(29 days)
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 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 Compress® Segmental Humeral Replacement System components are intended for uncemented use. 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 information provided states that no clinical or non-clinical data was submitted or deemed necessary for the determination of substantial equivalence for the Compress® Segmental Humeral Replacement System. Therefore, there is no study that proves the device meets specific acceptance criteria based on performance data.
Instead, the submission relied on demonstrating substantial equivalence to a predicate device (Compress® Segmental Humeral Replacement System, K112905) for an addition of compatibility to another system.
Given this, I cannot provide the requested information:
- A table of acceptance criteria and the reported device performance: No performance data or acceptance criteria are mentioned.
- Sample size used for the test set and the data provenance: No test set or data provenance mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No test set or ground truth established by experts mentioned.
- Adjudication method for the test set: No test set or adjudication method mentioned.
- 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 medical implant, not an AI diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical implant.
- The type of ground truth used: No ground truth used.
- The sample size for the training set: No training set mentioned.
- How the ground truth for the training set was established: No training set or ground truth mentioned.
§ 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.”