(303 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/R) and FRACTURE (F) humeral components are as follows:
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 4-part 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 Shoulder System comprises both cemented and press-fit semi-constrained glenohumeral prostheses for use in hemi-shoulder and total-shoulder joint replacement procedures and a cemented semi-constrained glenohumeral fracture prosthesis for use in fractures of the proximal humerus. The system includes various sizes and types of modulat humeral stems, humeral heads, glenoids, replicator plates, and screws for use in primary, revision, and fracture applications.
Exactech Equinoxe Cage Glenoid: The Equinoxe Caged Glenoids are designed to interface and articulate with the Equinoxe total-shoulder system. They are composed of an Ultra High Molecular Weight Polyethylene (UHMWPE) articulating surface modularly connected to a grit blasted titanium (Ti-6Al-4V) bone cage and three grit blasted titanium (Ti-6Al-4V) pegs. A posterior augment version of this cage glenoid is provided to preserve bone by limiting the amount of eccentric glenoid reaming necessary to correct the patient's glenoid version. All components are supplied sterile.
Exactech Equinoxe XL Keeled an XL Pegged Glenoid: The Equinoxe XL Keeled and XL Pegged Glenoids are designed to interface and articulate with the 47, 50, & 53 mm humeral head from the Equinoxe total-shoulder system. The subject devices are a modification of the previously cleared Equinoxe cemented keeled and pegged glenoids (#K042021). All components are supplied sterile. Additionally, this "Traditional" 510(k) proposes several modifications to our previously cleared Equinoxe cemented keeled and pegged glenoids. Specifically: 1) an addition of an XL keeled and pegged glenoid size, 2) a decrease in minimum UHMWPE thickness from 5mm to 4mm, 3) a modification in machining pattern on the backside surface (change from horizontal grooves to radial grooves that follow the profile of the device), and 4) a decrease in edge radius around each fixation surface from 0.047 inches to 0.031 inches.
The Exactech Equinoxe® Cage Glenoid and Exactech Equinoxe® XL Keeled & XL Pegged Glenoid were evaluated to demonstrate substantial equivalence to legally marketed predicate devices, not against specific quantitative acceptance criteria for device performance as would be seen in a study evaluating a diagnostic or AI device. This submission is for a medical implant (glenoid component for shoulder arthroplasty), and the "acceptance criteria" are based on demonstrating that the new devices are as safe and effective as existing, legally marketed devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices such as prostheses, acceptance criteria are typically qualitative and based on equivalence to predicate devices under various conditions (materials, intended use, mechanical performance, etc.). Therefore, there isn't a table of numerical acceptance criteria and a single "reported device performance" metric in the same way there would be for a diagnostic tool's sensitivity or specificity. Instead, the "performance" is demonstrated by showing that the new device meets the same standards and performs similarly to legally marketed predicates.
| Category | Acceptance Criteria (Demonstrated Equivalence to Predicate Devices) | Reported Device Performance (Summary of Findings) |
|---|---|---|
| Intended Use | Same intended use for Total Shoulder Arthroplasty (for Cage Glenoid); same intended use for Total Shoulder Arthroplasty (for XL Keeled/Pegged Glenoid). Both intended for cemented fixation. | The Exactech Equinoxe Cage Glenoids and XL Keeled/Pegged Glenoids and predicate devices are intended for use in Total Shoulder Arthroplasty, with the subject devices intended for cemented fixation. |
| Materials | Composed of equivalent materials conforming to recognized industry standards for permanent implants. | The Exactech Equinoxe Cage Glenoids and XL Keeled/Pegged Glenoids are composed of Ultra High Molecular Weight Polyethylene (UHMWPE) and grit-blasted titanium (Ti-6Al-4V), which are equivalent to predicate device materials and conform to recognized industry standards. |
| Dimensions | Available in equivalent size ranges to predicate devices. | The Exactech Equinoxe Cage Glenoids and XL Keeled/Pegged Glenoids (including the new XL size, minimum UHMWPE thickness, and edge radius modifications) are available in equivalent size ranges to predicate devices. A posterior augment version for the Cage Glenoid is also provided. |
| Sterilization | Sterilized using equivalent sterilization processes conforming to recognized industry standards. | The Exactech Equinoxe Cage Glenoids and XL Keeled/Pegged Glenoids are sterilized using equivalent processes conforming to recognized industry standards, and all components are supplied sterile. |
| Performance Specs | Conform to recognized performance standards for total shoulder joint replacement devices. | The devices demonstrated safety and effectiveness through mechanical tests (edge loading and displacement, wear, thermal expansion, disassembly force), finite element analyses, engineering analyses, biocompatibility studies, and simulated surgical implantations (sawbones and cadaveric). A modification in machining pattern from horizontal to radial grooves was also evaluated. Results of these tests and analyses supported the claim of substantial equivalence to the identified predicate devices. |
| Modifications (XL) | Demonstrating that modifications (XL size, decreased UHMWPE thickness, machining pattern, decreased edge radius) do not alter fundamental safety or effectiveness compared to predicate/previous cleared versions. | The XL Keeled and XL Pegged Glenoids include an additional XL size, a decrease in minimum UHMWPE thickness from 5mm to 4mm, a modification in machining pattern on the backside surface (horizontal to radial grooves), and a decrease in edge radius around each fixation surface from 0.047 inches to 0.031 inches. These modifications were evaluated to ensure continued substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
The "test set" for this type of device primarily consists of non-clinical data derived from:
- Mechanical Tests: The exact number of samples used for each mechanical test (edge loading, displacement, wear, thermal expansion, disassembly force) is not specified in the provided text. These tests are usually conducted on multiple representative samples of the device components.
- Finite Element Analyses (FEA): This is a computational method, so it doesn't involve "samples" in the traditional sense, but rather models of the device components.
- Engineering Analyses: Similar to FEA, these are theoretical or computational.
- Biocompatibility Studies: These typically involve in-vitro and/or in-vivo testing according to ISO standards, but the specific sample sizes are not detailed.
- Simulated Surgical Implantations: Conducted on sawbones and cadaveric models. The number of sawbones or cadavers used is not specified.
- Data Provenance: This is entirely laboratory-based (mechanical testing, FEA, engineering analysis, biocompatibility) or pre-clinical simulation (sawbones/cadaveric implantations). There is no patient data (retrospective or prospective) mentioned for the "test set" in the context of demonstrating substantial equivalence for these specific device modifications.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
For a 510(k) submission of a prosthetic device, the "ground truth" is typically established by:
- Recognized industry standards: These are developed by expert committees (e.g., ASTM, ISO) comprising engineers, clinicians, and scientists.
- Engineering principles: Applied by qualified engineers.
- Clinical consensus: The basic design principles and indications for use of predicate devices are established through years of clinical experience, often summarized by orthopedic surgeons.
The text does not specify a discrete number of individual experts or their qualifications who "established ground truth" for each specific test mentioned. Instead, the studies rely on established scientific and engineering methodologies overseen by qualified personnel within Exactech, Inc., and adherence to recognized industry standards. The FDA regulatory review process itself involves experts (medical officers, engineers) evaluating the submission.
4. Adjudication Method for the Test Set
There's no mention of an "adjudication method" in the context of human expert review for the non-clinical test data. The results of the mechanical, finite element, engineering, and biocompatibility studies are quantitative and evaluated against pre-defined scientific and engineering benchmarks or by direct comparison to predicate device data where applicable. Simulated surgical implantations would be evaluated by the surgeons performing them to assess ease of use and fit.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically used to evaluate the performance of diagnostic imaging devices or AI algorithms that assist human readers in interpreting medical images. This 510(k) submission is for a physical medical implant, not a diagnostic or AI tool requiring human interpretation comparison.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This is not applicable as the device is a physical implant, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this submission is multi-faceted and based on:
- Engineering specifications and standards: Adherence to defined dimensional tolerances, material properties, and mechanical performance limits established by recognized standards (e.g., ASTM, ISO) for implantable devices.
- Performance of predicate devices: The "ground truth" for safety and effectiveness is largely set by the demonstrated long-term clinical performance and regulatory clearance of the predicate devices. The new device must be shown to be substantially equivalent in design and performance characteristics.
- Biocompatibility standards: Confirmation that materials are safe for implantation in the human body.
- Simulated surgical outcomes: Assessing factors like fit, stability, and surgical technique feasibility in non-living models.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of machine learning or AI as this device is a physical implant. The "design process" for such a device involves engineering design, material selection, and iterative testing, not data training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set for an AI/ML algorithm.
§ 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.”