(25 days)
The Esteya is intended to deliver X-ray radiation for superficial radiotherapy procedures and surface brachytherapy. Applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Kaposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Keloids and Cutaneous Lymphomas (B and T cell).
The Esteva is designed for high dose rate treatment of skin surface lesions. The Esteva utilizes a mobile treatment unit with an isotope free small 69.5 kV X-rav source that focuses the treatment dose directly to the skin lesion with the aid of a shielded surface applicator. This technique provides a uniform dose to the underlying tissue within minutes. The small X-ray source is activated by the treatment control panel that is located adjacent to the treatment area where the operator is protected from radiation exposure during the patient treatment. The dedicated computer system of Esteya provides fractionated treatment times, plan approval, patient information and treatment reports in a protected database which is administrator controlled. The quality of the X-ray source output is measured on a daily basis with a dedicated quality assurance device that Is connected directly to the treatment unit. This quality assurance check ensures consistent and accurate electronic brachytherapy & superficial radiotherapy treatment.
The provided text is a U.S. FDA 510(k) summary for the "Esteya" X-ray radiation therapy system. It outlines the device's technical characteristics, intended use, and a comparison to predicate devices, along with a summary of performance testing (non-clinical).
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of acceptance criteria and the reported device performance
The document provides a table summarizing performance parameters for the device, which can be interpreted as demonstrating the device meets certain operational criteria. It does not explicitly state "acceptance criteria" but rather "Performance Data".
| Performance Criterion (from text) | Reported Device Performance (from text) |
|---|---|
| Fractionated treatment capabilities | ✓ |
| Source to Skin Distance (SSD) | 60 mm |
| 80% of the dose at a depth of: | 3 mm |
| Dose Rate at skin surface | 3 Gy/m |
| Maximum width of treatment surface (diameter of treatment area) | 30 mm |
| PDD curves demonstrate a sharp falloff of dose to protect underlying tissue | ✓ |
| Accelerating potential (V) | 69.5 kvp |
| Tube current (A) | 0.5, 1, 1.6 mA |
| Tube power (W) | 112 |
| Flattening Filter in the tube | ✓ |
| Range of applicator diameters (mm) | Standard: 0, 10, 15, 20, 25, 30; Mini set: 10, 15, 20 |
| Treatment applicator in contact with skin surface | ✓ |
| Contact material with skin surface | PPSU |
| Applicator Shielding | Densimet |
2. Sample size used for the test set and the data provenance
The document states: "No animal or clinical tests were performed to establish substantial equivalence with the predicate devices." This implies that there was no specific clinical test set with a sample size for human or animal subjects. The performance testing described is non-clinical, focusing on the device's physical and functional characteristics. Therefore, information about data provenance (country of origin, retrospective/prospective) is not applicable to a clinical test set in this context.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as no clinical test set was used to establish substantial equivalence.
4. Adjudication method for the test set
Not applicable, as no clinical test set was used to establish substantial equivalence.
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
Not applicable. The device is an X-ray radiation therapy system, not an AI-assisted diagnostic or interpretive tool. The document explicitly states "No animal or clinical tests were performed."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable in the context of this device. The Esteya is a radiation therapy system, not an algorithm being evaluated for standalone performance. The performance testing was focused on the system's physical and functional attributes.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document indicates that "the device safety and performance have been addressed by non-clinical testing in conformance with predetermined performance criteria. FDA guidance, clinical use and recognized consensus standards." This suggests that the "ground truth" for the non-clinical performance evaluation was based on:
- Predetermined performance criteria: These are likely engineering and design specifications.
- FDA guidance and recognized consensus standards: These provide established benchmarks for safety and effectiveness for such devices.
8. The sample size for the training set
Not applicable. The device is an X-ray radiation therapy system, not a machine learning algorithm that requires a training set in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as no training set was used for an AI algorithm.
§ 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.