(22 days)
The Equinoxe Shoulder System is indicated for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where total or hemi- arthroplasty is determined by the surgeon to be the preferred method of treatment.
The cemented primary humeral stem, long/revision stem, fracture stems and all Equinoxe glenoids are intended for cemented fixation.
The press-fit humeral stems are intended for press-fit applications but may be used with bone cement at the discretion the surgeon.
The reverse humeral components are intended to be used in cemented applications or in revision cases when the humeral component is well-fixed/stable, as deemed by the orthopaedic surgeon.
Humeral Heads are intended for use in cemented and press-fit applications.
Clinical indications for the PRIMARY (P), LONG/REVISION (L), and FRACTURE (F) humeral components 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.
Humeral head fracture with displacement of the tuberosities
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)
Displaced three-part and four-part upper humeral fractures
Spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
Revision of failed previous reconstructions when distal anchorage is required
To restore mobility from previous procedures (e.g. previous fusion)
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 Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures of the proximal humerus (hemi-arthroplasty), or acute fracture of the proximal humerus with failure of the glenohumeral joint (primary total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is also indicated for acute fracture of the proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
This submission proposes an increase in the angled surface from 8° to 12°, relative to the 8º posterior augment pegged glenoid devices previously cleared via 510(k) K103419. The proposed Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, #K093430, and #K103419.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™, structured according to your request.
Please note: This device is a physical medical implant, not an AI/Software as a Medical Device (SaMD). Therefore, many of your requested points regarding AI-specific studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone algorithm performance, training set details) are not applicable to this submission. The "study" described is a mechanical test to demonstrate substantial equivalence to a predicate device.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical testing per ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation. | Test results and analyses demonstrated substantial equivalence to the predicate device. (Implies performance met or exceeded the predicate and satisfied the standard). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated in the document. Mechanical tests typically involve multiple samples of the actual device component.
- Data Provenance: The study was a non-clinical mechanical test, not reliant on patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Not Applicable. This is a mechanical test of a physical device, not an evaluation requiring expert interpretation of clinical data or images. The "ground truth" is defined by the objective standards and measurements within the ASTM F2028 test method.
4. Adjudication Method for the Test Set
- Not Applicable. As a mechanical test, there is no adjudication of subjective expert opinions. Pass/fail criteria are based on objective measurements against the ASTM standard.
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
- No. This is a physical medical device, not an AI/SaMD. MRMC studies are not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
- No. This is a physical medical device, not an AI/SaMD. Standalone algorithm performance is not relevant.
7. The Type of Ground Truth Used
- Mechanical Performance Standards: The "ground truth" for this device's performance is adherence to the objective measurements and pass/fail criteria established by the ASTM F2028 standard for glenoid loosening or disassociation.
8. The Sample Size for the Training Set
- Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. This is a physical medical device, not an AI/SaMD. There is no "training set" or corresponding ground truth establishment process in this context.
Summary of the Study for this Device:
The study conducted for the Exactech® Equinoxe® UHMWPE 12° Posterior Augment Pegged Glenoids™ was a non-clinical mechanical test performed according to ASTM F2028 - Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation.
The purpose of this study was to demonstrate substantial equivalence to a previously cleared predicate device (Exactech Equinoxe UHMWPE 8 Degree Posterior Augment Pegged Glenoid, K103419). The primary change in the new device was an increase in the angled surface from 8° to 12°.
The acceptance criteria were that the new device's mechanical performance, specifically regarding glenoid loosening or disassociation, would meet the requirements of the ASTM F2028 standard and be comparable to the predicate device. The document explicitly states: "Test result and analyses provided in this 510(k) demonstrate Equinoxe UHMWPE 12° Posterior Augment Pegged Glenoids are substantially equivalent to the cited predicate device." This statement confirms that the device met its acceptance criteria based on the results of the mechanical testing.
§ 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.”