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The Monkey Bars Pin to Bar External Fixation System is intended to be used in adult and pediatric patients (specifically, children and adolescents aged 2 through 21 years) for provisional fixation of open and/or unstable fractures in the lower and upper extremities and pelvis. It may also be used for temporary fixation of peri-articular or intra-articular fractures. Additionally, the device can be used on fractures where soft tissue injury or an infected fracture site may preclude the use of other fracture fixation treatments.

The device is used for the external stabilization of bone fractures. It consists of: Carbon fiber composite bars, 11mm diameter by 150mm to 500mm lengths, titanium combination clamp, aluminum 5 & 8 hole multi-pin clamps, aluminum straight and 30 degree angled posts, stainless steel 3mm, 4mm and 5mm thread diameter pins with 5mm diameter shanks that come in blunt tip and self tapping with 125mm through 230mm overall lengths and 20mm through 65mm thread lengths, stainless steel transfixing pin with 5mm shank, 7.2mm thread diameter, and 325mm overall length, and stainless steel instruments for implantation. The pins are implanted into bone and then they are connected using the clamps, rods and posts to form a rigid construct which holds the bone fragments rigidly in place. The pins are offered in various lengths and thicknesses.

The provided text describes the "Monkey Bars Pin to Bar External Fixation System" and its substantial equivalence to predicate devices, but it does not contain information about the acceptance criteria or a study proving that an AI/software device meets these criteria.

Instead, the document is a 510(k) summary for a physical medical device (an external fixation system), and it focuses on demonstrating substantial equivalence to legally marketed predicate devices through performance testing, primarily mechanical testing, rather than a clinical study or AI/software validation.

Therefore, I cannot provide the requested information in the format given, as the input document does not contain details about:

1. A table of acceptance criteria and the reported device performance for an AI/software device. The "Performance Testing" section mentions "Minimal Construct Static Compression Testing" and "predetermined acceptance criteria or were otherwise considered acceptable," but it doesn't quantify these criteria or results in a table for an AI system.
2. Sample size used for the test set and data provenance for an AI/software device.
3. Number of experts and qualifications for establishing ground truth for an AI/software device.
4. Adjudication method for an AI/software device.
5. Multi-reader multi-case (MRMC) comparative effectiveness study.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI/software device.
8. Sample size for the training set for an AI/software device.
9. How the ground truth for the training set was established for an AI/software device.

The document explicitly states: "Clinical data are not needed to support the safety and effectiveness of the subject device." This further confirms that the provided text is not about an AI/software device's clinical performance.

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