XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

Device Description

The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.

AI/ML Overview

This submission is a 510(k) premarket notification for the Integra Radionics XKnife RT 4, a stereotactic radiation treatment planning system. The document states that the device is substantially equivalent to a predicate device (Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997) and relies on this substantial equivalence rather than presenting an independent study with acceptance criteria and performance data.

Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria cannot be fully provided from the given text.

Here's an explanation of why the specific sections of your request cannot be fulfilled:

A table of acceptance criteria and the reported device performance:
The document does not specify any new acceptance criteria for the Integra Radionics XKnife RT 4. It asserts substantial equivalence to a predicate device, meaning its performance is considered acceptable if it is comparable to the predicate. No specific performance metrics or a table comparing them are provided.
Sample size used for the test set and the data provenance:
No new clinical or performance study data is presented for the Integra Radionics XKnife RT 4. The submission relies on the established performance of its predicate device. Thus, there is no test set, sample size, or data provenance to report.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Since no new study data is presented, there is no test set for which ground truth would need to be established by experts.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
As no new study data is presented, no adjudication method was used.
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 device is a treatment planning system, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not applicable to this device type and was not performed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
While the device is a software system, the 510(k) submission primarily focuses on its technological characteristics and intended use being similar to its predicate. It does not describe a standalone performance study with specific metrics, but rather relies on the established safety and effectiveness of the essentially equivalent predicate.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
As no new study data is presented, there is no new ground truth established for the Integra Radionics XKnife RT 4.
The sample size for the training set:
This submission is for a medical device that appears to be rule-based or algorithm-based, rather than a machine learning model that would require a dedicated training set. No information regarding a training set or its size is provided.
How the ground truth for the training set was established:
Given that this does not appear to be an AI/ML device requiring a training set, the concept of establishing ground truth for a training set is not applicable here and no information is provided.

Summary of the K061893 Submission:

The Integra Radionics XKnife RT 4 is a stereotactic radiation treatment planning system. The submission (K061893) aims to demonstrate its substantial equivalence to an already legally marketed device, the Radionics XK.nife RT 3 with Non Stereotactic Module (K041997).

The basis for acceptance is this claim of substantial equivalence. The key arguments presented for substantial equivalence are:

Intended Use: The device is intended for "stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment," which is the same as its predicate.
Technological Characteristics: The technological characteristics are stated to be "the same or similar to those found with the predicate devices." The notable updates for XKnife RT 4 are its ability to be used on a Linux workstation and its capability to use PET scans as an additional image source.

In a 510(k) submission based on substantial equivalence, the "study" is often a comparison of the new device's specifications and performance to the predicate device, demonstrating that any differences do not raise new questions of safety or effectiveness. The provided text, however, does not include the detailed comparison data that would typically be part of such a submission, only the summary statement that such a comparison was made and found favorable.

Summary

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KD6/893

Section 6: 510(k) Summary

JUL 25 2006

Integra Radionics XKnife RT 4 510(k) Summary

This summary of the 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. 807.92.

1.0 The submitter of this premarket notification is:

Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue Burlington, MA 01803 Tel.: (781) 565-1227 Fax: (781) 238-0645

This summary was prepared on June 30, 2006.

2.0 The name of the device is the Integra Radionics XKnife RT 4. The common name is Stereotactic Radiation Treatment Planning System and Accessories, and its classification name is X-ray radiation therapy system.
3.0 The above device is substantial equivalent to the Radionics XK.nife RT 3 with Non Stereotactic Module 510(k), K041997.
4.0 The above system is a stereotactic treatment planning software with the ability to be used on a Linux workstation, and the ability to use PET scans as an additional image source.
5.0 The device like its predicates is intended for use in stereotactic, conformal, computer planned, LINAC (linear accelerator) based radiation. The indications for use are: XKnife RT 3 with Non-Stereotactic Module is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment .
6.0 The technological characteristics are the same or similar to those found with the predicate devices.

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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

JUL 25 2006

Mr. Kevin J. O'Connell Regulatory Affairs Manager Integra Radionics, Inc. 22 Terry Avenue BURLINGTON MA 01803-2516

Re: K061893

Trade/Device Name: Integra Radionics XKnife RT 4 Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: June 30, 2006 Received: July 3, 2006

Dear Mr. O'Connell:

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 either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/1/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" written below. Three stars are arranged beneath the word "Centennial". The logo is surrounded by a circular border with additional text, though the specific words are not clear due to the image quality.

Protecting and Promoting Public Health

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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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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

21 CFR 876.xxx	(Gastroenterology/Renal/Urology	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 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 its toll-free number (800) 638-2041 or (240) 276-3150

or at its Internet address http://www.fda.gov/edrh/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

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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Indications for Use

510(k) Number (if known): _ Ko 6 1 8 9 3

Device Name: Integra Radionics XKnife RT 4

Indications For use: XKnife RT 4 is a radiosurgery and radiotherapy treatment planning system intended for use in stereotactic and non-stereotactic (frameless), collimated beam, computer planned, LINAC based treatment

PRESCRIPTION USE XX (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)

Y. Alvarez Garcia

(Division Sign n
Division of Reproducere andominal,
and Radiological Devices
510(k) Number

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.