(181 days)
- The Meta-Fix Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the metacarpal and metatarsal bones.
- The Fixion FA (RU-Fix) Intramedullary Nailing System is intended for use in the fixation of long bone fractures, including diaphyseal fractures of the radius and ulna.
The Meta-Fix and Fixion FA Intramedullary Nailing Systems consist of the following main components: The nail is an expandable, stainless steel, cylindrical rod without interlocking holes. It is supplied in a reduced diameter. The instrumentation includes, mainly, an insertion handle and a pump. The insertion handle is connected to the nail proximal end; the instrumentation is used for nail insertion and expansion. In addition the system consists of accessory tools.
The provided text describes a 510(k) premarket notification for a medical device, the "Meta-Fix and Fixion FA Intramedullary Nailing Systems." This document is a regulatory submission for substantial equivalence to predicate devices and does not contain information about specific acceptance criteria, device performance studies, or clinical trial details as typically found in a clinical study report or performance evaluation report.
Therefore, I cannot provide the requested information regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
The document focuses on:
- Device Identification: Trade/Proprietary Names, Common Name, Classification Name, Product Code.
- Predicate Devices: Listing previously cleared devices to which the current device claims substantial equivalence.
- Intended Use: Specific clinical applications for the device.
- System Description: Brief overview of components and materials.
- Substantial Equivalence Claim: Stating that the new devices are substantially equivalent to predicate devices in intended use, design, materials, technological characteristics, and principles of operation.
- FDA Communication: The FDA's letter confirming the substantial equivalence determination and allowing the device to be marketed.
In summary, the provided text does not contain the information necessary to fulfill your request regarding acceptance criteria and performance study details.
§ 888.3020 Intramedullary fixation rod.
(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.