(100 days)
Indications For Use:
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- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
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- Rheumatoid arthritis.
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- Revision where other devices or treatments have failed.
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- Correction of functional deformity.
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- Fractures of the proximal humerus, where other methods of treatment are deemed inadequate.
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- Difficult clinical management problems, including cuff arthropathy, where other methods of treatment may not be suitable or may be inadequate.
- Humeral components with a Macrobond® surface coating are indicated for either cemented or uncemented press-fit applications.
- Humeral/glenoid components with a porous coated surface coating are indicated for either cemented or uncemented biological fixation applications. (Metal backed glenoid components offer optional screw fixation).
- Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications (Metal backed glenoid components offer optional screw fixation).
- Humeral components with a non-coated (Interlok") surface are indicated for cemented application only.
- Polyethylene glenoid components not attached to a metal back are indicated for cemented application only.
The Comprehensive Humeral Fracture Stem is intended for use with the Bio-Modular® humeral heads and glenoid components.
The Versa-Dial™ Humeral Head Prosthesis is intended for use only with the Comprehensive Humeral Fracture Stem and the glenoid components of the Bio-Modular® Shoulder System.
The Bio-Modular® Shoulder System is a set of components intended for total or hemi shoulder arthroplasty. It consists of humeral stems, humeral heads, and glenoid components. The only change to this system proposed by this submission is the addition of Hydroxyapatite (HA) coating to the glenoid components that utilize metal backs and are intended for biological fixation with optional screw fixation. The HA coated glenoid components are intended only for total shoulder arthroplasty.
This 510(k) premarket notification (K043100) for the Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components does not contain acceptance criteria or a study demonstrating the device meets such criteria in the way typically expected for an AI/ML medical device.
This submission is for a medical implant (shoulder prosthesis) and asserts substantial equivalence to a predicate device based on material, design, and functional characteristics, not on a performance evaluation like an AI/ML algorithm. Therefore, the requested information elements related to AI/ML device testing (sample sizes, expert ground truth, MRMC studies, standalone performance, training data) are not applicable to this document.
Here's a breakdown based on the provided text, addressing the points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the context of an AI/ML device. For this orthopedic implant, the "acceptance criteria" are generally related to demonstrating substantial equivalence in mechanical properties, biocompatibility, and manufacturing processes compared to a predicate device. The document states:
"The Bio-Modular Shoulder System with the Hydroxyapatite coated glenoid components has the same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy as the predicate device."
This statement serves as the core performance claim for substantial equivalence. No specific quantitative performance metrics (like accuracy, sensitivity, specificity) with pre-defined acceptance thresholds are provided, as this is not an AI/ML diagnostic or prognostic device.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. No "test set" in the AI/ML sense was used. The submission relies on non-clinical testing (presumably mechanical and material testing) to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. No medical expert ground truth was established for the purpose of evaluating an AI/ML algorithm.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No. This type of study is relevant for evaluating the impact of AI assistance on human reader performance, which is not applicable to a shoulder prosthesis submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This is not an algorithm.
7. The Type of Ground Truth Used
Not applicable. For this device, the "ground truth" would be established through established engineering and biocompatibility standards, mechanical testing, and material characterization, rather than clinical outcomes or expert consensus in an AI/ML context.
8. The Sample Size for the Training Set
Not applicable. No AI/ML model was trained.
9. How the Ground Truth for the Training Set was Established
Not applicable.
Summary of Device-Specific Information for K043100:
- Device Name: Bio-Modular® Shoulder System - Hydroxyapatite Coated Glenoid Components
- Predicate Device: Bio-Modular® Shoulder System (K030710) – Biomet Inc.
- Basis for Substantial Equivalence: New device has the "same intended use, the same mechanical design, the same functional characteristics, and is made of the same titanium alloy" as the predicate device, with the addition of Hydroxyapatite (HA) coating to glenoid components.
- "Study" (Non-Clinical Testing): "Non-Clinical Testing: The modified devices were found to be substantially equivalent to the predicate devices." (Details of this non-clinical testing are not provided in the 510(k) summary itself, but would have been part of the full submission).
- Clinical Testing: "No clinical testing was provided as a basis for substantial equivalence."
In conclusion, this 510(k) document is for an orthopedic implant and does not involve AI/ML technology. Therefore, the specific criteria for evaluating AI/ML devices outlined in your request are not present or applicable here.
§ 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.”