for a medical implant (prosthesis), not an AI/ML diagnostic or predictive device. Therefore, the concepts of sensitivity, specificity, accuracy, and reader performance you've asked about (typical for AI/ML) are not applicable here. The "acceptance criteria" here are related to engineering validation, material properties, and comparison to a predicate device, focusing on safety and efficacy in a mechanical context.

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

• Test Set Sample Size: Not explicitly stated for specific tests.
  • "Cadaver evaluations" were performed, but the number of cadavers is not mentioned.
  • "Mechanical bench testing" was performed, but the number of test samples is not specified.
• Data Provenance: Not specified, as this is primarily internal testing and evaluation data, not clinical patient data in the sense of AI/ML studies.

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)

This section is not applicable to this type of device submission. Ground truth, in the context of this device, refers to engineering specifications, material properties, and functional performance benchmarks rather than expert consensus on medical images or diagnoses.

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

This section is not applicable as there is no "adjudication" in the sense of reviewing disagreements among experts on a test set for this mechanical device.

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

This section is not applicable as this is a medical implant, not an AI-assisted diagnostic tool.

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

This section is not applicable as this is a physical medical device, not an algorithm.

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

The "ground truth" for this device's evaluation would be based on:
* Engineering specifications and design requirements: For CAD evaluations.
* Biomechanical principles and established testing standards: For mechanical bench testing and cadaver evaluations. This would include metrics like range of motion, stability, load-bearing capacity, wear resistance, etc., compared against natural joint mechanics or predicate device performance.
* Industry standards for sterilization and packaging.

8. The sample size for the training set

This section is not applicable as this is a physical medical implant, not an AI/ML device requiring a training set.

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

This section is not applicable as this is a physical medical implant, not an AI/ML device.

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