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TEMA Elbow system is intended for use in cemented applications for patients suffering from disability due to:

1. Elbow joint destruction which significantly compromises the activities of daily living
2. Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
3. Rheumatoid arthritis or degenerative arthritis with incapacitating pain
4. Revision where other devices or treatments have failed.
5. Correction of severe functional deformity.
6. Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
7. Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion

The unlinked, semi-constrained version is for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of disengagement between ulnar and humeral components, when intraoperative manual testing is performed.

TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.

TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.

The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.

The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.

TEMA Elbow system - Line extension introduces two new sizes of Ulnar stems to the ulnar stem range already cleared; moreover, a design change is introduced for the axle component, ulnar body component and for the humeral body compared to the original cleared version.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the TEMA Elbow system - Line extension.

It's important to note that the provided FDA 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, not on proving that a new medical device meets specific acceptance criteria in a clinical study. The document primarily discusses non-clinical (bench) testing. Therefore, several requested categories (like ground truth, expert qualifications, adjudication, MRMC studies, training set size) are not applicable or cannot be extracted from this type of FDA submission.

Acceptance Criteria and Device Performance

The core of this submission is to demonstrate that the "TEMA Elbow system - Line extension" is substantially equivalent to the previously cleared "TEMA Elbow system (K181362)". The acceptance criteria, in this context, are not explicit pass/fail thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) but rather the demonstration that the new device's performance, particularly mechanical, is comparable or superior to the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document uses terms like "demonstrated" and "substantially equivalent" rather than specific numerical performance metrics typical for software or diagnostic devices.

Study Details (Based on available information)

2. Sample size used for the test set and the data provenance

• Sample Size (Test Set): Not applicable in the context of a clinical test set from this document. The "test set" here refers to the physical samples used in bench tests. The document does not specify the number of physical components or prototypes tested for "Range of Motion," "Stability," "Fatigue," "Fretting-Corrosion," or "Wear Evaluation."
• Data Provenance: Not applicable. The document describes non-clinical (bench) testing, not human or animal data. The manufacturing company is LimaCorporate S.p.A. based in Italy.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not applicable. This was a non-clinical (bench) study. Ground truth in this context would likely be engineering specifications or established test standards, not expert clinical consensus.

4. Adjudication method for the test set

• Not applicable. As a non-clinical (bench) study, there is no mention or need for a clinical adjudication method.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a physical elbow prosthesis, not an AI-powered diagnostic or assistive tool.

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

• No, a standalone algorithm performance study was not done. This device is a physical implant.

7. The type of ground truth used

• For the non-clinical (bench) tests, the "ground truth" would be established engineering standards, material properties, and performance benchmarks for orthopedic implants, typically defined in ASTM or ISO standards. The document doesn't specify these exact standards but refers to "mechanical evaluations (both bench tests and rationales)."

8. The sample size for the training set

• Not applicable. There is no training set mentioned, as this is not an AI/machine learning device.

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

• Not applicable. No training set.

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