(30 days)
The MicroSelectron PDR is intended to enable an operator to apply, by remote control, a radionuclide source into the body (including Interstitial, Intracavitary, Intraluminal, Bronchial, intra-operative) or to the surface of the body for radiation therapy.
The microSelectron Afterloading System concerns a microSelectron -HDR (V2) with treatment chambers. The operator console is a PC running dedicated software. Treatment plans are transferred from the radiotherapy treatment planning software to the Treatment Console Software by file transfer. Connection to a LAN is only for the purpose of Transfer of Treatment Plan Files. It is the same as in the predicate device. The radiotherapy treatment planning software is not part of this 510(k) submission. Applicators and Transfer Tubes as available for microSelectron-HDR (V2) are also applicable for the microSelectron PDR. The PC based Afterloader workstation is the current TCS workstation, but ported from a DOS based Afterloader workstation. The PC based Afterloader workstation comes with functionality to support PDR procedures (i.e. Scheduling of treatments). The modifications to the previously cleared device K953946 are: - Addition of RCU and NSD previously cleared device K902533 . - Addition of Radiation Status Indicator . - Changes to TCS to enable the PDR workflow . - Addition of Smoothbase, part of previously cleared device K031158 . The software runs on a PC with a Windows XP platform.
The provided text is a 510(k) summary for the Nucletron MicroSelectron PDR, a remote-controlled radionuclide applicator system. It describes modifications to a previously cleared device (MicroSelectron HDR) and asserts substantial equivalence. However, the document does not contain the detailed information necessary to fully answer your request regarding acceptance criteria and a study proving device performance.
Specifically, the document focuses on regulatory compliance for a modified medical device, outlining its intended use, technological considerations, and comparison to predicate devices, rather than presenting a performance study with detailed acceptance criteria, sample sizes, ground truth establishment, or expert adjudication.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or information about a specific study proving the device meets these criteria based solely on the provided text.
Here's an analysis of what information is and is not present in the document, in relation to your questions:
1. A table of acceptance criteria and the reported device performance
- Not present. The document states that the MicroSelectron PDR is "substantially equivalent" to a predicate device (MicroSelectron HDR, K953946). This regulatory assertion implies that its performance is expected to be similar or equal to the predicate, but it does not define specific acceptance criteria or report performance data for the modified device itself.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not present. The document does not describe any specific performance study with a test set, sample sizes, or data provenance.
3. 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 present. No ground truth establishment process for a test set is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not present. No adjudication method is described.
5. 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 present. This device is a remote-controlled radionuclide applicator system for radiation therapy, not an AI-powered diagnostic imaging tool that would typically undergo MRMC studies with human readers assisting with interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not present. The device is hardware and software designed to "enable an operator to apply...a radionuclide source." It is not an algorithm for standalone performance evaluation in the context you're asking about (e.g., image analysis). The software (TCS) supports the PDR workflow and manages treatment plans.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not present. No specific ground truth is referenced as no performance study is detailed.
8. The sample size for the training set
- Not present. No training set for an algorithm is mentioned or implied.
9. How the ground truth for the training set was established
- Not present. No training set or ground truth establishment for it is mentioned.
Summary of Device and Regulatory Context (based on provided text):
The document is a 510(k) premarket notification for the "MicroSelectron PDR," a modified version of the "MicroSelectron HDR" (K953946).
- Device Type: Remote controlled radionuclide applicator system (Afterloader)
- Intended Use: To enable an operator to apply, by remote control, a radionuclide source into or onto the body for radiation therapy (Interstitial, Intracavitary, Intraluminal, Bronchial, Intra-operative).
- Modifications:
- Substantial Equivalence: Asserted to MicroSelectron HDR (K953946).
- Regulatory Class: Class II, Product Code JAQ (21 CFR 892.5700).
The 510(k) pathway primarily demonstrates that a new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, or if different, does not raise different questions of safety and effectiveness. It often does not require new comprehensive clinical studies detailed with acceptance criteria in the same way a PMA (Premarket Approval) might. The focus here is on regulatory equivalence rather than a detailed, standalone performance study with quantifiable acceptance criteria.
§ 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.