IsoSphere is indicated for implantation after tumor resection in the breast to deliver the prescribed radiation dose to the tumor bed and any residual tumor in the remaining margins.

The IsoSphere is a modification to the Advantage Strand™/Advantage Load™/Secure Strand Brachytherapy Kit cleared in 510(k) K113210 on August 10, 2012. Whereas the predicate device delivers radioactive brachytherapy seeds and spacers via numerous needles, one at a time in a linear design, the IsoSphere delivers multiple radioactive brachytherapy seeds and spacers within a Secure Strand sleeve to an excision site in the breast in one sphere-shaped configuration.

The IsoSphere is a 4 cm, spherical shaped device with hollow channels that contain radioactive brachytherapy seeds and spacers, depending on physician prescription. The device is composed of bioabsorbable copolymer (PLA) material, which is identical to the Secure Strand material. The IsoSphere is supplied with either Advantage I-125® seeds or Advantage Pd-103® seeds and spacers which are identical to those cleared in K113210. IsoSphere is supplied sterile for single use.

A sterile, single-use, non-radioactive 4cm Sizing Sphere is included in each package to assure a proper fit in the excision site. The package also contains one pair of sterile, radiation attenuating gloves.

The provided FDA 510(k) clearance letter for the IsoSphere device does not describe a study that validates the device meets acceptance criteria related to a specific clinical performance metric (e.g., diagnostic accuracy for an AI device).

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (Advantage Strand/Advantage Load Brachytherapy Kit) through non-clinical performance testing, material characterization, and a comparison of intended use, indications for use, and technical specifications.

Therefore, many of the requested criteria regarding clinical study design, ground truth establishment, expert adjudication, and MRMC studies are not applicable to the information provided in this 510(k) summary. The device in question is a physical brachytherapy device, not a diagnostic AI/software device that would typically undergo such clinical performance evaluations.

However, I can extract and present the acceptance criteria and performance data for the non-clinical tests conducted to demonstrate the device's safety and effectiveness in its operational context.

Acceptance Criteria and Reported Device Performance (Non-Clinical)

The IsoSphere device underwent performance and design integrity testing designed to ensure its physical and functional attributes are maintained after manufacturing, sterilization, and aging.

Table of Acceptance Criteria and Reported Device Performance (Non-Clinical)

Study Details (Based on provided 510(k) Summary - Non-Clinical Focus)

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

   • Test Set Sample Size: The document does not specify the exact number of samples (devices) used for each individual test (e.g., X number of units for sterile barrier integrity, Y for seal strength). It refers to "test samples" for Stability Testing and "Two sets of samples" for Design Integrity Testing (one aged for four months, one for six months).
   • Data Provenance: Not explicitly stated (e.g., country of origin), but implied to be from internal testing conducted by IsoAid, LLC in the USA. The tests are non-clinical, focusing on the physical device itself. The data is prospective, generated specifically for this submission.

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

   • Not Applicable. This is a physical medical device (brachytherapy source), not an AI/diagnostic imaging device that would require human expert interpretation or ground truth establishment for its performance validation in a clinical context. The "ground truth" here is determined by physical measurements, material properties, and visual inspection against engineering specifications.

3. Adjudication Method for the Test Set:

   • Not Applicable. See point 2. The tests are objective physical and material tests, not subjective interpretations requiring adjudication.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

   • No. This type of study is relevant for AI-powered diagnostic devices to assess the impact of AI assistance on human reader performance. The IsoSphere is a physical brachytherapy device.

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

   • No. This is relevant for AI devices. The IsoSphere is a physical device; its performance is inherent to its design and materials as demonstrated through the non-clinical tests.

6. The Type of Ground Truth Used:

   • Engineering Specifications / Physical Measurements / Material Compliance. For the non-clinical tests, the "ground truth" is defined by established engineering and material science standards (e.g., ASTM, ISO standards, internal specifications for dimensions, seal strength, and material integrity). Visual inspection confirms the absence of physical damage.

7. The Sample Size for the Training Set:

   • Not Applicable. There is no "training set" in the context of this device. This is not a machine learning or AI device that undergoes training.

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

   • Not Applicable. See point 7.

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The RadianceTx Radionuclide Brachytherapy Source (RTx-RBS) is indicated for episcleral brachytherapy of umors and benign growths.

The RTx-RBS is intended for use within a compatible manual brachytherapy applicator system.

Not Found

This is an FDA clearance letter for a medical device called "RadianceTx Radionuclide Brachytherapy Source (RTx-RBS)". This document type does not include information about acceptance criteria or a study proving the device meets those criteria.

FDA clearance letters affirm that a new device is "substantially equivalent" to a predicate device already on the market, meaning it performs as safely and effectively as a device already legally marketed. For such clearance, the FDA does not require a new clinical study to establish acceptance criteria and prove its performance in the same way a Premarket Approval (PMA) application would.

Therefore, I cannot extract the requested information from the provided text.

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GammaTile is indicated as a treatment for patients with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms.

GammaTile is a device intended for the treatment of intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile is designed to provide “adjuvant” radiation therapy – therapy to eliminate any remaining neoplastic cells – to patients who require surgical resection of 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 concerns the FDA 510(k) premarket notification for the GammaTile device, specifically a submission (K221539) related to a change in the collagen carrier material. The document details the regulatory classification, product description, and the rationale for claiming substantial equivalence to a predicate device (K190839 GammaTile).

However, the document does not contain information about:

• Acceptance criteria for a clinical study on device performance against specific metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria mentioned are related to manufacturing and product specification conformance ("all finished products must meet all acceptance criteria required by the product specification before distribution").
• A study that proves the device meets specific clinical performance acceptance criteria. The "studies" described (biocompatibility, collagenase, simulated use) are non-clinical and focused on demonstrating that the change in material does not negatively impact the device's technological characteristics, safety, or effectiveness compared to the predicate. They are not clinical performance studies.
• Sample sizes used for a test set (clinical data).
• Data provenance (country of origin, retrospective/prospective).
• Number of experts and their qualifications for ground truth establishment.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Effect size of human readers improving with AI assistance.
• Standalone (algorithm-only) performance.
• Type of ground truth used (expert consensus, pathology, outcomes data).
• Sample size for a training set (implying an AI/ML device, which this is not).
• How ground truth for a training set was established.

The GammaTile is a Radionuclide Brachytherapy Source, which is a physical medical device that delivers radiation. It is not an AI/ML device, nor is it a diagnostic imaging device that would typically have performance metrics like sensitivity or specificity. Therefore, the questions posed regarding AI/ML device performance validation (e.g., MRMC, standalone performance, training/test sets, ground truth methodology) are not applicable to the information provided in this regulatory submission for a brachytherapy source.

The document focuses on demonstrating substantial equivalence for a material change through non-clinical testing, ensuring the modified device maintains the same safety and effectiveness profile as its predicate.

In summary, the provided text does not contain the information necessary to describe acceptance criteria and a study proving device performance as requested, because the device is not an AI/ML or diagnostic performance device, and the submission focuses on non-clinical testing for a material change.

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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.

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LV Liberty Vision Model 1 90 Yttrium Brachytherapy Source with individual activity up to 20 mCi (740 MBq), is indicated for episcleral brachytherapy of tumors and benign growths. The Model 1 source is intended for use within a manual brachytherapy system.

LV Liberty Vision Model 1 90Yttrium Brachytherapy Source is a singly-encapsulated 99Yttrium Brachytherapy Source. It consists of a titanium capsule containing a solid radioactive 99Yttrium element. The radioactive element is hermetically sealed in the titanium capsule and, in use, will be attached to a manual radionuclide applicator system (21 CFR 892.5650).

The provided document is a 510(k) summary for the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. It describes the device, its intended use, and a comparison to a legally marketed predicate device (K163572), also the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source. This submission focuses on demonstrating substantial equivalence to an existing device rather than establishing novel performance metrics through clinical trials or standalone AI studies.

Here's an analysis based on your requested information:

1. Table of acceptance criteria and reported device performance

The document does not specify general "acceptance criteria" in the sense of performance targets for a new AI/diagnostic device. Instead, it demonstrates equivalence to a predicate device through physical and dosimetric characteristics.

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the "acceptance criteria" (defined here as demonstrating substantial equivalence to the predicate device) is documented through nonclinical physical testing and dosimetric analysis.

• Physical Testing: Prototype sources of the LV Liberty Vision Model 1 90Yttrium Brachytherapy Source were subjected to tests specified in American National Standard (ANSI) N43.6 and International Organization for Standardization (ISO) Standard 2919. The results "equaled or exceeded the requirements corresponding to a classification of C53211," which is the requirement for brachytherapy sources. This was deemed equivalent to the physical testing of the predicate device (K163572).
• Dosimetry: The dose distribution around the new device was calculated by Monte Carlo simulation. This was stated to be "similar to the dosimetry of the predicate device."

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

• Test Set Sample Size: The document refers to testing of "prototype sources." It does not specify a numerical sample size but implies a sufficient number of prototypes were tested to satisfy the standards.
• Data Provenance: Not explicitly stated, however, the testing standards (ANSI and ISO) are international. The company is based in Portsmouth, New Hampshire, USA. The testing would have been conducted to demonstrate compliance with US FDA requirements. The data is prospective in the sense that physical and dosimetric measurements/simulations were performed on the prototypes or models of this specific device to demonstrate its properties.

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)

This is not applicable as the study involves physical and dosimetric testing against established engineering standards (ANSI, ISO) and computational simulations (Monte Carlo), not clinical data requiring expert human interpretation for ground truth.

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

This is not applicable for physical and dosimetric testing. Adjudication methods are typically relevant for clinical studies where human expert consensus is used to establish ground truth for image or diagnostic interpretations.

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. This device is a brachytherapy source, a physical medical device, not an AI or diagnostic software tool that would involve human readers or AI assistance.

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

No, a standalone (algorithm only) performance study was not done. As stated above, this is a physical medical device, not an algorithm or AI.

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

For the physical testing and dosimetry, the "ground truth" is based on:

• Established Engineering Standards: ANSI N43.6 and ISO 2919 provide objective pass/fail criteria and specifications for brachytherapy sources.
• Physics Principles and Computational Models: Monte Carlo simulations for dosimetry are based on established physics principles to calculate dose distribution.

8. The sample size for the training set

This is not applicable. There is no training set mentioned or implied as this is not an AI/machine learning device.

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

This is not applicable as there is no training set.

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GammaTile is indicated as a treatments with newly diagnosed malignant intracranial neoplasms and patients with recurrent intracranial neoplasms

GammaTile is a device intended for the treatment of intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. GammaTile™ is designed to provide "adjuvant" radiation therapy - therapy to eliminate any remaining neoplastic cells - to patients who require surgical resection of 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. It outlines the regulatory clearance process for an expanded indication for use. However, it explicitly states:

"No additional testing was completed. The data obtained from the case studies suggest that GammaTile therapy adds no additional risk to the proposed patient population."

This means that a new study demonstrating the device meets acceptance criteria for the expanded indication was not performed. Instead, the submission relies on the technological equivalence to a previously cleared device (K190296) and an assessment of existing dosimetry data.

Therefore, it is not possible to provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as no such new study was conducted for this specific 510(k) submission (K190839).

The document clarifies that the "technological characteristics of the proposed device, GammaTile, are identical to those of the predicate, GammaTile as described in 510(k) K190296." The submission is for an expanded indication for use, not for a change in the device or its fundamental performance.

The only "assessment" mentioned for the expanded indication is: "An assessment of dosimetry to organs at risk using GammaTile in recurrent intracranial neoplasms has been completed. The assessment resulted in a determination the cumulative radiation dose delivered to the OARs was within ranges acceptable in clinical practice." This is an assessment, not a new clinical study with defined acceptance criteria for device performance as an AI/software device would undergo.

In summary, none of the requested information regarding a study proving the device meets acceptance criteria can be extracted from the provided text because no new study of this nature was conducted or submitted for this cleared 510(k). The clearance was based on substantial equivalence and a dosimetric assessment, not a performance study against specific acceptance criteria for the expanded indication.

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CivaDerm™ Pd103 indicated for treatment of temporary intraoperative or surface application to treat selected localized tumors. It can be used either as primary treatment for residual disease after excision of primary or recurrent tumors. This brachytherapy source may be used concurrently with or following treatment with other interventions, such as external beam therapy.

The CivaDerm utilizes biocompatible materials and bioabsorbable polymers to encapsulate Pd-103, a radionuclide with a long history in radiotherapy. CivaDerm is a planar unidirectional source intended to deliver x-ray radiation for surface brachytherapy procedures. By utilizing gold backing with the radionuclide. CivaDerm provides radiation in one direction. This allows it to target radiation dose to a contoured exterior surface without irradiating surrounding healthy tissue.

I apologize, but the provided text does not contain the information needed to answer your request. The document is an FDA 510(k) clearance letter and summary for a brachytherapy device called CivaDerm™.

It primarily focuses on:

• The FDA's determination of substantial equivalence to a predicate device.
• General device description and intended use.
• Confirmation of manufacturing and regulatory compliance (e.g., GMP, labeling).
• A statement that "All required non-clinical testing has been successfully performed according to published industry standards" and "CivaDerm finished devices are tested and meet acceptance criteria determined by product design specifications to verify each device is safe and effective."

However, it does not provide any specific details about:

• A table of acceptance criteria and reported device performance metrics.
• Sample sizes used for a test set or training set.
• Data provenance (country of origin, retrospective/prospective).
• Number or qualifications of experts for ground truth.
• Adjudication methods.
• Whether MRMC studies were done or any effect sizes.
• Standalone algorithm performance.
• Type of ground truth used (pathology, outcomes, etc.).
• How ground truth for training data was established.

This type of detailed performance study information is not typically included in an FDA 510(k) summary, which focuses on demonstrating substantial equivalence rather than a detailed report of clinical study results for a novel AI/software device.

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

GammaTile is a device intended for the treatment of recurrent intracranial neoplasms which uses cesium-131 radioactive sources embedded in a collagen matrix. 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.

This document is a 510(k) premarket notification for the GammaTile brachytherapy device. It focuses on demonstrating substantial equivalence to a previously cleared GammaTile device (K180515), rather than presenting a new clinical study to establish acceptance criteria and device performance from scratch.

Therefore, the requested information regarding acceptance criteria, reported device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as would be found in a clinical study report, is not present in this 510(k) summary.

The document primarily states:

• Acceptance Criteria (Implied): "To ensure that the devices are safe and effective, all finished products must meet all acceptance criteria required by the product specification before distribution. The required testing is defined in documented procedures that conform to the product design specifications." This indicates that internal product specifications define the acceptance criteria for manufacturing and release, but these specific criteria and their values are not detailed in this public FDA letter.
• Study That Proves Device Meets Acceptance Criteria: The study described here is a "risk/change analysis" and "validation testing" to confirm that changes made to the device since the clearance of the predicate (K180515) do not impact safety or efficacy and introduce no new risks.
  • Conclusion: "Test results confirmed that the changes made have no impact to product safety or efficacy and introduce no new risks." This refers to the assessment of changes, not an initial validation of the device's clinical performance.

Here's a breakdown of what can be extracted from the provided text, and what cannot:

1. Table of acceptance criteria and the reported device performance:

   • Acceptance Criteria: Not explicitly stated with specific metrics or values (e.g., success rates, P-values). The document generally refers to "all acceptance criteria required by the product specification."
   • Reported Device Performance: Not reported in clinical metrics for performance in patients. Instead, the document discusses that "test results confirmed that the changes made have no impact to product safety or efficacy and introduce no new risks," relative to the predicate device.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable or stated, as this is a substantial equivalence submission based on engineering and risk assessment of device changes, not a clinical trial.

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 or stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or stated.

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: Not applicable. This device is not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a brachytherapy source, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable or stated for clinical performance. The "ground truth" for this submission revolves around the unchanged technological characteristics and safety/efficacy profile compared to the predicate.

8. The sample size for the training set: Not applicable or stated.

9. How the ground truth for the training set was established: Not applicable or stated.

In summary: This 510(k) submission confirms that minor modifications to an already cleared device (GammaTile K180515) were assessed through a risk/change analysis and validation testing, concluding that these changes did not negatively impact safety or efficacy. It does not contain the kind of detailed clinical study data typically associated with establishing initial device performance and acceptance criteria.

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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.

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The Sirius MRI Marker NS 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: Iodine 125 (1251), Palladium 103 (103Pd) or Cesium 131 (131Cs). It is indicated for permanent interstitial implantation in the prostate of patients with confirmed prostatic malignancy.

The Sirius MRI Marker NS is intended to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation.

The Sirius MRI Marker NS is supplied non-sterile and will need to be sterilized by the end-user using either gamma radiation or ethylene oxide.

C4 Imaging's Sirius MRI Marker NS consists of a sealed polyether ether ketone (PEEK) polymer capsule containing a cobalt chloride:N-Acetylcysteine solution. It is used as an accessory to radionuclide sources (seeds) during prostate brachytherapy procedures. The length of the capsule is 5.5 mm and the diameter is 0.8 mm.

The Sirius MRI Marker NS will be supplied non-sterile and will be sterilized by the end-user using ethylene oxide or gamma radiation.

The provided text is a 510(k) summary for the Sirius MRI Marker NS, a medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for acceptance criteria in the traditional sense of a diagnostic or interventional AI/CADe/CADx device.

Therefore, the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details are not applicable to this type of regulatory submission as it does not describe a clinical performance study of the device's diagnostic or interventional capabilities.

The submission is primarily concerned with proving that the Sirius MRI Marker NS, which is an accessory device, is as safe and effective as a legally marketed predicate device (MRI Marker K131689), despite minor differences in sterilization and packaging. It explicitly states there are "no differences between the proposed device Sirius MRI Marker NS and the predicate device with regard to dimension, composition of the fill solution, and manufacturing process of the marker itself that would affect the safety or effectiveness of the proposed device."

The "Indications for Use" section (page 3 and 5) describes the intended purpose of the device: "to facilitate the anatomical localization of seeds after they have been implanted in the prostate of a patient with confirmed prostatic malignancy. It is intended to be imaged under MRI within sixty (60) days of implantation." This is a functional description, not a performance metric that would require a study with the criteria listed in the prompt.

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