(89 days)
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:
- A table of acceptance criteria and the reported device performance: Not provided.
- Sample size used for the test set and the data provenance: Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided.
- Adjudication method for the test set: Not provided.
- 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.
- 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.
- 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.
- The sample size for the training set: Not provided.
- 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.
§ 892.5900 X-ray radiation therapy system.
(a)
Identification. An x-ray radiation therapy system is a device intended to produce and control x-rays used for radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II.