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OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.

The Scanditronix & Wellhöfer OmniDos is a General Dosimetry System similar to Wellhöfer Dosimetrie: WP700, FDA K945321/S1, 1995, 29th of March. Scanditronix Medical: RFA-300, FDA K934303/S1, 510(k) Aug 1994, Scanditronix Medical: RFA-300, LDA Utility, FDA K961400: Jan. 1997. OmniDos and the marketed predicated products are radiotherapy quality assurance measuring devices designed to measure dose distribution. Using appropriate detectors and servo/scanners, the dose distribution can be accurately measured to provide acceptance testing, beam tuning, routine beam verifications, isodose tracking and linear scans. These devices are designed to function in conjunction with a PC, which controls the relative position of the detectors while measuring and storing dose information of the radiotherapy beam. Each device is designed to provide two or more channels from electrometers which have their results converted into digital information for storage, display, or transfer to other systems for radiation therapy treatment planning using data formats suitable for the other system. Depending on configuration the devices offer several options for use of the detector system, including film scanning, TMR measurements, and other options.

The provided text describes the Scanditronix Medical AB OmniDos General Dosimetry System, a device for measuring radiation dose distribution in radiotherapy quality assurance.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or specific performance metrics in a tabular format. Instead, it relies on demonstrating equivalence to predicate devices and adherence to relevant standards.

2. Sample Size Used for the Test Set and Data Provenance

The document refers to "final tests" performed on the "whole system consisting of software and hardware." However, it does not specify the sample size for these tests (e.g., number of measurements, number of devices tested).

• Sample Size: Not specified.
• Data Provenance: The tests are described as "Non-Clinical tests" and performed by the manufacturer ("Scanditronix Medical and its sister company Wellhöfer Dosimetrie GmbH"). The origin of the data (country) is not explicitly stated beyond the company's location in Sweden. It is presumably prospective testing conducted by the manufacturer for regulatory submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the device is for quality assurance measurement, not diagnostic interpretation. The testing involved comparing operational characteristics and adherence to technical standards, not expert-derived ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable as the testing did not involve human interpretation or subjective assessments requiring adjudication. The performance was assessed against objective characteristics and technical standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a measurement system, not an AI-assisted diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

The evaluation described is essentially a standalone performance assessment of the system (software + hardware) against its intended function and established technical standards. There isn't an "algorithm only" component separate from the hardware in the context of this dosimetry system. The "Non-Clinical tests" section details this standalone evaluation of the system's operational characteristics, electrical safety, and electromagnetic compatibility.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation was based on:

• Predicate device performance: The OmniDos system was compared to and declared "similar" or "as well as or better than" previously released predicate devices (WP700, RFA-300, RFA-300 with LDA Utility).
• Established industry practice and standards: Adherence to "recognized and established industry practice" for electrical hazards, and conformance with IEC 601-1 (electrical isolation, leakage current), CSA, UL (electrical performance), and IEC 601-1-2 (electromagnetic compatibility) standards.
• Intended use fulfillment: The device's ability to accurately measure dose distribution for quality assurance, calibration, input to treatment planning systems, acceptance testing, beam tuning, and research.

8. Sample Size for the Training Set

This is not applicable. The OmniDos is a dosimetry system, not an AI/machine learning model that requires a training set in the conventional sense. Its "training" would be inherent in its design and engineering based on physics and metrology principles, rather than data-driven machine learning.

9. How the Ground Truth for the Training Set Was Established

This is not applicable for the same reasons as #8. The "ground truth" for its development would be the fundamental principles of radiation dosimetry and engineering standards, not a labeled dataset for a machine learning algorithm.

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The DPD-12PC Direct Patient Dosemeter is used

• to monitor radiation dosage to a patient during radiotherapy procedure
• for quality control measurements of therapeutic radiation devices

The Scanditronix Medical DPD-12PC, Direct Patient Dosemeter is a device modification of DPD-3, Direct Patient Dosemeter, FDA K9420921, 510(k) July 1994 used for In Vivo Dosimetry in radiation therapy. It consists of a 12 channel electrometer, display unit (personal computer) semiconductor detectors, detector support, extension cable, communication cable.

The provided text describes a 510(k) summary for the DPD-12PC Direct Patient Dosemeter. According to the document, the device is a modification of a predicate device (DPD-3 and DPD-510) and is intended for in-vivo dosimetry in radiation therapy and quality control measurements of therapeutic radiation devices.

Here's an analysis of the acceptance criteria and the study as described:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a numerical or statistical format, nor does it provide specific reported device performance metrics against such criteria. Instead, it relies on a comparison to a predicate device and compliance with established standards.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not describe a "test set" in the context of clinical data or patient samples. The tests performed were non-clinical, focusing on engineering specifications and comparison to a predicate device. Therefore, information about sample size for a test set and data provenance (country of origin, retrospective/prospective) is not applicable or provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:

No ground truth established by experts for a test set is mentioned, as no clinical testing or performance evaluation against specific clinical outcomes was conducted. The evaluation primarily relied on engineering standards and comparison with a predicate device.

4. Adjudication Method for the Test Set:

Not applicable, as no test set requiring expert adjudication for ground truth was used.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the fact that the system is a quality assurance device in radiation treatment (In Vivo Dosimetry) not directly involved in the delivery of the treatment radiation, no clinical testing was performed."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

The device is not an algorithm or AI system. It is a physical medical device (direct patient dosemeter). Therefore, the concept of "standalone performance" in the context of an algorithm is not applicable. The device's performance was evaluated through non-clinical technical tests comparing it to its predicate.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical tests was adherence to established industry practices, international standards (IEC 601-1, IEC 601-2-9, IEC 601-1-2), and observed operational characteristics of a legally marketed predicate device (DPD-3). There was no ground truth derived from expert consensus, pathology, or outcomes data as no clinical testing was performed.

8. The Sample Size for the Training Set:

Not applicable. The device is not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set for this type of device.

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The Scanditronix Medical RFA-300, LDA Utility is used to more effectively perform radiation therapy beam measurements including acceptance testing, trimming information, routine beam checks and quality assurance measurements and on-line data analyses using personal computer (PC) monitor. These uses are similar to those of the predicate identified in section (3) of this Summary.

The Scanditronix Medical RFA-300, LDA Utility is an extension to the RFA-300 system used to measure radiation therapy beam intensity. For use, a complete RFA-300 system is needed extended with the following equipment:

1. Multichannel electrometers emX which provides 12 independent electrometer channels each or a DPD-510 which provides 10 independent electrometer channels.
2. Linear Detector Array LDA-11 (11 detectors) or LDA-25 (25 detectors).
3. PC-based software providing control, display, calibration and save functions.

This is a summary of the acceptance criteria and study details for the Scanditronix Medical RFA-300, LDA Utility:

Acceptance Criteria and Device Performance

Study Details

1. Sample Size used for the test set and the data provenance: Not applicable. The device is for radiation therapy beam measurements, not for patient data analysis. The testing involved comparing operational characteristics and adherence to engineering standards.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for this type of device (a measurement tool) is established through engineering standards, comparative performance against predicate devices, and adherence to regulatory compliance. No mention of human expert panel for ground truth assessment in the context of diagnostic interpretation.
3. Adjudication method for the test set: Not applicable. This document describes testing against engineering standards and comparison with predicate device performance, not a diagnostic adjudication process.
4. 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. This is not an AI-assisted diagnostic device. It's a measurement tool for radiation therapy.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The device itself is standalone in its function for measuring radiation beams. The "human-in-the-loop" involves a technician operating the system and interpreting the measurements as part of a larger radiation therapy quality assurance process. The document primarily focuses on the device's technical specifications and performance against established benchmarks without human involvement in evaluating its output for a diagnostic decision.
6. The type of ground truth used:
   • Engineering Standards: IEC 601-1, CSA, UL certifications for electrical safety and performance.
   • Accelerator Performance Standards: IEC-601C for measurement and data processing capabilities.
   • Electromagnetic Compatibility Standards: IEC 601-1-2.
   • Comparative Performance: Against identified predicate devices (RFA-300, Wellhöfer WP600, Wellhöfer MDA) regarding operational characteristics.
7. The sample size for the training set: Not applicable. This device is a measurement instrument, not a machine learning or AI system that requires a "training set" in the conventional sense.
8. How the ground truth for the training set was established: Not applicable, for the reason stated above.

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