(90 days)
The Equinoxe Shoulder System is indicated to relieve pain and restore function 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.
Clinical indications for the PRIMARY (P), LONG/REVISION (L/R) and FRACTURE (F) humeral components are as follows:
P, L/R: rheumatoid arthritis, osteoarthritis, osteonecrosis or post-traumatic degenerative problems
P, L/R: congenital abnormalities in the skeletally mature
P: primary and secondary necrosis of the humeral head.
P, F: humeral head fracture with displacement of the tuberosities
P, L/R: pathologies where arthodesis or resectional arthroplasty of the humeral head are not acceptable
P, L/R: revisions of humeral prostheses when other treatments or devices have failed (where adequate fixation can be achieved)
F: displaced three-part and four-part upper humeral fractures
L/R: spiral and other fractures of the mid-humerus (in combination with glenohumeral degenerative diseases)
L/R: revision of failed previous reconstructions when distal anchorage is required
P, L/R: to restore mobility from previous procedures (e.g. previous fusion)
The EQUINOXE® Shoulder System comprises both cemented and press-fit semiconstrained glenohumeral prostheses for use in hemi-shoulder and total-shoulder joint replacement procedures and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus. The system includes various sizes and types of modular humeral stems, humeral heads, glenoids, replicator plates, and screws for use in primary, revision, and fracture applications.
This 510(k) premarket notification for the Exactech Equinoxe® Shoulder System (K042021) does not contain a study that proves the device meets specific quantitative acceptance criteria in the format requested. Instead, it relies on demonstrating substantial equivalence to predicate devices and provides mechanical testing and engineering analyses to confirm safety and effectiveness.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document summarizes the performance testing as: "A number of mechanical tests and engineering analyses were conducted to demonstrate the safety and efficacy of the devices... Test reports detail: 1) the design rationale... 2) the methodology used to demonstrate how these devices were determined to be safe and effective; 3) the results from these mechanical tests and engineering analyses, and 4) the interpretations of the data."
However, specific quantitative acceptance criteria with corresponding device performance values (e.g., minimum fatigue strength, maximum wear rate, etc.) and direct "pass/fail" reporting against those criteria are not detailed in this summary. The general statement is that "these reports demonstrate the effectiveness of the design" and that the components "perform as intended."
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document mentions "a number of mechanical tests and engineering analyses." It does not specify the sample sizes for these tests (e.g., how many implants were tested for fatigue, wear, etc.).
- Data Provenance: The document implies that the testing was conducted internally by Exactech, Inc. (or contracted by them) as part of the submission process. There is no mention of external data, clinical study data, or data from specific countries of origin beyond the company's US location. The data would be considered prospective in the sense that the tests were designed and executed to support this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This information is not applicable to the type of data presented. Mechanical tests and engineering analyses do not typically rely on "ground truth" established by human experts in the same way clinical diagnostic studies do. The "truth" in these tests is objective, measurable physical properties and performance under defined mechanical loads.
4. Adjudication Method for the Test Set:
This is not applicable for mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert review of human-interpreted data (e.g., radiological images).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size:
No, an MRMC comparative effectiveness study was not done or reported. This document is a 510(k) summary for a medical device (shoulder system) that focuses on mechanical performance and substantial equivalence, not on the interpretative performance of human readers with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
No, a standalone performance study was not done or reported. This device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used:
For the mechanical tests, the "ground truth" would be the objective measurements obtained from the tests themselves (e.g., load-to-failure, displacement, wear volume) compared against internal design specifications, industry standards, or the performance of predicate devices. There is no "expert consensus," "pathology," or "outcomes data" ground truth referenced for the mechanical/engineering testing in this summary.
8. The Sample Size for the Training Set:
This is not applicable. The device is a physical implant, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the reasons stated above.
§ 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.”