(28 days)
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 Exactech Equinoxe Small Reverse Shoulder is a subsystem of the Exactech Equinoxe Reverse Shoulder System which provides small reverse glenoid plates, small reverse glenospheres, screw components, humeral liners, and surgical instrumentation for use in reverse total shoulder arthroplasty. The modifications proposed by this submission describe minor geometry changes to the predicate Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. As well as minor geometry modifications, this submission proposes Equinoxe Locking Cap compatibility with the Small Reverse Glenoid Plates and Small Reverse Glenospheres.
This document describes the Exactech Equinoxe Small Reverse Shoulder Glenospheres and Humeral Liners. The submission is a "Special 510(k)", which implies that minor changes have been made to a previously cleared device. Therefore, the "study" described focuses on demonstrating that these minor changes do not alter the substantial equivalence to the predicate device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Maintenance of mechanical and dimensional properties after minor geometry changes. | Engineering analyses (TM-2018-0755, TR-2018-0720, TM-2018-0523) demonstrated that the mechanical and dimensional properties of the modified glenospheres and humeral liners, as well as the compatibility with the Equinoxe Locking Cap, are maintained and within acceptable tolerances. These analyses provided justification for the internal bore modification, tolerance analysis, and undercut geometry update. |
| Sterility (Pyrogenicity) | Pyrogen testing (in accordance with USP , USP , and ANSI/AAMI ST72) confirmed that the proposed components meet recommended limits for devices labeled as sterile. |
| Substantial Equivalence to Predicate Device | Based on the engineering analyses, the proposed devices (Small Reverse Glenosphere and Humeral Liner) were deemed substantially equivalent to the cleared predicate Equinoxe Small Reverse Glenosphere and Humeral Liner devices. This equivalence is supported by identical indications for use, intended use, device materials, design features, basic scientific technology, and implant/instrument compatibility. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not applicable in the traditional sense of a clinical or in-vitro study with a distinct test set of data. The "test set" here refers to the specific design modifications and components that underwent engineering analysis and pyrogen testing.
- Data Provenance: The data provenance is internal to Exactech, Inc., as the tests and analyses were conducted by the manufacturer for their device modifications. The information is retrospective in terms of being generated to support the specific 510(k) submission for changes to an existing product. No external or prospective data is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This submission relies on engineering analyses and standardized pyrogen testing, not expert consensus on diagnostic images or clinical outcomes. The "ground truth" for the engineering analyses is based on established mechanical principles, material science, and design specifications. For pyrogen testing, the ground truth is defined by the standards (USP , USP , ANSI/AAMI ST72).
4. Adjudication Method for the Test Set
Not applicable. No clinical or expert review adjudication was performed for these engineering and sterility tests. The evaluation is based on meeting pre-defined engineering tolerances and standard test limits.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This is a submission for a modification to a medical device (implants), not an AI or diagnostic imaging device that would typically involve human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant for shoulder arthroplasty, not an algorithm or software. "Standalone" performance is not a relevant concept here.
7. The Type of Ground Truth Used
The ground truth used in this submission is based on:
- Engineering specifications and tolerances: for the mechanical and dimensional properties.
- Established industry standards: for pyrogen testing (USP , USP , ANSI/AAMI ST72).
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for this type of device modification submission. Device design and engineering are not typically "trained" in the machine learning sense.
9. How the Ground Truth for the Training Set was Established
Not applicable, as there is no training set.
§ 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.”