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The intended use of the device is the control of accurate patient positioning with assistance of a 3D Tracking System in a radiotherapy environment.

The iGUIDE System is a powered radiation therapy support assembly which provides patient positioning control before radiotherapy treatment. The iGUIDE System consists of the following system components: iGUIDE Reference Frame with optical markers, iGUIDE Calibration Phantom (calibration phantom for KV-imaginq). NDI Polaris Tracking System, iGUIDE Workstation with iGUIDE software (control room) and iGUIDE Terminal (treatment room). The iGUIDE System is intended to be used together with the HexaPOD RT CouchTop (K041448), which is intended to be used together with the following radiation therapy systems: Elektra Precise Treatment System with Precise Table (K983678), Varian Trilogy Radiotherapy Delivery System (K033343), Clinac 2300 C/D with Exact Couch (K913119),and Siemens PRIMUS or ONCOR Linear Accelerator with Siemens ZXT Treatment Table (K910971)

The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The 510(k) summary explicitly states:

"No performance data is required for this Class II device nor requested by the Food and Drug Administration (Office of Device Evaluation)."

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and the reported device performance
2. Sample size used for the test set and the data provenance
3. Number of experts used to establish the ground truth for the test set and their qualifications
4. Adjudication method for the test set
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of human readers improving with AI vs without AI assistance
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
7. The type of ground truth used
8. The sample size for the training set
9. How the ground truth for the training set was established

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External beam radiation therapy is typically delivered from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants) to patients in the prone or supine position, lying on a patient support assembly (also known as the treatment couch). AKTINA Medical Physics Corporation has designed and manufactured a replacement table top of carbon fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

AKTINA Medical Phvsics Corporation has designed and manufactured a replacement table top of Carbon Fiber that is compatible with the Elekta Precise Patient Support System. A treatment couch top that is made of carbon fiber is provides the structural strength necessary to support a broad range of patients while being light weight. In addition carbon fiber is radiolucent which allows a wide range of beam angle orientations to be used in external beam radiation therapy.

The provided document (K032248) is a 510(k) premarket notification for a medical device: "Precise Carbon Fiber Table Top". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting extensive new clinical studies to prove effectiveness with specific performance metrics against acceptance criteria.

Therefore, much of the requested information regarding acceptance criteria, specific study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness (MRMC or standalone AI performance) is not applicable to this type of regulatory submission. The document explicitly states that "The FDA under Section 514 of the Food, Drug and Cosmetic Act has not established performance standards for this product," which further indicates that specific, predefined acceptance criteria and a detailed study proving performance against them are not required or provided in this context.

The summary emphasizes substantial equivalence to predicate devices (Elekta AB, K983678 and AKTINA Medical Physics Corporation, K991546), focusing on similar design, intended use, and performance characteristics, and asserting that "No new issues of safety or effectiveness are introduced by using this device." The demonstration of safety and effectiveness for such a device would primarily revolve around material properties (biocompatibility, structural integrity, radiolucency) and compatibility with existing patient support systems, rather than diagnostic accuracy or human performance improvement.

Given these limitations, here's a breakdown of what can be extracted and what is not available from the provided text:

1. A table of acceptance criteria and the reported device performance

Note: The document does not provide specific quantitative acceptance criteria (e.g., maximum deflection under load, specific radiolucency percentages) or quantitative performance data, but rather states qualitative claims of compliance and equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This type of device (a patient support table top) does not typically involve a "test set" or "training set" in the context of diagnostic or AI performance evaluation. The "evaluation of product testing" mentioned for biocompatibility and "field experience for equivalent applications" would likely refer to engineering tests and general clinical usage knowledge for similar devices, not a formal study with a defined patient sample size.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. Ground truth establishment by experts is relevant for diagnostic devices (e.g., image analysis algorithms). This device is a component of a radiation therapy system, and its evaluation would not involve expert ground truthing in that manner.

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

• Not applicable / Not provided. See point 3.

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 / Not done. MRMC studies are used for evaluating diagnostic performance, often related to AI applications. This device is not an AI-driven diagnostic tool.

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

• Not applicable / Not done. See point 5.

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

• Not applicable / Not provided. The "ground truth" for this device would be established through engineering specifications, material science evaluations, and compatibility testing with the Elekta Precise Patient Support System, rather than clinical ground truth methods like pathology or outcomes data.

8. The sample size for the training set

• Not applicable / Not provided. See point 2.

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

• Not applicable / Not provided. See point 2 and 7.

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