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The DELTA XTEND Shoulder Prosthesis is indicated for use in treatment of a grossly deficient rotator cuff joint with:
• severe arthropathy and/or;
• a previously failed joint replacement and/or:
• fracture-dislocations of the proximal humerus where the articular surface is severely comminuted, separated from its blood supply or where the surgeon's experience indicates that alternative methods of treatment is unsatisfactory
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.
DELTA XTEND hemi-shoulder replacement is also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively or for the 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 humeral epiphysis components are HA coated and intended for cementless use. All other metallic components are intended for cemented use only.

The DELTA XTEND Reverse Shoulder System is currently cleared and marketed by DePuy Synthes and is comprised of multiple humeral and glenoid implant components. These are provided as separate, standalone devices and may be used in conjunction to form a total shoulder prothesis. This submission is pertinent to only those system components which are HA coated:
Humeral Implants: Modular humeral stems Modular epiphysis
Glenoid Implants: Metaglenes

This document describes a 510(k) premarket notification for the DELTA XTEND™ Reverse Shoulder System. The submission is for the introduction of an additional manufacturing and sterilization site for the hydroxyapatite (HA) coated system components and an update to packaging configuration for these components. No new device performance claims are being made beyond substantial equivalence to the predicate device.

Here's the information broken down as requested:

1. Table of Acceptance Criteria and Reported Device Performance

Since this 510(k) is primarily for the introduction of an additional manufacturing and sterilization site and packaging updates, and claims substantial equivalence to a previously cleared device, the "acceptance criteria" are the standards for manufacturing, sterilization, and material characterization, and the "reported device performance" is that the device meets these standards, thereby maintaining equivalence to the predicate.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical tests (biological safety, packaging, sterilization, HA coating characterization) rather than a clinical study with a "test set" of patients or data in the traditional sense of AI/diagnostic device evaluation.

• Sample Size for Test Set: Not applicable as this is not a clinical study on patient data for diagnostic or prognostic performance. The "samples" would be the manufactured device components undergoing the specified non-clinical tests. The document does not specify the number of units tested for each non-clinical test, but it is implied that a sufficient number were tested to satisfy the respective ISO and AAMI standards and FDA guidance.
• Data Provenance: Not applicable in terms of country of origin of patient data or retrospective/prospective nature, as no clinical data or patient data was involved in this particular 510(k) submission. The data provenance would be from laboratory testing performed at the manufacturer's facility or certified testing labs.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. No "ground truth" based on expert consensus on patient data was established, as this was a non-clinical submission.

4. Adjudication Method for the Test Set

Not applicable. No "test set" requiring adjudication by experts on clinical data was used.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The submission explicitly states: "No clinical tests were conducted to demonstrate substantial equivalence."

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical implant (shoulder prosthesis), not an algorithm or AI software. Therefore, an "algorithm only" or "standalone" performance study is not relevant.

7. Type of Ground Truth Used

The "ground truth" in this context refers to established standards and scientific principles that the non-clinical tests aim to verify.

• Biological Safety: Ground truth is defined by the acceptable levels of biological response as outlined in ISO 10993-1.
• Packaging: Ground truth is the ability of packaging to maintain sterility and product integrity as defined by ISO 11607 series and ISTA 3A.
• Sterilization: Ground truth is the sterility assurance level (SAL) achieved according to AAMI ANSI ISO 11137 series.
• HA Coating Characterization: Ground truth is the physical and chemical properties of the HA coating meeting the specifications and recommendations provided in the FDA Guidance for HA-coated orthopedic implants.

8. Sample Size for the Training Set

Not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this device.

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