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The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams.

The AKTINA Medical Physics Corporation ABC System is intended for use in Radiation Therapy as beam modifying agent. It is only for use in external beam radiation therapy with photon beams. This physical device is constructed of high-density materials that differentially attenuate the transmitted radiation beam.

The provided text describes a 510(k) premarket notification for a medical device and therefore does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.

This document is a regulatory submission for a Class II medical device (Radiation Therapy Wedges) and focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study data against specific acceptance criteria. The purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed device, not necessarily to present a de novo performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details of a study proving the device meets acceptance criteria.
• Sample size used for a test set or data provenance.
• Number or qualifications of experts for ground truth establishment.
• Adjudication method.
• Information on a Multi-Reader Multi-Case (MRMC) comparative effectiveness study or human reader improvement with AI.
• Details on a standalone algorithm performance study.
• Type of ground truth used.
• Sample size for a training set.
• How ground truth for a training set was established.

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