FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The provided document is a 510(k) premarket notification for the Synthes Pilon Plate, a medical device for bone fixation. It does not contain information about acceptance criteria or a study proving the device meets said criteria in the context of an AI/algorithm-based diagnostic or predictive tool.

The document primarily focuses on establishing "substantial equivalence" of the Synthes Pilon Plate to existing legally marketed devices. This process, common for Class II medical devices, means demonstrating that the new device is as safe and effective as a predicate device already on the market. It does this by comparing material, design, indications for use, and mechanical properties (though mechanical testing details are not provided in these specific excerpts).

Therefore, I cannot fulfill your request for the specific points related to acceptance criteria, device performance from a study, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance. These concepts are relevant to the evaluation of AI or diagnostic devices, not primarily to the substantial equivalence review of a bone fixation plate.

Here's what I can extract from the provided text, recognizing it doesn't fit your AI-centric framework:

1. Table of "Acceptance Criteria" and "Reported Device Performance":

Acceptance Criteria (Implicit for 510(k) Substantial Equivalence): The device must be as safe and effective as a legally marketed predicate device. This is determined by comparing intended use, technological characteristics, and performance data (mechanical, biocompatibility, etc.).
Reported Device Performance (from summary):
- Intended Use: Fixation of complex intra- and extra-articular fractures and osteotomies of the distal tibia.
- Design: Metal plate offering screw-to-plate locking for various fracture modes of the distal end of the tibia.
- Materials: Stainless Steel or Titanium.
- Equivalence: Documentation was provided which demonstrated the Synthes Pilon Plate to be substantially equivalent to other legally marketed devices.

The rest of the points are not applicable to the provided document:

2. Sample size used for the test set and the data provenance: Not applicable. This document refers to a physical device (bone plate), not an AI algorithm evaluated on a data set. The "test set" for substantial equivalence would involve mechanical testing, biocompatibility testing, etc., typically on device prototypes, not patient data in the way you're describing.
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 this context, would relate to clinical outcomes or pathology, which are not detailed as part of the 510(k) substantial equivalence submission for a bone plate.
4. Adjudication method (e.g. 2+1, 3+1, none) 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 is for AI diagnostic tools, not a bone plate.
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): Not explicitly stated as a "ground truth" method for this device. The regulatory pathway relies on demonstrating equivalent safety and effectiveness to predicate devices through design, material, and typically mechanical performance data.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

In summary, the provided text describes a regulatory filing for a medical implant (a bone plate), not an AI-powered diagnostic or predictive device. Therefore, the questions related to AI algorithm evaluation, data sets, and ground truth establishment are not addressed by this document.

Summary

Regulation Number and Section

§ 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.