(178 days)
The Copeland™ MB/HA Resurfacing Humeral Heads are indicated for the following conditions where the humeral head and neck are of sufficient bone stock and there is presence of an intact or reconstructable rotator cuff which is necessary for proper functioning and dislocation resistance:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
- Rheumatoid arthritis
- Correction of functional deformity
- Reconstructable rotator cuff
- Treatment of fractures of the humeral head
- Traumatic arthritis
For uncemented use only.
These devices are intended for use as a cementless fixation humeral replacement system that requires minimal bone resection. Copeland™ MB/HA Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical procedures in patients experiencing pain and disability of the gleno-humeral joint. By preserving the bone stock, this device gives a patient an alternative to other total shoulder devices where more bone is removed. This device can easily be revised to a longer stemmed prosthesis if necessary due to the initial bone preservation.
The humeral head components are available in four sizes - small, medium, large, and extra-large. The small, medium, and large humeral heads have the same radius of curvature, but the heights differ to cater for the range of anatomical sizes and offsets. The extra-large head has a larger radius of curvature to accommodate a patient with larger bone stock. The stem is tapered and fluted to provide maximum stability in the humerus. The components are manufactured from cobalt-chrome-molybdenum alloy (ASTM F-75) and have a thin layer of plasma spray coating known as MacroBond™ on the non-articulating surface. There is a depression in the surface of the inner spherical radius of the head. This depression is intended for the location of the MacroBond™ Coating. The MacroBond™ coated portion of the device is further coated with hydroxyapatite (HA).
The small, medium, and large humeral head components can be used with Biomet's Bio-Modular® Glenoids or Integrated Glenoids. The extra-large head can not be used with Integrated Glenoids due to the larger spherical radius.
Here's a breakdown of the acceptance criteria and study information for the Copeland™ MB/HA Resurfacing Humeral Heads, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|
| Maintain or improve clinical outcomes for shoulder arthroplasty, specifically regarding: | "Since 1994, sixty-nine HA coated resurfacing heads have been implanted in cementless surface replacement arthroplasty of the shoulder." |
| - No or minimal revisions | "The minimum follow-up was 2 years with no revisions reported." |
| - No or minimal radiolucencies | "Radiographically, no lucencies were observed surrounding these devices." |
| - Compatibility with surgical procedures | Implied by "can be used in hemi- or total shoulder replacement surgical procedures." |
| - Biocompatibility and structural integrity of new coating | MacroBond™ coating characterized by "various mechanical tests." (No specific acceptance criteria or performance values provided for these tests, but positive results are implied for substantial equivalence.) |
| - Similar biomechanical properties to predicate device | Finite Element Analysis done to compare to predicate. (No specific acceptance criteria or performance values provided, but results are implied to support equivalence.) |
Note: The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than setting explicit, quantifiable acceptance criteria for a novel device. The "acceptance criteria" are thus inferred from the positive outcomes reported to support equivalence to the previously cleared devices.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 69 HA coated resurfacing heads
- Data Provenance: The document does not explicitly state the country of origin. Given Biomet, Inc. is located in Warsaw, Indiana, USA, it's highly probable the data is from the USA. The data is retrospective, as it refers to implants that have been in use "since 1994" with a "minimum follow-up of 2 years."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The clinical data mentions "no revisions reported" and "no lucencies were observed radiographically," implying clinical and radiological assessment, but the number or qualifications of the individuals making these assessments are not specified.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a MRMC comparative effectiveness study was not explicitly mentioned or conducted as described in the document. The clinical testing described is primarily an observational study of outcomes for the new device type, comparing them implicitly to the expected performance of predicate devices based on the absence of reported adverse events (revisions, lucencies).
- Effect size of human readers improvement with AI vs. without AI assistance: Not applicable, as no AI component or human-in-the-loop study was conducted.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not done. This device is a physical medical implant (humeral head prosthesis), not a software algorithm.
7. The Type of Ground Truth Used
The ground truth was established through clinical observation and radiological assessment of patient outcomes.
- Clinical Outcomes: Absence of device revisions (suggesting successful implantation and function, and lack of adverse events requiring removal/replacement).
- Radiological Outcomes: Absence of lucencies surrounding the devices (indicating successful bone integration and stability of the uncemented implant).
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical implant, not an AI/software algorithm that requires a "training set" in the conventional sense. The "clinical testing" described serves as the test set for demonstrating safety and effectiveness.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there is no "training set" for this type of device.
§ 888.3690 Shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis.
(a)
Identification. A shoulder joint humeral (hemi-shoulder) metallic uncemented prosthesis is a device made of alloys, such as cobalt-chromium-molybdenum. It has an intramedullary stem and is intended to be implanted to replace the articular surface of the proximal end of the humerus and to be fixed without bone cement (§ 888.3027). This device is not intended for biological fixation.(b)
Classification. Class II.