(193 days)
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.
| Acceptance Criteria (Explicitly Stated in Document) | Reported Device Performance |
|---|---|
| Electrical Safety: Conformity to EN-60601-1-1 | Testing currently underway; not marketed until successfully completed. |
| Electromagnetic Compatibility: Conformity to EN-60601-1-2 | Testing currently underway; not marketed until successfully completed. |
| Intended Use Equivalence: Gating diagnostic x-ray or radiation therapy systems based on patient's respiratory cycle. | Considered substantially equivalent to Varian RPM Respiratory Gating System (K983629) with "similar, but not identical, indications for use" and "same technological characteristics." |
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.
§ 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.