(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.
{0}------------------------------------------------
OCT 02 2002
Exhibit IV: 510(k) Summary
Schick Computed Oral Radiology System
Common/Classification Name: Solid State X-ray Imager 21 CFR892.1650
Schick Technologies, Inc. 30-00 47th Avenue Long Island Citv. NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: September 4, 2002
A. Legally Marketed Predicate Devices
The original Computed Oral Radiology System notification was cleared on January 31st, 1994 (K933455). The device and its predicate are small digital imaging receptors that may be used in place of dental x-ray film.
B. Modification Description
The proposed device modification alters the method of communication between the sensor and computer from a wired to wireless interface. Thus, there is an introduction of a new energy type, a radio frequency transmitter. In this mode, the wireless sensor is powered via a battery rather than a DC-supply derived from AC mains voltage.
The operating principle differs in that image acquisition is mediated through hardware rather than software components. Whereas software in the predicate device "polled" the sensor to investigate whether acquisition had commenced, the modified device utilizes a hardware component. This modification is necessary to reduce the sensor's idle state power to a minimum.
To facilitate RF transmission, the sensor encapsulation material has been modified from aluminum to a thermoplastic resin. 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.
The existing firmware has been altered to support the modified and additional hardware. Whereas the predicate device had firmware installed on the Remote module, the new device has firmware installed both on the remote module and
{1}------------------------------------------------
on the sensor. The firmware on the sensor facilitates unidirectional communication of image and sensor status data to the remote module.
C. Indications for Use
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 dosaqe. This device modification in no way alters the indications for use of this machine bevond what was originally approved in K933455.
D. Substantial Equivalence Summary
The intended use of the Computed Oral Radiology System remains unchanged. The new product transmits data through a wireless rather than wired interface to the host image processing system. This and the concomitant modifications in no way alter the fundamental scientific technology governing image acquisition. 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.
E. Technological Characteristics
Part B of this section describes the technological characteristics of the modified device. The technological characteristics of this machine have been examined through a risk analysis. The fundamental technology remains unchanged from the predicate.
F. Risk Analysis and Validation study
As a result of risk analysis activities performed in conformance with our ISO9001 quality program along with supporting bench-lab measurements, Schick Technologies has determined the effect of the proposed changes to be negligible.
G. Conclusions
Schick Technologies has demonstrated through a risk analysis and validation studies that the device modification is substantially equivalent to the already cleared and marketed device.
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.
Public Health Service
OCT 02 2002
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Daniel Michaeli, M.S. Product Manager Schick Technologies, Inc. 30-00 47" Avenue LONG ISLAND CITY NY 11101 Re: K022953
Trade/Device Name: Computed Oral Radiology System Regulation Number: 21 CFR §892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Product Code: 90 MQB Regulation Number: 21 CFR §872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: 90 MUH Dated: September 3, 2002 Received: September 5, 2002
Dear Mr. Michaeli:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
{3}------------------------------------------------
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{4}------------------------------------------------
Exhibit III: Indications for Use
Page_1__of_1
510(k) Number (if known):____________________________________________________________________________________________________________________________________________________
Computed Oral Radiology System Device Name:
Indications For Use:
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.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
David A. Siggons
(Division Sign-Off) Division of Reproduc and Radiological Dev 510(k) Number
ﻪ Prescription Use
§ 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.