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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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