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Bolus Compensators are used by radiation therapy professionals for the treatment of cancer patients. They are designed by radiation therapy professionals for a unique patient and are intended to modify the shape of a beam from a radiation therapy source. Each Bolus Compensator must be validated and approved by the radiation therapy professional prior to use on a patient.

.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators for intensity modulation of external beam radiation therapy. The Bolus Compensators are designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue while guiding the radiation to the targeted area.

This document is a 510(k) Premarket Notification summary for a device called "Bolus Compensator". The key information related to acceptance criteria and supporting studies is as follows:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics using an established format. Instead, it states that "Clinically oriented validation test cases were written and executed in house .decimal personnel including Board Certified Medical Physicists where Bolus Compensators was deemed fit for clinical use." This implies that the acceptance criteria were met by these in-house validation tests. The "intended use" section suggests the implicit performance criteria:

• Manufactures solid Bolus Compensators for intensity modulation of external beam radiation therapy.
• Designed by the customer's treatment planning system to block radiation from hitting critical structures and healthy tissue.
• Guides radiation to the targeted area.
• Must be validated and approved by the radiation therapy professional prior to use on a patient.

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

• Sample Size for Test Set: The document mentions "Clinically oriented validation test cases were written and executed in house." It does not specify the number of test cases (i.e., sample size).
• Data Provenance: The tests were "executed in house" by .decimal personnel. This indicates the data is retrospective and generated internally for validation purposes. The country of origin would be the United States, given the company's address is in Sanford, Florida, and the submission is to the FDA.

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

• Number of Experts: The document states "including Board Certified Medical Physicists." It does not specify the exact number of medical physicists involved.
• Qualifications of Experts: The experts were "Board Certified Medical Physicists." No further details on their experience (e.g., years of experience) are provided.

4. Adjudication Method for the Test Set

The document simply states that the Bolus Compensators "was deemed fit for clinical use" based on the in-house validation. It does not describe a formal adjudication method (like 2+1 or 3+1 consensus). The "Board Certified Medical Physicists" were involved in deeming the product fit, implying their expertise formed the basis of the determination, but not a specific multi-reader adjudication process.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The document explicitly states: "Clinical testing was not performed as part of the development of this product. Clinical testing is not advantageous in demonstrating substantial equivalence or safety and effectiveness of the device since testing can be performed such that no human subjects are exposed to risk." This implies that no study comparing human readers with and without AI assistance was conducted.

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

The device is a "Bolus Compensator manufacturing service" and the physical bolus compensator itself. It is a physical device, not an AI algorithm. Therefore, the concept of a "standalone (algorithm only) performance" study does not apply here. The validation focused on the physical characteristics and functional performance of the manufactured compensators.

7. The Type of Ground Truth Used

The ground truth was established by "Board Certified Medical Physicists" deeming the manufactured Bolus Compensators "fit for clinical use." This suggests a form of expert judgment/consensus on the functional suitability and accuracy of the manufactured devices based on the "clinically oriented validation test cases." It is not based on pathology, outcomes data, or patient-level clinical results, as no clinical testing with human subjects was performed.

8. The Sample Size for the Training Set

This device is a physical product (.decimal's Bolus Compensator manufacturing service manufactures the solid Bolus Compensators), not an AI algorithm trained on data. Therefore, the concept of a "training set" is not applicable in the context of machine learning.

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

As stated above, this is not an AI/machine learning device, so there is no training set or ground truth for a training set in the conventional sense. The "ground truth" equivalent would be the engineering specifications and performance expectations for the manufactured bolus compensators, which were assessed by medical physicists during an in-house validation process.

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