(256 days)
Coonrad/Morrey Total Elbow: Indications include: post-traumatic lesions or bone loss contributing to elbow instability; ankylosed joints, especially in cases of bilateral ankylosis from causes other than sepsis; advanced rheumatoid or degenerative arthritis with incapacitating pain: revision arthroplasty, and instability or loss of motion when the degree of joint damage precludes less radical procedures. The candidate for total elbow arthroplasty should exhibit joint destruction which significantly compromises the activities of daily living. Patient with single joint involvement (generally those with traumatic or degenerative arthritis) or significant lower extremity disability which require walking aids are less amenable to treatment than patients with advanced and predominantly upper extremity involvement. If possible, elbow replacement should be done after hip or knee surgery to avoid excessive stress to the prosthesis required by crutch walking during total hip or knee rehabilitation.
Zimmer Nexel Total Elbow: Indications for use include: Elbow joint destruction which significantly compromises the activities of daily living; Post-traumatic lesions or bone loss contributing to elbow instability; Ankylosed joints, especially in cases of bilateral ankylosis from causes other than active sepsis; Advanced rheumatoid, post-traumatic, or degenerative arthritis with incapacitating pain; Instability or loss of motion when the degree of joint or soft tissue damage precludes reliable osteosynthesis; Acute comminuted articular fracture of the elbow joint surfaces that precludes less radical procedures, including 13-C3 fractures of the distal humerus; Revision arthroplasty. Caution: This device is intended for cemented use only.
The Coonrad/Morrey Total Elbow and Zimmer Nexel Total Elbow are total elbow prosthesis designed for use with bone cement. They are available in multiple sizes and in right and left configurations. The devices are designed to replace the articulating surfaces of and restore motion to the humeroulnar (elbow) joint. The implants are constrained in design and consist of a humeral component and an ulna component joined through bearings in a hinged fashion. The purpose of this submission is the addition of MR conditional language to the labeling for these products. The addition of MR labeling to the subject devices does not impact indications, materials, design features or dimensions of the components, compatibility, packaging or sterilization. Additionally, this submission includes minor modifications to the subject device systems.
The provided text is a 510(k) summary for the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow. It concerns the addition of MR conditional language to the product labeling and minor design modifications, not a study evaluating device performance against specific clinical acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving the device meets those criteria cannot be extracted from this document.
However, I can provide information on what was studied and the conclusions drawn related to substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not present clinical acceptance criteria for the elbow prostheses themselves (e.g., pain reduction, range of motion improvement). Instead, it focuses on the performance related to MR Conditional safety. The acceptance criteria are implicit in the adherence to ASTM standards for MRI compatibility.
| Acceptance Criteria (based on ASTM Standards for MR Conditional) | Reported Device Performance |
|---|---|
| No excessive RF heating (ASTM F2182-11a) | Studies performed to determine MR Conditional |
| Acceptable image distortion (ASTM F2119-07) | Studies performed to determine MR Conditional |
| Acceptable magnetically induced displacement force (ASTM 2052-14) | Studies performed to determine MR Conditional |
| Satisfactory CEM43 analysis | Studies performed to determine MR Conditional |
| Engineering rationale for minor design modifications | Engineering rationale and testing provided to support minor design modifications |
2. Sample Size for Test Set and Data Provenance:
- Sample Size: Not applicable in the traditional sense of a clinical trial. The "test set" here refers to the Zimmer Nexel Total Elbow and Coonrad/Morrey Total Elbow implants that underwent MRI compatibility testing. The document does not specify the number of individual implants tested for these non-clinical evaluations, but it refers to the performance of "implants."
- Data Provenance: The tests were non-clinical (laboratory/engineering) as performed by Biomet (presumably the manufacturer, as Zimmer is also the manufacturer listed). The location/country of origin of the testing facility is not specified. The studies are by nature prospective in the sense that they were conducted specifically for this submission to address MRI safety.
3. Number of Experts and Qualifications for Ground Truth:
Not applicable. This was a non-clinical evaluation based on adherence to engineering standards (ASTM) for MRI safety. Ground truth was established by the specified ASTM test methods. No human expert consensus was used for establishing MRI compatibility ground truth; it's a technical outcome.
4. Adjudication Method for Test Set:
Not applicable. Non-clinical engineering tests do not typically involve adjudication methods like those used in clinical image interpretation studies. The results are quantitative and determined by the test protocol.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, a MRMC comparative effectiveness study was not done. The submission is for non-clinical testing related to MRI safety and minor design modifications, not for assessing human reader performance or the clinical effectiveness of the elbow prostheses themselves.
6. Standalone Performance (Algorithm Only):
- Not applicable. This submission is for medical devices (total elbow prostheses), not a software algorithm.
7. Type of Ground Truth Used:
- For the MRI compatibility studies, the ground truth was based on established engineering standards and measurements as defined by ASTM F2503-13, F2182-11a, F2119-07, and F2052-14.
- For the minor design modifications, the ground truth was based on engineering rationale and testing to demonstrate that the modifications do not negatively impact device performance or safety.
8. Sample Size for Training Set:
- Not applicable, as this is not a machine learning or AI-based device requiring a training set.
9. How Ground Truth for Training Set Was Established:
- Not applicable.
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II. The special controls for this device are:(1) FDA's:
(i) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ”
(ii) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),”
(iii) “Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement,”
(iv) “Guidance Document for the Preparation of Premarket Notification (510(k)) Application for Orthopedic Devices,”
(v) “Guidance Document for Testing Non-articulating, ‘Mechanically Locked’ Modular Implant Components,”
(2) International Organization for Standardization's (ISO):
(i) ISO 5832-3:1996 “Implants for Surgery—Metallic Materials—Part 3: Wrought Titanium 6-Aluminum 4-Vandium Alloy,”
(ii) ISO 5832-4:1996 “Implants for Surgery—Metallic Materials—Part 4: Cobalt-Chromium-Molybdenum Casting Alloy,”
(iii) ISO 5832-12:1996 “Implants for Surgery—Metallic Materials—Part 12: Wrought Cobalt-Chromium-Molybdenum Alloy,”
(iv) ISO 5833:1992 “Implants for Surgery—Acrylic Resin Cements,”
(v) ISO 5834-2:1998 “Implants for Surgery—Ultra High Molecular Weight Polyethylene—Part 2: Moulded Forms,”
(vi) ISO 6018:1987 “Orthopaedic Implants—General Requirements for Marking, Packaging, and Labeling,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(3) American Society for Testing and Materials':
(i) F 75-92 “Specification for Cast Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implant Material,”
(ii) F 648-98 “Specification for Ultra-High-Molecular-Weight Polyethylene Powder and Fabricated Form for Surgical Implants,”
(iii) F 799-96 “Specification for Cobalt-28 Chromium-6 Molybdenum Alloy Forgings for Surgical Implants,”
(iv) F 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”