The Axxent® Electronic Brachytherapy System is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated.

Device Description

The Axxent Electronic Brachytherapy System consists of three primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Source); and an Axxentcompatible applicator (Applicator). The System is designed to deliver doses of X-ray radiation to the tissue in proximity to the applicator using a disposable, miniature X-ray tube powered by the Controller.

The Axxent Electronic Brachytherapy Controller is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a disposable, miniature X-ray tube located at the end of a flexible cable. The Source is inserted into a lumen of the appropriate Applicator.

AI/ML Overview

Here's an analysis of the provided text regarding the Axxent Electronic Brachytherapy System, focusing on acceptance criteria and study details.

Important Note: The provided text is a 510(k) summary and FDA clearance letter, which primarily focuses on demonstrating substantial equivalence to predicate devices and general safety/effectiveness. It does not contain the detailed information typically found in a clinical study report addressing specific performance metrics, sample sizes for ground truth, expert qualifications, or MRMC studies for AI devices. This device is a radiation therapy system, not an AI-powered diagnostic tool, so many of the requested categories (like MRMC, standalone AI performance, and AI-specific ground truth details) are not directly applicable or reported in this type of submission.

Acceptance Criteria and Reported Device Performance

Given that this is a radiation therapy system and the submission focuses on substantial equivalence, the "acceptance criteria" here refer more to the successful demonstration of the device meeting its performance, functional, and system requirements during verification and validation testing, rather than specific diagnostic accuracy metrics.

Acceptance Criteria Category	Reported Device Performance/Statement
System Functionality & Performance	All performance, functional, and system requirements were met.
Safety and Effectiveness	Device labeling contains instructions, cautions, and warnings for safe and effective use. Risk management via risk analysis. Potential hazards are controlled via software development, verification, and validation testing.
Substantial Equivalence to Predicates	The technological characteristics are the same as Axxent Electronic Brachytherapy System (K072683) and similar to Varian VariSource 200 HDR Afterloader (K061582) in terms of design, materials, principles of operation, and product specifications.

Study Details (Based on Available Information)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in the provided documents. The validation testing likely involved a series of engineering and functional tests on the device itself, rather than a "test set" of patient data in the way an AI diagnostic device would.
- Data Provenance: Not applicable in the context of patient data for a performance study. The "data" here refers to the outcomes of the engineering and software validation tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not directly applicable to a hardware/software system validation in the way it would be for a diagnostic AI system requiring expert consensus on images. The "ground truth" for this device's performance would be established by engineering specifications and regulatory standards. Expert oversight would be from the development and testing engineers and regulatory affairs personnel within iCAD/Xoft.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for diagnostic accuracy to resolve discrepancies between readers, particularly for ground truth establishment or comparative reader performance. This submission describes performance and functional testing of a radiation delivery system.
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 or reported. This device is a therapeutic device (radiation delivery system), not an AI-assisted diagnostic tool. Therefore, human reader (e.g., radiologist) improvement with AI assistance is not a relevant metric for this submission.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone performance (algorithm only) is partially relevant in that the device's control system and dose delivery algorithm operate in a "standalone" fashion to execute a treatment plan. The "Assessment of Non-Clinical Performance Data" indicates "Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met." This implies the software and system were tested independently to ensure they meet their specifications. However, this is not an "AI algorithm only" performance as conceptualized for diagnostic AI.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the device's function and performance is its adherence to predefined engineering specifications, design requirements, and regulatory standards. This is assessed through various verification and validation tests (e.g., electrical safety, radiation output accuracy, software functionality, mechanical integrity). For safety, a risk analysis identifies potential hazards.
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning system that requires a "training set" of data for model development. Its software and control algorithms are developed through traditional engineering and programming methods.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" for this type of medical device as described in the provided document.

Summary

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K 122951

510(k) Summary

510(k) OWNER:

JAN 1 7 2013

iCAD Inc. 98 Spit Brook Road, Suite 100 Nashua, NH 03062 T: 603-882-5200 Ext 7945 F: 603- 880-3843 Registered Establishment Number: 1225671

MANUFACTURER FACILITY:

Xoft Inc. a Subsidiary of iCAD Inc. 101 Nicholson Lane San Jose, CA 94134 Registered Establishment Number: 3005594788

NAME OF CONTACT:

John A. DeLucia VP, Regulatory Affairs, Clinical Affairs and Quality Assurance

DATE SUMMARY PREPARED: December 12, 2012

TRADE NAME: Xoft Electronic Brachytherapy System

COMMON NAME: Radiation Therapy System

CLASSIFICATION: Class II

CLASSIFICATION NAME: X-Ray Radiation Therapy System

CRF CLASSIFICATION: 21 CFR 892.5900

PRODUCT CODE: JAD

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SECTION 6: 510(K) Summary (con't)

Legally Marketed Devices to Which Substantial Equivalence is Claimed

The Axxent Electronic Brachytherapy System Controller is substantially equivalent to the following legally marketed predicate devices. When used with applicators or sources both devices treat lesions, tumors and conditions in or on the body where radiation is indicated.

Device Name	Manufacturer	510(k)Reference #	ConcurrenceDate
Axxent Electronic BrachytherapySystem	Xoft	K072683	2/29/08
VariSource 200 HDR Afterloader	Varian	K061582	7/25/06

Device Description

Intended Use / "Indications for Use"

Image /page/1/Picture/9 description: The image is a warning label. The label warns that the safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not been established. The warning sign is inside of a black rectangular box.

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. Summary of Technological Characteristics

The technological characteristics of the Axxent Electronic Brachytherapy System Controller are the same as the Axxent Electronic Brachytherapy System cleared in K072683, and are similar to the Varian VariSource 200 HDR Afterloader cleared under K061582. These devices are equivalent in terms of design, materials, principles of operation, and product specifications.

General Safety and Effectiveness Concerns

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of this device. Risk management is ensured via a risk analysis which is used to identify potential hazards. Any potential hazards are controlled via software development, verification and validation testing.

Assessment of Non-Clinical Performance Data

Validation testing was performed according to a Software System Test Plan. All performance, functional and system requirements were met.

Conclusion -

This traditional 510(k) for the Axxent® Electronic Brachytherapy System Controller contains adequate information and data to determine substantial equivalence to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized emblem. The emblem is a graphic representation of a human figure embracing a sphere, symbolizing the department's mission to protect the health of all Americans and provide essential human services.

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

January 17, 2013

Mr. John DeLucia VP, RA/QA/CA iCAD, Inc. 98 Spitbrook Rad NASHUA NH 03062

Re: K122951

Trade/Device Name: Axxent(R) Electronic Brachytherapy System Regulation Number: 21 CFR 892.5900 Regulation Name: X-ray radiation therapy system Regulatory Class: II Product Code: JAD Dated: December 12, 2013 Received: December 13, 2013

Dear Mr. DeLucia:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting 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 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122951

Device Name: Axxent® Electronic Brachytherapy System

Indications for Use: The Axxent® Electronic Brachytherapy System is a high dose rate brachytherapy device for use with Axxent Applicators to treat lesions, turnors and conditions in or on the body where radiation is indicated.

WARNING The safety and effectiveness of the Axxent Electronic Brachytherapy System as a replacement for whole breast irradiation in the treatment of breast cancer has not

been established.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(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 Diagnostics and Radiological Health (OIR)

Muchel (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health K122951 510(k)

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Regulation Number and Section

§ 892.5900 X-ray radiation therapy system.

(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for 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.