(64 days)
The ScanX Touch/ScanX Duo Touch is intended to be used for scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.
The ScanX Touch is a device that scans photostimulable phosphor storage plates that have been exposed in place of X-ray film and allows the resulting images to be displayed on a personal computer monitor and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. Two models are available: The Scanx® Touch processes one imaging plate while ScanX® Duo Touch processes two at a time. The ScanX Touch also includes an RFID Phosphor Plate identification system which requires that the Phosphor Plate has an RFID tag attached to the non-imaging side of the Plate. ScanX allows multi room dental clinics to produce digital radiographs within seconds using a flexible PSP (Phosphor Storage Plates). The workflow is supported by a touch screen, for job handling (ScanManager, Patient information), preview and standalone work. ScanX produces the digital diagnostic quality intraoral image by scanning PSPs, which have been exposed to X-rays. ScanX can also work independently. If the IT network goes down, the user can still scan and save X-ray images. The images are temporarily placed in the internal memory and are later transferred to the office database. This makes the device ideally suited to provide a mobile solution when it is necessary to visit the patient outside the office. Additionally, ScanX allows computer storage, processing, retrieval and display of the processed images utilizing a user supplied software (e.g. DBSWIN) and computer. An additional feature of ScanX consists of an in-line plate eraser function that removes the latent image from the plate immediately after scanning. This design provides an efficient one-operation scanning and erasing process leaving the user with a PSP ready for the next X-ray procedure
The provided text describes the Air Techniques ScanX Touch/ScanX Duo Touch, a device for scanning and processing digital images from Phosphor Storage Plates (PSPs) in dental applications. The information focuses on demonstrating substantial equivalence to a predicate device (ScanX Intraoral View, K170733) rather than a comprehensive study proving the device meets specific performance acceptance criteria for a novel AI algorithm.
Therefore, many of the requested sections (e.g., sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies) are not applicable or cannot be extracted from this document as it pertains to a traditional medical device clearance, not an AI-driven one.
Here's a breakdown of the information that can be extracted, aligning with the closest relevant details provided:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily framed around demonstrating substantial equivalence to the predicate device in terms of image quality and functional specifications. The "acceptance criteria" here are implicitly meeting or exceeding the predicate's performance in key imaging metrics.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (ScanX Touch/ScanX Duo Touch) | Predicate Device Performance (ScanX Intraoral View, K170733) |
|---|---|---|
| Indications for Use | Intended for scanning and processing digital images exposed on PSPs in dental applications. | SAME |
| Mechanical Design | SAME as Predicate Device (scans plates in two orthogonal directions using a 650 nm laser) | The exposed and unwrapped plates are scanned in two orthogonal directions using a laser with a wavelength of approximately 650 nm. |
| Electrical Design | SAME as Predicate Device (light 380 nm collected proportional to X-ray photons, formed into image for display/storage) | Light with a wavelength of approximately 380 nm is from the plate in proportion to the number of captured X-ray photons. This light is collected and formed into an image that may be viewed on a video display and stored for later recovery in a computer memory. |
| Image Scanning | Laser/Photomultiplier Tube | SAME |
| Erasing Residual Image | Inline erasing function | SAME |
| Viewing the Image | 7.0″ diagonal Touch Screen (preview only); diagnostic viewing on external monitor with computer and software. | 4.3″ Touch Screen (preview only); diagnostic viewing on external monitor with computer and software. |
| Transport / Feed Mechanism | SAME as Predicate Device (beltways, continuous feed) | The plates are transported by "beltways" down the axis of the cylinder past the slot. The motion of the laser and plates provides the two orthogonal scan directions. This is a continuous feed device that allows successive plates to be loaded as soon as the previous plates have moved past the slot. |
| Phosphor Plates | Operates with the same Dental intraoral size and material PSPs; includes RFID identification system. | Dental intraoral PSPs: Size 0 (22x35mm), Size 1 (24x40mm), Size 2 (31x41mm), Size 3 (27x54mm), Size 4 (57x76mm). |
| Image Quality (Resolution) | Theoretical resolutions: 10, 20, 25 or 40 Lp/mm | SAME |
| MTF (Modulation Transfer Function) | More than 46% at 3 Lp/mm (essentially the same) | More than 45% at 3 Lp/mm |
| DQE (Detective Quantum Efficiency) | More than 7.2% at 3 Lp/mm (essentially the same) | More than 7.5% at 3 Lp/mm |
| Image Data Bit Depth | 16 bits | SAME |
| Imaging Software | DBSWIN/VistaEasy (updated in K190629) | DBSWIN/VistaEasy (cleared in K161444, updated in K190629) |
| User Interface | Used by dentists and authorized dental auxiliary personnel. | SAME |
| Energy Source AC | 100 to 240VAC, 50/60 Hz | SAME |
| Electrical Safety Standards | IEC 60601-1 Electrical Safety Medical Devices, UL Listed. | EN 61010-1:2010 Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use - Part 1: General Requirements. |
| EMC Testing | IEC 60601-1-2 EMC Medical Devices; Complies with EN 61326-1:2013, FCC rules part 15 (RFID). | EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use. EMC requirements. General requirements. |
| Patient Contamination Prevention | Uses identical single-use barrier envelopes as predicate device. | Single patient use barrier envelope encloses the imaging plate while in the patient's mouth. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that "Test images were acquired on the new device and on the predicate device." However, a specific number of images or cases used for this comparison is not provided.
- Data Provenance: Not explicitly stated, but the testing was conducted by Air Techniques, Inc. likely within their facilities or through contracted labs (e.g., UL). There's no mention of country of origin for the data or whether it was retrospective or prospective in detail beyond the acquisition of "test images."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: "a licensed dentist" (singular)
- Qualifications: "licensed dentist" (no further details such as years of experience or specialization are given).
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. The evaluation was a single-reader assessment where a licensed dentist answered specific questions in the affirmative regarding the images. There was no mention of a consensus process among multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The evaluation involved a single licensed dentist.
- Effect Size of Human Readers with/without AI: Not applicable, as this device itself is not an AI algorithm but an imaging hardware and processing system. The study did not assess human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: Not applicable. The device is hardware for image acquisition and initial processing. The "standalone" testing referred to in the document relates to the device's ability to operate and save images independently if the IT network goes down, not an AI algorithm's standalone diagnostic performance.
7. The Type of Ground Truth Used
- Type of Ground Truth: "Expert assessment/satisfaction." A licensed dentist evaluated the images for representativeness, diagnostic usefulness, and absence of misleading artifacts, and comparability to the predicate. This is a subjective expert evaluation rather than an objective "ground truth" derived from pathology or definitive outcomes data.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This document does not describe an AI algorithm that was "trained." The device is an image acquisition and processing system.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or an AI algorithm that requires one.
§ 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.