(88 days)
Tomographic X-ray System, which is intended for diagnostic dental radiography at the dento-maxillofacial region and additionally cephalometry. The imaging methods are narrow beam radiography and spiral tomography and central projection cephalometry.
Cranex Tome Ceph is a high frequency Tomographic, Radiographic system capable of producing dental panoramic and tomographic images, TMJ (TemporoMandibular Joint) tomographic images and cephalometric images. It is available in two models with (Cranex Tome Ceph) and without (Cranex Tome) the cephalometric option. The Cranex TOME uses the principle of autotomography with a spiral blurring movement. This movement, which is similar to the movement used by the Soredex SCANORA®, is achieved by tilting and rotating the C-arm at the same time.
The Cranex Tome comprises of
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moving column
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C-arm
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An adjustable two-position chin support is used to carry out all exposure procedures.
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Four-point head support and bite-block system
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A large adjustable mirror
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The patient positioning lights
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control panel
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graphical display
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wide range of x-ray programs for mandible, maxilla, temporomandibular joint,
sinus, and cephalometric exposures.
- high-frequency generator
-15x30 cm panoramic cassette for paroramic and tomographic imaging
And the following with the cephalometric unit
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Soft tissue filter adjustment with LED positioning indicators
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selectable magnification ratio and a rotatable head support with positioning stops every 45 degrees.
-The system software makes it impossible to take an exposure if the cephalometric cassette is the wrong size or incorrectly positioned.
-Accepts 18x24, 8"x10" or 24x30 cm cephalometric cassettes
- The cephalometric arm can be mounted on either the left- or the right-hand side of the unit
-An cephalometric kit is available so that Cranex TOME can be upgraded to a Cranex TOME Ceph .
The submitted text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format typically required for modern medical device submissions. This document is a 510(k) summary from 1998, which typically focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance metrics from a dedicated study.
However, based on the provided text, I can infer and extract some information:
1. A table of acceptance criteria and the reported device performance
The document broadly states "Safety and effectiveness is demonstrated by: - clinical tests - software verification, validation and certification procedures - risk analysis - risk management file". It concludes that the device is "safe and effective when the unit is used as labeled." However, no specific performance metrics like sensitivity, specificity, accuracy, or quantitative image quality assessments are provided, nor are numerical acceptance criteria against which they would be measured.
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Safety | Demonstrated through clinical tests, software verification/validation/certification, risk analysis, and risk management file. | No specific quantitative safety metrics or thresholds are provided. |
| Effectiveness | Demonstrated through clinical tests, software verification/validation/certification, risk analysis, and risk management file. | No specific quantitative effectiveness metrics (e.g., image quality scores, diagnostic accuracy) or thresholds are provided. The general statement is that it's "effective when the unit is used as labeled" for producing X-ray images for dentistry, TMJ, and skull. |
| Substantial Equivalence | The Cranex Tome Ceph is substantially equivalent to predicate devices (Scanora, Oralix DC III Ceph/Cranex 3 Ceph) in design, operational, and functional features. | This is the primary "performance" metric for a 510(k) submission of this era. |
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 "clinical tests" as part of the safety and effectiveness demonstration. However, it does not provide any details about:
- The sample size of patients or images used in these clinical tests.
- The data provenance (e.g., country of origin, retrospective or prospective nature).
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 does not provide any information about experts involved in establishing ground truth for any tests, nor their qualifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not provide any information about an adjudication method.
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
This document is from 1998, well before AI assistance in radiology was prevalent. It does not mention any MRMC study or AI assistance. The focus is on the device itself as an imaging system, not on software-assisted interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Given the device is an X-ray imaging system, and the submission date, the concept of "standalone algorithm performance" as understood today (e.g., for AI/CAD systems) is not relevant. The device's performance is inherently tied to producing images for human interpretation. Therefore, no standalone algorithm-only performance assessment would have been conducted or reported in this context.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not explicitly state the type of ground truth used for its "clinical tests." However, for an imaging device, ground truth often involves clinical diagnosis, expert radiological interpretation, or in some cases, pathology, depending on the specific application. Without further detail, it's impossible to specify.
8. The sample size for the training set
The device is a hardware imaging system, not an AI algorithm that requires a training set in the modern sense. Therefore, the concept of a "training set sample size" as applies to machine learning models does not apply to this submission.
9. How the ground truth for the training set was established
As explained above, the concept of a "training set" in the context of an AI algorithm does not apply to this device. Therefore, this question is not applicable.
§ 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.