(30 days)
The Nucletron microSelectron HDR - GENIE Afterloading System has the same intended use as the legally marketed predicate device cited. This device is 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.
The entry-level microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels. The operators console of the microSelectron®HDR - GENIE Afterloading System concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device microSelectron-HDR (V2). In the microSelectron®HDR - GENIE Afterloading System there is on the operators console a second completely independent software program for radiotherapy treatment planning. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. It is the same as in the predicate device where treatment plans are transferred to the Treatment Console Software from radiotherapy treatment planning software running on a separate computer. The radiotherapy treatment planning software is covered by a separate 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron®HDR - GENIE Afterloading System. The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device. Connection to a LAN is only for the purpose of File Transfer of Treatment Plan Files.
The provided text describes a 510(k) premarket notification for a medical device called the "microSelectron®HDR - GENIE Afterloading System". This document focuses on demonstrating substantial equivalence to a previously cleared predicate device (microSelectron-HDR V2, K953946), rather than presenting a study with acceptance criteria and device performance metrics in the way one would for a novel AI/software medical device.
Therefore, many of the requested categories related to studies, sample sizes, ground truth, and expert evaluation are not directly applicable or present in this specific 510(k) summary. The information provided is primarily about the device's technical description, intended use, and its relation to a predicate device.
Here's an attempt to address the points based only on the provided text, noting where information is not available:
Acceptance Criteria and Device Performance (Not Applicable - Substantial Equivalence Submission)
This submission is for a medical device (a remote-controlled afterloading system for radiation therapy) that is demonstrating substantial equivalence to a predicate device (microSelectron-HDR V2). It is not presenting a performance study against predefined acceptance criteria for accuracy or efficacy in the same way a software or AI device submission would. The "acceptance" is based on the FDA's determination of substantial equivalence.
Therefore, a table of acceptance criteria and reported device performance, in the context of a new performance study, cannot be generated from this document. The performance is implicitly deemed acceptable because it is substantially equivalent to a device already on the market.
Additional Requested Information (Based on provided text)
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A table of acceptance criteria and the reported device performance:
- N/A. As explained above, this document is a 510(k) for substantial equivalence, not a performance study against novel acceptance criteria.
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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 provided. This type of information is typically associated with performance studies, which are not detailed in this 510(k) summary. The submission focuses on the technical characteristics and intended use being similar to a predicate device.
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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 provided. This information is relevant for performance studies involving expert review, which is not described here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not provided. This is relevant for performance studies involving expert review, which is not described here.
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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:
- No. This device is a "Remote Controlled Afterloading System" for radiation therapy, not an AI or imaging diagnostic device that would involve human readers interpreting cases. Therefore, an MRMC study is not applicable in this context.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, to some extent. The document states: "The entry-level microSelectron®HDR - GENIE Afterloading System is a standalone device." While this refers to the hardware system, the core of the submission (and the "study" in a very broad sense) is about the technical specifications of the device itself, functioning independently of real-time human interpretation or decision-making in a diagnostic sense. It's a control system for radionuclide application.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the typical sense of a diagnostic or AI device. The "ground truth" for this submission is implicitly the functional and safety performance of the predicate device (microSelectron-HDR V2). The new device is asserted to be substantially equivalent in its design and intended use. The "truth" being established is that the device safely and effectively performs its stated function of applying a radionuclide source, similar to the predicate.
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The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set" in that context.
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How the ground truth for the training set was established:
- Not applicable. As above, there is no "training set" for this type of device.
Summary of the "Study" and "Acceptance Criteria" for K021286:
The document K021286 is a Special 510(k) Premarket Notification for the Nucletron microSelectron®HDR - GENIE Afterloading System. The "study" presented here is a demonstration of substantial equivalence to a previously cleared predicate device, the microSelectron-HDR V2 (K953946).
- Acceptance Criteria (Implicit for Substantial Equivalence): The primary acceptance criterion for a 510(k) is that the new device has the same intended use as a legally marketed predicate device and has technological characteristics that are sufficiently similar to the predicate device that it can be determined to be as safe and effective as the predicate device. Minor differences in technological characteristics must not raise different questions of safety and effectiveness.
- Reported Device Performance (Implicit): The functional performance is asserted to be equivalent to the predicate device. The description highlights that the new system is an "entry-level" version with only three treatment channels and uses similar software and applicators as the predicate. The statement "The Nucletron microSelectron®HDR - GENIE Afterloading System concerns a microSelectron-HDR (V2) with only three treatment channels" and "The operators console ... concerns a PC running dedicated Treatment Console Software which is similar as in the predicate device" serves as the core of this claim.
- Proof: The entire 510(k) submission, by outlining the similarities in intended use, technological characteristics, and specifications, serves as the "proof" for substantial equivalence. The FDA's letter (pages 2-4) confirms that they found the device to be substantially equivalent.
§ 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.