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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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