VERSA-DIAL HUMERAL HEAD PROSTHESIS

• K Number: K060716
• Device Name: VERSA-DIAL HUMERAL HEAD PROSTHESIS
• Manufacturer: BIOMET MANUFACTURING CORP.
• Date Cleared: 2006-06-12 ( 87 days)
• Product Code: MBF , HSD , KWS , KWT
• Regulation Number: 888.3670
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K040610 , K030710 , K002998

Intended Use

The Versa-Dial™ Humeral Head Prosthesis Is intended for:

1. Non-Inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis.
3. Revision where other devices or treatments have failed.
4. Correction of functional deformity.
5. Corrector of the proximal humerus where other methods of treatment are deemed Inadequate.
   indequate: 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 blological fixation applications. (Metal backed glenoid components offer optional screw fixation.)

Polyethylene glenold components not attached to a metal back are indicated for cemented application only.

The Versa-Dial™ Humeral Head Prosthesis is Intended for use only with the Comprehensive® Shoulder Stems (Fracture, Primary and Revision), the Bio-Modular® Shoulder Stems, and the glenold components of the Blo-Modular® Shoulder System.

The device is a single-use implant.

Device Description

The Versa-Dial™ Humeral Head Prosthesis consists of a series of varioussized modular humeral heads with variable offset between 0.5mm and 4.5 mm. Each modular head consists of a head and a taper adaptor. The taper adaptor is impacted into the head in a certain position to achieve the desired amount of offset. The system can be used with Blomet's Comprehensive® Shoulder System or Biomet's BioModular® Shoulder System depending upon which taper is used (i.e., in order to use with the Comprehensive® shoulder stem, the Comprehensive® Taper Adaptor must be used).

AI/ML Overview

The provided document describes a 510(k) Premarket Notification for the Versa-Dial™ Humeral Head Prosthesis. This type of submission to the FDA focuses on demonstrating substantial equivalence to existing legally marketed devices, rather than proving safety and effectiveness through extensive clinical trials with pre-defined acceptance criteria and performance metrics.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria. Here's a breakdown of why and what information is present:

Missing Information (and why):

• 1. A table of acceptance criteria and the reported device performance: Not present. 510(k) submissions typically do not involve pre-defined performance acceptance criteria for clinical outcomes in the same way a PMA (Premarket Approval) would. The focus is on demonstrating that the new device is as safe and effective as a predicate device.
• 2. Sample sized used for the test set and the data provenance: Not applicable. No clinical test set data from the manufacturer is provided.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set data or expert-reviewed ground truth is mentioned.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• 5. 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. This is a medical device (prosthesis), not an AI-assisted diagnostic tool.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
• 8. The sample size for the training set: Not applicable (no clinical training data presented).
• 9. How the ground truth for the training set was established: Not applicable.

What the document does provide regarding "proving" the device (in the context of a 510(k)):

The proof provided in this 510(k) document is centered around demonstrating substantial equivalence to predicate devices. This is achieved by:

• Device Description and Comparison to Predicates: The document details the Versa-Dial™ Humeral Head Prosthesis and explicitly states, "The technological characteristics (material, design, sizing, indications) of the Versa-Dial™ Humeral Head Prosthesis are similar or identical to the predicate devices." It also notes a redesign of the taper adaptor material (TT-6Al-4V vs. Co-Cr-Mo) and changed indicia, implying these changes do not alter substantial equivalence.
• Non-Clinical Testing: The document states: "Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use." This non-clinical testing (likely mechanical, material, and performance bench testing) is the primary "study" mentioned to support the device's functionality. No specific metrics or acceptance criteria for this non-clinical testing are provided in this summary, but the FDA's acceptance of the 510(k) implies these tests met regulatory expectations for substantial equivalence.
• Clinical Testing: The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence." This is very common for 510(k) submissions where substantial equivalence can be demonstrated through non-clinical data and comparison to predicates.

In summary, for a 510(k) submission like this, the "acceptance criteria" are implicitly met by demonstrating that the device is substantially equivalent to legally marketed predicate devices, primarily through engineering analysis, material comparison, and non-clinical bench testing, and without the need for de novo clinical trials or pre-defined performance metrics against a clinical ground truth.

Regulation Number and Section

§ 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.”