(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.
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K05-3558
FEB 1 7 2006
Exhibit IV: 510(k) Summary
Schick Ceph Model 4900
Common/Classification Name: "DIGITAL X-RAY EXTRAORAL SOURCE SYSTEM" 21CFR872.1800
Schick Technologies, Inc. 30-00 47th Avenue Long Island City, NY 11101 718-937-5765, 718-937-5962 (FAX) Contact: Daniel Michaeli, Prepared: December 1, 2005
A. Legally Marketed Predicate Devices
KODAK T-MAT G FILM SO-381 (K837506) is a legally marketed predicate receptor that is indicated for cephalometric examinations. The CDR PANX, MODEL 4792 (K031291) is a legally marketed predicate x-ray generator indicated for extra-oral dental exams, and will be utilized as the host generator on the Ceph Model 4900. The integrated software is similar to that utilized in the COMPUTED ORAL RADIOLOGY SYSTEM (K041385).
B. Device Description
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.
C. Indications for Use
Ceph Model 4900 is indicated for individuals who require extra-oral dental radiographic examinations.
D. Substantial Equivalence Summary
The Ceph Model 4900 has the similar indications for use and is substantially equivalent to other cephalometric units currently marketed in the U.S (e.g. K837506). The already cleared CDR PANX, MODEL 4792 will be utilized as the
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extra-oral generator for this device. The device utilizes substantially equivalent software to the COMPUTED ORAL RADIOLOGY SYSTEM.
E. Testing
The device has been tested to comply with applicable electrical safety standards required for CE marking. 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". 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.
F. Conclusions
Schick Technologies has demonstrated through careful analysis and validation studies that the device is substantially equivalent to the already cleared and marketed device.
.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
FEB 1 7 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Schick Technologies, Inc. % Mr. Daniel W. Lehtonen Staff Engineer-Medical Devices Intertek Testing Services NA, Inc. 70 Codman Hill Road BOXBOROUGH MA 01719
Re: K053558
Trade/Device Name: Ceph Model 4900 Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: II Product Code: MUH Dated: February 2, 2006 Received: February 3, 2006
Dear Mr. Lehtonen:
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 do increative apperal controls provisions of the Act. The general controls provisions of the Act de nee, sayer to not go and prohibitions against misbranding and adulteration.
If your device is classified (see above) into cither class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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) (2) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) Fills tetter with anow you to organization of substantial equivalence of your device to a legally premative notification: "The 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 If you desire specific at nee for your de rest the following numbers, based on the regulation number at the top of this letter:
| 21 CFR | ||
|---|---|---|
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the 007.77). Tou may ootan outer gational 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/industrv/support/index.html.
Sincerely yours.
Nancy C. Brigdon
Nancy (). Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
K05-3558
Device Name: Ceph Model 4900
Indications For Use:
The Ceph Model 4900 is indicated for individuals requiring extra-oral dental examinations.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David B. Hunnem
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 510(k) Number
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§ 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.