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The Delta Xtend Reverse Shoulder prosthesis is indicated for use in a grossly deficient rotator cuff joint with severe arthropathy or a previous failed joint replacement with a grossly deficient rotator cuff 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.

In cases of bone defects in the proximal humerus, the monobloc implant should be used and then only in cases where the residual bone permits firm fixation of this implant.

Delta Xtend hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for revision of a previously failed Delta Xtend Reverse Shoulder.

The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation.

The modular humeral stem and epiphysis components are HA coated and intended for cementless use.

All other components are for cemented use only.

The Delta Xtend Reverse Shoulder prosthesis is intended for use in total or hemi-shoulder arthroplasty procedures in patients with non-functional rotator cuffs, with or without bone cement. HA components are for cementless use only.

The Delta Xtend Reverse Shoulder System is a modular shoulder prosthesis designed for use in patients with non-functional rotator cuffs.

The provided document is a 510(k) premarket notification summary for a medical device, the DePuy Delta Xtend™ Reverse Shoulder System. This type of document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing detailed study results against specific acceptance criteria for performance.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study that proves the device meets them, in the context of an AI/algorithm-driven device.

The questions you've asked (about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) are typically relevant for the regulatory review of AI/ML-enabled medical devices or diagnostic tools. The DePuy Delta Xtend™ Reverse Shoulder System is a physical orthopedic implant and its 510(k) submission process does not involve the types of performance studies you're inquiring about for AI-based systems.

To directly answer your request based on the provided text, while acknowledging it doesn't fit the AI/ML framework of your questions:

1. A table of acceptance criteria and the reported device performance

• Response: Not applicable. The document does not define explicit "acceptance criteria" in terms of statistical performance metrics (e.g., sensitivity, specificity, AUC) or report device performance against such metrics. The basis for clearance is "substantial equivalence" to predicate devices, meaning the device is considered as safe and effective as a legally marketed device.

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

• Response: Not applicable. This document does not describe a clinical performance study with a test set. Substantial equivalence for this type of device is typically demonstrated through bench testing (e.g., mechanical properties, wear), biocompatibility testing, and comparison of design, materials, and intended use to predicate devices, not through performance metrics on a clinical test set.

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)

• Response: Not applicable. No clinical test set or ground truth establishment by experts is described in this regulatory submission for a physical implant.

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

• Response: Not applicable. No clinical test set or expert adjudication is described.

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

• Response: Not applicable. This device is a physical orthopedic implant, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to its regulatory clearance.

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

• Response: Not applicable. This is not an algorithm-only device.

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

• Response: Not applicable. No ground truth is established as part of this type of regulatory submission for a physical orthopedic implant.

8. The sample size for the training set

• Response: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

• Response: Not applicable. No training set or ground truth establishment for a training set is relevant to this device.

In summary, the provided document is a 510(k) premarket notification for an orthopedic implant. It demonstrates substantial equivalence to existing devices based on characteristics like indications for use, materials, design, and manufacturing processes, rather than through clinical performance studies against specific quantitative acceptance criteria or the use of AI/ML algorithms.

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