(253 days)
The Sorbie Resurfacing Total Elbow System is indicated for use in total clbow arthroplasty for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) noninflammatory degenerative joint disease including osteoarthritis or traumatic arthritis; 2) inflammatory degenerative joint disease including rheumatoid arthritis; 3) correction of functional deformity; 4) revision procedures where other treatments and devices have failed; and 5) treatment of fractures that are unmanageable using other techniques.
The Sorbie Resurfacing Total Elbow System consists of humeral, ulnar, and radial head components. Each component is available in a range of sizes to fit varying anatomical requirements.
This document describes a 510(k) summary for the Sorbie Resurfacing Total Elbow System, a medical device for total elbow arthroplasty. The provided text is a premarket notification for a medical device and describes its components, intended use, and materials, along with a "Testing Summary" table demonstrating some performance characteristics. However, it does not include information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML powered device, which is implied by the structure of the prompt.
Therefore, many of the requested details cannot be extracted from the provided text because they pertain to AI/ML device validation, which is not relevant to this traditional medical device submission.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
The document provides a "Testing Summary" table, which lists mechanical tests and their results. These results implicitly serve as the "reported device performance" against some unstated acceptance criteria. The acceptance criteria themselves (e.g., minimum force values, stress limits) are not explicitly enumerated in a separate column as "acceptance criteria."
| Test Description | Reported Device Performance |
|---|---|
| Failure force analysis of the humeral component | Compressive loading will not result in failure of the component if bony support exists. |
| Stress analysis of the stemmed humeral component | Component exhibits peak stresses comparable to other devices and slightly over the fatigue strength of the material for joint forces typical of normal elbow joints. (Note: "slightly over the fatigue strength" could be interpreted as a potential concern depending on the actual values and safety margins, but the document presents it as a result). |
| Stress analysis of the ulnar component | When fully supported by bone, the component exhibits stresses well within the fatigue strength of the material. |
| Failure force analysis of the radial head component | All sizes demonstrate material strength properties suitable for this application. |
| Ulnar component lock detail testing | Any extraction forces will be countered by compressive loading placed on the components by the humerus. |
| Properties of the UHMWPE | The tensile properties of the test parts meet or exceed the minimum requirements by ASTM F 648. |
Missing Information (Not applicable to this document as it's not an AI/ML device):
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
§ 888.3160 Elbow joint metal/polymer semi-constrained cemented prosthesis.
(a)
Identification. An elbow joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace an elbow joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that consist of a humeral resurfacing component made of alloys, such as cobalt-chromium-molybdenum, and a radial resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.