(190 days)
XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.
The XKnife-4 system has similar technical characteristics as the commercially available XKnife-3 system. Both systems consist of treatment planning software, stereotactic hardware and a protocol of extensive verification and QA procedures to ensure proper transfer of the treatment parameters to the clinical delivery system. The XKnife-4 system also has similar technical characteristics as the commercially available XPlan-1 system. Both systems support the use of the LINAC jaws, in addition to a circular collimator, to further shape the radiation beam.
The provided text is a 510(k) summary for the Radionics Software Applications, Inc. XKnife-4, a radiation treatment planning system. However, it does not contain the detailed information required to answer all the questions about acceptance criteria and the study proving the device meets them.
Specifically, the document primarily focuses on establishing substantial equivalence to predicate devices (XKnife-3 and XPlan-1) based on similar technical characteristics and general safety/effectiveness. It mentions "Nonclinical tests were conducted to demonstrate that the XKnife-4 software meets all product requirements" but does not provide any specific acceptance criteria, performance metrics, or details about these tests.
Therefore, I can only address the questions for which information is present.
Summary of Available Information from the Provided Text:
The Radionics Software Applications, Inc. XKnife-4 is a radiation treatment planning system intended for stereotactic, collimated beam, computer-planned, LINAC-based radiosurgery and radiotherapy treatment.
The 510(k) process for this device focused on demonstrating substantial equivalence to existing predicate devices (Radionics Software Applications, Inc. XKnife-3 System and XPlan-1 System). The justification for substantial equivalence was based on:
- Similar technical characteristics: Both XKnife-4 and XKnife-3 consist of treatment planning software, stereotactic hardware, and a protocol for verification and QA. XKnife-4 and XPlan-1 both support the use of LINAC jaws.
- Nonclinical tests: "Nonclinical tests were conducted to demonstrate that the XKnife-4 software meets all product requirements." These tests also aimed to show that the performance is substantially equivalent to the predicate devices.
Missing Information:
The document explicitly lacks:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets or training sets.
- Data provenance.
- Details about expert involvement (number, qualifications, adjudication method).
- Information on MRMC comparative effectiveness studies.
- Effect size for human readers' improvement with AI assistance.
- Details about standalone algorithm performance studies.
- Specific types of ground truth used (beyond a general statement of "product requirements").
- How ground truth was established for any training or test sets.
Attempt to Answer Based on Provided Text (highlighting what is absent):
-
A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated. The document broadly mentions "meets all product requirements" and demonstrates "performance is substantially equivalent to the predicate devices." No specific numerical or qualitative criteria are provided.
- Reported Device Performance: Not explicitly stated. The document implies performance is on par with the predicate devices through the substantial equivalence claim, but no specific metrics or results from the nonclinical tests are detailed.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not mentioned.
- Data Provenance: Not mentioned.
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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)
- Experts: Not mentioned.
- Qualifications: Not mentioned.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not mentioned.
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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
- MRMC Study: Not mentioned as being conducted. The device is a "radiation treatment planning system," not typically assessed via MRMC studies in the way a diagnostic AI might be.
- Effect Size: Not applicable/not mentioned.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: The document states "Nonclinical tests were conducted to demonstrate that the XKnife-4 software meets all product requirements." This implies some form of standalone testing was performed to verify the software's functionality, but no specific performance metrics (e.g., accuracy, precision) or a detailed study description are provided. The context suggests product validation rather than a standalone performance study as understood for AI diagnostics.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not explicitly stated. The phrase "meets all product requirements" implies ground truth was established by adherence to design specifications and expected computational outcomes for treatment planning, rather than clinical ground truth like pathology or outcomes.
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The sample size for the training set
- Training Set Sample Size: Not mentioned. The document does not describe a machine learning or AI training process in the modern sense. It refers to a "software application" for treatment planning.
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How the ground truth for the training set was established
- Ground Truth for Training Set: Not mentioned. As above, this document does not describe a machine learning training paradigm.
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510(k) Summary of Safety and Effectiveness for Radionics Software Applications, Inc. XKnife-4
SUBMITTER 1.
Radionics Software Applications, Inc. 22 Terry Avenue Burlington, MA 01803 USA
Lisa Misterka Benati Contact Person: Senior Regulatory Engineer
NAME OF DEVICE 2.
Device Proprietary Name: XKnife-4 Radiation Treatment Planning System Device Common Name:
DEVICE CLASSIFICATION 3.
21 CFR 892.5900 X-ray Radiation Therapy System Class II:
DEVICE INTENDED USE 4.
XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.
PREDICATE DEVICES 5.
- Radionics Software Applications, Inc. XKnife-3 System .
- Radionics Software Applications, Inc. XPlan-1 System .
GENERAL SAFETY AND EFFECTIVENESS 6.
The device labeling contains instructions for use. It includes indications for use, cautions, warnings and user quality assurance procedures. The training and
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installation sessions provide assurance that the user understands all aspects of the XKnife-4 System: mechanical, computer and software, plus its intended functionality. This information promotes safe and effective use of the device.
COMPARISON OF TECHNICAL CHARACTERISTICS 7.
The XKnife-4 system has similar technical characteristics as the commercially available XKnife-3 system. Both systems consist of treatment planning software, stereotactic hardware and a protocol of extensive verification and QA procedures to ensure proper transfer of the treatment parameters to the clinical delivery system. The XKnife-4 system also has similar technical characteristics as the commercially available XPlan-1 system. Both systems support the use of the LINAC jaws, in addition to a circular collimator, to further shape the radiation beam.
NONCLINICAL TESTS USED IN DETERMINATION OF SUBSTANTIAL EQUIVALENCE 8.
The design of the XKnife-4 system, including the use of the LINAC jaws, has been thoroughly validated at the unit and system level. Nonclinical tests were conducted to demonstrate that the XKnife-4 software meets all product requirements. This testing also demonstrates that the performance is substantially equivalent to the predicate devices cited above.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 9 1998
Lisa Misterka Benati
Burlington, MA 01803
Senior Regulatory Engineer
Radionics Software Applications, Inc.
Re:
K981055 XKnife-4 Stereoactic RTP System Dated: July 13, 1998 Received: July 14, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 IYE
Dear Ms. Benati:
22 Terry Avenue
We have reviewed your Section 510/k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Modical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdch/dsmaldsmaman.html",
Sincerely yours,
Lillian Yih, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and ...... Radiological Health
Enclosure
l.
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510(k) Number (if known): K 981 051
Device Name: XKnife-4 Stereotactic Radiosurgery and Radiotherapy Treatment Planning System
Indications For Use:
XKnife-4 is intended for use in stereotactic, collimated beam, computer planned, LINAC (linear accelerator) based radiosurgery and radiotherapy treatment.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ilind C. Stym
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number . 1055
Prescription Use
(Per 21 CFR 801.109) ✓
OR
3/19/98
Over-The-Counter Use_
(Optional Format 1-2-96)
CONFIDENTIAL
§ 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.