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Intended Use: The Delta Xtend™ Reverse Shoulder prosthesis is intended for use in total or hemi shoulder arthroplasty procedures in patients with non-functional rotator cuffs.

Indications for Use: The Delta Xtend™ Reverse Shoulder prosthesis is intended for use as total shoulder or hemi-shoulder replacement. 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. The metaglene component is HA coated and is intended for cementless use with the addition of screws for fixation. All other components are for cemented use only.

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

This document pertains to a 510(k) premarket notification for the Delta Xtend™ Reverse Shoulder System. It is a regulatory submission for a medical device and, as such, does not contain information about clinical studies with acceptance criteria, sample sizes, expert involvement, or specific performance metrics in the way a clinical trial report would.

The provided text describes the device, its intended use, indications for use, and establishes substantial equivalence to previously cleared predicate devices. It also includes the FDA's clearance letter.

Therefore, I cannot provide the requested information, such as:

1. A table of acceptance criteria and the reported device performance: This document does not present acceptance criteria or detailed performance data from a clinical or analytical study. The basis for clearance is substantial equivalence to predicate devices, not meeting specific performance thresholds in a new study.
2. Sample size used for the test set and the data provenance: No new test set data is described. The clearance is based on comparison to existing devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no new test set requiring ground truth establishment is described.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
6. If a standalone performance study was done: No standalone algorithm performance study is indicated. This is a physical medical device (shoulder prosthesis), not an AI algorithm.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of available information related to the device and its clearance:

• Device Name: Delta Xtend™ Reverse Shoulder System
• Classification: Class II
  • 21 CFR 888.3660: Shoulder Prosthesis, Semi-Constrained, Metal/Polymer Cemented
  • 21 CFR §888.3690: Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
• Intended Use/Indications: Total or hemi-shoulder arthroplasty in patients with non-functional rotator cuffs, severe arthropathy, or previous failed joint replacement with a grossly deficient rotator cuff joint. Also indicated for hemi-arthroplasty if the glenoid is fractured intraoperatively. Requires a functional deltoid muscle.
• Basis of Clearance: Substantial equivalence to predicate devices:
  • DePuy Delta CTA Reverse Shoulder System (K021478)
  • DePuy Delta CTA Head (K062116)
  • DePuy Global Advantage Shoulder System (K992065)
  • DePuy Global Advantage CTA Head (K000575)

The 510(k) process for this device relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring new clinical studies to meet pre-defined performance acceptance criteria.

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