(269 days)
TEMA Elbow System is intended for use in cemented applications for patients suffering from disability due to:
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- Elbow joint destruction which significantly compromises the activities of daily living
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- Non-Inflammatory degenerative joint disease including osteoarthritis, and avascular necrosis with hemophilia.
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- Rheumatoid arthritis or degenerative arthritis with incapacitating pain
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- Revision where other devices or treatments have failed.
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- Correction of severe functional deformity.
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- Treatment of acute or chronic fractures with distal humerus epicondyle involvement.
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- Post-traumatic lesions or bone loss contributing to elbow instability or loss of motion
The unlinked, semi-constrained version is intended for use in cases where there are functioning medial and lateral elbow ligaments of good quality that provide immediate stability, resisting any tendency of dislocation or disengagement between ulnar and humeral components, when intraoperative manual testing is performed.
TEMA Elbow System is a cemented total elbow prosthesis. The system provides both linked (constrained) and unlinked (semi-constrained) configurations.
TEMA Elbow System consists of modular humeral and ulnar assemblies. The humeral assembly consists of a metallic humeral stem and a metallic humeral body component with pre-assembled polyethylene bushings. The ulnar assembly is composed of a metallic ulnar stem, a metallic ulnar body and a polyethylene ulnar liner. Screws are used to secure the taper couplings between the stems and bodies of the humeral and ulnar assemblies.
The constrained (linked) version of the elbow consists of the modular humeral assembly and the modular ulnar assembly with an axle component that is inserted across the joint to connect the humeral assembly to the ulnar assembly.
The semi-constrained (unlinked) version consists of the same components without the use of the axle to link the humeral and ulnar assemblies.
All of the system components are available in different sizes.
The modularity of the polyethylene ulnar component also allows replacement of the ulnar bearing, if needed, without removal of the humeral and ulnar assemblies. The modularity also provides an additional advantage that if replacement of the humeral and/or ulnar body is needed (e.g. due to damage from a traumatic event or due to excessive wear of the bushing of the humeral body) and the stem components are well fixed. the stems do not need to be removed and only disconnection of the humeral and ulnar bodies from the stems is required for their revision.
The provided text is a 510(k) Summary for the TEMA Elbow System. It describes the device, its indications for use, and compares it to predicate devices. However, this document does not contain information about the acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.
The TEMA Elbow System is a mechanical prosthetic device, and the evaluation for its substantial equivalence relies on non-clinical mechanical testing and a comparison of its design and materials to existing predicate devices.
Therefore, I cannot provide the requested information for an AI/ML device, as the document pertains to a traditional medical implant.
Specifically, the document does NOT contain information on:
- A table of acceptance criteria and reported device performance (for an AI/ML device).
- Sample sizes for a test set or data provenance (relevant to AI/ML studies).
- Number of experts or their qualifications for ground truth establishment (relevant to AI/ML studies).
- Adjudication methods (relevant to AI/ML studies).
- MRMC comparative effectiveness studies including effect sizes for human readers (relevant to AI/ML studies).
- Standalone algorithm performance (relevant to AI/ML studies).
- Type of ground truth used (relevant to AI/ML studies).
- Sample size for the training set (relevant to AI/ML studies).
- How ground truth for the training set was established (relevant to AI/ML studies).
The "Non-Clinical Testing" section mentions mechanical testing for the device's ability to perform in a substantially equivalent manner, but these are engineering tests for a physical implant, not a study of an AI/ML algorithm's diagnostic or prognostic performance. The document explicitly states, "Clinical testing was not necessary to demonstrate substantial equivalence of TEMA Elbow System to the predicate devices."
§ 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.”