(30 days)
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:
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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.
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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.
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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.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable or stated.
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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.
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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.
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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.
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The sample size for the training set: Not applicable or stated.
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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.
§ 892.5730 Radionuclide brachytherapy source.
(a)
Identification. A radionuclide brachytherapy source is a device that consists of a radionuclide which may be enclosed in a sealed container made of gold, titanium, stainless steel, or platinum and intended for medical purposes to be placed onto a body surface or into a body cavity or tissue as a source of nuclear radiation for therapy.(b)
Classification. Class II (special controls). A prostate seeding kit intended for use with a radionuclide brachytherapy source only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.