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

The ORTHOLOC™ APS consists of straight and pre-contoured plates that accept nonlocking and locking screws of various lengths and diameters. All components are manufactured from titanium alloy and available sterile or non-sterile.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the ORTHOLOC™ Ankle Plating System (APS). This regulatory submission focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a study with specific acceptance criteria and performance data for the device itself. Therefore, many of the requested sections (e.g., acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable as this type of submission does not typically involve such studies for mechanical devices like bone plating systems.

The clearance is based on demonstrating the device's design features, materials, and intended use are substantially equivalent to existing, legally marketed devices. The FDA letter confirms that the device is subject to general controls and, potentially, special controls for Class II devices.

Here's a breakdown of what can be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: The primary "acceptance criteria" for this 510(k) submission is demonstrational: Substantial Equivalence to legally marketed predicate devices. This is established through comparisons of design features, materials, and indications for use.

Reported Device Performance: The document does not report specific quantitative performance data for the ORTHOLOC™ APS in terms of clinical outcomes, mechanical strength, or other metrics often found in studies for diagnostic algorithms. Instead, the "performance" is implicitly deemed equivalent to the predicate devices due to similar design and materials.

Acceptance Criteria	Reported Device Performance
Substantial Equivalence to predicate devices in:	Similar design features, materials (titanium alloy), and indications for use (fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula).
- Design features	"substantially equivalent to the design features of other devices previously cleared for market."
- Materials	"All components are manufactured from titanium alloy."
- Indications for use	"is intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula."

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

Not Applicable: This type of submission does not typically involve a "test set" in the context of clinical or diagnostic performance studies. Substantial equivalence is primarily proven through engineering analysis, material testing, and comparison with predicate devices, not human or patient data analysis.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: No "ground truth" for a test set is established in this 510(k) submission. Regulatory review is performed by FDA personnel based on the provided documentation and existing regulations.

4. Adjudication method for the test set

Not Applicable: There is no test set or adjudication process described.

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 a bone plating system, not an AI-assisted diagnostic tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not Applicable: This is a physical medical device, not an algorithm.

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

Not Applicable: No ground truth in this sense is used. The "ground truth" for substantial equivalence is the existence and established safety and effectiveness of the identified predicate devices.

8. The sample size for the training set

Not Applicable: There is no "training set" for this type of medical device submission.

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

Not Applicable: No training set or associated ground truth establishment is described.

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.