(38 days)
Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur tibia and fibula.
The proposed products, Locking Plate System, contain (1) locking plates (1.Ps) with various specifications. (2) locking screws with various specifications and (3) various specific instruments. Locking Plates are the plates that made of Titanium. The limited-contact design of LPs reduces plate-to-bone contact, thus limiting vascular trauma. The screws are available in three kinds, which are 3.5mm Hexagonal Locking Screws with hexagonal interface, 3.5mm Stardrive Locking Screws with Torx interface, and 5.0mm Locking Screws with hexagonal interface. There are various instruments specific to the proposed device intend for completing the surgery.
This document is a 510(k) summary for a Locking Plate System, which is a Class II medical device. The submission focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.
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1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance (Test Results) |
|---|---|
| ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates | Performance tested: Static and Dynamic Performance tested per ASTM F382. (Implicitly, the device met the specifications of this standard to claim substantial equivalence.) |
| ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws | Performance tested: Torsional, Driving Torque and Pull out strength tested per ASTM F543. (Implicitly, the device met the specifications of this standard to claim substantial equivalence.) |
| ISO 17665-1:2006 Sterilization of health care products- Moist heat, Part 1: Requirements for the development, validation and routing control of a sterilization process for medical devices | Performance met: "The test results demonstrated that the proposed device complies with the following standards." (Specifically implied for sterilization, as the device is supplied non-sterile and "Subject to steam sterilized prior to use.") |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "No clinical study is included in this submission."
Therefore, there is no patient-specific test set, sample size, or data provenance (e.g., country of origin, retrospective/prospective) related to clinical outcomes. All testing was non-clinical (laboratory/bench testing).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. As no clinical studies were performed, there was no need for experts to establish ground truth from patient data. The "ground truth" for non-clinical testing is adherence to established engineering standards (ASTM and ISO).
4. Adjudication Method for the Test Set
Not applicable. No clinical studies were performed, so no adjudication method for human decisions on patient cases was required.
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. It's a hardware medical device (bone plates and screws), and 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. This is not an algorithm/software device.
7. The Type of Ground Truth Used
The "ground truth" for this submission are the performance requirements and specifications defined by the referenced international standards (ASTM F382, ASTM F543, ISO 17665-1). The non-clinical tests' goal was to demonstrate compliance with these established engineering standards.
8. The Sample Size for the Training Set
Not applicable. There is no training set mentioned, as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
Not applicable. There is no training set for this type of device.
§ 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.