(218 days)
The Equinoxe Shoulder System is indicated for use 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.
- The cemented primary humeral stem, long/revision stem, fracture 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 discretion 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 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 Equinoxe Platform Fracture Stem is indicated for use in skeletally mature individuals with acute fracture of the proximal humerus and displacement of the tuberosities, displaced 3- and 4part fractures of the proximal humerus (hemi-arthroplasty), 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 proximal humerus in combination with degenerative diseases of the glenohumeral joint and a grossly deficient, irreparable rotator cuff resulting in superior migration of the humeral head (reverse total shoulder arthroplasty). The Equinoxe Platform Fracture Stem is indicated for cemented use only.
The Equinoxe Laser Cage Glenoids are intended to be used with Exactech Equinoxe Humeral Head components in Total Shoulder Arthroplasty. The Laser Cage Glenoids are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) body molded onto Ti-6Al-4V peripheral pegs and a central cage. The central cage and peripheral pegs of the implant are additively manufactured using direct metal printing (DMP) technology. The Laser Cage Glenoids are available in four sizes and four augment angle options.
The provided text describes a 510(k) premarket notification for the Exactech® Equinoxe® Laser Cage Glenoid, which is a medical device for shoulder arthroplasty. The document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a study to prove the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.
Therefore, many of the requested categories (acceptance criteria, device performance, sample size, ground truth, experts, adjudication, MRMC studies, standalone performance, training set) are not applicable in the context of this 510(k) submission, as it is not a clinical study assessing an AI/ML diagnostic device.
Here's an analysis based on the information available:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria with reported device performance in a clinical or diagnostic sense. The "acceptance criteria" in a 510(k) submission for a device like this are related to demonstrating substantial equivalence, primarily through:
- Identical Indications for Use
- Identical Biocompatible Materials
- Same Design Features
- Dimensionally Comparable
- Provided sterile for single use only
- Conformity to the same recognized performance standards
The "reported device performance" in this context refers to the results of non-clinical (bench) testing to confirm the physical and mechanical properties, as well as sterility.
Acceptance Criteria and Reported Device Performance (Non-Clinical/Bench Testing)
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance (as per Non-Clinical Testing) |
|---|---|
| Indications for Use match predicate devices | Identical to predicate devices |
| Materials match predicate devices | Identical biocompatible materials to predicate devices |
| Design Features match predicate devices | Same design features as predicate devices |
| Dimensions are comparable to predicate devices | Dimensionally comparable to predicate devices |
| Sterility meets standards | Provided sterile for single use only |
| Performance Requirements conform to standards | Conforms to the same recognized performance standards as predicate devices. Specific tests conducted: Porous Structure Characterization, Glenoid Fixation, Peg Shear Resistance, Peg Pull-Off, Peg Bending Fatigue. Bacterial endotoxin testing conducted in accordance with USP , USP , and ANSI/AAMI ST72. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a 510(k) submission for a medical implant, not a study of an AI/ML diagnostic device with a test set of data. The "test set" in this context refers to the physical devices undergoing bench testing. The sample size for these bench tests is not specified in the summary document, and data provenance in terms of country of origin or retrospective/prospective is not relevant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No "ground truth" as typically defined for diagnostic performance studies was established. The assessments in this submission are based on engineering, material science, and regulatory compliance, not expert clinical interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method for a test set of data was performed, as this is not a diagnostic performance study.
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 submission is for a physical medical implant (shoulder prosthesis), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the conventional sense of diagnostic performance studies. The "ground truth" for this device's substantial equivalence claim relies on established engineering principles, material specifications, and validated manufacturing processes, all demonstrating that the new device is as safe and effective as the predicate devices. For non-clinical testing, the "ground truth" is defined by the recognized performance standards and internal engineering specifications, e.g., a peg must withstand a certain pull-off force.
8. The sample size for the training set
Not applicable. This is not an AI/ML device where a "training set" would be used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 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.”