(104 days)
Not Found
Yes
The device description explicitly states that the software operates with a "Machine Learning model" in its Decision Layer.
No
The device is a computer-assisted detection software that aids in the detection of periapical radiolucencies. It is not intended for treatment or direct therapy.
Yes
The device is described as "intended to aid in the detection of periapical radiolucencies," which directly supports diagnostic activities. It helps dentists identify a medical condition (periapical radiolucency) from radiological images.
Yes
The device description explicitly states "Overjet PARL Assist 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 medical devices intended for use in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- Device Function: The Overjet Periapical Radiolucency (PARL) Assist software analyzes radiographic images (periapical radiographs) of teeth. It does not examine specimens derived from the human body in vitro.
- Intended Use: The intended use is to aid in the detection of periapical radiolucencies on these images, providing information about a potential pathological state (radiolucency) based on the image data, not on the analysis of bodily fluids or tissues.
Therefore, while it is a medical device providing diagnostic information, its method of operation (analyzing images) places it outside the definition of an In Vitro Diagnostic.
No
The letter explicitly states "Not Applicable" for PCCP and does not contain any language indicating that the FDA has reviewed and approved or cleared a PCCP for this device.
Intended Use / Indications for Use
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
MYN
Device Description
Overjet Periapical Radiolucency "PARL" Assist is a module within the Overjet Platform. The Overjet PARL Assist (OPA) software automatically detects periapical radiolucency on periapical radiographs. It is intended to aid dentists in the detection of periapical radiolucency. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by professionally trained and licensed dentists. Overjet PARL Assist is a software-only device which operates in three layers: a Network Layer, aPresentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Machine Learning model
Input Imaging Modality
periapical radiographs
periapical images
Anatomical Site
permanent teeth
Indicated Patient Age Range
12 years of age or older.
Intended User / Care Setting
professionally trained and licensed dentists
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: 379 periapical radiographs (190 images with at least 1 PARL and 189 images with no PARL). Images were obtained from male and female patients aged 12 years and older. The consensus reference standard established by 3 endodontists.
Standalone Performance Testing: 763 periapical images + 384 additional standalone study images. The dataset was split with 326 images with no PARL. Images were obtained from male and female patients aged 12 years and older from various clinical sites across the U.S.. The results were compared to the consensus reference standard established by 3 endodontists.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
MRMC Reader Study:
Overjet evaluated the Overjet PARL Assist (OPA) in a multi case (MRMC) fully crossed reader improvement study. 19 US licensed dentists were asked to evaluate 379 periapical radiographs (190 images with at least 1 PARL and 189 images with no PARL). The consensus reference standard established by 3 endodontists.
The AUC of the ROC at the image level avers all readers showed a 4.8 % (95% Cl's 0.030, 0.066) improvement in assisted readers compared to unassisted readers. The p-value was highly statistically significant at
§ 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.
0
September 21, 2023
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Overjet, Inc. % Deepthi Paknikar Regulatory & Clinical Manager 560 Harrison Ave #403 BOSTON MA 02118
Re: K231678
Trade/Device Name: Overjet Periapical Radiolucency Assist Regulation Number: 21 CFR 892.2070 Regulation Name: Medical image analyzer Regulatory Class: Class II Product Code: MYN Dated: August 15, 2023 Received: August 15, 2023
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 (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 located 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.
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 803) for
1
devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K231678
Device Name Overjet Periapical Radiolucency Assist
Indications for Use (Describe)
Overiet Perianical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on permanent teeth captured on periapical radiographs. The device provides additional aid for the dentist to use in their identification of periapical radiolucency. The device is not intended as a replacement for a complete dentist's review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K231678
510(k) Summary
Prepared on: 2023-06-08
Contact Details
21 CFR 807.92(a)(1)
21 CFR 807.92(a)(5)
| Applicant Name | Overjet, Inc |
|---|---|
| Applicant Address | 560 Harrison Ave #403 Boston MA 02118 United States |
| Applicant Contact Telephone | 6302011612 |
| Applicant Contact | Deepthi Paknikar DDS, MS |
| Applicant Contact Email | deepthi.paknikar@overjet.ai |
21 CFR 807.92(a)(2)
| Device Trade Name | Overjet Periapical Radiolucency Assist |
|---|---|
| Common Name | Medical image analyzer |
| Classification Name | Analyzer, Medical Image |
| Regulation Number | 892.2070 |
| Product Code | MYN |
21 CFR 807.92(a)(3)
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K221921 | DTX Studio Clinic 3.0 | MYN |
| K210365 | Second Opinion® | MYN |
21 CFR 807.92(a)(4)
Overjet Periapical Radiolucency "PARL" Assist is a module within the Overjet Platform. The Overjet PARL Assist (OPA) software automatically detects periapical radiolucency on periapical radiographs. It is intended to aid dentists in the detection of periapical radiolucency. It should not be used in lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by professionally trained and licensed dentists. Overjet PARL Assist is a software-only device which operates in three layers: a Network Layer, aPresentation Layer, and a Decision Layer. Images are pulled in from a clinic/dental office, and the Machine Learning model creates predictions in the Decision Layer and results are pushed to the dashboard, which are in the Presentation Layer.
Intended Use/Indications for Use
Overjet Periapical Radiolucency (PARL) Assist is a radiological, automated, concurrent read computer-assisted detection software intended to aid in the detection of periapical radiolucencies on periapical radiographs. The device provides additional aid for the dentification of periapical radiolucency. The evice is not intended as a replacement for a complete dentist's review or their clinical judgment that considers other relevant information from the image or patient history. The system is to be used by professionally trained and licensed dentists.
The Overjet Periapical Radiolucency Assist software is indicated for use on patients 12 years of age or older.
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Indications for Use Comparison
The minor differences between the Overjet PARL Assist subject device and the Primary Predicate Device DTX Studio Clinic 3.0 (K221921) and secondary predicate device Pearl Second opinion (K210365) do not constitute a new intended use. The Overjet PARL Assist device shares the same intended use as the primary and secondary predicates, and the device is intended to aid in the detection of PARL on 2D periapical radiographs. The primary predicate device is intended to be used for ages 15+ and the secondary predicate device is intended for ages 12+, same as the Overjet PARL Assist Device. The Overjet PARL Assist Device is a concurrent read device same as the primary predicate device. The primary predicate device outputs a toggleable bounding box whereas the Overjet a segmented polygon of PARL. Both devices are intended to be diagnostic aids, and provide information for clinicians to use as additional information in their clinical examinations. The performance testing for the Overjet PARL Assist device demonstrates that aided readers improve in detection of PARL over unaided readers. In summary, the Overjet PARL Assist Device is substantially equivalent to the predicate device.
Technological Comparison
21 CFR 807.92(a)(6)
The primary predicate device outputs a toggleable bounding box whereas the Overjet device outputs a segmented polygon of PARL. The minor difference in technological characteristics do not raise a concern of substantial equivalence as demonstrated by the performance testing of the Overjet device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
MRMC Reader Study
Overjet evaluated the Overjet PARL Assist (OPA) in a multi case (MRMC) fully crossed reader improvement study. 19 US licensed dentists were asked to evaluate 379 periapical radiographs (190 images with at least 1 PARL and 189 images with no PARL), lmaqes were obtained from male and female patients aged 12 years and older. The consensus reference standard established by 3 endodontists.
Half of the data set contained unassisted images not run on the OPA device), and the second half contained radiographs that had been "assisted" or processed through the OPA device. The radiographs were presented to the readers in alternating groups. A 4 week washout period was utilized to limit recollection bias. Following the washout, the readers were presented the same data set but with alternate grouping. This means that if a reader saw a radiograph in the unassisted state in Session 1, the Overjet PARL Assist predictions in Session 2.
The results were compared against a consensus ground truth, and the curve (AUC) of the receiver operating characteristic curve (ROC) was evaluated as a primary endpoint to characterize the readers assisted and unassisted by the Overjet PARL Assist device.
The AUC of the ROC at the image level avers all readers showed a 4.8 % (95% Cl's 0.030, 0.066) improvement in assisted readers compared to unassisted readers. The p-value was highly statistically significant at