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The INTRABEAM is intended for use in radiotherapy treatments.
The INTRABEAM SMART Spherical Applicator is used with the INTRABEAM to deliver a prescribed dose of intraoperative radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.
The safety and effectiveness of the INTRABEAM as a replacement for whole breast irradiation in the treast cancer has not been established.
The INTRABEM Needle Applicator (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM to intraoperatively administer radiation to tissue including irradiation of intracranial tumors.
The INTRABEAM SMART Stand is designed as an instrument support and positioning unit for the INTRABEAM.
The INTRABEAM Spherical Sizer Set shall support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.

The INTRABEAM 700 is a radiation therapy device intended for targeted treatments of selected lessions for minimally invasive, intraoperative, interstital, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.
The INTRABEAM 700 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 700 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.
The main components of the INTRABEAM 700 system are:

• INTRABEAM Workplace - mobile cart containing the following:
  • Control Console 700 (CC700)
  • Computer with Software Version 5.0
  • Touchscreen monitor and mouse
  • UNIDOS Romeo Electrometer
  • V-guide
• XRS 4 X-ray Source
• Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization Chamber Holder
• radiance Third party treatment planning simulation software
  The INTRABEAM SMART Stand is connected to the INTRABEAM 700 and is used to mount the X-ray generator (XRS 4) and the necessary applicator, in order to deliver the prescribed radiation dose at the target site.
  The INTRABEAM Spherical Applicator is a sterile disposable product that shall be placed in contact with the tumor mass and/or tumor resection cavity to deliver a prescribed dose of intraoperative radiation.
  The INTRABEAM Spherical Sizer Set is a sterile disposable product that shall be placed in contact with body part and/or tumor mass to help support the doctor (surgeon and/or radiation oncologist) in assessing which spherical-shaped applicator shall be used for the radiation therapy procedure, involving INTRABEAM.
  The INTRABEAM Needle Applicator has not been updated since the last clearance, K162568.

The provided document is a 510(k) Premarket Notification from the FDA, which assesses the substantial equivalence of a new medical device (INTRABEAM 700) to a legally marketed predicate device (INTRABEAM 600). The document focuses on regulatory compliance, safety, and performance testing to demonstrate equivalence, rather than providing details of a clinical study designed to prove the device meets specific acceptance criteria in a clinical setting with human subjects.

Therefore, the document does not contain the information requested regarding acceptance criteria and the specifics of a study proving the device meets those criteria, particularly in the context of AI assistance or human reader performance. The "Performance Testing - Bench" section describes non-clinical system testing, software verification, and compliance with various IEC standards (EMC, Electrical, Mechanical, Thermal Safety, Radiation Safety, Usability/Human Factors), which are important for device safety and functionality but are not clinical performance "acceptance criteria" as would be evaluated in a multi-reader multi-case (MRMC) study or a standalone AI performance study.

The document primarily relies on demonstrating substantial equivalence to a predicate device through:

• Identical or equivalent indications for use.
• Similar technological characteristics.
• Compliance with relevant safety and performance standards (e.g., IEC 60601-series).

In summary, none of the requested information regarding acceptance criteria for clinical performance, test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or training set details are present in the provided text. The document focuses on bench testing and regulatory compliance, not clinical efficacy or AI performance metrics.

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The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

The X80 / RADiant / Photoelectric Therapy System (hereafter referred to as the RADiant System) is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

The RADiant System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time-based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the RADiant System.

The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.

The Xstrahl Photoelectric Therapy System (RADiant Aura) is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Here’s an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance metrics in a clinical study. The "acceptance criteria" here are generally understood as meeting design requirements, mitigating risks, and conforming to relevant standards, which are evaluated through non-clinical testing.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data. The testing described largely involves non-clinical (engineering and technical) verification and validation. This means the "sample size" would refer to the number of devices or components tested. The document mentions "Twenty Six independent verification tests and 18 independent validation tests were executed on the RADiant Aura systems." This implies that at least one, but likely a limited number (e.g., prototype or production units), of RADiant Aura systems were subjected to these tests.
• Data Provenance: This information refers to the origin of the data. Since the testing is non-clinical, the data provenance is primarily from internal testing conducted by Xstrahl Ltd. and independent testing by the National Physics Laboratory UK (NPL). The context is purely technical performance evaluation, not clinical outcomes from human patients. The data is prospective in the sense that it was generated specifically for this submission to verify the new design. There is no mention of country of origin of clinical data, as no clinical data is presented.

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

This section is not applicable as the document describes non-clinical performance and safety testing, not a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation or disease diagnosis). The "ground truth" here is adherence to engineering specifications, safety standards, and physical laws, verified by technical measurements and evaluations.

4. Adjudication Method for the Test Set

This is not applicable as the document describes non-clinical performance and safety testing. Adjudication methods are typically used in clinical studies when multiple human readers evaluate data, and their assessments need to be reconciled to establish a ground truth.

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, an MRMC comparative effectiveness study was not done. This device is an X-Ray radiation therapy system, not an AI diagnostic or assistance tool. The submission focuses on the safety and performance of the hardware and software for delivering radiation therapy, not on interpreting medical images or assisting human readers in diagnosis.

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

This question is not directly applicable in the context of this device. The "algorithm" in this case refers to the embedded software and control systems of the radiation therapy device. The non-clinical testing described (e.g., software run-through functionality test, dose reproducibility) effectively evaluates the "standalone" performance of these systems in meeting their intended technical specifications, without direct human intervention in the treatment delivery process once programmed. However, the device itself is a treatment device, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" used was based on:

• Engineering specifications and design requirements: The device was tested against its defined operational parameters and expected performance.
• International and national standards: Compliance with standards like BS EN 60601-2-8, IEC 60601-1, etc., served as the ground truth for safety, electrical performance, usability, and software lifecycle.
• Recognized codes of practice: For output measurements, protocols from AAPM (2001) and IPEMB (1996) were used as the benchmark for accurate dose delivery.

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is because the device is not an AI/ML-based diagnostic or predictive algorithm that typically requires large datasets for training. The software components mentioned (Concerto, Fisica, TP2) appear to be control software and firmware for the device's operation, not machine learning models.

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

This is not applicable as there is no training set for an AI/ML model mentioned in the context of this device.

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The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).

The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The dedicated computer system of Esteya provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that Is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy & superficial radiotherapy treatment.

The provided text is a U.S. FDA 510(k) summary for the "Esteya" X-ray radiation therapy system. It outlines the device's technical characteristics, intended use, and a comparison to predicate devices, along with a summary of performance testing (non-clinical).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document provides a table summarizing performance parameters for the device, which can be interpreted as demonstrating the device meets certain operational criteria. It does not explicitly state "acceptance criteria" but rather "Performance Data".

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

The document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate devices." This implies that there was no specific clinical test set with a sample size for human or animal subjects. The performance testing described is non-clinical, focusing on the device's physical and functional characteristics. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable to a clinical test set in this context.

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

Not applicable, as no clinical test set was used to establish substantial equivalence.

4. Adjudication method for the test set

Not applicable, as no clinical test set was used to establish substantial equivalence.

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

Not applicable. The device is an X-ray radiation therapy system, not an AI-assisted diagnostic or interpretive tool. The document explicitly states "No animal or clinical tests were performed."

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

This question is not directly applicable in the context of this device. The Esteya is a radiation therapy system, not an algorithm being evaluated for standalone performance. The performance testing was focused on the system's physical and functional attributes.

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

The document indicates that "the device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria. FDA guidance, clinical use and recognized consensus standards." This suggests that the "ground truth" for the non-clinical performance evaluation was based on:

• Predetermined performance criteria: These are likely engineering and design specifications.
• FDA guidance and recognized consensus standards: These provide established benchmarks for safety and effectiveness for such devices.

8. The sample size for the training set

Not applicable. The device is an X-ray radiation therapy system, not a machine learning algorithm that requires a training set in the conventional sense.

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

Not applicable, as no training set was used for an AI algorithm.

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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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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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The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

The Photoelectric Therapy System is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

The Photoelectric Therapy System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the Photoelectric Therapy System.

The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.

This document describes a 510(k) premarket notification for the Xstrahl Photoelectric Therapy System, an X-ray radiation therapy system. The notification primarily focuses on demonstrating substantial equivalence to a predicate device (Sensus Healthcare SRT-100 Superficial Radiation Therapy System) through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for a clinical evaluation. Instead, it details adherence to various international and national standards for electrical safety, electromagnetic compatibility, usability, and dosimetry for an X-ray therapy system. The "reported device performance" in this context refers to compliance with these standards, not necessarily clinical efficacy.

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

The document describes non-clinical testing for safety, EMC, usability, and dosimetry. Therefore, there is no "test set" of patient data in the context of a clinical study. The "test set" would refer to the physical device prototypes and components subjected to these engineering and physics tests. The data provenance is from non-clinical laboratory settings in the UK (Xstrahl Ltd. and National Physics Laboratory UK). The data is prospective in the sense that the device was specifically manufactured and tested against these standards.

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

Since this document focuses on non-clinical engineering and physics tests, the concept of "ground truth for a test set" established by medical experts (like radiologists) does not apply in the typical sense of a clinical trial.

However, the National Physics Laboratory UK (NPL) is a recognized authority in measurement science, and their involvement in dosimetry verification suggests that their experts (likely medical physicists or similar specialists) were used. The IPEMB Code of Practice and AAPM Task Group 61 Protocol are established by expert bodies in medical physics, and adherence to these protocols reflects an expert consensus on accurate dosimetry.

The "experts" involved in establishing the "ground truth" for these technical tests would be:

• Engineers and physicists at Xstrahl Ltd. involved in the design, development, and internal testing of the device.
• Independent medical physicists/scientists at the National Physics Laboratory UK (NPL) who performed the verification measurements according to recognized professional codes of practice. Their qualifications would typically include advanced degrees in physics, medical physics, or related fields, with expertise in radiation dosimetry and medical device testing.

4. Adjudication Method for the Test Set:

Not applicable in the context of non-clinical engineering and physics testing. Adjudication methods like "2+1" are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The non-clinical tests described involve objective measurements and compliance verification against predefined technical standards.

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. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI or human-in-the-loop performance. This device is an X-ray radiation therapy system, not an imaging or diagnostic AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This question is also not applicable. The device is a physical X-ray therapy system. There is no "algorithm only" performance reported in the context of AI or diagnostic interpretation. The "system" operates as a standalone piece of equipment for delivering radiation therapy as intended.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by:

• Established international and national standards: IEC 60601 series, EN 60601 series, IEC 62366. Compliance with these standards is the "truth" being verified for safety, EMC, and usability.
• Recognized codes of practice for dosimetry: IPEMB Code of Practice and AAPM Task Group 61 Protocol. The physical measurements conducted by NPL are compared against the expected values as defined by these protocols to establish the "ground truth" for radiation output accuracy.
• Manufacturer's own Customer Acceptance Test (CAT) procedure: This internal standard serves as a ground truth for the device's specific manufactured performance characteristics.

8. The Sample Size for the Training Set:

Not applicable. The document describes a medical device, not an AI or machine learning model. Therefore, there is no "training set" in this context.

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

Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is irrelevant to this submission.

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The INTRABEAM 600 is indicated for radiation therapy treatments.

The INTRABEAM Spherical Applicators are indicated for use with the INTRABEAM 600 to deliver a prescribed dose of radiation to the treatment margin or tumor bed during intracavity and intraoperative radiotherapy treatments.

The INTRABEAM Spherical Applicators used with the INTRABEAM 600 are able to deliver a prescribed dose of intraoperative radiation in conjunction with whole breast irradiation, based upon the medical judgment of the physician. The safety and effectiveness of the INTRABEAM 600 as a replacement for whole breast irradiation in the treatment of breast cancer has not been established.

The Needle Applicator set (comprising the Needle Applicator and guide shafts) is intended for use in combination with the INTRABEAM 600 to intraoperatively administer radiation to tissue including irraciation of intracranial tumors.

The INTRABEAM Flat Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600,

• during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
• during treatment of tumors on the body surface.

The INTRABEAM Flat Applicator is designed to deliver a flat radiation field at a distance of 5mm from its circular application surface in water.

The INTRABEAM Surface Applicator is intended to supply a specified radiation dose during applications in combination with the INTRABEAM 600.

• during intraoperative radiotherapy, on a surgically exposed surface or in a tumor bed.
• during treatment of tumors on the body surface.

The INTRABEAM Surface Applicator is designed to deliver a flat radiation field directly at the applicator's surface.

The INTRABEAM 600 is a radiation therapy device intended for targeted treatments of selected lesions for minimally invasive, intraoperative, interstitial, intracavity and contact radiation therapy of tumors or tumor beds within the body of cancer patients. By applying the radiation source in conjunction with various applicators, a prescribed dose of low energy radiation can be delivered to the target volume. The delivery of the radiation dose is controlled via the integrated control unit and software.

The INTRABEAM 600 is provided as a mobile workstation. Like the previously cleared versions of the INTRABEAM system, the INTRABEAM 600 provides several tools for Quality Assurance of radiation delivery, which are intended to verify the proper functioning of the radiotherapy treatment system.

The main components of the INTRABEAM 600 system are:

• INTRABEAM Workplace mobile cart containing the following:
  • Control Console 600 (CC600)
  • Computer with Software Version 4.0
  • Touchscreen monitor, keyboard and mouse
  • Dosimeter (UNIDOS E)
  • V-guide
• XRS 4 X-ray Source
• Quality Assurance Tools: PAICH, PDA, and Ionization Chamber with Ionization Chamber Holder
• radiance Third party treatment planning simulation software

The applicators used with the INTRABEAM 600 are identical to the applicators cleared in previous 510(k)s.

This document is a 510(k) premarket notification for the INTRABEAM 600, a radiation therapy system. It focuses on demonstrating substantial equivalence to a predicate device rather than defining acceptance criteria and presenting a study to prove they are met in the traditional sense of a clinical trial for a novel device.

The "acceptance criteria" here are essentially compliance with safety and performance standards for an X-ray radiation therapy system, and the "study" is a series of engineering tests and comparisons to a previously cleared device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: The document does not specify a "sample size" in terms of patients or a clinical dataset for a performance study. The testing described is primarily focused on engineering compliance verification and validation of the device itself (electrical safety, EMC, software, etc.).
• Data Provenance: Not applicable in the context of clinical data provenance. The data comes from internal engineering tests conducted by Carl Zeiss Meditec AG, likely at their facilities in Germany, as the applicant is based there. These are premarket tests, so they are not retrospective or prospective in the clinical sense.

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

• This information is not provided. The "ground truth" for the engineering tests would be the specifications and standards themselves (e.g., IEC standards, internal design requirements). The engineers conducting and verifying these tests would be the "experts," qualified in electrical engineering, software engineering, medical device safety, etc., but their specific number and qualifications are not detailed.

4. Adjudication method for the test set:

• Not applicable. The tests are compliance checks against objective standards and functional requirements. There's no subjective interpretation or "adjudication" in the clinical sense.

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 MRMC study was done. This device is an X-ray radiation therapy system, not an AI-powered diagnostic or decision support tool. It does not involve "human readers" interpreting images with or without AI assistance. The "radiance" software mentioned is a treatment planning simulation software, not an AI for image interpretation.

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

• This concept is not directly applicable to the INTRABEAM 600. It's a medical device that delivers radiation, not an algorithm that performs a diagnostic task. Its "performance" is about its physical and software functionality according to specifications and safety standards. The software verification and validation are essentially "standalone" checks of the software's functional correctness.

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

• The "ground truth" for this PMA is primarily:
  • International and national medical device safety and performance standards: e.g., IEC 60601 series.
  • Internal design specifications and requirements: for system functionality, electrical safety, software behavior, etc.
  • The predicate device (INTRABEAM System K051055): for demonstrating substantial equivalence in terms of intended use, indications, and technological characteristics.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a "training set" in the context of learning from data. The software within the device is designed and developed based on established engineering principles and programming, not trained on a dataset.

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

• Not applicable, as there is no "training set" for an AI/machine learning algorithm.

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The Axxent® Electronic Brachytherapy System Model 110 XP 1200 is a high dose rate Brachytherapy device for use with Axxent Applicators to treat lesions, tumors and conditions in or on the body where radiation is indicated. Only Xoft Axxent Surface Applicators can be used with the Axxent Electronic Brachytherapy System Model 110 XP 1200.

The Axxent Electronic Brachytherapy System consists of two primary components: the Axxent System Controller (Controller); the Axxent HDR X-ray Source-2.2 (Catheter/Source). The System is designed to deliver doses of X-ray radiation to tissue in proximity to the applicator using a miniature X-ray tube powered by the Controller.

The Axxent Electronic Brachytherapy System is a mobile, computer-controlled platform that is responsible for the overall operation of the System. The Controller is designed to work with the Source, which is a miniature X-ray tube located at the end of a flexible catheter. The Catheter/Source is inserted into a lumen of an appropriate Applicator which are cleared separately under their 510(k). The Axxent Electronic Brachytherapy System Model 110 XP 1200 described in this 510(k) will only be used for surface applications using Xoft Axxent Surface Applicators.

The provided text describes a 510(k) premarket notification for the Axxent Electronic Brachytherapy System Model 110 XP 1200. This is a medical device for radiation therapy, not an AI/ML imaging device. Therefore, much of the requested information regarding AI-specific criteria (such as sample sizes for test and training sets, expert ground truth adjudication, MRMC studies, or standalone algorithm performance) is not applicable or available in this document.

However, I can extract the acceptance criteria related to the device's performance and the nature of the study conducted to prove it meets those criteria.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for this device are focused on demonstrating that technological changes do not negatively impact the device's fundamental functional, scientific, and performance characteristics, particularly concerning radiation dosage. The device seeks substantial equivalence to its predicate device (Axxent Electronic Brachytherapy System, K122951).

Study Details (as per the document):

1. Sample size used for the test set and the data provenance: Not applicable in the context of an AI/ML study. The testing was non-clinical performance data (laboratory testing of the device's physical properties), not based on a "test set" of patient data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for this device's performance is based on physical measurements of radiation characteristics.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

4. 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: Not applicable. This is not an AI/ML imaging device.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML imaging device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for performance was established through physical measurements and validation testing of the device's characteristics (e.g., spatial parameters, depth dose, half-value layers, output linearity, longevity).

7. The sample size for the training set: Not applicable. This is not an AI/ML device.

8. How the ground truth for the training set was established: Not applicable.

Overall Study Description:

The study referenced is a non-clinical performance assessment conducted to support the substantial equivalence of the Axxent Electronic Brachytherapy System Model 110 XP 1200 to its predicate device. This involved a series of laboratory tests and validation activities focused on the physical and operational characteristics of the device, particularly the changes in the cooling system and anode target. The goal was to confirm that these changes did not alter the fundamental safety and effectiveness of the device, especially concerning radiation delivery. The conclusion from these non-clinical tests was that the clinical dose is identical regardless of whether the proposed or current source/catheter design is used in the surface applicator indication.

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The SRT-100 Vision System is a low energy x-ray system, with ultrasound imaging capability, intended for superficial radiotherapy and electronic brachytherapy 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 (f) the treatment of keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

The ultrasound capability, employed in a non-diagnostic mode, is used to assist the physician in the selection of the correct cone applicator size. The Derma-Scan C Ultrasound component was initially cleared with an indication for use as an ultrasonic scanning system used to visualize the layers of skin, including bold vessels, and to make approximate measurements of dimensions in layers of skin and blood vessels, by ultrasonic means.

The red-diode laser assembly is a commercial pointer device employed by physicians for improving the alignment of the focused beam.

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

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.

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) 0.10 mm Cu at 50 to 100 kV; (c) 0.45 mm Al at 50kV; (d) 0.75 mm Al at 70 kV; (e) 1.15 mm Al at 100 kV; and (f) 4.0 mm Al at 50 to100 kV; into the beam path depending on the kV setting selected by the operator.

Ultrasound Imaging: The Derma-Scan C Ultrasound System component is integrated with the SRT-100 Vision computer and contains: (a) scanning main unit; (b) handheld probe and (c) a medical grade power supply to provide power to the computer. The ultrasound component is designed to meet international safety requirements.

Red-Diode Laser: A red-diode laser is integrated with the SRT-100 Vision 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.

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 Vision System, driven by the treatment modality.

Here's the breakdown of the acceptance criteria and study information for the Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities (SRT-100 Vision System), based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with specific numerical performance metrics for the device's efficacy in treating medical conditions. Instead, it focuses on demonstrating substantial equivalence to a predicate device and adherence to safety and electrical standards.

The key "performance" demonstrated is that the device meets these standards and is "as safe and effective" as the predicate.

Here's a table based on the information provided, inferring the acceptance criteria from the testing described:

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

The document primarily describes non-clinical testing (bench, functional, system performance, safety standards adherence). Therefore, there isn't a "test set" in the sense of a clinical patient cohort.

• Sample Size for Test Set: Not applicable for a clinical test set; refers to the device itself and its components.
• Data Provenance: The testing was conducted by "qualified and accredited independent laboratories" (page 8). The exact country of origin is not specified, but the standards cited are international (IEC, ISO). The nature of this testing is prospective in the sense that the device was designed and then tested against established engineering and safety standards.

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

This question is largely not applicable for the type of non-clinical testing described. The "ground truth" for compliance with electrical and safety standards is the standard itself, as interpreted and verified by the independent testing laboratories.

• Number of Experts: Not specified, as this wasn't a clinical study requiring expert review of patient data.
• Qualifications of Experts: Not specified, but implied to be engineers and specialists from "qualified and accredited independent laboratories" who are experts in the listed IEC/ISO standards.

4. Adjudication Method for the Test Set:

None. Adjudication methods (like 2+1 or 3+1) are used in clinical studies where multiple human readers independently interpret data, and conflicts are resolved by a tie-breaking reader or consensus. This document describes engineering and performance testing against objective standards, not interpretation of clinical data by multiple readers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size:

No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The device itself is an X-ray radiation therapy system with ultrasonic imaging capabilities, not an AI-assisted diagnostic tool for human readers.

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

The device is a medical device (X-ray radiation therapy system) that delivers treatment and assists with treatment planning (ultrasound for cone selection). It is not an algorithm that performs a diagnostic task independently. While its components (like the ultrasound) have defined functionalities, the concept of "standalone algorithm performance" as typically applied to AI/CADe devices for diagnosis is not relevant in this context. The core function is therapy delivery, which is inherently human-controlled.

7. The Type of Ground Truth Used:

For the non-clinical performance and safety testing, the "ground truth" was:

• Established engineering specifications and product requirements for the Sensus Healthcare SRT-100 Vision System.
• International electrical safety and medical device standards (e.g., IEC 60601 series, IEC 60825-1, IEC 62366).
• The performance and safety profile of the predicate device (Sensus Healthcare SRT-100 Vision K131582), to which substantial equivalence was claimed.

For the clinical literature review referenced (page 7), the ground truth for efficacy would have come from the outcomes reported in those studies (e.g., tumor regression, keloid reduction, recurrence rates). However, this review is not a primary study conducted for this 510(k) but rather a summary of existing literature.

8. The Sample Size for the Training Set:

Not applicable. The device is an X-ray radiation therapy system. It is not an AI/machine learning algorithm that requires a "training set" of data in the typical sense. Its design and engineering are based on established physics, medical knowledge, and safety standards, rather than statistical learning from a dataset.

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

Not applicable, as there is no training set for this type of device.

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