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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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