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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 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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The SRT-100 Vision is a low energy X-ray system, with ultrasound imaging and reddiode laser-pointing capabilities, intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Applications include basal cell carcinoma, squamous cell carcinoma, Metatypic carcinoma, cutaneous appendage carcinoma, Kaposi's Sarcoma, and the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

The Sensus Healthcare SRT-100 Vision is a complete, stand-alone, X-ray radiation therapy system, with ultrasound capability. It consists of four major separate components: Control Console, Base Unit, Ultrasound Imaging, and Red-Diode Laser.

The provided text describes a 510(k) summary for the Sensus Healthcare SRT-100 Vision, an X-ray radiation therapy system with ultrasound imaging and red-diode laser pointing capabilities. It indicates that performance testing consisted of bench testing which demonstrated that the device "provided the same clinical capabilities as the predicate device" and that "the system successfully passed all tests required by IEC 60601-1, Part 2-8, Edition 1.1, 1999" and "tests developed internally for system characterization." Additional performance testing was also executed to "validate the operational characteristics associated with the Sensus Applicators." The ultrasound component was tested in accordance with IEC 60601-2-37 and the red-diode laser in accordance with IEC 60825-1.

However, the document does not provide specific acceptance criteria or the study details proving the device meets those criteria in a quantitative manner. It primarily focuses on the device's technical specifications, intended use, and adherence to various electrical and mechanical safety standards. There are no tables of acceptance criteria with reported performance values, no sample sizes for test or training sets, no details on expert adjudication for ground truth, and no mention of MRMC or standalone performance studies in a clinical context.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not provided.
2. Sample size used for the test set and the data provenance: Not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
4. Adjudication method for the test set: Not provided.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance: Not provided. The device is a therapy system, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided. The device is a therapy system, not an algorithm.
7. The type of ground truth used: Not provided. "Bench testing" is mentioned, implying engineering and safety compliance rather than clinical ground truth as typically understood for diagnostic AI.
8. The sample size for the training set: Not provided.
9. How the ground truth for the training set was established: Not provided.

The document states that the SRT-100 Vision's non-clinical performance testing "demonstrated that the output of the Sensus Healthcare SRT-100 Vision provided the same clinical capabilities as the predicate device (Sensus Healthcare SRT-100)." This suggests that the primary method of demonstrating effectiveness was through substantial equivalence to a previously cleared device, based on technical and safety performance rather than new clinical outcome studies. It also mentions "A summary of multiple clinical studies for the treatment of keloids and supporting literature can be found in Appendix D of this 510(k)," but the details of these studies are not included in the provided text.

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The NeuroMetrix SENSUS is intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain.

The device may be used during sleep. The device is labeled for use only with the NeuroMetrix SENSUS Electrode.

The SENSUS device, is a transcutaneous electrical nerve stimulator with a single output mode. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including pulse shape, amplitude (current), duration, pattern, and frequency. The device is powered by a permanent rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.

The device delivers electrical stimulation to the patient through disposable, single-patient use electrodes placed on the patient's body. The device is labeled for use only with the SENSUS Electrode (K121816), to which it connects through insulated female medical snap connectors embedded within its housing.

The device has a push-button that initiates stimulation, and controls the intensity. The device has a single two color LED for indication of stimulation status, battery charging, and error conditions.

Here's an analysis of the acceptance criteria and study for the NeuroMetrix SENSUS device, based on the provided text:

Acceptance Criteria and Device Performance

The primary focus of the study described is the validation of the device's electrode peeling detection feature, which allows the device to be safely used during sleep.

Study Details for Electrode Peeling Detection Validation

1. Sample Size Used and Data Provenance:

   • Test Set Sample Size: 66 subjects and 132 SENSUS electrodes were used. There were two protocol runs, each with 66 tests, totaling 132 tests. The prospective validation sample size was set to 60 tests to meet the 0% failure rate statistical criterion.
   • Data Provenance: The study was described as "prospective validation," indicating it was specifically designed and conducted for this purpose. The country of origin is not explicitly stated, but NeuroMetrix is based in Waltham, MA, USA, suggesting the study was likely conducted in the USA.

2. Number of Experts and Qualifications for Ground Truth:

   • The document does not explicitly mention the use of external experts to establish ground truth for the electrode peeling detection test. The "ground truth" for this test was the physical measurement of the electrode area remaining on the skin at the instant stimulation halted, as determined by the study methodology.

3. Adjudication Method:

   • Not applicable/Not mentioned. The study involved objective measurements of physical parameters (electrode contact area).

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No. This was a technical validation study for a safety feature, not a comparative effectiveness study involving human readers.

5. Standalone (Algorithm Only) Performance:

   • Yes. The study focused on the automatic performance of the device's embedded algorithm in detecting electrode peeling and halting stimulation. There was no human-in-the-loop component for this safety feature.

6. Type of Ground Truth Used:

   • Objective Measurement/Engineered Truth: The ground truth was established by direct measurement of the electrode-to-skin contact area at the point where the device halted stimulation. The "failure" condition was defined objectively as the remaining contact area being less than 3.5 cm².

7. Sample Size for Training Set:

   • Not applicable/Not mentioned. The document describes a validation study for a specific safety mechanism (electrode peeling detection). It does not provide details of any machine learning model training or a "training set" in the context of AI. The device uses "embedded software to control a high-voltage circuit," implying rule-based or control system logic rather than a conventional machine learning model with a distinct training phase.

8. How Ground Truth for Training Set was Established:

   • Not applicable, as no training set for a machine learning model is described. The device's operational parameters and safety thresholds (like the 3.5 cm² peeling threshold) would have been established through engineering design, risk analysis, and relevant standards, rather than a data-driven training process with a ground truth similar to clinical AI models.

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The SRT-100 is a low energy X-ray system intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin and keloids. Applications include basal cell carcinoma, squamous cell carcinoma, Metatypic carcinoma, cutaneous appendage carcinoma. Karposi's Sarcoma, and the treatment of keloids. Keloids are benign fibrous growths that arise from proliferation of dermal tissue typically arising from injuries to skin tissue.

The Sensus Healthcare SRT-100 is a complete, stand-alone, x-ray radiation therapy system. It consists of two major separate components: Control Console and Base Unit. The Control Console is 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. 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 into the beam path depending on the kV setting selected by the operator.

The provided text describes the Sensus Healthcare SRT-100, a superficial X-ray radiation therapy system. However, it does not contain details about specific acceptance criteria, a study proving device performance against those criteria, or information on human reader studies, ground truth establishment for a test set, or training set details.

The document primarily focuses on:

• Device Description: What the SRT-100 is and its components.
• Intended Use: The medical conditions it's designed to treat (e.g., basal cell carcinoma, keloids).
• Technological Characteristics/Principles of Operation: How it works (low energy X-ray, fractionation).
• Non-Clinical Performance Testing: Mentions bench testing to show similar clinical capabilities to predicate devices and additional testing for new applicators.
• Non-clinical Safety Tests: Lists compliance with various IEC, UL, and CAN/CSA standards for electrical and mechanical safety.
• Predicate Devices: Lists similar devices already on the market.
• FDA K-Summary Letter: Confirms substantial equivalence to predicate devices for its stated indications for use.

Therefore, I cannot fulfill your request for a table of acceptance criteria, details on specific studies proving performance against criteria, sample sizes, expert qualifications, or ground truth information because this information is not present in the provided text. The document describes a traditional medical device (X-ray therapy system) rather than an AI/ML-driven diagnostic or image analysis device, which typically have performance criteria and studies as per your enumerated points.

The "Non-Clinical Performance Testing" section broadly states that the device "provided the same clinical capabilities as the predicate devices" and "successfully passed all tests required by IEC 60601-1, Part 2-8, Edition 1.1, 1999 – Particular Requirements for the Safety of Therapeutic X-ray Equipment Operating in the Range 10 kV to 1 MV and also tests developed internally for system characterization." This is the closest the document comes to mentioning performance evaluation, but it lacks specific quantitative acceptance criteria or detailed study results.

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The NeuroMetrix SENSUS Electrode is intended for use as disposable, conductive, adhesive interface between the patient's skin and a transcutaneous electrical nerve stimulator.

The SENSUS Electrode provides an electrically conductive interface between a transcutaneous electrical nerve stimulator and a patient's skin. It is provided non-sterile, is designed and intended for single patient use only, and to be disposable.

The SENSUS Electrode is comprised of four individual electrodes, each of size 36 by 46 mm. The overall dimensions are 50 by 280 mm. The individual electrodes are electrically connected in pairs such that the two outer electrodes constitute one pair and the two inner electrodes constitute a second pair. The SENSUS Electrode contains two conventional male snap connectors for electrical connection to a transcutaneous electrical nerve stimulator.

The SENSUS Electrode has a multi-layer design. The first and outermost layer is a sheet of Mylar. The second layer contains conductive silver traces and silver electrode pads. Where the silver traces are not covered by hydrogel, they are covered by a dielectric mask. The third layer is the four individual electrodes which consist of a medical grade, self adhering, biocompatible hydrogel (KM-10G, Katecho, Inc., Des Moines, IA). When not in use, the hydrogel is covered by a Mylar release liner. Two male type snap connectors interface the SENSUS Electrode to the transcutaneous electrical nerve stimulator. The patient facing surface of the snap connectors are either under hydrogel or covered by a laminated dielectric polypropylene layer. Therefore in both cases the snap connectors do not directly contact the patient's skin.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not provide explicit sample sizes for the non-clinical tests (electrical, mechanical, biocompatibility). It states that NeuroMetrix determined that non-clinical (i.e., bench) testing was sufficient.

Regarding data provenance:

• Biocompatibility: The biocompatibility data is derived from related hydrogel formulations (KM-10B and KM-10P) from Katecho, Inc., which were previously cleared (K000870). This suggests a retrospective use of existing data from the hydrogel manufacturer.
• Electrical and Mechanical Testing: These appear to be prospective bench tests conducted on the SENSUS Electrode itself. The country of origin for this data is not specified, but the sponsor is NeuroMetrix, Inc. in Waltham, MA, USA, suggesting the testing was likely conducted in the USA or by a contract lab.

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

This information is not applicable as the SENSUS Electrode is a device and its performance is evaluated through objective physical and electrical measurements, not by expert interpretation of images or signals. Therefore, there is no "ground truth" established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation relies on objective measurements and comparison to standards, not human interpretation that would require adjudication.

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 type of study is relevant for diagnostic AI systems where human readers interpret medical data. The SENSUS Electrode is a physical medical device (an electrode), not a diagnostic AI system, so this type of study is not applicable.

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

This question is not applicable as the SENSUS Electrode is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" in this context is established by:

• Objective physical and electrical measurements: Such as impedance, current dispersion, adhesive strength, connection resistance, and retention force, compared against predefined target specifications.
• Compliance with recognized standards: ISO 10993-5:2009 (cytotoxicity) and ISO 10993-10:2010 (irritation and skin sensitization).
• Existing biocompatibility data: For the hydrogel, established by the manufacturer (Katecho, Inc.) through testing of related formulations.
• Substantial equivalence: To the predicate device, based on comparable intended use, materials, and technological characteristics.

8. The Sample Size for the Training Set

This information is not applicable as the SENSUS Electrode is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This information is not applicable for the same reasons as #8.

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The NeuroMetrix SENSUS device is intended for use as a transcutaneous electrical nerve stimulator for the symptomatic relief and management of chronic intractable pain.

SENSUS is a one-channel transcutaneous electrical nerve stimulator with a single output mode. The stimulator utilizes a microprocessor running embedded software to control a high-voltage circuit that generates stimulating pulses with specific technical characteristics including waveform shape, current intensity, waveform duration and frequency. The stimulator is powered by a permanent rechargeable Lithium-Ion battery that is recharged through a USB cable connected to an AC adapter. The stimulator delivers electrical stimulation to the patient through two disposable, single-patient use electrodes placed on the patient's body. The stimulator, as labeled, is for use with legally available electrodes. The electrodes should be self-adhering with an electrical connection made through a male medical snap connector and an electrode area ≥ 20 cm2. The stimulator connects to the electrodes through a patient cable consisting of two lead-wires that terminate in an insulated female medical snap connector. The stimulator has a push-button that initiates and halts stimulation. Taps to the stimulator enclosure, detected by an embedded accelerometer, control the stimulation intensity. The push button serves the dual purpose of powering up the device from a standby state and initiating and halting stimulation.

The NeuroMetrix SENSUS is a transcutaneous electrical nerve stimulator (TENS) intended for the symptomatic relief and management of chronic intractable pain.

Here's an analysis of its acceptance criteria and the study that proves its adherence, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the NeuroMetrix SENSUS are primarily based on demonstrating substantial equivalence to a predicate device, the EMPI Active Transcutaneous Nerve Stimulator (K090922). This involves showing similar intended use, technological characteristics, and safety and effectiveness profiles. There are no explicit quantitative acceptance criteria for performance metrics in the provided document beyond being "within the range of output parameters of legally-marketed transcutaneous electrical nerve stimulators."

The device performance is reported by comparing its specifications to the predicate device.

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