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The Hamamatsu PET Scanner Model SHR-22000 is indicated for the imaging of the distribution in the body of physiological tracer molecules labeled with positron-emitting isotopes. Such images are particularly useful in the assessment of brain function.

The Hamamatsu PET Scanner Model SHR-22000 is similar to previous PET scanners marketed by other companies, but it represents an increase in performance over other PET Scanners through improved resolution. The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation.

The SHR-22000 PET Scanner system consists of five main subsystems: the main gantry with the detector arrays, the signal processing unit, the data acquisition unit, the patient table and positioning sub-system, and the imaging workstation and user interface.

Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution. The gantry also has a 6Ge-6Ga source mounted in a stainless steel rod for calibration.

The provided document describes a 510(k) premarket notification for the Hamamatsu PET Scanner Model SHR-22000. This is a medical imaging device, and the submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria for an AI/CADe device.

Therefore, many of the requested elements (acceptance criteria, specific performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or not explicitly detailed in this type of regulatory submission for a hardware device like a PET scanner.

Here's an breakdown based on the information available:

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

• Acceptance Criteria: Not explicitly stated as quantifiable metrics for a specific diagnostic task like an AI/CADe device. The primary "acceptance criteria" for a 510(k) submission for a traditional medical device are demonstrating substantial equivalence to a legally marketed predicate device. This typically involves demonstrating similar technological characteristics and performance (e.g., image quality, resolution, safety) to the predicate.
• Reported Device Performance: The document states:
  • "Model SHR-22000 has almost 22000 scintillator segments in its detector arrays, providing very fine resolution." (This is a design characteristic, implying improved resolution).
  • "The system was developed in a joint venture with Hitachi Medical Corporation (HMC). HMC provided the imaging workstation, patient table, and user interface, adapted from its nuclear medicine imaging workstation."
  • "Imaging performance tests were carried out to assure equivalence of image characteristics with the predicate device." However, specific numerical performance metrics (e.g., spatial resolution in mm, sensitivity in cps/kBq) are not provided in this summary.

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

• Not applicable / Not explicitly detailed. This document is for a hardware PET scanner. The "testing" mentioned refers to compliance with electrical safety and general imaging performance characteristic equivalence, not a clinical study on a patient test set for a diagnostic algorithm.

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 such clinical test set or ground truth establishment is described in this 510(k) summary for a PET scanner.

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

• Not applicable. See point 3.

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:

• No. This is a hardware device (PET scanner), not an AI/CADe algorithm. MRMC studies are typically performed for AI or CADe devices to assess improved reader performance.

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

• Not applicable. This describes a hardware device, not an algorithm.

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

• Not applicable. No clinical ground truth is mentioned for performance evaluation in this 510(k) summary. The "testing" focused on device characteristics and safety.

8. The sample size for the training set:

• Not applicable. This is a hardware device; there isn't a "training set" in the context of an AI algorithm.

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

• Not applicable. See point 8.

Summary for the Hamamatsu PET Scanner Model SHR-22000:

This 510(k) summary demonstrates that the Hamamatsu PET Scanner Model SHR-22000 is substantially equivalent to the Siemens ECAT Exact HR PET scanner (K962797). The equivalence is based on similar indications for use, technological characteristics (coincidence detection, scintillator segments, image reconstruction), and the results of imaging performance tests to ensure similar image characteristics. The details provided are typical for a hardware device submission, focusing on safety and equivalence to established technology rather than rigorous clinical performance metrics for a diagnostic algorithm.

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