(28 days)
The Riverpoint Medical OrthoButton FL™ is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
The Riverpoint Medical OrthoButton FL™ is available in multiple configurations, see device specifications in Attachment 1. Configurations may be comprised of an ultra-high molecular weight polyethylene (UHMWPE) loop provided with or without a titanium (Ti-6Al-4V ELI per ASTM F136) plate or as a single titanium (Ti-6Al-4V ELI per ASTM F136) plate, Additional non-absorbable sutures consisting of UHMWPE, nylon, polyester, or polypropylene are looped through the titanium plate to aide in assembly of the device and passing the plate through the intended void. The UHMWPE is available undyed (white) or with trace filaments of black, blue, or green color suture.
For configurations that do not have a titanium plate preattached, the titanium plate component is affixed to the loop during the procedure. For models that come with a preattached titanium plate, the procedure is the same except the titanium plate is passed through the channel. In both configurations, additional sutures are used to pass the loop and titanium plate (if pre-attached) parallel through the femoral channel and secure into place. The UHMWPE is available undyed (white), dyed blue, dyed black or with trace filaments of black, blue, or green color suture. Available Suture sizes are standard according to USP and EP requirements (dependent on suture type). The OrthoButton FLTM device is provided sterile for single use.
This FDA 510(k) K202399 submission describes a medical device, the Riverpoint Medical OrthoButton FL™, a fastener for bone and soft tissue fixation. The submission focuses on demonstrating substantial equivalence to a predicate device (K171060 – Riverpoint Medical OrthoButton® AL) rather than providing extensive details of a clinical study with detailed acceptance criteria for diagnostic performance outcomes.
Therefore, many of the requested fields (e.g., test set sample size, number of experts, adjudication method, MRMC study, standalone performance, training set size, ground truth for training set) are not applicable or cannot be extracted from this document, as they pertain to studies evaluating the diagnostic or assistive performance of an AI/ML device, which is not the subject of this 510(k). The "acceptance criteria" discussed are primarily for non-clinical performance and safety attributes.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
This 510(k) is for a physical medical device (bone fixation fastener), not an AI/ML device. The "performance" discussed relates to non-clinical testing for safety and functionality rather than diagnostic accuracy. The document states that "All acceptance criteria were met, and the Riverpoint Medical OrthoButton FL performed as intended." However, specific numerical acceptance criteria for each test (e.g., a specific tensile strength value or a specific sterility assurance level) and their corresponding reported results are not quantified in this summary.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Sterilization | Per EN ISO14937:2009 standards. | Met all criteria. |
| Biocompatibility | Per ISO10993-1:2018 standards. | Met all criteria. |
| Stability (Product/Packaging) | Per ISO 11607-1:2019 standards. | Met all criteria. |
| Usability | Per EN62366: 2015 standards for simulated use. | Met all criteria. |
| Endotoxin/Pyrogenicity | Per ANSI/AAMI ST72:2019, USP , and USP standards. | Met all criteria. |
| Overall Performance | Device performs as intended for bone and soft tissue fixation. | Performed as intended. |
2. Sample size used for the test set and the data provenance
Not applicable for diagnostic or AI/ML performance testing as this is a non-AI physical medical device. The "test sets" would refer to samples used for engineering and biocompatibility testing, but specific numbers are not provided in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable for this type of device submission. Ground truth as typically understood for AI/ML diagnostic studies is not relevant here.
4. Adjudication method for the test set
Not applicable.
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 not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, "ground truth" would be related to engineering specifications, material properties, and biological safety standards (e.g., sterility confirmed by lab tests, biocompatibility by toxicology tests, mechanical strength by load testing). The document states that performance testing was conducted according to recognized international and national standards (e.g., ISO, EN, ASTM, USP, AAMI).
8. The sample size for the training set
Not applicable. This device does not involve a training set for an algorithm.
9. How the ground truth for the training set was established
Not applicable.
§ 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.