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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:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes for test sets, data provenance, or details of a study proving performance against acceptance criteria.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication methods.
5. Multi-reader multi-case (MRMC) comparative effectiveness studies or human reader improvement with AI assistance.
6. Standalone (algorithm-only) performance studies.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The 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 is a 510(k) premarket notification letter and summary for the Anzai Medical Co. Ltd. AZ-733VI Respiratory Gating System. It does not contain information about acceptance criteria or a study proving that a device meets such criteria in the context of AI/ML performance.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (AZ-733V Respiratory Gating System, K031358) based on technological characteristics and non-clinical performance data, specifically:

• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1:2005, IEC 60601-1-6:2010, IEC 62366:2007, IEC 60825-1:2007, and IEC 60601-1-2:2007 standards.
• Software Verification and Validation Testing: Documentations provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submission for Software Contained in Medical Devices." The software was considered a "major" level of concern.

There is no mention of:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or their data provenance.
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for a training set or how its ground truth was established.

This device is a hardware/software system for respiratory gating in diagnostic x-ray or radiation therapy, not an AI/ML-based diagnostic or prognostic device that would typically involve the types of studies and performance metrics requested in the prompt.

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