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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 cardian 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 rradiated 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.

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 Special 510(k) describes the addition of an alternative mouthpiece and filter kit (Aktina Part Number: 12-210) for the Active Breathing Coordinator (ABC). There is no change to the intended use or indications for use with this modification.

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 is a 510(k) premarket notification for the "Active Breathing Coordinator" device, specifically for an alternative mouthpiece and filter kit. It aims to demonstrate substantial equivalence to a previously cleared predicate device.

Here's an analysis of the provided text in relation to your request:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance results similar to what would be found in a detailed study report. However, it mentions specific performance characteristics for the filter kit and states that "Hardware specification testing has been performed ... to show that the verification, validation and safety requirements have been met."

Based on the information provided, we can infer some "acceptance criteria" through comparison with the predicate device and the stated performance of the new component:

Note: The predicate device had a Filter Flow Resistance of "1.00 CM H2O@50LPM" and Bacterial Efficiency of "99.99%". The alternative kit's filter flow resistance is slightly higher at a higher flow rate, and its bacterial efficiency is marginally better. The document implies these differences are acceptable and do not raise new safety or effectiveness concerns.

2. Sample size used for the test set and the data provenance

The document focuses on a modification to an existing device (an alternative mouthpiece and filter kit). It mentions "Hardware specification testing has been performed" but does not specify any sample sizes for this testing, nor does it detail the provenance (country of origin, retrospective/prospective) of any data beyond stating that performance characteristics were measured for the new components. This type of submission (Special 510(k)) usually relies on demonstrating that the change does not impact the safety and effectiveness established for the original device.

There is no mention of a clinical "test set" in the context of patient data for the device's overall function.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document. The submission is a Special 510(k) for a device modification, focusing on engineering and material equivalence rather than clinical performance requiring expert ground truth for interpretation (e.g., image analysis).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided as there is no described clinical "test set" and no mention of expert adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

An MRMC study was not relevant and therefore not done for this submission. The "Active Breathing Coordinator" is a patient monitoring and breath-hold device for radiation therapy, not an AI-assisted diagnostic imaging device that would involve human "readers" interpreting images with or without AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable to the Active Breathing Coordinator device. The device is hardware-based, with software controlling patient monitoring and breath-hold instructions. It is designed to be used in conjunction with radiation therapy equipment and requires a human operator (therapist) to coach the patient and deliver radiation. There is no "algorithm only" performance that would be evaluated in a standalone manner without human interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the specific aspect of this submission (the alternative mouthpiece and filter kit), the "ground truth" used for evaluation relates to engineering specifications, material science, and biocompatibility standards. This involves testing materials against established biocompatibility guidelines and measuring physical properties like flow resistance and bacterial efficiency, comparing them to the predicate device and relevant standards. There is no mention of clinical "ground truth" like pathology or outcomes data for this specific modification.

8. The sample size for the training set

This information is not applicable and therefore not provided. The device is not an AI/ML model that requires a "training set" in the conventional sense. The submission is for a hardware modification, and its performance is evaluated based on engineering tests and comparisons to a predicate device.

9. How the ground truth for the training set was established

This information is not applicable and therefore not provided for the same reasons as #8.

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