(49 days)
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification has been developed to function as accessories/applicator for the positioning of HDR Remote After-Loader sealed sources during intraoperative procedures or externally on the patient surface.
The Mick HDR IORT Shielded Applicator presented in this 510(k) notification have been developed to function as accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer. The design of these systems is the similar to that of the predicate devices listed below. The delivery of radiation therapy via high dose rate Brachytherapy for superficial or interoperative treatment requires not only a stable system for precise dosimetry but also a reproducible and predictable geometry for positioning of the radioactive source under remote control. The Mick HDR IORT Shielded Applicator is designed to act as such a device.
This 510(k) submission for the Mick HDR IORT Shielded Applicator does not contain a study that proves the device meets specific acceptance criteria in the way described in your request (e.g., involving AI performance, human reader improvement, or detailed statistical analysis of performance metrics).
Instead, this document is a premarket notification (510(k)) based on substantial equivalence to previously approved devices. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed predicate devices, and therefore does not require a new premarket approval (PMA). The "study" here is essentially the comparison to predicate devices, demonstrating that the new device shares similar design, materials, intended use, and performance characteristics, and introduces no new issues of safety or effectiveness.
Here's how to interpret the provided information in the context of your questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: The primary acceptance criterion for a 510(k) submission based on substantial equivalence is that the device is as safe and effective as a legally marketed predicate device and does not raise new questions of safety or effectiveness. This is not quantified with specific performance metrics in the way you might see for an AI algorithm study.
- Reported Device Performance: 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."
- The device is designed to function as "accessories/applicators for the positioning of HDR Remote After-Loader scaled sources in the superficial or interoperative treatment of cancer" and provides "a reproducible and predictable geometry for positioning of the radioactive source under remote control."
Since this is a substantial equivalence determination and not a performance study comparing the device to specific clinical outcomes or statistical thresholds, a table like the one you requested cannot be populated from this document. The performance is implicitly "equivalent to predicate devices."
2. Sample size used for the test set and the data provenance
- N/A. No "test set" in the sense of a dataset for evaluating an AI algorithm or a clinical trial for performance metrics is described. The evaluation is based on engineering design, material equivalence, and intended use comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- N/A. Ground truth for a test set is not applicable here as there is no such test set or performance study described. The "ground truth" for this submission is that predicate devices are already considered safe and effective by the FDA.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- N/A. No adjudication method is described because there is no test set or performance study.
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
- No. This document describes a medical device (a radionuclide applicator system), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance is entirely irrelevant and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- N/A. This is a hardware medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" here is the established safety and effectiveness of the predicate devices, as determined by their prior FDA clearance (K-numbers). The current device's safety and effectiveness are established by demonstrating its substantial equivalence to these predicates in terms of design, materials, and intended use.
8. The sample size for the training set
- N/A. As this is not an AI/machine learning device, there is no concept of a "training set."
9. How the ground truth for the training set was established
- N/A. Not applicable for the reasons stated above.
In summary: This document is a regulatory submission demonstrating substantial equivalence for a physical medical device. It does not involve performance studies or evaluations in the manner typically associated with AI or diagnostic imaging devices where your requested criteria would be relevant. The "study" is the comparison to predicate devices.
§ 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.