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The GliaSite RTS with Cesitrex, (Liquid 131CsCl), is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.

The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, GliaSite Access Tray, and Iotrex®, (125)-HBS) or Cesitrex, (liquid 131CsCI) Radiotherapy Solutions. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS Catheters are provided in three balloon sizes: 2 cm, 3 cm, and 4 cm. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the Iotrex or Cesitrex. Iotrex and Cesitrex radiotherapy solutions are the radiation sources that can be used with the GliaSite RTS.

The provided text is a 510(k) summary for the GliaSite® RTS Cesitrex, a medical device used for intracavity radiation therapy in brain tumor patients. The submission claims substantial equivalence to a previously marketed device, the GliaSite RTS with Iotrex, and therefore focuses on demonstrating that Cesitrex is safe and effective and exhibits equivalent performance to the predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the specific sample sizes used for the "bench testing" mentioned. It refers to "results of bench testing" in a general sense.

The data provenance is non-clinical bench testing. The information does not specify a country of origin or whether it was retrospective or prospective, as these terms are typically applied to clinical studies involving human or animal subjects. For bench testing, it would generally be prospective testing conducted in a laboratory setting.

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

The document does not mention the use of experts to establish ground truth for the bench testing. The evaluation is based on compliance with predefined engineering and performance specifications, not on expert interpretation of results in a clinical context.

4. Adjudication Method for the Test Set:

No adjudication method is mentioned, as the testing described is primarily objective bench testing (e.g., measuring leak rates, tensile strength) against predetermined specifications, rather than subjective assessments requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was conducted or mentioned. The device is a radiation therapy system component (radionuclide source), not an imaging or diagnostic device that typically involves human readers interpreting results.

6. Standalone Performance:

The "bench testing" described in section 3.12, conducted on both Cesitrex and Iotrex, represents a form of standalone performance evaluation for the radionuclide source and its interaction with the GliaSite RTS catheter. The equivalence claim is based on both sources complying with identical acceptance criteria. This testing evaluates the device's inherent characteristics and performance without human interaction for interpretation of results.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on engineering specifications and predefined performance criteria. For example, the acceptable leak rate or tensile strength would be established engineering parameters that the device must meet to be considered safe and effective. In the context of radiation dose, the ground truth is the established radiation dose delivery capabilities of the predicate device (Iotrex).

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of an algorithm or AI model, as this device is a physical medical device (radionuclide source and applicator system), not a software or AI-driven system.

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

This question is not applicable to the information provided, as there is no mention of a training set for an algorithm or AI. The "ground truth" for the device's performance is established through direct physical and radiometric measurements against design specifications and comparison to the predicate device's established performance.

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The GliaSite RTS is intended to deliver intracavity radiation therapy (brachytherapy) in patients with malignant brain tumors following tumor resection surgery.

The GliaSite® RTS is a radiation therapy system that includes the GliaSite Catheter Tray, Iotrex™ Radiotherapy Solution, and the GliaSite RTS Access Tray. The GliaSite Catheter Tray includes the GliaSite catheter and accessories to assist with the implantation of the Catheter. The GliaSite catheter is a double balloon applicator that positions the radiation source within the resected cavity for radiation delivery. The GliaSite RTS is provided in three balloon sizes: 2 cm, 3 cm, and 4 cm.

lotrex is an 129 radiotherapy solution and is the radiation source to be used with the GliaSite RTS. The GliaSite RTS Access Tray contains the items needed for the afterloading and retrieval of the lotrex Radiotherapy Solution.

The provided document describes a 510(k) premarket notification for the GliaSite® RTS (Radiation Therapy System), a medical device used for intracavity radiation therapy in patients with malignant brain tumors following resection surgery.

However, the documentation does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on establishing substantial equivalence to a legally marketed predicate device (GliaSite RTS as described in 510(k) #K003206) by comparing intended use and technological characteristics.

Instead of providing a study with acceptance criteria and performance data, the document states:

• "To ensure that the devices are safe and effective, all finished products are tested and must meet all required release specifications before distribution."
• "The testing required for release includes, but is not limited to leak testing, testing for external contamination, apparent activity, sterility, pyrogens, and labeling."
• "The required testing is defined by written and approved procedures that conform to the product design specifications. The testing for the GliaSite RTS is detailed in the Device Master Record."

This indicates that acceptance criteria and performance testing are internal quality control measures for each manufactured unit, rather than a clinical or performance study demonstrating overall device efficacy or accuracy against specific clinical endpoints or ground truth data.

Therefore, I cannot provide the requested table or detailed information as it is not present in the provided text.

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