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The Reverse Humeral Socket Shell is indicated for revision surgeries in patients with a grossly rotator cuff deficient shoulder joint with severe arthropathy or a previously failed joint replacement with a grossly rotator cuff deficient shoulder joint. The patient's joint must be anatomically and structurally suited to receive the selected implant(s), and a functional deltoid muscle is necessary to use the device. The socket shell is only indicated for use with a well fixed Turon Humeral Stem.

In cases of revision surgeries to a well fixed Turon Humeral socket shell can be mated with the Turon stem to convert to a reverse shoulder application.

The provided document is a 510(k) summary for the "Reverse Humeral Socket Shell" device. It outlines non-clinical testing performed, but explicitly states "Clinical Testing: None provided." Therefore, based on the provided text, there is no study that proves the device meets acceptance criteria through clinical performance.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and by having comparable features to predicate devices.

Here's the information parsed from the document regarding the non-clinical testing, which serves as the "study" demonstrating equivalence and meeting certain performance standards:

1. Table of acceptance criteria and the reported device performance:

Note: The document doesn't explicitly state numerical acceptance criteria for these tests, but rather indicates that the device met "minimum load conditions" and demonstrated "equivalence to the cleared Turon socket and stem interface" or applied results from predicate devices due to identical geometry.

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

• Sample Size: Not specified in the document for any of the non-clinical tests.
• Data Provenance: The tests were performed as part of the device's 510(k) submission, likely by the manufacturer (DJO Surgical / Encore Medical, L.P.). It's a prospective experimental study conducted in a lab setting, not involving human or patient data.

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

• This is not applicable as the "ground truth" for mechanical testing is defined by engineering standards (e.g., ASTM) and direct measurement of physical properties, not by expert consensus.

4. Adjudication method for the test set:

• Not applicable for this type of non-clinical mechanical testing. Results are typically determined by instrumentation and direct comparison to a standard or predicate device's performance.

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:

• Not applicable. This is a medical device for orthopedic surgery (a shoulder implant component), not an AI/imaging diagnostic device. No MRMC study was performed.

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

• Not applicable. This is a physical medical implant, not an algorithm or AI.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is based on:
  • Engineering Standards: Adherence to ASTM standards provides a baseline for acceptable performance.
  • Predicate Device Performance: Equivalence to the mechanical performance and design of previously cleared predicate devices (e.g., Turon Humeral socket, RSP socket shells, Turon Humeral Neck).
  • Direct Measurement: Physical properties and resistance to loads are directly measured through experimental setups.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

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