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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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The intended use of the SIEMENS branded ARTISTE™, ONCOR™ and PRIMUS™ family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer.

The linear accelerator is a high-dose rate medical linear accelerator optimized for 3D conformal radiation therapy, intensity-modulated radiation therapy (IMRT) and when used in conjunction with a multi-leaf collimator, supports precision radiation therapy treatment. The radiation therapy treatment may include single-session treatment, fractionated radiation therapy treatments, fractionated intensity modulated radiation therapy (IMRT) for lesions, turnors and conditions anywhere in the body where radiation therapy is indicated.

Additionally, the SIEMENS branded linear accelerators includes as an optional feature, a 160 leaf multi-leaf collimator that is marketed as 160MLC™. The 160MLC is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. The indications for use for the 160MLC Option remains unchanged from the previously cleared 160MLC used on the ARTISTE linear accelerator (K072485).

The syngo® Suite for Oncology Workspaces includes a number of syngo® based software applications whose indication for use include the viewing, processing, filming, and archiving of medical images. The workspaces also permit patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

The 160MLC™ Option is an integral feature of the currently cleared SIEMENS ARTISTE™ system and is intended to be marketed as an optional upgrade to the ONCOR™ Klystron class family of medical linear accelerator devices. The basic design, safety features and function of the 160-leaf Multi-Leaf Collimator and the ONCOR Linear Accelerator remain unchanged from their currently cleared intended use and functions. The 160MLC™ supports the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation using the conventional linear accelerator. The 160MLC, in conjunction with the Linear Accelerator and control systems, arrough to delivery of X-Ray photon or electron energy for precise treatment of lesions, turnors and onditions anywhere in the body where radiation therapy is indicated.

The 160MLC™ option supports the dynamic IMRT and dynamic Arc delivery of up to 1,000 (± 2%) MU / Minute X-Ray photon beam using a calibrated MV photon energy spectrum with an edge position acouracy at isocenter of 0.5mm (± 0.5mm) with minimal leakage and penumbra.

The provided text describes a 510(k) premarket notification for the Siemens 160MLC™ Option, an accessory for linear accelerators used in radiation therapy. However, the document does not contain a detailed study proving the device meets specific acceptance criteria in the way that would typically be presented for an AI/ML medical device.

Instead, this submission is centered on demonstrating substantial equivalence to previously cleared predicate devices, asserting that the 160MLC™ Option's basic design, safety features, and function remain unchanged from already approved components. It focuses on the technological characteristics and intended use being similar to existing cleared devices.

Therefore, many of the requested items (e.g., sample sizes for test/training sets, ground truth establishment, expert qualifications, MRMC studies, standalone performance) are not applicable or not provided in this specific type of regulatory submission, as it's not a study demonstrating AI/ML performance.

However, I can extract what is provided regarding performance claims and the general approach to safety and effectiveness.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria provided are not quantitative performance metrics in the typical sense for an AI/ML device but rather technical specifications and aspects deemed important for safe and effective use.

2. Sample size used for the test set and the data provenance

Not applicable/provided. This is a technical device submission, not a study evaluating an AI/ML algorithm's performance on a dataset. The "test set" would refer to internal verification and validation of the device's physical and software components during development, which is summarized as adhering to industry practices and relevant international standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable/provided. "Ground truth" in this context would implicitly be derived from established physics principles of radiation therapy, engineering specifications, and clinical requirements rather than expert annotation of data for an AI/ML model.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable/provided. Adjudication methods are typically for resolving discrepancies in expert annotations for AI/ML ground truth.

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/provided. This submission is for a hardware accessory (Multi-Leaf Collimator) and associated software, not an AI-assisted diagnostic or treatment planning tool that would undergo an MRMC study.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable/provided. The "160MLC™ Option" is an integral part of a larger medical linear accelerator system, designed to operate in conjunction with clinical users and other system components. It's not a standalone AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for the performance of the 160MLC™ Option, in a general sense, would be based on:

• Physical measurements and engineering specifications: For parameters like edge position accuracy, leakage, and penumbra, which are quantifiable physical properties.
• Compliance with established standards: Adherence to recognized and established industry practices and relevant international standards (as stated in the "General Safety and Effectiveness" section).
• Clinical effectiveness of predicate devices: The claim of substantial equivalence relies on the known safe and effective performance of the predicate linear accelerator systems and MLCs.

8. The sample size for the training set

Not applicable/provided. This is not an AI/ML device that requires a training set in the typical sense.

9. How the ground truth for the training set was established

Not applicable/provided (as above).

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