(56 days)
The Imaging Sciences International Inc. i-CAT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The Imaging Sciences i-CAT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The system is designed for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
The i-CAT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional matrix of the examined volume and produces two dimensional views of this volume. The i-CAT Scanner can measure distances and thickness on two dimensional images. Images produced by the i-CAT Scanner can be printed or exported on magnetic and optical media.
The i-CAT Scanner gantry is comprised of an X-ray source, image detector, and motorized gantry. The gantry 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 workstation monitor for viewing.
This 510(k) summary for the i-CAT Scanner does not contain specific acceptance criteria or details about a study designed to prove the device meets those criteria. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing performance against specific, quantifiable metrics.
Therefore, many of the requested information points cannot be extracted from this document.
However, I can provide what is available:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not define specific performance acceptance criteria (e.g., accuracy, resolution benchmarks) for the i-CAT Scanner, nor does it report performance metrics against such criteria. The "Conclusions" section broadly states that potential hazards are controlled by the design, verification, and validation process, and that the device complies with 21 CFR 807.87 and poses no new safety risks or effectiveness issues.
2. Sample size used for the test set and the data provenance:
Not specified. The document does not describe a clinical or technical test set used to evaluate the device's performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no described test set with ground truth is mentioned.
4. Adjudication method for the test set:
Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study:
No MRMC study is mentioned. The document focuses on the device's technical specifications and intended use in comparison to predicate devices, not on human reader performance with or without AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable. This is an imaging device, not an AI algorithm for interpretation. Its performance is inherent in the image acquisition and reconstruction process, which is then interpreted by a human.
7. The type of ground truth used:
Not explicitly stated for any performance evaluation. The document implies that the device's ability to "construct a three dimensional model" and "measure distances and thickness" is a functional truth, but it doesn't detail how the accuracy of these functions was verified against a "ground truth."
8. The sample size for the training set:
Not applicable. This device is an X-ray scanner, not a machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable.
Summary of what is available from the document:
- Device Name: i-CAT Scanner
- Intended Use: Constructs a three-dimensional model from images taken during a rotational X-ray sequence. Intended for use whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects, specifically for TM Joint studies, mandible & maxilla for implant planning, sinuses, and other areas of the maxillofacial complex.
- Substantial Equivalence: Claimed against NewTom QR - DVT 9000 (K003787) and 3D Accu-I-tomo XYZ Slice View Tomograph (K030450).
- General Compliance: The device is stated to comply with 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues. Potential hazards are reportedly controlled by design development, verification, and validation processes, including a risk management system.
The provided text is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing comprehensive performance testing and acceptance criteria. For devices like this X-ray scanner, the performance is often assessed through bench testing and verification activities that ensure the device meets its design specifications (e.g., image quality, dose, measurement accuracy), but these specific details are not included in this summary.
§ 872.1800 Extraoral source x-ray system.
(a)
Identification. An extraoral source x-ray system is an AC-powered device that produces x-rays and is intended for dental radiographic examination and diagnosis of diseases of the teeth, jaw, and oral structures. The x-ray source (a tube) is located outside the mouth. This generic type of device may include patient and equipment supports and component parts.(b)
Classification. Class II.