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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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