(165 days)
Prosthetic replacement with this device may be indicated for the treatment of severe pain or significant disability in degenerative, rheumatoid, or traumatic disease of the glenohumeral joint; ununited humeral head fractures of long duration; irreducible 3- and 4-part proximal humeral fractures; avascular necrosis of the humeral head; or other difficult clinical management problems where arthrodesis or resectional arthroplasty is not acceptable. The assembled humeral component may be used alone for hemiarthroplasty or combined with the glenoid component for total shoulder arthroplasty. Humeral heads with heights of 27mm or greater may be used for difficult clinical management problems involving rotator cuff deficiency where arthrodesis or conventional nonconstrained arthroplasty is not acceptable. The humeral component can be implanted either cemented or press-fit while the glenoid component is designed for cemented use only.
The Bigliani/Flatow 56mm Offset Humeral Heads are a line extension to the Bigliani/Flatow Shoulder system. The proposed devices are larger diameters of offset humeral heads.
This is a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study with acceptance criteria and performance data in the format requested.
Based on the provided document, here's an analysis of the requested information:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the document as it is a 510(k) submission. A 510(k) submission for a line extension primarily focuses on demonstrating that the new device (Bigliani/Flatow 56mm Offset Humeral Heads) is substantially equivalent to a legally marketed predicate device (Bigliani/Flatow The Complete Shoulder Solution, K982981).
The document states:
- "The proposed device is identical to the predicate device in: intended use/indications for use, material specifications, mode of assembly, surface specifications, manufacturing processing, shelf life and sterilization method."
- "The proposed device is a larger size of the predicate device."
- "Non-Clinical Performance and Conclusions: The results of non-clinical (lab) performance testing and/or engineering analyses demonstrate that the devices are safe and effective and substantially equivalent to the predicate devices. Performance testing and/or analyses included: Magnetic Resonance Imaging (MRI) Compatibility testing, and Engineering Analysis of proposed offset humeral heads' effect on humeral stem stresses."
Therefore, the "acceptance criteria" appear to be meeting the safety and effectiveness standards of the predicate device, demonstrated through non-clinical testing. Specific quantitative acceptance criteria or detailed performance reports are not included.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device (K982981) in: | Demonstrated (Implicitly Met): |
| - Intended Use/Indications for Use | ✓ Identical |
| - Material Specifications | ✓ Identical |
| - Mode of Assembly | ✓ Identical |
| - Surface Specifications | ✓ Identical |
| - Manufacturing Processing | ✓ Identical |
| - Shelf Life | ✓ Identical |
| - Sterilization Method | ✓ Identical |
| Safety and Effectiveness through Non-Clinical Testing: | Demonstrated (Implicitly Met): |
| - Magnetic Resonance Imaging (MRI) Compatibility | ✓ Testing Performed |
| - Engineering Analysis of proposed offset humeral heads' effect on humeral stem stresses | ✓ Analysis Performed |
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 for clinical data, as the document explicitly states, "Clinical data and conclusions were not needed for this device." For non-clinical testing (MRI compatibility and engineering analysis), specific sample sizes are not provided, but these would typically involve a small number of physical samples for testing and/or computational models.
- Data provenance: Not applicable for clinical data. For non-clinical testing, it would be laboratory-based data, presumably from the manufacturer (Zimmer, Inc., USA).
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)
- Not applicable. No clinical test set or ground truth established by experts is mentioned, as clinical data was not required. The "ground truth" for substantial equivalence is based on the characteristics and performance of the predicate device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No clinical test set requiring adjudication is mentioned.
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
- Not applicable. This device is a shoulder prosthesis, not an AI-powered diagnostic tool, so an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this 510(k) submission is primarily the performance and safety profile of the predicate device (Bigliani/Flatow The Complete Shoulder Solution, K982981). The new device is deemed substantially equivalent because it performs identically in key aspects and any differences (larger size) were assessed via engineering analysis to ensure no new questions of safety or effectiveness.
8. The sample size for the training set
- Not applicable. This refers to a physical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set for a machine learning model is involved.
§ 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.”