(75 days)
Use of the LoCon-T Distal Radial Plate System is intended to be used for fixation of unstable distal radius fractures in which closed reduction is not suitable:
- Joint destruction and/or subluxation visible on x-ray; .
- Failed fracture fixation with or without bone graft; .
- Osteotomy and repair of distal radius malunion with or without bone . graft;
- Displaced or non-displaced fracture which may or may not involve . angulation or fragmentation of bone;
- Dorsal plates are indicated for use with comminuted articular fractures, . shearing fractures of the articular surface, severely comminuted extraarticular fractures, and fractures in which reduction has been lost following fixation with percutaneous pins with or without an external fixator; or
- T-plates are indicated for use with volar articular shearing fractures
The LoCon-T Distal Radial Plate System includes four side specific dorsal plate, one volar T-plate, a dorsal plate extender, cortical screws, cancellous screws, and buttress pins. The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. The dorsal plates are available in two sizes for both right and left configurations. The cancellous screws are available in partially and fully threaded 4.0mm diameter designs ranging in length from 10.0 to 40.0mm in 2.0mm increments. The cortical screws are available in 3 diameters. The pins are 1.8mm in diameter and range in length from 12mm to 30mm.
The provided text describes the 510(k) summary for the LoCon-T Distal Radial Plate System. It details the device, its intended use, and a summary of mechanical testing.
Acceptance Criteria and Study Details:
Based on the provided text, the acceptance criteria and study that proves the device meets them are focused on mechanical performance and substantial equivalence to a predicate device. This is typical for Class II medical devices like a metallic bone fixation system, where the primary concern is the device's physical integrity and comparability to already approved products.
Here's the breakdown of the requested information:
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Table of Acceptance Criteria and Reported Device Performance:
Acceptance Criteria Reported Device Performance Substantial equivalence to predicate device The LoCon-T Distal Radial Plate System was declared substantially equivalent to the predicate devices (Zimmer Forte Distal Radial Plate System). Meets strength requirements of the predicate device Mechanical test data demonstrated that the material and subject device design meets the strength requirements of the predicate device. Material composition (Stainless Steel ASTM F 139, F 138, F 1314) The plates and plate extender are manufactured from Stainless Steel (ASTM F 139). The screws are manufactured from Stainless Steel (ASTM F 138). The pins are manufactured from Stainless Steel (ASTM F 1314). (This is a design specification, implicitly met if materials were used as stated). Design for lower profile and secure bone fragments The plates, pins, extender, and screws are designed to be lower in profile and secure bone fragments. (This is a design specification, implicitly met if the design was followed). -
Sample Size used for the test set and the data provenance:
- Sample Size: The document does not specify a numerical sample size for the mechanical testing. It simply states "Mechanical test data." For mechanical testing of medical devices, sample size is often determined by engineering principles and statistical power calculations to ensure robust data.
- Data Provenance: The data provenance is derived from "Mechanical test data" supporting the 510(k) submission. The exact location or nature of this testing (e.g., in-house lab, third-party lab) is not specified, but it would have been part of the regulatory submission process in the USA (Arlington, TN is the company's address, and the submission is to the FDA in Rockville, MD). It is a prospective study in the sense that the testing was performed specifically to demonstrate compliance for this device.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and testing. The "ground truth" for mechanical testing is established by engineering standards, material specifications (e.g., ASTM standards), and predefined strength requirements, not by expert consensus on clinical findings. The FDA reviewer, Neil RP Ogden, Acting Director Division of General and Restorative Devices, made the determination of substantial equivalence, which is a regulatory rather than a clinical ground truth establishment.
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Adjudication method for the test set:
- Not applicable. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies, particularly those involving human interpretation of data (e.g., image analysis). For mechanical testing, the results are quantitative and objective measurements against predefined criteria, not subject to subjective adjudication in the same way.
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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:
- No. An MRMC study is completely irrelevant here. This is a medical device (metallic bone fixation system) that is mechanically tested, not an AI or diagnostic imaging device that involves human interpretation of output.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a physical medical device, not a software algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" in this context is defined by engineering standards and pre-specified mechanical strength requirements derived from the predicate device and relevant industry standards for bone fixation systems. The predicate device (Zimmer Forte Distal Radial Plate System) itself serves as a benchmark for comparison regarding strength requirements.
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The sample size for the training set:
- Not applicable. There is no "training set" in the context of mechanical testing for a metallic orthopedic implant. Training sets are relevant for machine learning or AI models, which are not involved here.
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How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.
§ 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.