(24 days)
The CS 9600 is extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxillofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
CS 9600 is an extraoral system intended to produce two-dimensional digital X-ray images of the dento-maxilofacial, ENT (Ear, Nose and Throat), cervical spine and wrist regions at the direction of healthcare professionals as diagnostic support for pediatric and adult patients.
CS 9600 is cone-beam computed tomography (CBCT) x-ray system. It means CS 9600 rotates around the patient, capturing data using a cone-shaped x-ray beam. These data are used to reconstruct a two or a three-dimensional (3D) image of the following regions of the patient's anatomy: dental (teeth); oral and maxillofacial region (mouth, jaw and neck); ears, nose and throat region (ENT); cervical spine or wrist region.
Additional features such as low dose mode, scout image, metal artifact reduction are also provided by the CS 9600.
The provided text describes the 510(k) summary for the CS 9600 device. However, it does not include specific acceptance criteria with numerical targets, nor does it detail a study that rigorously proves the device meets such criteria in terms of clinical performance or diagnostic accuracy. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Planmeca ProMax 3D Max, K160506) through technical comparisons and general performance testing.
Here's a breakdown of the information requested, based on the provided text, and highlighting what is not present:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state numerical acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy for specific diagnostic tasks). Instead, it states that "The images were reviewed by a qualified expert and were evaluated to be of acceptable clinical effectiveness for the proposed indications for use. The CS 9600 set of images were deemed to be of a clinically usable diagnostic quality." This is a qualitative statement of performance rather than a quantitative comparison against defined criteria.
A comparison of technical specifications between the CS 9600 and its predicate device is provided, which implicitly serves as a form of "performance" comparison to demonstrate similarity.
| Feature | CS 9600 Reported Performance | Predicate Device (Planmeca ProMax 3D Max) Performance |
|---|---|---|
| General Specifications | ||
| X-ray tube voltage | 60-90 KV (60-120 kV in option) | 60-96 KV (60-120 kV in option) |
| X-ray tube current | 2-15 mA | 1-14 mA |
| Tube focal spot | 0.3 or 0.7 mm | 0.5 or 0.6 mm |
| Patient sizes | 4 (child, small adult, medium adult, large adult) | 5 (child, small adult, medium adult, large adult, extra large adult) |
| Sensor technology | CMOS | Amorphous silicon |
| Sensor active area (mm) | 120 x 140 | 193 x 242 |
| Pixel size (µm) | 100 x 100 | 127 x 127 |
| Sensor resolution | 1200 x 1400 pixels | 1536 x 1920 pixels |
| Gray scale | 16384 - 14 bits | 32768 - 15 bits |
| Limiting resolution | 5 lp/mm | 3.94 lp/mm |
| MTF, X-ray (%) at 1 lp/mm | 60 | ≥48 |
| DQE, X-ray (%) at 0 lp/mm | 60 | 70 |
| Unit dimensions (mm) | 1284 (L) x 1669 (D) x 2526 (H) | 1280 (L) x 1430 (D) x 2390 (H) |
| Two-dimensional modality: Panoramic | ||
| Magnification | 1.28 | 1.2 |
| Exposure time | 2-14 seconds | 2.7-16 seconds |
| Dose Estimation (Full Panoramic) | Child: 58.5 mGy.cm²; Adult Small: 87.8 mGy.cm²; Adult Medium: 122 mGy.cm²; Adult Large: 139 mGy.cm² | Child: 55 mGy.cm²; Adult Small: 92 mGy.cm²; Adult Medium: 111 mGy.cm²; Adult Large: 136 mGy.cm² |
| Three-dimensional modality: 3D | ||
| Magnification | 1.4 | 1.4 |
| Voxel size (µm) | 75, 150, 300 and 400 | 75, 100, 150, 200, 400 and 600 |
| Field of View (cm) | Various, e.g., 4x4 to 16x17* | Various, e.g., 5x5 to 23x26 (with stitching) |
| Exposure time | 3-20 seconds | 2.8-18 seconds |
| Dose Estimation (FoV 5x5 cm) | Child: 211 mGy.cm²; Adult Small: 220 mGy.cm²; Adult Medium: 440 mGy.cm²; Adult Large: 550 mGy.cm² | Child: 288 mGy.cm²; Adult Small: 472 mGy.cm²; Adult Medium: 598 mGy.cm²; Adult Large: 758 mGy.cm² |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "The performance testing for imaging applications was carried out taking clinical images representative of the range of the different radiological exams available." It does not specify the sample size of these clinical images, their provenance (country of origin), or whether they were collected retrospectively or prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document states: "The images were reviewed by a qualified expert." It refers to a singular "expert" and provides no details about their number, specific qualifications (e.g., years of experience, subspecialty), or how ground truth was established beyond a general review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for establishing ground truth from multiple experts. It only mentions review by "a qualified expert."
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. This device is an imaging system (CBCT scanner), not an AI-assisted diagnostic tool, so such a study would not be applicable in this context. The testing described is focused on the inherent imaging quality and clinical usability of the system itself, not its impact on human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the CS 9600 is a CBCT imaging system, not an AI algorithm. Its "performance" refers to the quality of the images it produces for human interpretation, not an automated diagnostic output.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth was established by "a qualified expert" who "evaluated [images] to be of acceptable clinical effectiveness for the proposed indications for use." This implies an expert opinion/review rather than a definitive histological (pathology) or patient outcomes-based ground truth.
8. The sample size for the training set
This device is an imaging system, not a machine learning algorithm. Therefore, there is no "training set" in the context of AI model development described in the document. The performance testing involves clinical images, but these are for testing the device's output, not for training an algorithm within the device.
9. How the ground truth for the training set was established
As there is no training set mentioned for an AI model, this question is not applicable.
§ 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.