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The Intraluminal Applicator Set is intended for intraluminal brachytherapy treatments including endobronchial treatments and treatments on body sites such as the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set is intended for intrapy treatments including endobronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set acts to guide the radioactive source to the correct location for treatment.

Key performance characteristics are as follows:

• . Suitable for treating body sites allowing insertion of a catheter.
• CT compatible. ●
• MR Compatibility: Safe. ●
• Fits a 2 mm diameter bronchoscope biopsy channel allowing for easy insertion.
• Elastomer construction provides increased flexibility for easy placement and luminal rigidity to avoid kinks. ●
• Nylon monofil adds luminal stability during catheter insertion and manipulation. ●
• Comes with 2.8 mm spacing tubes, which minimize surface dose. .
• . Spacing tubes enable secure placement during treatment.
• The bronchial catheter and monofil are supplied sterile, and for single use.
• . The guide tubes, the bronchial catheter, the bite catheters are intended for continuous use for less than 24 hours of contact with patients.

The provided document is a 510(k) Premarket Notification for a medical device called the "Intraluminal Applicator Set." This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting effectiveness studies with explicit acceptance criteria and performance metrics.

Therefore, the document does not contain the detailed information requested regarding acceptance criteria for device performance, the specific study design to prove those criteria (like sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, or standalone algorithm performance), or the type of ground truth used.

Instead, the document details non-clinical testing performed to establish the device's safety and effectiveness in comparison to its predicate. The "Summary of Performance Testing (Non-Clinical Testing)" section outlines the types of tests conducted:

• Biocompatibility Testing: Confirms the compatibility of skin-contact components with requirements as per ISO 10993-1. Specific tests included Hypersensitivity, Material Mediated Pyrogen, and Acute Systemic Toxicity.
• Cleaning, Disinfection, and Sterilization Testing: Verifies that components can be effectively sterilized and reused for the specified number of times.
• Human Factors Validation Study: Conducted according to IEC 62366 to ensure the device is safe and effective for intended users, uses, and environments.
• Mechanical and Acoustic Testing: Formal design validation testing to demonstrate the device performs as intended.
• Magnetic Resonance Testing (MR): Confirms the device is MR Safe, complying with ASTM F2503-23.
• Electromagnetic Compatibility (EMC) Testing: Assessed against IEC 60601-2-17 to demonstrate compatibility in an electromagnetic setting.

The "Determination of Substantial Equivalence to the Predicate" section states: "The results of verification as well as conformance to relevant safety standards demonstrate that the safety and performance criteria." This implies that the 'acceptance criteria' for this submission are met when the device successfully passes these non-clinical tests and conforms to the listed standards.

Without the specific details of a clinical performance study with acceptance criteria, I cannot complete the requested tables and information as described in the prompt. The document is a regulatory submission for substantial equivalence based on technical and safety characteristics, not a clinical efficacy trial.

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The Intraluminal Applicator Set is indicated for use for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy.

The Intraluminal Applicator Set is designed for intraluminal brachytherapy treatments including endo-bronchial treatments and treatments on body sites such as the esophagus and the bile duct using HDR brachytherapy. It is compatible with Varian GammaMedplus afterloaders and can be used in combination with the appropriate accessories. The devices are intended to be used by trained and qualified personnel such as Radiation Oncologists, Physicians, Radiologists, Dosimetrists, Medical Physicists, and Nurses/MTRAs/Radiology Technicians/Radiographers in a hospital environment.

This document describes the premarket notification for the "Intraluminal Applicator Set GM11000620" by Varian Medical Systems, Inc. The submission is for a Class II medical device, specifically a remote-controlled radionuclide applicator system, used for intraluminal brachytherapy treatments.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the device. Instead, it lists the types of non-clinical tests performed and states that the "Results of Bench Testing showed conformance to applicable requirements and specifications." The "Conclusions" section reiterates that "All the tests that were performed met the applied pass criteria."

However, based on the non-clinical tests described, we can infer the broad categories of acceptance criteria and the claimed performance:

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

• Sample Size for Test Set: The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The tests performed are described as "Bench Testing," implying laboratory or engineering tests on the device hardware itself. There is no indication of retrospective or prospective data use from human subjects in these tests.
• Data Provenance: The data provenance is from bench testing conducted by Varian Medical Systems, Inc. This is not human patient data, therefore country of origin is not applicable in the context of clinical studies.

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

This question is not applicable as the study involved non-clinical bench testing. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The "ground truth" for these engineering tests would be derived from physical measurements (e.g., using calipers, gauges, radiation detectors) and engineering specifications, not expert medical opinion.

4. Adjudication Method for the Test Set

This question is not applicable as the study involved non-clinical bench testing. Adjudication methods like 2+1 or 3+1 are used for resolving discrepancies among expert readers in clinical or imaging studies.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a physical applicator set for brachytherapy, not an AI-powered diagnostic or treatment planning software meant to improve human reader performance.

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

This question is not applicable. The device is a physical intraluminal applicator set, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests would have been derived from:

• Engineering specifications and design documents: For functional compatibility, durability, material resistance, and physical dimensions.
• Calibration standards/measurement devices: For positional accuracy of the radioactive source.
• Sterilization efficacy testing protocols and standards: For sterilization effectiveness and reusability.
• IEC 62366:2007 standard requirements: For usability assessment.

It is not expert consensus, pathology, or outcomes data, as these are clinical ground truths.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this device is not an AI/machine learning algorithm. The tests described are engineering verification and validation tests for a physical medical device.

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

This question is not applicable as there is no "training set."

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