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The CRC PC Smart Chamber K1 is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure radiopharmaceuticals, including high energy beta and gamma emitters for diagnostic applications. The CRC PC Smart Chamber K1 is intended to be used only with the TEMA Karls 100 radiopharmaceutical dose administration system.

The Capintec CRC PC Smart Family of dose calibrators are sealed, pressurized reentrant well style ionization chambers which use a networked PC as the user interface. The CRC PC Smart Chamber K1 is modified CRC PC Smart Chamber, which has been shortened in height to fit into the Karl 100 Dose Administration System, which is manufactured by TEMA.

This document describes the CRC PC Smart Chamber K1, a radionuclide dose calibrator. The information provided heavily relies on a comparison to a predicate device and states that safety and effectiveness were confirmed through "verification and validation testing." However, it does not provide details about a specific study designed to prove the device meets defined acceptance criteria in the way a clinical study for an AI/CADe device would.

Instead, the submission focuses on demonstrating substantial equivalence by highlighting design similarities with a previously cleared device (CRC-PC Smart Chamber, K141413) and confirming compliance with relevant electrical and safety standards.

Therefore, I cannot populate most of the requested fields as they pertain to a detailed performance study with defined acceptance criteria and human expert evaluation, which is not described in this document.

Here's how I can address the specific points based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state quantitative acceptance criteria or detailed performance metrics from a dedicated study. It generally mentions:

• "Risk assessment confirms that all identified risks were either mitigated or are within acceptable limits."
• "Verification and validation testing confirmed the CRC-PC Smart Chamber K1 meets all stated specifications and functions as expected."

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. No specific test set data is described. The device is a physical instrument, and its performance is likely evaluated through engineering verification and validation against technical specifications, not typically through a "test set" of patient data in the way an AI algorithm might be.

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)

Not applicable. No ground truth establishment by experts for a test set is described.

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

Not applicable. No adjudication 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

Not applicable. This is not an AI/CADe device that assists human readers. It's a dose calibrator for radiopharmaceuticals.

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

Not applicable. This is not an algorithm, but a physical device. Its "standalone" performance would be its accuracy and precision in measuring radioactivity, which is stated to meet "all stated specifications."

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not applicable directly in the context of clinical "ground truth." For a dose calibrator, "ground truth" would be established by reference standards or highly accurate laboratory measurements of radioactivity, which are typically used during calibration and verification processes.

8. The sample size for the training set

Not applicable. This is not a machine learning device that requires a training set.

9. How the ground truth for the training set was established

Not applicable.

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The CRC-77tHR is intended to be used by qualified radiochemists, radiation physicists, or other appropriately trained personnel in isotope production sites to measure a wide range of measure a wide range of high activity radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters. The device is not intended for use with brachytherapy sources. This device is also used in numerous research applications for measurement of high activity levels of radioactive materials.

The Capintec CRC-77tHR is dose calibrator which uses a touch screen user interface and sealed reentrant well chamber as the detector. The gas fill pressure has been lowered in order to extend the maximum activity range for isotope manufacturing and radiopharmaceutical production environments.

The provided document pertains to the FDA 510(k) clearance for the Capintec CRC-77tHR radionuclide dose calibrator. The information details the device's technical specifications and performance data, but it does not describe a study involving AI assistance, human readers, or image-based diagnostics with associated ground truth and expert adjudication methods.

The document outlines a traditional medical device clearance process for a dose calibrator, focusing on:

• Substantial equivalence to a predicate device (CRC-55t Dose Calibrator series).
• Technical specifications, including measurement range, resolution, energy range, electrometer accuracy, linearity, and reproducibility.
• Compliance with electrical safety, electromagnetic compatibility (EMC), and usability standards (e.g., IEC 60601-1, IEC 62304 for software).
• Software verification and validation testing, with a "moderate" level of concern.
• Evaluation at an isotope production site.

Therefore, many of the requested points regarding AI, human-in-the-loop performance, multi-reader multi-case studies, and specific ground truth methodologies for image-based diagnostics are not applicable to this device's clearance information.

However, I can extract and present the acceptance criteria and reported device performance related to the dose calibrator's technical specifications from the provided text.

Acceptance Criteria and Reported Device Performance (CRC-77tHR Radionuclide Dose Calibrator)

The acceptance criteria for this device are primarily tied to its technical specifications and its performance metrics, which demonstrate substantial equivalence to its predicate device (CRC-55t) while operating at a higher activity range.

1. Table of Acceptance Criteria and Reported Device Performance:

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The Veenstra Instruments VDC-506 Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

The Veenstra Instruments VDC-506 Dose Calibrator (VDC-506) is a software application installed on a personal computer (PC) running Windows XP, and is used in conjunction with the Veenstra Instruments VIK-202 ionization chamber (VIK-202) to measure the radioactive strength of radioactive material in vials, syringes and ampoules placed inside the ionization chamber.

The VDC-506 software, in conjunction with the PC, serves as the control mechanism and display for the VIK-202 ionization chamber. The PC on which the VDC-506 software is installed is connected to the VIK-202 ionization chamber using a RS-232 cable.

It is recommended that the PC includes a touchscreen display for convenient navigation within the software; however, a touchscreen is not necessary.

The document provided describes the Veenstra Instruments VDC-506 Dose Calibrator, a radionuclide dose calibrator designed to measure radioactive material. The information focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study proving the device meets specific acceptance criteria in a clinical setting in terms of diagnostic accuracy.

The acceptance criteria provided are primarily related to technical specifications and compliance with electrical safety, electromagnetic compatibility (EMC), and software standards, rather than performance metrics like sensitivity, specificity, or reader improvement in a clinical diagnostic context. The document confirms that the device meets these technical criteria.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Given that the document is a 510(k) submission for a non-diagnostic device, the "acceptance criteria" are predominantly technical specifications and regulatory compliance. The "reported device performance" refers to the device meeting these specifications and complying with relevant standards.

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

The document does not describe a clinical "test set" in the traditional sense of a diagnostic device evaluating patient data. The performance testing conducted was against technical specifications and international standards for radionuclide dose calibrators. Therefore, there is no patient-specific sample size or data provenance (e.g., country of origin, retrospective/prospective) for a clinical test set for diagnostic accuracy.

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

This device is a dose calibrator, not a diagnostic imaging device that requires interpretation by medical experts (like radiologists). Therefore, no experts were used to establish ground truth for a test set in a diagnostic context. The "ground truth" for the device's accuracy would be established by reference standards or highly accurate measurement techniques in a physics or engineering lab setting.

4. Adjudication Method for the Test Set

As there is no clinical "test set" requiring expert interpretation, no adjudication method was employed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically conducted for diagnostic imaging devices to assess the impact of AI on human reader performance. The Veenstra Instruments VDC-506 Dose Calibrator is a measurement device for radioactive materials, not a diagnostic interpretation tool, and it does not involve human-in-the-loop diagnostic tasks.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device itself is a standalone system for measuring radionuclide activity. The "performance testing" described in the document (electrical safety, EMC, software, and general performance testing against standards) is essentially standalone performance evaluation of the device's technical specifications. It's not an "algorithm only" performance in the context of AI diagnostic applications, but rather the performance of the integrated hardware and software system as a whole.

7. The Type of Ground Truth Used

The ground truth used for performance verification would be:

• Reference standards/Calibrated sources: For evaluating the accuracy, linearity, and reproducibility of the dose measurements.
• International standards: For assessing compliance with electrical safety, EMC, and specific performance characteristics for radionuclide calibrators (e.g., IEC 60601-1, IEC 60601-1-2, IEC 61145, IEC 61303).
• Predetermined specifications: Internal specifications set by the manufacturer against which the device's performance is verified.

8. The Sample Size for the Training Set

The document describes a physical device with software, not a machine learning or AI model that requires a "training set" of data in the common sense. The software development and testing follow standard engineering practices. Therefore, there is no "training set sample size" as would be applicable to an AI algorithm.

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

As there is no "training set" for an AI algorithm, this question is not applicable to the VDC-506 Dose Calibrator. The "ground truth" for software robustness and functionality is established through verification and validation activities based on software requirements and design specifications.

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The CRC 55t series, which includes the standard 55tR dose calibrator, reduced pressure chamber (CRC 55tPET) and well counter (CRC55tW), is intended to be used by qualified nuclear medicine technologists, nuclear medicine physicians, and radiopharmacists to measure a wide range of radiopharmaceuticals and radioactive materials, including high energy beta and gamma emitters for diagnostic, therapeutic, or in vitro laboratory tests. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including LDR, HDR, and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions in vitro laboratory test applications. This device is also used in numerous research applications for measurement of radioactive materials.

Capintec's CRC 55t series dose calibrators are designed for measurement of radioactive materials used in nuclear medicine, therapy, laboratory tests, and research applications. The unit is intended for use by trained nuclear medicine technologists, nuclear medicine physicians, radiopharmacists, or medical physicists for diagnostic, in vitro, and therapeutic applications. The CRC 55t series uses the same principles of operation, same basic electronic circuitry, and same detector technology as the predicated device, CRC 25 series. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device. There are no differences in intended use or effectiveness. The 55t replaces the traditional keypad interface with a larger color touch screen display. The CRC 55t provides enhanced user interface features associated with newer touch screen technology. In addition, the CRC 55t provides an expanded MCA for isotope identification. The predicate device contains 6 fixed channels which provides only preliminary information. The CRC 55t includes a 256 channel MCA which permits spectral identification.

The provided text describes a Capintec CRC 55t series dose calibrator, focusing on its features, intended use, and substantial equivalence to a predicate device. However, it does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets such criteria in terms of quantitative performance metrics (e.g., accuracy, precision for dose calibration).

The document is a summary of safety and effectiveness information for a 510(k) premarket notification and an FDA clearance letter. It highlights the device's adherence to various EMC and electrical safety standards, but these are related to electrical and operational safety, not directly to the accuracy or performance of the dose measurement function in a clinical context that would require a ground truth study or human reader evaluations.

Therefore, I cannot provide the requested information. The document focuses on:

• Device Description: The CRC 55t series dose calibrators measure radioactive materials in nuclear medicine, therapy, laboratory tests, and research.
• Technological Equivalence: The 55t series uses the same principles, circuitry, and detector technology as the predicate CRC 25 series.
• Key Differences: The 55t introduces a larger color touchscreen and an expanded 256-channel MCA for isotope identification, replacing the 6 fixed channels of the predicate device.
• Intended Use: For trained nuclear medicine technologists, physicians, radiopharmacists, and medical physicists in diagnostic, in vitro, and therapeutic applications, as well as research.
• Safety and Effectiveness Justification: Enhanced user interface and improved MCA are cited as features that enhance safety and effectiveness.
• Compliance: The device has been tested and approved to various IEC, UL, and CAN/CSA electrical and safety standards for laboratory equipment.

There is no data presented in the document regarding:

• A table of acceptance criteria and reported device performance (quantitative measurements).
• Sample sizes for test sets or data provenance for performance evaluation.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size or methods for establishing ground truth for a training set (as this device is not an AI/ML-based diagnostic algorithm in the way a computer-aided detection system would be).

The FDA's substantial equivalence determination is based on the new device being as safe and effective as a legally marketed predicate device, primarily through technological similarity and adherence to safety standards, rather than a clinical performance study with defined ground truth and statistical endpoints for diagnostic accuracy.

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The Atomlab dose calibrators are used in Nuclear Medicine Departments, clinics and nuclear pharmacies for calibrating radioactive doses for administration to patients. The instrument is used to verify the radioactivity of a radionuclide before administration to the patient.

The Atomlab dose calibrator is comprised of a display unit and one or more connected argon gas filled pressurized jonization chamber detector unit. The calibration for the dose calibrator is contained in the chamber has a callbration certificate with it when it is shipped. Any of the Atomlab 400 and 500 displays can be connected to the chamber and will work correctly with the chamber since the calibration is stored in the chamber.

Based on the provided text, the Atomlab 400 and Atomlab 500 Radionuclide Dose Calibrators are Class II devices used in Nuclear Medicine departments, clinics, and nuclear pharmacies for calibrating radioactive doses. The submission focuses on substantial equivalence to predicate devices rather than establishing novel acceptance criteria through a new clinical study.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state specific quantitative acceptance criteria (e.g., a certain percentage accuracy or linearity range) for the Atomlab 400 and 500. Instead, it relies on demonstrating substantial equivalence to predicate devices and compliance with established performance standards.

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

• Sample Size: Not explicitly stated as a numerical value for "test set" in terms of patient data or a specific number of doses measured. The text mentions "Testing has been done by physicists at Northwestern Memorial Hospital and Stony Brook University Hospital of device accuracy, linearity, constancy, and geometry." This implies a series of tests performed on the physical devices themselves, likely involving multiple measurements of various radionuclides.
• Data Provenance: The testing was conducted at "Northwestern Memorial Hospital and Stony Brook University Hospital." This indicates the data was gathered in a prospective manner, as physicists actively performed tests on the devices. The country of origin for the data is the USA.

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

• Number of Experts: "Physicists" (plural) from Northwestern Memorial Hospital and Stony Brook University Hospital performed the testing. A specific number is not given.
• Qualifications of Experts: They are identified as "physicists." While general "physicist" is mentioned, in the context of nuclear medicine dose calibrators, these would typically be medical physicists with expertise in radiation measurement, quality assurance, and nuclear medicine instrumentation. Their experience level is not specified, but it's implied they are qualified professionals in their field.

4. Adjudication Method for the Test Set:

Not applicable. This was not a study involving human reader interpretation of medical images or data requiring adjudication of subjective findings. The testing described focuses on objective measurements of device performance (accuracy, linearity, constancy, geometry).

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

No, an MRMC comparative effectiveness study was not done. The device is a measurement instrument, not an AI intended to assist human readers in interpreting medical cases. No human-in-the-loop performance or effect size of AI improvement is discussed.

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

Yes, a form of standalone performance assessment was conducted. The "device accuracy, linearity, constancy, and geometry" were tested by independent physicists. This represents the direct, objective performance of the dose calibrator itself, independent of a human interpreting its output for clinical decision-making.

7. The Type of Ground Truth Used:

The ground truth for the device's performance (accuracy, linearity, constancy, geometry) was established through reference standards and established physical principles. For example:

• Accuracy: The device's measurements would be compared against known activities of calibrated radioactive sources (e.g., sources traceable to NIST).
• Linearity: Measurements across a range of activities would be compared to the expected linear response.
• Constancy: Repeat measurements of a stable source over time would confirm consistent readings.
• Geometry: Measurements with the same source in different geometries would be compared to expected values.

These are objective physical measurements, not subjective expert consensus, pathology, or outcomes data in the traditional sense of diagnostic imaging.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical instrument for measurement, not an algorithm trained on a dataset of images or clinical outcomes. There is no "training set" in the context of machine learning. The device's calibration is "contained in the chamber has a calibration certificate with it when it is shipped."

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

Not applicable, as there is no training set for this type of device. The accuracy of the device is inherent in its design, manufacturing ("manufactured to the product's specifications"), and initial calibration, which is "contained in the chamber" and comes with a "calibration certificate." Further verification is done by users or physicists upon installation through acceptance testing.

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The CRC 25R dose calibrator, which includes optional well counter (CRC 25W) or reduced pressure chamber (CRC 25PET), is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high energy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR. LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.

The Capintec CRC 25 series is a reduced feature version of the CRC 15Ultra. The CRC 25 series uses the same basic hardware, and same detectors as the CRC 15 Ultra, but does not provide the ability to use multiple chambers, nor does the CRC 25 support the addition of a beta counter. The basic detection, measurement process, design concepts, functionality, calculations, algorithms, and response remain the same as the predicate device.

This document is a 510(k) premarket notification for the Capintec CRC 25 series radionuclide dose calibrator. It details the device's substantial equivalence to a predicate device (CRC 15Ultra) and its compliance with safety standards, but it does not contain any information regarding acceptance criteria or the results of a study designed to prove the device meets those criteria.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval and substantial equivalence based on existing hardware and concepts, rather than presenting a performance study with detailed acceptance criteria and results.

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The CRC 15Ultra multiple chamber dose calibrator, which includes optional beta counter and well counter, is intended to be used by qualified nuclear medicine technologists to measure a wide range radiopharmaceuticals, including high mergy beta and gamma emitters. It is also designed for use by trained medical physicists to measure the output of most radioactive brachytherapy sources, including HDR, LDR and IVBT sources. All brachytherapy sources must be measured in the appropriate source holder. The well counter is designed for measurement of low activity radioactive sources or solutions, including laboratory test applications. This device is used in numerous research applications for measurement of radioactive materials.

The Capintec CRC 15Ultra is a multiple detector system, which may include up to eight sealed pressurized re-entrant well chambers, plus a high energy beta counter, and a well counter. The CRC 15Ultra combines the features of several well established Capintec models: CRC 35R, CRC 15R, Beta Counter, and Caprac R Counter into one unit with flexible configurations which are field upgradeable. The 15Ultra incorporates enhanced electronic circuitry and faster microprocessor capabilities, which extends it capability to network eight ionization chambers, as did the CRC 35R. However, the CRC 15Ultra can also add the detector assembly from the Beta C Counter, or the detector assembly from the Caprac R Well Counter, to the same universal readout. The basic design concepts, functionality, calculations, algorithms, and response are the same.

This document is a 510(k) summary for the Capintec CRC 15Ultra. It does not contain information about the acceptance criteria and a study proving the device meets those criteria. The document is primarily focused on demonstrating substantial equivalence to predicate devices and lists applicable safety standards.

Therefore, I cannot fulfill your request for information on acceptance criteria and studies demonstrating device performance based on the provided text.

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PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples. It is intended to assay vials, syringes, and mainly capsules before administration to patients, by measuring the residual of radiopharmaceutical in vials, the activity of the injectable in syringes, the activity of capsules before they are administered to patients, etc. The best applications of PET-Dose are activity measurements of beta emitters used in PET diagnostics such as. 18F, 12N, 150, etc.

PET-Dose is best fitted for use in nuclear medicine departments and, particularly, in PET centers.

PET-Dose is a radionuclide dose calibrator designed to measure the amount of radioactity in vials, syringes, and in any other user-defined geometry samples.

I am sorry, but the provided text is a 510(k) clearance letter for the PET-Dose device. It confirms that the device has been cleared by the FDA as substantially equivalent to a predicate device.

However, this document:

• Does not contain detailed information about the acceptance criteria used in a study to validate the device's performance.
• Does not describe a specific study (like a clinical trial or performance study) that proves the device meets any acceptance criteria.
• Does not provide data on sample sizes, ground truth establishment, expert qualifications, or MRMC study results.

Therefore, I cannot extract the information required to populate the table and answer the specific questions about the device's performance study from this document.

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The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. It is used to measure the amount of activity used to prepare radiopharmaceutical kits, measure the activity in syringes of radiopharmaceuticals prior to injection and to quantify the activity remaining in the syringe following injection. It is indicated for use in the preparation of radiopharmaceuticals and verification of the activity prior to patient administration.

The Mark VI Dose Calibrator is designed to measure the amount of radioactive material in vials, syringes and capsules. Data related to the factory calibration is stored in the chamber. This standardizes the response of each ion chamber, allowing each chamber to report the same amount of electric current for the same radiation source. The isotopic calibration factors are stored in the control/readout unit. The ion chamber current is processed using the isotopic calibration factors stored in the control unit in order to determine the amount of radioactive material present.

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter from the FDA for a radionuclide dose calibrator. It confirms that the device is substantially equivalent to a legally marketed predicate device but does not detail acceptance criteria, study methodologies, sample sizes, expert qualifications, or ground truth establishment.

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The CRC 15BT dose calibrator is intended to be used by trained medical physicists, or qualified technologists to measure the activity or output of radioactive brachytherapy sources, including HDR, LDR and IVBT sources.

The CRC 15BT dose calibrator is a well type ionization chamber specifically designed to accurately and rapidly measure all types of brachytherapy sources with appropriate calibration and source positioning device. The ionization chamber is connected to a readout, which converts measured current into a displayed value in units of either Ci (activity) or U (air kerma strength). The unit is sealed and pressurized with UPC Argon. which improves sensitivity and eliminates the need for temperature and pressure corrections.

Based on the provided text, the device in question is the Capintec CRC 15BT calibrator, a radionuclide dose calibrator. The document is a 510(k) submission review with an acceptance letter from the FDA. This type of document typically focuses on establishing "substantial equivalence" to a predicate device rather than detailing specific acceptance criteria and performance studies in the way a clinical trial might for a new drug or an AI-powered diagnostic device.

Therefore, much of the requested information (related to AI algorithms, test sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance) is not applicable to this device and this type of regulatory submission. The CRC 15BT is a physical medical device for measuring radioactive sources, not a software-based diagnostic tool with AI components.

However, I can extract the relevant information regarding the device's validation and "acceptance criteria" as described in the document, framed within the context of a 510(k) submission for a physical device.

Here's the breakdown of what can be synthesized from the text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not explicitly stated in terms of a specific number of brachytherapy sources tested. The evaluation was done by the University of Wisconsin ADCL, implying a testing protocol was followed, but the "sample size" of sources is not quantified.
• Data Provenance: The testing was carried out by the University of Wisconsin ADCL (Accredited Dosimetry Calibration Laboratory), an independent, accredited laboratory. This indicates an objective, third-party evaluation. The data would be prospective testing data, specifically for the CRC 15BT.

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

• Not Applicable in the AI/Diagnostic Sense. For a dose calibrator, "ground truth" is typically established by physical standards and reference measurements, often against primary standards maintained by national metrology institutes or through cross-calibration with other precisely calibrated instruments. The University of Wisconsin ADCL is accredited for dosimetry calibration, indicating they possess the expertise and equipment to establish accurate reference measurements for brachytherapy sources. The text doesn't mention "experts" in the context of subjective interpretation like radiologists, but rather a specialized laboratory performing objective measurements.

4. Adjudication method for the test set

• Not Applicable. This concept is for subjective interpretations/diagnoses (e.g., by human readers in an AI study). For a physical measurement device like a dose calibrator, the "adjudication" is the verification of the calibration and measurement accuracy against established physical standards by the ADCL.

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. This is a physical device, not an AI software requiring human reader interaction or augmentation.

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

• Not Applicable / Interpreted Differently. The device is standalone in its operation of measuring radiation. It's a sensor system that performs its function without human interpretation of its core measurement (though humans operate it and use its output). There is no "algorithm" in the AI sense.

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

• For the CRC 15BT, the "ground truth" for its performance would be physical measurement standards and reference sources with known activities or air kerma strengths, established and traceable to national or international primary standards. The University of Wisconsin ADCL's role is to ensure the calibrator accurately measures these known quantities.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device 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, this question is irrelevant.

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