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The Accuray Precision® Treatment Planning System is indicated for creation and assessment of external photon beam irradiation treatment plans for radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated. A treatment plan provides an estimate of the dose distribution and the parameters utilized by the radiation delivery system. Plans must be reviewed and approved by qualified medical practitioners prior to delivery.

The Accuray Precision® Treatment Planning System is a radiation therapy planning system used for the creation and assessment of treatment plans for delivery by radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery treatment systems.

The radiation treatment plan is developed by using diagnostic CT (primary image series) and/or secondary images (MR and PET) of the patient previously acquired prior to treatment and saved into the central database server (iDMS Data Management System). The images are imported from the database server into the Accuray Precision® Treatment Planning System to register/ fuse for dose calculation, and to accurately define/contour regions of interest (target) and the surrounding critical anatomical structures to avoid.

The user (dosimetrist/ medical physician) then specifies the treatment delivery machine (CyberKnife or TomoTherapy systems, Radixact systems), treatment delivery mode (e.g., 3DCRT, IMRT) and the patient alignment at the treatment machine. This is followed by specifying the radiation dose criteria for the identified regions of interest, as well as the number of fractions over which this dose is to be administered. After the relevant data has been entered, the user initiates the treatment plan calculation or optimization process. When the treatment plan has been calculated, the user may refine the plan with adjustments to the regions of interest, avoidance structures, and dose criteria and re-optimize the plan.

Once an optimized treatment plan is produced that meets the requirements of the intended therapy, the prescribing physician approves the plan for delivery and the plan is saved on the database server as a treatment delivery plan. The plan reports are also printed for the patient record.

The provided text describes a 510(k) submission for the Accuray Precision® Treatment Planning System. It states that the subject device, with modifications, is substantially equivalent to its predicate device. However, the document does not contain the specific details regarding acceptance criteria, reported device performance in a table, sample sizes, expert qualifications, ground truth establishment, MRMC studies, or standalone performance data for an AI/ML component.

The document only generally mentions:

• "Software verification and validation was conducted, and documentation is provided as recommended by FDA's Guidance for Industry and FDA staff, 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices'."
• "The results from testing included in the premarket notification demonstrate that the performance characteristics of the subject device are substantial equivalent to the predicate device."
• "The performance test data for subject device... confirms that the user will be able to create, save, review and modify treatment plans with the same or higher level of quality as compared to the treatment plans created using the predicate device."

Without specific numerical performance data or detailed study descriptions, it's impossible to fill out the requested information. The text indicates that these performance data exist and were submitted to the FDA, but they are not included in this public summary.

Therefore, I cannot provide the requested information from the given text. A typical 510(k) summary (public version) does not usually include the granular details of the V&V studies, especially for features like "dose calculation algorithms" which are mentioned as having "minor enhancements." If these enhancements involved an AI/ML component, the detailed study would be in a separate, non-public section of the submission.

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The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

The TomoTherapy Treatment Delivery System with iDMS is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The TomoTherapy Treatment Delivery System with iDMS is a modified version of the predicate TomoTherapy Treatment System (last cleared on K121934). The TomoTherapy Treatment Delivery System with iDMS is the same as the predicate device minus the Data Management System and Treatment Planning Station, but substituting the Treatment Delivery Console (TDC) from the Radixact Treatment Delivery System (last cleared on K161146) in place of the predicate Operator Station. The TomoTherapy Treatment Delivery System with iDMS is designed to deliver radiation therapy treatment plans generated on planning systems such as the Accuray Precision™ Treatment Planning System (last cleared on K171086) and stored on data management systems such as the Accuray iDMS™ Integrated Data Management System (last cleared on K161144).

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and explicitly stating what is not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not present a formal table of acceptance criteria with corresponding performance metrics for the TomoTherapy Treatment Delivery System with iDMS. Instead, it relies on a comparison to a predicate device, asserting "substantial equivalence." The document states that the new device has "imaging and treatment capabilities equivalent to those of the predicate" and "employs the same fundamental scientific principles, and have substantially equivalent intended uses, principles of operation, performance specifications and technological characteristics."

The only specific performance data mentioned is a general statement: "Results of verification and validation testing confirm that the TomoTherapy Treatment Delivery System with iDMS conforms to design specifications and meets the needs of the intended users." It also notes compliance with "applicable FDA recognized consensus safety standards for radiation therapy medical devices."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This implies that there was no separate "test set" in the traditional sense involving patients or biological samples to evaluate the device's performance against specific clinical acceptance criteria. The evaluation was primarily based on technical comparisons to a predicate device and engineering verification and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical or animal tests were performed, there was no "test set" requiring ground truth established by experts in the context of clinical performance. The evaluation was based on engineering and design specifications and a comparison to a previously cleared device. Therefore, this information is not applicable/not provided.

4. Adjudication Method for the Test Set

As no clinical or animal test set was used, an adjudication method for such a set is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not done, as the document explicitly states: "No animal or clinical tests were required to establish substantial equivalence." This type of study would typically involve human readers.

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

The device described is a treatment delivery system, not an algorithm in the AI sense for diagnosis or interpretation. The performance evaluation focused on the physical device's technical specifications and functional equivalence to a predicate device. Therefore, a "standalone algorithm performance" study as typically understood in AI/medical imaging is not applicable/not provided.

7. The Type of Ground Truth Used

The ground truth used for establishing "substantial equivalence" appears to be the design specifications, performance characteristics, and regulatory clearance of the predicate device (TomoTherapy Treatment System (K121934)), along with compliance to relevant consensus safety standards. The new device was deemed substantially equivalent because its technological characteristics, intended use, and fundamental scientific principles were the same as the predicate.

8. The Sample Size for the Training Set

Since no clinical or animal studies were conducted to establish substantial equivalence for this device, there was no training set used in the context of a statistical or machine learning model. The device's "training" would be analogous to its design and manufacturing process, which adheres to established engineering principles and the specifications of the predicate.

9. How the Ground Truth for the Training Set was Established

As there was no training set in the conventional sense, the establishment of "ground truth" for a training set is not applicable/not provided. The device's functionality is based on its design and manufacturing to meet pre-defined engineering and safety standards, which are continuously refined and validated during product development (verification and validation testing).

Summary of the Study and Device Validation:

The validation of the TomoTherapy Treatment Delivery System with iDMS was primarily a non-clinical equivalency study. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (TomoTherapy Treatment System (K121934)).

The study involved:

• Detailed comparison of technological characteristics: This included comparing system configuration, physical dimensions, environmental parameters, gantry mechanical features, photon beam characteristics, imaging capabilities, laser systems, patient couch, power distribution, operator station, machine control software, data interfaces, and safety features.
• Verification and validation testing: This was internal engineering testing to confirm the device conforms to its own design specifications and meets the needs of intended users. Specific details of these tests (e.g., number of test cases, methodologies) are not given in the 510(k) summary, but it's stated that they confirm conformance.
• Compliance with recognized safety standards: Testing was performed by an independent certified testing laboratory to ensure compliance with applicable FDA recognized consensus safety standards for radiation therapy medical devices.

The conclusion is that the minor differences between the new device and the predicate do not raise different questions of safety or effectiveness, and the performance data (from verification, validation, and standards compliance) demonstrates substantially equivalent safety and performance. This approach eliminated the need for animal or clinical studies to demonstrate substantial equivalence for this particular 510(k) submission.

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The CyberKnife® Treatment Delivery System is indicated for image-guided stereotactic radiosurgery and precision radiotherapy for lesions, tumors and conditions anywhere in the body when radiation treatment is indicated.

The CyberKnife® Treatment Delivery System may be used to treat astrocytoma, glioma, skull base tumors, metastases (brain and bony), nasopharyngeal carcinoma, meningioma, acoustic neuroma, schwannoma, pituitary adenoma, hemangioblastoma, craniopharngioma, arteriovenous malformation, cavernous malformation, trigeminal neuralgia, and tumors of the neck, spine, pancreas, liver, lungs, ovary, prostate, and bladder. Patients should be examined by a team of physicians to determine if they are candidates for CyberKnife treatment.

The CyberKnife® Treatment Delivery System (CKTDS), subject of this submission, is a computer-controlled radiation treatment delivery system for performing minimally invasive stereotactic radiosurgery and precision radiotherapy. The CyberKnife Treatment Delivery System is intended to work with Accuray Precision™ Treatment Planning System (K161136) and iDMS™ Data Management System (K161144).

The CKTDS uses a 6 MV linear accelerator mounted on a manipulator (robot) and a target locating subsystem to accurately deliver high-energy radiation (1000 MU/minute dose rate) to the treatment target. The target locating subsystem of the treatment delivery system provides X-rays of the treatment area that lets the user know the position of the target. The CyberKnife® Treatment Delivery System uses skull tracking, fiducial tracking (tracking of implanted radiographic markers), skeletal structure tracking, lung tumor tracking, Lung Optimized Treatment, and Synchrony Tracking for dynamic positioning and pointing of the linear accelerator. The fixed aperture, variable aperture, and multileaf collimators are available as various beam-limiting secondary collimators.

I am sorry, but the provided text does not contain the detailed information necessary to describe the acceptance criteria and the study that proves the device meets them, as outlined in your request. The document is a 510(k) summary for the CyberKnife® Treatment Delivery System, which primarily focuses on establishing substantial equivalence to a predicate device.

Specifically, it lacks:

• A table of acceptance criteria and reported device performance. While it states "Testing was done to verify that all hardware and software perform as designed" and "The results from testing included in the premarket notification demonstrate that subject device performance characteristics are equivalent to the treatment delivery component of the predicate device," it does not provide specific acceptance criteria or quantitative performance data.
• Sample sizes used for the test set and data provenance.
• Number of experts used to establish ground truth and their qualifications.
• Adjudication method.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document primarily states that the CyberKnife® Treatment Delivery System is substantially equivalent to the treatment delivery component of the predicate, CyberKnife M6 Systems (cleared under K150873), based on shared intended use, principles of operation, technological characteristics, design, materials, and physical properties. It mentions "regressing testing" was performed to verify existing features, but no details of this testing are provided.

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