(30 days)
Synthes Sterile Adjustable Distal Radius Fixator System is intended for stabilizing fractures of the distal radius.
The Sterile Adjustable Distal Radius Fixator is a pre-assembled mechanically adjustable external wrist fixator. It is a one-piece construct, which consists of plastic and metal components. The device is applied to the bone with four self-drilling Schanz screws that lock into two fixator clamps. The device operates by turning screws, which operate gears, to achieve incremental movement. The sterile packaged ADRF is packaged with Synthes 4.0 mm/3.0 mm stainless steel, self-drilling Schanz screws or Synthes 4.0 mm/3.0 mm titanium self-drilling Schanz Screws.
The provided text is a 510(k) summary for a medical device called the "Synthes Sterile Adjustable Distal Radius Fixator (ADRF)". This document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device, rather than a study proving the device meets specific performance acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth establishment is not present in this type of document.
Here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is not provided in the 510(k) summary. A 510(k) primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than presenting detailed performance acceptance criteria and results from a new study against those criteria. It states: "Documentation is provided which demonstrates that the Synthes Sterile Adjustable Distal Radius Fixator is substantially equivalent to its predicate device."
2. Sample size used for the test set and the data provenance:
This information is not provided. The document describes a medical device, not a study involving a test set of data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. This document does not describe a study involving expert-established ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided.
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:
This information is not provided. The device is a physical medical device (an external fixator), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is not applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
This information is not provided. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
This information is not provided. This document does not describe a study that required a ground truth determination.
8. The sample size for the training set:
This information is not provided. This is not an AI/machine learning device, and therefore, there is no training set mentioned.
9. How the ground truth for the training set was established:
This information is not provided. As above, there is no training set for this type of device.
In summary, the provided 510(k) document is for a physical medical device (an external fixator) seeking approval based on substantial equivalence to a predicate device, not for a software or AI-based diagnostic tool that would typically involve the types of studies and criteria requested in your prompt.
§ 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.