Search Results

The MiniCAT 2D is a diagnostic x-ray system for general radiographic x-ray imaging of the head and neck for use in hospitals, clinics, medical imaging centers, and medical practices.

The MiniCAT 2D is a dedicated X-ray imaging device that acquires a 360° rotational X-ray sequence and produces two dimensional views. MiniCAT 2D provide immediate access to images at the patient's point-of-care resulting in faster diagnosis and treatment. The MiniCAT 2D system consists of a high voltage x-ray generator, 360-degree rotational overhead gantry, x-ray tube assembly, x-ray controller, fixed detector panel, and x-ray controls containing a "power distribution unit and operator PC (user interface)."

This document does not contain information about the acceptance criteria and study that proves the device meets the acceptance criteria for a new AI/algorithm feature. Instead, it is a 510(k) summary for a general X-ray system (MiniCAT 2D) seeking substantial equivalence to a predicate device (Carestream DRX-Evolution).

The document details the device description, indications for use, and a comparison of technological characteristics to the predicate device to demonstrate substantial equivalence, rather than providing performance data for a specific algorithm or AI component.

Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, or training set details.

Ask a specific question about this device

The MiniCAT is an X-ray imaging device that constructs a three dimensional model of the head and neck from images taken during a rotational X-ray sequence. The MiniCAT is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

The MiniCAT is a dedicated X-ray imaging device that acquires a 360-degree rotation x-ray sequence of images. The MiniCAT consists of both software and hardware components. The software is used for image acquisition, processing, and viewing and consists of the following main functional units patient database, study (scan) acquisition, study reconstruction, study view, report generation, and file saving. The software also controls the hardware components of the device. The major hardware components include the X-ray source, scanning arm (motor), and detector.

This submission is for a special 510(k) to address reported software failures in the MiniCAT device, specifically regarding a forced 10-minute delay between scans, running the software as a Windows shell, a daily calibration date checking function, and DICOM image unique identifiers compliance. This is a modification to a previously cleared device (K032243). The focus of the performance data is on software verification and validation, as the changes are software-only and do not raise new questions of safety or effectiveness regarding the core imaging performance.

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

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not specify a sample size for a test set in the context of clinical image evaluation, nor does it mention data provenance (e.g., country of origin, retrospective or prospective) for such a test set. This submission is for software modifications, and the "performance data" section focuses on software verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

The provided text does not mention the use of experts to establish a ground truth for a test set. The submission focuses on software functionality rather than diagnostic performance assessed by human readers.

4. Adjudication Method for the Test Set

The provided text does not mention an adjudication method. As no expert review or test set is described, adjudication would not be applicable within the scope of this regulatory submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size of Improvement

An MRMC comparative effectiveness study was not done or at least not reported in this submission. The submission is for software modifications to an existing device, not for a new device requiring a comprehensive clinical performance evaluation with human readers.

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

A standalone performance study of the algorithm's diagnostic capabilities (without human-in-the-loop) was not explicitly described for this software modification. The performance data focuses on verification and validation of the software changes themselves. The core imaging algorithm's standalone performance would have been assessed in the initial 510(k) for the MiniCAT (K032243).

7. The Type of Ground Truth Used

For the software modifications, the "ground truth" was programmatic and functional:

• Compliance with specifications: The "forced 10-minute delay" was verified to correctly implement the delay.
• Operating system compatibility: "Running as a Windows shell" was verified for correct integration.
• Warning message functionality: The "daily calibration date checking function" was verified to display the warning under the correct conditions.
• DICOM standard adherence: "DICOM image unique identifiers (UIDs) have been brought into compliance" was verified against the DICOM standard.

There is no mention of pathology, outcomes data, or expert consensus being used as ground truth for diagnostic performance, as that was not the scope of this specific software modification submission.

8. The Sample Size for the Training Set

The provided text does not mention a training set or its sample size. This submission is about software modifications, not the development or training of a new AI/machine learning algorithm.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a training set, there is no information on how its ground truth was established.

Ask a specific question about this device

The MiniCAT™ is an X-ray imaging device that constructs a three dimensional model of the head and neck are from images taken during a rotational X-ray sequence. The MiniCAT™ is optimized for the imaging of the maxillofacial complex, temporal bone, sinuses, and for neuro-angiography.

The MiniCAT™ is a dedicated X-ray imaging device that acquires a 360° rotational Xray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The MiniCAT™ can measure distances and thickness on two dimensional images. Images produced by the MiniCAT™ can be printed or exported on magnetic and optical media.

The building blocks of the MiniCAT™ are a motorized scanning arm carrying an X-ray source and image detector, and a computer running the MiniCAT™ software. The scanning arm facilitates the acquisition of a full X-ray sequence by the software. The software receives the two dimensional images acquired by the detector transforms them into three dimensional images and displays them on the computer monitor for viewing.

The provided text describes the MiniCAT™ imaging device and its 510(k) submission to the FDA. However, it does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance criteria.

The document states that the MiniCAT™ "complies with the requirements of 21 CFR 807.87(h) and does not pose any new safety risks or effectiveness issues.". This is a regulatory statement confirming substantial equivalence to predicate devices, but it does not detail specific performance metrics, acceptance criteria, or a study to demonstrate these. The document focuses on device description, intended use, and comparison with predicate devices to establish substantial equivalence.

Therefore, I cannot provide the requested table or details about a performance study based on the input given.

Summary of missing information:

• No acceptance criteria are mentioned.
• No study proving the device meets acceptance criteria is described.
• No performance metrics for the device are reported.
• No sample size for test or training set, data provenance, expert qualifications, or ground truth methods are provided.
• No multi-reader multi-case (MRMC) or standalone study details are available.

Ask a specific question about this device