(85 days)
The indications for the Osteonics® Total Elbow System, in keeping with the legally marketed Osteonics® Linked Constrained Total Elbow Prosthesis, are as follows:
- Painful, disabling joint disease of the elbow resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis.
- Distal humeral fracture and/or dislocation.
- Revision of previous unsuccessful total elbow replacement, resurfacing, or other procedure.
- Clinical management problems where arthrodesis or alternative reconstructive techniques are less likely to achieve satisfactory results.
- The Osteonics® Total Elbow System is indicated for cemented use only.
The Osteonics® Total Elbow System, available in right and left versions, is a semi-constrained elbow system that is linked across the joint and achieves fixation to the prepared humerus and ulna through the use of polymethylmethacrylate (PMMA) bone cement. The humeral and ulnar components, which are satin finished, function together through the use of a polyethylene bearing and bushing between the two component surfaces. The axle pin, which is threaded on the lower 3mm to 5mm (depending in implant size chosen) portion of the shaft, fits through the lateral aspect of the humeral component with a polyethylene sleeve (bushing). The axle pin is used to prevent dislocation.
The Osteonics® Total Elbow System components are characterized by the following features:
- · A satin finish on the titanium alloy humeral and ulnar components.
- · Bearings and bushings manufactured from ultra high molecular weight polyethylene.
- A titanium alloy axle pin which screws directly into the humeral component.
The Osteonics® Total Elbow System differs from the predicate Osteonics® Linked Semi-Constrained Total Elbow Prosthesis in that it features: a) a threaded axle pin that screws directly into the humeral component instead of using a "snap-fit" to lock into a retaining ring; b) it offers a medium size not offered by the predicate, and; c) it offers a longer humeral component, if desired. In all other aspects, the subject device is virtually identical in design and function to the predicate device.
This document is a 510(k) Premarket Notification Summary for the Osteonics® Total Elbow System. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study of the device's performance against specific acceptance criteria.
Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this document. The submission relies on comparative analysis with a previously approved device and pre-clinical data (incorporated by reference from a prior submission) to establish substantial equivalence.
Here's a breakdown of what can be gleaned from the provided text, and what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The "acceptance criteria" in this context are interpreted as the demonstration of "substantial equivalence" to the predicate device in terms of intended use, materials, and design features, and that any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: No specific performance metrics (e.g., success rates, complication rates, range of motion, durability testing results) are reported in this summary document. The document primarily focuses on establishing similarity to the predicate device.
| Acceptance Criteria (Inferred) | Reported Device Performance (Summary) |
|---|---|
| Intended Use is identical to predicate device. | Met: "The intended uses of the subject Osteonics® Total Elbow System are identical to those of the predicate device." |
| Materials are identical to predicate device. | Met: "Both subject and predicate devices use the identical materials: ASTM F-136-96 titanium alloy (Ti6Al-4V ELI) for the humeral and ulnar components, and the axle pin, and ASTM F-648-96 UHMWPE for the bearings and bushings." |
| Design differences do not raise new questions of safety or effectiveness. | Met: The summary concludes, "None of these design differences [threaded axle pin vs. snap-fit, additional medium size, option for longer humeral component] raise any new questions of safety or effectiveness." This is supported by the "supporting testing summary" and "pre-clinical data incorporated by reference to a prior submission" (though these details are not provided in the document itself). The FDA's clearance letter ("We have reviewed your Section 510(k) notification...and we have determined the device is substantially equivalent...") confirms this acceptance. |
| Compliance with general controls provisions of the Act (e.g., annual registration, GMP, labeling, etc.). | Assumed/Required: The FDA letter states, "A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement... and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions." |
2. Sample size used for the test set and the data provenance
- Not Applicable / Not Provided. This document does not describe a clinical study with a "test set" in the sense of patient data. The evaluation is based on technical comparison to a predicate device and existing pre-clinical data (not detailed here).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable / Not Provided. No ground truth establishment by experts for a test set is described.
4. Adjudication method for the test set
- Not Applicable / Not Provided. No test set or adjudication method is described.
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 is a medical device for surgical implantation, not an AI or imaging diagnostic device. Therefore, an MRMC study with human readers assisting AI is irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a medical device for surgical implantation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Not Provided. The "ground truth" for this submission is established through the regulatory process of demonstrating substantial equivalence to a legally marketed predicate device, which itself would have undergone its own rigorous testing and approval process (including in vivo data if required for its classification). The current submission relies on comparison, prior pre-clinical data, and existing clinical experience with the predicate device.
8. The sample size for the training set
- Not Applicable / Not Provided. No "training set" is mentioned as this is not an AI/machine learning submission.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. No "training set" or its ground truth establishment is mentioned.
§ 888.3150 Elbow joint metal/polymer constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. It is made of alloys, such as cobalt-chromium-molybdenum, or of these alloys and of an ultra-high molecular weight polyethylene bushing. The device prevents dislocation in more than one anatomic plane and consists of two components that are linked together. This generic type of device 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,”
(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,”
(vii) ISO 9001:1994 “Quality Systems—Model for Quality Assurance in Design/Development, Production, Installation, and Servicing,” and
(viii) ISO 14630:1997 “Non-active Surgical Implants—General Requirements,”
(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 981-93 “Practice for Assessment of Compatibility of Biomaterials (Nonporous) for Surgical Implant with Respect to Effect of Material on Muscle and Bone,”
(v) F 1044-95 “Test Method for Shear Testing of Porous Metal Coatings,”
(vi) F 1108-97 “Specification for Titanium-6 Aluminum-4 Vanadium Alloy Castings for Surgical Implants,”
(vii) F 1147-95 “Test Method for Tension Testing of Porous Metal Coatings, ” and
(viii) F 1537-94 “Specification for Wrought Cobalt-28 Chromium-6 Molybdenum Alloy for Surgical Implants.”