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This device provides integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy. The diodes produce a current directly proportional to the ionizing radiation to which they are exposed. The diodes are connected to this readout device. The purpose of the combination of the diodes and this product are to measure ionizing radiation independently at various points of interest. The VeriDose V is intended for use by persons responsible for the proper interpretation of its readings and observing the appropiate safety procedures in the presence of radiation.

The Veridose V (Five) - Model Number 37-705 is used to provide integrated dose and dose rate readout capabilities for radiation sensing diodes when used for patient dose verification or quality assurance in radiation therapy.

The product is a five channel diode dosimeter. The device will measure and display real time dose rate or integrated dose on up to 5 diodes simultaneously. The features include a keyboard, an ON / OFF switch, a power input connector (12VDC), 5 BNC connectors for diode inputs, a RS-232 connector, and a parallel printer port connector. Up to 21 sets of calibration data can be acquired, stored, and selected for use. Calibration and patient data is transmitted to a printer or the RS-232 port.

The provided text describes a medical device called "Veridose V (five), Model number 37-705," which is a five-channel diode dosimeter. It measures and displays real-time dose rate or integrated dose using radiation-sensing diodes for patient dose verification or quality assurance in radiation therapy.

However, the document is a Premarket Notification [510(k)] Summary, which is a submission to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This type of document does not typically contain detailed studies with acceptance criteria, sample sizes, expert ground truth, or adjudication methods in the way that would be found in a clinical trial report or a comprehensive validation study.

Instead, the document focuses on comparing the new device's specifications to those of a predicate device to establish substantial equivalence.

Based on the provided information, here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table between the "Veridose V" and its predicate device ("Model 526"). While it doesn't explicitly state "acceptance criteria," the comparison implies that the Veridose V should meet or exceed the performance of the predicate device for various specifications.

Study Proving Acceptance Criteria:

The document explicitly states: "The VeriDose V and the predicate device are technologically the same. Both are based on a multi-channel electrometer designed to measure the charge provided by a variety of diode detectors. Both devices convert this charge to a dose or dose rate value."

Further, it asserts, "These differences [referring to the VeriDose V having more channels and an RS232 interface], while providing additional capability, do not degrade performance of the device."

The "study" proving the device meets the (implied) acceptance criteria is the demonstration of substantial equivalence to the predicate device, Model 526 (K912249/A). This is a regulatory pathway, not a detailed technical performance study in the way one might expect for a new diagnostic or AI device. The comparison table itself serves as the primary evidence provided in this document to show how the VeriDose V meets or exceeds the predicate's performance.

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

• Sample Size for Test Set: This information is not provided in the document. The filing focuses on a comparison of specifications and intended use, not a clinical or performance study with a 'test set' of data.
• Data Provenance: This information is not provided. The document describes the device's technical specifications and how it compares to a predicate, not where performance data was collected.

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

• This information is not applicable and not provided. The device is a measurement tool (dosimeter), not an interpretive device like an AI for image analysis where expert ground truth is typically established for a test set. The factory calibration procedure is described, but it doesn't involve multiple experts establishing ground truth for performance testing.

4. Adjudication Method for the Test Set:

• This information is not applicable and not provided. As explained above, this isn't a study involving human interpretation that would require adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• This information is not applicable and not provided. MRMC studies are typically for evaluating the impact of AI on human reader performance in diagnostic tasks. The VeriDose V is a direct measurement device and does not involve human interpretation in the same way.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• This information is not directly applicable in the context of an "algorithm-only" study for an AI device. The VeriDose V itself is a standalone device that performs measurements. Its performance is characterized by its accuracy, reproducibility, and other specifications listed in the table, independently of human interpretation of the raw electrical signals from the diodes. The "study" done is the establishment of its specifications and comparison to the predicate.

7. The Type of Ground Truth Used:

• For the device's inherent function, the ground truth is established through physical standards and calibration. The document mentions: "Factory calibration of the product is limited to calibration of each of the five channels with a current source to a nominal 2 nC = 1 cGy." For user calibration, "The diodes are exposed to a known quantity of radiation and the charge acquired. The actual radiation exposure will be entered by the user." This indicates that a known, precisely measured radiation exposure acts as the "ground truth" for calibration.

8. The Sample Size for the Training Set:

• This information is not applicable and not provided. These terms (training set, test set, validation set) are typically used for machine learning or AI models. The VeriDose V is an electronic measurement device; it is not "trained" on data in that sense.

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

• This information is not applicable and not provided, for the same reasons as #8.

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