(266 days)
The Equinoxe Shoulder System is indicated for use individuals with degenerative diseases or fractures of the glenolumeral joint where total or hemi-arthroplasty is determined by the preferred method of treatment.
- The cemented primary humeral stem, longrevision 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 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), and FRACTURE (F) humeral components are as follows:
| P | L | F | Indications |
|---|---|---|---|
| √ | √ | 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 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 in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4-part fractures (hemi-athroplasty), 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 proximation with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superil head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
The proposed Exactech Equinoxe Reverse Humeral Liners and Humeral Adapter Trays are intended for use in skeletally mature individuals with degenerative diseases or fractures of the glenohumeral joint where reverse total arthroplasty is determined by the surgeon to be the preferred method of treatment.
This document is a 510(k) summary for medical device clearance, not a study report. It describes the device, its intended use, and claims substantial equivalence to existing predicate devices. It does not contain information about a study that proves the device meets specific acceptance criteria in the way a clinical trial or performance study for a diagnostic AI device would.
Therefore, many of the requested fields cannot be populated from the provided text because they pertain to a type of performance study (e.g., AI algorithm performance, human-in-the-loop studies, ground truth establishment) that is not included in this regulatory submission for a physical orthopedic implant.
Here's a breakdown of what can and cannot be extracted:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the format of acceptance criteria and reported performance metrics in the context of device function (e.g., accuracy, sensitivity, specificity). Instead, the document lists various non-clinical testing performed and states that the proposed device conforms to "the same recognized performance standards" as the predicate devices. This implies that the acceptance criteria are adherence to these standards, and the reported performance is simply that the device passed these tests.
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Conformance to recognized performance standards for: | Proposed device evaluated for and passed: |
| - Humeral Liner Wear | - Humeral Liner Wear |
| - Range of Motion | - Range of Motion |
| - Scapular Notching | - Scapular Notching |
| - Humeral Adapter Tray/Humeral Stem Fatigue | - Humeral Adapter Tray/Humeral Stem Fatigue |
| - Humeral Stem Fatigue | - Humeral Stem Fatigue |
| - Humeral Liner/Humeral Adapter Tray Fatigue | - Humeral Liner/Humeral Adapter Tray Fatigue |
| - Humeral Liner Lever Out | - Humeral Liner Lever Out |
| - Humeral Liner Pull Out | - Humeral Liner Pull Out |
| - Humeral Liner Torque-Out | - Humeral Liner Torque-Out |
| - Biocompatibility | - Biocompatibility |
| - Bacterial endotoxins (LAL) | - Bacterial endotoxins (LAL) |
| Technological characteristics similar to predicate devices: | Proposed device has similar characteristics to predicates: |
| - Indications for Use (identical) | - Indications for Use (identical) |
| - Materials (identical biocompatible materials) | - Materials (identical biocompatible materials) |
| - Design Features (similar) | - Design Features (similar) |
| - Dimensions (dimensionally comparable) | - Dimensions (dimensionally comparable) |
| - Sterilization (provided sterile for single use only) | - Sterilization (provided sterile for single use only) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable in the context of this document. The "tests" are non-clinical, mechanical, and biological evaluations, not a test set for an algorithm. The non-clinical testing likely involved a certain number of physical device samples for each test, but those numbers are not specified here.
- Data provenance: Not applicable. The "data" pertains to the results of biomechanical and material tests, not clinical patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable as this is a physical device clearance, not an AI or diagnostic device requiring ground truth established by experts for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable for the same reason as above.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. For a physical orthopedic implant, "ground truth" generally refers to physical measurements, material properties, and biomechanical responses validated against established engineering and medical standards, rather than clinical diagnostic ground truth.
8. The sample size for the training set:
- Not applicable. The device is a physical implant, not an AI model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.”