(133 days)
The Equinoxe Humeral Reconstruction Prosthesis System is intended for use in hemi or total shoulder arthroplasty where proximal humeral resection is deemed necessary in cases of:
- Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis
- Rheumatoid arthritis
- Revision where other devices or treatments have failed
- Correction of functional deformity
- Treatment of acute or chronic fracture with humeral head involvement, which are unmanageable using other treatment
- Traumatic arthritis
- Oncology applications including bone loss due to tumor resection.
- Significant humeral resection which are unmanageable using other treatment methods
The Equinoxe Humeral Reconstruction Prosthesis System can be used in either primary or revision arthroplasty procedures.
The Equinoxe Humeral Reconstruction Prosthesis System is indicated for proximal humeral replacement in conjunction with reverse shoulder arthroplasty in which significant resection of the proximal humerus is necessary, the rotator cuff is irreplaceable and grossly deficient, and a functional deltoid muscle is present.
In the USA, the Equinoxe Humeral Reconstruction Prosthesis System is not indicated for use with the Equinoxe Reverse Shoulder System components in oncology applications.
The Equinoxe Humeral Reconstruction Prosthesis Distal Stems are for cemented use only, while the HA coated Equinoxe Humeral Reconstruction Prosthesis Distal Stem Collars are only for uncemented, press-fit use.
The proposed Exactech Equinoxe Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies represent a modification of the predicate Exactech Equinoxe Humeral Reconstruction Prosthesis Proximal Bodies cleared in K143659. Both the predicate and proposed devices have the same intended use, general design features and basic fundamental scientific technology. The only difference between the predicate and the proposed device is a decreased tuberosity thickness.
Based on the provided text, the device in question is the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies, which is a type of shoulder joint prosthesis. The document is a 510(k) premarket notification summary submitted to the FDA.
It is crucial to understand that a 510(k) submission for this type of device (a Class II orthopedic implant) focuses on demonstrating substantial equivalence to a previously legally marketed predicate device, primarily through engineering analysis and mechanical testing, rather than clinical performance (like an AI/software device would). This means the type of acceptance criteria and supporting studies are very different from what one would expect for an AI/ML medical device.
Therefore, many of the requested points regarding AI/ML device performance (e.g., sample size for test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) are NOT applicable to this document as it describes a hardware orthopedic implant, not an AI/ML software.
Here's an analysis based on the provided text, addressing the relevant points:
Acceptance Criteria and Study for Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies
The document describes the acceptance criteria and study to demonstrate substantial equivalence of a modified orthopedic implant to a predicate device. The focus is on mechanical and material integrity, not clinical effectiveness of an AI/ML algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Tests Conducted | Reported Device Performance (as implied by conclusion) |
|---|---|---|
| Mechanical Integrity | - Taper Analysis | Demonstrated equivalence to predicate device. |
| - Suture Abrasion | Demonstrated equivalence to predicate device. | |
| - Axial Pull-off | Demonstrated equivalence to predicate device. | |
| - Fatigue Testing | Demonstrated equivalence to predicate device. | |
| - Torsion Testing | Demonstrated equivalence to predicate device. | |
| Biocompatibility/Sterility | - Pyrogen Testing (in accordance with USP , USP , and ANSI/AAMI ST72) | Met recommended limits for sterility/biocompatibility. |
2. Sample Size and Data Provenance
- Test Set Sample Size: Not applicable in the context of clinical trial or AI/ML test sets. The "sample size" here refers to the number of test articles/specimens used for the mechanical tests. The exact number of specimens tested for each mechanical test (e.g., how many constructs were subjected to fatigue testing) is not explicitly stated in this summary document.
- Data Provenance: The tests are described as "engineering analysis" and "pyrogen testing" conducted by the manufacturer, Exactech Inc., in Gainesville, Florida, USA. These are laboratory studies, not retrospective or prospective patient data studies.
3. Number of Experts and Qualifications for Ground Truth
- Not applicable. This submission focuses on the safety and performance of a physical implant through engineering tests, not on diagnostic accuracy requiring expert image interpretation or clinical outcomes. Ground truth for mechanical properties is established by engineering standards and measurements, not expert consensus from medical professionals.
4. Adjudication Method for Test Set
- Not applicable. There is no "test set" in the sense of patient data requiring adjudication for diagnosis or outcomes. The "test set" consists of physical specimens undergoing standardized mechanical tests.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for evaluating the impact of AI on human readers for diagnostic tasks (e.g., interpreting medical images). This document describes a physical orthopedic implant and its mechanical properties.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop)
- Not applicable. This is not an AI/ML algorithm. The "performance" is the mechanical integrity of the implant itself.
7. Type of Ground Truth Used
- The "ground truth" for this device's acceptance is based on engineering standards and regulatory limits for mechanical properties (e.g., material strength, fatigue life, pull-off force) and biocompatibility (e.g., pyrogen levels). It's essentially "performance against established engineering specifications and predicate device performance."
8. Sample Size for Training Set
- Not applicable. There is no AI/ML model being "trained" here.
9. How Ground Truth for Training Set was Established
- Not applicable. (See #8)
Summary of Relevant Information from the Document:
The acceptance criteria for the Exactech® Equinoxe® Humeral Reconstruction Prosthesis Extra-Small Proximal Bodies are primarily functional and material-based, demonstrating that the modified device performs similarly to or better than the predicate device under specific mechanical challenges and meets biocompatibility standards. The study proving this involved engineering analyses and mechanical bench testing, focusing on parameters like taper, suture abrasion, axial pull-off, fatigue, and torsion, along with pyrogen testing. The ultimate "acceptance" is the FDA's determination of substantial equivalence to the predicate device K143659.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”