(175 days)
The Coonrad/Morrey Total Elbow is indicated for:
- 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
- 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. Patients 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 closely based on the Coonrad III Total Elbow (K883665) cleared by FDA on February 3, 1989, with several exceptions.
The provided text is a K973357 510(k) Pre-Market Notification for a medical device (Coonrad/Morrey Total Elbow, New Hinge Pin). It describes the device, its intended use, and states that performance testing was conducted. However, the document does NOT contain the detailed information required to answer most of the questions about acceptance criteria, study methodologies, sample sizes, ground truth establishment, or multi-reader multi-case studies.
Here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated in the document. The document only broadly mentions "force required to unlock the hinge pin assembly." | "Results indicate the product is safe and effective." (Specific numerical results or thresholds are not provided.) |
Missing Information:
- Specific numerical acceptance criteria (e.g., minimum force to unlock).
- Detailed quantitative results of the performance testing.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable, as this was a physical performance test for a mechanical device, not a diagnostic or image-based study requiring expert ground truth establishment in the typical sense.
- Qualifications of experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable, as this was a physical performance test.
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 K973357 510(k) for a joint replacement device, not an AI/imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a K973357 510(k) for a joint replacement device, not an AI/imaging diagnostic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device would be its mechanical integrity and function as measured by the "force required to unlock the hinge pin assembly." This is a physical measurement, not a diagnostic finding.
8. The sample size for the training set
- Not applicable. This is a physical performance test, not a machine learning study with training sets.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The provided document is a 510(k) summary for a physical medical device, not a study report for an AI or diagnostic device. Therefore, most of the requested information regarding AI study methodologies, expert ground truth, and training/test sets is not present and not applicable to this type of submission. The document only generically states that "Performance testing was conducted to determine force required to unlock the hinge pin assembly. Results indicate the product is safe and effective." without providing the specific criteria or quantitative outcomes.
§ 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.”