(84 days)
The 3D Accu-I-tomo is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.
The C-arm assembly is mounted to the support column, which has an x-ray control panel for loading factors, an emergency stop switch, and a remote control for patient positioning. The C-arm assembly includes an image intensifier and an x-ray head with a beam-limiting device. The control box, which includes operational lights and an x-ray emission button, is typically placed in a separate room from the rest of the system. The patient chair includes an armrest and a headrest to fix the patient's head during the x-ray emission. An optional headrest for ENT applications is available which can be replaced with the headrest for dental applications.
A Windows-based personal computer is connected to the 3D Accu-I-tomo, on which is installed "3DXD" driver software and "3DX Integrated Information System" application software. For the network environment, "3DXD" driver software and "3DX Integrated Information System" are installed in the server computer and "3DX Integrated Information System" is installed in the client computer. The Windows-based personal computer is not manufactured by J. Morita Manufacturing Corp.
The 3D Accu-I-tomo operates in either CT mode or Fluoroscopic mode. In CT mode, it generates three-dimensional images that make possible precise diagnosis of the head and neck areas. It produces high resolution images and uses less x-radiation in comparison with conventional computed tomography x-ray systems. Fluoroscopy is available using the same x-ray head and image intensifier that are used for the CT mode. Fluoroscopy is mainly used with a contrast medium for ENT applications and surgery of the TM Joint. The same device can provide three-dimensional images and fluoroscopy. Both two- and three-dimensional images are taken for diagnosis before and after surgery. The fluoroscopic setting has three modes: a fluoroscopic moving image mode, a still image mode, and a testing mode. In the testing mode, it can take but not save a moving image.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets them. The document is primarily a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices and compliance with regulatory standards, rather than presenting a detailed performance study with acceptance criteria.
However, based on the information provided, we can infer some general areas of performance that were assessed and the types of tests conducted:
Inferred Acceptance Criteria and Reported Device Performance (General):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Image Quality: Produce high-resolution images for diagnosis of head and neck areas. | "It produces high resolution images." "The 3D Accu-I-tomo also passed the image quality testing." |
| X-ray Radiation Dose: Use less x-radiation compared to conventional CT systems. | "uses less x-radiation in comparison with conventional computed tomography x-ray systems." |
| Software Functionality and Safety: Software performs as intended, free from critical defects, and adheres to safety standards. | "The software used in the 3D Accu-I-tomo has been successfully validated by J. Morita Manufacturing Corp. The software validation report describes: the development process for the device's firmware; and driver software and application software installed in Windows-based personal computer; the software change control and code revision procedures; the system and software requirements; the software handling and storage procedures; a hazard analysis; and a software/firmware certification that the company followed the above-described procedures and policies." |
| Electrical, Mechanical, and Thermal Safety: Compliance with relevant international safety standards. | "The 3D Accu-I-tomo was tested to ensure compliance with UL2601-1 and IEC 60601-1, and its collateral standards, and it complied with the applicable requirements." "The 3D Accu-I-tomo complies with the applicable thermal, mechanical, and electrical safety requirements of UL2601-1, IEC 60601-1, and its collateral standards..." |
| Biocompatibility: Body-contacting surfaces are biocompatible. | "The 3D Accu-I-tomo uses biocompatible plastics on all body contacting surfaces... Such plastics have been used in predicate devices or widely used in other medical applications in which the plastic is in contact with the patient's body." |
| Regulatory Compliance: Compliance with FDA regulations. | "The 3D Accu-I-tomo will be tested and will comply with the applicable requirements of 21 CFR Subchapter J prior to marketing." (This is a forward-looking statement for approval.) |
Detailed Information Not Available in the Provided Text:
The provided 510(k) summary does not contain the following specific information regarding a detailed study:
- Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): This information is not present. The document mentions "image quality testing" was passed but provides no details on the study design or data characteristics.
- 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): This information is not present.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: This information is not present.
- 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: This information is not present. The device is a tomograph (imaging hardware with associated software for reconstruction and viewing), not specifically an AI-driven diagnostic aid that would typically be evaluated with MRMC studies for reader performance improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present. The device's software is integral to image reconstruction and display, but the document doesn't describe an "algorithm-only" performance evaluation in a diagnostic context.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not present for any specific image quality or diagnostic performance study.
- The sample size for the training set: This information is not present. The document refers to "software validation" and "development process for the device's firmware; and driver software and application software," which implies testing and development, but not specifically machine learning model training.
- How the ground truth for the training set was established: This information is not present.
Summary of Study Information Available:
The document primarily focuses on regulatory compliance and substantial equivalence to predicate devices (Siemens Medical Systems' Siremobil C02, Siemens Siremobil Iso-C 3D Imaging Option, and NIM s.r.l.'s NewTom Model QR-DVT 9000).
The "study" or testing mentioned includes:
- Software Validation: This confirms the development process, requirements, hazard analysis, and adherence to procedures for firmware, driver, and application software.
- Compliance Testing: For safety standards like UL2601-1, IEC 60601-1, and anticipated 21 CFR Subchapter J.
- Image Quality Testing: Stated that it "passed," but no details on the methodology, metrics, or independent evaluation are provided.
In conclusion, while the document asserts that the device meets certain high-level performance attributes (high-resolution images, less radiation, successful software validation, image quality pass), it does not provide the specific details of a clinical or technical study that would delineate precise acceptance criteria alongside detailed performance metrics, sample sizes, expert qualifications, or ground truth establishment. This is typical for a 510(k) summary demonstrating substantial equivalence for an imaging device whose core technology is well-established.
§ 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.