(103 days)
Biomet's Bipolar Shoulder Prosthesis is indicated for use in most cases where a conventional shoulder hemi-arthroplasty would be indicated. Typical indications include osteoarthritis, avascular necrosis, traumatic arthritis, rheumatoid arthritis, correction of severe functional deformity, revision procedures where other treatments or devices have failed, fracture, and cuff tear arthropathy.
This device is a single use implant intended for cemented application only. It is intended for use with Biomet's humeral components previously cleared by the FDA for cemented application.
The Bipolar Shoulder Prosthesis is a self retaining humeral component. The outer surface of the shell is highly polished. The inner polyethylene liner is preassembled with the outer metal shell. A polyethylene retaining ring is inserted into the shell of the shell.
The shell is available in four outer diameters, 40mm through 52mm. The modular head components are available in various neck lengths to correct laxity in the joint. Two types of modular heads are available to correspond with the geometry of the humeral stems.
The device is designed to articulate with the natural glenoid surface eliminating the need for a separate glenoid component similar to a hemi-arthroplasty. Potentially a greater range of motion can be obtained with this device because of its bi-rotational nature.
The provided document primarily focuses on the FDA's 510(k) clearance for the Biomet Bipolar Shoulder Prosthesis based on substantial equivalence. It does not contain an "acceptance criteria" table or a detailed study proving the device meets those criteria in the way one would typically find for a new device's performance evaluation.
The FDA's 510(k) pathway for medical devices relies on demonstrating "substantial equivalence" to a predicate device, rather than requiring extensive clinical trials to establish new acceptance criteria and prove performance against them.
Therefore, many of the requested details about acceptance criteria, specific studies, sample sizes, ground truth establishment, and MRMC studies are not present in this type of regulatory submission.
Here's an attempt to answer the questions based only on the provided text, highlighting what is not available:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in the document in the format of a table with quantitative criteria the device needs to meet (e.g., specific range of motion, reduction in pain score by X percent).
- Reported Device Performance: Not presented as quantitative performance metrics from a study designed to meet specific acceptance criteria. The document states the device's "intended use" and describes the biomechanical design (e.g., bi-rotational nature for potentially greater range of motion), but these are not "reported device performance" in the context of meeting defined acceptance criteria.
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 for Test Set: Not applicable/not provided. This document is a 510(k) clearance based on substantial equivalence to predicate devices, not a clinical study with a test set.
- Data Provenance: Not applicable/not provided. There isn't data from a study of the Biomet Bipolar Shoulder Prosthesis presented here.
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)
- Number of Experts & Qualifications: Not applicable/not provided. There is no mention of a test set with ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/not provided.
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
- MRMC Study: Not applicable/not provided. This device is a physical shoulder prosthesis, not an AI-assisted diagnostic or treatment planning tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not applicable/not provided. This device is an implantable prosthesis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable/not provided.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable/not provided. This is a medical device, not a machine learning algorithm requiring a training set in the conventional sense. The "training" for such a device would be based on engineering principles, material science, and prior clinical experience with similar devices, not a digital dataset.
9. How the ground truth for the training set was established
- Ground Truth for Training Set: Not applicable/not provided.
Summary of Information from the Document that Pertains to "Proof":
The "proof" for this device's safety and effectiveness, as per this 510(k) document, relies entirely on demonstrating substantial equivalence to existing, legally marketed predicate devices.
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Predicate Devices:
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Basis of Equivalence: The document states, "In function and overall design the Bipolar Shoulder Prosthesis is equivalent to other commercially available shoulder hemi-arthroplasties." This implies that the device's design, materials, and intended use are similar enough to existing successful devices that it can be presumed to be safe and effective without new, extensive clinical trials proving performance against specific acceptance criteria.
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Potential Risks: The document lists potential risks associated with the device, which are similar to those for other shoulder hemi-arthroplasties (e.g., reaction to bone cement, fracture, loosening/migration, infection, metal sensitivity). This acknowledges common risks for the type of device without providing performance data on their frequency for this specific device.
§ 888.3650 Shoulder joint metal/polymer non-constrained cemented prosthesis.
(a)
Identification. A shoulder joint metal/polymer non-constrained cemented prosthesis is a device intended to be implanted to replace a shoulder joint. The device limits minimally (less than normal anatomic constraints) translation in one or more planes. It has no linkage across-the-joint. This generic type of device includes prostheses that have a humeral 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 “Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vi) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings,”
(vii) F 1378-97 “Specification for Shoulder Prosthesis,” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”