(29 days)
The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius.
The proposed Multidirectional Threaded Peg is manufactured from Cobalt Chromium (CoCr) and is available in 2.5 mm diameter and in a variety of lengths, ranging from 10 – 30 mm in 2 mm increments to accommodate varying patient anatomies and fracture morphologies.
This submission describes a medical device, the Multidirectional Threaded Peg, which is a component of a bone fixation system. The FDA 510(k) summary provided indicates that this is a substantially equivalent device filing, meaning the device's performance is compared to an already legally marketed predicate device. Therefore, a comprehensive "study that proves the device meets the acceptance criteria" in the sense of a standalone clinical trial with acceptance criteria for device performance (e.g., sensitivity, specificity, accuracy for an AI system) is generally not applicable for this type of submission.
Instead, the "acceptance criteria" and "study" for this type of device revolve around demonstrating substantial equivalence to the predicate device through pre-clinical testing, primarily mechanical testing, to ensure that the new device performs at least as well as the predicate for its intended use.
Here's the breakdown of the information requested, tailored to this device type and the provided documents:
1. Table of Acceptance Criteria and the Reported Device Performance:
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Material Biocompatibility | Meet requirements of ASTM F 1537-00 for Cobalt Chromium (CoCr) alloy. | The Multidirectional Threaded Peg is manufactured from CoCr alloy that meets the requirements of ASTM F 1537-00. This is considered an acceptable demonstration of biocompatibility, thus no further testing was deemed necessary. |
| Mechanical Performance | Demonstrate equivalent mechanical performance (e.g., strength, fatigue resistance, fixation stability) to the predicate device's threaded peg. | The equivalence was "confirmed through pre-clinical testing." Although specific numerical results or detailed test methods are not provided in this 510(k) summary, the FDA's clearance implies that these tests were conducted and the Multidirectional Threaded Peg's performance met the criteria for substantial equivalence to the predicate's threaded peg. (No specific quantitative performance metrics are given in the summary.) |
| Indications for Use | Maintain the same Indications for Use as the predicate device. | The Multidirectional Threaded Pegs have the same indications for use as the predicate device: "The Distal Volar Radius Anatomical Plate System is intended for the fixation of fractures and osteotomies involving the distal radius." |
| Device Configuration | Available in 2.5 mm diameter and lengths ranging from 10–30 mm in 2 mm increments. | The device is available in 2.5 mm diameter and in a variety of lengths, ranging from 10–30 mm in 2 mm increments, matching the described specifications. |
Regarding the other requested points (2-9), these are mostly relevant for diagnostic AI/software devices or clinical studies with human subjects, not for demonstrating substantial equivalence for a new mechanical implant component via pre-clinical testing as seen in this 510(k) summary.
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable for an implantable medical device undergoing pre-clinical mechanical testing for substantial equivalence. The "test set" would refer to physical prototypes or engineering samples.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable. Ground truth for mechanical testing is established by engineering standards, test methods, and quantitative measurements, not expert human assessment.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable for pre-clinical mechanical testing.
- 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 device or a diagnostic imaging device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical implant component, not an algorithm.
- The type of ground truth used (expert concensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" is defined by the objective physical properties and performance measured against established ASTM standards and benchmarked against the predicate device's known performance.
- The sample size for the training set: Not applicable. There is no "training set" in the context of mechanical pre-clinical testing for substantial equivalence.
- How the ground truth for the training set was established: Not applicable.
In summary, for this particular medical device (Multidirectional Threaded Peg), the "study" demonstrating its meeting of "acceptance criteria" is a series of pre-clinical mechanical tests (implicitly, as detailed test reports are not in the summary) comparing its performance to a legally marketed predicate device, ensuring substantial equivalence in material, design, and function for its stated indications for use. The acceptance criteria primarily centered on material compliance (ASTM F 1537-00) and comparable mechanical performance to the predicate 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.