Search Results

The Isoray Medical, Inc. Cs-131 Implant Devices with SiriusTM MRI Markers are indicated for the treatment of malignant prostatic disease. These devices may be used as a primary treatment or in conjunction with other modalities. The MRI Markers are used to facilitate the anatomical localization of seeds after they have been implanted.

The Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers are a combination of two commercially available devices: The Isoray Medical Cs-131 Implant Devices, and the Sirius™ MRI Markers. They come in two configurations and listed below:

• Isoray Medical, Inc. Cs-131 PL-7 Preloaded Strands with Sirius™ Markers
• Isoray Medical, Inc. Cs-131 PL-8 Preloaded Strands with Sirius™ Markers in 18G Needles ●
  The Sirius™ MRI Markers combined with the Isoray Cesium-131 Implant Devices will be used to facilitate the anatomical location of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy.
  The Cs-131 Implant Devices are a small, cylindrical, sealed source that consists of a welded pure titanium capsule containing the low energy gamma (x-ray) emitting isotope, Cesium-131 (Cs-131), adsorbed onto an internal inorganic substrate. The external seed dimensions are 4.5 mm length and 0.8 mm diameter and the only patient-contacting material is commercially pure titanium.
  The Sirius™ MRI markers consist of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride: N-Acetylcysteine solution. The Sirius™ MRI Marker is a component device indicated as an accessory for use in conjunction with brachytherapy seed carrier sleeves and radionuclide brachytherapy seeds containing one of the following isotopes: lodine-125, Palladium-103 or Cesium-131. The Sirius™ MRI Markers combined with the Isoray Cesium-131 Brachytherapy Seeds will be used to facilitate the anatomical location of seeds after they have been implanted.
  The spacers are used to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physicist. They are made of PLA/PGA copolymer and are absorbable. The spacer length is variable since it is a function of how many seeds are required by the patient treatment plan. The spacers are 0.8mm in diameter.
  The Cs-131 Implant Devices with MRI Markers comes in two (2) configurations as listed in the table below.
  The seeds, spacers, and Sirius™ MRI markers are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on the treatment plan prepared by the physician or medical physicist. There are no product specific guidance documents or product specific standards for brachytherapy seeds. The subject devices are EtO sterilized and are a single-use device.

The provided text is a 510(k) summary for the Isoray Medical, Inc. Cs-131 Implant Devices with Sirius™ Markers. This document describes the device, its intended use, and its substantial equivalence to previously cleared predicate devices.

However, this document explicitly states that "No performance data testing was performed as each of the components has been previously cleared for this intended use." and "No additional biocompatibility test was performed as biocompatibility evaluation was conducted for each of the components in previous regulatory clearances."

Therefore, the supplied text does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics. It indicates that the device's components (Cs-131 implant devices and Sirius™ MRI Markers) were previously cleared and have established safety and effectiveness.

As a result, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them, because such a study is explicitly stated as not having been performed for this specific 510(k) submission.

The document focuses on demonstrating substantial equivalence to existing predicate devices based on:

• Identical product code, regulation number, device classification name, and device classification.
• Similar indications for use, with the subject device's indication being a combination of the predicate and reference device, specifically limiting use to the prostate due to the MRI markers.
• Similar principle of operation.
• Identical condition of use, Rx or OTC status, materials of construction (for the core components), packaging, and sterilization method. The new combination device incorporates the MRI markers, which were previously cleared.

In summary, the provided text does not contain the information needed to answer your request about acceptance criteria and a performance study, as the filing strategy for this device was based on substantial equivalence to pre-cleared components rather than new performance testing.

Ask a specific question about this device

GammaTileTM is intended to deliver radiation therapy (brachytherapy) in patients with recurrent intracranial neoplasms.

The GammaTile™ is a device, intended for the treatment of recurrent intracranial neoplasms that uses cesium-131 radioactive sources embedded in a collagen matrix. The GammaTile™ is designed to provide "adjuvant" radiation therapy therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of recurrent brain neoplasms. GammaTile™ is positioned within the resection cavity immediately after surgical excision of the brain neoplasm to deliver radiation therapy to any neoplastic cells that remain in proximity of the resection cavity.

The provided text is a 510(k) summary for the GammaTile™ device, which is a brachytherapy source. It does not describe a study involving an AI/ML device or its performance criteria, but rather a regulatory submission for a medical device. Therefore, I cannot extract the requested information as it pertains to AI/ML device performance and studies.

Specifically, the document focuses on demonstrating substantial equivalence to a predicate device (Proxcelan™). The "Assessment of Non-Clinical Performance Data" section mentions "simulated clinical use testing, characterization of the radionuclide source and source spacing during bench testing," but these are not studies that fit the criteria of evaluating an AI/ML device's diagnostic or predictive performance in a clinical setting with human readers.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria for an AI device, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set information.

Ask a specific question about this device

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.

Ask a specific question about this device

Proxcelan™ (Cesium-131) Implant Devices containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity 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 a treatment for residual disease after excision of primary tumors.

The Proxcelan (Cesium-131) Implant Devices are single use, prescription devices consisting of IsoRay Model CS-1 Brachytherapy Seeds that are combined with bioabsorbable spacers and preloaded into bioabsorbable hollow strands or 18 gauge brachytherapy needles for implant. The Implant Devices are designed to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. These Implant Devices are described as follows: PL-1 Cs-131 Preloaded Strands, PL-2 - Cs131 Preloaded Strands in 18 Gauge Needles, PL-3 - Cs131 Preloaded 18 Gauge Needles.

The provided text is a 510(k) summary for the Proxcelan™ (Cesium-131) Implant Devices, primarily focusing on its substantial equivalence to a previously marketed device (K062384) and general safety and effectiveness.

It does NOT contain specific information about detailed acceptance criteria, a specific study proving device performance against those criteria, or the methodology for such a study (sample sizes, ground truth establishment, expert qualifications, adjudication, MRMC studies, or standalone performance).

The text primarily describes:

• Device Description: What the Proxcelan (Cesium-131) Implant Devices are (preloaded strands or needles with Cesium-131 seeds and bioabsorbable spacers).
• Intended Use/Indications for Use: Treatment of malignant disease in various body sites, used as primary treatment or in conjunction with other modalities.
• Technological Characteristics: Cesium-131 seeds, bioabsorbable spacers, preloaded into needles/strands. Mentions a change in copolymer formulation from the predicate device.
• Safety and Effectiveness (General Statement): States that "all finished products are tested and must meet all requires release specifications before distribution." This includes leak testing, external contamination, apparent activity, sterility, and labeling, defined by written and approved procedures conforming to product design specifications. It refers to a "Device Master Record" for details.

Based on the provided text, I cannot complete the requested information for acceptance criteria and the study that proves the device meets them because the document does not contain this level of detail.

However, I can extract what is explicitly stated regarding safety and effectiveness testing, which implies general acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Not provided in the text. The document only states "all finished products are tested," implying a manufacturing quality control process rather than a specific clinical or performance study with a defined test set sample size.

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 applicable / Not provided. The described testing relates to manufacturing quality control (e.g., leak testing, sterility), not clinical performance requiring expert ground truth for interpretation.

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

• Not applicable / Not provided. Adjudication methods are typically for studies interpreting complex data, which is not described here.

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-assisted diagnostic tool.

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

• No. This device is a brachytherapy implant, not an algorithm.

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

• Not explicitly stated for the "release specifications" testing. For manufacturing quality control, ground truth would likely be internal quality standards, calibrated measurement instruments, and predefined tolerances for physical and radioactive properties (e.g., a known standard for activity measurement, absence of microbial growth for sterility).

8. The sample size for the training set

• Not applicable / Not provided. This is not an AI/ML device.

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

• Not applicable / Not provided. This is not an AI/ML device.

Ask a specific question about this device

Proxcelan™ (Gesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands, containing cesium-131 brachytherapy seeds are indicated for the treatment of malignant disease (e.g. head and neck, brain, breast, lung, prostate, eye, etc.) and may be used in surface, interstitial, and intracavity applications for tumors with known radiosensitivity. These devices may be used as a rimary treatment or in conjunction with other treatment modalities, such as external beam radiation therapy, chemotherapy or as a treatment modalites, after excision of primory tumore after excision of primary tumors.

The Proxcelan (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands are single use, prescription devices, will consisting of IsoRay Model CS-1 Brachytherapy Seeds that are preloaded into into a body series of the Implant Devices are designed to be preloaded into into a body cavity or tissue as a source of nuclear radiation for the treatment of malignant disease. The PL-5 – Cs-131 Preloaded Braided Braided Strands consist of a series of Proxcelan (Cesium-131) Brachytherapy Seeds held in place within a bioabsorbable braided sleeve (or strand). The seeds are arranged in a precise pattern in order to maintain the exact locations and separation distances between the seeds as indicated on a treatment plan prepared by the physician or medical physicist for an individual patient. If required by the treatment plan, the braided strands containing the brachytherapy seeds may be woven into a bioabsorbable mesh supplied as a kit component for implant. A (non-patient contact) needle may also be provided either attached or unattached to the braided strand to attach it to the mesh.

This document is a 510(k) Summary and an FDA clearance letter for a medical device called Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands. The purpose of this submission is to demonstrate substantial equivalence to a previously cleared device, not to present a new clinical study proving effectiveness. Therefore, many of the requested categories related to clinical study design and performance metrics cannot be answered from the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not define specific clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) for the device in a clinical setting, nor does it report on such performance for this submission. The device is a brachytherapy source, and its effectiveness is related to its physical characteristics and how it's used in treatment, not a diagnostic or AI-driven performance metric.

However, the document does mention "release specifications" for finished products to ensure safety and effectiveness. These are internal manufacturing and quality control criteria, not clinical performance metrics.

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

Not applicable. This submission is for demonstrating substantial equivalence based on material and structural changes to an existing device, not a clinical effectiveness study requiring a test set of patient data.

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

Not applicable. As above, this is not a clinical effectiveness study.

4. Adjudication Method for the Test Set

Not applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

Not applicable. This device is a brachytherapy seed, not an AI-driven image analysis tool or a diagnostic aid requiring human reader interpretation studies.

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

Not applicable.

7. The Type of Ground Truth Used

Not applicable for clinical performance. For manufacturing release, the "ground truth" would be established by validated test methods demonstrating that the device meets its design specifications (e.g., activity levels, leak integrity).

8. The Sample Size for the Training Set

Not applicable. This is not an AI/machine learning device.

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

Not applicable.

Summary of Device and Approval:

• Device Name: Proxcelan™ (Cesium-131) Implant Devices, Model PL-5 – Cs-131 Preloaded Braided Strands
• Manufacturer: IsoRay Medical, Inc.
• Intended Use: Single-use prescription devices for interstitial, surface, and intracavity brachytherapy for malignant disease (e.g., head and neck, brain, breast, lung, prostate, eye). Can be used as primary treatment or with other modalities.
• Nature of Submission: 510(k) clearance for a modification to a previously cleared device (K062384). The modification is the addition of a preloaded flexible braided strand instead of a rigid hollow tubular strand.
• Basis for Equivalence: Substantial equivalence to the IsoRay Proxcelan™ (Cesium-131) Implant Devices (K062384). The technical characteristics are essentially the same (Cesium-131 brachytherapy seeds), with the change being the flexible braided sleeve. All materials are biocompatible and used in similar marketed devices.
• Safety and Effectiveness (as stated in the document): Ensured through internal testing of all finished products to meet required release specifications (e.g., leak testing, apparent activity, labeling) as defined by written and approved procedures conforming to product design specifications. This refers to manufacturing quality control, not clinical study results.
• FDA Decision: Substantially equivalent.

Ask a specific question about this device