(103 days)
Not Found
Yes
The device description explicitly states that the "Machine Learning model creates predictions in the Decision Layer".
No
The device is a computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries, providing additional information for diagnosis rather than directly treating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs" and "provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious." This directly relates to the diagnostic process.
Yes
The device description explicitly states "OCA-Ped is a software-only device".
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Overjet Caries Assist-Pediatric (OCA-Ped) analyzes radiological images (bitewing and periapical radiographs). These are images of the inside of the body, not samples taken from the body.
- Intended Use: The intended use is to aid in the detection and segmentation of caries on these radiographs. This is an analysis of imaging data, not a test performed on a biological sample.
Therefore, while it is a medical device used in diagnosis, it falls under the category of radiological image analysis software rather than an in vitro diagnostic device.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.
Product codes
MYN
Device Description
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
OCA-Ped is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Laver and results are pushed to the dashboard, which are in the Presentation Layer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
bitewing and periapical radiographs
Anatomical Site
teeth
Indicated Patient Age Range
4-11 years old
Intended User / Care Setting
clinician or dentist
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
MRMC Reader Study:
636 images, each from a unique patient. Roughly half the images had caries, and half without. Images were obtained from male and female patients aged 4-11 years. The results were compared to the consensus reference standard established by 3 general dentists.
Standalone Performance Testing:
1190 bitewing and periapical images. The dataset was split with roughly 50-50 images with and without caries, for patients aged 4-11. Images were obtained from male and female patients, from a range of distinctly different geographic regions. The results were compared to the consensus reference standard established by 3 general dentists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MRMC Reader Study:
Overjet evaluated the Overjet Caries Assist-Pediatric "OCA-Ped" in a multi reader multi case (MRMC) fully crossed reader improvement study. 20 US licensed dentists were asked to evaluate 636 images, each from a unique patient. The results were compared to the consensus reference standard established by 3 general dentists. Half of the data set contained unassisted images, and the second half contained radiographs that had been "assisted" or processed through the OCA-Ped device. The AUC of the wAFROC averaged across all readers showed a 7.5% improvement, with 95% Cl's (0.062, 0.088) in assisted readers compared to unassisted readers. The p-value was highly statistically significant. Average Tooth level sensitivity across all readers increased by 11.8% (0.102, 0.137) when compared to unassisted readers. The average specificity at the tooth level decreased slightly with a difference of -0.011 (-0.015, -0.008) between the assisted and unassisted readers.
Standalone Performance Testing:
Standalone performance of the Overiet Caries Assist-Pediatric device was evaluated for 1190 bitewing and periapical images. The dataset was split with roughly 50-50 images with and without caries, for patients aged 4-11. Images were obtained from male and female patients, from a range of distinctly different geographic regions. The results were compared to the consensus reference standard established by 3 general dentists. Tooth level standalone sensitivity was 83.9%, 95% CI's (0.816, 0.860). Tooth Level standalone specificity was 97.5%, 95% CI's (0.971, 0.979). Standalone Dice was a mean of 79.0%, 95% CI's (0.784, 0.797).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
MRMC Reader Study:
AUC of the wAFROC: 7.5% improvement, with 95% Cl's (0.062, 0.088) in assisted readers compared to unassisted readers.
Average Tooth level sensitivity: increased by 11.8% (0.102, 0.137) when compared to unassisted readers.
Average specificity at the tooth level: decreased slightly with a difference of -0.011 (-0.015, -0.008) between the assisted and unassisted readers.
Standalone Performance Testing:
Tooth level standalone sensitivity: 83.9%, 95% CI's (0.816, 0.860).
Tooth Level standalone specificity: 97.5%, 95% CI's (0.971, 0.979).
Standalone Dice: mean of 79.0%, 95% CI's (0.784, 0.797).
Tooth Level Standalone Sensitivity with 95% CI's by sensor category:
Carestream 0.870 (0.832, 0.900)
Dexis 0.872 (0.841, 0.902)
E2V 0.761 (0.713, 0.806)
Gendex 0.843 (0.800, 0.882)
Schick 0.844 (0.805, 0.878)
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2070 Medical image analyzer.
(a)
Identification. Medical image analyzers, including computer-assisted/aided detection (CADe) devices for mammography breast cancer, ultrasound breast lesions, radiograph lung nodules, and radiograph dental caries detection, is a prescription device that is intended to identify, mark, highlight, or in any other manner direct the clinicians' attention to portions of a radiology image that may reveal abnormalities during interpretation of patient radiology images by the clinicians. This device incorporates pattern recognition and data analysis capabilities and operates on previously acquired medical images. This device is not intended to replace the review by a qualified radiologist, and is not intended to be used for triage, or to recommend diagnosis.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Design verification and validation must include:
(i) A detailed description of the image analysis algorithms including a description of the algorithm inputs and outputs, each major component or block, and algorithm limitations.
(ii) A detailed description of pre-specified performance testing methods and dataset(s) used to assess whether the device will improve reader performance as intended and to characterize the standalone device performance. Performance testing includes one or more standalone tests, side-by-side comparisons, or a reader study, as applicable.
(iii) Results from performance testing that demonstrate that the device improves reader performance in the intended use population when used in accordance with the instructions for use. The performance assessment must be based on appropriate diagnostic accuracy measures (
e.g., receiver operator characteristic plot, sensitivity, specificity, predictive value, and diagnostic likelihood ratio). The test dataset must contain a sufficient number of cases from important cohorts (e.g., subsets defined by clinically relevant confounders, effect modifiers, concomitant diseases, and subsets defined by image acquisition characteristics) such that the performance estimates and confidence intervals of the device for these individual subsets can be characterized for the intended use population and imaging equipment.(iv) Appropriate software documentation (
e.g., device hazard analysis; software requirements specification document; software design specification document; traceability analysis; description of verification and validation activities including system level test protocol, pass/fail criteria, and results; and cybersecurity).(2) Labeling must include the following:
(i) A detailed description of the patient population for which the device is indicated for use.
(ii) A detailed description of the intended reading protocol.
(iii) A detailed description of the intended user and user training that addresses appropriate reading protocols for the device.
(iv) A detailed description of the device inputs and outputs.
(v) A detailed description of compatible imaging hardware and imaging protocols.
(vi) Discussion of warnings, precautions, and limitations must include situations in which the device may fail or may not operate at its expected performance level (
e.g., poor image quality or for certain subpopulations), as applicable.(vii) Device operating instructions.
(viii) A detailed summary of the performance testing, including: test methods, dataset characteristics, results, and a summary of sub-analyses on case distributions stratified by relevant confounders, such as lesion and organ characteristics, disease stages, and imaging equipment.
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Image /page/0/Picture/0 description: The image contains the logo of the FDA U.S. Food & Drug Administration. The logo consists of the FDA acronym in a blue box, followed by the full name of the organization in blue text. The text is stacked, with "U.S. FOOD & DRUG" on the top line and "ADMINISTRATION" on the bottom line.
March 4, 2024
Overjet, Inc % Deepthi Paknikar Senior Manager, Regulatory and Clinical Affairs 50 Milk Street, 16th Floor BOSTON, MA 02109
Re: K233738
Trade/Device Name: Overjet Caries Assist-Pediatric Regulation Number: 21 CFR 892.2070 Regulation Name: Medical Image Analyzer Regulatory Class: Class II Product Code: MYN Dated: February 2, 2024 Received: February 2, 2024
Dear Deepthi Paknikar:
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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Lu Jiang
Lu Jiang, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiologic Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K233738
Device Name
Overjet Caries Assist-Pediatric
Indications for Use (Describe)
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
NOVERJET
K233738
Applicant Name: Overjet, Inc Applicant Address: 50 Milk Street 16th Floor Boston MA 02109 United States Applicant Contact Telephone: 630-201-1612 Applicant Contact: Dr. Deepthi Paknikar Applicant Contact Email: deepthi.paknikar@overjet.ai Correspondent Name: Overjet, Inc Correspondent Address: 50 Milk Street 16th Floor Boston MA 02109 United States Correspondent Contact Telephone: 630-201-1612 Correspondent Contact: Dr. Deepthi Paknikar Correspondent Contact Email: deepthi.paknikar@overjet.ai
Device Trade Name: Overjet Caries Assist-Pediatric Classification Name: Medical image analyzer Common Name: Analyzer, Medical Image Regulation Number: 892.2070 Product Code: MYN
Legally Marketed Predicate Device: Overjet Caries Assist Predicate Product Code: MYN Predicate K number: K222746
Device Description Summary
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted
detection (CADe) software intended to aid in the detection and segmentation of caries on bitewing and periapical radiographs. The device provides additional information for the dentist to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
OCA-Ped is a software-only device which operates in three layers: a Network Layer, a Presentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Laver and results are pushed to the dashboard, which are in the Presentation Layer.
Intended Use/Indications for Use
Overjet Caries Assist-Pediatric (OCA-Ped) is a radiological, automated, concurrent-read, computer-assisted detection (CADe) software intended to aid in the detection and segmentation of caries
4
on bitewing and periapical radiographs. The device provides additional information for the clinician to use in their diagnosis of a tooth surface suspected of being carious. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that takes into account other relevant information from the image, patient history, or actual in vivo clinical assessment.
The intended patient population of the device is patients aged 4-11 years old that have primary or permanent teeth (primary or mixed dentition) and are indicated for dental radiographs.
Indications for Use Comparison
The minor differences between the Overjet Caries Assist-Pediatric "OCA-Ped" subject device and the Primary Predicate Device Overjet Caries Assist "OCA" (K222746) do not constitute a new intended use. The OCA-Ped device shares the same intended use as the primary predicate, and the device is intended to aid in the detection of caries on 2D bitewing and periapical radiographs. The primary predicate device is intended to be used for patients with permanent teeth, ages 12+. The subject OCA-Ped device is intended to be used for patients with permanent and primary teeth (primary or mixed dentition) ages 4-11. The OCA-Ped device is a concurrent read device same as the primary predicate device. The primary predicate device outputs a polygon annotation in areas of suspected caries, that can be adjusted, hidden, deleted, and viewed with or without a color fill. The subject device has the same output and same adjustable features for the user. Both devices are intended to be diagnostic aids, and provide information for clinicians to use as additional in their clinical examinations. Both devices are not intended to replace a complete review and clinical judgment of a clinician. The performance testing for the Overjet Caries Assist-Pediatric device demonstrates that aided readers improve in detection of caries over unaided readers.
Technological Comparison
There are no differences in technological characteristics that raise a concern of substantial equivalence as demonstrated by the performance and software testing of the Overjet Caries Assist-Pediatric device.
Non-Clinical and/or Clinical Tests Summary & Conclusions
MRMC Reader Study
Overjet evaluated the Overjet Caries Assist-Pediatric "OCA-Ped" in a multi reader multi case (MRMC) fully crossed reader improvement study. 20 US licensed dentists were asked to evaluate 636 images, each from a unique patient. Roughly half the images had caries, and half without. Images were obtained from male and female patients aged 4-11 years. The results were compared to the consensus reference standard established by 3 general dentists.
Half of the data set contained unassisted images (raw images not run on the OCA-Ped device), and the second half contained radiographs that had been "assisted" or processed through the OCA-Ped device. The radiographs were presented to the readers in alternating groups. A 4 week washout period was utilized between two sessions to limit recollection bias. Following the washout, the readers were presented the same data set but with alternate grouping.
5
Image /page/5/Picture/0 description: The image shows the logo for Overjet. The logo consists of a stylized blue tooth icon on the left, followed by the word "OVERJET" in a light blue sans-serif font. The tooth icon is a geometric design, giving it a modern and technological appearance.
The results were compared against a consensus ground truth, and the area under the curve (AUC) of the wAFROC was evaluated as a primary endpoint to characterize the performance of the readers assisted and unassisted by the Overjet Caries Assist-Pediatric device.
The AUC of the wAFROC averaged across all readers showed a 7.5% improvement, with 95% Cl's (0.062, 0.088) in assisted readers compared to unassisted readers. The p-value was highly statistically significant.
Average Tooth level sensitivity across all readers increased by 11.8% (0.102, 0.137) when compared to unassisted readers. The average specificity at the tooth level decreased slightly with a difference of -0.011 (-0.015, -0.008) between the assisted and unassisted readers.
Standalone Performance Testing
Standalone performance of the Overiet Caries Assist-Pediatric device was evaluated for 1190 bitewing and periapical images. The dataset was split with roughly 50-50 images with and without caries, for patients aged 4-11. Images were obtained from male and female patients, from a range of distinctly different geographic regions. The results were compared to the consensus reference standard established by 3 general dentists. Tooth level standalone sensitivity was 83.9%, 95% CI's (0.816, 0.860).
Tooth Level standalone specificity was 97.5%, 95% CI's (0.971, 0.979). Standalone Dice was a mean of 79.0%, 95% CI's (0.784, 0.797).
Tooth Level Standalone Sensitivity with 95% CI's by sensor category is as follows: Carestream 0.870 (0.832, 0.900) Dexis 0.872 (0.841, 0.902) E2V 0.761 (0.713, 0.806) Gendex 0.843 (0.800, 0.882) Schick 0.844 (0.805, 0.878)
The 2 types of device performance testing in this submission include standalone and MRMC performance testing as described in the guidance documents "Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions" and "Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions".
The results of the MRMC reader performance assessment demonstrates that readers assisted by the Overjet Caries Assist-Pediatric device improve in detection of caries when compared to unassisted readers.