(90 days)
The Mick Radio-Nuclear Instruments, Inc. Segmented Vaginal Applicators are intended for use in Brachytherapy. The system described in this 510(k) has been developed to function as an applicator for the positioning of sealed sources in the intracavitary treatment of the vagina.
The Mick Radio-Nuclear Segmented Vaginal Applicator meets these requirements by providing an system that can be adjusted in length and diameter to meet the dimensions of the treatment volume and by utilizing radio opaque markers for visualization.
This submission K993472 is for a Segmented Vaginal Applicator, which is a medical device used in brachytherapy. The submission asserts substantial equivalence to a predicate device and does not involve a study to demonstrate performance against specific acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text as the application did not involve a performance study with acceptance criteria.
Here's what can be stated based on the given document:
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A table of acceptance criteria and the reported device performance: Not applicable. The submission asserts substantial equivalence based on design, construction, materials, intended use, and performance characteristics being similar to a predicate device, rather than providing specific performance metrics against pre-defined acceptance criteria for a new study.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. No test set or data provenance is mentioned as this was not a clinical performance study.
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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): Not applicable. No ground truth establishment for a test set is mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No test set adjudication is mentioned.
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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: Not applicable. This device is an applicator for radiation therapy, not an AI-assisted diagnostic tool.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device, not a standalone algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. No ground truth was established for a performance study. The "ground truth" for this submission is the established safety and effectiveness of the predicate device to which it claims substantial equivalence.
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The sample size for the training set: Not applicable. This device is not an AI algorithm requiring a training set.
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How the ground truth for the training set was established: Not applicable.
The core argument for the device's marketability lies in its substantial equivalence to a previously cleared device, not in a new performance study with specific acceptance criteria. The document states:
"This device is similar in design and construction, utilizes the identical materials, and has the same intended use and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device."
§ 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.