(27 days)
Respiratory Gating System AZ-733VI is intended to be used with diagnostic X-ray or radiation therapy systems to gate these devices on and off when target points of the patient's respiratory cycle are within preset limits.
The Respiratory Gating System AZ-733VI employs a respiratory sensor which can be fixed directly to or near to a patient, and detects the respiratory motion changes according to the type of sensor, the Load Cell (standard component), the Laser Sensor (option component) or the IRP Sensor (option component).
The signal from the sensor is primarily amplified at the Amp Box which is attached to each Respiratory Sensor and sent to the Sensor Port as an analog signal. At the Sensor Port, the analog signal is coarsely adjusted manually, converted to digital signal, smoothed by moving-average method and processed to detect a respiratory phase. Then, as a respiratory information, the respiratory waveform and the respiratory phase are sent to the Application on the Personal Computer via the Relay Box.
The Application performs the fine adjustment of the selected respiratory waveform by the user manually or automatically. The user also sets a Gate signal output condition and selects a mode for the method of generating Gate signal. This Gate signal is output to external equipment (image diagnostic equipment such as a whole body CT equipment, linear accelerator system and radiotherapy equipment) from the Relay Box or the Sensor Port when those respiratory signals reach the preset conditions set by the user. The status of the Gate signal ON and OFF is also displayed on the LCD Display. The Application has a function of managing patient information. This function involves the input, registration, referring, revision and delete of patient information. The Application also provides the function of recording, playback, referring and output by a text file format of respiratory information and Gate signal ON/OFF status as well as Beam signal ON/OFF status.
The provided text discusses a 510(k) premarket notification for the AZ-733VI Respiratory Gating System. However, it does not contain any information regarding acceptance criteria or the study that proves the device meets those criteria, especially for AI/algorithm performance.
The document primarily focuses on demonstrating substantial equivalence to a predicate device (AZ-733VI Respiratory Gating System, K160432) based on:
- Identical Indications for Use.
- Similar technological characteristics, with the only stated difference being the "Addition of ABLE which utilizes wireless Bluetooth technology."
- Non-clinical performance data covering electrical safety, electromagnetic compatibility (EMC), and software verification and validation testing, confirming compliance with relevant IEC standards and FDA guidance for software in medical devices.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test sets, data provenance, or details of a study proving performance against acceptance criteria.
- Number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
- Standalone (algorithm-only) performance studies.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in 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. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.