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The Sensus IORT System is indicated for radiation therapy treatments. The Sensus IORT System is an electron linear accelerator with a beam-forming x-ray target used for low energy to treat lesions, tumors, and conditions in or on the body where radiation is indicated. Only Sensus TVM Balloon Applicators can be used with the Sensus IORT System.

The Sensus IORT System is a mobile robotically-guided low-energy intraoperative radiotherapy device for treating cancer lesions and tissue beds during and post-surgery. The Xray source with beam shaping Morpheus provides radiation emission in the low energy therapy ranges of 50, 60, and 70 kV (a total of 3 kV modes) and is held and moved in place by an IEC 60601 medical certified robotic-arm. The robotic-arm uses a 7-axis motion system and is designed for human-robot collaboration for optimized treatment delivery and dosimetry.

The robotic-arm and its control cabinet mounted in the base of the Sensus IORT System contains multiple sensory capabilities for safety and simple operator control that allows it to act as an assistant to the doctor. The robot's joint torque sensors allow it to touch the patient with enough sensitivity to move with respiratory tracking (dubbed Cybernetic Respiratory Motion Tracking, or CRMT) and allow hand-guided movement by the doctor to control and place the xray source into position to deliver therapy.

The X-ray source held by the robotic arm consists of a drift tube and electron acceleration stage. In general, kilovoltage x-ray sources produce x-rays by accelerating electrons onto a tungsten target, which is a high-Z material. The electrons decelerate in the target, and their energy is converted to x-ray radiation (referred to as Bremsstrahlung, literally "braking" radiation), which is emitted in a roughly isotropic radiation pattern.

The Morpheus x-ray gun enables the Sensus IORT System to deliver an optimal and effective therapy beam to the targeted tissue bed that requires localized treatment. The Morpheus x-ray gun is operated by the system's control circuits and software and it is being fed by the high voltage power supply (HVPS), which provides the high voltage through the HV Feedthrough to the Morpheus x-ray gun and the integrated cooling module, which circulates the cooling fluid in order to maintain the Morpheus x-ray gun at a stable and optimal thermodynamic condition. The currently available kV modes of the Morpheus x-ray gun are 50kV, 60kV, and 70kV (Gen 1.0). The high voltage potential from the HVPS is fed to the Cathode by the HV Feedthrough onto the Cathode Assy.

Once the electron beam hits the Diamond-Tungsten-Molybdenum (CW-Mo) target, x-ray photons are generated in an isospheric pattern that is emitted towards the front and back of the target. The x-ray photons have no attenuating barrier in the front of the target (the attached Cooling Jacket is x-ray translucent) and the x-ray photons that are emitted from the back side of the target are emitted out with no significant attenuation through the SiC Window Sleeve. This allows the x-ray photons to be effectively generated and emitted from both sides of the target, thus rendering an optimal geometric distribution and coverage of the generating x-ray beam to deliver therapy.

The system base unit is self-propelled with full battery backup, which allow the operators to move it between surgical suites and hospital facilities. It also features a 3KW back up UPS, which allows the operators to complete a full treatment, even if the hospital power grid goes off line.

The Sensus IORT System is a stand-alone system that incorporates its own cooling module, power supplies, and networking. It consists of five separate core components:

• Computer Control Console .
• . Beam Shaping Morpheus / X-Ray Source (to delivery X-ray radiation)
• Cybernetic Respiratory Motion Tracking (using the Robotic Arm) .
• Base Unit with Drive/Propulsion System (device cabinet with motor) .
• . Red-Diode laser for positioning

The Sensus IORT System X-ray source interacts with a sterile tissue volume management (TVM) Balloon Catheter to act as a barrier between the X-ray source and the patient.

The provided text describes a medical device, the Sensus IORT System, and its substantial equivalence to a predicate device. However, it does not describe acceptance criteria or a study proving the device meets those criteria in the context of an AI/algorithm performance study. The document focuses on the physical and operational characteristics of the radiation therapy system and its safety compliance.

Therefore, I cannot extract the information required for a table of acceptance criteria, sample sizes, expert involvement, or MRMC studies related to AI/algorithm performance. The information provided pertains to the device's safety and effectiveness as a radiation therapy system, not the performance of an AI or algorithm.

The document discusses:

• Safety Tests: Compliance with IEC 60601 series standards for electrical and mechanical safety, usability, and electromagnetic compatibility.
• Verification & Validation: General mention of V&V activities and reports, including "Cybernetic Respiratory Motion Tracking (CRMT) Testing Protocol" and "Sterile drape compatibility testing protocol." These appear to be functional tests of the device's features, not performance metrics of an AI in a diagnostic or predictive capacity.
• Substantial Equivalence: A comparison table showing the Sensus IORT System's characteristics against a predicate device (Xoft Axxent Brachytherapy System). This table highlights physical, operational, and regulatory similarities and differences. The differences discussed (e.g., kV range, target material, robotic arm) are hardware and functionality related, not AI performance.

In summary, this document does not contain information about an AI or algorithm acceptance criteria study. The "Cybernetic Respiratory Motion Tracking" feature mentioned appears to be a real-time motion tracking system, likely based on sensor feedback and control algorithms, but its performance is described in terms of general functionality ("allow it to touch the patient with enough sensitivity to move with respiratory tracking" and "optimizing the therapy delivery") rather than specific AI/algorithm performance metrics and study designs as requested.

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Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System, a device suitable for intraoperative radiotherapy.

The treatment plans provide treatment unit set-up parameters and estimates of dose distributions expected during the proposed treatment, and may be used to administer treatments after review and approval by the intended user. The system functionality can be configured based on user needs.

The intended users of Sensus TPS Workstation shall be clinically qualified radiation therapy staff trained in using the system.

The Sensus TPS Workstation is a multi-functional, integrated software suite that forms a comprehensive electronic oncology management system for radiation oncology facilities. For radiation oncology users, the TPS Workstation provides image-enabled electronic patient charting and record management. For radiation oncology users, it also includes the ability to import and export radiation treatment plan information, beam geometry planning, treatment plan review, and verification and record treatment setup and delivery. The Sensus Healthcare TPS Workstation is dedicated for use with the Sensus Healthcare IORT System only. The software is not a general-use product compatible with other IORT systems.

The Sensus TPS Workstation is a software system intended for treatment planning and analysis of intraoperative radiation therapy administered with the Sensus IORT System. The software has undergone design verification and validation testing to ensure it functions according to its design parameters and meets safety and performance criteria.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes the acceptance criteria in terms of the successful completion of various verification and validation tests. The reported device performance is that the device passed all these tests.

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

The document does not explicitly state the sample size (e.g., number of patient cases or specific test data points) used for each listed test protocol. It mentions "several test treatment plans" were generated for the treatment plan-to-beam generation fidelity testing, but no specific number is provided.

The data provenance is not explicitly mentioned as country of origin; however, the testing was performed internally by Sensus Healthcare as part of their design and development process for regulatory submission. The testing appears to be based on an internal bench testing paradigm rather than patient data.

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

The document does not specify the number or qualifications of experts used to establish the ground truth for the test set. The "ground truth" for the performance testing appears to be based on established engineering benchmarks, system requirements, and the expected output of a radiation treatment planning system, rather than expert clinical interpretation of patient data. For the "Comparison of the measured dose and the dose calculated by the radiation treatment planning system," the truth was against "measured dose."

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. The tests appear to be pass/fail based on predetermined criteria outlined in the test protocols and system requirements.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided document. The study focuses on the standalone performance and safety of the Sensus TPS Workstation itself and its equivalence to a predicate device, rather than the improvement of human readers with AI assistance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone study was performed. The described "Non-Clinical Performance Testing" and "Non-clinical Safety Tests" are essentially standalone evaluations of the Sensus TPS Workstation software. The system functionality, dose calculation engine, and various software modules were tested to ensure they performed according to their specifications and produced accurate and consistent results independently. The "treatment plan-to-beam generation fidelity testing" directly evaluates the algorithm's output against actual physical measurements.

7. Type of Ground Truth Used

The ground truth used for testing includes:

• System Requirements Specifications (SRS): The tests were executed to ensure the system functioned "in accordance with its design parameters" and passed "all of the requirements determined in the testing procedures."
• Measured Dose and Beam Output: For the treatment plan-to-beam generation fidelity testing, the "ground truth" was established by measuring the actual beam output and yield from the Sensus IORT System's x-ray source and comparing it with the computational engine output and results.
• Predicate Device Performance: Performance testing demonstrated that the Sensus TPS Workstation "provided the same technical capabilities as the predicate device," implying the predicate device's established performance served as a benchmark for equivalence.

8. Sample Size for the Training Set

The document does not mention a training set, as this device is a treatment planning software system, not a machine learning or AI model that typically requires a training set in the conventional sense. The "pre-calculated Monte Carlo simulations" for the Sensus IORT System described under "Calculation for photons" could be considered analogous to a foundational data set used by the algorithm, but it's not a "training set" in the context of supervised learning for image analysis, for example.

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

As noted above, there is no mention of a traditional "training set" for a machine learning model. For the pre-calculated Monte Carlo simulations (which could be seen as foundational data), the document states: "A set of Monte Carlo simulations has been performed to predict the dose distribution produced by each operating point of the Sensus IORT device with high accuracy." This implies that the ground truth for these simulations would be based on established physics principles and validated simulation methods, likely compared against physical measurements of dose distribution for the IORT system, though the specific validation of the Monte Carlo simulations themselves is not detailed here.

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The Sensus Healthcare TVM Balloon Applicator is intended to support the delivery of high-dose-rate X-ray radiation in support for brachytherapy.

The Sensus TVM Balloon Applicator is indicated for use with the Sensus IORT System to deliver intracavity or intraoperative brachytherapy wherever the physician chooses to deliver radiation treatment.

The Sensus Healthcare TVM Balloon Applicator is a component of the Sensus Healthcare IORT system, which utilizes an X-ray source and does not employ radioactive isotopes. The TVM Balloon Applicator supports the Sensus Healthcare IORT System's ability to deliver intraoperative brachytherapy wherever the physician chooses to delivery radiation therapy. The Sensus Healthcare TVM Balloon Applicator is provided in one size (variablevolume balloon) to support the achievement of proper fit within the varying patient anatomies. The applicator is a single-use disposable device that is provided sterile. Product sterility is achieved through the use of Gamma radiation (reference ISO 11137-1).

The provided text is a 510(k) summary for the Sensus Healthcare TVM Balloon Applicator. It describes the device, its intended use, and the non-clinical performance and safety testing conducted to demonstrate substantial equivalence to a predicate device.

However, it does not contain information regarding the acceptance criteria, the study design, or the performance results of an AI/ML-based medical device as typically outlined in the request. The Sensus Healthcare TVM Balloon Applicator is a physical medical device (a balloon applicator for brachytherapy) and the testing described is related to its physical and functional integrity, sterility, and biocompatibility, not its performance as an AI/ML algorithm.

Therefore, I cannot extract the information required to populate the table and answer the questions about AI/ML device study parameters (such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) from the provided text.

The closest relevant information, though not for an AI/ML device, would be in the "Non-Clinical Performance Testing" and "Non-clinical Safety Tests" sections which list the types of tests performed (e.g., System Level Verification Test, Pull Testing, Cytotoxicity) and the associated report numbers. However, these are mechanical and biological tests, not statistical performance metrics for an AI algorithm.

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The SRT-100+ System is a low energy x-ray system, intended for superficial radiotherapy treatments of primary malignant epithelial neoplasms of the skin and keloids. Applications include: (a) basal cell carcinoma; (b) squamous cell carcinoma; (c) Metatypic carcinoma; (d) cutaneous appendage carcinoma (e) Kaposi's Sarcoma; and (t) the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

A red-diode laser is employed for the assisting with cone applicator placement.

The Sensus Healthcare SRT-100+ is a complete, stand-alone, x-ray radiation therapy system. It consists of four separate components: (a) control console; (b) base unit; (c) red-diode laser; and (d) applicators.

• (a) Control Console: Specifically designed module housing the switches and indicators used by the operator to set up and execute x-ray exposures. The controls adjust the machine functions and settings only! There is no treatment planning capability. The Control Console is connected, through a cable, to the Base Unit.
• (b) Base Unit: The base unit consists of a cabinet containing the high voltage generator, power supply components, cooling system, and an arm/positioning mechanism on which the x-ray tube housing assembly is mounted. A series of Applicators are included, which are affixed to the x-ray port on the x-ray tube housing assembly to limit the x-ray beam and provide fixed Source-to-Skin Distance (SSD). The X-ray Tube-Housing Assembly contains a motorized filter mechanism, which moves the appropriate beam filter: (a) 0.10 mm Al at 20 to 30 kV: (b) 0.45 mm A1 at 50kV: (c) 0.75 mm Al at 70 kV; and (d) 1.15 mm Al at 100 kV; into the beam path depending on the kV setting selected by the operator.
• (c) Red-Diode Laser: A red-diode laser is integrated with the SRT-100+ System. The laser is manufactured by U.S. Laser and is classified as FDA Laser Class 3A. The application of the red-diode laser with the Sensus SRT-100 Vision has been tested in accordance with IEC 60825-1.
• (d) Applicators: The system is shipped with a set of interchangeable treatment applicators, which define the source to skin distance (SSD) and the diameter of the treatment beam's exposure. The applicator size, therefore, determines the amount of total dose delivered per minute to the lesion and the actual area that will be treated by the system's x-ray beam. Each applicator is embedded with a unique magnet binary combination, which allows the system to automatically detect an applicator as it is mounted on the x-ray port. This provides the system with the information about the applicator's SSD and diameters, which allows it to correlate the applicable dose rate for each applicator that is attached to the x-ray port, thus allowing for a precise and user-error-free dose rate per minute calculation. There are a variety of applicator sizes available for use with the Sensus Healthcare SRT-100+ System, driven by the treatment modality.

This document describes the Sensus Healthcare SRT-100+, an X-ray radiation therapy system. However, the provided text does not contain any information about acceptance criteria or specific studies demonstrating that the device meets those criteria, as typically found in clinical trials or performance evaluations for AI/ML-based medical devices.

Instead, the document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a previously cleared predicate device (Sensus Healthcare SRT-100 Vision, K150037). The "studies" mentioned are primarily non-clinical performance and safety testing, and a "review of clinical literature," not a study specifically designed to prove acceptance criteria for a new AI-powered diagnostic or treatment device.

Therefore, I cannot directly answer your prompt with the requested table of acceptance criteria, reported device performance, sample sizes for test sets, expert ground truth establishment, or multi-reader multi-case studies.

However, I can extract the information that is present and explain what kind of "studies" were conducted in the context of a 510(k) for this type of device:

Summary of Device Evaluation (based on the provided text):

The Sensus Healthcare SRT-100+ is an X-ray radiation therapy system intended for superficial radiotherapy treatments. The evaluation presented here is for 510(k) clearance, which demonstrates substantial equivalence to a predicate device rather than undergoing a de novo clinical trial to establish new safety and effectiveness endpoints.

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, the document does not provide a table of acceptance criteria and reported device performance related to clinical outcomes or diagnostic accuracy for an AI/ML-based device. Instead, the document focuses on compliance with safety and performance standards for an X-ray therapy system.

The "acceptance criteria" can be inferred as meeting the requirements of the listed electrical and mechanical safety standards and demonstrating that the technological characteristics are similar enough to the predicate device not to raise new questions of safety or effectiveness.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

• Sample Size for Test Set: Not applicable in the context of clinical data for AI/ML. The "test set" here refers to the physical device undergoing bench and functional testing. No specific sample size (e.g., number of patients or images) is mentioned because it's hardware testing.
• Data Provenance: Not applicable for clinical data. The testing was performed by "qualified and accredited independent laboratories" for compliance with electrical and mechanical safety standards.

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

• Not applicable. This device is an X-ray therapy system, not an AI/ML diagnostic device requiring expert-established ground truth on patient data. The "ground truth" for the non-clinical testing was defined by the established industry standards (e.g., IEC, ISO, AAMI, CSA) and Sensus Healthcare's own product requirements.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. This is not a study involving human reader adjudication of clinical cases.

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. This is an X-ray therapy device, not an AI-assisted diagnostic or interpretation tool that would involve human readers or MRMC studies.

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

• No. This device is an X-ray therapy machine. It does not have a standalone algorithm in the sense of AI/ML performance on data. It performs radiation therapy under human operator control.

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

• For the non-clinical performance testing: The "ground truth" was defined by the specifications and requirements of the relevant international and national electrical, mechanical, and safety standards (e.g., IEC 60601 series, IEC 62366, IEC 60825-1). The device was tested to ensure it met these predetermined engineering and safety performance metrics.
• For the "Review of Clinical Literature": The clinical literature collected supports claims of safety and efficacy for the application of superficial radiotherapy for the stated indications. This implies that the ground truth for efficacy in the broader context of radiation therapy for these conditions comes from established medical practice and previously published clinical evidence in the medical literature, not a de novo study conducted for this specific 510(k).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of AI/ML models.

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

• Not applicable. (See #8).

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