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The Mini Gamma Camera MGC500-101U and MGC500-301U are indicated for use in imaging the distribution of radionuclides in the human body using planer imaging techniques. The MGC500-101U and MGC500-301U may also be used intraoperatively if a protective sheath is used.

The Mini Gamma Camera MGC500-101U and MGC500-301U , are nuclear medical imagers (commonly known as a scintillation or gamma camera) that are smaller, lighter and more portable than most existing gamma cameras. The MGC500-101U and MGC500-301U are 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 MGC500-101U and MGC500-301U incorporate solid-state CdTe semiconductor detectors. This allows the device to be smaller, lighter, and more portable. Both of the modified models have a new high-uniformity mode and the Model MGC500-301U has been reconfigured into a more compact design.

The provided 510(k) summary for the Mini Gamma Camera MGC500-101U and MGC500-301U does not contain specific acceptance criteria or an explicit study that proves the device meets such criteria in terms of a quantifiable performance metric (e.g., sensitivity, specificity, accuracy) compared to a gold standard or a statistically significant improvement over a predicate.

Instead, the submission focuses on demonstrating substantial equivalence to a previously cleared predicate device (MGC500, K040587). This typically means showing that the new device has the same intended use, the same technological characteristics, and raises no new questions of safety or effectiveness.

Here's an analysis based on the provided text, addressing your points where possible:

Acceptance Criteria and Device Performance

The document does not specify quantitative acceptance criteria or reported device performance in terms of clinical metrics (e.g., diagnostic accuracy, sensitivity, specificity). The primary "acceptance criteria" here is substantial equivalence to the predicate device, meaning it performs similarly and safely for its intended use.

However, the submission mentions compliance with performance standards and safety regulations:

Study Details

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

   • The document does not specify a sample size for a test set in the context of clinical performance evaluation (e.g., number of patients or images).
   • The testing primarily involved compliance with industry standards (NEMA, IEC) and verification/validation activities, not a clinical study on a patient cohort.
   • Data provenance is not directly relevant here as it's not a clinical performance study with patient data.

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

   • Not applicable. There is no mention of a test set with ground truth established by experts for diagnostic performance evaluation. The device's performance was assessed against engineering and imaging standards, not clinical diagnostic accuracy.

3. Adjudication Method for the Test Set:

   • Not applicable. There was no clinical test set requiring adjudication of ground truth.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. An MRMC study was not conducted or reported in this submission. This type of study would typically be used to assess the impact of an AI algorithm on human reader performance, which is not the focus of this 510(k).

5. Standalone (Algorithm Only) Performance Study:

   • Yes, implicitly. The device itself is a standalone imaging system. Its performance was evaluated against NEMA and IEC standards directly, without human-in-the-loop performance being a specific endpoint. The "device performance" in this context refers to its ability to acquire and process gamma ray emissions according to established technical specifications.

6. Type of Ground Truth Used:

   • For the NEMA and IEC standards testing, the "ground truth" would be the defined technical specifications and measurement protocols of those standards. For example, spatial resolution might be measured against a known phantom with precisely defined features. It's an engineering/physical ground truth, not a clinical outcome or pathology.

7. Sample Size for the Training Set:

   • Not applicable. This device is a hardware imaging system, not an AI algorithm that requires a training set in the conventional machine learning sense. The "training" for such a device would involve engineering design, calibration, and manufacturing processes.

8. How the Ground Truth for the Training Set Was Established:

   • Not applicable for the same reason as point 7.

Summary of Approach in the 510(k):

This 510(k) submission leverages the concept of substantial equivalence. The manufacturer argues that the modified Mini Gamma Camera (MGC500-101U and MGC500-301U) is sufficiently similar to its predicate device (MGC500) that extensive new clinical performance trials are not necessary. The changes primarily involve a "new high-uniformity mode" and a more compact design for one model. The technological characteristics (CdTe detectors, signal processing) are stated to be unchanged from the original version.

To support substantial equivalence, the submission relies on:

• Comparison of intended use and technological characteristics to the predicate device.
• Compliance with recognized electrical safety (IEC-60601-1) and performance standards (NEMA) for scintillation cameras. These standards define how imaging devices should perform in terms of attributes like spatial resolution, sensitivity, uniformity, etc., under controlled conditions. The "testing" mentioned is likely the verification that the device meets these established technical standards, rather than proving a specific diagnostic accuracy in a clinical setting.
• Internal verification/validation activities carried out under the manufacturer's quality system.

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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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