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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 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 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 EV™ 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 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.

This document is a 510(k) premarket notification for a medical device (LATITUDE EV Total Elbow Arthroplasty). It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical performance testing. Crucially, it explicitly states: "No clinical studies were performed."

Therefore, based on the provided text, there is no information to answer the questions regarding acceptance criteria and a study proving the device meets those criteria, as no clinical studies were conducted.

The device clearance relies on demonstrating substantial equivalence to existing legally marketed devices (predicates) through non-clinical bench testing and process validations, not on meeting specific performance acceptance criteria derived from a clinical trial.

To reiterate the reason for not being able to provide the requested information:

• No clinical studies were performed. This means there was no study designed to prove the device meets acceptance criteria in a clinical setting.
• The acceptance criteria for this 510(k) submission were likely focused on demonstrating mechanical performance, material properties, and biological safety through bench testing, which is different from clinical performance metrics.

Therefore, I cannot populate the table or answer the specific questions about clinical study design, sample sizes, expert involvement, ground truth, or MRMC studies because such studies were not conducted for this FDA clearance.

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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:

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