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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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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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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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