(51 days)
The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
The Mayfield® ScanMate™ Mobile CT System is a whole body CT scanning system. It is intended for use as a Computed Tomography X-ray Sus on for diagnostic purposes, producing cross-sectional images of the body through computer reconstruction of X-ray transmission data from the same axial plane taken at different angles.
This document is a 510(k) summary for the Mayfield® ScanMate™ Mobile CT System, primarily focused on establishing substantial equivalence to a predicate device rather than detailing specific performance studies against acceptance criteria. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth establishment is not present in this document.
Here's an attempt to extract the relevant information based on the provided text, with explicit notes where the information is not available:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Available | Not Available |
| (No specific performance metrics or acceptance criteria are provided in the 510(k) summary. The summary focuses on substantial equivalence to a predicate device.) | (No specific performance values such as sensitivity, specificity, accuracy, or image quality metrics are reported.) |
Study Details
1. Sample sized used for the test set and the data provenance:
- Sample Size for Test Set: Not available.
- Data Provenance: Not available. The document is a 510(k) summary for substantial equivalence and does not describe a clinical performance study with a distinct test set.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable, as no specific test set ground truth establishment is described.
- Qualifications of Experts: Not applicable.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable, as no specific test set or adjudication process is described.
4. 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:
- MRMC Study: No, an MRMC comparative effectiveness study is not mentioned or described. The device is a CT system, not an AI-assisted diagnostic tool in the context of this document.
- Effect Size of Human Readers with/without AI: Not applicable, as it's not an AI-assisted device for diagnostic improvement, but a standalone imaging system.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: The device itself is a standalone CT system. However, the document does not describe a performance study for the algorithm only (as it's a medical device, not solely an algorithm). It's a system to produce images for human interpretation. The 510(k) process focuses on demonstrating that the device is as safe and effective as a legally marketed predicate device.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: Not applicable, as no specific performance study requiring ground truth establishment is detailed. The 510(k) relies on comparison to a predicate device.
7. The sample size for the training set:
- Sample Size for Training Set: Not applicable. The document describes a CT system, not a machine learning algorithm that requires a training set in the conventional sense.
8. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable, as it's not a machine learning algorithm.
Summary of Document's Focus:
The provided 510(k) summary primarily asserts that the Mayfield® ScanMate™ Mobile CT System is substantially equivalent to the Analogic Corporation's ANATOM 2000. It states that the ScanMate Mobile CT System shares "the same uses, indications for use, technological characteristics, and principles of operation" as its predicate device. This implies that the device's acceptable performance is demonstrated by its similarity to an already approved device, rather than through a detailed independent performance study with specific acceptance criteria, test sets, and ground truths as typically associated with new algorithmic or AI-based devices.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.