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The DevMed is designed to allow precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments. A specific application is the treatment of prostate cancer.

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The provided text is a 510(k) summary for the DevMed™ Stepping and Stabilizing System, which is a device used for precision ultrasound probe alignment and radioactive seed implantation in brachytherapy treatments, specifically for prostate cancer.

The document does not describe any acceptance criteria or a study proving the device meets those criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market, which is the basis for 510(k) clearance.

Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria and a study proving their fulfillment. The provided text explicitly states that the "510(k) 'Substantial Equivalence' Decision-Making Process (Detailed) from ODE Guidance Memorandum #86-3 was followed" and lists comparisons based on intended use, technological characteristics, and materials.

Key takeaway from the provided text: The DevMed™ Stepping and Stabilizing System was cleared based on its substantial equivalence to previously cleared devices, not on a study proving it meets specific performance acceptance criteria in the way a new medical device would typically be evaluated for efficacy or diagnostic performance.

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