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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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The TrueBeam and Edge Systems are intended to provide stereotactic radiotherapy for lesions, and conditions anywhere in the body where radiation therapy is indicated for adults and pediatric patients.

The TrueBeam and Edge Systems may be used in the delivery of radiation for treatment that includes: bram and spine tumors (such as glioma, meningioma, craniopharyngioma, pituitary tumors, spinal cord tumors, hemangioblastoma, orbital tumors, optic nerve tumors, and skull based tumors (such as unknown primary of the head and neck, oral cavity, hypopharynx, larynx, oropharynx, sinonasal, salivary gland, and thyroid cancer), thoracic tumors (such as ung cancer, esophageal cancer, thymic tumors, and mesothelioma), gynecologic tumors (such as ovarian, endometrial, vulvar, and vaginal), gastrointestinal tumors (such as gastric, hepatobiliary, colon, rectal, and anal carvinoma), genitourinary tumors (such as prostate, bladder, testicular, and kidney), breast tumors, sarcomas, lymphoid tumors (such as Hodgkin's lymphoma), skin cancers (such as squamous cell, and melanoma), benign diseases (such as schwannoma, arteriovenous malformation, cavemous malformation, trigeninal neuralgia, chordoma, glomus tumors, and hemangiomas), metastasis (including all parts of the body such as brain, bone, liver, lung, kidney, and skin) and pediatric tumors (such as glioma, pitutary tumors, hemangioblastoma, craniopharyngioma, metastasis, medulloblastoma, nasopharyngeal tumors, arteriovenous malformation, cavernous malformation and skull base tumors).

The TrueBeam™ and Edge™ Radiotherapy Delivery Systems are medical linear accelerators that integrate the previously cleared Trilogy Radiotherapy system and associated accessories into a single device.

The system consists of two major components, a photon, electron, and diagnostic kV X-ray radiation beam-producing component that is installed in a radiation-shielded vault and a control console area located outside the treatment room.

This document is a 510(k) Premarket Notification for the TrueBeam/Edge Radiotherapy Delivery Systems from Varian Medical Systems, Inc. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

The document states that no changes have been made to the device and no new testing has been performed. This implies that the current submission relies on the performance data and acceptance criteria established for the predicate devices. Therefore, the specific details regarding acceptance criteria and a study proving the device meets them are not explicitly provided for this specific submission. Instead, the submission asserts that the device is substantially equivalent to previously cleared devices which would have undergone such scrutiny.

Based on the provided text, here is what can be inferred and what information is not available:

1. A table of acceptance criteria and the reported device performance:

• Not explicitly provided in this document for the current submission. The document states, "No changes have been made to the device and no new testing has been performed." This implies reliance on previous testing and acceptance criteria for predicate devices like K123291 (TrueBeam Radiotherapy System and Accessories).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Not available in this document. Since no new testing was performed for this submission, these details would be found in the documentation for the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

• Not available in this document. As no new testing was performed, this information is not included here. This would have been established during the testing of the predicate devices.

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

• Not available in this document. Similar to the above, this information pertains to the testing of predicate devices, not this specific submission which states no new testing.

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:

• Not applicable and not available.
  • This device is a radiation therapy delivery system, not an AI or imaging interpretation device that would involve human readers interpreting AI outputs.
  • The document explicitly states, "No changes have been made to the device and no new testing has been performed."

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

• Not applicable and not available. This is a hardware system for radiation delivery, not an algorithm that would be tested in a standalone manner for performance metrics like sensitivity or specificity.

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

• Not available in this document. This information would be relevant to the performance testing of the predicate devices, which is not detailed here.

8. The sample size for the training set:

• Not applicable and not available. This is a radiation therapy delivery system, not an AI/machine learning algorithm requiring a "training set" in the typical sense.

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

• Not applicable and not available. As above, this is not an AI/machine learning algorithm with a training set.

Summary of what is provided by the document regarding performance and equivalence:

The core of this 510(k) submission is that the TrueBeam and Edge Radiotherapy Delivery Systems are substantially equivalent to their previously cleared predicate devices.

• Predicate Devices: TrueBeam Radiotherapy System and Accessories (K123291), CyberKnife Robotic Radiosurgery System and CyberKnife VSI Systems (K102650), Agility™ (K123808).
• Reason for Substantial Equivalence Claim:
  • "The device itself is unchanged from the previous submission K123291."
  • "The principles of operation, technological characteristics and labeling are substantially equivalent."
  • The only change highlighted for this submission is the addition of specific examples of lesions, tumors, and conditions to the Indications for Use statement, which "does not change the therapeutic effect of the device" and "fall within the previously cleared general indication."
  • "No changes have been made to the device and no new testing has been performed."

Therefore, for the current submission (K140528), the "proof" that the device meets acceptance criteria is the argument of substantial equivalence to predicate devices that have already met their respective acceptance criteria through prior studies and FDA clearance. The document explicitly states that no new testing was performed for this specific submission because the device itself is unchanged.

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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 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.

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