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The Lattude 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 treatments or devices have failed; treatment of fractures that are unmanageable using other techniques.

The Latitude EVIM Total Elbow Arthroplasty system is intended for cemented use only.

The Latitude EV™ Total Elbow Arthroplasty system is a 2- or 3-part 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 elbow. The prosthesis is a semi-constrained 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 Latitude EV™ humeral and ulnar stems are available in multiple sizes for primary and revision surgery and include a plasma spray coating. The optional radial implant is uncoated and is available in several sizes corresponding to the humeral and ulnar construct size selected.

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Latitude EV™ Total Elbow Arthroplasty device:

Based on the provided 510(k) summary, this device is a medical implant, not an AI/software device, which explains why many of the requested AI-specific points (like MRMC studies, standalone performance, training data, etc.) are not applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details

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

• Sample Size: Not specified for the bench tests. For mechanical testing, this typically refers to the number of components or assemblies tested.
• Data Provenance: The studies were non-clinical performance bench testing. Thus, there is no patient data provenance (country of origin, retrospective/prospective) as it involves laboratory testing of physical devices.

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. This is a physical device (Class II medical implant), and the studies described are non-clinical mechanical bench tests and an endotoxin test. There is no "ground truth" in the clinical sense established by human experts for these types of tests. Compliance is typically assessed against engineering standards and specifications by engineers and quality control personnel.

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

• Not Applicable. As mentioned above, this is non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for clinical image interpretation or diagnosis where there can be inter-reader variability.

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:

• No. An MRMC comparative effectiveness study was not done. This device is a physical total elbow arthroplasty, not an AI algorithm or a diagnostic tool that assists human readers.

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

• No. This is a physical medical device. The concept of "standalone performance" applies to AI algorithms operating independently, which is not relevant here.

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

• Not Applicable in the clinical sense. The "ground truth" for the non-clinical tests would be the established engineering specifications, material standards, and performance characteristics for mechanical strength, durability (fatigue), and biocompatibility (endotoxin levels). For the "substantial equivalence" claim, the predicate device's established performance serves as a comparative benchmark.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device, not a machine learning model. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, there is no ground truth established for it.

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