(86 days)
The Exactech Equinoxe™ Reverse Shoulder System is indicated to relieve pain and restore function 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 failed glenohumeral joint replacement with loss of rotator cuff function resulting in superior migration of the humeral head.
The Equinoxe™ Reverse Shoulder System includes a reverse semi-constrained prosthesis for use in total-shoulder joint replacement procedures in cases with an irreparable or nonfunctional totator cuff. The system includes primary and revision humeral stems, various sizes and types of humeral adapter plates, glenospheres, humeral liners, and screws. The reverse shoulder System is designed to function with the Equinoxe primary press-fit, primary cemented, and long/revision humeral stems. All components are supplied sterile.
The Exactech Equinoxe™ Reverse Shoulder System is a medical device for total shoulder joint replacement. The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared devices rather than providing specific acceptance criteria and a detailed study report with performance metrics for this particular device.
However, based on the information provided in the "Summary of Non-Clinical Performance Data," we can infer the types of tests conducted and what would typically serve as acceptance criteria for such a device, even if explicit numerical targets are not stated. The study focuses on mechanical testing and engineering analyses to ensure safety and effectiveness.
Here's an attempt to structure the information based on your request, with the caveat that explicit numerical acceptance criteria and a direct "performance vs. acceptance criteria" table are not present in this type of submission.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Typical Qualitative Acceptance Criteria (Inferred) | Reported Device Performance (as summarized in the 510(k)) |
|---|---|---|
| Stability (Dynamic Loading) | Micromotion between glenoid plate/glenosphere should be acceptable and comparable to predicate devices under dynamic loading. | "A dynamic loading study in which the stability of the Equinoxe Reverse Shoulder was assessed... The glenoid plate/glenosphere micromotion measurements obtained in this study are compared to that associated with the Depuy Delta III and Encore RSP components when subjected to a similar loading pattern." |
| Glenosphere - Center of Rotation | Location of the glenosphere's center of rotation should be similar to well-established, clinically successful designs (e.g., Grammont/Delta III) to minimize glenoid loosening. | "A comparative assessment of the glenosphere center of rotation that demonstrates the location of the center of rotation is similar for the Equinoxe and Delta III designs. This observation in conjunction with the micromotion test results... suggest that the low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder is applicable to the Equinoxe™ Reverse Shoulder design." |
| Range of Motion (ROM) & Impingement | Design should optimize ROM and minimize inferior impingement (scapular notching) compared to predicate devices, while maintaining stability. | "A geometric analysis verification study that demonstrates the Equinoxe Reverse Shoulder achieves an increase in the amount of motion and a decrease in the amount of inferior impingement (a measure of motion and stability, indicative of scapular notching) while maintaining a similar amount of jump distance (a measure of stability, indicative of the probability of dislocation) relative to the Grammont/Delta III design." |
| Structural Integrity (Fracture Resistance) | The device should not fracture under worst-case loading conditions. | "A finite element analysis that demonstrates the geometry of the proposed devices is not subject to fracture when subjected to a worst-case load." |
| Geometric Analysis of Design Parameters | Design parameters should be optimized to maximize ROM and minimize inferior impingement based on established relationships between design and clinical failure modes. | "A geometric analysis of the Grammont Reverse Shoulder Prosthesis - an evaluation of the relationships between prosthetic design parameters and clinical failure modes... This assessment was used to optimize the design parameters associated with the Equinoxe design in order to maximize ROM and minimize inferior impingement." |
2. Sample size used for the test set and the data provenance
- Dynamic Loading Study:
- Polyurethane bone substitute (TR-2006-052): Sample size for this part is not specified but it involved a "polyurethane bone substitute."
- Cadaver (TS-2006-024): Sample size not specified, but involved "a cadaver."
- Geometric Analysis Studies (TR-2006-028, TR-2006-029) and Finite Element Analysis (TR-2006-039): These are analytical studies, not involving a "test set" in the sense of patient data or traditional biological samples. They are based on computer models and existing design principles.
- Data Provenance: The studies are non-clinical (mechanical tests, engineering analyses, simulated surgical implantations) and were conducted by Exactech, Inc. The provenance of the specific materials (e.g., cadavers) is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies involving expert interpretation of patient data to establish ground truth.
4. Adjudication method for the test set
This section is not applicable as the studies are non-clinical mechanical and engineering analyses, not clinical studies requiring human adjudication of results.
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
This section is not applicable. This submission is for a physical medical device (reverse shoulder system), not an AI/imaging device, and therefore, no MRMC study or AI assistance evaluation was performed or required.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This section is not applicable. This submission is for a physical medical device, not an algorithm, so the concept of "standalone algorithm performance" does not apply.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical studies:
- Dynamic Loading and Micromotion: The "ground truth" for comparison appears to be the performance of "Depuy Delta III and Encore RSP components when subjected to a similar loading pattern" (predicate devices).
- Glenosphere Center of Rotation: The "ground truth" for comparison is the "low reported incidence of glenoid loosening associated with the Grammont Reverse Shoulder" and the design characteristics of the Delta III.
- Geometric Analyses: "Ground truth" is based on established relationships between prosthetic design parameters and clinical failure modes, as described in literature and previous studies (e.g., Grammont Reverse Shoulder Prosthesis).
- Finite Element Analysis: "Ground truth" is derived from engineering principles and material science, demonstrating that the geometry is not subject to fracture under theoretical worst-case loads.
8. The sample size for the training set
This section is not applicable as this is a physical medical device. The "training" for the design often comes from iterative design processes, engineering calculations, and understanding of biomechanics and clinical outcomes of existing devices, rather than a quantifiable "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This section is not applicable as this is a physical medical device. The 'ground truth' for the design process would be established through a combination of:
- Literature review: Understanding biomechanics, materials science, and clinical performance of existing devices.
- Clinical experience: Insights from surgeons and observations of prior device performance.
- Engineering principles: Application of mechanical and material science principles to design and validate components.
- Predicate device analysis: Studying the design and performance of legally marketed predicate devices to understand successful characteristics and potential areas for improvement.
§ 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.”