(18 days)
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:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Performance Standard Compliance | Tested to the specifications of the NEMA Performance Standard for scintillation cameras. |
| Electrical Safety Compliance | Tested to the requirements of the IEC-60601-1 for electrical safety. |
| Technological Equivalence | Uses a detector head with CdTe detectors, similar to the predicate, with unchanged technological characteristics. |
| Intended Use Equivalence | Same indications for use as the legally marketed predicate device. |
Study Details
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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.
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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.
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Adjudication Method for the Test Set:
- Not applicable. There was no clinical test set requiring adjudication of ground truth.
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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).
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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.
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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.
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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.
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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.
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.