(153 days)
QuickRay HD is used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw and oral structures.
Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structure.
The QuickRay HD dental sensor is intended to replace film and to capture an intraoral x-ray image, when exposed to X-rays, for dental diagnostic purposes.
The subject QuickRay HD are intraoral digital x-ray systems comprised of two components: (1) an intraoral detector which connects to a PC via a USB port; and (2) an Image Mangement Software package.
The subject devices comes in two sizes: Size 1 is 600mm² and Size 2 is 884mm².
QuickRay HD, Size 1 is also known as factory code S11684-12; QuickRay HD, Size 2 is also known as factory code S116845-12.
The type of x-ray systems that integrate with the QuickRay HD sensor are wall-mounted xray generators (both AC and DC) with a tube current between 1 and 15 mA inclusive, and with a tube voltage between 50 and 100 kV inclusive, with in-built controls to set exposure parameters. Generators allow variable mA/kV to be selected, all will control the exposure time.
This device and software cannot act as an x-ray generator controller. All control of x-ray generation is done by controls built into the generator itself. There is no connection between the subject device and the x-ray generator. The subject device does not control the generator, it is a receiver.
The Xray Vision software by Apteryx is a Windows based image management database/software primarily used by dentists to acquire, enhance, store, communicate, print, recall and display digital images.
Here's an analysis of the provided text to extract information related to acceptance criteria and the study proving the device meets them. It's important to note that this document is a 510(k) summary for a premarket notification, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting a full clinical trial. As such, some of the requested information (like detailed MRMC studies or large-scale multi-expert ground truthing) may not be explicitly present or required for this type of submission.
The device in question is the QuickRay HD Intraoral Sensor.
Acceptance Criteria and Device Performance Study for QuickRay HD Intraoral Sensor
Context: The QuickRay HD Intraoral Sensor is an intraoral digital X-ray system intended for radiographic examination to assist in diagnosing diseases of the teeth, jaw, and oral structures. The 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device (Opteo, K133271) and an identical device cleared later (EDLENi Intra-oral Sensor, K150823), rather than extensive new clinical performance studies, which is typical for Class II dental imaging devices.
1. Table of Acceptance Criteria and Reported Device Performance
For this specific 510(k) submission, the "acceptance criteria" are implied by the claim of substantial equivalence to the predicate device, meaning the QuickRay HD must perform comparably or better than the predicate, especially in terms of image quality and safety. The performance is assessed through bench testing and by comparing technological characteristics.
| Criterion Category (Implied Acceptance Basis) | Specific Criterion / Metric | QuickRay HD Performance (Subject Device) | Predicate Opteo Performance (for comparison) | Notes / Supporting Information |
|---|---|---|---|---|
| Intended Use | Radiographic examination to assist with diagnosis of diseases of the teeth, jaw, and oral structures. | QuickRay HD used for radiographic examination by dental professional to assist in diagnosing diseases of the teeth, jaw and oral structures. | Same. | QuickRay HD is intended to replace film and capture intraoral x-ray images for dental diagnostic purposes. |
| Technological Characteristics | Sensor Technology | CMOS chip + optical fiber plate + CSi scintillator | CMOS chip + optical fiber plate + CSi scintillator | Identical. |
| Image Resolution | Real Resolution | ≥ 20 lp/mm | ≥ 20 lp/mm | Meets or exceeds the predicate. |
| Pixel Size | 20 x 20 μm | 20 x 20 μm | Identical. | |
| Matrix Dimensions (Active Area) | Size 1 | 600mm² | 600mm² | Identical. |
| Size 2 | 884mm² | 900mm² | "None" (difference not considered significant for equivalence). | |
| Matrix Dimensions (Pixels) | Size 1 | 1000 lines X 1500 columns | 1000 lines X 1500 columns | Identical. |
| Size 2 | 1300 X 1700 | 1300 X 1700 | Identical. | |
| Grey Levels | 14 bits | 14 bits | Identical. | |
| Lifespan (CMOS) | Minimum cycles | Min. 100,000 cycles | Min. 100,000 cycles | Identical. |
| Electrical Safety | Conformance to IEC 60601-1 | Conforms | Conforms | Confirmed by testing data. |
| EMC | Conformance to IEC 60601-1-2 | Conforms | Conforms | Confirmed by testing data. |
| Bench Testing (Performance) | Detective Quantum Efficiency (DQE) | DQE plot provided (Figure/3) | (Not directly compared in table, but implied to be comparable to predicate performance in similar technologies) | Conforms to IEC 62220-1. Calculation includes MTF and NMPS, with plots provided. |
| Modulation Transfer Function (MTF) | MTF plot provided (Figure/0) | (Not directly compared in table) | Conforms to IEC 62220-1. | |
| Noise Power Spectrum (NNPS) | NNPS plot provided (Figure/1) | (Not directly compared in table) | Conforms to IEC 62220-1. | |
| Biocompatibility | Patient contact | No direct or indirect patient-contacting components. Single-use protective barrier used. | Same. | Not warranted for separate testing. |
| Clinical Relevance | Diagnostic relevance and reliability | Clinical images examined by Dr. Parham and found to be diagnostically relevant and reliable. | Implied equivalent. | Limited clinical assessment, primarily by one practitioner. |
Note: The document explicitly states that the EDLENi Intra-oral Sensor (K150823) is identical to the QuickRay HD, providing further support for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of number of patients or images for a comparative clinical study. The performance assessment is primarily based on:
- Bench Testing: Conformance to standards (IEC 62220-1 for performance, IEC 60601-1/1-2 for electrical/EMC, IEC 60529 for IP Code). These involve standardized phantom or controlled laboratory tests rather than patient images as a "test set."
- Clinical Image Examination: "Clinical images were examined" by Dr. Parham. The number of images or cases examined is not specified.
- Data Provenance: The document does not explicitly state the country of origin for the "clinical images" examined by Dr. Parham, but given the location of Dr. Parham (Ormond Beach, FL), it implies the data is from the United States. The study type appears to be retrospective in nature ("clinical images were examined"), rather than a prospectively designed clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Only one expert is explicitly mentioned: "Dr. Parham".
- Qualifications of Experts: Dr. Parham is described as "a qualified practitioner in Ormond Beach, FL." No further specific qualifications (e.g., years of experience, specific board certifications like radiologist) are provided in this summary, other than the implication of being a dental professional.
4. Adjudication Method for the Test Set
- Adjudication Method: None explicitly stated or implied. The assessment was done by a single "qualified practitioner."
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission relies on bench testing and a single expert's review of clinical images to demonstrate substantial equivalence, not a direct human reader performance comparison with and without AI assistance. Therefore, no effect size for human readers improving with AI assistance is provided.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone Performance: The QuickRay HD is an imaging sensor, not an AI algorithm. Its "performance" is inherently tied to its ability to capture images suitable for human diagnosis. Therefore, the concept of a "standalone (algorithm only)" performance study doesn't directly apply here in the typical AI sense. The bench tests (DQE, MTF, NNPS) represent the inherent technical performance of the device itself (analogous to "standalone" in a hardware context) before image interpretation by a human.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the "clinical images," the ground truth was expert consensus / expert opinion, specifically from "Dr. Parham," who found them "diagnostically relevant and reliable." For the technical performance aspects (resolution, DQE, etc.), the ground truth was based on physical measurements and conformance to established international standards (e.g., IEC 62220-1).
8. The Sample Size for the Training Set
- Training Set Sample Size: The QuickRay HD is a hardware device (intraoral sensor) with associated firmware and image management software. It is not an AI/ML algorithm that is "trained" on a dataset in the typical sense. Therefore, there is no stated training set sample size. The electronics and firmware are reported to be from Hamamatsu and the software from Apteryx, and these components have presumably undergone their own development and testing processes, but no specific training data for the sensor itself for a machine learning purpose is relevant or mentioned.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: As the device is not an AI/ML algorithm requiring a training set, the concept of "ground truth for the training set" is not applicable in this context. The "truth" for this device lies in its physical and electrical engineering specifications and its ability to produce images that meet diagnostic quality standards established by experts and industry benchmarks.
§ 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.