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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 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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