i-Scan Imaging Plate Scanner is a dental device that scans IP imaging plates that have been exposed in place of dental X-ray film and allows the resulting images to be displayed on a personal computer and stored for later recovery. It will be used by licensed clinicians and authorized technicians for this purpose. The device is an intraoral Plate Scanner, which is designed to read out intraoral Plates of the size 0, 1, 2 and 3. Intraoral plate scanners are state of the art since 2002 and are available in various designs from many companies around the world. The intraoral plates are put into the mouth of the patient, exposed to Xrays and then are read out with the device. The read-out-process is carried out with 651-665 nm laser. The laser beam is moved across the plate by an oscillating MEMS mirror. The laser beam stimulates the top coating of the plates, which consists of Xray sensitive material. Depending on the exposed dose, the coating emits different levels of light. These light particles are then requisitioned by an optical sensor (Photo Multiplier Tube/ PMT) and transferred into an electrical output signal is digitalized and is the data for the digital X-ray image. The data is transmitted via WIFI to a computer. Before the plate is discharged, the remaining data is erased by a LED-PCB. The user chooses which size of plate he must use and prepares the device by inserting the appropriate plate insert into the device. He then exposes the plate and then puts the plate directly into the insert by pushing it out of the light protection envelope. The user closes the light protection over and starts the read-out process. After the read out process the picture is transmitted to the connected computer, the picture can be viewed, and the IP is erased and ready to use for the next acquisition.

AI/ML Overview

The provided document, a 510(k) summary for the i-Scan Imaging Plate Scanner, does not contain information about acceptance criteria or a study proving the device meets specific performance metrics in the way typically expected for an AI/ML medical device. This device is an X-ray imaging plate scanner, not an AI-powered diagnostic or assistive tool.

Therefore, many of the requested sections (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable to the information provided in this document.

However, I can extract information related to performance testing and comparison with a predicate device, which are relevant to the device's substantial equivalence determination.

Here's a breakdown of the available information based on your request, with "Not Applicable (N/A)" for criteria not found or relevant to this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" for clinical performance. Instead, it compares the subject device's technical specifications to those of a predicate device (Duerr Dental AG ScanX Intraoral View). The performance testing conducted was against international standards for X-ray imaging devices.

Characteristic	Acceptance Criteria (from Predicate/Standard)	Reported Device Performance (i-Scan Imaging Plate Scanner)	Discussion/Compliance
Image Quality
Theoretical Resolutions	Predicate: 10, 20, 25 or 40 LP/mm	10 or 33 LP/mm	The difference in theoretical resolutions does not affect the operating principle. Image quality distinctness is such that it does not affect the effectiveness of the device.
MTF	Predicate: More than 45% at 3 lp/mm	More than 45% at 3 lp/mm	Identical.
DQE	Predicate: More than 7.5% at 3 lp/mm	More than 21.0% at 3 lp/mm	Note 5 details that the subject device's DQE is higher. When spatial frequency is lower than 3lp/mm, DQE > 29% and MTF > 45%. When spatial frequency is higher than 7lp/mm, DQE < 1% implying it does not have the ability of resolution. The minor deviations in DQE, tested based on IEC62220-1, were attributed to the dental application and did not adversely affect image quality as demonstrated by solid-state device testing.
Image data bit depth	Predicate: 16 bits	16 bits	Identical.
Other Technical Characteristics
Indication for Use	Predicate: Scanning and processing digital images exposed on Phosphor Storage Plates (PSPs) in dental applications.	Scanning and processing digital images exposed on IP Imaging Plate in dental applications.	Identical.
Mechanical Design	Predicate: Two orthogonal directional scanning.	Line-by-line scanning pattern.	Note 1: Different scanning methodology but collects the same data and processes for visual imaging. Supports the same intended use and does not raise issues of safety and effectiveness.
Electrical Design	Predicate: Light with ~380nm wavelength from plate, collected and formed into image.	Light with ~380nm wavelength from plate, collected and formed into image.	Identical.
Image Scanning	Predicate: Laser/Photomultiplier Tube	Laser/Photomultiplier Tube	Identical.
Residual Image Erasing	Predicate: Inline erasing function.	Inline erasing function.	Identical.
Phosphor Plates	Predicate: Sizes 0, 1, 2, 3, 4	Sizes 0, 1, 2, 3	Note 3: Subject device offers four plate sizes vs. predicate's five. Does not affect effectiveness as the sizes offered are the same as the predicate.
Imaging Software	Predicate: DBSWIN/VistaEasy	Air-dental-woodpecker	Note 7: Different software but both followed FDA guidance for software in medical devices and passed performance testing, demonstrating functionality to convert digital data to acceptable images.
Applicable Standards	Predicate: ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62220-1, IEC 61223-3-4, IEC 60825-1	ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 62220-1, IEC 61223-3-4, IEC 60825-1	Identical (compliance demonstrated in Performance Testing section).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable. This device is an imaging hardware device, not an AI/ML algorithm evaluated on a dataset of patient images. Performance testing was conducted on the device itself against technical standards.
Data Provenance: Not applicable.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Number of Experts: Not applicable. Ground truth, in the context of an AI/ML device, would involve expert annotations of medical images. For this hardware device, performance was measured against physical standards and technical specifications.
Qualifications of Experts: N/A

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

Adjudication Method: Not applicable. No expert clinical review for ground truth was performed for this type of device.

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

MRMC Study: No. This device is an imaging plate scanner, a hardware component for acquiring digital dental X-ray images, not an AI-assistive technology for human readers.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This device is not an algorithm, but a hardware scanner. Its "performance" is measured by its ability to capture and process images according to technical standards.

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

Type of Ground Truth: Not applicable in the clinical sense. The "ground truth" for the performance testing of this device would involve measurements against established physical standards and benchmarks, as detailed in the cited IEC standards (e.g., IEC 62220-1 for Detective Quantum Efficiency).

8. The sample size for the training set

Sample Size: Not applicable. This device is not an AI/ML algorithm that requires a training set.

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

Ground Truth Establishment: Not applicable.

Summary

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September 27, 2021

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 and 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.

Guilin Woodpecker Medical Instrument Co., Ltd. % Charles Mack Principal Engineer IRC 2950 E Lindrick Drive CHANDLER AZ 85249

Re: K212080

Trade/Device Name: i-Scan Imaging Plate Scanner Regulation Number: 21 CFR 872.1800 Regulation Name: Extraoral Source X-Ray System Regulatory Class: Class II Product Code: MUH Dated: June 21, 2021 Received: July 2, 2021

Dear Charles Mack:

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

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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 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 (OS) 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,

, for

Thalia T. Mills, Ph.D Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and 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) K212080

Device Name i-Scan Imaging Plate Scanner

Indications for Use (Describe)

i-Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

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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K212080 510(k) SUMMARY

Preparation Date:	September 26, 2021
Manufacturer's Name and Address:	Guilin Woodpecker Medical InstrumentCo., LtdInformation Industrial Park, Guilin NationalHigh-Tech Zone, Guilin City, GuangxiProvince, China 541004
Corresponding Official:	Charles Mack
Telephone Number:	931-625-4938
Email Address:	charliemack@irc-us.com
Trade Name:	i-Scan Imaging Plate Scanner
Common Name(s):	system, x-ray, extraoral source,
Regulation Name(s):	Extraoral source x-ray system
Regulation Number(s):	21CFR872.1800
Product Code:	MUH
Device Class:	Class II
Predicate Device:Predicate Trade Name:Predicate Common Name:Predicate Regulation Name:Predicate Regulation Number:Predicate 510(k):Predicate Product Code:Predicate Device Class:	Duerr Dental AGScanX Intraoral Viewsystem, x-ray, extraoral source,Extraoral source x-ray system21CFR872.1800K170733MUHClass II

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Device Description:

Intended Use / Indications for Use

Scan Imaging Plate Scanner is intended to be used for scanning and processing digital images exposed on IP Imaging Plate in dental applications.

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Comparison of Technological Characteristics with the Predicate Device

Characteristics	Submitted Device	Predicate Device	Discussion
Device Name and model	i-Scan Imaging Plate Scanner	ScanX Intraoral View	-
Device Photo	Image: i-Scan Imaging Plate Scanner	Image: ScanX Intraoral View	-
Manufacturer	Guilin Woodpecker Medical InstrumentCo., Ltd	Duerr Dental AG	-
510(K) Number	Pending	K170733	-
Product Code	MUH	MUH	-
Indication for Use	i-Scan Imaging Plate Scanner isintended to be used for scanning andprocessing digital images exposed onIP Imaging Plate in dental applications.	The ScanX Intraoral View is intendedto be used for scanning andprocessing digital images exposedonPhosphor Storage Plates (PSPs)in dental applications.	Identical
Mechanical design	The exposed and unwrapped plates arescanned using a laser with a certainwavelength of 651-665 nm. The scanpattern is line by line.	The exposed and unwrapped platesare scanned in two orthogonaldirections using a laser with awavelength of approximately 650 nm.	Note 1
Electrical design	Light with a wavelength ofapproximately 380 nm is from the platein proportion to the number of capturedx-ray photons. This light is collectedand formed into an image that may beviewed on a video display and storedfor later recovery in a computermemory.	Light with a wavelength ofapproximately 380 nm is from theplate in proportion to the number ofcaptured x-ray photons. This light iscollected and formed into an imagethat may be viewed on a videodisplay and stored for later recoveryin a computer memory.	Identical
Image scanning	Laser/Photomultiplier Tube	Laser/Photomultiplier Tube	Identical
Erasing the residual imagefollowing scanning for plate reuse	The residual image is erased in thescanner by an inline erasing function.	The residual image is erased in thescanner by an inline erasing function.	Identical
Characteristics	Submitted Device	Predicate Device	Discussion
Viewing the image	The touch screen only shows a preview which serves to provide an initial impression of the final x-ray image. For the purposes of diagnosis, the x-ray image must be viewed on a diagnostic monitor. The scanned images are displayed on an internal LCD or an external monitor using a computer and user software including image storage, retrieval and manipulation.	4.3" Touch Screen. The touch screen only shows a preview which serves to provide an initial impression of the final x-ray image. For the purposes of diagnosis, the x-ray image must be viewed on a diagnostic monitor. The scanned images are displayed on an internal LCD or an external monitor using a computer and user software including image storage, retrieval and manipulation.	Identical
Transport/feedmechanism	The Plate realizes transmission movement through a conveyor belt, and the movement of the laser and the IP image board provides two orthogonal scanning directions.	The plates are transported by "beltways" down the axis of the cylinder past the slot. The motion of the laser and plates provides the two orthogonal scan directions. This is a continuous feed device that allows successive plates to be loaded as soon as the previous plates have moved past the slot.	Note 2
Phosphor Plates	Dental intraoralSize 0: 22 × 35 mmSize 1: 24 × 40 mmSize 2: 31 × 41 mmSize 3: 27 × 54 mm	Dental intraoralSize 0: 22 x 35 mmSize 1: 24 x 40 mmSize 2: 31 x 41 mmSize 3: 27 x 54 mmSize 4: 57 x 76 mm	Note 3
Image Quality	Theoretical resolutions: 10 or 33 LP/mm	Theoretical resolutions: 10, 20, 25 or 40 LP/mm	Note 4
MTF	More than 45% at 3 lp/mm	More than 45% at 3 lp/mm	Identical
DQE	More than 21.0% at 3 lp/mm	More than 7.5% at 3 lp/mm	Note 5
Image databit depth	16 bits	16 bits	Identical
Body size andweight	138 x 245.5 x 290.2 [mm] (W x L x H)4.5 [kg] (9.93 lbs.)	380 x 410 x 450 [mm] (W x L x H)19.5 [kg] (42.99 lbs.)	Note 6
Imaging Software	Air-dental-woodpecker	DBSWIN/VistaEasy as cleared in K161444	Note 7
User interface	It will be used by dentists and authorized dental auxiliary personnel.	It will be used by dentists and authorized dental auxiliary personnel.	Identical
Energy Source AC	100 to 240VAC, 50/60 Hz	100 to 240VAC, 50/60 Hz	Identical
PatientContaminationprevention	Single patient use barrier envelope encloses the imaging plate while in the patient's mouth.	Single patient use barrier envelope encloses the imaging plate while in the patient's mouth.	Identical
RFID	No.	No.	Identical
Electronic UserManual	User manual is provided in printed form to the user.	User manual is provided in printed form to the user.	Identical
ApplicableStandard	ANSI AAMI ES60601-1IEC 60601-1-2IEC 62220-1IEC 61223-3-4IEC 60825-1	ANSI AAMI ES60601-1IEC 60601-1-2IEC 62220-1IEC 61223-3-4IEC 60825-1	Identical

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Discussion:

Note 1

The operating principle of scanning the image plates with a laser of approximately the same wavelength. The difference lies in scanning methodology. The subject device scans the plates with a line-by-line pattern and the predicate uses two orthogonal directional scans. The scans collect the same data and process this for visual imaging.

They support the same intended use; the differences in the mechanical design does not raise issues of safety and effectiveness.

Note 2

The subject device shows different constructive solutions for the performance itself, without influencing the intended use or safety. The operating principle is still the same. The image plates are scanned by means of that the image plate is transported in the scan position. After the scanning procedure the image plate is ejected from the device.

Note 3

The subject device offers four selections of phosphor plates whereas the predicate device is available in five sizes. This does not affect the effectiveness and the plate sizes that are offered by the subject device are the same size as the predicate device.

Note 4

The subject device displays theoretical resolutions of 10- or 33-Line Pairs per mm, whereas the predicate shows greater designation of Line Pairs per mm. The differences do not affect the operating principle and the Image Quality distinctness is such that it does not affect the effectiveness of the device.

Note 5

When the spatial frequency is lower than 3lp/mm, the MTF value is greater than 45%, and the DQE value is greater than 29%. The resolution and the quantum efficiency are both very high. Therefore, it can be considered that there is no aliasing, which is equivalent to the predicate device. When the spatial frequency is higher than 7lp/mm, the MTF value is only 5.1%, and the resolution is very low. It can be considered that there is a sign of aliasing. Coupled with the influence of quantum noise, the DQE value is less than 1%, so it does not have the ability of resolution. The difference in detective quantum efficiency was tested based on IEC62220-1 and there were minor deviations due

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to the dental application of the radiography device. This difference did not adversely affect the image quality as demonstrated by the solid-state device testing.

Note 6

The size and weight of the subject and predicate device differ, but this has no bearing on the safety or effectiveness of the image plate scanning operations.

Note 7

The software is not the same between the subject device and the predicate, but both the subject and predicate have followed the FDA Guidance for the Content of Premarket for Submissions for Software Contained in Medical Devices. Also, both the subject and predicate have passed performance testing, demonstrating the software functions to convert the digital data to acceptable images.

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Performance Testing

Performance testing was provided in support of the substantial equivalence determination and to validate and verify that the Imaging Plate Scanner, Model i-Scan met all requirements of related international standards. The results of these tests demonstrate compliance with the requirements of the consensus standards noted below.

Non-clinical Testing

Performance Testing

IEC 61223-3-4 First edition 2000-03 Evaluation and routine testing in medical imaging departments - Part 3-4: Acceptance tests - Imaging performance of dental X-ray
IEC 62220-1 Medical electrical equipment Characteristics of digital X-ray imaging devices - Part 1: Determination of the detective quantum efficiency
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
IEC 60601-2-63 Edition1.1 2017-07, CONSOLIDATED VERSION Medical electrical equipment - Part 2-63: Requirements for the basic safety and essential performance of dental extra-oral X-ray equipment
IEC 60601-2-65 Edition 1.1 2017-05 CONSOLIDATED VERSION Medical electrical equipment - Part 2-65: Requirements for the basic safety and essential performance of dental intra-oral-X-ray equipment

FDA Guidance Documents

The following quidance documents were used in the development of the subject device:

FDA Guidance for the Content of Premarket Submissions for Software -Contained in Medical Devices.
FDA Guidance for the Submission of 510(k)s for Solid State X-ray Imaging -Devices
FDA's cybersecurity quidance, "Content of Premarket Submissions for -Management of Cybersecurity in Medical Devices

EMC and Safety Testing

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ANSI AAMI ES60601-1 :2005/(R) 2012 and A1 :2012, C1 :2009/(R)2012 and A2:201 0/(R)2012 Medical electrical equipment - Part 1: General requirements for basic requirements: safety and essential performance (IEC 60601-1 :2005, MOD)
IEC 60601-1-2:2007 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - requirements: Collateral standard: Electromagnetic compatibility - EMC Requirements and tests

Biocompatibility Information

No Biocompatibility testing was performed, as this device has no components which are patient contact devices.

Sterility Information

No sterility testing was accomplished, as this device is not delivered sterile, nor does it use require sterility.

Clinical Test:

No clinical study is included in this submission.

Conclusions:

The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Imaging Plate Scanner, Model i-Scan is substantially equivalent to the Duerr Dental AG, Inc. ScanX Intraoral View cleared under K170733 with respect to the indications for use, target populations, treatment method, and technological characteristics.

-END-

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.