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The 2 Basic is intended to be used by trained medical physicist to measure the radiation output from radiation therapy machines for verification of patient treatment plan, quality assurance, or beam characteristics. It is not intended to function as a primary calibration device. The 2 Basic can be used in direct surface contact with patients or in a phantom material.

The 2 Basic is a solid state diode detector system coupled with a precision electrometer and PC for radiation measurement, data storage and display. It is intended to be used by trained medical physicists for the measurement of radiation output from radiation therapy treatment machines. The 2 Basic can be used with direct patient contact for entrance skin measurements, or in air, water, or other suitable phantoms materials for beam output measurements.

Measurement data is used to verify and document the beam characteristics of radiation therapy treatment machines for quality assurance programs and to very therapeutic doses delivered to patients during treatments.

The Capintec 2 Basic system consists of 2 diode detectors permanently attached to a precision electrometer and application software. The detectors are solid state silicon diodes with a hemispherical shape optimized for direct patient contact. They provide high sensitivity, excellent linearity, and uniform output vs. gantry angle. The diodes are completely water resistant and enclosed in biocompatible molded epoxy. The high precision electrometer measures the current from the detector and converts the value into a displayed dose and provides automatic zero compensation. Application software controls the system and stores measurement data for each detector, and associated beam parameters such as energy, MU, and patient demographic data. Data can be stored on the PC or printed for hard copy record. Customer must supply a UL recognized PC to be used with application software.

This document is a 510(k) premarket notification for the Capintec 2 Basic device. It primarily focuses on the device's substantial equivalence to predicate devices and its intended use, rather than detailed performance study results against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and study data is not present in the provided text.

Based on the provided text, here's what can be extracted:

Acceptance Criteria and Reported Device Performance:

The document broadly states that "The risk analysis, safety testing and verification and validation testing has addressed patient contact hazards, software hazards, and operator hazards and concluded that the unit is safe and fully meets the intended use and stated specifications of the product." However, specific numerical acceptance criteria for performance metrics (e.g., accuracy, precision) and their corresponding reported device performance values are not provided in this summary.

The document lists the following relevant standards, which would typically contain performance requirements that the device aims to meet:

• Medical Electrical Equipment, Part 1 General Requirements - UL2601-1:2nd
• Medical Electrical Equipment, Part 1 General Requirements - IEC60601-1:
• Collateral standard: Electromagnetic Compatibility-IEC 60601-1-2
• Medical Electrical Equipment, Part 1 General Requirements for Safety
• Medical Electrical Equipment, Part 1 General Requirements-Can/CSA C22.2 No.606101-M90
• Medical Electrical Systems-IEC 606601-1-1:1993+A1
• IEC 60601-2-9 Patient Contact Dosimeters Used in Radiation Therapy with Electrically Connected Radiation Detectors.

Sample sizes used for the test set and data provenance:

This information is not provided in the document. The document refers to "verification and validation testing" but does not detail the specifics of such testing, including sample size or data provenance.

Number of experts used to establish the ground truth for the test set and their qualifications:

This information is not provided in the document.

Adjudication method for the test set:

This information is not provided in the document.

If a multi-reader multi-case (MRMC) comparative effectiveness study was done:

This information is not provided in the document. The device is a measurement system, not typically one that involves human readers interpreting diagnostic images for which an MRMC study would be conducted.

If a standalone study (i.e. algorithm only without human-in-the-loop performance) was done:

The document refers to "verification and validation testing," which would imply standalone performance testing of the device. However, the details of such a study (e.g., specific metrics, results, sample size) are not provided. The device consists of "2 diode detectors permanently attached to a precision electrometer and application software" and measures current to convert it into a displayed dose. This is an automated measurement system, so its performance is inherently "standalone."

The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Given the device's function to "measure the radiation output from radiation therapy machines," the ground truth would typically be established by highly accurate primary calibration standards or reference dosimetry systems. However, the specific type of ground truth used in their testing is not explicitly stated in the provided text.

The sample size for the training set:

This information is not provided in the document. The term "training set" is usually associated with machine learning models. While the device includes "application software," the document does not suggest an AI or machine learning component that would require a distinct "training set" in the conventional sense.

How the ground truth for the training set was established:

As the existence of a "training set" for an AI model is not indicated, this information is not applicable or not provided.

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