(109 days)
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or ostectomies for the clavicle, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia, and fibula.
The Acu-Loc 2 Plate is a volar plate which is intended to provide fixation for distal radius fractures. The purpose of this Special 510(k) is to add 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate. All components are made of titanium alloy conforming to ASTM F136. This addition does not affect the intended use of the device or alter the fundamental scientific technology of the device.
The provided text describes a Special 510(k) submission for the Acumed Congruent Bone Plate System, specifically adding 2.3mm Locking Variable Angle Screws for use with the Acu-Loc 2 Plate.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Defined in the Design Control Activities Summary for the screw/plate interface. | Met |
| Note: The specific numerical or qualitative acceptance criteria are not detailed in the provided document. The document only states that such criteria existed and were met. |
2. Sample Size Used for the Test Set and Data Provenance
The text mentions "mechanical testing to characterize the screw/plate interface." However, it does not specify the sample size used for this mechanical testing.
- Test Set Sample Size: Not specified.
- Data Provenance: The testing was preclinical, implying it was conducted in a laboratory setting. The country of origin of the data is not specified, but the manufacturer is Acumed, LLC, located in Hillsboro, OR, USA, and the regulatory consultant is in Washington, DC, USA, suggesting the testing was likely conducted in the USA or by a facility adhering to US standards. The data is retrospective in the sense that the testing was completed before the 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is "preclinical testing" focusing on mechanical characteristics of a medical device (screws and plates), not a study involving human patients or interpretations by medical experts. The "ground truth" here would relate to the physical properties and performance of the device under specific mechanical loads, not a diagnostic outcome.
4. Adjudication Method for the Test Set
This information is not applicable for the same reasons as point 3. Mechanical testing results are typically evaluated against predefined engineering specifications, not through adjudication by experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
This information is not applicable as the study described is preclinical mechanical testing, not a clinical study involving human readers or comparative effectiveness with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical bone plate system and screws, not an AI algorithm.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for this preclinical mechanical testing would be the engineering specifications and performance metrics defined for the screw/plate interface (e.g., screw pull-out strength, torque limits, bending stiffness, fatigue life). These are established through recognized engineering standards and biomechanical principles, not typically by expert consensus in a medical diagnostic sense, pathology, or direct patient outcomes.
8. The Sample Size for the Training Set
This information is not applicable as the device is mechanical hardware, not an AI algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information 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.