(125 days)
The Equinoxe Preserve Stems are indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total arthroplasty, anatomic hemi-arthroplasty, or reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total arthroplasty and anatomic hemi-arthroplasty are as follows:
- · Rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
- · Congenital abnormalities in the skeletally mature
- · Primary and secondary necrosis of the humeral head.
- · Pathologies where arthrodesis or resectional arthroplasty of the humeral head are not acceptable
- · Revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
- · To restore mobility from previous procedures (e.g. previous fusion)
The Equinoxe Preserve Stems are additionally indicated for use in reverse total arthroplasty in skeletally mature individuals with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff or a failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Equinoxe Preserve Stems are intended for press-fit applications but may be used with bone cement at the discretion of the surgeon.
The Exactech Equinoxe Preserve Stem is a line extension to the range of humeral stems marketed by Exactech under the Equinoxe brand name. The subject device is intended to provide surgeons with a short-stem, distal bone preserving option that is compatible with minimally invasive surgical techniques. The proposed device is manufactured from Ti-6Al-4V and has Titanium Plasma Spray, grit blasted, and polished regions. The stems are available in 10 sizes, with distal stem diameters between 6mm and length of 70mm.
This document is a 510(k) premarket notification for a medical device called the Exactech® Equinoxe® Preserve Stem, a humeral stem for shoulder replacement surgery. It establishes substantial equivalence to previously marketed predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the context of AI/algorithm performance. Therefore, I cannot extract the requested information regarding acceptance criteria and studies in the way you've outlined, as this document pertains to a physical orthopedic implant and its regulatory clearance process based on substantial equivalence, not an AI/software as a medical device.
The document discusses:
- Indications for Use: What the device is intended for.
- Technological Characteristics: How the device is similar to predicate devices (materials, design, dimensions, sterilization).
- Non-Clinical Testing: Engineering analyses performed to demonstrate performance (Fatigue Testing, Subsidence and Pull-out Testing, Pyrogen testing).
It does not contain information about:
- A table of acceptance criteria and reported device performance (in terms of AI metrics).
- Sample size for a test set, data provenance, or ground truth.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How ground truth for the training set was established.
This document is a regulatory submission for a physical medical device, not an AI/ML-driven diagnostic or therapeutic device that would require the specific types of studies and acceptance criteria you're asking about.
§ 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.”