(53 days)
The Riverpoint Medical OrthoButton AL is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon reconstruction.
The Riverpoint Medical OrthoButton ALTM is comprised of a braided ultra-high molecular weight polyethylene ("UHMWPE") adjustable loop combine with a titanium (Ti-6Al-4V ELI per ASTM F136) plate. The device is provided sterile for single use.
This document describes the premarket notification for the Riverpoint Medical OrthoButton AL™ device. As an AI, I am designed to extract and synthesize information related to acceptance criteria and performance studies. However, the provided document does not contain the level of detail typically found in reports of studies proving a device meets acceptance criteria, particularly for AI/machine learning medical devices. This document is a 510(k) summary for a physical medical device (bone fixation fastener), not an AI/ML diagnostic tool.
Therefore, I cannot fulfill all parts of your request as they pertain to AI/ML device studies (e.g., sample size for training/test sets, number of experts, MRMC studies, ground truth establishment for AI).
However, I can extract information regarding the performance testing performed for this physical device and its acceptance criteria, to the extent described in the document.
Here's what can be extracted and what cannot:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Test/Performance Parameter (as mentioned) | Reported Device Performance |
|---|---|---|
| Sterilization Validation | ISO11135-1:2007 requirements | Met |
| Biocompatibility Testing | ISO10993-1:2009 requirements | Met |
| Stability Testing | ISO 11607-1:2006 (product and packaging) | Met |
| Usability Validation | EN62366: 2008 requirements (simulated use) | Met |
| Mechanical Strength | Cyclic loading | Performed as intended, acceptance criteria met |
| Mechanical Strength | Ultimate load to failure conditions | Performed as intended, acceptance criteria met |
| Pyrogenicity | LAL and rabbit pyrogenicity testing | Does not raise additional concerns regarding pyrogenicity |
2. Sample size used for the test set and the data provenance:
- Not specified for any of the performance tests. The document broadly states "testing" was performed.
- Data Provenance: Not applicable in the context of this physical device's performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This document describes performance testing for a physical bone fixation device, not a diagnostic device requiring expert interpretation of results to establish ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods are relevant for subjective interpretations, primarily in diagnostic studies, not for the objective physical/chemical tests described here.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, not performed/applicable. MRMC studies are for evaluating diagnostic imaging devices where human readers interpret results, often with and without AI assistance. This is a physical implantable device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used:
- For the physical tests, the "ground truth" is defined by the standards themselves (e.g., ISO, EN standards for sterilization, biocompatibility, packaging, and specific mechanical testing protocols for strength and elongation). The device performance is compared against the requirements of these standards.
8. The sample size for the training set:
- Not applicable. There is no "training set" as this is not an AI/ML model.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set or AI model.
In summary: The provided 510(k) summary focuses on demonstrating substantial equivalence of a physical medical device (OrthoButton AL™) to a predicate device (OrthoButton CL®) through adherence to relevant engineering and biological performance standards. It does not contain information related to AI/ML device studies, which involve different types of acceptance criteria and validation methodologies.
§ 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.