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The Ionization Chamber model 1041 is intended for the purpose of calibrating and measuring the ionizing radiation output from medical radiation therapy machines. This includes beam scanning as well as absolute dose calibration.

The Sun Nuclear model 1041 "SUN125c" is a waterproof, fully-guarded, cylindrical "thimble" type ionization chamber constructed primarily of ABS plastic. The chamber is mounted to a lownoise, high impedance triaxial cable which is terminated with either a bayonet (BNC) or threaded triaxial (TNC) connector. The ionization volume of the chamber is 0.125 cc, which is appropriate for beam scanning and absolute dose measurements. This active volume is vented to the atmosphere through the cable sheath, allowing for conventional air density corrections.

This 510(k) premarket notification describes the Sun 125c Ionization Chamber (model 1041), a medical device intended for calibrating and measuring ionizing radiation output from medical radiation therapy machines, including beam scanning and absolute dose calibration. It does not contain information about studies with patient data, AI/human reader performance, or ground truth establishment in a medical diagnostic context. The submission focuses on device safety and equivalence to a predicate device based on engineering principles and performance specifications.

Here's an analysis based on the provided text, addressing the points where information is available:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly state acceptance criteria in the form of a detailed table or report a study with performance metrics like accuracy, sensitivity, or specificity in a clinical diagnostic context. Instead, the "acceptance criteria" are implied by the comparison to a predicate device and the demonstration of similar functional principles and safety.

The reported "device performance" is primarily characterized by its design specifications and functionalities, as well as its similarity to the predicate.

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

This information is not provided in the document. The submission focuses on the technical specifications and equivalence of the device, not on clinical performance studies involving patient data or a specific "test set" in the context of diagnostic accuracy.

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

This information is not provided as the device is not for diagnostic interpretation of medical data where expert radiologists or similar specialists would establish ground truth.

4. Adjudication Method for the Test Set

This information is not provided as there is no mention of a diagnostic test set requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not performed or mentioned in this submission. This type of study is relevant for diagnostic devices that involve human interpretation of images or data, which is not the primary function of this ionization chamber.

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

No, a standalone algorithm performance study was not performed or mentioned. This device is a physical instrument for measurement, not an AI algorithm.

7. The Type of Ground Truth Used

The concept of "ground truth" in this context is based on established physics principles of radiation dosimetry and metrology. The "truth" is derived from calibrated standards and known physical properties, not from pathology, outcomes data, or expert consensus in a diagnostic sense. The device is validated against the expected physical behavior of an ionization chamber and its ability to measure radiation accurately according to these principles.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This device is a physical instrument, not a machine learning model that requires a "training set."

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

This information is not applicable and not provided for the same reasons as point 8.

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The 3D Scanner system, model 1230, is intended for radiotherapy dosimetry measurements and export of those measurements for commissioning a treatment planning system (TPS) computer. It is also intended for periodic beam quality assurance (QA) tests as defined by the medical physicist responsible for the QA program.

The 3D Scanner Model 1230 is an electromechanical and software system that includes:

1. a cylindrical tank to contain the water:
2. a 3 axis computer controlled scanning mechanism that is mounted on the tank,
3. a field detector mount that moves with the scan mechanism,
4. a reference detector mount that remains stationary during a scan,
5. electrometers with chamber polarization voltage supplies for said mounted detectors,
6. motor controllers for the 3 axis scanning mechanism,
7. a water level sensor that locates the water surface,
8. computer code that controls the detector location and records the detector's dosimetry data,
9. a user interface to the computer that enables
   a. automatic data collection at pre-programmed field detector locations,
   b. data processing and analysis that enable data transfer to the TPS system,
10. an optional EDGE detector (diode) for waterproof Field scanning and Reference
11. an optional leveling platform
12. an optional lift table accessory to support the tank

Here's an analysis of the provided text regarding the 3D Scanner Model 1230, focusing on acceptance criteria and study details.

Important Note: The provided document is a 510(k) Premarket Notification Summary from 2010. For this type of device (a medical physics tool for radiation oncology dosimetry), the "acceptance criteria" and "device performance" are typically related to its ability to accurately measure radiation beams and provide data compatible with treatment planning systems, rather than clinical outcomes on patients. The "study" here refers to the demonstration of substantial equivalence to a predicate device. This is not a clinical trial with patient data or a typical AI/ML study.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" with quantitative targets in the way one might see for, say, an imaging device's sensitivity or specificity. Instead, the substantial equivalence hinges on functional similarity and intended use compared to the predicate device. The "performance" is implicitly demonstrated by comparing the device's capabilities to the predicate.

The core "acceptance criteria" can be inferred from the "Similarities with Marketed Devices" section, which outlines the functional capabilities that make the new device equivalent to the predicate. The "reported device performance" is the statement that the SNC 3D Scanner Model 1230 possesses these same capabilities.

Study Details

This document describes a substantial equivalence submission, not a clinical study in the traditional sense, especially not for an AI/ML device. The "study" is a comparison of the new device to a legally marketed predicate device to demonstrate that it is as safe and effective.

1. Sample size used for the test set and the data provenance:

   • There is no "test set" in the context of patient data or clinical images. The "test" consists of comparing the features and specifications of the SNC 3D Scanner Model 1230 against those of the predicate device (IBA RFA-200) and ensuring the intended use is the same.
   • Data Provenance: The comparison is based on the functional description and intended use of the predicate device, as obtained from IBA literature (manuals, datasheets, system manuals). It does not involve experimental data from the predicate device itself, nor does it specify country of origin for such data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Not applicable in this context. "Ground truth" for this regulatory submission is established by reference to the predicate device's documented functions and specifications, and potentially by widely accepted standards for radiation dosimetry (e.g., AAPM TG-142), rather than expert adjudication of clinical cases.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There is no "test set" of cases requiring adjudication by experts.

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:

   • No MRMC study was done, as this is not an AI/ML diagnostic device with human readers. This device is a measurement tool.

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

   • Not applicable. This is a measurement system, not a standalone algorithm. While its "computer code" controls functions automatically, its performance is evaluated based on its functional equivalence as a dosimetry tool, not as an AI algorithm.

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

   • The "ground truth" for this submission is the functional definition and intended use of the predicate device (IBA RFA-200), as well as the generally accepted principles and guidelines for medical accelerator quality assurance (e.g., AAPM TG-142). The new device is substantially equivalent if it performs the same function in a similar manner for the same intended use.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set. The device's design and engineering are based on established physics and engineering principles for radiation dosimetry.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for an AI/ML model. The "truth" for the development of such a device is rooted in physics and engineering standards for accurately measuring radiation.

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The PC Electrometer Model 1014 is a dosimetry electrometer intended for measuring the output charge of an ion chamber in a radiotherapy beam and using these measurements in dosimetry protocols, such as Report 67 as recommended by the AAPM Task Group #51. . In addition the PC Electrometer Model 1014 is intended for measurements with ion chamber or diode detectors as recommended during periodic QA testing protocols such as Report 46, Comprehensive QA for Radiation Oncology, as recommended by the AAPM Task Group #40. as well as AAPM Report 13 (TG-22, 24 and soon to be published TG-142, an update to TG-40.

The PC Electrometer Model 1014 has two triaxial BNC inputs for connection to ion chambers for dosimetric measurements. The ion chamber voltage bias can be adjusted to various levels at either polarity. For air density correction, there are internal temperature and pressure sensors that measure ambient conditions and an input for an external remote temperature sensor. A USB port provides power and data communication with a Personal Computer (PC) which runs the application software to display and record data; an auxiliary power jack is also provided in case USB power is not available. The conductive enclosure (4cm x 10.5cm x 14cm) provides EMI shielding and LED status indicators. The PC Electrometer Model 1014 is a Radiation Oncology Medical Physics tool used to measure ion current from either ion chambers or diode dosimeter. These applications include periodic or annual calibration of the radiation output of the delivery machine when a calibrated ion chamber is connected such as AAPM Report 67 (TG-51) as well as periodic QA applications that do not require calibrated radiation detectors, such as described in AAPM Report 13 (TG-22, 24), AAPM Report 46 (TG-40) TG-40 and soon to be published TG-142, an update to TG-40.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary for the PC Electrometer Model 1014 does not explicitly state acceptance criteria in a quantitative format, nor does it present device performance data in a dedicated table. Instead, it establishes substantial equivalence to a predicate device (Sun Nuclear Model 1010 Dosimetry Electrometer #K002444) based on functional similarities and intended use. The performance evaluation is implied through the comparison of features and intended applications, demonstrating that the new device is suitable for the same tasks as the predicate.

However, based on the description of the device and its intended use, the implicit acceptance criteria would revolve around its ability to accurately measure the output charge of ion chambers and diode detectors for dosimetry protocols and QA testing in radiation oncology. The reported performance is that it meets the same intended uses and performs similar functions to the predicate device.

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

The provided document is a 510(k) premarket notification summary. For devices of this nature (electrometers not considered imaging AI devices), the "test set" in the context of clinical studies (like those for AI/ML) is not applicable or described in this document. Substantial equivalence for this type of device is typically established through engineering bench testing, performance verification against specifications, and comparison to a predicate device, rather than patient-level data.

• Sample Size for Test Set: Not applicable/not specified in the provided document. The evaluation relies on comparing the device's technical specifications and functionalities to a legally marketed predicate device.
• Data Provenance: Not applicable, as there are no clinical data sets described. The "data" evaluated would be performance metrics gathered during engineering and functional validation, compared to the predicate's known performance and specifications.

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

Not applicable. This device is an electrometer, a measurement tool used in medical physics. Its "ground truth" is defined by physical principles and established measurement standards (e.g., AAPM reports), not by expert interpretation of patient data or images. Therefore, the concept of experts establishing ground truth for a test set in this context is not relevant to the information provided.

4. Adjudication Method for the Test Set

Not applicable. Since there is no "test set" in the context of clinical images or patient data requiring expert ground truth and adjudication, no such method 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

No. The PC Electrometer Model 1014 is a standalone medical physics measurement device, not an AI-powered diagnostic or assistive tool for human readers (e.g., radiologists). Therefore, an MRMC study or an AI assistance evaluation is not relevant to this submission.

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

Yes, in essence, the fundamental evaluation of an electrometer is its "standalone" performance. The device itself (the PC Electrometer Model 1014) is designed to perform its function (measuring charge) independently of real-time human interpretation needing "assistance" from an AI algorithm. Its performance is assessed based on its ability to accurately and reliably measure physical quantities, as demonstrated through engineering testing and comparison to the predicate device's established performance under specified conditions.

7. The Type of Ground Truth Used

The "ground truth" for this type of device is established by physical measurement standards, calibration protocols, and established dosimetry guidelines (e.g., AAPM Report 67, Report 46, Report 13). The device's performance is validated against these accepted physical principles and the known performance of a legally marketed predicate device that also adheres to these standards. It is not based on expert consensus, pathology, or outcomes data in the usual clinical sense.

8. The Sample Size for the Training Set

Not applicable. The device is not an AI/ML algorithm that requires a training set. Its development involves traditional engineering design, manufacturing, and calibration processes.

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

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

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The Profiler 2 is a device that is designed for use as a radiation scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.

Profiler 2 is only used by the radiation therapy professionals, and is not used with the patient. A standard commercial power converter converts the power from the wall outlet voltage (100 to 240 VAC) to 18 VDC. The converter is then connected to a power/data interface (PDI) and then supplies the 18 VDC power to the Profiler 2 through a single 8 pin DIN connector. A standard 9 pin serial connectors connects the PDI to a computer. The commercial power converter and PDI device are fully tested for safety. Therefore, Profiler 2 should not generate a shock hazard to the operator.

The provided text describes a medical device, Profiler 2, which is used to measure beam data in radiotherapy for dose modeling. However, the text does not contain any information regarding acceptance criteria, a study proving the device meets those criteria, or specific performance metrics and their supporting data provenance.

The document is primarily a 510(k) premarket notification approval letter from the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory compliance, safety features, and the intended use of the device.

Therefore, I cannot fulfill your request for the following information based on the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set, sample size, or data provenance is mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No information on ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set details are provided.
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. Profiler 2 is not an AI-based diagnostic tool for human readers; it's a measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. Profiler 2 is a physical device measuring radiation, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no ground truth for a test set is discussed.
8. The sample size for the training set: Not applicable as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable.

The document confirms that "Sun Nuclear has deemed the devices safe and effective for their intended uses as long as they are used in accordance with all of the accompanying labeling and instructions," and "Sun Nuclear believes that responsible design and quality assurance practices were followed during the development and manufacture of Profiler 2 (Model 1174)." However, these are statements of belief and internal assessment, not a description of a study proving specific performance against acceptance criteria.

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The Edge™ Detector is a device that is designed for use as a radiation scanning detector in any water tank scanning system that is used to measure beam data in radiotherapy departments for dose modeling in the treatment planning computer.

The Edge™ detector is a radiation hardened silicon diode. The diode is encapsulated in a rectangular housing made of thin brass sheet. The active dimension of The Edge™ detector is 0.8 x 0.8 mm2. The diode die plane is parallel with the long axis of the detector housing with the center of the die marked by the cross on the top surface. The detector is mounted such that its top surface is parallel to the water surface and perpendicular to the incident radiation beam axis. The Edge™ detector is water-proof.

The Edge™ detector is designed to measure the radiation distribution in a water phantom. Because of its very small active dimension, The Edge™ detector can measure small field beam parameters, such as penumbra and flatness, more accurately than the conventional ionization chamber with larger active dimensions. Therefore, The Edge™ detector is especially useful for beam modeling in radiation therapy techniques involving small field sizes, such as IMRT (Intensity Modulation Radiation Therapy).

The provided document is a 510(k) Premarket Notification Summary for "The Edge™ - Scanning Diode Detector." It describes the device, its intended use, similarities and differences with marketed predicate devices, and a safety summary. However, it does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, ground truth establishment, or comparative effectiveness studies typically associated with AI/ML-based medical devices.

The document is a regulatory submission demonstrating substantial equivalence to predicate devices, focusing on safety and effectiveness for its intended use, rather than a performance study report for predefined acceptance criteria.

Therefore, I cannot provide the requested information in the format specified because the document does not contain it. The content is primarily a descriptive submission for regulatory clearance.

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The Model 1008 (44D as marketed under CNMC) is a well-type, re-entrant ionization chamber intended for measurement of source strength of both clinical HDR and LDR brachytherapy sources and intravascular brachytherapy (IVB) sources. Both types of IVB sources can be measured; those designed to deliver a gamma dose and those designed to deliver a beta dose. The chamber must be calibrated before any measurement of a clinical source takes place. Source strength calculation must be done with the accompanying calibration certificate from the calibration laboratory. The calibration must be performed by an accredited dosimetry calibration laboratory, with the same source type and isotope that is used clinically. The chamber constancy must be monitored after calibration with a proper Measurement Quality Assurance program in order to validate the chamber calibration over a period of time.

The Model 1008 / Model 44D is a well-type re-entrant ionization chamber designed for application with brachytherapy and intravascular brachyterapy source measurement. The chamber is hermetically sealed, there is no air density correction requirement. The fill gas is pure argon at an absolute pressure of 23.5 psi, which provides several distinct benefits. These include enhancing the response at low photon energies from both gamma and Bremsstahlung from beta radiation. higher ion collection efficiency and long term constancy measurements. The Model 1008/44D is fully guarded into the chamber and is equipped with a 1.5 meter low-noise triaxial signal cable terminated with a triaxial collection electrode inside the chamber. When properly connected to a dosimetry electrometer, the chamber housing will be common to the electrometer housing: the collection electrode will be floating with the guard at the chamber bias potential. Therefore, no shock hazard should exist.

This document describes Sun Nuclear Corporation's Model 1008 Re-entrant Chamber / Model 44D Re-entrant Chamber, which is an ionization chamber used for measuring the source strength of brachytherapy and intravascular brachytherapy sources.

The document is a 510(k) summary (K013689) submitted to the FDA, detailing the device's description, intended use, and its substantial equivalence to predicate devices. It does not contain a study that proves the device meets specific acceptance criteria in the format requested.

Therefore, I cannot populate the table or answer the subsequent questions about device performance against acceptance criteria, sample sizes, ground truth establishment, or comparative effectiveness studies.

The information provided focuses on demonstrating substantial equivalence to predicate devices, which is a regulatory pathway for low-to-moderate risk medical devices. This pathway typically relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than providing detailed studies against predefined performance acceptance criteria as might be seen for novel technologies or higher-risk devices requiring PMA.

The document highlights the features of the device which contribute to its safety and effectiveness:

However, these are design features and their intended benefits, not quantitative performance values compared to acceptance criteria. The closest to a "performance" claim is "long term constancy measurements," but no specific metrics or data are provided to quantify this.

In summary, the provided document does not contain the information required to fill out the table or answer the detailed questions about acceptance criteria, study methodology, or performance metrics. It is a regulatory submission focused on substantial equivalence rather than a detailed performance study report.

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The PC Version of the IVD Model 1133 has the same Indications for Use as the rf IVD submitted under K011332 which is quoted here: Sun Nuclear's Model 1133 rf-IVD is a battery operated dosimetry system designed to measure the patient's dose during radiation therapy treatment.

The Sun Nuclear Model 1133 rf-IVD (In-Vivo Dosimetry) is a system that measures the radiation output of a linear accelerator or a radioactive substance such as a Co-60 source, during the treatment of a patient. It has 3 detector inputs per detector pod, with only one detector pod usable at a time. The radiation therapist connects the radiation detectors (diodes) to the Detector Module and then positions them on the patient in order to measure the radiation from the accelerator. The Detector Module communicates with the Base Station by radio frequency communication. The measurement data is then sent through a line to an optically isolated interface, then to the PC. The Detector Module and Base Station are battery powered. The therapist leaves the treatment room. Dose measurement is then remotely started on the rf-IVD from the control room using the PC Software and then the radiation beam is turned on. When the beam turns off, the rf-IVD is stopped and the dose value is displayed. The rf-IVD display value is recorded or printed on an accessory printer. The therapist then enters the room and removes the detector from the patient.

I am unable to provide a description of the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided text does not contain this information.

The document discusses the "Sun Nuclear Model 1133 IVD PC Version" which is a patient radiation dose monitor. It describes its function, intended use, and technological characteristics, and notes its substantial equivalence to a previously marketed device (Model 1133 IVD, K011332). It also lists various safety and operational features and mentions the effectiveness of the tool in radiation oncology departments.

However, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details of any specific study (e.g., sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
• Information about MRMC comparative effectiveness studies or standalone algorithm performance.
• Training set details.

The text is a 510(k) Premarket Notification Summary, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed efficacy or performance studies with specific acceptance criteria that would typically be found in a clinical trial report or a more comprehensive validation study.

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