A tabletop for supporting a patient's torso in the prone position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.
A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.

The imaging-oriented supporting structure is CT radiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.

The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices.

AI/ML Overview

The provided text describes a medical device called "Pronex" and its 510(k) summary for FDA clearance. However, it does not contain the detailed information necessary to complete the requested table and study analysis.

Specifically, the document focuses on:

The device's name, applicant, contact information, classification, and predicate devices.
A general description of the device's components and intended use (positioning a patient for prone breast radiation therapy).
The FDA's determination of substantial equivalence to predicate devices.
The formal "Indications for Use Statement."

The document does not include any information regarding:

Acceptance criteria for performance (e.g., specific measurements, thresholds).
Reported device performance data.
Details of a study conducted to prove the device meets acceptance criteria.
Sample size for test or training sets.
Data provenance (country of origin, retrospective/prospective).
Number of experts or their qualifications for ground truth.
Adjudication method.
MRMC comparative effectiveness study (AI vs. human readers).
Standalone algorithm performance.
Type of ground truth used (pathology, outcomes, expert consensus).
How ground truth for training data was established.

Therefore, I cannot populate the requested table or answer the specific questions about the study from the provided input. The document establishes the device's regulatory clearance based on substantial equivalence to existing devices, inferring that safety and effectiveness are established by this comparison, rather than through a new performance study with explicit acceptance criteria.

Summary

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SECTION 3 510(K) SUMMARY

DEC - 7 2010

Pronex
510(K) number K102765

Date Prepared	September 2010
Applicant's Name	Direx Systems Corporation
	437 Turnpike Street
	Canton, MA 02021
	Tel:(339) 502-6013
Contact Person:	Fax:(339) 502-6018Ms. Larisa Gershtein
Trade Name	e-mail:lgershtein@direxusa.comPronex
Classification Name	Medical Charged -Particle Radiation Therapy System
Classification	The FDA has classified this type of devices as class II(Product code IYE,21 CFR. 892.5050). Radiology Panelreviews this type of device.
Predicate Devices	ClearVue prone Breast Treatment Table, K090349,
Establishment	Prone Breast Positioning Board, Model 37-018, K9713821224828
Registration Number
Intended use	Positioning a patient for prone breast radiation therapy.
Device Description	The device comprise two rigid mechanical structures,each incorporating:
	* A tabletop for supporting a patient's torso in the prone

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position such that a treated breast is able to hang down through a tabletop opening. The tabletops for each structure are identical.

A selection of two application-oriented supporting structures. Each supporting structure is composed of a base for interfacing the device to a couch, and spacers that connect the tabletop to the base such that a space is provided for a treated breast. The applications are imaging and radiation treatment.

The imaging-oriented supporting structure is CTradiation transparent and is compatible with a 70cm bore and with a CT couch. The treatment-oriented supporting structure is treatment-radiation transparent and is compatible with the treatment couch. The supporting structures do not affect the patient's torso positioning on the tabletop, so as to allow imaging and treatment in the same position.

The respective couches provide positioning motion. The intended use, functionality, technological characteristics and materials of the device are similar to those of the predicate devices. Analysis of similarities and differences led Direx Systems Corp. to conclude that the device is substantially equivalent to its predicate devices without raising new safety and/or effectiveness issues

Substantial Equivalence

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

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

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

DEC - 7 2010

Re: K102765

Trade/Device Name: Pronex Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 15, 2010 Received: September 24, 2010

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 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/ReportalProblem/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.

Dan

David G. Brown, Ph.D. 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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Image /page/4/Picture/0 description: The image shows the logo for Direx Systems Corp. The logo is black and white and features the word "Direx" in large, bold letters. Below the word "Direx" is a horizontal line, and below that is the text "SYSTEMS CORP." in smaller letters. The logo is simple and professional.

SECTION 2 INDICATIONS FOR USE STATEMENT

Indications for Use Statement

510(k) Number (if known):

1/102765

DEC - 7 2010

Device Name: Pronex

Indications for Use:

Pronex is used to position a patient for prone breast radiation therapy.

Prescription Use - Yes (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 Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K.	K102765

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.