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The Imaging Sciences International Inc. DVT Scanner constructs a three dimensional model from images taken during a rotational X-ray sequence. The DVT Scanner is intended to be used whenever a dentist, oral surgeon, or other physician needs 3D information of high contrast objects. The DVT Scanner is optimized for imaging of TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, temporal bone, etc.

The DVT Scanner is a dedicated X-Ray imaging device that acquires a 360 degree rotational X-ray sequence, reconstructs a three-dimensional that aod a boo adgrounde and produces two dimensional views of this volume. The matix of the oxamined stances and thickness on two dimensional images. Images produced by the DVT Scanner can be printed or exported on magnetic and optical media.

The DVT 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, sonward. The bormal images and displays them on the workstation monitor for viewing.

This 510(k) submission (K051980) for the DVT Scanner by Imaging Sciences International Inc. primarily focuses on substantial equivalence to predicate devices and does not include a comparative study or detailed acceptance criteria with performance metrics in the provided document. The submission is a premarket notification to establish that the DVT Scanner is at least as safe and effective as a legally marketed device.

Therefore, many of the requested sections below cannot be populated as the information is not present in the provided text.

Acceptance Criteria and Study Details for DVT Scanner (K051980)

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly state specific acceptance criteria or quantitative performance metrics for the DVT Scanner. The approval is based on substantial equivalence to predicate devices, implying that its performance is considered comparable to those devices.

The document states, "The DVT Scanner complies with the requirements of 21 CFR 807.87 and does not pose any new safety risks or effectiveness issues." This is a high-level statement and not a specific performance metric.

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

The provided document does not mention any specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective) for a standalone device performance study. The approval is based on substantial equivalence.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided document does not describe any study involving experts to establish ground truth. The submission is focused on substantial equivalence to existing devices.

4. Adjudication Method for the Test Set

Since no specific test set or study for ground truth establishment is described, there is no mention of an adjudication method in the provided document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The provided document does not indicate that a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed. The submission focuses on device equivalence, not on comparing human reader performance with and without AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

The provided document does not describe a standalone performance study for the DVT Scanner's algorithm. The device is described as an X-ray imaging system that reconstructs 3D models and displays them for interpretation by a dentist, oral surgeon, or other physician, inherently implying human-in-the-loop use.

7. Type of Ground Truth Used

The provided document does not mention the type of ground truth used as no specific performance study against a ground truth is detailed.

8. Sample Size for the Training Set

The provided document does not specify any training set size as it does not describe the development or validation of a machine learning or AI algorithm in the context of a training set. The device is an imaging system, not an AI-driven diagnostic tool in the sense of modern AI/ML submissions.

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

As no training set is mentioned (see point 8), there is no information on how ground truth for a training set was established in the provided document.

Summary of Information from the Provided Text:

The K051980 submission for the DVT Scanner is a premarket notification for a Computed Tomography X-ray System. It asserts substantial equivalence to three predicate devices: NewTom QR - DVT 900 (K003787), Advantage 3-D XR (K945375), and 3D Accu-l-tomo XYZ Slice View Tomograph (K030450). The DVT Scanner is described as a device that acquires a 360-degree rotational X-ray sequence to reconstruct a three-dimensional model, producing two-dimensional views for dentists, oral surgeons, or other physicians to obtain 3D information of high-contrast objects. Its intended uses include TM Joint studies, mandible & maxilla for implant planning, sinuses, the maxillofacial complex, and temporal bone studies. The document concludes that the device complies with regulations and does not pose new safety risks or effectiveness issues, based on its design, development, verification, and validation process, which includes a risk management system. However, specific performance metrics, study designs, sample sizes, or ground truth methodologies are not detailed in this 510(k) summary.

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