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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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