(24 days)
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.
The Coonrad Morrey Total Elbow is a total elbow prosthesis designed for use with bone cement. It is available in regular, small and extra small sizes, in right and left configurations.
The provided document is a 510(k) premarket notification for a medical device, the Coonrad/Morrey Total Elbow prosthesis. It is a submission for substantial equivalence to a predicate device, not a study evaluating a new AI/ML-based device. Therefore, the questions related to AI/ML device performance (acceptance criteria, sample sizes for test/training, expert ground truth, adjudication, MRMC studies, standalone performance) are not applicable to this document.
The document indicates that the modified device (modified stem lengths for ulnar assemblies) is substantially equivalent to its predicate device (Coonrad/Morrey Total Elbow, K001989).
Here's the relevant information based on your request, highlighting what is not applicable due to the nature of the submission:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable. This is a 510(k) submission for substantial equivalence of an updated mechanical implant, not an AI/ML device with performance metrics like accuracy, sensitivity, or specificity. The "acceptance criteria" here is the demonstration of substantial equivalence.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Device is substantially equivalent to a predicate device in terms of intended use, technological characteristics, and safety and effectiveness. | Nonclinical analysis indicates that the modified device is substantially equivalent to the predicate. |
2. Sample Sizes used for the Test Set and Data Provenance
Not Applicable for an AI/ML context. The submission mentions "nonclinical analysis" to support substantial equivalence. This would typically involve engineering analysis, bench testing, and comparisons to the predicate device's design specifications and performance, rather than a "test set" of patient data for an algorithm. No sample sizes for testing or data provenance are specified in this document.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not Applicable. No "test set" in the context of AI/ML evaluation is described. The assessment relied on engineering and design comparison.
4. Adjudication Method for the Test Set
Not Applicable.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not Applicable. This study is not relevant for a mechanical elbow prosthesis.
6. Standalone Performance Study (Algorithm Only)
Not Applicable. This is not an algorithm.
7. Type of Ground Truth Used
Not Applicable for an AI/ML context. The "ground truth" for this submission would be the established safety and effectiveness of the predicate device and engineering principles ensuring the modified device meets those standards.
8. Sample Size for the Training Set
Not Applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not Applicable.
Summary based on the document:
- Device Type: Coonrad/Morrey Total Elbow, a metal/polymer constrained elbow prosthesis.
- Submission Type: 510(k) premarket notification for substantial equivalence.
- Modification: Ulnar Assemblies of modified stem length.
- Predicate Device: Coonrad/Morrey Total Elbow (K001989).
- Performance Data: "Results of nonclinical analysis indicate that the modified device is substantially equivalent to the predicate." This suggests engineering analysis and bench testing were performed to compare the modified device's characteristics (e.g., strength, fit) to the original.
- The FDA concluded that the device is "substantially equivalent" for its stated indications for use.
§ 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.”