(130 days)
The Gemini Revision Glenoid is indicated for un-cemented use for the following indications:
- noninflammatory degenerative joint disease including osteoarthritis and avascular . necrosis;
- . rheumatoid arthritis;
- correction of functional deformity; .
- other difficult management problems where arthrodesis or resectional arthroplasty are not . acceptable (e.g. revision of a failed primary component);
- . cuff tear arthropathy.
Uncemented fixation may be supplemented by optional screw fixation.
The Encore Metal-Backed Revision Clenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene insert.
Metal Baseplate: The metal baseplate component, manufactured from Ti-6Al-4V per ASTM F136, is porous coated with commercially pure titanium (per ASTM F67 grade 2). It has an integrated central screw that provides initial fixation of the glenoid component as well as compression between the baseplate and the glenoid surface. HA porous coating on the surface of the medial side of the baseplate promotes biological fixation. No enhanced claims regarding the calcium phosphate coating will be made for this device. Additional fixation of the baseplate is achieved using four peripheral screws that can lock to the baseplate or have varying angles. All screws are manufactured from Ti-6Al-4V per ASTM F136.
Polyethylene Insert: The polyethylene inscrt component, molded from Ultra High Molecular Weight Polyethylene (per ASTM F648), snaps into the baseplate and provides a smooth bearing surface with the humeral head.
The provided document is a 510(k) summary for the Encore Shoulder System - Metal-Backed Revision Glenoid. It describes the device, its intended use, predicate devices, and the FDA's substantial equivalence determination.
However, the document does not contain any information about acceptance criteria or specific studies proving the device meets performance criteria beyond non-clinical mechanical testing. This is common for 510(k) submissions of orthopedic implants, where substantial equivalence to a legally marketed predicate device often relies on demonstrating similar materials, design, and mechanical performance, rather than requiring extensive clinical trials with specific performance metrics.
Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement cannot be extracted from this document.
Here's a breakdown of what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Information Not Present: The document does not define specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life thresholds with numerical values) or provide a table summarizing device performance against such criteria. It generally states that "Mechanical testing has demonstrated the device's ability to perform under expected clinical conditions," which is a qualitative statement of compliance rather than a detailed performance report.
2. Sample Size Used for the Test Set and Data Provenance
Information Not Present: Since the document reports "Clinical Testing: None provided" and primarily relies on non-clinical mechanical testing, there is no "test set" of patient data in the typical sense. For mechanical testing, the "sample size" would refer to the number of components tested, but this detail is not provided. Data provenance (country of origin, retrospective/prospective) is also not applicable for non-clinical mechanical tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Information Not Present: This information is relevant for clinical studies where expert consensus might establish ground truth for diagnostic or prognostic outcomes. As no clinical testing is provided and the primary evidence is mechanical testing, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
Information Not Present: Similar to point 3, adjudication methods are applicable to clinical studies where different experts might disagree on an outcome. This is not reported for the non-clinical mechanical testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
Information Not Present: No MRMC study was reported. The document explicitly states "Clinical Testing: None provided." Therefore, there is no effect size for human reader improvement with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Information Not Present: This question relates to AI or software-as-a-medical-device. The Encore Shoulder System is a physical orthopedic implant. Therefore, the concept of a "standalone algorithm" performance is not applicable to this device.
7. The Type of Ground Truth Used
Information Present (for non-clinical testing): For the non-clinical mechanical testing, the "ground truth" would implicitly be relevant engineering standards (e.g., ASTM F136 for Ti-6Al-4V, ASTM F67 for commercially pure titanium, ASTM F648 for Ultra High Molecular Weight Polyethylene) and design specifications. The document states materials conform to these ASTM standards. The "ability to perform under expected clinical conditions" (mentioned in "Non-Clinical Testing") serves as a general statement that the device met internal ground truth/specifications.
Information Not Present (for clinical outcomes): No clinical ground truth (e.g., pathology, patient outcomes data) is discussed as no clinical studies were performed or provided.
8. The Sample Size for the Training Set
Information Not Present: As this is a mechanical medical device and not an AI/ML-driven diagnostic or therapeutic tool, the concept of a "training set" in the context of data analysis or model development is not relevant.
9. How the Ground Truth for the Training Set Was Established
Information Not Present: See point 8. Not applicable to this type of device submission.
§ 888.3670 Shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer/metal nonconstrained or semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits movement in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral component made of alloys such as cobalt-chromium-molybdenum (Co-Cr-Mo) and titanium-aluminum-vanadium (Ti-6Al-4V) alloys, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, or a combination of an articulating ultra-high molecular weight bearing surface fixed in a metal shell made of alloys such as Co-Cr-Mo and Ti-6Al-4V. The humeral component and glenoid backing have a porous coating made of, in the case of Co-Cr-Mo components, beads of the same alloy or commercially pure titanium powder, and in the case of Ti-6Al-4V components, beads or fibers of commercially pure titanium or Ti-6Al-4V alloy, or commercially pure titanium powder. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. This generic type of device is designed to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance: Shoulder Joint Metal/Polymer/Metal Nonconstrained or Semi-Constrained Porous-Coated Uncemented Prosthesis.”