(76 days)
The Comprehensive® Primary Shoulder Stems are intended for hemi or total shoulder replacement:
- Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis.
- Revision where other devices or treatments have failed.
- Correction of functional deformity.
- Fractures of the proximal humerus where other methods of treatment are deemed inadequate.
- Difficult clinical management problems, Including cuff tear arthropathy, where other methods of treatment may not be suitable or may be inadequate.
Humeral/glenold components with a porous coated surface coating are Indicated for either cemented or uncemented biological fixation applications. (Metal backed glenold components offer optional screw fixation.)
The Comprehensive® Primary Shoulder Stems are intended for use only with the Blo-Modular@ humeral heads and glenoid components and the Versa-Dial™ humeral head components.
The devices are single-use implants.
The Comprehensive® Primary Shoulder Stems are humeral stems comprised of titanium alloy. The stems are available in various lengths and sizes. Portions of the devices are coated with plasma-spray titanium porous coating. The taper geometry of the new devices is the exactly the same as the predicate Comprehensive® Humeral Fracture Stems (K023063). The new devices are comprised of the exact same material as the predicate Bio-Modular® Shoulder System stems (K030710). The Comprehensive® Primary Shoulder Stems are designed to be used with Biomet's Bio-Modular® and Versa-Dial™ humeral heads and can be used in hemi or total shoulder arthroplasty.
This document describes the Biomet Manufacturing Corp.'s "Comprehensive Primary Shoulder Stems" device, which received 510(k) clearance (K060692) from the FDA on May 30, 2006.
The 510(k) summary explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This means that the device's substantial equivalence to predicate devices was not established through clinical trials comparing its performance against predefined acceptance criteria. Instead, it was based on non-clinical testing and similarity to predicate devices.
Therefore, the following information, which typically pertains to clinical studies and acceptance criteria, cannot be provided from the given document:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
- If a standalone (algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
What can be extracted from the document regarding the study:
Summary of Study (Non-Clinical):
- Type of Study: Non-clinical laboratory testing.
- Purpose: To determine substantial equivalence to predicate devices.
- Findings: "The results indicated that the device was functional within its intended use."
Details Available from the Document:
- Device Name: Comprehensive® Primary Shoulder Stems
- Applicant/Sponsor: Biomet Manufacturing Corp.
- FDA 510(k) Number: K060692
- Approval Date: May 30, 2006
- Predicate Devices:
- Technological Characteristics Comparison: The technological characteristics (material, design, sizing, indications) of the Comprehensive® Primary Shoulder Stems are similar or identical to the predicate devices. Specifically:
Conclusion:
The 510(k) clearance for the Comprehensive® Primary Shoulder Stems was based on non-clinical bench testing demonstrating functionality and substantial equivalence to existing predicate devices, rather than a clinical study with predefined acceptance criteria for performance metrics on patient data. Therefore, the detailed information requested about acceptance criteria, clinical study parameters, and AI-related performance metrics is not applicable or available in the provided document.
§ 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.”