(126 days)
Dental Cone-beam Computed Tomography (Model:iDT901X1) is intended to produce two-dimensional digital x-ray images including panoramic and cephalometric image, and three-dimensional digital x-ray images of the dental, oral, maxillofacial region, at the direction of healthcare professionals as diagnostic support for adult and pediatric patients.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
( Product Name: Dental Cone-beam Computed Tomography, The product Model:iDT901X1) uses cone-beam computed tomography (CBCT) through X-ray cone-beam, panoramic radiography, cephalometric radiography to produce images of the dental, oral and maxillofacial areas to provides diagnostic details for the medical facilities. This product consists of Frame, X-ray generator (including Integrated X-ray source tube head, X-ray tube,Collimator), Image receptor and Image processing system (including Computer, Monitor, Software workstation).
The provided document is a 510(k) Summary for a Dental Cone-beam Computed Tomography device (Model: iDT901X1). It includes a comparison with a predicate device and a summary of testing conducted. Based on the document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of specific quantitative acceptance criteria for image quality and a direct comparison with reported device performance in a tabular format. However, it broadly states that "The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric" based on a clinical evaluation.
Instead of clear acceptance criteria for image quality, the document lists various standards and guidance documents that the device complies with, which implicitly define performance expectations in relation to safety, electromagnetic compatibility, radiation protection, usability, software lifecycle, and acceptance tests for imaging performance. These standards serve as the basis for the "acceptance criteria" and the device's adherence to them is the "reported device performance."
Here's an interpretation based on the provided text, focusing on performance aspects mentioned in the comparison table and the summary of non-clinical tests:
| Acceptance Criterion (Implicit) | Reported Device Performance (Compliance/Characteristic) |
|---|---|
| Image Quality (General Acceptability) | "The overall image quality was acceptable for all cases and image types in various scanning mode for both adult and pediatric." (Based on clinical evaluation by a radiologist) |
| Device Performance (Safety & Effectiveness Equivalent to Predicate) | "The Dental Cone-beam Computed Tomography (Model:iDT901X1 ) and its predicate device, have the equivalent intended use, functions and similar physical characteristics, performance characteristics." "The differences between the proposed device and the predicate device will not raise any new issues of safety or effectiveness." "The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device." |
| Electrical Safety | Compliance with IEC60601-1 Edition 3.2 2020-08 and ANSI/AAMI ES:60601-1:2005/A2:2010/AMD2:2021. |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 Edition 4.1 2020-09 and IEC /TR 60601-4-2 Edition 1.0 2016-05. |
| Radiation Safety/Protection | Compliance with IEC 60601-1-3 Edition 2.2 2021-01 and 21 CFR 1020.30, 21 CFR 1020.31, 21 CFR 1020.33. |
| Usability | Compliance with IEC 60601-1-6 Edition 3.2 2020-07 and IEC 62366-1 Edition 1.1 2020-06. |
| Software Life Cycle Processes | Compliance with IEC 62304 Edition 1.1 2015-06. |
| Performance for Dental X-ray Equipment (General) | Compliance with IEC 60601-2-63 Edition 1.1 2017-07. |
| Acceptance Tests for Imaging Performance of Dental X-ray Equipment | Compliance with IEC 61223-3-4:2000. |
| Acceptance Tests for Imaging Performance of X-ray Equipment for Dental Cone Beam Computed Tomography | Compliance with IEC 61223-3-7 Edition 1.0 2021-12. |
| Biocompatibility | Compliance with ISO 10993-1, -5, -10, -23 series. |
| Spatial Resolution (comparison to predicate) | Subject Device: 5 lp/mm; Predicate Device: 4 lp/mm. (Subject device meets or exceeds this aspect compared to predicate which implies meeting or exceeding the acceptance criteria if predicate is considered a benchmark) |
| Scan Time (CBCT, Panoramic, Cephalometric) (comparison to predicate/functional performance) | CBCT: 22s (Predicate: 10-20s); Panoramic: 15s (Predicate: 8-16s); Cephalometric: 2.3s (Predicate: 0.16s). (These are functional characteristics. The document implies these times are acceptable for the intended use and do not raise new safety/effectiveness concerns, even if some are longer than the predicate). |
| General performance for overall operation by taking and reviewing test images (bench testing summary statement) | "Validation was performed for overall operation by taking and reviewing test images. The non-clinical tests demonstrate that the device is as safe, as effective, and performs as well as the predicate device." (This confirms that operational performance was validated and found acceptable, though specific metrics are not detailed.) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document refers to "a number of sample scans and diagnostic images" for the clinical evaluation. It does not specify the exact number of cases or images used in this "test set."
- Data Provenance: Not specified. The document states that the manufacturer is "Yian Medical Technology (Haining) Co., Ltd." in CHINA, but does not explicitly mention the country of origin for the clinical evaluation data. It also does not specify if the data was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: "One US radiation-board certified experienced radiologists."
- Qualifications: "US radiation-board certified experienced radiologists." No specific years of experience are mentioned.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable/Not specified. The clinical evaluation was performed by a single radiologist who "studied independently a number of sample scans and diagnostic images to score different essential image quality related items." There is no mention of an adjudication process for consensus or conflict resolution, as only one expert was involved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size
- MRMC Study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The clinical evaluation involved a single radiologist.
- Effect Size of Human Readers Improvement with AI vs. without AI: Not applicable, as no AI component for image interpretation by human readers is described in the provided sections, nor was an MRMC study conducted. The device is a Dental Cone-beam Computed Tomography system for image acquisition, not an AI software for interpretation assistance.
6. If a Standalone (i.e. Algorithm only without human-in-the-loop performance) was Done
- Standalone Performance: The document describes the device as a "Dental Cone-beam Computed Tomography" system, which is a hardware device that produces X-ray images. There is no mention of an independent algorithm or AI component that would have standalone performance separate from human-in-the-loop operation. The "image processing system" is part of the overall device. However, the summary of testing includes "overall operation by taking and reviewing test images" and "image quality was acceptable," which implies an evaluation of the device's intrinsic imaging capabilities.
7. The Type of Ground Truth Used
- Type of Ground Truth: The ground truth for the clinical evaluation of image quality was based on expert consensus (or in this case, expert opinion from a single radiologist). The radiologist "scored different essential image quality related items." There is no mention of pathology or outcomes data being used as ground truth.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not specify a training set sample size. The device is a hardware imaging system with an image processing system, not a machine learning algorithm or AI model that typically requires a distinct training set in the context of diagnostic performance evaluation for regulatory submission. The term "training set" is not used in relation to device performance testing in this document.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as no training set for a machine learning model is mentioned or implied by the document.
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.