(83 days)
The SBI Radio-Capitellar implant is indicated for use in the elbow for reduction or relief of pain and/or improved elbow function in skeletally mature patients with the following conditions: 1) non-inflammatory degenerative joint disease including osteo-arthritis 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 Avanta Radio-Capitellar implant is intended for cemented use only.
The SBI Radio-Capitellar Implant provides an alternative to hemi-arthroplasty of the proximal radial head. The implant is used for the treatment of degenerative joint disorders of the radio-capitellar joint allowing activities of daily living to be performed with no or significantly reduced pain. The radio-capitellar implant is designed to be used with the radial stem components of the rHead and rHead Recon stem implants cleared for market under 510(k) K011819 and K023604 respectively.
This document is a 510(k) summary for a medical device called the SBI Radio-Capitellar Implant. It focuses on establishing substantial equivalence to previously marketed devices rather than presenting a study of its performance against specific acceptance criteria. Therefore, the information required for this request is largely not available in the provided text.
Here is what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The 510(k) summary focuses on demonstrating substantial equivalence, not on pre-defined performance acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided text. The document refers to "Documentation is provided which demonstrated the SBI Radio-Capitellar Implant to be substantially equivalent to other legally marketed devices," but does not describe a new study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not available in the provided text. No new study requiring expert ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available in the provided text. No new study is described.
5. 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
This information is not available in the provided text. The device is an implant, not an AI-assisted diagnostic tool, so an MRMC study related to human readers is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not available in the provided text. The device is a physical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not available in the provided text. No new study requiring ground truth is described.
8. The sample size for the training set
This information is not available in the provided text. As this is a 510(k) for a physical implant, there is no "training set" in the context of device performance in the document.
9. How the ground truth for the training set was established
This information is not available in the provided text. As there is no training set mentioned, there is no information on its ground truth.
In summary, the provided 510(k) document is a regulatory submission for a physical medical implant (SBI Radio-Capitellar Implant) seeking clearance based on substantial equivalence to existing devices. It does not describe a clinical study with detailed acceptance criteria, test sets, or performance metrics in the way one would for a diagnostic or AI-powered device.
§ 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.