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TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

TIGRT MLC is a dynamic multileaf collimator designed to be mounted on the linear accelerator. It is intended to shape the specific fields, either in static or dynamic mode, to assist the radiation oncologist in the delivery of radiation to well-defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation.

The provided document, KO90802 from July 7, 2009, is a 510(k) summary for the TiGRT MLC (Dynamic Multileaf Collimator). This document establishes substantial equivalence to a predicate device and does not contain information about acceptance criteria or a study that specifically proves the device meets such criteria in terms of analytical or clinical performance metrics.

Instead, this submission focuses on demonstrating substantial equivalence to the DMLC (K060187) based on similarity in design, construction, intended use, and performance characteristics. The comparison table (Table 1) highlights minor differences in operating system, number of COM ports, and selectable leaf pairs, which are not presented as acceptance criteria or performance metrics derived from a study.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and the reported device performance: This information is not present in the provided document. The table in the document is for comparing characteristics with a predicate device, not for reporting performance against acceptance criteria.
• Sample sized used for the test set and the data provenance: No test set or data provenance is mentioned as part of a performance study.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Ground truth establishment for a test set is not discussed.
• Adjudication method for the test set: No test set adjudication is mentioned.
• 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 MRMC study is described. This device is a mechanical component for radiation delivery, not an AI-assisted diagnostic tool for human readers.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No standalone algorithm performance is discussed.
• The type of ground truth used: No ground truth is mentioned in the context of a performance study.
• The sample size for the training set: No training set is mentioned.
• How the ground truth for the training set was established: No training set ground truth establishment is mentioned.

The document primarily states:

• "This device is similar in design and construction, and has the same intended use and performance characteristics to the predicate device."
• "No new issues of safety or effectiveness are introduced by using this device."

This type of submission relies on demonstrating that the new device functions similarly to an already approved device, rather than providing novel clinical or analytical performance data against specific, quantifiable acceptance criteria.

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