(66 days)
The Fragment Plate System is intended for essentially non load-bearing stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis, and craniomaxillofacial skeleton.
The Fragment Plate System is comprised of a variety of titanium plates with shapes and sizes designed for internal fixation of small bone fragments. The set also includes screws, pins, and k-wires. The screws and pins are have a center drive head and are 2.5 mm in diameter. The plates will include "Y," straight, right, and left configurations. Manual surgical instruments are supplied with the system to facilitate implantation.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fragment Plate System:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Standard | Reported Device Performance |
|---|---|
| Material/Mechanical Standards: | |
| ASTM F366-82 (Reapproved 2000), Standard Specification for Fixation Pins and Wires | The Hand Innovations, Inc. Fragment Plate Systems comply with this standard. |
| ASTM F136-96, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy (R56401) for Surgical Implant Applications | The Hand Innovations, Inc. Fragment Plate Systems comply with this standard. |
| Substantial Equivalence: | |
| Substantial equivalence to a legally marketed predicate device (Distal Volar Fracture Repair System) | Demonstrated through a 13-point technological comparison of features and bench testing. The devices were found to be substantially equivalent in terms of technological characteristics. The Fragment Plate System is deemed to be as safe and effective as, or better than, the predicate device. |
| Manufacturing Practices: | |
| Good Manufacturing Practices (GMP) | The Fragment Plate System will be manufactured per specifications using good manufacturing practices to ensure safety and effectiveness for its intended use. |
| Biocompatibility: | |
| Implantable and tissue contact materials have a long history of safe usage in medical devices. | Materials used in the Fragment Plate System have a long history of safe usage in medical devices. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a premarket notification (510(k)) where substantial equivalence is claimed. It does not present clinical study data with a "test set" in the traditional sense for evaluating device performance in patients.
Instead, the "test set" equivalent primarily involves:
- Bench Testing: Used for the 13-point technological comparison to demonstrate substantial equivalence to the predicate device. The specific sample sizes for these bench tests are not provided in the document.
- Compliance with Standards: The document states compliance with ASTM material and fixation standards. These standards themselves define sample sizes and testing methodologies, but the report doesn't detail the specific number of samples tested by Hand Innovations to meet these standards.
Data Provenance: Not applicable in the context of a clinical test set. The data presented is from internal bench testing and compliance assessments, not patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This device's clearance is based on substantial equivalence to a predicate device and compliance with material standards, not on a clinical ground truth established by medical experts for a test set of patient data.
4. Adjudication Method for the Test Set
Not applicable. No clinical ground truth requiring adjudication by experts was established for a test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is a medical device (fragment plate system) for surgical fixation, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
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
The "ground truth" in this context is established by:
- Predicate Device: The performance and safety profile of the "Distal Volar Fracture Repair System" by Hand Innovations, Inc. is the primary ground truth for comparison.
- Industry Standards: The specifications and performance requirements outlined in ASTM F366 and ASTM F136 serve as a ground truth for material properties and fixation characteristics.
- Historical Biocompatibility: The "long history of safe usage" of the implantable materials establishes a form of historical ground truth for biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set for an algorithm was used.
§ 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.