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Aktina Thermoplastic Masks are medical devices used for patient positioning and immobilization during external beam radiation therapy procedures. Thermoplastic masks are intended for the duration of the treatment.

This is a Traditional 510(k) for the Aktina Medical Thermoplastic Mask. The low-temperature thermoplastic mask is made of Aquaplast polycaprolactone sheets. When immersed in water heated to 70-75°C [160 to 170°F], the material softens, allowing the user to shape or stretch the mask over the contours of the patient's anatomy while cooling. When the material reaches room temperature, the mask hardens into the anatomical shape. The mask can then be placed over the patient treatment area to consistently immobilize the area from treatment to treatment. Predicate device manufacturers have used polycaprolactone materials for this intended use for over 25 years. The mask also has a polycarbonate frame with holes for mounting to the user's existing patient support hardware.

The provided document is a 510(k) summary for the Aktina Medical Thermoplastic Mask, not a study describing the acceptance criteria and performance of an AI/ML-based device. This document is for a medical device (thermoplastic mask) used for patient immobilization during radiation therapy and does not involve AI/ML.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set information) as it is not present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material properties, design, and intended use, rather than performance evaluation against specific acceptance criteria for an AI/ML algorithm.

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The Circular Small Field Collimators, Elekta Integrated, are intended for use with the Elekta line of digital medical linear accelerators (LINAC) for the creation of small circular fields. These fields are used for patients who require external beam radiation therapy or stereotactic radiosurgery of the cranial or extra cranial regions for the treatment of tumors or lesions.

This is a Traditional 510(k) that describes the Circular Small Field Collimators, Elekta Integrated, 50-370, a tertiary collimation system used in conjunction with digital medical linear accelerators (LINAC) for external beam radiation therapy. It consists of collimator cone inserts and a cone insert mounting adapter. The collimator cone inserts create small circular fields of various sizes. Each cone insert is uniquely identified with the diameter in millimeters on the top and bottom covers. The cone mounting adapter is inserted directly into the beam block tray slot of the LINAC head without any need for modification to the LINAC. The collimator cones are easily inserted into and removed from the mounting adapter without removing the adapter from the LINAC. The collimator cone inserts are also uniquely identified electronically, and use the LINAC beam block tray electronic interlock to prevent irradiation, if the cone insert size does not conform to the treatment plan.

The provided document is a 510(k) premarket notification for a medical device called "Circular Small Field Collimators, Elekta Integrated." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and detailed performance of an AI/algorithm. Therefore, much of the requested information regarding AI study specifics cannot be extracted.

However, I can extract information related to the device's performance validation as described in this regulatory submission.

Summary of Device Performance and Validation:

The document describes the device as tertiary collimation system used with linear accelerators for creating small circular radiation fields for radiation therapy. The validation focused on demonstrating that the device meets functional, performance, safety, and labeling requirements, and performs comparably to or better than the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a medical hardware device (collimators) and not an AI/software algorithm, the "acceptance criteria" are not reported as statistical performance metrics (like sensitivity, specificity, or AUC) against a ground truth dataset in the way an AI study would. Instead, the acceptance criteria are met through compliance with established standards and successful functional and safety testing.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable as the document describes the validation of a hardware medical device (collimators) and not a data-driven AI/software device. The "test set" would refer to specific physical device units and their components being tested, rather than a dataset. The document does not specify the number of collimator units tested or the specific provenance of any data beyond compliance with standards and physical testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable. For this hardware device, "ground truth" is established by engineering specifications, physical measurements, and adherence to established medical device standards, rather than expert consensus on diagnostic interpretations. The document refers to "hardware specification testing" and assessment against ISO and IEC standards.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for resolving discrepancies in expert interpretations during the establishment of ground truth for image-based diagnostic AI studies. The validation of this hardware device does not involve such a process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

This information is not applicable. An MRMC study is used to evaluate the impact of an AI system on human reader performance. This document concerns a hardware device, not an AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

This information is not applicable. This device is a hardware component, not an algorithm. Therefore, a standalone algorithm performance study was not conducted.

7. The Type of Ground Truth Used

For this device, the "ground truth" is based on:

• Engineering Specifications: The design and manufacturing specifications for the collimators (e.g., precise diameter sizes, material composition).
• Physical Measurements: Verification of the actual performance (e.g., field size accuracy, beam attenuation) against these specifications.
• Compliance with Standards: Adherence to recognized national and international medical device safety and performance standards (e.g., ISO 14971, IEC 60601-1, IEC 60601-2-1, IEC 62366-1).
• Comparative Performance to Predicate: Demonstrating that the device performs "as well as or better than" the predicate device based on its design, intended use, and functional characteristics.

8. The Sample Size for the Training Set

This information is not applicable. This hardware device does not involve machine learning or AI, and therefore does not have a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no training set for this hardware device.

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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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