(87 days)
The Lever Action Plate System is indicated for:
- Fixation of fractures or non-unions of the distal radius
- Osteotomies of the distal radius to correct malunion
The Lever Action Plate System is a distal radius plate implanted in the treatment of distal radius fractures, non-unions, or osteotomies. The system consists of the plates, screws, beams, beam screws and instrumentation. The plates have either 1 or 2 beam slots which allow for implantation of the beams into the distal radius bone. The beams and their supporting beam screws are intended for maintaining volar correction intra-operatively. The plate and beam(s) are used in conjunction with screws and beam screws to fixate fragments in the wrist. The implants are composed of Ti-6Al-4V and are available in multiple configurations and sizes.
This FDA 510(k) summary is for the Lever Action Plate System, a medical device used for bone fixation. It describes the device's indications for use, its similarity to a predicate device, and the preclinical testing performed.
Here's an analysis based on your request, highlighting that this is a mechanical device clearance, not an AI/software device, which impacts the applicability of many of your requested points.
1. Table of Acceptance Criteria and Reported Device Performance
Acceptance Criteria (Mechanical Properties): The document implies that the acceptance criteria for the Lever Action Plate System's mechanical properties were established by demonstrating equivalence to the predicate device and by conforming to relevant ASTM standards. The specific quantitative thresholds for acceptance (e.g., minimum bending strength in Newtons) are not explicitly stated in the provided text. Instead, the acceptance is based on demonstrating that the subject device's mechanical strength is "equivalent" to the predicate and "sufficient" for its intended use.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Static Mechanical Compression Bend Testing | The subject plates demonstrated equivalent strength in comparison to the predicate device (Trimed Bearing Plate). |
| Dynamic Mechanical Compression Bend Testing | The subject plates demonstrated equivalent strength in comparison to the predicate device (Trimed Bearing Plate). |
| Static Torsion Testing (Screws) | The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543). |
| Driving Torque Testing (Screws) | The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543). |
| Removal Torque Testing (Screws) | The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543). |
| Static Axial Pullout Testing (Screws) | The screws were demonstrated to be of sufficient strength for their intended use (per ASTM F543). |
| Disassembly Pushout Testing (Beams/Plate Interface) | The fixation components were demonstrated to be of sufficient strength, fixation, and usability for their intended use. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document describes preclinical mechanical testing of physical device components, not a study involving human subjects or data sets.
- Sample Size for Test Set: Not specified in terms of "test set" as typically understood for software or clinical studies. The mechanical tests would have involved a certain number of device samples (plates, screws, beams) for each test condition, but these specific numbers are not detailed in the summary.
- Data Provenance: The data comes from in-vitro (benchtop) mechanical testing conducted on the manufactured device components. The country of origin for this testing is not specified, but it's related to the manufacturer (McGinley Orthopaedic Innovations in Wyoming, USA) and regulatory consultants (MCRA, LLC in Washington, DC, USA). The testing is prospective for the purpose of demonstrating substantial equivalence.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This question is not applicable to this type of device clearance. Ground truth, in the context of expert consensus, is typically established for diagnostic algorithms or subjective assessments. For a mechanical device, the "ground truth" for performance is determined by objective physical measurements conforming to engineering standards (e.g., ASTM F543) and direct comparison of mechanical properties. There were no human experts establishing ground truth in this context.
4. Adjudication Method for the Test Set
This question is not applicable. The "test set" relates to mechanical testing where outcomes are objective measurements, not subjective human assessments requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted and is not relevant for this type of mechanical bone fixation device. MRMC studies are typically performed for imaging diagnostics or AI-assisted diagnostic tools to assess how human reader performance changes with or without AI assistance. This device is a physical implant.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
No. This is a physical medical implant, not an algorithm or AI software. Therefore, a standalone performance study in the context of "algorithm only" is not applicable.
7. Type of Ground Truth Used
The "ground truth" for this mechanical device application is established through objective mechanical testing against established industry standards (e.g., ASTM F543) and direct comparison of mechanical properties to a legally marketed predicate device. The document states, "The testing demonstrated that subject plates have equivalent strength in comparison to the predicate" and that screws/components are of "sufficient strength" and "fixation and usability."
8. Sample Size for the Training Set
This question is not applicable. This is a physical device, not an AI or machine learning model. There is no concept of a "training set" in the context of its development and preclinical testing as described.
9. How the Ground Truth for the Training Set was Established
This question is not applicable for the same reasons as point 8.
§ 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.