(105 days)
The Equinoxe Reverse Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff. The Equinoxe Reverse Shoulder is also indicated for a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Exactech Equinoxe Reverse Shoulder Glenospheres and Extended Locking Cap are for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Glenospheres and Locking Cap; these geometry modifications are the entire basis for the proposed devices.
The provided text describes a 510(k) premarket notification for a medical device, the Exactech® Equinoxe® Reverse Shoulder Glenospheres. However, the document does not contain information related to an AI/ML-driven device or diagnostic software. Instead, it details the engineering and material testing performed for a physical medical implant.
Therefore, I cannot fulfill your request to describe acceptance criteria and study proving device performance for an AI/ML device based on the provided text, as the document does not discuss such a device.
To provide the requested information, the input text would need to describe a study evaluating the performance of an AI/ML algorithm or software for a diagnostic or predictive task.
Here's why the provided text is not relevant to your request:
- Device Type: The device described is a shoulder joint prosthesis (implant), not an AI/ML diagnostic or assistive tool.
- Testing: The non-clinical testing listed (ASTM F2028, ASTM F1378, pyrogen testing) are standard mechanical, materials, and sterility tests for physical implants, not performance evaluations for algorithms (e.g., sensitivity, specificity, AUC).
- Ground Truth: The concept of "ground truth" (expert consensus, pathology, outcomes data) is typically for validating diagnostic accuracy, which is not applicable to a physical implant in the same way.
- Human Readers/Experts: The document does not mention human readers, experts establishing ground truth for image interpretation, or MRMC studies, as these are relevant to evaluating diagnostic image analysis.
- Training/Test Sets: There is no mention of data sets for training or testing an algorithm.
If you can provide a different document that describes an AI/ML medical device, I would be happy to analyze it according to your specific criteria.
§ 888.3660 Shoulder joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a glenoid resurfacing component made of ultra-high molecular weight polyethylene, and 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,” and
(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,” and
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(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 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(v) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal,”
(vii) F 1378-97 “Standard Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”