(56 days)
The GateCT-RT system is used to obtain tracking of the subject's respiratory pattern for respiratory synchronized image acquisition, and radiation therapy treatment. It can be also used, either independently or in conjunction with Vision RT's AlignRT (K052682), to monitor the patient position during the image acquisition, simulation and treatment and to disable the radiation beam automatically.
The GateCT-RT device is an attachment to radiation therapy treatment systems, simulators and image acquisition devices used for diagnostics and radiation therapy. The GateCT-RT system senses and records the respiratory motion and respiratory state of a patient using real time 3D surface tracking of the patient without the need of any externally positioned markers. Regions to be tracked are selected remotely in a location indicated by the physician on the GateCT-RT workstation. These may be automatically detected during subsequent sessions. GateCT tracks the patient's breathing CT acquisition in order to facilitate 4DCT reconstruction. GateRT tracks respiratory motion during treatment or imaging and automatically disables the beam when the breathing signal moves outside the user defined gating window. GateCT-RT may also be employed within the monitoring mode of AlignRT to disable the beam automatically if any patient movement is detected which exceeds a user defined tolerance. The Vision RT camera unit is connected to a PC workstation and is used for surface tracking of the patient.
The provided 510(k) summary for the GateCT-RT Respiratory Gating System does not contain specific details about acceptance criteria, a standalone study, or a multi-reader multi-case (MRMC) comparative effectiveness study with human readers. The information focuses on device description, intended use, and technological characteristics compared to predicate devices for substantial equivalence.
Therefore, many of the requested sections regarding study specifics cannot be extracted from this document, as this type of information is generally not included in a 510(k) summary, which primarily establishes substantial equivalence to predicate devices.
However, based on the provided text, I can infer some aspects related to the purpose of such a device, and answer what info is available.
Here's the breakdown of what can and cannot be answered from the provided text:
Acceptance Criteria and Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics from a study (e.g., accuracy, precision of respiratory tracking). It focuses on technological characteristics and intended use for substantial equivalence.
| Acceptance Criteria (Inferred from Intended Use) | Reported Device Performance (Not present in document) |
|---|---|
| Obtain tracking of subject's respiratory pattern | (No specific performance metrics reported in this summary) |
| Facilitate 4DCT reconstruction | (No specific performance metrics reported in this summary) |
| Track respiratory motion during treatment/imaging | (No specific performance metrics reported in this summary) |
| Automatically disable beam when breathing signal moves outside user-defined gating window | (No specific performance metrics reported in this summary) |
| Monitor patient position during image acquisition, simulation, and treatment | (No specific performance metrics reported in this summary) |
Sample Size and Data Provenance
The document does not describe any specific clinical or performance studies with sample sizes. It is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on technological characteristics and intended use.
Number of Experts and Qualifications for Ground Truth
The document does not describe any study involving experts to establish ground truth.
Adjudication Method
The document does not describe any study, and therefore, no adjudication method is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned in the provided text. The submission focuses on device characteristics, not on comparative effectiveness with human readers.
Standalone Performance Study
The document does not explicitly describe a standalone performance study with quantitative results. While the device itself performs tracking, the submission does not include a study demonstrating its standalone accuracy or precision against a gold standard.
Type of Ground Truth Used
The document does not describe any study, and therefore, no ground truth type is mentioned.
Sample Size for Training Set
The document does not refer to any training set or machine learning model, and thus no sample size for a training set is provided.
How Ground Truth for Training Set was Established
The document does not refer to any training set, and thus no method for establishing its ground truth is provided.
Summary of what is available from the 510(k) Summary:
The provided document is a 510(k) summary, which is a submission to the FDA for medical device clearance based on substantial equivalence to predicate devices. It typically describes the device, its intended use, and compares its technological characteristics to existing legally marketed devices. It generally does not include detailed clinical study data, performance metrics, or information about training/test sets, expert adjudication, or MRMC studies, unless these were part of specific tests needed to prove substantial equivalence for unique characteristics. In this case, the clearance seems to be based on comparison of technological characteristics rather than a new standalone clinical efficacy study.
§ 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.