MIGUE is intended to be used to place patients at the isocenter of a linear accelerator for stereotactic radiosurgery or radiotherapy procedures. MIGUE uses x-ray registration as the method of locating the position of the patient. It is indicated for all body procedures.

The device consists of three units:

MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
Console Workstation PC with embedded software, used for control, display and image processing.
Electronics Cabinet.

Principle of operation:
a) Acquire two images, one from each channel.
b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.

AI/ML Overview

The provided text does not contain detailed information regarding the acceptance criteria, study design, or performance data for the MIGUE device. The document is a 510(k) summary and an FDA clearance letter, which primarily focuses on the device's substantial equivalence to predicate devices and its indications for use.

Therefore, many of the requested details cannot be extracted from the given input.

Here's a breakdown of what can be inferred or stated from the provided text, and what cannot:

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

This information is not present in the provided text. The document states "The Substantial Equivalence table provides a comparison of MIGUE's technological characteristics to those of the predicate devices. The table is located in Section 8 of this submission." However, Section 8 is not included in the provided snippets. Without this section, specific acceptance criteria or performance metrics are unknown.

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

This information is not present in the provided text. The document does not describe any specific clinical or performance studies, test sets, or data provenance.

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)

This information is not present in the provided text. There is no mention of ground truth establishment or expert involvement in any testing.

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

This information is not present in the provided text. No adjudication method is described.

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

This information is not present in the provided text. The MIGUE device, as described, is an X-ray registration system for patient placement, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance would not be applicable, and no such study is mentioned.

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

This information is not explicitly stated as a formal "standalone study." However, the description of MIGUE indicates its primary function is automated X-ray registration for patient positioning. Its "Principle of operation" describes acquiring images, displaying them, and indicating the isocenter projection. This implies an inherent standalone algorithmic function to perform its intended task, operating without direct human intervention in the core image analysis for positioning (though human oversight and control are certainly part of the workflow). The document doesn't detail a specific study proving this standalone performance, but the device's function implies it.

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

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. There is no mention of a "training set," implying that if machine learning is involved, it's not discussed in this summary, or the device relies on traditional image processing/registration algorithms rather than learned models requiring a training set.

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

This information is not present in the provided text, as no training set or ground truth for it is mentioned.

In summary, the provided document is a regulatory submission summary (510(k)) focusing on equivalence to predicate devices and indications for use, rather than a detailed technical or clinical study report. Therefore, most of the requested performance and study details are not available within the given text.

Summary

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K0522/2

SECTION 4 - 510(k) SUMMARY

[Submitted pursuant to 21 CFR 807.92(a)]

Summary Date: October 17, 2005

1. Submitter Information

Submitter:

Direx Systems Corporation 11 Mercer Road Natick Business Park Natick, MA 01760

Telephone:	(508) 651-0900
Fax:	(508) 651-8125
Contact Person	Larisa GershteinQA Manager
Contact Person e-mail address:	lgershtein@direxusa.com

2. Device

Trade / Proprietary Name:	MIGUE
Classification Name:	Accelerator, Linear, Medical
Classification Name/ Product code:	90 IYE
Regulatory Class:	Class II
Regulation Number:	21 CFR 892.5050

3. Predicate Devices

3Dscope K041213 ExacTrac X-Ray 6D K040585

4. Device Description

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The device consists of three units:

1. MIGUE Main Unit incorporates two angularly spaced identical Fluoroscopic Channels, mounted on a rigid ring, for acquisition of X-ray images.
1. Console Workstation PC with embedded software, used for control, display and image processing.
1. Electronics Cabinet.

Principle of operation:

a) Acquire two images, one from each channel.
b) Each channel displays an acquired image and a marker indicating the IsoCenter projection onto the fluoroscopic screen.

5. Indications for Use

6. Technological Characteristics

The Substantial Equivalence table provides a comparison of MIGUE's technological characteristics to those of the predicate devices. The table is located in Section 8 of this submission.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Larisa Gershtein Quality Assurance Manager Direx Systems Corp. 437 Turnpike Street CANTON MA 02021

Re: K052212 Trade/Device Name: MIGUE Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 9, 2006 Received: February 10, 2006

Dear Ms. Gershtein:

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 stred 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, weret 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 provices , labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affer ting 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 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) I labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

MAR 1 0 2006

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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 1egally 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation promoter at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at inst the netition the 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Nancy C. Brigdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 3 - INDICATIONS FOR USE STATEMENT

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K052212 Device Name: MIGUE Indications for Use:

MIGUE is intended to aid in patient target to radiation beam set-up for administration of radiation therapy. It is indicated for all body procedures.

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

510(k) Number _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)

Over the Counter Use___________________________________________________________________________________________________________________________________________________________________________

David A. Syverson
(Division Sign-Off)

Division of Reproductive, Abdominal, ological Devic

Regulation Number and Section

§ 892.5050 Medical charged-particle radiation therapy system.

(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.