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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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The AZ-733 Respiratory Gating System 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 AZ-733 Respiratory Gating System system employs a respiratory sensor which can be fixed directly to or nearly to a patient, and detects the respiratory motion changes according to the type of sensor, a load cell (standard) or laser sensor (optional). The Load Cell detects the mechanical expansion of the thoracic cavity resulting from the respiratory motion as the pressure changes of up/downward movement of the chest and abdomen. The Laser Sensor detects the distance change to the chest surface with the expansion of the thoracic cavity resulting from the respiratory motion of the chest and abdomen. The analog signals from the Respiratory Sensor are detected and transmitted to the Sensor Port. There those signals are amplified, converted into digital form, and then output through a cable to the Wave Deck. The Wave Deck processes the signals, changing them into serial format for transmission to the Personal Computer. The Personal Computer monitors the respiratory signals all the time and commands the Wave Deck to output the gating signals when those respiratory signals reach the preset phase of respiration. Those gating (TTL) signals are transmitted to diagnostic imaging apparatus like X-ray CT or radiation therapy equipment.

Here's an analysis of the provided text regarding the AZ-733-V Respiratory Gating System's acceptance criteria and studies:

Based on the provided 510(k) summary (K031385), the following information can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, precision, latency) for the device's respiratory gating functionality. Instead, the substantial equivalence determination is based on the device having "similar, but not identical, indications for use" and "the same technological characteristics" as a predicate device, with some differences in sensors.

The primary proof of equivalence is rooted in the device's design to conform to electrical safety and electromagnetic compatibility standards, rather than performance-based acceptance criteria related to its respiratory gating function.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective) for evaluating the core performance of the respiratory gating function. The "Testing" section refers to compliance with electrical safety and EMC standards, not clinical or functional performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not provided in the given summary. There is no mention of experts establishing a ground truth for a performance test set.

4. Adjudication Method for the Test Set

This information is not provided as there is no described test set or ground truth establishment process.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done or described. The 510(k) process for this device relies on substantial equivalence to a predicate device, not on proving improved human reader performance with AI assistance. The device is a "Respiratory Gating System," not an AI-assisted diagnostic tool for human interpretation.

6. If a Standalone Performance Study Was Done

No, a standalone (algorithm only without human-in-the-loop performance) study of the respiratory gating accuracy or effectiveness was not described. The documented testing focuses on electrical safety and EMC. While the system processes signals and commands gating, there's no performance data presented on how accurately it tracks respiration or gates devices.

7. The Type of Ground Truth Used

Given the absence of a described performance study for respiratory gating, there is no mention of a specific type of ground truth used (e.g., expert consensus, pathology, outcomes data). The "ground truth" for the device's approval seems to be its compliance with regulatory standards (electrical safety, EMC) and its technological similarity to a predicate device, as opposed to a detailed functional performance evaluation.

8. The Sample Size for the Training Set

The document does not describe a training set for the device. Clinical performance data or machine learning model training is not referenced in the summary.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set, the method for establishing its ground truth is not provided.

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The Anzai eZ-Scope AN Portable Gamma Camera is indicated for use to image the distribution of radionuclides in the human body using planar imaging techniques. The eZ-Scope may be used intraoperatively or on pathological specimens if a protective sheath is used.

The Anzai EZ-Scope AN Portable Gamma Camera is a currently marketed portable gamma camera. utilizing a solid state detector. rather than a scintilator, to detect gamma rays. The cadmium-zinc-tellurium detector allows sharp energy discrimination and spatial resolution. The detector arrav is made from pixelized cadmium-zinc-telluride (CZT) crystals, with each of the 256 pixels having dimensions of 2 x 2 mm. The system is available in two configurations, eZ-Scope AN and eZ-Scope Light. These differ primarily in the computer, the former model using a desktop computer and the latter a laptop. In the desktop version, the computer is mounted on a cart, while the laptop version does not have a cart.

The present 510(k) is for an addition to the indications for use statement (see next section) pertaining to intraoperative use. The user manual has been modified to include instructions for disinfecting the camera head and covering it with a protective plastic sheath to prevent contamination of a sterile field in case of an accidental puncture of the sheath during intraoperative use.

The provided text states that "No new performance testing was necessary for the present submission." Therefore, it does not contain the information required to populate the acceptance criteria and study details. The submission is for an additional indication for use (intraoperative use) for an already legally marketed device, and the manufacturer claims substantial equivalence to predicate devices without the need for new performance testing.

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