(29 days)
The Acclaim™ Total Elbow System is indicated to reduce pain and improve the function and mobility of the affected joint in patients with a painful arthritic joint due to osteoarthritis, theumatoid arthritis, or post traumatic arthritis and pathological fractures of the distal humerus in which adequate bone stock exists for the fixation of prosthetic components.
Total Elbow replacement may be considered for younger patients, if, in the opinion of the surgeon, an unequivocal indication for elbow replacement outweighs the risks associated with the age of the patient , and if limited demands regarding activity and elbow joint loading can be assured. This included patients for whom an immediate gain of elbow mobility may lead to an expectation of significant improvement in the quality of their lives.
The Acclaim™ Total Elbow System is intended for cemented use only.
The Acclaim™ Total Elbow System replacement hinge pin assembly is designed as a replacement of a linked (constrained) elbow hinge pin assembly due to hinge pin disassociation. When the Acclaim Total Elbow System is implanted as a linked system. it is held together with the linked ulnar component and pin assembly, and is used when there is poor bone stock.
The Acclaim™ Total Elbow System replacement hinge pin assembly is comprised of a polyethylene humeral yoke and locking sleeve, with a metal locking pin, ulnar bearing, ulnar bearing screw, washer, and wire. The replacement hinge pin assembly is used in conjunction with well-fixed humeral and ulnar components.
Acclaim™ Total Elbow System replacement hinge pin assembly design includes modifications to the ulnar bearing, polyethylene sleeve, and locking pin. In addition, a washer and cross-pin locking mechanism has been included to the assembly using the same design as the Mark II Total Elbow System locking mechanism, previously cleared in K872084 dated June 25, 1987.
This document describes a 510(k) premarket notification for a medical device – the Acclaim™ Total Elbow System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and efficacy through clinical studies with specific acceptance criteria as you've outlined.
Therefore, the requested information regarding acceptance criteria, specific device performance, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone algorithm performance cannot be found in this document because:
- This is a 510(k) summary for a medical implant (prosthesis), not a software device or AI algorithm. The questions you've posed are typically relevant for the assessment of AI/ML-based medical devices or diagnostic tools.
- 510(k) submissions focus on substantial equivalence. The primary goal is to show the new device is as safe and effective as a predicate device already on the market, not to meet pre-defined performance metrics against a "ground truth" using statistical studies as would be done for novel devices or AI.
- The "study" referenced here is the comparison to predicate devices and conformance to voluntary performance standards, not a clinical trial or performance study against an adjudicated ground truth in the way your questions are framed.
Here's a breakdown of what the document does provide in relation to your questions, and what it does not provide:
1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Performance:
- Does NOT Provide: The document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy, precision, etc.) or specific device performance metrics in numerical terms. It's a regulatory submission demonstrating substantial equivalence, not a performance study report for an AI.
- Does Provide (Implicitly): The "performance" is implicitly tied to the performance and safety record of the predicate devices (Acclaim™ Total Elbow System - K992656, Mark II Elbow System - K872084). The submission states, "The determination of substantial equivalence for this device was based on a detailed device description, and conformance with voluntary performance standards." This implies the new device performs at least as well as the predicate devices and meets relevant industry standards, but no new empirical performance data or specific criteria are listed.
2. Sample Size Used for the Test Set and Data Provenance:
- Does NOT Provide: This document does not describe a "test set" in the context of evaluating an AI or diagnostic algorithm's performance on a specific dataset. Therefore, there's no mention of sample size or data provenance in that regard.
- Does Provide (Indirectly): The "test" for substantial equivalence involved comparing the new device's design, materials, sterilization, and packaging to the predicate devices. This isn't a data-driven test set as you've implied.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Does NOT Provide: Not applicable. There is no mention of experts establishing a "ground truth" for a test set, as this is not an AI/diagnostic device.
4. Adjudication Method:
- Does NOT Provide: Not applicable. There is no adjudication method described as there's no ground truth to establish for a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Does NOT Provide: This is a mechanical prosthetic device, not a diagnostic imaging tool or AI. Therefore, an MRMC study is completely irrelevant to this submission and is not mentioned.
7. The Type of Ground Truth Used:
- Does NOT Provide: No "ground truth" as a reference standard (like pathology, expert consensus, or outcomes data) is used because this is an orthopedic implant, not a diagnostic tool requiring such validation. The "truth" in this context is that the device is substantially equivalent to a legally marketed predicate device.
8. Sample Size for the Training Set & 9. How Ground Truth for Training Set was Established:
- Does NOT Provide: These concepts are entirely irrelevant to a 510(k) submission for a mechanical implant. There is no AI model, no training set, and no ground truth for a training set in this context.
In summary, the provided document is a 510(k) summary for an elbow prosthesis aiming to demonstrate substantial equivalence to existing devices. It does not contain the type of AI/ML performance study information you are requesting.
§ 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.”