(27 days)
The Computed Oral Radiology System is indicated for patients undergoing an intra-oral dental x-ray examination. It produces instant, digital, intra-oral x-ray images of a patient's mouth while reducing the necessary x-ray dosage.
The device is a small digital imaging receptor that may be used in place of dental x-ray film. The proposed device modification alters the method of communication between the sensor and computer from a wired to wireless interface, introducing a radio frequency transmitter. The wireless sensor is powered via a battery. Image acquisition is mediated through hardware rather than software components. The sensor encapsulation material has been modified from aluminum to a thermoplastic resin. The existing firmware has been altered to support the modified and additional hardware, with firmware installed on both the remote module and the sensor. The firmware on the sensor facilitates unidirectional communication of image and sensor status data to the remote module.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Schick Computed Oral Radiology System, structured to answer your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document (K022953) is a 510(k) summary for a modification to an already cleared device. As such, it primarily focuses on demonstrating substantial equivalence to the predicate device, rather than defining new, specific acceptance criteria for performance metrics like sensitivity or specificity. The "acceptance criteria" here implicitly revolve around demonstrating that the modifications did not negatively impact the established performance or safety of the predicate device.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Maintain Substantial Equivalence to Predicate Device (K933455): Ensure that the modified device (wireless communication, hardware-mediated image acquisition, thermoplastic resin encapsulation, updated firmware) retains the intended use and fundamental scientific technology governing image acquisition of the original, cleared Computed Oral Radiology System. This implies no degradation in image quality, diagnostic accuracy, or safety compared to the wired version. | The device's intended use and fundamental scientific technology governing image acquisition remain unchanged. "Those imaging parameters that could be potentially affected by the modification as are outlined generally in the document, 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' were found to be substantially equivalent to the predicate." The risk analysis determined the effect of the proposed changes to be negligible. The FDA concurred with the substantial equivalence determination. |
| Safety - Introduction of New Energy Type (Radio Frequency Transmitter): Demonstrate that the new wireless interface and associated power source (battery) do not introduce unacceptable risks. | A risk analysis was performed in conformance with ISO9001 quality program. Bench-lab measurements also supported negligible effect. The FDA cleared the device, indicating satisfaction with the safety profile of the modifications. |
| Safety - Change in Sensor Encapsulation Material: Demonstrate that the thermoplastic resin is safe for its intended use and does not pose new biocompatibility or other safety concerns. | "Thermoplastic resins are utilized in other FDA-approved dental sensors. The specific thermoplastic resin chosen for this application has been approved for incidental food contact. The duration and nature of body contact with materials in that discipline is greater than what a patient would endure with a sheath encapsulated sensor." This comparison indicates the material is deemed safe for a lesser contact duration than already approved uses. |
| Performance - Image Acquisition and Processing: Ensure that the changes to the image acquisition method (hardware vs. software polling) and firmware updates do not negatively impact the quality or speed of image acquisition. | "The operating principle differs in that image acquisition is mediated through hardware rather than software components... This modification is necessary to reduce the sensor's idle state power to a minimum." While the mechanism changed, this was done for a functional improvement (power efficiency) and the claim of substantial equivalence implies no negative impact on image quality or acquisition performance. |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify a distinct "test set" sample size for evaluating clinical image performance, nor does it provide details on data provenance (country of origin, retrospective/prospective).
The study described is primarily a risk analysis and validation study focused on the changes introduced by the modification. This type of study (for a 510(k) modification) would typically involve engineering tests, bench-top measurements, and consideration of regulatory standards to ensure the modified device functions as intended and remains safe and effective, rather than a large-scale clinical image evaluation comparing diagnostic accuracy against a new, independent test set.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Given the nature of the study as presented (risk analysis and demonstration of substantial equivalence for a device modification), there is no mention of experts establishing ground truth for a clinical image test set. The reliance is placed on demonstrating that the modified device's technical characteristics and performance are "substantially equivalent" to the previously cleared predicate.
4. Adjudication Method for the Test Set
As there is no clearly defined clinical "test set" and associated ground truth establishment described, there is no adjudication method mentioned.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No, a multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not done or described in this document. This document pertains to the sensor technology itself, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done
No, a standalone algorithm performance study was not done or described. This submission is for a dental x-ray sensor, an imaging device, not an AI algorithm.
7. The Type of Ground Truth Used
For the specific modifications described, the "ground truth" implicitly refers to:
- Engineering specifications and performance characteristics of the predicate device (e.g., imaging parameters as per the "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices").
- Safety standards and biocompatibility data for materials (thermoplastic resin).
- Risk analysis methodology (ISO9001).
There is no mention of pathology, expert consensus on clinical images, or outcomes data being used as ground truth for evaluating the changes introduced by this specific modification, because the core imaging capability was assumed to be maintained from the predicate device.
8. The Sample Size for the Training Set
This document describes a device modification, not the development of an AI algorithm based on a training set of data. Therefore, there is no concept of a "training set" sample size mentioned.
9. How the Ground Truth for the Training Set was Established
As there is no training set mentioned, there is no description of how its ground truth was established.
§ 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.