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The Mini Gamma Camera MGC-500 is indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC-500 may also be used intraoperatively if a protective sheath is used.

The Mini Gamma Camera, MGC500, is a nuclear medical imager (commonly known as a scintillation or gamma camera) that is smaller, lighter and more portable than the existing gamma cameras. The MGC500 is intended for use in nuclear medicine procedures, including intraoperative procedures. To collect such information, it extracorporeally detects and visualizes the gamma ray emitted from an administered radiopharmaceutical. While previous gamma cameras have consisted of a sodium iodide scintillating crystal and photomultiplier tube (PMT), the design of the MGC-500 incorporates a solid-state CdTe semiconductor detector. This allows the device to be smaller, lighter, and more portable.

The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or most of the requested parameters related to study design (sample size, expert qualifications, adjudication, MRMC, standalone performance, ground truth details, or training set information).

The text is a 510(k) summary for a Mini Gamma Camera (MGC-500) and primarily focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with general safety and performance standards.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

• Acceptance Criteria: Not explicitly stated as quantifiable metrics. The text generally refers to meeting "specifications of the NEMA Performance Standard for scintillation cameras" and "requirements of the IEC-60601-1 for electrical safety" as the basis for performance validation. These are industry standards, not specific numerical acceptance criteria for a clinical study.
• Reported Device Performance: No specific numerical performance data (e.g., sensitivity, specificity, accuracy, image quality metrics) is provided in the document. The submission states that "The performance data and descriptions in this submission will demonstrate that the MGC-500 is substantially equivalent to the predicate devices," but these data are not included in the provided summary.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned.

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

• Not mentioned.

4. Adjudication method for the test set

• Not mentioned.

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 mentioned. This device is a gamma camera, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance would not be applicable here.

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

• Not mentioned. The device itself is a standalone imaging system, but "standalone performance" in the context of AI usually refers to the algorithm's performance without human intervention, which is not applicable here. The device's performance would be inherent to its operation as an imaging system.

7. The type of ground truth used

• Not mentioned. Given it's an imaging device, ground truth for performance studies typically involves physical phantoms, clinical studies with confirmed diagnoses (e.g., pathology, surgical findings), or comparison to a gold standard imaging modality. However, the document does not specify.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning system that requires a training set.

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

• Not applicable. This device is not an AI/machine learning system that requires a training set.

Summary of available information:
The document (K040587) states that the MGC-500 was "tested to the specifications of the NEMA Performance Standard for scintillation cameras" and "the requirements of the IEC-60601-1 for electrical safety." It claims that "performance data and descriptions in this submission will demonstrate that the MGC-500 is substantially equivalent to the predicate devices." However, these specific performance data, acceptance criteria metrics, and details of any clinical or technical study beyond compliance testing are not included in the provided 510(k) Summary. The submission aims to demonstrate substantial equivalence based on technical characteristics and adherence to existing standards, rather than providing detailed clinical performance study results against specific acceptance criteria.

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