This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities.
This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Device Description

These systems are single or dual plane systems that employ x-rays to obtain fluoroscopy or radiography images of the body. The system is comprised of a computer system, support arms that contain the tube and solid state detector (either one or two), x-ray generator and a patient table.

AI/ML Overview

The provided text is a 510(k) summary for the Toshiba America Medical Systems, Inc. INFX-8000V. This document is a pre-market notification for a medical device and does not contain the specific detailed information typically found in a study report regarding acceptance criteria and performance data for a device under evaluation.

Here's a breakdown of why the requested information cannot be extracted from the provided text and what the document does indicate:

What the document is:

510(k) Summary: This is a concise overview of the device and its substantial equivalence claim, submitted to the FDA for pre-market notification.
Substantial Equivalence Claim: The core of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and technological characteristics, and raises no new questions of safety or effectiveness.

Why the requested information is not present:

For a 510(k) submission that relies on substantial equivalence to a predicate device, a full-blown clinical study with defined acceptance criteria and performance metrics like accuracy, sensitivity, or specificity is often not required. Instead, the focus is on demonstrating that the new device performs similarly or no worse than the predicate.

Therefore, the document does not include:

A table of acceptance criteria and reported device performance (in terms of clinical outcomes, diagnostic accuracy, etc.).
Details about sample sizes for test sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training/test sets. These are typical components of a study proving a device meets specific performance criteria.

Information that can be inferred or directly stated from the document, relevant to the spirit of your request:

The acceptance criteria in this context are primarily related to safety, effectiveness, and substantial equivalence to the predicate devices, rather than specific clinical performance metrics.

A table of acceptance criteria and the reported device performance:

Acceptance Criteria (Implied)	Reported Device Performance (Summary)
Compliance with Quality System Regulations (21 CFR § 820)	"This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820."
Compliance with Federal Diagnostic Equipment Standard (21 CFR § 1020)	"All requirements... will be met and reported via an initial report."
Conformance with IEC 60601-1, IEC 60601-2-32, and IEC 60601-2-28	"Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards."
Substantial Equivalence to Predicate Devices (GE Innova 3130, Toshiba DFP-8000D/FPD)	"The INFX-8000V is of comparable type and substantially equivalent to: GE Innova 3130... Toshiba DFP-8000D/FPD... Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device."
Manufacturing processes and materials similar to predicate device	"This device employs similar materials and processes as found in the predicate device."
Same intended use as predicate devices	"This device is a digital x-ray system configured for use as a diagnostic x-ray angiography system. This x-ray angiography system is used for diagnostic and interventional procedures for cardiac blood vessels, cerebral blood vessels, abdominal blood vessels and lower extremities." (Matches the general use of predicate angiography systems).

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable / Not Provided: The document does not describe a clinical study with a specific test set. The substantial equivalence claim is based on technological characteristics and comparison to predicate devices, not on a new clinical performance study.
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 / Not Provided: No such information is present as no specific test set requiring expert ground truth is detailed.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided: No test set described.
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:
- Not Applicable / Not Provided: This device is an X-ray system, not an AI-assisted diagnostic tool. No MRMC study is mentioned.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Provided: The device is a medical imaging system, not an AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not Applicable / Not Provided: No specific ground truth is referenced for performance evaluation in this type of submission. The "ground truth" for substantial equivalence is primarily the established safety and effectiveness of the predicate devices and compliance with regulatory standards.
The sample size for the training set:
- Not Applicable / Not Provided: This device is an X-ray system; there's no mention of a "training set" in the context of an AI algorithm.
How the ground truth for the training set was established:
- Not Applicable / Not Provided: As above.

In summary, the provided 510(k) document is for an imaging system demonstrating substantial equivalence to existing devices. It does not detail specific performance studies with clinical endpoints or AI evaluations, which are common for different types of medical devices, especially AI/ML-driven ones. The "proof" that it meets acceptance criteria comes from its demonstrated similarity to already-approved predicate devices and its adherence to general safety and quality standards.

Summary

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K081582
pg.: 1 of 2

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

510(k) Summary

Date:	May 29, 2008JUN 17 2008
Submitter's Name:	Toshiba America Medical Systems, Inc.
Submitter's Address:	P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:	Paul Biggins, Director Regulatory Affairs(714)730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	INFX-8000V (Infinix CFi and Infinix VFi)
Common Name:	Electrostatic Fluoroscopic x-ray System)[Fed. Reg. No. 892.1650, Pro. Code: 90MQB]
Regulatory Class:	II (per 21 CFR 892.1650)
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Predicate Device(s):	GE Innova 3130; 510(k) Control # K060259Toshiba DFP-8000D/FPD; 510(k) Control # K052884
Reason For Submission	Model Number Change

Description of this Device:

Summary of Intended Uses:

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K081582
pg. 2 of 2

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

Technological Characteristics:

This device employs similar materials and processes as found in the predicate device. The device produces ionizing radiation that is employed to generate fluoroscopic and radiographic images of the anatomy.

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020,that apply to this device, will be met and reported via an initial report. Additionally this system is in conformance with the applicable parts of the IEC 60601-1 {applicable portions}; IEC 60601-2-32, and IEC 60601-2-28. - Medical Device Safety standards.

Substantial Equivalence:

The INFX-8000V is of comparable type and substantially equivalent to:

GE Innova 3130; 510(k) Control # K060259 Toshiba DFP-8000D/FPD; 510(k) Control # K052884

Therefore the INFX-8000V complies with the same or equivalent standards and has the same intended use as the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services. The logo consists of two parts: a symbol on the left and the text on the right. The symbol is a stylized image of a human figure, and the text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES".

Public Health Service

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

Toshiba America Medical Systems. Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

AUG 2 0 2013

Re: K081582

Trade/Device Name: INFX-8000V; Infinix-CFi and Infinix-VFí Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: JAA and MOB Dated: June 4, 2008 Received: June 5. 2008

Dear Mr. Job:

This letter corrects our substantially equivalent letter of June 17, 2008.

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 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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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for INFX-8000V

Indications for Use

510(k) Number (if known):

K081582

Device Name: INFX-8000V; Infinix-CFi and Infinix- VFi

Indications for Use:

This device is a digital radiography/fluoroscopy system used in a diagnostic angiography configuration. This system is indicated for use in diagnostic and angiographic procedures for blood vessels in the heart, brain, abdomen and lower extremities.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Azu Nathing
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Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

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.