(197 days)
Nucletton CET Prostate Applicator Set is intended for use with Interstitial Prostate brachytherapy procedures involving the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR. The applicator provides a means of delivering the prescribed radiation dose to the treatment area. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids.
The Nucletron CET Prostate Applicator as described in this submission is designed as an accessory to the Nucletron remote afterloading equipment: mHDR, mHDR-Classic, mPDR and mLDR, for Interstitial Prostate brachytherapy procedures. The CET Prostate Applicator Set consists of a template and needles used for the Interstitial Prostate brachytherapy. The template is sutured to the skin surface and is designed to guide the needles into the prostate tissue. The needle while positioning around the template will anatomically encompass the prostate volume. Once the needles are in position the fixing screws are tightened to immobilize the needles within the tissue. Radiographic images, planar films or transverse slices, i.e. CT, MR are obtained to determine the precise location of the applicator within the body. This information is then used for brachytherapy treatment planning purposes. When the treatment planning is completed the applicator is then attached to the Nucletron remote afterloading equipment (treatment head): mHDR, mHDR-Classic, mPDR and mLDR, by the Nucletron transfer tubes. The transfer tubes lock into the open end of the applicator and the remote afterloading equipment (treatment head) prior to treatment. When the applicator is properly attached, a check cable run is performed to ensure that the applicator is properly attached and that there is no obstructions which will interrupt treatment. After the check cable run, the radioactive source will step through the applicator to deliver that prescribed dose of radiation. When the treatment is complete, the applicator is detached from the transfer tube and remote afterloading equipment. The applicator is then removed from the patient. The applicator is a closed system to prevent the radioactive source from coming in contact with body fluids. The applicator does not control the treatment unit; it strictly provides a treatment path for the radioactive source. The Nucletron remote afterloading system and the clinical staff verify that the applicator is properly attached prior to treatment.
This document is a 510(k) Pre-Market Notification for a medical device called the "Nucletron CET Prostate Applicator Set." It is a regulatory submission to the FDA, not a study report. Therefore, it does not contain the acceptance criteria or results from a study proving the device meets acceptance criteria in the way you've outlined for performance studies.
Instead, this document focuses on demonstrating substantial equivalence to a previously marketed predicate device, which is the primary route for many Class I and Class II medical devices to gain FDA clearance.
Here's a breakdown of why your requested information isn't present and what the document does provide:
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No "Acceptance Criteria" or "Reported Device Performance" Table: The document doesn't define specific performance metrics or acceptance criteria because it's not a clinical trial or performance validation study. Its goal is to show the new device is as safe and effective as an existing one.
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No "Sample Size" (for test set), "Data Provenance," "Number of Experts," "Adjudication Method," "MRMC Study," or "Standalone Performance" information: These are all elements of a clinical or performance study. As this is a 510(k) submission based on substantial equivalence, such studies are typically not required, especially for an accessory like this applicator. The focus is on comparing design, materials, and intended use to a known device.
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No "Type of Ground Truth" or "Sample Size for Training Set" or "How Ground Truth for Training Set was Established": These concepts apply to AI/ML device development and validation. This document describes a physical medical device (an applicator set) and doesn't involve AI or machine learning.
What the document does describe that is relevant to regulatory clearance:
- Device Name: Nucletron CET Prostate Applicator Set
- Intended Use: For Interstitial Prostate brachytherapy procedures with specific Nucletron remote afterloading equipment (mHDR, mHDR-Classic, mPDR, mLDR). It provides a means of delivering prescribed radiation and is a closed system to prevent radioactive source contact with body fluids.
- Classification Name: Accessory to remote afterloader (21 CFR 892.5700, Class II).
- Predicate Device: The document states, "Our device is substantially equivalent to the legally marketed predicate device cited in the table below," but the table provided (labeled "1 11 50
1" and then generic text) is incomplete or corrupted in the provided text and does not list the specific predicate device(s). In a proper 510(k), this table would clearly name the predicate device(s) and provide their 510(k) numbers. - Technological Considerations: The new device "combines the functionality, components and design of the predicate device while incorporating a new material." This is the core argument for substantial equivalence.
In summary: This document is a regulatory filing for a physical medical device, not a performance study. It establishes "substantial equivalence" based on similar intended use, design, materials, and technological characteristics to a legally marketed predicate device, rather than providing detailed performance metrics from a clinical or validation study. Therefore, the specific information requested in your prompt (acceptance criteria, study details, expert involvement, etc.) is not present in this type of document.
§ 892.5700 Remote controlled radionuclide applicator system.
(a)
Identification. A remote controlled radionuclide applicator system is an electromechanical or pneumatic device intended to enable an operator to apply, by remote control, a radionuclide source into the body or to the surface of the body for radiation therapy. This generic type of device may include patient and equipment supports, component parts, treatment planning computer programs, and accessories.(b)
Classification. Class II.