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

The TOBY® WOLF® Long Bone Plate system consists of implantable titanium alloy bone plates and fasteners used for the repair of fractures, osteotomies, and non-unions of upper extremity diaphyses. The system includes specialized stainless steel instrumentation that is provided to assist with the installation of the bone plates and fasteners.

AI/ML Overview

The provided text describes the 510(k) summary for the TOBY® WOLF® Long Bone Plate System. This is a medical device and the submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against defined acceptance criteria using a study in the way an AI/ML device would.

Therefore, many of the requested categories are not directly applicable or cannot be extracted from this specific document. However, I will do my best to map the available information to your request.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria (from document)	Reported Device Performance (from document)
Material Compliance	ASTM F136-12a, Standards Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401)	The TOBY® WOLF® Long Bone Plate system complies with the requirements of listed FDA Recognized Consensus Standards, including ASTM F136-12a and ASTM F899-12b. The implantable and tissue contact materials used...have a long history of safe usage in medical devices. The materials of construction are safe and effective, and similar to those used in the predicate device system.
	ASTM F899-12b, Standard Specification for Wrought Stainless Steels for Surgical Instruments
Mechanical Performance	Demonstrated through a multi-parameter comparison with predicate devices. Specific tests mentioned: Stiffness, Strength, and Fatigue testing per ASTM F382-99, and Screw Pullout testing.	Substantial equivalence is demonstrated… through a 20-point comparison of technological features and a multiparameter comparison of mechanical performance. The design features are similar in the device systems, as are the indications for use. Results from stiffness, strength and fatigue testing per ASTM F382-99, and screw pullout testing, demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.
Technological Features	Comparison performed to demonstrate substantial equivalence to predicate devices.	A comparison of the technological characteristics and performance characteristics of the WOLF® Long Bone Plate system and the predicate devices was performed. The devices were found to be substantially equivalent. The design features are similar in the device systems.
Intended Use	The WOLF® Long Bone Plate system is intended for fractures, osteotomies, and non-unions of upper extremity diaphyses (must be substantially equivalent to predicates).	The WOLF® Long Bone Plate system is indicated for fractures, osteotomies, and non-unions of upper extremity diaphyses. The indications for use are similar to those of the predicate devices.
Safety and Effectiveness	Demonstrated through compliance with material standards and mechanical testing, and similarity to predicate devices.	The implantable and tissue contact materials… are safe and effective. Results from [mechanical testing] demonstrate that the WOLF® Long Bone Plate system is safe and effective, and substantially equivalent to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: This document describes a traditional medical device (implantable plate system) and its mechanical testing, not a diagnostic or AI/ML device that would have "test sets" of data provenance. The testing would involve physical samples of the device components.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: Ground truth in the context of expert review for medical images or diagnoses is not relevant to this type of device submission. The "ground truth" for material and mechanical properties would be established by standardized testing methods and specifications (e.g., ASTM standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: Adjudication methods are typically for subjective assessments (like image interpretation) in clinical studies or AI/ML ground truth establishment, which is not relevant here.

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 / Not Provided: This is not an AI/ML device, so no MRMC study would be performed.

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

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

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

Material and Mechanical Standards: The "ground truth" for the device's properties relies on established engineering standards (e.g., ASTM F136, F899, F382) for material composition, strength, stiffness, fatigue, and screw pullout. The performance is compared against the requirements of these standards and against the performance of legally marketed predicate devices.

8. The sample size for the training set

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

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

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

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" outlined in the document to prove the device meets acceptance criteria is primarily an engineering and materials compliance assessment, rather than a clinical trial or AI performance study.

The primary method used to demonstrate substantial equivalence and confirm safety and effectiveness is:

Bench Testing / Mechanical Performance Testing: The device underwent several standardized tests to evaluate its mechanical properties:
- Stiffness testing
- Strength testing
- Fatigue testing (per ASTM F382-99)
- Screw pullout testing
  These tests are designed to evaluate how the device performs under various forces and stresses it would experience in the human body. The results from these tests were then compared to the performance of predicate devices and against the requirements of the ASTM F382-99 standard.
Materials Compliance: The materials used for the plate (Wrought Titanium-6Aluminum-4Vanadium ELI Alloy) and instruments (Wrought Stainless Steels) were evaluated against recognized FDA consensus standards (ASTM F136-12a and ASTM F899-12b, respectively) to ensure they meet established biocompatibility and material strength specifications. The document states these materials have a "long history of safe usage in medical devices" and are "safe and effective, and similar to those used in the predicate device system."
Technological Features Comparison: A "20-point comparison" of technological features was performed between the WOLF® system and its predicate devices. This likely involves comparing design elements, dimensions, locking mechanisms, plate profiles, etc., to ensure no significant differences exist that would raise new questions of safety or effectiveness.
Indications for Use Comparison: The intended use statement of the WOLF® system was compared to that of the predicate devices to establish substantial equivalence.

Conclusion: The document asserts that through this comprehensive comparison of technological features and mechanical performance testing, the TOBY® WOLF® Long Bone Plate system is "substantially equivalent" to its predicate devices, thereby demonstrating its safety and effectiveness for its intended use. This is the common regulatory pathway for many traditional medical devices.

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.