(206 days)
EZFluence is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields.
The EZFluence device (model RADEZ) is software is intended to assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields. Inputs are obtained from plan and patient data obtained from the Eclipse Treatment Planning System (also referred to as Eclipse TPS) of Varian Medical Systems. EZFluence runs as a dynamic link library (DLL) plugin to Varian Eclipse. It is designed to run on the Windows Operating System. EZFluence performs calculations on the plan obtained from Eclipse TPS (Version 13.5 (K141283) and Version 13.7 (K152393)) which is a software device used by trained medical professionals to design and simulate radiation therapy treatment plans for malignant or benign diseases.
The document provided discusses the EZFluence device, a software intended to assist radiation treatment planning professionals. However, it does not contain specific details about acceptance criteria, reported device performance figures (like sensitivity, specificity, or accuracy), sample sizes for test or training sets, data provenance, the number or qualifications of experts, ground truth establishment, or any MRMC studies.
The document primarily focuses on establishing substantial equivalence to a predicate device (Eclipse Treatment Planning System) based on similar indications for use and technological characteristics. It mentions that "Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements," but it does not elaborate on these criteria or the results.
Therefore, based solely on the provided text, I cannot generate a table of acceptance criteria and reported performance, nor can I answer many of the specific questions about the study design and results, as this information is not present in the excerpt.
Here's what I can extract and what's missing:
Inability to Fulfill Request Due to Lack of Information
The provided document (K171352) is a 510(k) summary for the EZFluence device. While it describes the device's intended use and compares it to a predicate device, it does not contain the detailed performance data, acceptance criteria, sample sizes, expert qualifications, or ground truth methodology that would be required to answer the questions in the prompt.
The document explicitly states under "5.7 Performance Data": "As with the Predicate Device, no clinical trials were performed for EZFluence. Verification tests were performed to ensure that the software works as intended and pass/fail criteria were used to verify requirements." However, it does not provide the specific "pass/fail criteria" or the results of these "verification tests."
Therefore, I cannot construct the requested table or provide answers to most of the specific questions.
What can be inferred or directly stated from the document:
- Device Name: EZFluence
- Intended Use: To assist radiation treatment planning professionals in generating optimal fluences for producing a homogeneous dose distribution in external beam radiation therapy treatment plans consisting of photon treatment fields. (Section 5.5)
- Regulatory Class: Class II (Section 5.2)
- Predicate Device: Eclipse Treatment Planning System (K152393) (Section 5.3)
- Study Type: Verification tests were performed; no clinical trials were performed. (Section 5.7)
- Performance Metrics Reported: None explicitly stated (e.g., no sensitivity, specificity, accuracy, or any quantitative metric of "optimal fluence" or "homogeneous dose distribution" quality).
Missing Information (Cannot be answered from the provided text):
- A table of acceptance criteria and the reported device performance: This information is not present. The document mentions "pass/fail criteria were used to verify requirements" but does not detail them or the results.
- Sample sizes used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: The document explicitly states "no clinical trials were performed for EZFluence," suggesting no such MRMC study was conducted. The device is also described as assisting professionals, not as an AI-driven diagnostic tool for human readers in the typical MRMC context.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly detailed. The "verification tests" mentioned are likely standalone software tests, but no performance metrics are given.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
Conclusion based on provided text: The document serves as a regulatory submission demonstrating substantial equivalence rather than a detailed scientific study report detailing performance metrics and validation methodologies.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.