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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.

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The Acclaim system is primarily a tool to provide visual information to dental patients so that they can better understand the necessity and quality of the health care they receive.

Not Found

This is a notification about the clearance of the Acclaim system, a dental operative unit, and accessories. Due to the nature of the document, there is no information regarding the acceptance criteria, study details, or device performance as it would be found in a clinical study report. The document is a 510(k) clearance letter from the FDA, which confirms that the device is substantially equivalent to legally marketed devices.

The key information provided is:

• Trade/Device Name: Acclaim
• Regulation Number: 21 CFR 872.6640
• Regulation Name: Dental Operative Unit and Accessories
• Regulatory Class: I
• Product Codes: NRD and EAY
• 510(k) Number: K042266
• Indications for Use: The Acclaim system is primarily a tool to provide visual information to dental patients so they can better understand the necessity and quality of the healthcare they receive. This is the same intended use as previously cleared for the VistaCam Omni IC, 510(k) number K974204.

Since this is a Class I device and a 510(k) clearance, a full clinical study with specific acceptance criteria and detailed performance metrics is often not required, especially if the device is found to be substantially equivalent to a predicate device. The substantial equivalence is typically based on technological characteristics and intended use.

Therefore, I cannot provide the detailed information requested in the prompt based on the provided FDA clearance letter.

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The subject device is intended for intravenous fluid, blood and blood products, short-term epidural administration not exceeding 96 hours, and for delivery of enteral feeding solutions to patients in hospital and home care environments.

Abbott LifeCare Standard Tubing Pump (Acclaim)

I am sorry, but the provided text does not contain the detailed information necessary to answer your request about acceptance criteria and a detailed study description. The document is a 510(k) clearance letter from the FDA for a device called "Acclaim™ Infusion Pump."

This type of document typically:

• Confirms that the device is substantially equivalent to a legally marketed predicate device.
• States the intended use and regulatory class of the device.
• Outlines general regulatory obligations.
• Does not include the specific results of performance studies, acceptance criteria, sample sizes, expert qualifications, or ground truth establishment.

To answer your questions, I would need access to the actual 510(k) submission or a summary of safety and effectiveness (SSE) document, which would contain the details of the studies performed to demonstrate substantial equivalence.

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Ask a specific question about this device