(176 days)
The Liverpool Radial Head Replacement Device is intended for:
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- Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, creptation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
- a) Joint destruction and/or subluxation visible on x-ray
- b) Resistance to conservative treatment
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- Primary replacement after fracture of the radial head
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- Symptomatic sequelae after radial head resection
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- Revision following failed radial head arthroplasty
The device is intended for single use with bone cement.
The Biomet Liverpool Radial Head Replacement Device is a one-piece cobalt alloy device. The tapered stem is centered into the intramedullary canal of the radius. The articulating surface is a highly polished concave surface to articulate with the capitellum of the humerus. Except for the articulating surface, the device is roughened by a process called "Microbond" Coating. The device is available in two sizes, 16mm and 18mm. The 16mm device has a stem length of 32.76mm and head heights that vary from 14 to 24mm. The 18mm device has a stem length of 32.76mm and head heights that vary from 14 to 24mm.
This document is a 510(k) premarket notification for a medical device, the Liverpool Radial Head Replacement Device. Such notifications are for demonstrating substantial equivalence to a predicate device, not for proving the device meets specific acceptance criteria through a study. Therefore, most of the information requested in your prompt is explicitly not applicable or not provided in this type of submission.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not Applicable/Not Provided. This 510(k) is a submission for substantial equivalence based on technological characteristics and intended use, not performance against specific acceptance criteria from a study.
2. Sample Size Used for the Test Set and Data Provenance
Not Applicable/Not Provided. The document explicitly states: "Non-Clinical Testing and Clinical Testing: none provided as a basis of substantial equivalence." This means no test set was used to evaluate the device against specific performance criteria in a study for this submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not Applicable/Not Provided. No test set means no ground truth was established by experts for performance evaluation in this submission.
4. Adjudication Method for the Test Set
Not Applicable/Not Provided. No test set.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
Not Applicable/Not Provided. No clinical testing was provided, so no MRMC study was conducted or reported.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
Not Applicable/Not Provided. This is a physical orthopedic implant device, not an algorithm. Therefore, "standalone" performance in the context of an algorithm is irrelevant. No standalone testing of the device's performance against specific criteria was reported or required for this type of submission.
7. The Type of Ground Truth Used
Not Applicable/Not Provided. As no new performance study was conducted for this 510(k) submission, the concept of a "ground truth" for the device's performance is not present in this document. The submission relies on the substantial equivalence to predicate devices that are already legally marketed.
8. The Sample Size for the Training Set
Not Applicable/Not Provided. This is a physical medical device, not an AI/ML algorithm. Therefore, the concept of a "training set" is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not Applicable/Not Provided. As above, the concept of a "training set" and its ground truth is not applicable to this type of device and submission.
In summary, this 510(k) submission demonstrates substantial equivalence by comparing the technological characteristics (materials, design, sizing, and indications) of the Liverpool Radial Head Replacement Device to legally marketed predicate devices, rather than through new performance studies with specific acceptance criteria.
§ 888.3170 Elbow joint radial (hemi-elbow) polymer prosthesis.
(a)
Identification. An elbow joint radial (hemi-elbow) polymer prosthesis is a device intended to be implanted made of medical grade silicone elastomer used to replace the proximal end of the radius.(b)
Classification. Class II.