(198 days)
The Medline UNITE® REFLEX™ Dynamic Discs are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Discs are intended for single use only.
The Medline UNITE® REFLEX™ Dynamic Discs are manufactured from nickel titanium alloy (nitinol). The discs utilize chemical etching and passivation to form a protective oxidation layer on the outer surface. The discs are offered in various diameters and thicknesses to be used in conjunction with screws of various diameters.
The provided text is related to a 510(k) premarket notification for a medical device (Medline UNITE® REFLEX™ Dynamic Discs). This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria via a clinical or comparative effectiveness study as would be seen for an AI/ML medical device.
Therefore, the document does not contain the information requested regarding acceptance criteria related to device performance in a clinical or AI/ML context. It focuses instead on non-clinical (bench) testing to support material and design equivalency.
Here's why the requested information cannot be extracted from this document:
- No AI/ML Component: The device described (Dynamic Discs) is a metallic bone fixation appliance, not an AI/ML-driven diagnostic or analytical tool. Therefore, there are no AI/ML performance metrics, acceptance criteria, or studies (like MRMC or standalone performance) to report.
- Focus on Substantial Equivalence: The 510(k) pathway is primarily about demonstrating that a new device is "substantially equivalent" to a predicate device already on the market. This often relies on comparing technological characteristics, intended use, and performing non-clinical (bench) tests to ensure safety and performance are comparable, rather than conducting large-scale clinical trials with specific performance endpoints and expert ground truth establishment.
- Non-Clinical Testing Only: The "Summary of Non-Clinical Testing" section describes tests like transformation temperature (ASTM F2004), galvanic corrosion (ASTM F3044), and corrosion susceptibility (ASTM F2129). These are material and safety tests, not performance studies in a clinical setting determining diagnostic accuracy or human reader improvement.
- "Summary of Clinical Testing: Not applicable.": This explicitly states that clinical testing was not performed or required for this submission, further reinforcing that there won't be data on human reader improvement or standalone diagnostic performance.
In summary, none of the specific bullet points regarding acceptance criteria, study details (sample sizes, data provenance, expert adjudication, MRMC, standalone performance, ground truth), or training set information are applicable or present in this 510(k) submission for the Medline UNITE® REFLEX™ Dynamic Discs.
§ 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.