(234 days)
The Compress® Segmental Humeral Replacement System is intended to replace the resected part of the humerus in cases of severe bone loss in either the proximal or distal humerus. The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Compress® Segmental Humeral Replacement System is indicated for:
- Correction or revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement.
- Tumor resections.
- Revision of previously failed total joint arthroplasty.
- Trauma.
The Compress® Segmental Humeral Replacement System components are intended for uncemented use.
The Discovery Elbow components when used in conjunction with the Compress® Segmental Humeral Replacement System are restricted to the Compress® Segmental Humeral Replacement System indications and are intended to be inserted with bone cement.
The Modular Hybrid Glenoid when used in conjunction with the Compress® Segmental Humeral Replacement System is restricted to the Compress® Segmental Humeral Replacement System indications and is intended to be used with bone cement. The optional porous titanium peg may be inserted without bone cement. The optional polyethylene peg should be inserted with bone cement.
The Compress® Segmental Humeral Replacement System is a metallic segmental fixation system intended to replace the resected part of the humerus in cases of severe bone loss. The design of the Compress® System allows a compressive load to be applied at the prosthetic implant-bone interface at the time of device insertion. This is accomplished through a spring system built into the stem.
The Compress® Segmental Humeral Replacement System is a set of Compliant - Pre-Stress implants that replace the humeral stems that would normally be used during a proximal or distal humeral replacement surgery.
Here's a summary of the acceptance criteria and the study information based on the provided text, formatted as requested:
1. Table of Acceptance Criteria and Reported Device Performance
| Test Name | Acceptance Criterion | Reported Device Performance |
|---|---|---|
| Mini Compress® Taper Fatigue Test | Cyclic fatigue testing to ten million cycles without failure (implied) | All test specimens passed cyclic fatigue testing to ten million cycles without failure. |
| Mini Compress® Pull-off Test | Exceeded minimum acceptance criterion (specific value not given) | Each individual specimen exceeded the minimum acceptance criterion, as did the average pull-off strength. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes non-clinical (bench) testing only. It does not mention a "test set" in the context of patient data.
- Sample Size for Test Set: Not applicable, as no clinical test set was used.
- Data Provenance: Not applicable, as no clinical data was used.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
Not applicable. The tests performed are mechanical engineering tests, not clinical evaluations requiring expert consensus on ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set with ground truth establishment was performed. The non-clinical tests likely followed standardized engineering practices for evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No. A multi-reader multi-case (MRMC) comparative effectiveness study was not done.
6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. The device is a physical medical implant (Compress® Segmental Humeral Replacement System), not an algorithm or AI system. Therefore, a standalone performance study in the context of AI is not relevant.
7. The Type of Ground Truth Used
The ground truth for the non-clinical tests was based on engineering specifications and predefined performance thresholds for mechanical properties (fatigue life, pull-off strength). This is a form of objective physical measurement against a standard.
8. The Sample Size for the Training Set
Not applicable. The device is a physical medical implant, not an AI or machine learning model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set for an AI/ML model.
§ 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.”