(92 days)
The Active Breathing Coordinator is indicated for use when there is a need to reduce the anatomical movement in the thorax and abdomen caused by breathing and cardiac motion. It is intended for breath-hold (BH) during simulation and delivery of External Beam Radiation Therapy (EBRT) using photons, in single or multiple fractions, administered via static and/or dynamic delivery processes, in any and all areas of the body where such treatment is indicated. It also provides electrical prompts and status information for the Elekta Limited Response™ gating interface when automated gating of the linac is used.
The Active Breathing Coordinator is specifically indicated for:
- a. Breast tumors, including total and partial breast irradiation techniques, where immobilized anatomy provided by deep inspiration breath-hold (DIBH) allows critical organ sparing, such as decreasing radiation dose to heart, lung and other surrounding normal tissue.
- b. Lung cancers and other thoracic tumors (such as esophagus, lymphoma, and metastatic lesions) where immobilized anatomy provided by DIBH allows critical organ sparing, including reducing both dose and volume of irradiated normal tissue, and enabling potential reduction of tumor target margins. Also included is the use of linac-based Stereotactic Radiosurgery (SRS) and Stereotactic Radiation Therapy (SRT) that may be employed to treat such lesions.
- c. Liver tumors, where immobilized anatomy provides critical organ sparing, including reducing both dose and volume of irradiated normal tissue enabling potential reduction of tumor target tissue margins. Also included is the use of linac-based SRS and SRT that may be employed to treat such lesions.
- d. Pancreatic tumors, where immobilized anatomy allows critical organ sparing including reducing both dose and volume of irradiated normal tissue, enabling potential reduction of tumor target tissue margins. Also included is the use of linacbased SRS and SRT that may be employed to treat such lesions.
This Traditional 510(k) describes product enhancements for the Active Breathing Coordinator (ABC). The ABC is a flow meter device that allows radiation therapy patients to graphically observe the volume of air that enters and exits their lungs on a computer monitor. The patients are coached prior to the treatment and instructed to hold their breath when the volume of air entering or exiting their lungs reaches a predefined threshold volume. Accurate and reproducible timing of the breath hold period is aided by a patient controlled balloon valve which is connected to the flow meter device. Radiation is only delivered during the breath hold period. Radiation may be delivered by the therapist manually turning the beam on and off, or automatically by using the Elekta Limited Response™ gating interface (FDA 510(k) clearance number K123808, available separately from Elekta, Ltd., Crawley, UK).
This document describes the Active Breathing Coordinator (ABC), a flow meter device used in radiation therapy to help patients hold their breath, thereby reducing anatomical movement during treatment. The specific enhancements in this 510(k) submission relate to supporting automated gating of the treatment beam from a linear accelerator via the Elekta Ltd. Response linac gating interface.
Here's an analysis of the provided text with respect to your questions:
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary does not contain a table of acceptance criteria with numerical performance metrics for the device. Instead, it states that:
"Hardware and software specification testing have been performed on the enhanced ABC to show that the verification, validation and safety requirements have been met."
This general statement indicates that internal testing was conducted, but specific acceptance criteria and their corresponding performance results are not detailed in the public summary. The submission focuses on demonstrating substantial equivalence to predicate devices rather than providing quantifiable performance from a clinical study with defined acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a test set or the provenance (country of origin, retrospective/prospective) of data. The submission relies on demonstrating substantial equivalence to existing predicate devices, implying that extensive new clinical data with a test set was not a primary component of this particular 510(k) application.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention the use of experts to establish a ground truth for a test set. This type of information would typically be part of a clinical performance study, which is not detailed in this 510(k) summary focusing on substantial equivalence.
4. Adjudication Method for the Test Set
Since no test set adjudicated by experts is mentioned, there is no information on any adjudication method (e.g., 2+1, 3+1, none).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. The focus is on the device's technical functionality and its equivalence to predicate devices, not on comparing human reader performance with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The document does not describe a standalone (algorithm only) performance study. The device is a patient monitor with a flow meter and balloon valve, not an AI algorithm that operates independently. The "enhancement" involves an electrical interface for automated linac gating, which is a technical integration rather than a standalone AI performance.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for performance evaluation, as it doesn't detail a clinical performance study with a defined ground truth. The "ground truth" in this submission is implicitly related to whether the device correctly facilitates breath-hold and interfaces with the linear accelerator as intended, demonstrating equivalence to already cleared devices.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This type of information is relevant for AI/machine learning models, which are not the primary focus of this device. The device is a patient monitoring and control system, not a data-driven diagnostic or predictive algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no training set is discussed or implied to be part of the device's development, there is no information on how ground truth for a training set was established.
Summary of Device Acceptance:
The acceptance of the Active Breathing Coordinator (ABC) in this 510(k) submission (K131313) is based on demonstrating substantial equivalence to existing predicate devices (Aktina Medical's ABC K003330 and Anzai Medical's AK-733 K031385).
The study that "proves the device meets the acceptance criteria" in this context is the comparison against the predicate devices and internal hardware/software specification testing. The submission states:
"Hardware and software specification testing have been performed on the enhanced ABC to show that the verification, validation and safety requirements have been met."
"This device is similar in design and intended use, technological, physical, and performance characteristics to the predicate devices. No new issues of safety or effectiveness are introduced by using this device."
The core of the "proof" is the argument that the enhanced ABC's technology for "Automatic and Manual Linac Gating" is substantially equivalent to the Anzai AK-733 (K031385), and its updated "Indications for Use" are substantially equivalent to the original ABC (K003330). The FDA's clearance letter confirms this determination of substantial equivalence.
Therefore, the "acceptance criteria" are implicitly met by demonstrating that the enhanced device performs comparably to legally marketed devices for its stated intended use and does not raise new safety or effectiveness concerns, as evidenced by internal verification and validation and the detailed comparison against predicates. No specific quantitative performance metrics or clinical study results are presented in this summary to define "acceptance criteria" in a numerical sense.
§ 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.