Search Results

Verista Imaging ISOCAM II Gamma Camera is intended to image the distribution of radionuclides in the body by means of photon radiation detector(s).

The ISOCAM II Gamma Camera is a medical imaging device used in nuclear medicine. It produces gamma ray distribution emitting radionuclides. It consists of one or more detectors mounted on a gantry that is connected to an acquisition system for operating the camera and storing the images. The base unit is a nuclear imaging device which utilizes gamma ray scintillation technologies. The modification to the device is limited to an upgrade to the mechanical operation of the device. The modifications improve patient safety through changes to the arm drive mechanical components and the addition of a weighted counter balance system.

The provided text describes a 510(k) summary for the Verista Imaging ISOCAM II Gamma Camera. It focuses on demonstrating substantial equivalence to predicate devices, primarily due to a mechanical upgrade, rather than a clinical performance study involving acceptance criteria for diagnostic accuracy. Therefore, several requested tables and sections are "Not Applicable" or cannot be filled due to the nature of the submission.

Here's a breakdown of the requested information based on the provided text:

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

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

• Sample size for test set: Not applicable. No clinical test set involving patient data was used for this submission. The testing conducted was non-clinical, focusing on mechanical changes.
• Data provenance: Not applicable.

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 expert review of a test set for ground truth establishment was conducted or mentioned, as the submission is for mechanical modifications, not clinical performance.

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

Not applicable. No test set requiring adjudication was used.

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 applicable. This device is a gamma camera, not an AI-powered diagnostic tool, and the submission is for mechanical upgrades. No MRMC study was conducted.

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

Not applicable. This is a medical imaging device (gamma camera), not an algorithm or AI. The submission focuses on device mechanics.

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

Not applicable. No ground truth for diagnostic accuracy was established or used, as the submission is for mechanical modifications to an existing device. The software "remains identical" to the predicate device.

8. The sample size for the training set

Not applicable. No training set was used. This submission is for mechanical modifications to an existing device, not for training a new algorithm or AI model.

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

Not applicable. No training set was used.

Ask a specific question about this device