(69 days)
The SBi Distal Radius Volar Plating System is intended for use in fixation of distal radial fractures. The implants are intended for one time use only
The SBi Distal Radius (DR) Plating System consists of plates and screws that provide internal fixation of the distal radius. The devices are supplied non-sterile and are available in various sizes and configurations. There are several plate configurations in right and left hand orientations. The System also includes an assortment of cortical and cancellous screws some of which can be locked into the plates at varying angles.
The provided text is related to a 510(k) premarket notification for a medical device: the SBi Distal Radius Volar Plating System. This document focuses on demonstrating substantial equivalence to a predicate device, which is a regulatory pathway for medium-risk medical devices in the US.
In the context of 510(k) submissions for such traditional devices, "acceptance criteria" and "device performance" are typically proven through bench testing (mechanical and material properties) and sometimes biocompatibility testing, rather than clinical studies involving human patients or complex AI algorithm evaluations. The "study" proving acceptance criteria here refers to these engineering tests.
Therefore, many of the requested points related to AI modeling, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of device and submission.
Here's an breakdown based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document broadly states "Documentation is provided which demonstrated the SBi Distal Radius Volar Plating System to be substantially equivalent to other legally marketed devices." This implies that the device's material properties, mechanical strength, and design features were tested and compared against established standards for existing legally marketed devices (predicates). Specific numerical acceptance criteria and performance results are not detailed in this summary document, as they would typically be in the full submission referenced.
However, given the nature of bone fixation systems, the acceptance criteria would generally fall into categories like:
| Acceptance Criteria Category | Reported Device Performance (Inferred from Substantial Equivalence Claim) |
|---|---|
| Material Composition | Meets ASTM F67 (Grade 1 titanium) for plates; Meets ASTM F1295-05 (Ti-6Al-7Nb) or ASTM F136 (Ti-6Al-4V) for screws. |
| Biocompatibility | Expected to be biocompatible, similar to predicate devices made of the same materials. |
| Mechanical Strength | Demonstrated to be mechanically equivalent (e.g., tensile strength, fatigue strength, construct stiffness) to the predicate devices under relevant loading conditions for distal radius fixation. (Specific values not provided in this summary.) |
| Design & Dimensions | Design features (e.g., plate configurations, screw types, locking mechanisms) are comparable to predicate devices and suitable for stated intended use. |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: For mechanical testing (e.g., fatigue, static strength), samples typically involve a statistically significant number of devices, often 3-6 or more specimens for each test condition, to demonstrate statistical equivalence or compliance with standards. The exact number is not specified in this summary.
- Data Provenance: The tests would have been performed in a laboratory setting (e.g., by the manufacturer or a third-party testing facility). This is not human clinical data, so country of origin of data and retrospective/prospective distinctions are not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. For mechanical testing, the "ground truth" is established by direct physical measurement according to validated test methods and standards (e.g., ASTM standards). It does not involve expert consensus in the way a clinical image interpretation would. Engineering and materials science experts would design and conduct the tests, but not "establish ground truth" in the clinical sense.
4. Adjudication method for the test set:
- Not Applicable. Adjudication relates to resolving discrepancies in expert opinions on clinical data. For bench testing, test results are objective measurements evaluated against pre-defined engineering specifications and standards.
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 is a traditional medical device (bone plate system), not an AI/CADe/CADx device. Therefore, no MRMC study involving human readers or AI assistance would have been performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical implant, not a software algorithm.
7. The type of ground truth used:
- For this device, the "ground truth" for proving acceptance criteria is based on established engineering standards, material specifications, and validated mechanical test methods. The direct measurement of physical and mechanical properties against these standards constitutes the ground truth. There is no clinical "ground truth" in the sense of pathology, expert consensus on imaging, or outcomes data used to establish the performance of the device itself (beyond clinical outcomes of the procedure the device is used in, which are generally not part of a 510(k) for devices like this).
8. The sample size for the training set:
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established:
- Not Applicable. As there is no training set.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.