(130 days)
The Equinoxe Stemless Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases of the glenohumeral joint where anatomic total shoulder arthroplasty is determined by the surgeon to be the preferred method of treatment.
Clinical indications for anatomic total shoulder arthroplasty are as follows:
- 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 Stemless Shoulder humeral components are indicated for press-fit, uncemented use.
The Equinoxe Stemless Shoulder System is intended to be used with the cemented Equinoxe glenoid components.
The Equinoxe Stemless Shoulder is intended to be used with Exactech glenoid components for use in Total Shoulder Arthroplasty. The Exactech glenoid components are indicated for cemented use. The Equinoxe Stemless Shoulder includes humeral components and humeral heads. The proposed Equinoxe Stemless Humeral Components are additively manufactured from Ti-6Al-4V, and have porous regions. The Equinoxe Stemless Humeral Heads are manufactured from Cobalt Chrome. The Equinoxe Stemless Humeral Components are available in two types, Caged and Non-Caged, with each type available in three sizes, with lengths between 17mm and 24mm. The Equinoxe Stemless Humeral Heads are available in 12 sizes, with diameters between 38mm and 53mm and two height options (Extra Short, Short).
This FDA 510(k) premarket notification for the Exactech® Equinoxe® Stemless Shoulder device does not describe an AI/ML-based medical device. Therefore, the questions related to acceptance criteria, AI/ML study design, ground truth, and sample sizes for training/testing sets are not applicable in this context.
This submission is for a medical implant (a shoulder prosthesis) and focuses on demonstrating substantial equivalence to previously approved predicate devices through non-clinical (mechanical) testing, material comparisons, and similar indications for use.
Instead of AI/ML performance metrics, the document presents mechanical performance criteria.
Here's a breakdown of the relevant information provided:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Non-Clinical) | Reported Device Performance |
|---|---|
| Fatigue Testing | Performed to demonstrate performance and substantial equivalence. (Specific results not detailed in this summary document, but inferred to meet criteria for substantial equivalence.) |
| Axial Pull Out Testing | Performed to demonstrate performance and substantial equivalence. |
| Torque out Testing | Performed to demonstrate performance and substantial equivalence. |
| Taper Disengagement Testing | Performed to demonstrate performance and substantial equivalence. |
| Pyrogen Testing (USP , USP , ANSVAAMI ST72) | Conducted to ensure components meet recommended limits for sterility. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable for AI/ML device. The "test set" here refers to mechanical test samples, not clinical data for an algorithm. The document does not specify the number of mechanical samples used for each test. Data provenance is not relevant as it's mechanical testing of a physical device.
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):
- Not applicable for AI/ML device. Ground truth, in the context of AI/ML, refers to labels or diagnoses. For a physical implant, ground truth would be established through engineering specifications and standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for AI/ML device. Adjudication methods are used to resolve disagreements in expert labeling for AI/ML ground truth.
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 not an AI/ML device, so no MRMC studies or human reader improvement with AI assistance were performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable for AI/ML device. For this physical device, "ground truth" equates to the established engineering specifications, performance standards (e.g., ISO, ASTM for fatigue, pull-out strength), and material properties that the device must meet to function safely and effectively.
8. The sample size for the training set:
- Not applicable for AI/ML device. There is no training set for a physical implant.
9. How the ground truth for the training set was established:
- Not applicable for AI/ML device. There is no ground truth or training set in the AI/ML sense for this device.
§ 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.”