Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device