(49 days)
The SunilQ Digital Radiography system is used to collect dental x-ray photons and convert them into electronic impulses that may be stored, viewed and manipulated for diagnostic use by dentists.
The SuniIQ Digital Radiography System reduces x-ray exposure by producing real time digital intra-oral images. The System accomplishes this by replacing X-ray film with a reusable electronic sensor that captures the X-ray photons and converts them to an electronic signal which, in turn, is captured in a computer for viewing, manipulating, storing, and output.
The acceptance criteria and study information for the SuniIQ Digital Radiography System are outlined below:
1. Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for specific performance metrics. However, it indicates a general acceptance criterion that the device must be "as safe, as effective, and performs as well as or better than the predicate device."
| Tested Function | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Relative error | Must meet functional requirements; comparable to predicate. | Pass |
| X-Ray Saturation | Must meet functional requirements; comparable to predicate. | Pass |
| Image size | Must meet functional requirements; comparable to predicate. | Pass |
| Image orientation | Must meet functional requirements; comparable to predicate. | Pass |
| Set up time, USB current, and clock pattern | Must meet functional requirements; comparable to predicate. | Pass |
| Dose loss and focus to detector distance (FDD) | Must meet functional requirements; comparable to predicate. | Pass |
| Saturation Comparison | Must meet functional requirements; comparable to predicate. | Pass |
| Printed Circuit Board (PCB) | Must meet functional requirements; comparable to predicate. | Pass |
| Software Development Kit (SDK) | Must meet functional requirements; comparable to predicate. | Pass |
| Time to ready for exposure state | Must meet functional requirements; comparable to predicate. | Pass |
| Test Pattern Images | Must meet functional requirements; comparable to predicate. | Pass |
| Dental Phantom Images | Must meet functional requirements; comparable to predicate. | Pass |
| Other Operating systems | Must meet functional requirements; comparable to predicate. | Pass |
| Software Verification & Validation | Operate as specified, meeting IEC 62304 standards and FDA guidances. | All features verified to operate as specified. All test passing criteria met. |
| Biocompatibility | Meet ISO 10993-1:2009 and FDA draft guidance. | Met requirements. |
| Disinfection | Recommended cleaning method confirmed. | Confirmed. |
| Electromagnetic Compatibility and Electrical Safety | Meet IEC 60601-1:2005 and ANSI/AAMI ES60601-1:2005 for safety, IEC 60601-1-2:2007 for EMC. | Met requirements. |
The study concludes that "Testing confirms that the SuniIQ System is as safe, as effective, and performs as well as or better than the predicate device," and that "The identified technological differences between the subject and predicate devices were assessed through bench performance testing data and software V&V testing to demonstrate that they are substantially equivalent."
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a distinct "test set" in terms of patient data. The testing described focuses on bench testing and software verification and validation (V&V).
- Bench Testing: The "tested functions" listed cover various technical aspects of the device, likely using controlled laboratory conditions and specific testing protocols (e.g., test pattern images, dental phantom images). The sample sizes for these tests are not explicitly stated, but are implied to be sufficient for verifying the functional requirements.
- Data Provenance: The document does not refer to clinical data or country of origin for a test set. The validation is primarily technical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
No information is provided regarding experts establishing ground truth for a clinical "test set," as the device's performance was evaluated through bench testing and software V&V, not a clinical study involving diagnostic interpretations by experts.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study is mentioned. The document primarily focuses on demonstrating substantial equivalence through technical performance comparisons with a predicate device, rather than assessing human reader improvement with AI assistance. The device is a "digital radiography system," which captures images; it is not presented as an AI-powered diagnostic aide.
6. Standalone (Algorithm Only) Performance Study
The document describes the performance of the "SuniIQ Digital Radiography System" itself, which is a hardware and software system for capturing and displaying dental x-ray images. The "software components" within the SuniIQ handle sensor control, data transfer, and include an "optional filter algorithm" for image correction. The performance reported in the "Bench Testing" and "Software V&V" sections can be considered the standalone performance of this system, demonstrating its ability to acquire and process images. There is no mention of a separate "AI algorithm" being evaluated independently.
7. Type of Ground Truth Used
The ground truth for the evaluations conducted was primarily based on:
- Functional Requirements/Specifications: The device's performance was compared against defined functional requirements for items like relative error, X-ray saturation, image size, etc.
- Predicate Device Performance: Direct comparison to the performance of the predicate SuniRay II System (K070219) was used as a benchmark for many functional tests.
- Industry Standards: Compliance with standards like IEC 62304 for software, ISO 10993-1 for biocompatibility, IEC 60601-1 for safety, and IEC 60601-1-2 for EMC served as ground truth for regulatory and quality aspects.
- Test Pattern Images and Dental Phantom Images: These are controlled inputs with known characteristics, used to assess image quality and system response under controlled conditions.
There is no mention of pathology, expert consensus on clinical findings, or outcomes data being used as ground truth.
8. Sample Size for the Training Set
The document does not mention a "training set." The device is a digital radiography system, not a machine learning or AI algorithm in the context of typical AI device approvals that involve training datasets. The "software components" are described as drivers, control software, and an optional filter algorithm, implying traditional software development and verification rather than machine learning training.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this device.
§ 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.