(199 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 proposed Exactech Equinoxe Reverse Shoulder Compression Screws. Glenosphere Locking Screw, and Locking Cap devices represent a modification of the predicate Exactech Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap (K063569 and K110708) used in reverse shoulder arthroplasty. All devices were cleared via 510(k) K063569 except the 50mm and 54mm Equinoxe Reverse Shoulder Compression Screws. These sizes were cleared via 510(k) K110708. The only difference between the proposed Equinoxe Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap and predicate Equinoxe Compression Screws, Glenosphere Locking Screw, and Locking Cap is the sterilization method. The predicate compression screws, glenosphere locking screw, and locking cap are provided sterile via gamma radiation. The modified compression screws, glenosphere locking screw, and locking cap will be supplied non-sterile and must be sterilized by steam sterilization in a separately provided re-usable sterilization container prior to implantation. Cleaning and sterilization instructions are provided in the package insert for the Equinoxe Reverse Shoulder System Screw Components.
This document describes a Special 510(k) submission for modifications to the Exactech® Equinoxe® Reverse Shoulder Compression Screws, Glenosphere Locking Screw, and Locking Cap. The core of the submission is to demonstrate substantial equivalence to previously cleared predicate devices, primarily focusing on a change in sterilization method.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Preamble Information:
The document is a letter from the FDA regarding a K162325 submission for Exactech Inc. for the devices mentioned. The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion | Reported Device Performance (as per submission) |
|---|---|
| Indications for Use (same as predicate) | Confirmed: "The same indications for use" |
| Intended Use (same as predicate) | Confirmed: "The same intended use" |
| Materials (same as predicate) | Confirmed: "The same materials" |
| Design Features and Basic Fundamental Scientific Technology (same as predicate) | Confirmed: "The same design features and basic fundamental scientific technology" |
| Dimensions (same as predicate) | Confirmed: "The same dimensions" |
| Device Compatibility (same as predicate) | Confirmed: "The same device compatibility" |
| Sterilization Method (modified from predicate) | Modified from gamma radiation (predicate) to steam sterilization (proposed). |
| Pyrogenicity (for modified sterilization) | Met recommended limits per FDA's Guidance Document. |
| Cleaning and Sterilization Effectiveness (for modified sterilization) | Assessed to demonstrate substantial equivalence to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set in the traditional sense of a clinical or imaging study. The "testing" primarily refers to bench testing related to the new sterilization method.
The data provenance is for engineering studies and pyrogen testing which focus on materials, design, and sterilization. There's no indication of human or animal data being used for this particular submission's testing. The devices are orthopedic implants, and the context of the submission is a modification to a previously cleared device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The studies referenced are engineering and pyrogenicity tests, which typically rely on standardized protocols and laboratory analysis rather than expert consensus on medical images or clinical outcomes.
4. Adjudication Method for the Test Set
This information is not provided and is not applicable given the nature of the engineering and pyrogenicity testing described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This submission focuses on a modification to an existing device (change in sterilization method), and the testing described is limited to demonstrating the safety and effectiveness of this specific modification through engineering studies and pyrogen testing.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical orthopedic implant (reverse shoulder system components) and not an algorithm or AI-powered device.
7. The Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Engineering specifications and standards: For material properties, dimensions, design features, and device compatibility, ensuring they remain the same as the predicate.
- Standardized testing protocols: For cleaning, sterilization effectiveness, and pyrogenicity (e.g., USP , USP , ANSI/AAMI ST72). The "ground truth" here is compliance with these predefined standards and the associated recommended limits.
8. The Sample Size for the Training Set
This information is not applicable. This is not an AI/machine learning device that would have a training set. The "training" for this device would refer to the historical data and experience with the predicate devices, which are already marketed.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reasons as point 8.
In summary:
The provided document describes a Special 510(k) where the primary "study" proving the device meets acceptance criteria revolves around demonstrating that a change in sterilization method (from gamma radiation to steam sterilization) for components of an already cleared reverse shoulder system does not alter the fundamental characteristics, performance, safety, or effectiveness of the device. The acceptance criteria are met by proving that the modified components maintain the same indications for use, intended use, materials, design, dimensions, and compatibility as their predicate versions, and that the new sterilization method is effective and meets pyrogenicity standards through engineering and laboratory testing. This is a technical (bench) evaluation, not a clinical study involving human subjects, experts for ground truth, or statistical sample sizes in the context of clinical outcomes.
§ 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.”