(138 days)
Biomet Comprehensive Reverse Shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. The patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary.
The Comprehensive Reverse Shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency.
Titanium glenospheres are intended for patients with Cobalt Alloy material sensitivity. The wear of these devices has not been tested but, based on pin on disk testing, the wear rate is inferior to that of cobalt alloy glenospheres. A Cobalt Alloy glenosphere is the recommended component for reverse shoulder arthroplasty patients without material sensitivity to cobalt alloy.
Glenoid components with Hydroxyapatite (HA) coating applied over the porous coating are indicated only for uncemented biological fixation applications. The Glenoid Baseplate components are intended for cementless application with the addition of screw fixation.
Interlok finish humeral stems are intended for cemented use and the MacroBond coated humeral stems are intended for press-fit or cemented applications. Humeral components with porous coated surface coating are indicated for either cemented or uncemented biological fixation applications.
This submission is for manufacturing of an alternate version of exiting Comprehensive Standard and Mini Baseplates components with the porous plasma spray (PPS) coating applied by an outside vendor and the addition of Zimmer's Calcicoat coating. There is no change to the design to these existing products.
The new Comprehensive Reverse Augmented Baseplate has an augmented backside while retaining the existing Comprehensive Reverse baseplate geometry. The device will be available with three augment sizes, Small, Medium and Large. The new variant will be manufactured with PPS coating applied by a vendor and Zimmer Calcicoat coating.
This document is a 510(k) Summary for the Zimmer Biomet Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, and Comprehensive Mini Baseplate. It describes the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of a medical device submission for substantial equivalence to predicates, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to the information provided in this document.
The acceptance criteria and device performance are described in terms of engineering and material characteristics for orthopedic implants.
1. Table of Acceptance Criteria and Reported Device Performance
The document summarizes the non-clinical tests performed to demonstrate substantial equivalence. These are not performance metrics in the sense of accuracy, sensitivity, or specificity as would be the case for AI/ML models, but rather engineering and material properties.
| Acceptance Criteria (Non-Clinical Tests) | Reported Device Performance (Summary) |
|---|---|
| PPS and HA/TCP Coating Pore Size and Porosity | Not explicitly detailed, but implied to be compliant with acceptance criteria as part of the overall "Substantial Equivalence Conclusion" |
| Glenoid Loosening/Disassociation Test Method | Not explicitly detailed, but implied to be compliant. |
| Shear Testing Justification | Justified |
2. Sample Size Used for the Test Set and the Data Provenance
This is an orthopedic implant 510(k) submission, not a study of an AI/ML device. Therefore, the concept of a "test set" in the machine learning sense, or data provenance in terms of patient data origin and retrospectivity/prospectivity, is not applicable. The documentation refers to mechanical and material testing, which would have specific sample sizes for engineering tests (e.g., number of specimens tested for shear strength, porosity), but these details are not provided in this summary document.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This is not an AI/ML device that requires human expert review for establishing ground truth on image data or similar. The "ground truth" here refers to established engineering standards and material specifications.
4. Adjudication Method for the Test Set
Not applicable. Ground truth establishment for AI/ML model test sets.
5. If a Multi Reader Multi Case (MRMC) comparative effectiveness study was done
Not applicable. This is not an AI/ML device where human readers interact with AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is an orthopedic implant, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to:
- Engineering Standards and Material Specifications: The device's performance against established industry standards for orthopedic implants, including mechanical strength, durability, material composition (e.g., PPS and HA/TCP coating properties), and resistance to loosening/disassociation.
- Predicate Device Performance: The comparison of the proposed device's characteristics to those of legally marketed predicate devices, demonstrating that any differences "do not raise new questions of safety and effectiveness."
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
Not applicable. This is not an AI/ML device.
Summary of Device and Performance Aspects from the Document:
- Device Name: Comprehensive Augmented Glenoid Components, Comprehensive Standard Baseplate, Comprehensive Mini Baseplate
- Purpose: Manufacturing of alternate versions of existing Comprehensive Standard and Mini Baseplates with a different porous plasma spray (PPS) coating vendor and the addition of Zimmer's Calcicoat coating. Also includes a new Comprehensive Reverse Augmented Baseplate with an augmented backside.
- Basis for Substantial Equivalence:
- Intended Use & Indications for Use: Identical to predicate devices.
- Materials: Substrate and porous coating are the same as the predicate; Calcicoat® coating has been previously cleared.
- Design Features: Identical or similar to predicates.
- Sterilization: Identical assurance level and validation methods to predicate (new vendor).
- Performance Data Provided: Non-clinical tests were conducted. These included assessments of PPS and HA/TCP Coating Pore Size and Porosity, Glenoid Loosening/Disassociation Test Method, and Shear testing justification. No clinical tests were provided.
- Conclusion: The proposed devices are deemed substantially equivalent because they have the same intended use and indications for use, similar technological characteristics, and the differences do not raise new questions of safety and effectiveness, meaning they are at least as safe and effective as the legally marketed predicate devices.
§ 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.”