(444 days)
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
The device consists of the following components and accessories: proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist, commercially-available metal, plastic, or ceramic brackets supplied by the orthodontist for that patient, a camera wand with a light curing feature, and customized indirect bonding trays containing the brackets, which are in a hard plastic case. The device does not include the adhesive that affixes the brackets to the teeth or the wires that are used with the brackets to form braces.
Here's an analysis of the provided text, focusing on the acceptance criteria and study data for Cadent's OrthoCAD iQ device:
Acceptance Criteria and Device Performance for Cadent's OrthoCAD iQ
Based on the provided 510(k) summary, the information regarding specific, quantifiable acceptance criteria and detailed study results is very limited. This document is a summary for regulatory approval, which often focuses on establishing substantial equivalence rather than presenting extensive clinical trial data with specific metrics.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Electrical Safety | "Testing has demonstrated the electrical safety of the OrthoCAD iQ." |
| Software Functionality/Performance | "Software verification and validation confirmed the performance of the device." |
| Intended Use Performance (Aid in orthodontic treatment planning, proper bracket placement, repositioning teeth) | "Clinical cases demonstrate that it functions as intended." |
| Substantial Equivalence to Predicate Devices | "OrthoCAD iQ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. ... The minor technological differences between this device and its predicate devices raise no new issues of safety or effectiveness. Thus, the OrthoCAD iQ is substantially equivalent." |
Critique: The acceptance criteria are broadly stated and the reported performance is qualitative rather than quantitative. There are no specific thresholds (e.g., "accuracy of bracket placement must be within X mm," or "software reliability must be Y%"). This is typical for a 510(k) summary that relies heavily on substantial equivalence to predicate devices, where the predicates' established safety and effectiveness implicitly serve as benchmarks.
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: Not specified.
- Data Provenance: The document states "Clinical cases demonstrate that it functions as intended." This implies the use of real patient data, but the country of origin, whether it was retrospective or prospective, or the number of cases are not detailed.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: The intended users are "dental professionals trained in orthodontic treatment." It can be inferred that these professionals, likely orthodontists, would have been involved in the "clinical cases." Specific qualifications (e.g., years of experience, board certification) are not provided.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. With no specified number of experts or details on how ground truth was established, an adjudication method cannot be inferred.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned or described in the provided text. The document focuses on the device's functionality and substantial equivalence, not on comparing human reader performance with and without AI assistance.
- Effect Size of Human Readers with/without AI: Not applicable, as no MRMC study was performed.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Standalone Performance Study Done: Yes, implicitly. The "Software verification and validation confirmed the performance of the device" and "Clinical cases demonstrate that it functions as intended" suggest the software's performance was evaluated independently in its role of calculating bracket positions and aiding treatment planning. However, specific metrics for this standalone performance (e.g., accuracy of bracket placement prediction) are not provided. The device itself is described as a "computer-guided system" where the software calculates bracket positions.
7. Type of Ground Truth Used
- Type of Ground Truth: Inferred to be expert consensus/clinical outcomes. The statement "Clinical cases demonstrate that it functions as intended" suggests that the success of the treatment planned and executed with the device (i.e., whether the teeth were repositioned as intended and the brackets were placed correctly to achieve this) served as the ground truth. This would typically be assessed by the treating orthodontist or a panel of experts.
8. Sample Size for the Training Set
- Training Set Sample Size: Not specified. The document describes the system's function but does not detail its development or any machine learning aspects that would explicitly involve a training set. If there's an underlying AI/machine learning component, the size of a training set would be relevant, but this information is absent. If the software is purely deterministic based on predefined rules, a "training set" in the machine learning sense might not apply.
9. How Ground Truth for the Training Set Was Established
- Ground Truth Establishment for Training Set: Not specified. Given the lack of information on a training set or explicit machine learning components, how its ground truth would be established is not addressed.
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K082207
510(k) SUMMARY
Cadent's OrthoCAD iQ
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared
OCT 2 3 2009
Cadent. Inc. 640 Gotham Parkway Carlstadt, NJ 07072
Phone: (201) 842-0800 Facsimile: (201) 842-0850
Contact Person: Edward J. Sitar
Date Prepared: October 21, 2009
Trade Name of Device
OrthoCAD iQ
Common or Usual Name of Device
Accessory to Orthodontic Brackets
Classification Name, Classification Regulation, and Product Code(s)
Classification Name: Orthodontic Plastic Brackets
Classification Regulation: 21 C.F.R. 872.5470
Product Codes: DYW (Orthodontic Plastic Bracket), NJM (Orthodontic Ceramic Bracket), and EJF (Orthodontic Metal Bracket)
Predicate Devices
Cadent Inc.'s OrthoCAD System Align Technologies, Inc.'s Invisalign System OraMetrix, Inc.'s SureSmile System
Intended Use / Indications for Use
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment
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including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
Technological Characteristics
The device consists of the following components and accessories: proprietary software that calculates the position of dental brackets based on the dental impressions and treatment plan supplied by the patient's orthodontist, commercially-available metal, plastic, or ceramic brackets supplied by the orthodontist for that patient, a camera wand with a light curing feature, and customized indirect bonding trays containing the brackets, which are in a hard plastic case. The device does not include the adhesive that affixes the brackets to the teeth or the wires that are used with the brackets to form braces.
Principles of Operation
OrthoCAD iQ's software creates a computer model of the patient's dentition based on a stone model. The orthodontist uses this computer model to determine the placement of dental brackets to achieve the intended repositioning of the teeth. Cadent, using the camera wand, manufactures an indirect bonding tray with the brackets in the positions prescribed by the orthodontist. The orthodontist uses the indirect bonding trays to place the brackets and a commercially-available dental adhesive to affix them to the patient's teeth.
Performance Data
Testing has demonstrated the electrical safety of the OrthoCAD iQ. Software verification and validation confirmed the performance of the device. Clinical cases demonstrate that it functions as intended.
Substantial Equivalence
OrthoCAD iQ has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate devices. All of these devices create customized dental appliances based on computer models of the patient's pretreatment and post-treatment dentition. The minor technological differences between this device and its predicate devices raise no new issues of safety or effectiveness. Thus, the OrthoCAD iQ is substantially equivalent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
Cadent, Incorporated C/O Ms. Laurie Clarke King & Spalding, L.L.P. 1700 Pennsylvania Avenue, North West Washington, DC 20006-4706
OCT 2:3 2009
Re: K082207
Trade/Device Name: OrthoCAD iQ Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket 8Regulatory Class: II Product Code: DYW, NJM, EJF Dated: October 19, 2009 Received: October 19, 2009
Dear Ms. Clarke:
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.
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Page 2 - Ms. Clarke
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
for
Susan Runner, D.D.S., M.A. Acting Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K082207
Device Name: OrthoCAD iQ
Indications for Use:
OrthoCAD iQ is a computer-guided system intended for use as an aid in orthodontic treatment planning for use by dental professionals trained in orthodontic treatment including radiographic analyses and treatment planning. OrthoCAD iQ is intended for use with commercially-available brackets and wires that apply continuous gentle force to reposition the teeth. It also uses indirect bonding trays to affix the brackets in position.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Keun Mickey for MSE
(Division Sign-Off)
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Division of Anesthesiology, General Hospital Infection Control, Dental Devices 082207
510(k) Number:
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.