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The indications for use for the CORVUS Radiation Therapy Planning System have not changed as a result of this modification.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machinespecific data and are intended to provide a quide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The CORVUS system is a radiation treatment planning package designed to allow medical physicists, dosimetrists, and radiation oncologists to create conformal treatment plans using photon (x-ray) external beam radiation therapy. The treatment plans generated by CORVUS are based upon treatment machine-specific data and are intended to provide a guide to delivering external beam radiation therapy which conforms to the target volume defined by the radiation oncologist.

The CORVUS System is valid for use only with external beam photon therapy; calculations for electrons and intracavitary sources (Brachytherapy) are not supported.

The modification described in this premarket notification consists of a change to the operating system upon which the device operates. The currentlymarketed CORVUS System utilizes the NextStep operating system, while the modified device runs on the Macintosh OS X (Mac OSX) operating system. This change did not modify the intended use of the device or the fundamental scientific technology of its design. Testing performed demonstrates that the modified device produces clinically equivalent results. Therefore, this change does not affect the safe and effective use of the device within its prescribed indications.

The provided text describes a 510(k) premarket notification for the NOMOS CORVUS 5.0M System, which is a Radiation Therapy Treatment Planning System. The core of this submission is a modification to the operating system from NextStep to Macintosh OS X (Mac OSX), with the claim that this change did not modify the intended use or fundamental scientific technology, and that testing demonstrates clinically equivalent results.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the modification to the CORVUS system (changing the operating system) did not modify the intended use, fundamental scientific technology, or performance specifications. Therefore, the "acceptance criteria" are implicitly that the new system performs at least equivalently to the predicate device (the currently marketed CORVUS System) and adheres to its existing performance specifications.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature of the test data). It generally refers to "testing performed" and "hazard analysis and testing" without providing specific details about the dataset or methodology.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

The document does not specify the number of experts used or their qualifications to establish ground truth for any testing. Given the nature of the device (a treatment planning system), expert review would typically involve medical physicists and radiation oncologists, but this is not explicitly mentioned.

4. Adjudication Method for the Test Set

The document does not mention any specific adjudication method (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. This is not a diagnostic device where human readers interpret images, but rather a treatment planning software. The focus is on the equivalence of the software's output to the previous version, not on human interpretive improvement.

6. Standalone (Algorithm Only Without Human-in-the-loop Performance) Study

Yes, a standalone performance study was implicitly done. The "testing performed" to demonstrate clinical equivalence would involve comparing the output of the CORVUS 5.0M (algorithm only on the new OS) against the output of the predicate CORVUS system (algorithm only on the old OS). The claim is that the device itself, functioning on the new OS, produces equivalent results. There is no mention of a "human-in-the-loop" component to this specific performance evaluation, as the change is at the operating system level, not the core algorithms or user interaction for treatment planning.

7. Type of Ground Truth Used

The "ground truth" in this context is the performance of the predicate CORVUS System. The new CORVUS 5.0M System's performance was compared against the established, accepted performance of the previous version. This is a case of device-to-device equivalence, where the "truth" is what the previously cleared device produces, and the goal is to show the modified device produces the same "truth." This would involve comparing the treatment plans (e.g., dose distributions, conformality indices, etc.) generated by both systems for the same input data.

8. Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning or AI models. This device is a treatment planning system based on algorithms, not a machine learning model that undergoes a training phase with a dataset. The system uses "treatment machine-specific data" for its calculations, which is more akin to calibration data for physics models than a training set for an AI.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" in the context of an AI/ML model, this question is not applicable. The device's calculations are based on "treatment machine-specific data," which would be established through appropriate calibration and commissioning procedures for the radiation therapy machines it interfaces with.

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This device is intended to be used as an integrated system for the planning and delivery of dynamic conformal radiation therapy to produce a radiation field which is modulated to conform to the projected tumor volume plus margins by means of a dynamic (moving) multileaf collimator, while simultaneously moving the accelerator gantry.

Integrated radiation therapy treatment planning and delivery system

The provided text is a Premarket Notification (K953258) for the NOMOS PEACOCK System, dated November 18, 1995. This document is a summary of safety and effectiveness, primarily focused on establishing substantial equivalence to predicate devices, as per the regulations in place at the time (pre-1996 for 510(k) submissions).

Crucially, this type of document from 1995 does NOT align with the modern understanding and requirements for demonstrating device performance with specific acceptance criteria and detailed study results as you've requested. The regulatory landscape and expectations for evidence of performance were significantly different then.

Therefore, I cannot extract the information you've requested because it is not present in this 1995 premarket notification. Here's a breakdown of why and what information is available:

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

• Not Available. The document does not define explicit "acceptance criteria" in the modern sense (e.g., sensitivity, specificity, accuracy targets). Instead, it relies on the concept of "substantial equivalence" to predicate devices. The "reported device performance" is broadly stated as "Physics and clinical testing has demonstrated that the Peacock System performs as intended," without specific metrics or comparisons to acceptance criteria.

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

• Not Available. The document mentions "Physics and clinical testing" but does not provide any details about sample sizes, the nature of the studies (retrospective/prospective), or data provenance.

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 Available. Ground truth establishment, expert involvement, and their qualifications are not mentioned.

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

• Not Available. Adjudication methods are not discussed.

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 Available and Not Applicable. This device is a radiation therapy treatment planning and delivery system, not an AI-assisted diagnostic tool for "human readers." Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device's intended use in the context of this document.

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

• Not Applicable in the modern AI sense. The "algorithm" here is the treatment planning software, and it is inherently designed to be used by human oncology professionals. The concept of "standalone" algorithm performance as understood for AI-based diagnostic tools isn't directly applicable in the same way. The document doesn't detail specific performance studies of the software in isolation.

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

• Not Available. The document refers to "clinical testing" generally, but does not specify how "ground truth" was established for any performance evaluations. For a treatment planning system, ground truth would typically relate to dose distribution accuracy, tumor targeting, patient outcomes, etc., but these details are not provided.

8. The sample size for the training set:

• Not Applicable / Not Available. The "Peacock System" is described as an integrated treatment planning and delivery system. In 1995, this would involve computational models and algorithms for dose calculation and beam shaping, not machine learning or AI models that require specific "training sets" in the modern sense.

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

• Not Applicable / Not Available. See point 8.

Summary of Information Available from the Provided Text:

• Device Name: NOMOS PEACOCK System (consisting of CORVUS and MIMiC)
• Proprietary Name: PEACOCK™ System
• Common Name: Integrated radiation therapy treatment planning and delivery system
• Applicant: NOMOS Corporation
• Predicate Devices: Varian Varisource HDR Afterloader with integrated planning system (K852842), GE Target Planning System (K896353) & Arc Therapy (K802809)
• Classification: Class II (under 21 CFR 892.5050 for simulation systems, 21 CFR 892.5710 for beam-shaping blocks)
• Intended Use: Integrated system for planning and delivery of dynamic conformal radiation therapy to modulate a radiation field to conform to the projected tumor volume plus margins, by means of a dynamic multileaf collimator while simultaneously moving the accelerator gantry.
• Performance Claim: "Physics and clinical testing has demonstrated that the Peacock System performs as intended." (No specific data provided in this summary.)
• Substantial Equivalence Claim: Similar in design, construction, materials, intended use, and performance characteristics to predicate treatment planning systems and multileaf collimators. No new issues of safety or effectiveness introduced.

Conclusion:

The provided document is a very old (1995) 510(k) summary focused on substantial equivalence. It predates modern regulatory expectations for detailed performance studies, particularly for AI/machine learning devices. Therefore, it does not contain the specific information regarding acceptance criteria, study designs, sample sizes, ground truth establishment, or expert involvement that you have requested.

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