(132 days)
These devices are intended for shoulder joint arthroplasty.
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.
The Comprehensive® Reverse Shoulder (CRS) is a total shoulder replacement system in a reverse configuration. The CRS was designed to provide a complete, seamless system based on the Comprehensive Shoulder platform by avoiding the need to remove a well-fixed humeral stem associated with a prior anatomical shoulder arthroplasty for conversion to reverse shoulder arthroplasty. This is made possible because the CRS can utilize any of the existing Comprehensive stems, including primary, revision, or fracture stems in cemented or uncemented applications. The CRS performs its function by replacing the damaged or diseased articular surfaces of the native shoulder with artificial surfaces with the intent to improve shoulder function and/or reduce shoulder pain.
The provided document is a 510(k) premarket notification for the Biomet Comprehensive® Reverse Shoulder. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a standalone study. Therefore, much of the requested information regarding acceptance criteria and a study proving their fulfillment is not directly applicable or explicitly stated in this document in the way it would be for a de novo submission or a product with novel technology requiring extensive clinical trials to establish safety and effectiveness.
However, based on the non-clinical tests described, we can infer the acceptance criteria and the "study" (non-clinical testing) that supports the device's performance relative to these criteria.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Inferred from Non-Clinical Tests) | Reported Device Performance |
|---|---|
| Fatigue Strength: Maintain structural integrity under a clinically relevant load without fracture or failure. (Specifically, withstand 566N for 5 million cycles). | The humeral bearing and tray construct could withstand a fatigue load of 566N for 5 million cycles. The testing demonstrated that the modifications did not adversely impact the fatigue strength. |
| Range of Motion (ROM): Conformance to ASTM F1378-12. | Range of Motion analysis provides verification of the Range of Motion (ROM) conformance to ASTM F1378-12. |
| Wear Rate (Titanium Glenospheres): Inferior to Cobalt Alloy glenospheres. | Not an acceptance criterion for improvement, but a known characteristic: "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." This is a caution for clinical use rather than a performance target. |
| Biocompatibility of Materials: (Inferred by "Materials: Identical to predicate.")** | Materials are identical to predicate, implying acceptable biocompatibility as previously established for the predicate. |
Information not available or not applicable based on the provided document:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified for the fatigue strength or ROM testing. Non-clinical mechanical tests typically use a smaller number of samples sufficient to demonstrate statistical significance or meet a deterministic threshold.
- Data Provenance: The fatigue testing was "performed in the Zimmer Fatigue and Fracture Mechanics Laboratory (Warsaw, IN)". This indicates a U.S.-based, internal laboratory setting for the non-clinical tests. The tests themselves are prospective for the specific design changes.
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)
- This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or clinical data requiring expert ground truth establishment. The "ground truth" for these tests is the physical performance under controlled conditions.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This question is not applicable for the same reason as point 3. Adjudication methods are relevant for subjective data interpretation, not for objective mechanical performance tests.
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
- No MRMC study was done. This is a mechanical implant, not an AI-powered diagnostic device. The document explicitly states "Clinical Tests: None provided."
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- This question is not applicable as it pertains to AI/software performance. The device is a surgical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests: The "ground truth" is defined by the physical and mechanical properties of the device as measured under controlled laboratory conditions, against established engineering standards (e.g., ASTM F1378-12) and internal test requirements. It's an objective measurement of material and design performance.
- For the overall submission: The primary "ground truth" or basis for clearance is substantial equivalence to legally marketed predicate devices, meaning the new device is as safe and effective as existing ones.
8. The sample size for the training set
- This question is not applicable as the document describes a mechanical implant, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
- This question is not applicable for the same reason as point 8.
§ 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.”