(55 days)
The SRT-100 is a low energy x-ray system intended for superficial radiotherapy treatment of primary malignant epithelial neoplasms of the skin. Typical applications include basal cell carcinoma, squamous cell carcinoma, metatypic carcinoma, cutaneous appendage carcinoma and Kaposi's sarcoma.
The Topex, Inc. SRT100 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 a specifically designed module housing the switches and indicators used by the operator to set up and execute x-ray exposures. The Base Unit is 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 is 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 move the appropriate beam filter into the beam path depending on the kV setting selected by the operator.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Topex SRT100 Superficial Radiation Therapy System:
It's important to note that the provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed clinical trial data for acceptance criteria. Therefore, much of the requested information regarding a statistical study for device performance metrics will not be present.
Instead, the document emphasizes compliance with safety and electrical standards and bench testing to show similar clinical capabilities to predicate devices.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Safety Standards | Compliance with IEC 60601-1: General requirements for basic safety and essential performance | Successfully designed and constructed to meet IEC 60601-1. |
| Compliance with UL 60601-1: Medical Electrical Equipment, Part 1: General Requirements for Safety | Successfully designed and constructed to meet UL 60601-1. | |
| Compliance with CAN/CSA-C22.2 NO. 601.1-M90 (R2005): Medical Electrical Equipment, Part 1: General Requirements for Safety | Successfully designed and constructed to meet CAN/CSA-C22.2 NO. 601.1-M90 (R2005). | |
| Compliance with IEC 60601-1-4: Collateral Standard: Programmable Electrical Medical Systems | Successfully designed and constructed to meet IEC 60601-1-4. | |
| Compliance with IEC 60601-2-32: Particular Requirements for the Safety of Associated Equipment of X-ray Equipment | Successfully designed and constructed to meet IEC 60601-2-32. | |
| Performance Testing | Compliance with 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 | System successfully passed all tests required by IEC 60601-1, Part 2-8, Edition 1.1. 1999. |
| Demonstrate the output provides the "same clinical capabilities" as predicate devices (Pantak Superficial X-ray Therapy System K971074, Gulmay D3100/Xstrahl 100 K962613, Philips RT100). This is assessed through bench testing and internal characterization. | Performance testing consists of bench testing that demonstrates that the output of the Topex SRT100 provides the same clinical capabilities as the predicate devices. Also, "tests developed internally for system characterization" were successfully passed. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of the provided document. The performance testing was bench testing on the device prototypes, not a clinical study with a patient "test set."
- Data Provenance: Not applicable. No clinical patient data (retrospective or prospective) is described as being used for performance testing or to prove substantial equivalence. The "data" comes from bench testing of the device itself and compliance with engineering standards.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There was no clinical "test set" requiring expert ground truth establishment.
4. Adjudication method for the test set
- Not applicable. There was no clinical "test set" requiring adjudication.
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 MRMC comparative effectiveness study was conducted or described. This device is an X-ray therapy system, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- This is not a software algorithm or AI device. It's a hardware medical device (X-ray system). The "performance" is its ability to meet specified physical outputs (e.g., kV, dose, emission) and safety standards.
7. The type of ground truth used
- The "ground truth" for this device's performance is objective measurements against engineering specifications and international/national safety standards during bench testing. For "clinical capabilities," the ground truth is the established performance and output characteristics of the predicate devices.
8. The sample size for the training set
- Not applicable. This device does not use machine learning or AI, so there is no concept of a "training set" in the traditional sense.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for machine learning. The "ground truth" for the device's design and manufacturing standards would be established by relevant regulatory bodies and engineering principles.
§ 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.