(141 days)
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.
| Acceptance Criteria (Inferred from regulatory context) | Reported Device Performance (Summary from text) |
|---|---|
| Compliance with electrical safety standards (IEC 60601-1, AAMI ES60601-1, CSA C22.2#60601-1) | "engineered and tested to meet Sensus Healthcare product requirements, required electrical and mechanical safety standards" |
| Compliance with electromagnetic compatibility (IEC 60601-1-2) | Tested to meet this standard. |
| Compliance with usability standards (IEC 60601-1-6, IEC 62366) | Tested to meet these standards. |
| Compliance with particular requirements for therapeutic X-ray equipment (IEC 60601-2-8) | Tested to meet this standard. |
| Compliance with laser safety standards (IEC 60825-1) | Tested in accordance with IEC 60825-1 for the red-diode laser. |
| Functional equivalence to predicate device (SRT-100 Vision) in core therapeutic function | "core functionality... is very similar to the SRT-100" and "can perform radiation emissions in the 20, 30, 50, 70, or 100 kV range" (compared to predicate's 20-100kV with more steps). |
| No new questions of safety or effectiveness | "Any technological changes to the device are minor... and do not 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).
§ 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.