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The RSVP Phantom™ Pelvis is designed for use in a variety of radiation therapy applications including, final quality verification of therapy dose delivery and for comparing the delivered dose profiles for different treatment plans. It is also used for periodic quality assurance evaluations and acceptance testing and to perform reevaluations after equipment or software upgrades.

The RSVP Phantom™ Pelvis provides isodose distribution and verification information for both conventional and intensity modulated radiation therapy machines. The life-size pelvic shape is formed from CAB material and filled with water to simulate the radiation absorption and scatter of human soft tissue.

Here's an analysis of the provided 510(k) summary for the RSVP Phantom™ Pelvis, focusing on acceptance criteria and supporting studies:

Acceptance Criteria and Device Performance for RSVP Phantom™ Pelvis

Based on the provided document, the RSVP Phantom™ Pelvis is a medical device phantom used for quality assurance in radiation therapy. Its primary function is to simulate human tissue for dose verification.

1. Table of Acceptance Criteria and Reported Device Performance:

Study Details:

The primary study mentioned is a comparative verification study against a predicate device.

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

• Sample Size: Not explicitly stated as a numerical value in terms of "cases" or "test samples." The document refers to "numerous measurements and pressure leak tests" for prototypes and "additional radiation measurements" conducted by the physicist. This suggests a series of experiments and tests rather than a single fixed "test set."
• Data Provenance: The testing was conducted during the device's development process and by a U.S. academic institution (Vanderbilt University). The nature of the measurements suggests prospective experimental data rather than retrospective clinical data.

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

• Number of Experts: One expert is explicitly named: "Physicist Charles W. Coffey, II, Ph.D. of Vanderbilt University."
• Qualifications of Experts: Ph.D. holder and a physicist at Vanderbilt University. While "physicist" is mentioned, his specific specialization (e.g., medical physicist, radiation physicist) is not detailed, but is implied by the context of radiation therapy measurements.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable or not explicitly detailed. The verification work appears to have been performed by a single expert (Dr. Coffey) comparing the new device against the predicate device's known functions and performance standards. There is no mention of multiple reviewers adjudicating discrepancies.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

• MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a phantom for calibrating and verifying radiation therapy machines, not an imaging or diagnostic device requiring human interpretation of medical images. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not relevant.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

• Standalone Performance: This concept is not directly applicable to a physical phantom. The phantom itself is a tool. Its "performance" is its ability to accurately simulate tissue properties for radiation dose measurements. The verification measurements performed by Dr. Coffey would be considered the assessment of the phantom's standalone performance in its intended function. There is no "algorithm" in the typical sense for this device.

7. The Type of Ground Truth Used:

• Ground Truth: The ground truth for evaluating the RSVP Phantom™ Pelvis was primarily based on:
  • Benchmarking against a legally marketed predicate device (K954634): The predicate device's established performance and "functions" served as a "gold standard" for functional equivalence.
  • "Actual patient absorbed dosages" simulation: The phantom is designed to mimic these, suggesting general physical principles and known dosimetric properties as part of the ground truth.
  • Calibrated measurements with traceability to NIST: This ensures the accuracy and reliability of the measurement equipment used during testing.

8. The Sample Size for the Training Set:

• Training Set Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set." It is a physical phantom.

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

• Ground Truth for Training Set: Not applicable, as there is no training set for this device.

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