COPELAND MB RESURFACING HUMERAL HEADS

• K Number: K010657
• Device Name: COPELAND MB RESURFACING HUMERAL HEADS
• Manufacturer: BIOMET MANUFACTURING, INC.
• Date Cleared: 2001-09-14 ( 192 days)
• Product Code: HSD
• Regulation Number: 888.3690
• Type: Traditional
• Panel: OR
• Reference & Predicate Devices: K003044 , K002998 , K991585 , K992119

Intended Use

The Copeland™ MB 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:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
2. Rheumatoid arthritis
3. Correction of functional deformity
4. Reconstructable rotator cuff
5. Treatment of fractures of the humeral head
6. Traumatic arthritis
   For uncemented use only.

Device Description

These devices are intended for use as a cementless fixation humeral replacement system that requires minimal bone resection. Copeland™ MB Resurfacing Humeral Heads can be used in hemi- or total shoulder replacement surgical procedures in Patients experiencing pain or 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 small, medium, and large humeral head components can be used with the BioModular Glenoids or Integrated Glenoids. The extra-large head can only be used with Biomet's BioModular Glenoids due to the larger spherical radius.

AI/ML Overview

The acceptance criteria for the Copeland™ MB Resurfacing Humeral Heads are not explicitly stated in the provided document in a quantitative or pass/fail format typical for AI/ML device evaluations. Instead, the document describes the device's substantial equivalence to predicate devices and provides a summary of clinical follow-up as evidence of safety and effectiveness.

The study that proves the device meets the acceptance criteria is a clinical follow-up study of previously implanted resurfacing heads.

Here's an breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Inferred from device description and intent)	Reported Device Performance
Safety and Effectiveness for Intended Use:

• Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis)
• Rheumatoid arthritis
• Correction of functional deformity
• Reconstructable rotator cuff
• Treatment of fractures of the humeral head
• Traumatic arthritis | Clinical Results:
• 103 resurfacing heads implanted in cementless surface replacement arthroplasty of the shoulder.
• Minimum follow-up: 2 years.
• These clinical results "provide data that demonstrates the substantial equivalence" of the Copeland™ MB Resurfacing Humeral Heads. |
  | Mechanical Integrity & Durability (for MacroBond™ coating): | Non-Clinical Testing:
• Finite Element Analysis (FEA) compared the device to the predicate.
• MacroBond™ coating characterized by various mechanical tests. |
  | Substantial Equivalence to Predicate Devices: | Demonstrated through design similarity and the clinical data mentioned above, specifically addressing the differences in coating and cementing. |

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size for Test Set: 103 resurfacing heads.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study began "Since 1990," suggesting prospective data collection for these specific implants. The data is clinical, implying real-world patient outcomes.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• The document does not provide details on the establishment of ground truth by experts in the context of specific case analysis for the 103 implants. The "ground truth" for the clinical study would be the patient's actual clinical outcomes (e.g., function, pain relief, absence of complications, need for revision). These outcomes are assessed by orthopedic surgeons and clinical staff as part of their standard practice.
• No information is given on external review by a panel of experts for each case.

4. Adjudication Method for the Test Set:

• No specific adjudication method is mentioned for the clinical data. Clinical follow-up studies typically rely on standard medical record keeping, clinical assessments by treating physicians, and potentially independent review of endpoints, but no specific adjudication panel or method (like 2+1) is described here.

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:

• No MRMC study was done. This device is a surgical implant, not an AI/ML diagnostic tool used by human readers. Therefore, the concept of human readers improving with AI assistance is not applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a medical device (implant) and not an algorithm.

7. The Type of Ground Truth Used:

• The ground truth for the clinical study was based on patient outcomes data, including clinical follow-up for a minimum of 2 years, assessing performance in terms of safety and effectiveness for the stated indications.

8. The Sample Size for the Training Set:

• Not applicable. This device is an implant, not an AI/ML algorithm that requires a training set. The "training" in this context would refer to the historical clinical experience and engineering knowledge that led to its design, which is not quantified as a "training set" in the AI sense.

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As above, there is no AI/ML training set. The design of the device is based on established biomechanical principles and clinical experience with predicate devices.

Regulation Number and Section

§ 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.