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The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are intended for use in Brachytherapy. The delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR) requires not only proper visualization and localization of the treatment volume. but precise dosimetry and then a stable delivery system from which treatment can be administered. The Mick Radio-Nuclear "HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The Mick Radio-Nuclear Instruments, Inc. HDR Contour TP Template and Implant Accessories are designed to act as accessories to commercially available HDR Systems (Varian K952913; Gammamed K891131/A: Nucletron K852842). By providing a template that can be attached to the patient perineum as described in the currently cleared H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601), and hold multiple HDR needles in a pre-defined array for treatment delivery, again as cleared in the H.A.M. Applicator (Mick Radio-Nuclear Instruments K961601) the Contour TP Template System provides a system for needle placement in the use of HDR for radiotherapy treatments of the Prostate.

The provided document is a 510(k) premarket notification for a medical device: the "HDR Contour TP Template and Implant Accessories." This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets acceptance criteria through detailed performance studies.

Therefore, the document does not contain the information requested regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or MRMC comparative effectiveness studies.

Here's why and what information is available:

• 510(k) Submissions and Performance Studies: For Class II devices like this one, a 510(k) typically demonstrates substantial equivalence by showing the new device is as safe and effective as a predicate device. This is often achieved by comparing design, materials, intended use, and performance characteristics to existing, cleared devices. Full-scale clinical trials or extensive performance studies with detailed acceptance criteria and statistical analysis are generally not required for a 510(k) unless the device introduces new technology, new indications for use, or raises new safety/effectiveness concerns.
• "Performance Standards": The document explicitly states: "Performance standards for applicators for remote controlled afterloading brachytherapy have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act." This confirms that formal, regulator-defined performance standards with specific acceptance criteria are not applicable here.
• "Summary of Substantial Equivalence": The document states: "This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device." This is the core argument for clearance, not a report of specific test results against defined acceptance criteria.

Information that is present in the document but does not address your specific questions:

• Device Name: HDR Contour TP Template and Implant Accessories
• Intended Use: For use in Brachytherapy, specifically for "delivery of radiation therapy to the Prostate via High Dose Rate Remote Afterloading (HDR)." It acts as an accessory to commercially available HDR Systems, holding multiple HDR needles in a pre-defined array for treatment delivery.
• Predicate Devices: A list of predicate templates, needles, and applicators (e.g., Syed/Neblett Prostate Template, Mick 200-TP and Mick TP Needle, H.A.M. Applicator).
• Classification: Class II device (21 CFR 892.5700).

In summary, none of the requested information regarding acceptance criteria, device performance results, study details (sample size, data provenance, ground truth, experts, adjudication, MRMC, standalone performance, training set details) can be extracted from the provided 510(k) document because such detailed studies are not typically part of a substantial equivalence demonstration for this type of device.

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