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The HDR ProstateTemplate and Accessories are indicated for use as an accessory to commercially available high dose rate remote afterloading systems for prostate brachytherapy.

The Photon Technologies HDR Prostate Template and Accessories are designed to work as accessories to commercially available high dose rate remote afterloader systems and consists of a template, plastic needles and needle obturators. The template is designed to mount on various ultrasound stepping devices and the grid of needle sized holes is compatible with the standard ultrasound image grid. The template is also designed with a simple locking mechanism for holding the needles in place and suture holes for suturing the template to the patient. The needle is a plastic tube that is closed to a sharp point at one end and equipped with a metal connector for attaching the needle to the remote afterloader transfer tube on the open end. The needle obturator is a spring temper metal rod that is inserted into the needle before use to straighten and stiffen it before implantation and to prevent damage between treatments or the possible entry of bodily fluids or other foreign matter. The HDR Prostate Template and Accessories are single use accessories that are provided unsterile and whose components are compatible with steam autoclave sterilization.

This document is a 510(k) summary for the HDR Prostate Template and Accessories by Photon Technologies Corporation. It describes a medical device intended to assist in prostate brachytherapy and argues for its substantial equivalence to a predicate device.

Crucially, this document is a regulatory submission for device clearance and does not contain any information regarding acceptance criteria, performance data from a specific study, sample sizes, expert involvement, or ground truth establishment relevant to AI/ML device evaluation.

Therefore, I cannot provide the requested information. The concepts of acceptance criteria, device performance metrics, sample sizes, expert adjudication, MRMC studies, standalone performance, and ground truth types are typically associated with performance evaluation studies for diagnostic or predictive AI/ML models, especially those involving image analysis or clinical decision support. This document describes a physical medical accessory, not an AI/ML system.

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