Search Results

The Mobile CT ProSpeed is indicated for head and whole body x-ray computed tomography applications to be mounted in a trailer. The Mobile CT ProSpeed has the same indications for use as the CT ProSpect Plus (formerly known as CT Sytec 8000 K913485) and CT ProSpeed Family with HiLight Detector K944013.

The device is an x-ray computed tomography scanner consisting of a gantry, patient table, console, computer, and associated accessories, mounted within a trailer.

This document is a Summary of Safety & Effectiveness for the Mobile CT ProSpeed. It is a premarket notification (510(k)) application, the purpose of which is to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

Crucially, this document does not contain a study with acceptance criteria and reported device performance in the way that an AI or diagnostic device submission would. This document describes a new CT scanner (Mobile CT ProSpeed), not an AI algorithm or a diagnostic device whose performance is measured against a specific clinical task.

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to this type of submission.

Here's an analysis based on the provided text, highlighting what is (and isn't) present:

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

Not Applicable (N/A) in the context of this 510(k) submission for a CT scanner.

This document is for a physical medical device (CT scanner), not a diagnostic algorithm with specific performance metrics like sensitivity, specificity, or AUC as acceptance criteria. The acceptance criteria for such a device largely revolve around safety, electrical standards, radiation dose, image quality specifications (which are typically technical, not clinical outcome-based), and substantial equivalence to a predicate device. These are generally demonstrated through engineering tests, compliance with standards, and comparison of technical specifications.

The document states:

• "Materials and construction are equivalent to the CT ProSpeed Plus and are CT ProSpeed Family with HiLight Detector which are compliant with UL 187, IEC 601-1, and 21 CFR Subchapter J."
• "The design is essentially the same as the CT ProSpeed with larger mounting bolts for the table and gantry as well as special instructions for the set-up and take down of the system."
• "The energy source is the same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector with the same x-ray tube and generator."
• "Principals of Operation: The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector."
• "Features: The same as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector."
• "Accessories: The same accessories as the CT ProSpeed Plus and CT ProSpeed Family with HiLight Detector."
• "Potential electrical, mechanical and radiation hazards are controlled by compliance with industry standards (UL 187 & IEC 601-1), the Federal performance standard (21CFR Subchapter )), and warnings in the labeling."

These statements implicitly define the "performance" as being equivalent to and compliant with established standards and predicate devices. There's no table provided because the performance is described qualitatively as "the same as" or "equivalent to" existing, cleared devices, and by compliance with regulatory standards.

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

N/A. No clinical "test set" in the context of diagnostic performance studies is mentioned or required for this type of 510(k) submission for a CT scanner. The assessment is based on engineering design, technical specifications, and compliance with standards.

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)

N/A. No ground truth establishment for a diagnostic test set is detailed in this document.

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

N/A. No test set or adjudication method is described.

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

N/A. This is a CT scanner, not an AI-based diagnostic tool. No MRMC study is mentioned.

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

N/A. This is a CT scanner, not an algorithm.

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

N/A. No ground truth for diagnostic performance is relevant to this submission. The "ground truth" for this device's safety and effectiveness relies on its technical specifications meeting established safety and performance standards for CT scanners and being equivalent to predicate devices.

8. The sample size for the training set

N/A. No training set for an algorithm is applicable.

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

N/A. No training set or ground truth establishment relevant to an algorithm is applicable.

In summary:

This document is a 510(k) submission for a mobile CT scanner, demonstrating its substantial equivalence to previously cleared CT scanners. It focuses on the physical device's design, materials, energy source, and compliance with safety standards, rather than the diagnostic performance of an AI algorithm or a new diagnostic technique. Therefore, the detailed performance study criteria typically associated with AI/diagnostic device submissions are not present in this document. The "study" for this device effectively consists of the engineering design, component sourcing, and verification that it meets the same technical and safety specifications as its predicate devices, in compliance with regulatory standards.

Ask a specific question about this device