(58 days)
Ceph Model 4900 is indicated for individuals who require extra-oral dental radiographic examinations.
The Ceph Model 4900 is intended to replace x-ray film in the acquisition of diagnostic cephalometric x-ray images of the skull as are commonly used in orthodontics to measure skeletal changes and monitor oral growth and development. The device works with a cleared x-ray device, along with a specialized collimator and positioning elements that are bundled together and sold as the PanCeph system.
The provided text describes a 510(k) premarket notification for the Schick Ceph Model 4900, a digital x-ray extraoral source system for cephalometric examinations.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission is for a 510(k) for a medical device. For 510(k) submissions, the primary "acceptance criterion" is generally substantial equivalence to a legally marketed predicate device. This means the new device must have the same intended use and be as safe and effective as the predicate, or have different technological characteristics but not raise different questions of safety and effectiveness.
The document does not provide a table with specific, quantifiable acceptance criteria or performance metrics (e.g., sensitivity, specificity, accuracy, resolution, signal-to-noise ratio) and their corresponding reported device performance values. Instead, it makes general claims of equivalence.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence | "Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed device." |
| Electrical Safety Standards Compliance | "The device has been tested to comply with applicable electrical safety standards required for CE marking." |
| FDA Guidance Compliance | "It also complies with FDA documents 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' and 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'." |
| Radiation Dose/Scatter | "A radiation survey has confirmed that the system, when used with the generator, imparts similar scatter, and less dose as compared to the film predicate." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set. The testing described focuses on compliance with standards and a radiation survey comparing to a film predicate. No patient data or image dataset testing is explicitly mentioned. The data provenance is not applicable as no test set of clinical data is described.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as no test set requiring expert ground truth establishment is described. The submission focuses on device characteristics and comparison to a predicate, not clinical performance evaluation with expert adjudication.
4. Adjudication Method for the Test Set
This information is not provided as no test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size
No MRMC study is mentioned in the provided text. The submission focuses on establishing substantial equivalence based on technical characteristics and regulatory compliance, not on comparing reader performance with and without AI assistance.
6. If a Standalone Performance Study was done
A standalone performance study, as typically understood for AI algorithms (i.e., algorithm only without human-in-the-loop performance using a clinically relevant image dataset), was not explicitly described in the provided text. The "Testing" section mentions electrical safety, compliance with FDA guidance for solid-state x-ray imaging devices and software, and a radiation survey. These are device-level safety and performance checks, not a clinical standalone performance study against a ground truth.
7. The Type of Ground Truth Used
The concept of "ground truth" as it relates to clinical accuracy (e.g., expert consensus, pathology, outcome data) is not applicable or mentioned in the context of the testing performed. The "ground truth" here is implied by the predicate device's established safety and effectiveness, and the device's adherence to regulatory standards and performance characteristics (like radiation output).
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device described is a digital x-ray hardware system with integrated software. The submission does not indicate that the device uses machine learning or AI that would require a "training set" in the conventional sense of an AI model. The integrated software is described as "similar to that utilized in the COMPUTED ORAL RADIOLOGY SYSTEM (K041385)," implying re-use or adaptation of existing software, not the training of a new AI model.
9. How the Ground Truth for the Training Set was Established
This information is not applicable and not provided for the same reasons as #8.
§ 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.