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Reverse Total Shoulder

The INHANCE SHOULDER SYSTEM Reverse Total Shoulder with a humeral stem is indicated for primary, fracture or revision total reverse shoulder replacement procedures to address the following. The system is indicated for use in patients whose shoulder joint has a gross rotator cuff deficiency. The patient must be anatomically suited to receive the implants and a functional deltoid muscle is necessary. The system is also indicated from an anatomic to reverse shoulder prosthesis without the removal of a well-fixed INHANCE humeral stem.

• · A severely painful, disabling, arthritic joint
• · Fractures of the humeral head (with Short Humeral Stems)
• · Fractures of the humeral head and proximal humerus (with Standard or Long Stems)
• · Revisions of previously failed shoulder joint replacements

Fixation Methods

The humeral stem is intended for cementless use. The glenoid baseplate components are intended for cementless application with the addition of screw fixation.

The INHANCE REVERSE SHOULDER SYSTEM with Glenoid Peripheral Posts is intended for use in reverse total replacement procedures.

The Reverse Total Shoulder Prosthesis consists of individually packaged implants: a metal humeral stem (titanium alloy), a shell (titanium alloy), a liner (Cross-linked, VE UHMWPE) in combination with a glenosphere (cobalt-chromium), baseplate (titanium alloy), peripheral screws (titanium alloy), peripheral posts (titanium alloy), and either a central screw (titanium alloy) or a central post (titanium alloy).

The INHANCE REVERSE SHOULDER SYSTEM includes Peripheral Posts that are offered in 4MM, 6MM and 8MM lengths. The Peripheral Posts can be simply prepared for, and placed through, one of the peripheral holes of the Baseplate to increase contact area and aid in stability. This versatile option allows for interoperative flexibility and simple preparation to address various glenoid morphologies.

Note(s):

• . When using a Peripheral Post implant, the INHANCE Reverse Shoulder System is only indicated for use with a Central Screw and Peripheral Locking Screws that are 25mm or greater in length.
• . The Peripheral Post implants are only indicated for use in anterior, posterior, and superior glenoid defects.

The provided document is a 510(k) premarket notification letter from the FDA to Ignite Orthopedics LLC regarding their INHANCE™ Reverse Glenoid Peripheral Posts. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets specific performance criteria through a study with acceptance criteria.

The document discusses non-clinical testing conducted to support substantial equivalence. However, it explicitly states: "Clinical testing was not necessary to demonstrate substantial equivalence of the INHANCE™ Reverse Glenoid Peripheral Posts to the predicate devices."

Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in terms of clinical performance (e.g., diagnostic accuracy, patient outcomes) is not available in this document. The document describes engineering and biocompatibility testing criteria, but not criteria related to clinical performance or human reader studies.

Here's a breakdown of the information that is available based on your request, highlighting what is missing due to the nature of this submission (a 510(k) based on substantial equivalence, not a clinical performance study):

Acceptance Criteria and Device Performance (Based on Non-Clinical Testing):

Since "Clinical testing was not necessary," the following points of your request cannot be answered from the provided text:

2. Sample sizes used for the test set and data provenance: Not applicable for clinical performance study.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable, as no clinical test set requiring expert ground truth was described.
4. Adjudication method for the test set: Not applicable.
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, as this is a physical medical device, not an AI-assisted diagnostic tool, and no clinical study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (not an algorithm/AI device).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for clinical performance. For non-clinical tests, the "ground truth" or reference is the specified ASTM/ISO standard criteria.
8. The sample size for the training set: Not applicable (no algorithm/AI device or clinical training set described).
9. How the ground truth for the training set was established: Not applicable (no algorithm/AI device or clinical training set described).

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