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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 IsoRay Medical, Inc. Cesium-131 Implant Devices are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.), and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. These devices may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

The Cesium-131 Implant Devices have the same indications for use as the original device, the IsoRay Medical, Inc. Cs-131 Brachytherapy Seed, Model CS-1.

The IsoRay Medical, Inc. Cesium-131 Strand, Model PL-1, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds enclosed in a bio-absorbable brachytherapy sleeve and sterilized using ethylene oxide. The seeds and spacers are arranged according to a treatment plan provided by a physician or medical physicist.

For the IsoRay Medical, Inc. Cesium-131 Strand Preload, Model PL-2, each Cesium-131 Strand, Model PL-1, is placed in a brachytherapy needle which is pre-plugged with bone wax to hold the strand in position. The arrangement of the seeds and spacers and the strands in the needles is dictated by the treatment plan. The strands are sterilized after loading into needles using ethylene oxide.

The IsoRay Medical, Inc. Cesium-131 Preload, Model PL-3, contains absorbable seeding spacers and Cs-131 Brachytherapy Seeds within a brachytherapy needle which is pre-plugged with bone wax to keep the seeds and spacers in position. The arrangement of the seeds and spacers in each needle is dictated by the treatment plan. The preloaded needles are then sterilized using ethylene oxide.

The IsoRay Medical, Inc. Cesium-131 S-Cartridge, Model PL-4 contains Cs-131 Brachytherapy Seeds, loaded into Mick® cartridges and sterilized by either steam or ethylene oxide.

Note: The above-listed devices may be assembled using components with equivalent composition and function that are FDA-cleared for the same intended use or otherwise determined to be exempt or pre-amendment devices.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cesium-131 Implant Devices:

The provided document is a 510(k) Summary of Safety and Effectiveness, not a detailed study report. A 510(k) submission demonstrates substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria through a clinical or performance study in the way one might expect for a novel device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts, MRMC study, training set details) are not applicable or not specified in this type of regulatory document.

However, I can extract the relevant information regarding the approach to demonstrating equivalence, which serves as the "study" in this context.

Acceptance Criteria and Study for Cesium-131 Implant Devices (K062384)

1. Table of Acceptance Criteria and Reported Device Performance

In a 510(k) submission, the "acceptance criteria" are generally that the new device is substantially equivalent to legally marketed predicate devices, meaning it has the same intended use, and the technological characteristics are either the same or, if different, do not raise new questions of safety and effectiveness. The "performance" is demonstrated by showing these equivalencies.

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

• Sample Size: Not applicable. This is a substantial equivalence submission, not a study involving a "test set" in the context of clinical or performance data. The "test" is the comparison against predicate devices based on their established characteristics.
• Data Provenance: Not applicable. The comparison is based on the characteristics of the devices themselves and existing predicate device information.

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

• Not applicable. No external experts were used to establish "ground truth" for a test set in this 510(k) for device characteristics. The "ground truth" is essentially the regulatory classification and demonstrated safety/effectiveness of the predicate devices.

4. Adjudication Method for the Test Set

• Not applicable. No test set or expert adjudication was involved.

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. This device is a brachytherapy implant, not an AI-powered diagnostic tool. MRMC studies are not relevant here.

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

• Not applicable. This is a medical device (brachytherapy implant), not an algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this 510(k) substantial equivalence determination is the established safety and effectiveness profile of the legally marketed predicate devices, as determined by prior FDA clearances. The new devices are deemed safe and effective because they are demonstrated to be equivalent to these already-cleared devices.

8. The Sample Size for the Training Set

• Not applicable. This is not a machine learning model.

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

• Not applicable. This is not a machine learning model.

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IsoRay, Inc. Lawrence CSERION seeds are indicated for the treatment of malignant disease (e.g., head and neck, brain, breast, prostate, etc.) and may be used in surface, interstitial, and intracavitary applications for tumors with known radiosensitivity. The seeds may be used as a primary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as treatment for residual disease after excision of primary tumors.

The IsoRay, Inc. Lawrence CSERION Model CS-1 is a small, cylindrical sealed source which contains the low energy gamma (X-ray) emitting radionuclide, cesium-131, adsorbed onto an internal inorganic substrate. The nominal external seed dimensions (4.5 mm length and 0.8 mm diameter) and patient-contacting material (titanium) are identical to predicate device(s).

The provided text is a 510(k) Summary for the IsoRay, Inc. Lawrence CSERION Model CS-1, a brachytherapy source. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than establishing acceptance criteria and conducting a primary study to prove that the device meets those criteria.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training and test sets is not available in this document.

The document states that the device is "substantially equivalent" to predicate devices based on a comparison of parameters. The "Comparison Chart" on page 0 outlines these parameters. This comparison is the "study" demonstrating the device meets the criteria for substantial equivalence, implying that if the new device's parameters are similar enough to an already approved device, it is considered safe and effective.

Here's a breakdown of what is provided, framed in terms of the closest available information to your request:

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

The document doesn't provide "acceptance criteria" in the traditional sense of a performance study with specific thresholds. Instead, it presents a "Comparison Chart" to demonstrate substantial equivalence to predicate devices. The "acceptance criterion" here is essentially that the new device's parameters are comparable to those of already cleared devices.

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