(21 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/R) 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 4part 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.
The proposed Equinoxe UHMWPE Posterior Augment Pegged Glenoids are intended to be used with Equinoxe shoulder system components described in #K042021, #K061454, and #K093430. Equinoxe UHMWPE posterior augment glenoids combine materials and features found in the cited predicates. The proposed Equinoxe UHMWPE posterior augment glenoids are manufactured from the same materials as glenoid components cleared via #K042021 and #K093430, and feature the same articulating and angled geometry as glenoid components cleared via #K093430.
The provided text describes a Special 510(k) submission for the Exactech® Equinoxe® UHMWPE Posterior Augment Pegged Glenoids™. This submission is for a medical device (glenoid component in shoulder arthroplasty) and therefore, the acceptance criteria and study detailed are for mechanical testing to demonstrate substantial equivalence, not for AI/ML device performance.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Meets requirements specified in ASTM F2028, "Standard Test Methods for Dynamic Evaluation of Glenoid Loosening or Disassociation" | Proposed devices meet requirements specified in ASTM F2028. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample size for the mechanical testing conducted under ASTM F2028.
- Data Provenance: The data provenance is "mechanical testing referenced in this submission," implying that the testing was conducted by Exactech, Inc. or a contracted laboratory for the purpose of this submission. It's a prospective test specifically for this device modification. There is no information regarding the country of origin of the data beyond the manufacturer being based in Gainesville, Florida, USA.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This question is not applicable to this type of device and study. The "ground truth" for mechanical testing is established by the specifications and methodologies of the ASTM F2028 standard itself, which is a recognized industry standard for evaluating glenoid loosening or disassociation. It does not involve human expert consensus for interpreting test results in the way an AI/ML diagnostic device would.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in human expert interpretations (e.g., in medical image analysis) are resolved to establish a ground truth. Mechanical testing relies on quantifiable measurements and adherence to a standard protocol, not human adjudication of subjective assessments.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC comparative effectiveness study is used to compare the diagnostic performance of human readers, often with and without AI assistance, on a set of medical cases. This submission concerns the mechanical performance of an orthopedic implant, not diagnostic interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No. This concept is relevant for AI/ML algorithms. The device in question is a physical orthopedic implant. The "performance" here refers to its mechanical integrity, not an algorithm's output.
7. The Type of Ground Truth Used
The ground truth used is adherence to a recognized industry standard for mechanical performance, specifically ASTM F2028. This standard defines the acceptable parameters and methodologies for dynamic evaluation of glenoid loosening or disassociation.
8. The Sample Size for the Training Set
This question is not applicable. There is no "training set" in the context of mechanical testing for a physical medical device. Training sets are used in AI/ML development to train an algorithm.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable, as there is no training set for this type of device submission.
§ 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.”