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

The CLAW® II Polyaxial Compression Plating System consists of plates and screws of various anatomic configurations and lengths. All plates and screws are manufactured from implant grade stainless steel. The plates accept 2.7mm and 3.5mm ORTHOLOCTM 3DSi locking screws.
The ORTHOLOC™ 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CLAW® II Polyaxial Compression Plating System, demonstrating substantial equivalence to predicate devices rather than a study proving the device meets specific acceptance criteria with performance metrics. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be directly extracted or are not applicable.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the document in the format of specific, measurable acceptance criteria and corresponding performance data. The device demonstrates "substantial equivalence" to predicate devices through non-clinical testing.

Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance (Based on Substantial Equivalence)
Mechanical strength/durability comparable to predicates	"The results of the test show that the subject CLAW® II Polyaxial Compression Plating System and ORTHOLOC™ 3DSi Locking Screws can be expected to perform at least as well as the legally marketed predicate identified in this 510(k) submission."
Polyaxial performance comparable to predicates	Demonstrated through "polyaxial performance testing."
Design features comparable to predicates	"The design features... are substantially equivalent to the design features of the predicate devices."
Safety and effectiveness comparable to predicates	"The safety and effectiveness... are adequately supported by the substantial equivalence information, materials information, and analysis data..."

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

Sample Size: Not specified for any test sets. The document describes "worst-case plate analysis, plate mechanical testing, and polyaxial performance testing," but does not detail the number of samples or specimens used in these tests.
Data Provenance: The studies are non-clinical, likely conducted in a laboratory setting by the manufacturer, Wright Medical Technology, Inc. There is no information on country of origin of data or whether it's retrospective or prospective, as these terms usually apply to clinical studies.

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

Not applicable. This device is cleared based on non-clinical substantial equivalence, not on expert-adjudicated ground truth from a clinical data set. The "ground truth" here is the performance of the predicate devices.

4. Adjudication method for the test set

Not applicable, as no external experts were used to establish a ground truth for a clinical test set. The determination of substantial equivalence was made by the FDA based on the presented non-clinical evidence.

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/software device, but a physical orthopedic plating system. No MRMC studies or AI involvement are mentioned.

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

Not applicable, as this is a physical medical device, not an algorithm or AI.

7. The type of ground truth used

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The subject device's performance (mechanical, polyaxial performance) was assessed to be "at least as well as" the predicate devices. The ground truth for the predicate devices themselves would have been established through their original clearance processes, likely including non-clinical testing and potentially clinical data depending on their classification and introduction date.

8. The sample size for the training set

Not applicable, as this is not a machine learning or AI device that requires a training set.

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

Not applicable, as this is not a machine learning or AI device that requires a training set with established ground truth.

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.