(87 days)
The Riverpoint Medical OrthoButton CL® is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
The Riverpoint Medical OrthoButton CL is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") continuous loop combined with a titanium (Ti-6AI-4V ELI per ASTM F136) plate. The device is provided sterile for single use.
The provided text describes a 510(k) premarket notification for a medical device called the OrthoButton CL®. This document is concerned with demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance criteria through a clinical study involving human patients and AI for diagnosis or treatment.
Therefore, the information requested in your prompt (acceptance criteria for AI, sample sizes for medical imaging data, expert ground truth, MRMC studies, etc.) is not present in this document. This submission primarily focuses on:
- Device Description: What the device is made of and how it functions.
- Intended Use/Indications for Use: What the device is designed to do.
- Comparison to Predicate Device: How it is similar to an already approved device.
- Non-Clinical Performance Data: Sterilization validation, biocompatibility testing, stability testing, and usability validation. These are engineering and material science tests, not clinical studies for diagnostic accuracy.
The document explicitly states: "All acceptance criteria were met, and the Riverpoint Medical Orthobutton CL performed as intended" regarding the non-clinical performance testing. However, it does not provide a table of these criteria or detailed results, nor does it describe a study involving AI or human readers for diagnostic purposes.
To answer your prompt with the available information:
1. A table of acceptance criteria and the reported device performance:
The document mentions "All acceptance criteria were met" for non-clinical testing. However, it does not provide a specific table of these criteria (e.g., sterilization parameters, biocompatibility pass/fail, tensile strength thresholds for the button loop) or the numerical 'reported device performance' against those criteria. It only lists the types of tests conducted:
- Sterilization validation (per ISO11135-1:2007)
- Biocompatibility testing (per ISO10993-1:2009)
- Stability testing (per ISO 11607-1:2006)
- Simulated use Usability Validation (per EN62366: 2008)
For each of these, the reported performance is simply "All acceptance criteria were met, and the Riverpoint Medical Orthobutton CL performed as intended."
2. Sample sized used for the test set and the data provenance:
Not applicable. The tests described are non-clinical, focusing on materials and manufacturing processes (e.g., number of units sterilized for validation, number of samples for biocompatibility, packaging samples for stability). There is no "test set" of patient data for diagnostic evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. Ground truth, in the context of diagnostic AI, relates to confirmed medical diagnoses. This document concerns a surgical fixation device and its non-clinical performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. There is no diagnostic test set requiring expert adjudication.
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:
Not applicable. This device is a mechanical implant, not an AI-based diagnostic tool. No MRMC study was performed or required for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. There is no algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable. The "ground truth" here would be established by the standards governing the non-clinical tests themselves (e.g., a sample is sterile or not, a material is biocompatible or not, packaging integrity is maintained or not).
8. The sample size for the training set:
Not applicable. There is no AI model requiring a training set.
9. How the ground truth for the training set was established:
Not applicable. There is no AI model or training set.
In summary, this document is an FDA 510(k) clearance for a physical medical device (a bone fixation fastener) based on substantial equivalence to a predicate device and non-clinical performance testing. It does not provide the kind of information relevant to the testing and evaluation of an AI-powered diagnostic device.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.