(106 days)
The Integrated Brachytherapy Unit (IBU) is intended to be used for the visualization, localization and confirmation of the volume and size of the Brachy radiation therapy irradiation field(s), using a fluoroscopic and/or radiographic system. Localization and simulation for Brachy radiation therapy can be performed more effectively on the IBU than on a standard radiation treatment simulator. The additional L-arm allows the user to visualize under many angles easier for the operator than with the predicate device. The IBU will not be used for the simulation of external beam radiation treatments.
The IBU integrated Brachy therapy imaging unit is a localization and simulation device for a radiation therapy department especially for Brachy therapy treatments. It consists of a gantry that supports an L-arm and a C-arm which can rotate isocentrically. The C-arm houses an X-Ray tube housing assembly with collimator on one side and an image intensifier with optional rotatable cassette holder. The movements of the IBU are manually driven, after the relevant electrical locks are lifted. The mobile IBU patient couch has mechanical motions which can be controlled from a hand pendant affixed to the table.
The provided documentation for the Nucletron IBU (K973848) is a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with detailed acceptance criteria and results. Therefore, the document does not contain the specific information requested about acceptance criteria, a study proving device performance against those criteria, sample sizes, expert qualifications, or ground truth establishment.
A 510(k) submission typically compares the new device to a predicate device in terms of technological characteristics and intended use, asserting that any differences do not raise new questions of safety or effectiveness. It does not generally include a prospective clinical trial or a formal performance study against predefined numerical acceptance criteria in the way envisioned by the prompt.
Here's what can be extracted and what information is not present based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in numerical or statistical terms. The acceptance criteria for a 510(k) submission are generally that the device is "substantially equivalent" to predicate devices and does not raise new issues of safety or effectiveness.
- Reported Device Performance: Not provided in terms of specific metrics or quantitative results from a performance study. The document describes the device's technical capabilities and intended use.
2. Sample sized used for the test set and the data provenance
- Not applicable/Not provided. The submission does not describe a performance study with a test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. No test set or ground truth establishment process is described in the context of a performance study.
4. Adjudication method for the test set
- Not applicable/Not provided. No test set or adjudication process 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 applicable/Not provided. This device is an imaging unit (Image-intensified fluoroscopic RT simulation system), not an AI-assisted diagnostic tool. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware imaging device, not an algorithm.
7. The type of ground truth used
- Not applicable/Not provided. No ground truth is established for a performance study. The device is intended for visualization, localization, and confirmation of irradiation fields, implying that its output (images) would be interpreted by clinicians.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware device; there is no mention of a training set as would be found in an AI/machine learning context.
9. How the ground truth for the training set was established
- Not applicable/Not provided.
Summary based on the provided text:
The Nucletron IBU (K973848) is an imaging unit for Brachytherapy simulation. Its premarket notification focused on demonstrating substantial equivalence to existing predicate devices (Nucletron Simulix-HP and Philips Integris). The core "acceptance criteria" for this specific submission type is meeting the FDA's requirements for substantial equivalence, primarily by showing that its intended use and technological characteristics are similar to predicate devices and that any differences do not raise new questions of safety or effectiveness.
The document highlights the following about the device:
- Intended Use: Visualization, localization, and confirmation of volume and size of Brachytherapy irradiation field(s) using fluoroscopic and/or radiographic systems.
- Technological Considerations: Substantially equivalent to predicate devices, allowing visualization under various angles. Features a mobile table for patient preparation in a separate room.
- Standards: Subject to Federal Performance standard 21 CFR 1020.30 and voluntary safety standards like UL 187 and IEC 601. Compliance with these standards would be an implicit "acceptance criterion" for safety and basic functionality.
There is no mention of a clinical performance study with specific quantitative acceptance criteria or results as typically seen for diagnostic algorithms or new treatment modalities requiring efficacy data.
§ 892.5840 Radiation therapy simulation system.
(a)
Identification. A radiation therapy simulation system is a fluoroscopic or radiographic x-ray system intended for use in localizing the volume to be exposed during radiation therapy and confirming the position and size of the therapeutic irradiation field produced. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.