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The Precision Stepper and Needle Guide is intended for use with a rectal probe in ultrasound-guided prostate brachytherapy (transperineal radioactive seed implantation), and prostate gland voluming. The Precision Stepper and Needle Guide system is an accessory to an ultrasound system used for these medical procedures in a clinical setting.

Condition to be screened, monitored, treated or diagnosed. Prostate gland voluming and treatment of prostate cancer by transperineal brachytherapy

Physiological purpose. The Precision Stepper provides equipment support and quidance for a rectal probe. When used with its Needle Guide, an ultrasonic imaging system, and a rectal probe, the Precision Stepper and Needle Guide System is an accessory to clinical procedures for prostate gland voluming and ultrasound-guided radioactive seed implantation.

The Precision Stepper and Needle Guide is a manually operated medical device used to provide mechanical support for the application of a radionuclide source into the prostate in the course of a brachytherapy procedure in a clinical setting. The Stepper guides and secures a rectal probe which is used for imaging of the prostate. The Stepper moves the transducer in precise increments, or steps. When used in conjunction with the Stepper, the Needle Guide is used to aid the clinician in guiding needles through a template into the prostate. Under the guidance of the ultrasound probe, these needles are used to implant radioactive seeds that irradiate the prostate in cancer therapy.

The provided text is related to a 510(k) premarket notification for a medical device called the "Northwest Radiation Therapy Products Precision Stepper and Needle Guide." It describes the device, its intended use, and its comparison to predicate devices, but it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/software as a medical device (SaMD) submission.

This document is for a physical medical device with no software component or energy source. The "Testing" section concisely states that the device "has been subject to extensive inspection and testing to verify that the device meets all its physical and performance specifications." It then mentions that "Test results are maintained in the design history file and/or device history files for this device." However, it does not provide details about these tests, their acceptance criteria, or the study design/results.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a detailed study as requested in your prompt based on the provided text. The requested information (sample sizes, ground truth establishment, MRMC studies, standalone performance, etc.) are commonly associated with performance evaluations of AI algorithms or software, which is not applicable to this physical, manually operated device.

The document essentially claims substantial equivalence to predicate devices (CIVCO Seed Implant Needle Guide K875241 and CIVCO Ultra-Step Stepper K871413) based on similar materials, design, principle of operation, and technology, and confirms manufacturing in accordance with U.S. Quality System Regulation (21 CFR 820).

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