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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.

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.

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

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).

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