The InfiMed i5m Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5m Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

Device Description

The InfiMed i m Digital X-ray Imaging System is a high resolution digital imaging system designed for digital X-ray imaging through the use of an X-ray detector. The InfiMed i-1 Digital X-ray Imaging System is designed to support general radiography (excluding mammography), fluoroscopy, interventional fluoroscopy or angiography imaging procedures through a single common imaging platforms.

The modified InfiMed if me Digital X-ray Imaging System consists of an X-ray imaging receptor (any of the following: CCD Camera, Trixell Pixium 3543, Trixell Pixium 4600, Varian PaxScan 4336R, Varian PaxScan 4343R, Carestream Health Detector, Samsung LTX240AA01-A, Toshiba FDX 4343R), computer, monitor, and the digital i maging system. The InfiStitch for i-m Digital X-ray Imaging System is an option which allows the operator to generate sequential radiographic images and electronically jointhum to create a single electronic image. This feature will be available for any InfiMed customer utilizing the i-The Digital X-ray Imaging System DR application on any flat parel detector.

AI/ML Overview

The provided document is a 510(k) summary for the InfiMed InfiStitch for i5 Digital X-ray Imaging System. It describes the device, its intended use, and states that validation was completed with predetermined test methods and acceptance criteria. However, it does not provide a detailed breakdown of specific acceptance criteria or the study results that demonstrate the device meets those criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from this document. Many of the requested details about the study are also not explicitly stated.

Based on the provided text, here's what can be extracted and what remains unknown regarding the acceptance criteria and the study:

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

Acceptance Criteria: Not explicitly stated in the document. The document mentions "predetermined test methods and corresponding acceptance criteria" were used for validation, and "all release criteria have been met." However, it does not specify what those criteria are (e.g., specific quantitative metrics for image quality, resolution, stitching accuracy).
Reported Device Performance: The document generally states that the modified device "delivers equivalent or better image quality as the predicate device" and is "as safe and effective as the predicate device." It does not provide specific performance metrics or data.

2. Sample size used for the test set and the data provenance:

Sample Size (Test Set): Not specified.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not specified. The document only mentions "Non-clinical Tests Discussion" and "Clinical Tests Discussion."

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

Not specified.

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

Not specified.

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 mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a digital X-ray imaging system with a stitching function, not an AI-assisted diagnostic tool in the sense of providing automated readings or decision support that would typically involve a detailed MRMC study to show reader improvement.

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

The document implies that the device (including the InfiStitch algorithm) was tested, but it does not specify whether a standalone algorithm-only performance assessment was conducted separately from the overall system performance. The "InfiStitch" feature is an "option which allows the operator to generate sequential radiographic images and electronically join them to create a single electronic image," suggesting it's part of the operator's workflow rather than a fully autonomous diagnostic algorithm.

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

Not specified. Given it's an imaging system, ground truth would likely relate to image quality assessment criteria (e.g., spatial resolution, contrast-to-noise ratio, geometric accuracy for stitching), but the specific methods are not detailed.

8. The sample size for the training set:

The document does not mention a "training set." This type of device (digital X-ray imaging system with stitching function) typically undergoes verification and validation through engineering tests, phantom studies, and possibly human factors evaluations rather than machine learning training/testing paradigms with distinct training and test sets.

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

Not applicable, as no training set is mentioned in the context of this device's validation.

In summary, the document states that validation was performed and that the device meets its release criteria, implying acceptance criteria were met. However, it does not provide the specific details of these criteria or the results of the studies in a manner that allows for the completion of the requested table and answers to most of the specific questions. The document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance metrics against pre-defined acceptance criteria for a novel algorithm.

Summary

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Section 3: 510(k) Summary

Date Prepared:

6/30/10

Contact Person:

Catherine Mulcahy Quality Assurance Manager

Telephone: Fax:

315-453-4545 x288 315-453-4550

Submitter Name:

InfiMed. Inc. 121 Metropolitan Drive Liverpool, NY 13088

Device Trade Name:

·InfiStitch for i5™ Digital X-ray Imaging System

Common Name:

Digital X-ray Imaging System

Classification Name(s): InfiStitch for i5m4 Digital X-ray Imaging System

Product Codes: JAA, MQB, oWB

101833

JUL 2 8 2010

(

Predicate Device: iSTM Digital X-ray Imaging System

510(k) Number: K093066

Product Codes: JAA. MOB

Device Description:

Intended Use:

The InfiMed i5m Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in

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multipurpose or dedicated applications specified below. The i5m Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i500 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

Technological Characteristics Comparison:

The modified device supports the same modalities as the predicate device with the same components or imaging concepts, and delivers equivalent or better image quality as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the modified if TM Digital X-ray Imaging System. The modified device, InfiStitch for if Digital X-ray Imaging System, also has the ability to interface with an additional image receptor, Toshiba FDX4343R. Therefore, the modified device is substantially equivalent to the predicate device.

Non-clinical Tests Discussion:

Validation was completed in accordance with the Validation Protocols included with this submission. Protocols were designed, executed and documented according to the Design Validation process with predetermined test methods and corresponding acceptance criteria. In conclusion, all release criteria have been met and the modified i-m Digital Xray Imaging System is as safe and effective as the predicate device.

Clinical Tests Discussion:

Clinical Data submitted is consistent with FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" available at the website http://www.fda.gov/downloads/McdicalDevices/DeviceRegulationandGuidance/Guidanc eDocuments/ucm073781.pdf.

Conclusion:

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Based upon the results of Verification and Validation testing, the InfiMed InfiStitch for if TM Digital X-ray Imaging System has no new indications for use, has no simificant technological differences, and is as safe and effective as, and therefore substantially equivalent to the above listed current legally marketed predicate device.

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Public Health Service

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

InfiMed, Inc. % Mr. Jigar Shah Consultant mdi Consultants, Inc. 55 Northern Blvd., Suite 200 GREAT NECK NY 11021

JUL 30 2012

Re: K101833

Trade/Device Name: InfiStitch for iSTM Digital X-ray Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, and MQB Dated: June 30, 2010 Received: July 1, 2010

Dear Mr. Shah:

This letter corrects our substantially equivalent letter of July 23, 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. Drue, 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 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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Section 2: Indications for Use

K101833 510(k) Number (if known):

Device Name: InfiStitch for i5m Digital X-ray Imaging System

Indications for Use:

The InfiMed if TM Digital X-ray Imaging System is a high resolution digital imaging system intended to replace conventional film techniques, or existing digital systems, in multipurpose or dedicated applications specified below. The i5m Digital X-ray Imaging System enables an operator to acquire, display, process, export images to portable media, send images over a network for long term storage and distribute hardcopy images with a laser printer. Image processing algorithms enable the operator to bring out diagnostic details difficult to see using conventional imaging techniques. Images can be stored locally for temporary storage. The i2m Digital X-ray Imaging System has the ability to interface with a variety of image receptors from CCD cameras to commercially available flat panel detectors. The major system components include an image receptor, computer, monitor and imaging software.

For the DR application, the InfiMed i-714 Digital X-ray Imaging System is intended for use in general radiographic examinations and applications (excluding fluoroscopy, angiography, and mammography).

For the RF/DSA application, the InfiMed if TM Digital X-ray Imaging System is intended for use where general fluoroscopy, interventional fluoroscopy or angiography imaging procedures are performed.

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 Device Evaluation (ODE)	OIVD


(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
610K.	K101833

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. 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). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic 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. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.