(52 days)
The Cleaning Cap is intended to close the lumens of applicator parts during and disinfection process. New sterilized Cleaning Caps can be placed onto applicators during patient insertion if this is desired.
The Leak Stop Buttons are intended to prevent liquid entering the applicator or source guide tube connector during implantation and treatment. They are also used for fixation of the individual channel marker clips.
The Leak Stop Channel Marker Sets are intended for the individual numbering of the multiple channels in combination of avoiding liquid entering the applicator or source guide tube connectors.
The Cleaning Caps, the Leak Stop Buttons and Leak Stop Channel Marker Sets are brachytherapy applicator accessories. The Cleaning Cap is used to close the lumens of applicator parts during the cleaning and disinfection process. During treatment the Leak Stop Buttons and Leak Stop Channel Marker Sets prevent blood or liquid from entering the source guide tube connector.
The provided text is a 510(k) Premarket Notification Summary for Varian Medical Systems, Inc.'s Cleaning Caps, Leak Stop Buttons, and Leak Stop Channel Marker Sets. This type of document is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
The document does not contain the information requested regarding acceptance criteria and a study proving a device meets those criteria, specifically:
- No specific measurable acceptance criteria are listed for the device's performance. The device is a set of accessories for brachytherapy applicators, primarily intended for closing lumens during cleaning/disinfection and preventing liquid ingress, along with marking channels. Its performance is assessed through general compliance with safety and biocompatibility standards rather than quantitative performance metrics.
- No detailed study is described that would demonstrate the device meets specific performance acceptance criteria. The document refers generally to "verification and validation testing" and "non-clinical 10993 standard testing" and states that "Results of verification and validation testing showed conformance to applicable requirements specifications and assured hazard safeguards functioned properly." However, it does not provide details of such a study, including sample sizes, data provenance, ground truth establishment, or specific performance metrics.
Therefore, I cannot populate the requested table or detail most of the bullet points as the necessary information is not present in the provided text.
Here's a breakdown of what can be inferred or directly stated from the document, and what is missing:
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A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as measurable criteria with thresholds. The document broadly states "conformance to applicable requirements specifications" and "assured hazard safeguards functioned properly."
- Reported Device Performance: The document concludes that the devices "are as safe, effective and performs as well as or better than the legally marketed device identified in section III above" (the predicate device). This is a statement of equivalence rather than a report of specific performance metrics against defined acceptance criteria.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- This information is not provided.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- This information is not provided. The testing mentioned appears to be related to engineering, materials, and safety standards rather than clinical performance requiring expert ground truth in the way an AI diagnostic device would.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not provided.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable. The devices are physical accessories, not AI software, and no MRMC study or AI assistance is mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable. The devices are physical accessories, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for these devices would likely be defined by engineering specifications, material standards (e.g., biocompatibility), and functional tests (e.g., ability to physically close lumens, prevent liquid ingress). These are not clinical ground truths as seen in diagnostic AI. The document broadly refers to "verification and validation testing" and "Biocompatibility testing requirements" and "Cleaning validation test requirements" as being met, implying the "truth" is established by adherence to these technical requirements.
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The sample size for the training set
- This is not applicable. The device is not an AI model requiring a training set.
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How the ground truth for the training set was established
- This is not applicable because there is no training set for this type of device.
In summary, the provided document is a regulatory submission for physical medical device accessories and does not contain the detailed performance study information, acceptance criteria, or AI-specific data (like training/test sets, ground truth establishment for AI, expert involvement for diagnostic assessment) requested for a typical AI/software-as-a-medical-device product.
§ 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.