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The intended use of the Mobile Compact Digital Cardiac (MCDCC) is to detect the location and distribution of gamma ray emitting radionuclides in the body and store data for analysis. This device resides on a mobile platform and includes accessories such as signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts and accessories.

The Mobile Compact Digital Cardiac Camera (MCDCC) is a gamma camera system. It includes a detector head, gantry, and resides on a mobile platform. It includes accessories such as signal analysis and display equipment supports, radionuclide anatomical markers, component parts and accessories.

This document is a 510(k) summary for the Mobile Compact Digital Cardiac Camera (MCDCC). It does not contain acceptance criteria or the results of a study that proves the device meets specific performance criteria.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Compact Digital Cardiac Camera, K033199). This means the manufacturer is asserting that the new device is as safe and effective as a legally marketed device and does not introduce new questions of safety or effectiveness.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance study details from the given text.

Here's why each point cannot be answered:

1. A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing design features and intended use to a predicate device.
2. Sample sized used for the test set and the data provenance: No performance testing data is presented, and thus no sample sizes or data provenance are mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant to a substantial equivalence claim, as no new performance study is being presented.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable as no test set or expert adjudication is described for performance evaluation.
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-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a medical imaging system, not an algorithm being tested in isolation.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable as no new performance study with ground truth establishment is detailed.
8. The sample size for the training set: Not applicable as this is not an AI/ML device that undergoes training.
9. How the ground truth for the training set was established: Not applicable for the same reason as above.

The core of this 510(k) is the statement: "The Mobile Compact Digital Cardiac Camera (MCDCC) has been deemed safe and is certified to the same safety standards as the predicate device by a third party organization prior to use on patients. A matrix was constructed comparing the features and intended use of the Mobile Compact Digital Cardiac Canera (MCDCC) with the predicate device. We conclude that the Mobile Compact Digital Cardiac Camera (MCDCC) is substantially equivalent to the predicate device and that no new safety or effectiveness concerns are raised." This indicates a comparison study of design and function, not a clinical performance study with specific acceptance criteria.

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