The X3C 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pediatic patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatri patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 (510k submission device) is not intended for mammography.

Device Description

The X3C 1600 is a modification to Xplorer 1600 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 system is replaced with X3C digital radiographic detector, previously marketed device under 1000 The X3C 1600 system is manufactured by Imaging Dynamics.

AI/ML Overview

The provided text describes a 510(k) submission for the X3C 1600 Digital Radiographic System. This is a submission for a modification to an existing device (Xplorer 1600), where the detector is replaced. The key takeaway from the provided information is that no clinical tests were conducted for this device. Therefore, there is no study described that proves the device meets specific acceptance criteria based on clinical performance.

Instead, the submission relies on the concept of "substantial equivalence" to a predicate device (Xplorer 1600, K042041). This means the manufacturer demonstrated that the new device (X3C 1600) is as safe and effective as a legally marketed device without needing to perform new clinical trials.

Given that no clinical study was conducted, I cannot provide information on acceptance criteria related to device performance in a clinical setting, sample sizes, expert ground truth, MRMC studies, or standalone performance.

However, I can extract the information provided regarding the non-clinical tests and the basis for substantial equivalence.

Based on the provided text, here is what can be inferred about the acceptance criteria and the "study" (non-clinical evaluations) proving the device meets them:

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

Since no clinical study was performed, there are no reported clinical performance metrics in terms of sensitivity, specificity, accuracy, etc. The "acceptance criteria" here refer to meeting the requirements for substantial equivalence through non-clinical evaluations.

Acceptance Criteria Category	Reported Device Performance (Non-Clinical)
Performance	Evaluated and found to be "substantially equivalent" to predicate device (Xplorer 1600, K042041).
Biocompatibility	Evaluated and found to be "substantially equivalent" to predicate device.
Effectiveness	Evaluated and found to be "substantially equivalent" to predicate device.
Thermal Safety	Evaluated and found to be "substantially equivalent" to predicate device.
Electrical Safety	Evaluated and found to be "substantially equivalent" to predicate device.
Mechanical Safety	Evaluated and found to be "substantially equivalent" to predicate device.
Quality Systems	Design and development process conforms to 21 CFR part 820, ISO 9001, and ISO 13485 quality systems.
Intended Use	Has the same intended use as the predicate devices: diagnostic radiographic exposures of skull, spinal column, chest, abdomen, extremities, and other body parts on adult and pediatric patients (not mammography).
Fundamental Technology	Does not alter the fundamental scientific technology from Xplorer 1600 predicate device. The only significant change is the replacement of the digital radiographic detector.

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

No clinical test set was used. The evaluation was based on non-clinical tests for an engineering modification and comparison to a predicate device.
Data provenance: Not applicable as no clinical data was generated for this specific 510(k) submission.

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)

Not applicable. No clinical test set requiring expert ground truth was used.

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

Not applicable. No clinical test set requiring adjudication was used.

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 MRMC study was done. This is not an AI-assisted device, and no clinical studies were performed.

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

Not applicable. This device is a digital radiographic system, not an algorithm, and no standalone clinical performance was assessed for this 510(k) submission. The evaluation was non-clinical.

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

Not applicable. No clinical ground truth was established as no clinical study was conducted. The "ground truth" for the non-clinical evaluations would be established engineering and quality standards for device performance, safety, and effectiveness.

8. The sample size for the training set

Not applicable. This is not a machine learning/AI device, and no training set was used in the context of this 510(k) submission.

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

Not applicable. No training set was used.

Summary

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Special 510k Submission X3C 1600 Digital Radiographic System

510k Summary

1. Submitter:	Imaging Dynamics Company LtdSuite 151, Pegasus Way NECalgary, AB,Canada T2E 8M5
Contact person:	Shirantha SamarappuliManager - Regulatory AffairsTel: 403 251 9939; Fax: 403 251 1771
Date Prepared:	May 14, 2007
2. Device Name:	X3C 1600 Digital Radiographic System,
3. Device Classification:	Class II, 892.1680 (KPR), 892.1630 (MQB),
4. Predicate Device:	Xplorer 1600 Digital Radiographic System (K042041)

Device Description: 5. The X3C 1600 is a modification to Xplorer 1600 where the Xplorer 1000 digital radiographic detector (a previously marketed device covered by 510k K992955) in Xplorer 1600 system is replaced with X3C digital radiographic detector, previously marketed device under 1000 The X3C 1600 system is manufactured by Imaging Dynamics.
Indications for Use: 6. The X3C 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pediatic patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatri patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. The X3C 1600 (510k submission device) is not intended for mammography.
1. Comparison with predicate device: The X3C 1600 is substantially equivalent to the currently marketed Xplorer 1600. X3C 1600 device does not alter the fundamental scientific technology from Xplorer 1600 predicate device. The replacement of Xolorer 100 digital radiographic detector (K992955) with X3C digital radiographic detector (K170079) is the only significant change between the 2 devices. X3C 1600 has the same intended use as the predicate devices
- Non-clinical tests: The device has been evaluated for performance, biocompatibility and a. effectiveness as well as thermal, electrical and mechanical safety and has been found to substantially equivalent to predicate device. The design and development process of the manufacturer conforms to 21 CFR part 820, ISO 9001 and ISO 13485 quality systems.
- ﻗ Clinical tests: No clinical tests conducted.
- Conclusion: The device was evaluated against the predicate device (Xplorer 1600 -C. K042041) for all performance, safety & effectiveness requirements and found as substantially equivalent to the predicate device.

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Image /page/1/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of a stylized blue emblem on the left, followed by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue. The emblem appears to be a stylized representation of the human form.

Public Health Service

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

Ms. Shirantha Samarappuli Manager-Regulatory Affairs Imaging Dynamics Company, Ltd. Suite 151, 2340 Pegasus Wav NE CALGARY ALBERTA T2E 8M5 CANADA

AUG - 9 2013

Re: K071403

Trade/Device Name: X3C 1600 Digital Radiographic System Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR and MOB Dated: May 18, 2007 Received: May 21, 2007

Dear Ms. Samarappuli:

This letter corrects our substantially equivalent letter of June 11, 2007.

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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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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1 - 2 -* Indications for Use

1.1 Indications for Use

The U.S. Food and Drug Administration (FDA) requires the following statement to appear in this manual:

"The 1600 is intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts but not mammography. Applications can be performed with patient sitting, standing, or lying in the prone or supine positions."

FDA 510(k) for the X4C 1600: K042041

FDA 510(k) for the X3C 1600: to be assigned by FDA

FDA 510(k) for the X3C Detector Head: K070079

· The 1600 digital radiography system is not to be used for mammography.
· The 1600 digital radiography system should only be operated in conjunction with specified medical x-ray equipment and by trained and licensed personnel.
WARNING! Only certified and properly trained, authorized personnel should be permitted to take x-ray exposures. No practical design can incorporate complete protection for personnel who do not follow proper safety precautions.
WARNING! The appropriate x-ray imaging exposure parameters should be consistent with established Federal and Provincial/State radiation protection practices and medical imaging standards in your institution.

Prescription Use

Duhal Lema (45)

(Division Sign-Off) Division of Reproductive, Abdominal, a Radiological Devices 510(k) Number

Imaging Dynamics Company « PN: 902-0001-015 v1.0 • May 29, 2007

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.