The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of x-ray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose. These scanners are not intended to be used for mammographic images.

Device Description

The ScanX D5000 series scanner is a device that reads photostimulable phosphor plates that have been exposed in place of x-ray film and allows those images to be displayed on a personal computer display.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the "Air Techniques, Inc. ScanX D5000 Series Scanner with and without Battery":

Overview:
This 510(k) summary describes a new device, the ScanX D5000 series scanner, which reads photostimulable phosphor plates. The primary claim for regulatory clearance is substantial equivalence to previously cleared predicate devices (ScanX 10/12 and Dental ScanX Scanner) and a predicate portable X-Ray system ("Any Ray" for the battery component). The document focuses on demonstrating that the D5000 series is "identical in concept, design, and function" to its predicates, with specific modifications detailed.

Acceptance Criteria and Reported Device Performance:

The document does not explicitly present a table of "acceptance criteria" in the format one might expect for a quantitative performance study (e.g., target sensitivity/specificity). Instead, it relies on demonstrating substantial equivalence to predicate devices through a comparison of characteristics. The "reported device performance" is implicitly that it functions identically or equivalently to the predicate devices.

Here’s a table summarizing the relevant characteristics and how they relate to demonstrating equivalence (which serves as the "acceptance criteria" here):

Characteristic	Acceptance Criteria (Implicit: Substantial Equivalence to Predicate)	Reported Device Performance (ScanX D5000 Series)
Intended Use	Same as predicate, plus intraoral PSP plates for dentists/veterinarians	Same as predicate (extraoral & medical imaging plates) and includes intraoral PSP plates for dentists and veterinarians (expanded).
Mechanical Design	Same as predicate ScanX 12	Same as predicate (reads exposed plates with laser, ~635nm)
Mechanical Enclosure	Metal enclosure (predicate)	Metal and plastic enclosure
Electrical Design	Same as predicate ScanX 12	Same as predicate (390nm light collected by photo multiplier tube, image displayed on PC)
Erasing Residual Image	Manual insertion into external plate eraser (predicate)	In-Line Erase (ILE) with red LEDs, automatically erases image
Viewing Image	Same as predicate	Same as predicate (displayed on computer with user software for storage, retrieval, manipulation)
Plate Input/Exit Heights	Accepts 10x12 inch plates and smaller (predicate)	Accepts 14x17 inch plates and smaller (improved capability)
Manufacturer	Air Techniques, Inc., doing business as All-Pro Imaging	Same as predicate
Body Size and Weight	14"W x 14"L x 28"H, 55 lbs (predicate)	15 ½"W x 17 ½"L x 13.75"H, 45 lbs (smaller, lighter)
Software	PCB and controller boards programmed with software/firmware (predicate)	New PC Boards and reconfigured firmware
User Interface	Licensed and trained dentist and medical technicians (predicate)	Same as predicate
Energy Source AC	100 to 240VAC, 50/60 Hz, 1.5A minimum (predicate)	100 to 240VAC, 50/60 Hz, 2.5A maximum
Energy Source DC (Battery)	Not Applicable (predicate ScanX 12)	Rechargeable 26.4V DC Lithium ion 8 cell battery pack
Battery Rating	Not Applicable (predicate ScanX 12)	2300 mAh
Battery Safety & Performance Testing	Not Applicable (predicate ScanX 12)	Battery pack tested to UL 2054; Battery cells tested to UL 1642
Electrical Safety Standards	UL60601-1 (safety) (predicate)	Same as predicate and UL2054
EMI Safety Testing	IEC 61000 (predicate)	IEC 61000
Performance Standards	IEC EMC testing /EN 60601-1-2 (predicate)	Same as predicate
Biocompatibility, Sterility, Shelf Life	Not applicable (no patient contact for predicate)	Not applicable (no patient contact)

Study Details:

The provided document describes a substantial equivalence determination rather than a traditional performance study with a test set of images, ground truth, or expert readers. This is a common approach for 510(k) submissions when a device is highly similar to existing cleared devices.

Sample size used for the test set and the data provenance:
- No explicit "test set" of images or patient data is mentioned. The study is a comparison against predicate device specifications and functionalities.
- Data provenance: Not applicable in the sense of patient data. The comparison is against the specifications and performance of existing, legally marketed devices from Air Techniques, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. No "ground truth" for a test set of images was established by experts in this type of submission. The "ground truth" is effectively the established performance and safety of the predicate devices.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. There was no test set requiring adjudication.
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 MRMC study was done. This device is a scanner, not an AI-assisted diagnostic tool.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a hardware/firmware device that produces images for human interpretation, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" is implied to be the established safety and effectiveness of the predicate devices based on their prior clearance and market performance. The submission argues that the new device, despite some differences (like plate size, in-line erase, and battery option), maintains the same fundamental performance characteristics for image acquisition. For the battery component, the "ground truth" is the safety and performance certification (UL 2054, UL 1642) of the battery itself and its equivalence to a predicate portable X-ray system.
The sample size for the training set:
- Not applicable. There is no machine learning or AI component requiring a "training set" in the context of this 510(k) submission.
How the ground truth for the training set was established:
- Not applicable, as there was no training set.

Conclusion from the document:

Air Techniques, Inc. concludes that the ScanX D5000 Series scanners are "safe and effective and substantially equivalent to the predicate devices as described herein," based on the detailed characteristic comparison and specific validation for new features like the battery and reconfigured firmware (mitigated through product and process validation located in Exhibit 7, though Exhibit 7 is not provided in the input). The FDA's letter concurs with the substantial equivalence finding.

Summary

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Air Techniques, Inc Quality Assurance Department ScanX D5000 Series Scanner with and without Battery

510(K) SUMMARY

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR §807.92.

1. Date Summary Prepared: May 5, 2010
  જ

ﺎ

1. Submitter's Identification: Air Techniques. Inc. 1295 Walt Whitman Road Melville, NY, 11747
  AUG.0 3 2010

Contact: Pablo Martinez Tel: 516-214-5541 Email: pmartinez@airtechniques.com

3. Device Name:

Trade /Proprietary Name: ScanX D5000 Series Scanner

Product codes: D5000-F, D5000-FB, D5000-FVB. D5000-Q. D5000-QB Common Name: Scanner for Computed Radiography Classification name: Solid State X-Ray Imaging System, 892:1630

4. Predicate Device Information:

The legally marketed devices to which equivalence is being claimed are:

ScanX 10- 510K 031198 Air Techniques, Inc., Melville, New York USA

ScanX Scanner. 510K 013893 Air Techniques, Inc., Melville, New York USA

Portable X-Ray System : AnyRay - 510K 081899 Giheung-Gu, Yongin-Si, Gyeonggi-Do, Korea

5. Device Description:

6. Intended Use/Indications for use:

The ScanX D5000 series scanners, with and without battery option are devices that read photostimulable phosphor plates that have been exposed in place of xray film and allow those images to be displayed on a personal computer display and stored for later recovery in a computer's memory. It will be used by

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Air Techniques, Inc Quality Assurance Department ScanX D5000 Series Scanner with and without Battery

physicians, dentists, veterinarians, and authorized medical auxiliary personnel for this purpose.

7. Basis for Determining Substantial Equivalence:

The ScanX D5000 series scanners are identical in concept, design, and function to the ScanX 10 Medical Imaging System and the Dental ScanX Scanner manufactured by Air Techniques, Inc. These medical and dental units currently in commercial distribution were cleared under K031198 and K013893. The ScanX D5000 series scanners consist of models provided with and without an internal battery that can be used in the medical, dental, and veterinary markets,

The rechargeable lithium battery used in the ScanX D5000-FB, D5000-FVB, and D5000-QB battery operated scanners is equivalent to a predicate Portable X-Ray System "Any Ray", 510(K) number K081899. The indications for use and basic overall specifications, operational characteristics, and materials used for the rechargeable battery are substantially equivalent.

The ScanX D5000 series scanners with battery option will be marketed under our All-Pro Imaging brand name.

Characteristic	Air Techniques ScanX D5000with Battery(modified device)	Air Techniques ScanX 12(formerly ScanX 10)(predicate device)
Mechanical design	same as predicate	The exposed plates are scanned.in two orthogonal directions usinga laser and a wavelength ofapproximately 635 nm
Mechanical enclosure	Metal and plastic enclosure	Metal enclosure
Electrical design	same as predicate	390 (approximately) nm lightemitted from the laseredplate is collected by a photomultiplier tube and formed into animage that may be viewed on acomputer monitor and stored forlater recovery in a PC-computermemory.
Erasing the residualimage followingscanning for platereuse.	Upon completion of the scanning,the PSP passes through the ILE(In-Line Erase) a row of Red LEDswhich erases the image on thePSP.	Upon exit from the scanner, theplate is manually inserted into anexternal plate eraser (non-medicaldevice) where it is exposed to highintensity light for a controlled time.
Viewing the image	Same as predicate device	The scanned image is displayedusing a computer and usersoftware (not part of the scannersystem) which accommodatesimage storage, retrieval andmanipulation.

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Air Techniques, Inc Quality Assurance Department ScanX D5000 Series Scanner with and without Battery

Plate input and exitheights	Accepts 14x17 inch plates andsmaller plates	Accepts 10 x12 inch plates andsmaller plates
Intended use	Same as predicate device, andadded the use of intraoral PSPplates used by dentists andveterinarians.	System is intended to be usedwith extraoral and medicalimaging plates by medicalprofessionals.
Manufacturer	Same as predicate	Air Techniques, Inc., doingbusiness as All-Pro Imaging
Body size and weight	15 ½"W x 17 ½"L x 13.75"H45 lbs.	14"W x 14"L x 28"H55 lbs.
Software	New PC Boards and reconfiguredfirmware, mitigated thru productand process validation located inExhibit 7	PCB and controller boardsprogrammed with software andfirmware.
User interface	Same as predicate	Licensed and trained dentist andmedical technicians
Energy Source AC	100 to 240VAC, 50/60 Hz, 2.5Amaximum	100 to 240VAC, 50/60 Hz, 1.5Aminimum
Energy Source DC	Rechargeable 26.4V DC Lithiumion 8 cell battery pack	Not Applicable
Battery Rating	2300 mAh	Not Applicable
Battery Safety &Performance Testing	Battery pack tested to UL 2054.Battery cells tested to UL 1642	Not Applicable
Electrical safetystandards	Same as predicate and UL2054	UL60601-1 (safety)
EMI Safety Testing	IEC 61000	IEC 61000
Performance standards	Same as predicate	IEC EMC testing /EN 60601-1-2
Biocompatibility	Not applicable (no patient contact)	Not applicable (no patient contact)
Sterility	Not applicable	Not applicable
Shelf Life	Not applicable	Not applicable

8. Conclusions:

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, Air Techniques, Inc. concludes that the ScanX D5000 Series scanners are safe and effective and substantially equivalent to the predicate devices as described herein.

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Image /page/3/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a symbol on the left and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" on the right. The symbol is a stylized representation of a human figure, and the text is in a sans-serif font.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Mr. Pablo Martinez Director of Compliance & Regulatory Affairs Air Techniques, Inc. 1295 Walt Whitman Road MELVILLE NY 11747-3062

AUG 2 3 2013

Re: K101289

Trade/Device Name: ScanX D5000 Series, Models: D5000-F, D5000-FB, D5000-FVB, D5000-Q and D5000-QB

Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: May 5, 2010 Received: May 7, 2010

Dear Mr. Martinez:

This letter corrects our substantially equivalent letter of August 8, 2010.

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. 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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21. Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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Page 2

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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AUG 0 3 2010

Indications for Use

510(k) Number (if known): K101289

K10128/9

Device Name: ScanX D5000 Series Product Codes: D5000-F, D5000-FB, D5000-FVB, D5000-Q and D5000-QB

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)

DIVISION SIGNATURE

ic Davice Evaluat

510K K101289

Page 1 of 1

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.