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

The OrthoPediatrics PediLoc™ Tibial Plates are machined metallic plates that offer screw to plate locking designed for various fracture modes of the distal end of the tibia and other small bones.

AI/ML Overview

The provided submission describes a medical device, the OrthoPediatrics PediLoc™ Tibial Plate System, and its substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, nor does it include details on clinical studies with defined endpoints, statistical analysis, or ground truth establishment relevant to AI/ML device evaluations.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth for an AI/ML device is not applicable or cannot be extracted from this document.

However, based on the document's content, here's what can be inferred about the "acceptance criteria" and "study" in the context of this 510(k) submission:

Acceptance Criteria and Device Performance (in the context of 510(k) for a traditional medical device)

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance
Technological Characteristics Substantial Equivalence: Device shares indications for use, similar materials, and similar technological characteristics with predicate devices.	"Components comprising OrthoPediatrics PediLoc™ Tibial Plate (and screws) System are similar to the predicate devices listed above in that they share indications for use, are made from similar materials, and incorporate similar technological characteristics."
Performance Characteristics (Strength): Device's mechanical strength is comparable to predicate devices.	"Engineering (strength) calculations were included demonstrating these devices are as strong as the devices cleared through K080522." (K080522 is Synthes LCP Distal Tibia T-Plates, a predicate device).
Materials: Device is manufactured from materials meeting established standards.	"The devices are manufactured from 316L stainless steel which meets the ASTM-F138 standard."
Intended Use: The intended use aligns with the predicate devices and is appropriate for the device design.	"OrthoPediatrics PediLoc™ Tibial Plates are indicated for fractures, osteotomies, and non-unions of the pediatric and small stature adult tibia." This is compared to and found similar to predicate devices.

Study Information (in the context of 510(k) for a traditional medical device)

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This 510(k) relies on engineering calculations and comparison to predicate devices, not a test set of data in the AI/ML sense. Mechanical testing (implied by "engineering (strength) calculations") would involve a sample of manufactured devices, but the specific number is not provided, and it's not a "test set" of patient data.
Data Provenance: Not applicable in the context of patient data. The "data" here refers to engineering and material specifications.

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 AI/ML sense, is not established for patient data in this submission. The "ground truth" for a mechanical device would be the physical properties and performance measured against engineering standards. The FDA reviewers and the manufacturer's engineers are the "experts" involved in assessing this.

4. Adjudication method for the test set

Not Applicable. There is no "test set" of patient data requiring 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 is not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Engineering Specifications and Material Standards: The "ground truth" for this device's performance is its adherence to mechanical engineering principles, material science standards (e.g., ASTM-F138 for 316L stainless steel), and comparison of its design and intended use to legally marketed predicate devices.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no training set.

9. How the ground truth for the training set was established

Not Applicable. This is not an AI/ML device, so there is no training set or associated ground truth establishment.

In summary: This document is a 510(k) premarket notification for a traditional surgical implant. The "study" predominantly refers to engineering calculations and a comparison to known predicate devices to establish substantial equivalence, rather than a clinical trial or AI/ML performance evaluation study against specific acceptance criteria.

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.