MOBETRON by INTRAOP MEDICAL, INC.

The Mobetron is a mobile electron linear accelerator that produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.

For delivery of electron beam radiation during a surgical procedure, known as Intraoperative Radiation Therapy (IORT), the Mobetron system includes a sterile cap and sterile drapes for each IORT procedure, IORT applicators, a QA system, a surgical table extender with added support leg, and bolus material.

Device Description

The MOBETRON is a mobile electron beam accelerator designed specifically for use in the operating room (O.R.). Once in the OR, the accelerator head can be positioned in the horizontal plane, rotated about the coronal plane, and moved along the beam axis direction to facilitate docking with an electron applicator that is inserted into the patient. Together with the C-arm rotation, the accelerator head motion is designed to allow the accelerator to be easily and safely positioned for intraoperative treatments. All motorized motions are variable speed and are controlled by a lightweight hand-held control. The operator control system contains the dosimetry readout parameters, accelerator controls, machine interlock status, and a video output of the periscopic viewing system.

When the electrons emerge from the accelerator, they are scattered by a set of thin metallic foils and are pre-collimated to a circular field size of 10 cm. (at the standard treatment distance of 50 cm. SSD) by a primary tungsten collimator. The scattered electron beam passes through two independent transmission ion chambers and is further collimated to the desired field size by electron applicators which are inserted into the patient. The scattering foil and collimation technique and applicator systems used in the Mobetron is similar to techniques used for IORT in other electron accelerator systems. The Mobetron provides four (4) electron beams of energy 4, 6, 9 and 12 MeV, and a set of electron applicators of various diameters from 3 cm to enable the delivery of Intraoperative Radiotherapy (IORT) treatment.

AI/ML Overview

The provided text from K981112 describes a 510(k) submission for a medical device called "MOBETRON," an electron linear accelerator for Intraoperative Radiation Therapy (IORT). However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of clinical performance or diagnostic accuracy.

This 510(k) submission is focused on demonstrating substantial equivalence to a predicate device (Siemens Mevatron ME Linear) based on technological characteristics and intended use, rather than a clinical performance study with specific acceptance criteria that would typically involve human readers, ground truth establishment, or sample sizes for diagnostic accuracy.

Here's an attempt to answer your questions based on the limited information related to device performance as described in the document, and a clear indication where information is not provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Produce electron beams for radiation therapy of malignant and benign conditions.	Produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions.
Provide four electron beam energies.	Provides four (4) electron beams of energy 4, 6, 9 and 12 MeV.
Provide a set of electron applicators for various field sizes.	Provides a set of electron applicators of various diameters from 3 cm to enable the delivery of Intraoperative Radiotherapy (IORT) treatment. Field sizes from 3 to 10 cm in diameter.
Be mobile for use in more than one O.R.	Mobile and can be used in more than one O.R.
Perform equivalently to the predicate device in terms of electron beam energies, field size, and dose rate.	"This system produces electron beams of energies, field size, and dose rate equivalent to other electron accelerators used for IORT."
Maintain correct performance after being moved to a new location (output and energy checks).	"To assure that the Mobetron is performing correctly after it is moved to a new location, output and energy checks are made using a quality assurance device provided with the unit."
Consistently perform within design parameters.	"Performance tests were conducted and the results indicated that the Mobetron consistently performed within the design parameters."
Perform equivalently to the predicate device.	"Performance tests were conducted and the results indicated that the Mobetron consistently performed...equivalently to the predicate device."

2. Sample size used for the test set and the data provenance

Not provided. The document describes engineering/design performance tests, not a clinical study involving a "test set" of patient data in the sense of diagnostic imaging or AI performance evaluation. The "tests" mentioned are likely technical specifications and physical performance measurements of the LINAC.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/Not provided. This type of information is relevant for studies evaluating the diagnostic accuracy of AI or imaging devices where expert consensus is needed. For a linear accelerator, ground truth relates to physical parameters like beam energy, dose rate, and field size, which are established through established physics and dosimetry principles, not expert consensus in the clinical sense.

4. Adjudication method for the test set

Not applicable/Not provided. Similar to above, this is not relevant for the type of device performance described.

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

No, not done. This is a physical device (linear accelerator) for therapy delivery, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant to this submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is a piece of hardware. While it has controls and internal systems, the performance evaluation in this context is about the physical characteristics of the electron beam and the machine's operation, not an algorithm's standalone performance in a diagnostic or interpretive sense.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's performance would be based on physical dosimetry measurements and established engineering specifications. For example, the "ground truth" for a 4 MeV beam would be a beam measured to truly have 4 MeV, verified by standard calibration and measurement equipment.

8. The sample size for the training set

Not applicable/Not provided. As this is not an AI/machine learning device, there is no "training set."

9. How the ground truth for the training set was established

Not applicable/Not provided. As there is no "training set," this question is not relevant.

Summary of the Study (as described in the 510(k)):

The study described is a performance evaluation of the MOBETRON device. The purpose was to demonstrate that the MOBETRON consistently performed within its design parameters and equivalently to a predicate device (Siemens Mevatron ME Linear).

Nature of the Study: This appears to be a technical and engineering performance study, rather than a clinical trial assessing patient outcomes or a diagnostic accuracy study.
Methodology (implied): The company conducted various "performance tests" likely involving physical measurements of the electron beams (energies, field sizes, dose rates) and functional checks of the device's mobility and control systems.
Comparison: The key comparison was against its own design parameters and against the performance characteristics of the predicate device.
Conclusion: The results indicated that the MOBETRON performed "consistently within the design parameters and equivalently to the predicate device."
Ground Truth for Equivalence: Implicitly, the ground truth for "equivalence" to the predicate device was established through comparing the physical and operational specifications and measured output characteristics of the MOBETRON against those of the predicate device (or generally accepted standards for such devices).

Summary

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K981112

Accelerator, 510(k) Device

Number K852907

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS as required by section 807.92(c)

1.	Submitter's Information:	Dated March 24, 1998Intraop Medical, Inc.3170 De La Cruz Blvd., Suite 108Santa Clara, CA 95054
	Contact Person:	Donald A. Goer, Ph.D.President & CEO(408) 986-6020 (phone)(408) 986-0222 (fax)
2.	Common or Usual Name:	Electron Linear Accelerator (Linac)
	Proprietary and Trade Name of Device:	MOBETRON
	Device Classification:	System, Radiation Therapy, Charged-Particle, Medical
3.	Predicate Device:	Siemens Mevatron ME Linear

The MOBETRON is a mobile electron beam accelerator designed 4. Description of Device: specifically for use in the operating room (O.R.). Once in the OR, the accelerator head can be positioned in the horizontal plane, rotated about the coronal plane, and moved along the beam axis direction to facilitate docking with an electron applicator that is inserted into the patient. Together with the C-arm rotation, the accelerator head motion is designed to allow the accelerator to be easily and safely positioned for intraoperative treatments. All motorized motions are variable speed and are controlled by a lightweight hand-held control. The operator control system contains the dosimetry readout parameters, accelerator controls, machine interlock status, and a video output of the periscopic viewing system.

Statement of Intended Use: The Mobetron is a mobile electron linear accelerator that న. produces beams of electrons used in the radiation therapy treatment of both malignant (cancer) and benign conditions. The Mobetron has four electron beam treatment energies and a set of electron applicators which provide a range of field sizes from 3 to 10 cm in diameter.

The intended use is the same as the predicate device.

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i ર. Statement of Technological Characteristics: The basic operation of the Mobetron is similar to that of any electron linear accelerator system, in that it employs a modulator, electron gun, rf-system and accelerator guide system. In the Mobetron, a lightweight electron beam linear accelerator is mounted on a motor driven gantry. The gantry is attached to a stand which is supported on a selfcontained transportation system. A modulator and operator control console complete the system. This system produces electron beams of energies, field size, and dose rate equivalent to other electron accelerators used for IORT.

The intended use and performance characteristics are equivalent to the predicate device and therefore we believe it is substantially equivalent to it.

Differences: The differences between the systems are minor and do not effect the safety and 7. efficacy of the treatment. The major difference between the Mobetron and the predicate device is that the predicate device is fixed in location and limited to a single O.R. The Mobetron is mobile and can be used in more than one O.R. Once it is in a specific O.R., its use is essentially identical to the predicate device. To assure that the Mobetron is performing correctly after it is moved to a new location, output and energy checks are made using a quality assurance device provided with the unit. The predicate device requires similar testing of output and energy prior to use even though the device is not moved. The Mobetron is thus substantially equivalent to the predicate device.

Performance Evaluation: Performance tests were conducted and the results indicated that 8. the Mobetron consistently performed within the design parameters and equivalently to the predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized image. The image is of a caduceus, a symbol of medicine, with a single snake winding around a staff. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 4 1998

Donald A. Goer, Ph.D. President Intraop Medical 3170 De La Cruz Blvd., Suite 108 Santa Clara, CA 95054

Re:

K981112 Mobetron (Electron Linear Accelerators) Dated: March 24, 1998 Received: March 26, 1998 Regulatory class: II 21 CFR 892.5050/Procode: 90 LHN

Dear Dr. Goer:

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 Cosmenc 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 II (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 Medical Devices: General regulation (21 CFR Part 820) and that, through periodic OS 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 531 through 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/cdrh/dsmaldsmamain.html".

Sincerely yours,

Kilian Yin

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INDICATIONS FOR USE

Daniel G. Symm

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

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.