(293 days)
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energized (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
The provided text is a 510(k) summary for the Accuthera CygneX I System. It primarily focuses on demonstrating substantial equivalence to a predicate device (Accuray CyberKnife System) rather than detailing a specific study to prove acceptance criteria with quantitative results from a test set.
However, based on the information provided, I can infer and extract some details about performance testing and acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't provide a direct "acceptance criteria" table with specific thresholds and numerical performance metrics from a study. Instead, it compares features and specifications of the CygneX I System to its predicate device (Accuray CyberKnife) in Table ES-1. The "Reported Device Performance" would be implied by the CygneX I column, with the "Consideration of the difference(s)" column indicating whether the CygneX I meets or exceeds the predicate's performance, or if the differences are not adverse.
Therefore, I'll adapt the request to present the key performance-related features and their comparison to the predicate. The "Acceptance Criteria" for these would implicitly be "comparable to or better than the predicate," or "achieves same level of safety and effectiveness."
| Feature/Metric | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (CygneX I System) | Consideration of Difference |
|---|---|---|---|
| Intended Use | Same as predicate | "The CygneX I System is a medical charged-particle radiation therapy system accelerating electrons intended to provide photon radiation for treatment." | Same |
| Indication for Use | Comparable to predicate to ensure safety and effectiveness | "The System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain and base of skull (BOS)." | No, but while it is less, it is included by the predicate. |
| Principles of Radiation Delivery | Same as predicate | Same principles of stereotactic radiotherapy, using a Linac mounted on a robotic arm. | Same |
| Patient Position Monitoring | Comparable safety and effectiveness to fluoroscopic imaging | Uses commercially available (510K cleared) positioning device for monitoring body surface movement (e.g., AlignRT PLUS) and mobile C-Arm imaging/fluoroscopic system (e.g., Philips Veradius Neo System, K133819, or equivalent) to confirm target position. | No, but same safety can be achieved by confirmation of the patient position using a device which can image the position of the target inside the patient. |
| Single dose & fractionated treatment | YES | YES | Same |
| X-band Accelerator | YES | YES | Same |
| X-ray energy | 6MV (Standing wave Linac) | 6MV (Standing wave Linac) | Same |
| Dose rate | 300 cGy/min (maximum BUILD UP) | 300 cGy/min (maximum BUILD UP) | Same |
| Isocenter floor height SAD | 127cm (nominal isocenter, system is not isocentric); 80cm | 130cm (nominal isocenter, system is not isocentric); 60cm | No, but it is only 3 cm higher. No, but it still treats the target to the prescribed dose. |
| Source Target positioning | Six-axis manipulator | Six-axis manipulator | Same |
| Patient Positioning device (Treatment Couch) | Stationary/Adjustable | CygneX I System does not include a Treatment Couch. It uses commercially available Adjustable Treatment Couch which complies with conditions specified by Accuthera Inc. | No, but same level of safety & effectiveness can be achieved by using a specified 510K cleared treatment couch. |
| Mechanical Isocenter accuracy | Less than 0.05cm radius | Sphere less than 0.05cm radius | Same |
| Dosimetry system reproducibility position | ±3% or 3MU whichever is greater at any fixed treatment node | ±2% or 1 MU whichever is greater at any fixed treatment node | No, but has improved specification. |
| Beam collimation | Fixed secondary collimators delivering circular field sizes of 5-60 mm diameter at SAD | Variable secondary collimator delivering regular hexagonal fields sizes, with distances between opposite sides of 5, 7.5, 10, 12.5, 15, 20, 25 and 30 mm at SAD. | Comparable field sizes up to 30 mm. |
| Target location reference | Patient's skull | Patient's skull | Same |
| Treatment Planning System | YES | YES | Same |
| Safety Interlocks | YES | YES | Same |
| Emergency Stop | YES | YES | Same |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states, "comprehensive nonclinical testing in accordance with FDA Recognized Consensus Standards as shown in the TAB 8-2 and in the TAB-14, and testing in accordance with our internal performance specifications as shown in the TAB-15 demonstrates that the minor differences do not adversely impact performance..."
This indicates that the "test set" for this device consisted of nonclinical testing, which typically involves physical measurements, bench testing, and simulations, rather than patient data. Therefore, the concept of sample size as applied to patient cases or data provenance (country of origin, retrospective/prospective) is not applicable in this context. The testing was conducted on the device hardware and software itself.
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)
Since this was nonclinical testing of a radiation therapy system, the "ground truth" was established by engineering specifications, recognized consensus standards (e.g., IEC standards for medical electrical equipment), and physics principles, rather than expert medical consensus on patient data. Experts involved would likely be qualified engineers (e.g., electrical, mechanical, software) and medical physicists with expertise in radiation therapy equipment and relevant standards. The number and specific qualifications are not detailed in the provided text.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like "2+1" or "3+1" are relevant for resolving discrepancies in human readings or clinical assessments. As this was nonclinical testing against technical specifications and standards, an adjudication method is not applicable in the traditional sense. Test results were objectively compared against predefined engineering and performance specifications.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study is applicable to diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance. The CygneX I System is a medical charged-particle radiation therapy system used for treatment planning and delivery, not for diagnostic imaging or interpretation by human readers. Therefore, an MRMC study and the concept of "human readers improve with AI" are not applicable to this device's function as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is a complex system involving "therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem." The "Summary of Performance Testing" refers to nonclinical testing, electromagnetic compatibility testing, functional performance characteristics testing, and software verification and validation testing. This implies that performance of the individual components and the integrated system (including the algorithm for treatment planning and control systems) was assessed in a standalone manner against its specifications. The entire system effectively operates without a human in the real-time control loop during radiation delivery, based on the pre-approved treatment plan. So, a form of "standalone" testing for the algorithmic and functional aspects was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the nonclinical testing of this device, the ground truth was based on:
- Engineering specifications and design requirements
- Performance metrics defined by recognized consensus standards (e.g., those referenced in TAB 8-2, TAB-14, and TAB-15, which commonly include IEC standards for safety and performance of medical electric equipment)
- Physics principles for radiation generation and delivery.
8. The sample size for the training set
The device is a radiation therapy system, not an AI/ML algorithm that requires a "training set" in the sense of a large dataset of patient images or clinical outcomes used to train a model. Therefore, the concept of a training set sample size is not applicable in this context. The "training" for such a system refers to its design, calibration, and verification against physics models and engineering principles.
9. How the ground truth for the training set was established
As the concept of a "training set" is not applicable, the method of establishing ground truth for it is also not applicable.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 5, 2015
Accuthera, Inc. % Mr. Robert Morton CEO Ouality and Regulatory Services, Inc. 1244 Fairway Valley Court LINCOLN CA 95648
Re: K143560 Trade/Device Name: CygneX I System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: September 3, 2015 Received: September 8, 2015
Dear Mr. Morton:
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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D'Hara
For
Robert Ochs, Ph.D. 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) K143560
Device Name CygneX I System
Indications for Use (Describe)
The CygneX I System is intended to provide treatment planning and surface-guided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. atteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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ACCUTHERA
510(k) Summary
The following information is provided following the format of 21 CFR 807.92.
Submitter: Accuthera Inc. 2-8-22 Kurigi, Asao-ku, Kawasaki-shi Kanagawa, 215-0033 Japan
| Contact Name: Eiji Tanabe, Ph.D. | |
|---|---|
| President & CEO | |
| Phone: | +81-44-980-1511 |
| Fax: | +81-44-980-1522 |
| Email: | etanabe@accuthera.com |
Date Summary was prepared: 10 December 2014
Name of the Device:
| Trade/Proprietary Name: | CygneX I System |
|---|---|
| Common or Usual Name: | Medical Linear Accelerator |
| Classification Name: | Medical charged-particle radiation therapy system |
| 21 CFR 892.5050, Class II | |
| Product Code: IYE |
Predicate Device: Accuray CyberKnife System, K984563
Description of Device:
The CygneX I System consists of therapeutic CygneX I Treatment Delivery Subsystem and the dedicated CygPlan I Treatment Planning Subsystem. The CygneX I Treatment Delivery Subsystem consists mainly of a Therapeutic Xray Generation Part, 6-Axis Manipulator Part, and X-ray Delivery Control Console Part. A linear accelerator with a variable collimator is incorporated in the X-ray head, the main portion of the Therapeutic X-ray Generation Part, which generates a very fine, highly- energized (6 MV) and controlled dose of X-ray beams. The variable secondary collimator is capable of delivering regular hexagonal fields, with the distances between the two opposite sides
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ACCUTHERA
Accuthera Inc. Head Office 2-8-22 Kurigi, Asao-ku, Kawasaki-Shi, 215-0033 Japa TFI : +81-44-980-1511 FAX: +81-44-980-1522 E-mail: info@accuthera.com URL: http://www.accuthera.com
from 5mm to 30 mm, at 60 SAD. The CygPlan I Treatment Planning Subsystem provides the capability for forward and inverse planning from CT data. It provides a plan after physician approval, to the CygneX I Treatment Delivery Subsystem to deliver the treatment from the selected treatment nodes.
Statement of Intended Use:
The CygneX I System is a medical charged-particle radiation therapy system accelerating electrons intended to provide photon radiation for treatment.
Statement of Indications For Use:
The CygneX I System is intended to provide treatment planning and surfaceguided stereotactic radiosurgery and precision radiotherapy for lesions (e.g. arteriovenous malformations), tumors and conditions of the brain and base of skull (BOS).
Summary of the Technological Characteristics:
The CygneX I System has same Intended Use, principles of operation, and major technological characteristics and a similar Indication For Use as the predicate device, the CyberKnife System For Stereotactic Radiosurgery/Radiotherapy, K984563, manufactured by Accuray, Inc.
A comparison table summarizing the similarities and differences between the CygneX I System and the predicate device is provided in Table ES-1.
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| Feature | Accuray CyberKnife System ForStereotacticRadiosurgery/RadiotherapyK984563 | Accuthera CygneX I System(CygneX I with CygPlan I) | Consideration of thedifference(s) |
|---|---|---|---|
| Intended Use | The CyberKnife System (K984563) is a medical charged-particle radiationtherapy system acceleratingelectrons intended to provide photonradiation for treatment. | The CygneX I System is a medicalcharged-particle radiation therapysystem accelerating electrons intendedto provide photon radiation for treatment. | Same |
| Indication for use | To provide treatment planning andimage-guided stereotacticradiosurgery and precisionradiotherapy for lesions (e.g.arteriovenous malformations), tumorsand conditions of the brain, base ofskull (BOS), cervico-thoracic spine(CTS), head and neck. | The System is intended to providetreatment planning and surface-guidedstereotactic radiosurgery and precisionradiotherapy for lesions (e.g.arteriovenous malformations), tumorsand conditions of the brain and base ofskull (BOS). | No, but while it is less, it isincluded by the predicate. |
| Principles ofRadiationdelivery | The System is a type of stereotacticradiotherapy, a non-invasivetreatment in which high doses offocused radiation beams aredelivered from multiple locationsoutside of the body to destroy atumor or lesion within the body. Thisminimizes radiation exposure tohealthy tissue surrounding the tumor.The system uses a linear accelerator(Linac), producing the radiation whilemounted on a robotic arm. | The System is a type of stereotacticradiotherapy, a non-invasive treatment inwhich high doses of focused radiationbeams are delivered from multiplelocations outside of the body to treat atumor or lesion within the body. Thisminimizes radiation exposure to healthytissue surrounding the tumor.The system uses a linear accelerator(Linac), producing the radiation whilemounted on a robotic arm. | Same |
| Patientpositionmonitoring | The predicate incorporates afluoroscopic imaging device. | CygneX I uses commercially available(510K cleared) positioning device formonitoring of the patient's body surfacemovement, such as AlignRT PLUS and amobile C-Arm imaging or fluoroscopicsystem be used to confirm the targetposition, such as the Philips VeradiusNeo System, K133819, or equivalent. | No, but same safety can beachieved by confirmation of thepatient position using a devicewhich can image the position ofthe target inside the patient. |
| Technical characteristic | |||
| Single doseandfractionatedtreatment | YES | YES | Same |
| X-bandAccelerator | YES | YES | Same |
| X-ray energy | 6MV(Standing wave Linac) | 6MV(Standing wave Linac) | Same |
| Dose rate | 300 cGy/min (maximum BUILD UP) | 300 cGy/min (maximum BUILD UP) | Same |
| Isocenterfloor heightSAD | 127cm (nominal isocenter, system isnot isocentric)80cm | 130cm (nominal isocenter, system is notisocentric)60cm | No, but it is only 3 cm higher.No, but it still treats the target tothe prescribed dose. |
| Source Targetpositioning | Six-axis manipulator | Six-axis manipulator | Same |
| PatientPositioningdevice(TreatmentCouch) | Stationary/Adjustable | CygneX I System does not include aTreatment Couch. It uses commerciallyavailable Adjustable Treatment Couchwhich complies with conditions specifiedby Accuthera Inc. | No, but same level of safety &effectiveness can be achievedby using a specified 510Kcleared treatment couch. |
| MechanicalIsocenteraccuracy | Less than 0.05cm radius | Sphere less than 0.05cm radius | Same |
| Dosimetrysystemreproducibilityposition | ±3% or 3MU whichever is greater atany fixed treatment node | ±2% or 1 MU whichever is greater at anyfixed treatment node | No, but has improvedspecification. |
| Beamcollimation | Fixed secondary collimatorsdelivering circular field sizes of 5, 7.5,10, 12.5, 15, 20, 25, 30, 35, 40, 50and 60 mm diameter at SAD | Variable secondary collimator deliveringregular hexagonal fields sizes, thedistances between the two oppositesides are 5, 7.5, 10, 12.5, 15, 20, 25 and30 mm at SAD | Comparable field sizes up to 30mm. |
| Targetlocationreference | Patient's skull | Patient's skull | Same |
| TreatmentPlanningSystem | YES | YES | Same |
| SafetyInterlocks | YES | YES | Same |
| EmergencyStop | YES | YES | Same |
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Table ES-1: Comparison of major feature of CygneX I System and the Predicate Device
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Summary of Performance Testing:
There are some minor differences. However, comprehensive nonclinical testing in accordance with FDA Recognized Consensus Standards as shown in the TAB 8-2 and in the TAB-14, and testing in accordance with our internal performance specifications as shown in the TAB-15 demonstrates that the minor differences do not adversely impact performance of the device for its intended use nor do the differences raise new safety concerns. The nonclinical testing performed includes essential performance and basic safety testing, electromagnetic compatibility testing, functional performance characteristics testing and software verification and validation testing. All of these testing confirmed that the CygneX I System performs as intended.
Thus the CygneX I System is substantially equivalent to the Accuray CyberKnife System For Stereotactic Radiosurgery/Radiotherapy (K984563).
§ 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.