Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

Device Description

Brasseler GEM is a USB-driven digital sensor designed for health care professionals already acquainted with the standard procedures for acquiring dental intraoral radiographs. Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience.

Brasseler GEM10 is for pediatric use and adult periapical use, GEM15 is for pediatric and adult bitewing and periapical use, and GEM20 is for adult use including bitewings. The Brasseler GEM design uses advanced ergonomic principles with four beveled corners, a moderate profile, and a rounded casing providing enhanced comfort for patients. Brasseler GEM is positioned in the patient's mouth in the same manner as intraoral film is positioned.

Brasseler GEM has a CMOS x-ray imager that creates a digital image from x-ray doses perceptible by the sensor. The digital image created is immediately visible on the screen of a personal computer connected to Brasseler GEM through the standard USB port. Image analysis software is not part of the submission. For Brasseler GEM to be used in a dental practice, an optional image analysis software will be necessary. Only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer. Software provides drivers and utilities for x-ray dose optimization, sensor activation and settings. Brasseler GEM capture x-ray images suitable for recognition of normal anatomical structures, dental pathologies, and abnormal conditions. Inadequate images may result in misdiagnosis thereby subjecting the patient to incorrect or unnecessary dental procedures that would present an unacceptable risk to the patient. Functions of the Brasseler GEM detector are controlled by software (firmware). The software of Brasseler GEM is of Moderate Level of Concern and is not based on the software of the predicate, Clio Prime.

Brasseler GEM shall be operated by healthcare professionals who are educated and competent to perform the acquisition of dental intraoral radiographs. Brasseler GEM can be used either in combination with positioners manufactured to facilitate the positioning and alignment with an x-ray beam, or it may also be positioned by hand with the assistance of the patient. Brasseler GEM can be used with patients of any age, providing the correct positioning of the sensor in the patient mouth can be realized. Using Brasseler GEM is a suitable diagnostic method and may offer reduced radiation exposure compared to analog procedures. Available software image enhancement tools may enhance sensitivity and consequently reduce errors introduced by subjective analysis. Brasseler GEM can perform and achieve the same type of two-dimensional images as conventional (traditional) film sizes 0, 1 and 2. Brasseler GEM cannot be used to, or as a substitution for extraoral or other types of dental x-ray. When using Brasseler GEM and software as a diagnostic aide, clinical experience and a combination of the diagnostic aides should be used to form a diagnosis and should not be solely relied upon for diagnosis.

AI/ML Overview

The provided text describes Brasseler GEM, a digital intraoral x-ray sensor, and its equivalence to a predicate device, Clio Prime. The document primarily focuses on demonstrating substantial equivalence through comparison of technical specifications, rather than providing detailed acceptance criteria from a clinical study for diagnostic performance.

Therefore, the response below will focus on the information available in the provided text, and will explicitly state when information requested cannot be found.

Acceptance Criteria and Device Performance Study for Brasseler GEM

The provided document, a 510(k) summary, primarily relies on bench testing and comparison to a predicate device (SOTA Imaging's Clio Prime) to establish substantial equivalence. It does not detail specific diagnostic performance acceptance criteria in the manner one might find for an AI-based diagnostic device (e.g., sensitivity, specificity thresholds). Instead, the acceptance is based on demonstrating that the Brasseler GEM is as safe and effective as the legally marketed predicate device.

The "study that proves the device meets the acceptance criteria" largely refers to the comparative analysis presented through the Comparison Table and the stated equivalence of technical performance metrics like MTF and DQE.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the "acceptance criteria" are implied by the demonstration of substantial equivalence to the predicate device, Clio Prime. The performance is assessed by comparing technical specifications and affirming identical/equivalent performance in areas relevant to image quality.

Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance (Brasseler GEM)	Predicate Device Performance (Clio Prime)
Intended Use	Acquire dental radiographic images by healthcare professionals for intraoral diagnostic purposes.	Acquire dental intraoral radiography images by healthcare professionals for intraoral diagnostic purposes.
Indications for Use	Same as Intended Use. Can be used with positioning devices or handheld.	Same as Intended Use. Can be used with positioning devices or handheld.
Sensor Exterior Sizes	3 sizes: 36.36 x 24.53 mm, 38.83 x 29.63 mm, 41.80 x 30.48 mm	2 sizes: 36.31 x 30.42 mm, 41.76 x 30.42 mm
Sensor Imaging Sizes	3 sizes: 30.26 x 20.32 mm, 33.15 x 26.25 mm, 36.08 x 26.25 mm	2 sizes: 30.26 x 20.32 mm, 36.08 x 26.25 mm
Overall Imaging Areas	3 sizes: 615 mm2, 870 mm2, 947.1 mm2	2 sizes: 615.0 mm2, 947.1 mm2
Pixel Size	19.5 µm	19.5 µm
Imager Resolution	3 resolutions: 1539 x 1026, 1692 x 1324, 1842 x 1324 pixels	2 resolutions: 1539 x 1042, 1842 x 1342 pixels
X-Ray Resolution	20+ visible lp/mm	20+ visible lp/mm
Dynamic Range	16,384:1	16,384:1
Technology	CMOS	CMOS
Scintillator Technology	Cesium Iodide	Cesium Iodide
Operating System Compatibility	Microsoft Windows 7 and 10	Microsoft Windows 7 and 10
Interface to PC	USB 2.0, Type A	USB 2.0, Type A
Cable Length	1.9 m and 2.9 m	1.9 m and 2.9 m
Power Consumption	0.8 Watts Max	0.8 Watts Max
Electrical Rating	DC 5V, 350 mA max	DC 5V, 350 mA max
Sterilization Suitability	Not suitable for sterilization; requires hygienic barrier.	Not suitable for sterilization; requires hygienic barrier.
Housing	IPx8 Equivalent ISO 10993-1 Biocompatible	IPx8 Equivalent ISO 10993-1 Biocompatible
MTF (Modulation Transfer Function)	Identical to Clio Prime	(Baseline for comparison)
DQE (Detective Quantum Efficiency)	Substantially equivalent to Clio Prime	(Baseline for comparison)
Biocompatibility	Based on predicate device, identical materials and manufacturing.	(Baseline for comparison)
Software Level of Concern	Moderate (not based on predicate software)	(Predicate software not described in detail)

Note: The document emphasizes that "Brasseler GEM is not only similar in performance as Clio Prime but is also safe and effective based on performance testing." The performance testing mentioned is primarily bench testing and direct comparison of specifications.

2. Sample sizes used for the test set and the data provenance

The document refers to "extensive bench testing" and "clinical images" for performance testing.

Test Set Sample Size: The specific sample sizes for bench testing are not explicitly quantified in terms of number of devices or number of test cases run beyond "extensive bench testing." For "clinical images," no specific number of images is provided, nor the number of patients/cases represented.
Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The document only states "RealCloud Imaging has provided clinical images."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable / Not specified. The study described focuses on technical equivalence and image acquisition capabilities, not on diagnostic accuracy requiring ground truth established by experts for clinical images. The text states: "Digital x-ray imaging is an aide for diagnosis and should always be confirmed by the doctor using appropriate additional diagnostic aides, professional judgement, and experience." This implies the device provides images for human interpretation, rather than an AI producing a diagnosis that needs expert ground truth for validation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not specified. As the study is focused on technical equivalence rather than diagnostic accuracy determined by human readers, an adjudication method for a test set is not detailed.

5. 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

No. An MRMC comparative effectiveness study was not performed as this is a device for image acquisition, not an AI assisting human readers with diagnosis. There is no AI component described that would augment human diagnostic performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, in a sense. The "performance testing" described (bench tests, MTF, DQE comparison) reflects the standalone performance of the Brasseler GEM sensor and its ability to acquire images, independent of human interpretation or an AI algorithm. However, this is not an "algorithm only" performance meant for diagnostic output. The text states: "Image analysis software is not part of the submission... only with image analysis software can acquired images be optimized for specific diagnostic tasks, archived as image files, and printed out on a suitable printer." This implies the device itself is an image capture hardware without integrated diagnostic algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable / Not specified. The "performance testing" detailed focuses on technical specifications (MTF, DQE validation against a predicate device) and basic functionality via "clinical images" to show the system works as intended. There is no mention of "ground truth" for diagnostic accuracy established by expert consensus, pathology, or outcomes data, as the device's role is imaging, not diagnosis.

8. The sample size for the training set

Not applicable / Not specified. This device is an x-ray sensor (hardware), not an AI algorithm that requires a training set. The firmware of the device is mentioned as "software... of Moderate Level of Concern," but this refers to its operational control, not an AI model for image interpretation or diagnosis.

9. How the ground truth for the training set was established

Not applicable / Not specified. As this device is a hardware sensor and not an AI algorithm requiring a training set, the concept of establishing ground truth for a training set does not apply here.

Summary

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August 31, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services logo. To the right of that 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.

RealCloud Imaging Inc. dba RealCloud Imaging % Mr. W. Edward Johansen Official Correspondent W. Edward Johansen 1239 Stanford Street, Apartment Number 205 SANTA MONICA CA 90404

Re: K221955

Trade/Device Name: Brasseler GEM Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral source x-ray system Regulatory Class: Class II Product Code: MUH Dated: July 1, 2022 Received: July 5, 2022

Dear Mr. Johansen:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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,

Laurel Burk, 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) K221955

Device Name

Brasseler GEM

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 - K221955

Submitted: July 27, 2022

A. Corporation Information

Name: RealCloud Imaging Inc.

Address: 2625 North Loop Drive, Suite 2130, Ames, Iowa 50010

Telephone:(712) 301-3882

E-mail address: doug.golay@realcloudimaging.com

Official Correspondent: W. Edward Johansen

Telephone: (310) 795-7425

E-mail address: wedjohansen@msn.com

Address: 1239 Stanford Street, #205, Santa Monica, California 90404

B. Identification of New Device

Owner/Operator: RealCloud Imaging Inc. doing business as RealCloud Imaging

Owner/Operator Number: 10052982

Establishment Registration Number: 3013464458

Trade Name: Brasseler GEM

Premarket Notification Number: K221955

Common Name: Dental digital x-ray sensor

Classification Name: Extra-oral source x-ray system

Product Code: MUH

Class: Il

Panel/Medical Specialty: Radiology/Dental

Regulation Number: 21 C.F.R. §872.1800

Manufacturer: RealCloud Imaging

Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE

Systems Inc.

Sterilization Facility: Not Applicable

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C. Identification of Predicate Device

Owner/Operator: SOTA Precision Optics, Inc. doing business as SOTA Imaging

Owner/Operator Number: 905754

Establishment Registration Number: 3000190675

510(k) Premarket Notification Number: K202664

Trade Name: Clio Prime

Common Name: Dental intraoral x-ray sensor

Classification Name: Extra-oral source x-ray system

Product Code: MUH

Classification: Class II

Panel/Medical Specialty: Radiology/Dental

Regulation Number: 21 C.F.R. §872.1800

Manufacturer: Sota Precision Optics, Inc. dba SOTA Imaging

Contract Manufacturer: BAE Systems Imaging Solutions, a division of BAE

Systems Inc.

Sterilization Facility: Not Applicable

D. Device Description

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E. Indications for Use

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Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy. Brasseler GEM can also be aligned by hand with assistance of patient.

F. Intended Use

Brasseler GEM is intended for any dental practice that uses x-ray equipment for intraoral diagnostic purposes. Brasseler GEM can be used by trained dental professionals for patients receiving intraoral x-ray examinations and produces digital images for patients receiving intraoral x-ray examinations for diagnostic purposes. An image analysis software is not part of this submission. When Brasseler GEM is to be used in a dental practice, an optional software will be necessary. Brasseler GEM is a USB-driven digital intraoral x-ray sensor which is intended to acquire dental radiographic images. Brasseler GEM must be operated by healthcare professionals who have been trained and are competent using various methods of acquiring radiographic images of dental anatomy. Brasseler GEM can be used with dental positioning devices and holders to assist with aligning an x-ray source beam with the sensor and anatomy.

G. Performance Testing-Animal

RealCloud Imaging did not perform animal performance testing.

H. Performance Testing-Bench

On behalf of RealCloud Imaging Intertek performed extensive bench testing on Brasseler GEM in accordance with the following reference standards: ANSI AMI ES 60601-1; IEC 62304; IEC 60529; IEC 60601-1-2; and EN 60601-1-2.

Comparison Table

The following comparison table compares Brasseler GEM to the predicate device, Clio Prime, with respect to intended use, indications of use, environment of use, limitations of use, technical performance, and technological characteristics, and provides more detailed information regarding the basis for the determination of substantial equivalence.

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Comparison Table

DescriptiveInformation	Brasseler GEM	Clio Prime
510(k) Number	K221955	K202664
Manufacturer	RealCloud ImagingInc. doing business asRealCloud Imaging	Sota Precision Optics,Inc. doing business asSOTA Imaging
Trade Name	Brasseler GEM10Brasseler GEM15Brasseler GEM20	Clio PrimeClio Pedo
Classification Name	Digital x-ray sensor	Digital x-ray sensor
Classification	Class II	Class II
Classification Panel/Medical Specialty	Radiology/Dental	Radiology/Dental
Regulation Number	21 C.F.R. §872.1800	21 C.F.R. §872.1800
Product Code	MUH	MUH
Number of Sensors	3	2
Sensor Exterior Sizes	36.36 mm x 24.53.mm38.83 mm x 29.63 mm41.80 mm x 30.48 mm	36.31 mm x 30.42 mm41.76 mm x 30.42 mm
Sensor Imaging Sizes	30.26 mm x 20.32 mm33.15 mm x 26.25 mm36.08 mm x 26.25 mmAll with four clippedcorners	30.26 mm x 20.32 mm36.08 mm x 26.25 mmAll with four clippedcorners
Overall Imaging Areas	615 mm2870 mm2947.1mm2	615.0 mm2947.1 mm2
Pixel Size	19.5 µm	19.5 µm
Imager Resolution	1539 x 1026 pixels(1.70 M pixels)1692 x 1324 pixels(2.2 M Pixels)1842 x 1324 pixels(2.40 M pixels)	1539 x 1042 pixels(1.70 M Pixels)1842 x 1342 pixels(2.40 M Pixels)
X-Ray Resolution	20+ visible lp/mm	20+ visible lp/mm
Dynamic Range	16,384:1	16,384:1
Technology	CMOS	CMOS
Scintillator Technology	Cesium lodide	Cesium lodide
Operating System	Microsoft Windows 7and 10	Microsoft Windows 7and 10
Extraoral source	x-ray system	x-ray system
Interface to PC	USB 2.0, Type A	USB 2.0, Type A
Cable Length	1.9 m and 2.9 m	1.9 m and 2.9 m
Power Consumption	0.8 Watts Max	0.8 Watts Max
Electrical Rating	DC 5V, 350 mA max	DC 5V, 350 mA max
Sterilization	Not suitable forsterilization	Not suitable forsterilization
Housing	IPx8 Equivalent ISO10993-1 Biocompatible	IPx8 Equivalent ISO10993-1 Biocompatible
Indications for Use	Brasseler GEM is aUSB-driven digitalintraoral x-ray sensorwhich is intended toacquire dentalradiographic images.Brasseler GEM mustbe operated byhealthcareprofessionals whohave been trained andare competent usingvarious methods ofacquiring radiographicimages of dentalanatomy. BrasselerGEM can be used withdental positioningdevices and holders toassist with aligning anx-ray source beamwith the sensor andanatomy. BrasselerGEM can also bealigned by hand withassistance of patient.	Clio Prime is a USB-driven, digital intraoralx-ray sensor which isintended to acquiredental intraoralradiography images.Clio Prime shall beoperated by healthcareprofessionals, who areeducated andcompetent to performthe acquisition ofdental intraoralradiographs. ClioPrime can be usedeither in combinationwith special positioningdevices to facilitatepositioning andalignment with an x-raybeam or Clio Primecan also be positionedby hand with theassistance of thepatient.
Intended Use
Brasseler GEM is intendedfor any dental practice thatuses x-ray equipment forintraoral diagnosticpurposes. Brasseler GEMcan be used by traineddental professionals forpatients receiving intraoralx-ray examinations andproduces digital images forpatients receiving intraoralx-ray examinations fordiagnostic purposes. Animage analysis software isnot part of this submission.When Brasseler GEM is tobe used in a dental practice,an optional software will benecessary. Brasseler GEMis a USB-driven digitalintraoral x-ray sensor whichis intended to acquire dentalradiographic images.Brasseler GEM must beoperated by healthcareprofessionals who havebeen trained and arecompetent using variousmethods of acquiringradiographic images ofdental anatomy. BrasselerGEM can be used withdental positioning devicesand holders to assist withaligning an x-ray sourcebeam with the sensor andanatomy.	Clio Prime is intended forany dental practice thatuses x-ray equipment forintraoral diagnosticpurposes. Clio Prime canused by trained dentalprofessionals for patientsreceiving intraoral x-rayexaminations and producdigital images for patientsreceiving intraoral x-rayexaminations for diagnospurposes. An imageanalysis software is not pof this submission. WhenClio Prime is to be used indental practice, an optionsoftware will be necessarClio Prime is a USB-driverdigital intraoral x-ray senswhich is intended to acquidental radiographic imageClio Prime must be operatby healthcare professionawho have been trained anare competent using variomethods of acquiringradiographic images ofdental anatomy. Clio Primcan be used with dentalpositioning devices andholders to assist withaligning an x-ray sourcebeam with the sensor andanatomy.

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J. Comparison of MTF of Brasseler GEM and MTF of Clio Prime

Brasseler GEM uses a sensor component from contract manufacturer BAE Systems Imaging Solutions, a division of BAE Systems Inc., which is also responsible for the manufacture of Clio Prime which is the predicate device. The components used in Brasseler GEM are the exact same components used in predicate device Clio Prime. The sensor MTF versus spatial frequency for Brasseler GEM and the sensor MTF versus spatial frequency for the predicate device, Clio Prime, are identical.

Comparison of DQE for Brasseler GEM and DQE of Clio Prime K.

On behalf of RealCloud Imaging, BAE Systems Imaging Solutions has compared the DQE for Brasseler GEM with the DQE of Clio Prime has determined that they are substantially equivalent to each other.

L. Meaningful Differences

Brasseler GEM and Clio Prime are CMOS x-ray image sensors. RealCloud Imaging has compared the MTF and the DQE of Brasseler GEM to the MTF and the DQE of Clio Prime and has determined they are substantially equivalent to each other. Brasseler GEM is not only similar in performance as Clio Prime but is also safe and effective based on performance testing.

M. Sterilization

Brasseler GEM is not sold as sterile. RealCloud Imaging recommends that usage of Brasseler GEM requires a hvgienic barrier that meets ISO 10993 requirements for biocompatibility. There is foreseeable misuse where a clinician would place Brasseler GEM in the oral cavity without a barrier thereby exposing the housing of Brasseler GEM to the oral cavity.

N. Biocompatibility

Biocompatibility testing is not needed with a rationale that considers all relevant endpoints because all materials and manufacturing/processing are identical to the predicate device, Clio Prime. The biocompatibility of Brasseler GEM is based on the biocompatibility of the predicate device, Clio Prime. Both Brasseler GEM and the predicate device, Clio Prime, are intended to be used in the oral cavity by a trained clinician.

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O. SABIC Resin for Sensor Housing of Brasseler GEM

BAE Systems Imaging Solutions uses the same SABIC resin for the sensor housing of Brasseler GEM that BAE Systems Imaging Solutions uses for the sensor housing of the predicate device. Clio Prime.

P. Software Information

The software for the Brasseler GEM consists of a simple API that can be provided to developers of existing FDA cleared image capture/dental imaging software to facilitate Brasseler GEM.

Q. Risk Analysis

RealCloud Imaging used a specified a procedure for evaluating the safety of a device by identifying potential hazards and estimating the associated risks as required in the Software Design and Development Procedure subsection of the Software Information section. RealCloud Imaging performed extensive risk analysis bench of Brasseler GEM in accordance with the following reference standards: ISO 14971, IEC 60601-1; and IEC 60601-1-2: Medical Electrical Equipment, Part 1-2 to generate a risk analysis report.

R. Comparison of Safety and Effectiveness of Brasseler GEM to Safety and Effectiveness of Clio Prime

Using the above Comparison Table, Brasseler GEM can be compared to the predicate device, Clio Prime, with respect to intended use, indications of use, environment of use, limitations of technical performance and technological characteristics and provides more detailed information regarding the basis for the determination of substantial equivalence. There are no differences between Brasseler GEM and Clio Prime with respect to indications and intended use.

S. Performance Testing-Clinical

RealCloud Imaging performed a clinical performance testing to determine that Brasseler GEM performed as well or better than did the predicate device,

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Clio Prime. RealCloud Imaging has provided clinical images. These clinical images provide further evidence in addition to the laboratory performance data that shows that the complete system works as intended.

T. Conclusion

Sota Precision Optics, Inc. dba SOTA Imaging markets the predicate device, Clio Prime, under the cleared 510(k) Premarket Notification No. K202664. On behalf of RealCloud Imaging, BAE Systems Imaging Solutions has compared Brasseler GEM with the predicate device, Clio Prime, and has determined that they are substantially equivalent to each other in intended use, indications for use, safety and effectiveness, and technical characteristics.

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.