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The NOVAC 11 is an electron linear accelerator used for radiation therapy during surgical procedures in an operating room for the treatment of malignant and benign conditions. Known as Intraoperative Radiation Therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites while avoiding dosage to surgically mobilized normal tissues.

The device is a linear electron accelerator for intra-operative treatments. Thanks to its construction characteristics, it can be used directly in the operating room. NOVAC 11 is a reusable and non sterile electromedical device.

It is a mobile and articulated device. It can be moved towards the patient and put in the needed positions to carry out the necessary radiotherapy.

Radiation technique consists of administering a uniform and collimated dose of ionizing radiations to the tumor or other site. It is made through the surgical incision.

Collimation is performed by "Applicators" made of PMMA to minimize braking radiation.

Applicators are positioned according to the "Hard Docking" technique which ensures the maximum alignment accuracy, thus ensuring highly reproducible dosages.

The accelerator is equipped with an uninterruptible power supply which makes it completely independent during the radiation phase. Indeed, it ensures radiation continuity even if there are network power interruptions.

The provided documentation is a 510(k) summary for the NRT S.p.A. NOVAC 11, an electron linear accelerator for intra-operative radiation therapy (IORT). It does not contain specific details about acceptance criteria, device performance metrics, or a study design for evaluating these aspects. The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to international safety and quality standards for medical electrical equipment.

Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from the given text, nor can I elaborate on specific study details as they are not present.

However, I can extract information about the regulatory context and the general nature of the performance data presented, and explain what is missing based on your request.

Here's an analysis of the provided text in relation to your questions:

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

• Information in document: The document explicitly states: "The New Radiant Technology S.p.A. NOVAC 11 device has been developed and tested according to the following international standards" and then lists several IEC and ISO standards. It also mentions "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices - FDA - May 2005".
• Missing Information: The document does not provide specific, quantifiable acceptance criteria for performance metrics (e.g., accuracy of radiation dose, beam uniformity, consistency) or the reported device performance values against these criteria. Instead, it refers to compliance with general safety and performance standards. For a medical device like a radiation therapy system, acceptance criteria would typically include parameters like dose accuracy, beam energy stability, field size accuracy, and safety interlock effectiveness, each with specific pass/fail thresholds. The document does not provide these.

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

• Information in document: The document does not describe any specific clinical or performance test set, sample size, or data provenance. The "Performance Data" section refers to adherence to international standards and guidance documents, implying testing was done to meet these standards, but details of such testing (e.g., number of test cases, origin) are not provided.
• Missing Information: There is no mention of a test set size, its origin, or whether the study was retrospective or prospective.

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)

• Information in document: The document does not mention any experts being used to establish ground truth for a test set, as no test set requiring such expert assessment is described.
• Missing Information: No information is provided regarding experts or their qualifications for establishing ground truth.

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

• Information in document: The document does not describe any adjudication method for a test set.
• Missing Information: No adjudication method is mentioned.

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

• Information in document: The NOVAC 11 is an electron linear accelerator for radiation therapy, not a diagnostic imaging device with an AI component designed to assist human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable to this device and is not mentioned.
• Missing Information: Not applicable to this type of device.

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

• Information in document: The NOVAC 11 is a physical medical device (an electron linear accelerator) that delivers radiation therapy. It is operated by human users (medical professionals) and does not inherently function as a standalone "algorithm" in the typical sense of AI/software performance evaluations. The "Software life cycle processes" standard (IEC EN 62304) is mentioned, indicating software is part of the device, but its performance is integrated into the device's overall function, not evaluated as a standalone algorithm in isolation from the hardware components and human operation.
• Missing Information: Not applicable in the context of an "algorithm only" study as typically understood for AI-driven diagnostic tools. Performance of the device's software would be part of the overall device performance verification, not an "algorithm-only" standalone study.

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

• Information in document: Since no specific clinical or performance study with a test set needing ground truth is described, no type of ground truth is mentioned. For a radiation therapy device, "ground truth" for performance would often refer to physical measurements of radiation output, beam characteristics, and geometric accuracy using phantoms and dosimetry equipment calibrated to established standards.
• Missing Information: No information on the type of ground truth specifically used for a performance study.

8. The sample size for the training set

• Information in document: This information is not provided. The document refers to development and testing according to standards, but does not detail any "training set" in the context of machine learning or AI.
• Missing Information: No sample size for a training set is mentioned.

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

• Information in document: This information is not provided, as no training set is mentioned.
• Missing Information: No information on how ground truth for a training set was established.

Summary of Device and its "Performance Data" in the Document:

The NOVAC 11 is an electron linear accelerator for Intraoperative Radiation Therapy (IORT). Its "Performance Data" presented in this 510(k) summary focuses entirely on adherence to a list of international standards for medical electrical equipment safety, electromagnetic compatibility, software life cycle processes, risk management, and specific requirements for electron accelerators.

The document uses these standards as evidence of the device's "performance" in terms of safety, design, and manufacturing quality, rather than presenting results from a clinical efficacy or specific performance accuracy study with quantifiable metrics. This approach is common in 510(k) submissions where the device is substantially equivalent to existing predicate devices and is primarily evaluated based on meeting recognized industry standards and established safety profiles.

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