The Intraoral Dental Digital Imaging Sensor is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals.

Device Description

This Intraoral Dental Digital Imaging Sensor employs CMOS (Complementary Metal-Oxide-Semiconductor), protective optical fiber and scintillator. There are three names proposed for this device: EAGLE S/ SAEVO SLIM/D700 SLIM. The three models are all identical except for the name. This sensor was developed to obtain a high-quality x-ray image from the human arch and its structures. The acquisition process is made by positioning the sensor inside the mouth, behind the structure you want to perform the exam. The structure must be exposed to an x-ray dose using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital sign and transfers it to a computer through USB connection (Universal Serial Bus). The device performs the acquisition by positioning the sensor inside of the patient's mouth, behind the structure to be examined. The structure should be exposed to a dose of x-rays, using an external source. Once exposed, the sensor performs a conversion of the x-ray photons into a digital signal and then transfers it to a computer via a Universal Serial Bus (USB) connection. The x-ray generator (an integral part of a complete dental x-ray system) is not part of the device.

AI/ML Overview

The provided text describes the marketing submission for an Intraoral Dental Digital Imaging Sensor (Eagle S/Saevo Slim/D700 Slim) and its claim of substantial equivalence to a predicate device. However, it does not contain detailed acceptance criteria or a comprehensive study demonstrating performance against specific numerical or qualitative endpoints. The document primarily focuses on non-clinical testing (safety, EMC, biocompatibility) and a general statement about clinical images.

Here's an analysis of what information is available and what is missing, structured according to your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly define acceptance criteria as pass/fail thresholds for specific performance metrics. Instead, it presents a comparison table and discusses general improvements over the predicate device.

Acceptance Criteria (Implicit/Derived)	Reported Device Performance (vs. Predicate)
Resolution (Line pairs/mm)	25 lp/mm (Predicate: 15 lp/mm)
Pixel Size	20 µm (Predicate: 33 µm)
Number of Pixels (Size 1)	1000 x 1500 (Predicate: 600 x 900)
Number of Pixels (Size 2)	1300 x 1800 (Predicate: 800 x 1000)
MTF (Modulation Transfer Function)	>70% @ 1.47 lp/mm (at RQA5) (Predicate: Not specified)
DQE (Detective Quantum Efficiency)	>61.3% @ 0 lp/mm (at RQA5) (Predicate: Not specified)
Contrast	12 bits (Same as Predicate)
Gray Level	4096 (Same as Predicate)
Clinical Acceptability	Images are of "good quality, clinically acceptable, and better than the predicate images."

Study Details

Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the "clinical images" or "submitted intra-oral radiographs."
- Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only mentions "submitted intra-oral radiographs" and "adequate clinical images."
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: One expert was mentioned for the image quality analysis.
- Qualifications: "USA Board Certified Radiologist." No mention of years of experience.
Adjudication method for the test set:
- Adjudication Method: Not specified. It mentions a single "USA Board Certified Radiologist" performed an "image quality analysis" comparing the predicate to the new device. This suggests a sole expert review rather than a multi-reader adjudication process (e.g., 2+1 or 3+1).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. The device is an imaging sensor, not an AI-assisted diagnostic tool for humans, so an MRMC study related to AI assistance for human readers is not relevant in this context. The clinical evaluation mentioned focused on inherent image quality of the sensor itself.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in the sense that the sensor's technical performance (resolution, MTF, DQE) was evaluated through bench testing, which is an algorithm/device-only evaluation. The "adequate clinical images" and radiologist review also reflect the standalone performance of the imaging sensor.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Ground Truth (for image quality): Expert opinion/comparison. The "USA Board Certified Radiologist" compared images from the predicate and the new device. For the technical metrics (MTF, DQE, resolution), these are physical measurements rather than clinical ground truth established by pathology or outcomes.
The sample size for the training set:
- Sample Size for Training Set: Not applicable. This document describes an imaging sensor, not a machine learning or AI algorithm that requires a training set.
How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable (as above).

Summary

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April 11, 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.

Alliage S/A Industrias Medica Odontológico % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114

Re: K230732

Trade/Device Name: Eagle S/Saevo Slim/D700 Slim Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH, EHD, MQB Dated: March 16, 2023 Received: March 16, 2023

Dear Prithul Bom:

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

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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 medical devices and radiation-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) K230732

Device Name EAGLE S/SAEVO SLIM/D700 SLIM

Indications for Use (Describe)

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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510(k) Summary K230732 EAGLE S/SAEVO SLIM/D700 SLIM Intraoral Dental Digital Imaging Sensor

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This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 872.1800. Date prepared: March 23, 2023

1. Company and Correspondent making the submission:

Name: Alliage S/A Indústrias Médica Odontológico. Address: Rod. Abrao Assed, Km 53+450m Recreio Anhanguera, Zipcode 14097-500 Telephone: +55 16 3512-1212. Contact: Daniel Camargo.

2. Trade /Proprietary Names: EAGLE S/SAEVO SLIM/D700 SLIM

Device: Dental, Intraoral, Sensor Regulation Description: Extraoral Source X-ray system Regulation Medical Specialty: Dental Review Panel: Radiology Classification Product Code: MUH Secondary Product Codes: EHD, MQB Regulation Number: 872.1800 Device Class: 2

3. Legally Marketed Predicate Device Information:

510(k) Number: K162585 Manufacturer: Suni Medical Imaging, Inc Trade /Proprietary Name: SunilQ Digital Radiography System Device: Dental, Intraoral, Sensor Regulation Medical Specialty: Dental Review Panel: Radiology Classification Product Code: MUH Regulation Number: 872.1800 Device Class: 2

4. Description:

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Size 1: 20 x 30 mm, Size 2: 26 x 36 mm. A description of the parts that accompany the product is below: PARTS THAT ACCOMPANY THE PRODUCT

Image /page/4/Picture/1 description: The image shows four different objects labeled with numbers 01 through 04. Object 01 is a white sensor connected to a USB cable. Object 02 is a white holder, object 03 is a black USB drive with a red light, and object 04 is a clear plastic container.

5. Indications for use:

The Intraoral dental digital imaging sensor is aimed at the acquisition of intra-oral medical images from teeth, jaw and oral structure, only for exclusive dental use and must be handled by trained and qualified health professionals.

6. Comparison with predicate device:

The predicate SunilQ Digital Radiography System is a device intended for intra-oral x-ray examinations. Two sensor sizes are available. The new device Intraoral Digital Imaging Sensor and its predicates are small digital imaging receptors that may be used in place of dental x-ray film. Predicate sensor sizes: Size 1: 20.2 x 31.1 mm, Size 2: 26.2 x 35.2 mm.

Subject device sensor sizes: Size 1: 20 x 30 mm, Size 2: 26 x 36 mm.

The images are displayed on a computer workstation. The technologies employed by the predicate and our new device are almost identical. The proposed sensors have greater resolution than the predicate via smaller pixel size and greater numbers of total pixels. The same sensor sizes are available, and the computer interface is the same (USB). Both sensors use CMOS technology. Similarities: Indications for Use, available sizes, USB interface, CMOS technology employed. Differences: New device has greater resolution via smaller pixel size and greater number of pixels. The sensor sizes are nearly identical. A comparison table follows:

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PRODUCT	K162585 SunilQ Digital RadiographySystem	EAGLE S/SAEVO SLIM/D700 SLIMComparison + Discussion
Indicationsfor use	The SunilQ Digital Radiography system is usedto collect dental x-ray photons and convertthem into electronic impulses that may bestored, viewed and manipulated fordiagnostic use by dentists.	The Intraoral dental digital imaging sensor isaimed at the acquisition of intra-oralmedical images from teeth, jaw and oralstructure, only for exclusive dental use andmust be handled by trained and qualifiedhealth professionals.(Means the same thing)
Where Used	Clinics, hospitals, dental offices	SAME
OperatingTemperatureRange	Not stated	50°F (10°C) to 86°F (30°C)
Supply Voltage	+5 Vdc	+5 Vdc
Technology	CMOS	CMOS
Contrast	12 bits	12 bits SAME
Gray Level	4096	4096 SAME
Pixel Size	33 μm	20 μm
Number of pixels	600 x 900 Size 1800 x 1000 Size 2	1000 x 1500 Size 11300 x 1800 Size 2
Line pairs/mm	15	25
MTF	Not speciified	MTF @ RQA5: >70% @ 1.47 lp/mm
DQE	Not specified	DQE @ RQA5: >61.3% @ 0 lp/mm
Active Sensor Area	Size 1: 20.2 x 31.1 mmSize 2: 26.2 x 35.2 mm	Size 1: 20 x 30 mmSize 2: 26 x 36 mmAlmost identical sizes
Connection type	USB 2 or 3	USB 2 or 3
Replaceable Cable	No	Yes
Cable Length	6 ft. or 15 ft.	10 ft.
Patient Protection	(Not stated)	Single Use Patient Protective Barrier, FDAckeared
Photo	Image: SunilQ Digital Radiography System	Image: EAGLE S/SAEVO SLIM/D700 SLIM

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7. Non-clinical Testing Performed: Safety, EMC, Biocompatibility and Performance Data:

Safety testing: Electrical, mechanical, environmental safety and performance testing according to standard ABNT NBR IEC 60601-1:2016 (IEC 60601-1:2005/AMD1:2012) was performed by a nationally certified test laboratory. Note there is no electrical contact with the patient. Required tests passed. EMC testing was done according to IEC 60601-1-2 Ed. 4.0 (2014) – Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbance - Requirements and tests .

Biocompatibility testing was conducted to ISO 10993-1:2020 - Biological assessment of medical devices - Part 1: Assessment and testing within a risk management process. Tests conducted: Cytotoxicity; Sensitization; Intracutaneous irritation or reactivity. These items (although there is no direct patient contact) were tested:

Product Part	Material
Plastic Cover	Polycarbonate
USB Cable	Polyurethane
Silicone Cover	Silicone

The main patient contact material is the FDA cleared barrier sheath (K160232, Disposable Barrier Sleeves and Covers), not supplied by us. Although direct contact is unlikely inside the oral cavity, the subject dental sensor Eagle S has been tested for biocompatibility and all test results indicate compliance with biocompatibility standards. Successful software validation and risk analysis was conducted. All test results were satisfactory. Cybersecurity concerns were addressed via labeling and internal software controls. Reference: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. The subject detector Eagle S has been bench tested, and successful test results (resolution, MTF, DQE) indicate substantial equivalence to the predicate.

1. Clinical Testing Performed: Device clinical testing has been performed, and the submitted intra-oral radiographs are deemed of diagnostic quality. Adequate clinical images are additional proof of device effectiveness, and they enforce the bench testing results that are already supporting our claim of substantial equivalence.
  We compiled a Clinical Performance Report for the Intraoral Dental Digital Imaging Sensor. The purpose was to provide analysis results and records of the requirements arising during the empirical evaluation process of the Intraoral Dental Digital Imaging Sensor clinical performance. In this report, all information related to the tests or studies required for the survey and characterization of the clinical performance based on empirical data are in their entirety. We also had an image quality analysis performed by a USA Board Certified Radiologist who compared the predicate images to the proposed device images. He concluded that the images are of good quality, clinically acceptable, and better than the predicate images.
1. Conclusions: Our conclusions drawn from the nonclinical tests (discussed above) are that we have demonstrated that the proposed device is as safe, as effective, and performs as well as or better than the legally marketed predicate device identified according to 807.92(b)(3), 57 FR 18066, Apr. 28, 1992, as amended at 59 FR 64295, Dec. 14, 1994,According to the Federal Food, Drug and Cosmetic Law, 21 CFR Part 872. Based on the information provided in this pre-marketing notification, Alliage S/A Indústrias Médica Odontológico concludes that Intraoral Digital Imaging Sensor is safe and effective and substantially equivalent to predicated devices, as described in this document.

Regulation Number and Section

§ 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.