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The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT).

The Linac Collimator Assembly Housing (LCAH) consisting of a collimator sliding tray, collimator baseplate, and collimator tube. It is designed as a slide-in attachment for the Siemens MLC-160 LINAC Accessory Holder. The LCAH positions and aligns Radionics radiation beam shaping collimators to the Siemens ARTISTE LINAC (K072485) internal collimator and radiation source during radiosurgery and radiation therapy procedures.

This document describes a medical device, the Linac Collimator Assembly Housing (LCAH), and its 510(k) summary for substantial equivalence review. This type of regulatory submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device.

Therefore, the document does not contain specific acceptance criteria, performance data from a clinical study, or details about ground truth establishment, expert review, or statistical methodologies like MRMC studies typically found in submissions for novel devices or those requiring clinical performance validation.

Based on the provided text, the following information is either not applicable or not available:

1. A table of acceptance criteria and the reported device performance: Not provided. The submission focuses on substantial equivalence to predicate devices, not performance against specific criteria.
2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set or performance study is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 a physical accessory for a LINAC, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable as no clinical performance study is detailed.
8. The sample size for the training set: Not applicable as this is not an AI/algorithm-based device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

Summary of Device and Regulatory Context (from the provided text):

• Device Name: Linac Collimator Assembly Housing (LCAH)
• Intended Use: "The Integra Radionics™ Linac Collimator Assembly Housing (LCAHART) is indicated to be mounted on the Siemens Artiste MV linac with MLC-160 Accessory Hollder as an Accessory tray to attach Integra Radionics collimators for treatment modalities such as stereotactic radiosurgery (SRS) and radiotherapy (SRT)."
• Regulatory Mechanism: 510(k) Premarket Notification, seeking substantial equivalence.
• Predicate Devices: XKnife Radiosurgery System (K912630) and the ARTISTE MV SA (K072485).
• Conclusion for Equivalence: The LCAH is "substantially equivalent to the XKnife Radiosurgery System (K912630) and the Siemens ARTISTE MV SA (K072485). The Linac Collimator Assembly Housing (LCAH) is similar to the predicate devices in the intended use, the fundamental scientific technology of the device, and does not raise new issues of safety and effectiveness."

In the context of a 510(k) for a device like the LCAH, the "acceptance criteria" are primarily met through demonstrating equivalence to existing legally marketed devices, often through engineering analysis, mechanical testing, and comparison of specifications, rather than clinical performance studies with specific statistical endpoints. The study proving it meets criteria would be the submission itself, detailing how its design and function compare to the predicates.

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