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The XBeam Software can be used for validating the monitor units or radiation dose to a point that has been calculated by hand or another treatment planning system for external beam radiation therapy. In addition, the XBeam Software can also be used as a primary means of calculating the monitor units or radiation dose to a point for external beam radiation treatments.

XBeam is only intended to be used with Xstrahl's superficial and orthovoltage radiotherapy and surface electronic brachytherapy systems. XBeam is intended to be used by authorized personnel trained in medical physics.

XBeam is a standalone dose calculation software for Xstrahl's medical devices include:

• Xstrahl 100, Xstrahl 150, Xstrahl 200, Xstrahl 300 (K962613)
• X80 RADiant Photoelectric Therapy System (K172080)
• . RADiant Aura (X80 RADiant Photoelectric Therapy System) (K230611)

XBeam's dose calculation algorithm can be used to determine the beam-on time or monitor units based on the applicator and filter selected for the specific device. The beam-on time / monitor units are calculated based on the percent dose depth (PDD) curve and the absolute dose output for the specified applicatorfilter combination. The software allows for calculating treatment parameters for single or two (parallel opposed) beams.

XBeam is intended to be used within a clinical environment where the patient is treated with Xstrahl's medical systems. XBeam is intended to be used by authorized personnel trained in medical physics. It is not intended to be used by patients or general public.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets those criteria:

The provided FDA 510(k) summary for the XBeam (v2) device focuses on demonstrating substantial equivalence to its predicate device, RADCalc (K193381), primarily through a comparison of intended use, technical characteristics, and a summary of non-clinical testing. While it mentions "acceptance criteria" through verification and validation activities, it does not explicitly define specific numerical acceptance criteria (e.g., "accuracy must be > 95%") for its performance when compared against ground truth.

Instead, the summary reports the results of the performance testing and concludes that they are acceptable, implying that these results meet implicit acceptance criteria for clinical equivalence and safety/effectiveness.

Given this, I will infer the implicit acceptance criterion based on the reported results.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document states: "Three hundred twenty-three (323) independent verification tests were executed." This refers to verification activities (system tests, module tests, etc.) rather than a specific test set of patient cases or dosimetric scenarios for performance evaluation against ground truth.

For the dosimetric accuracy validation:

• Sample size: Not explicitly stated as a number of distinct cases or patient datasets. It refers to comparing XBeam's output against two standard methods (hand calculations and RadCalc) and then comparing planned dose (presumably from XBeam) to delivered dose using physical measurements. The number of such comparisons or the range of parameters tested is not quantified.
• Data provenance: Not specified in terms of country of origin. The study appears to be a prospective validation of the software's dose calculation against established methods and physical measurements, rather than clinical retrospective or prospective patient data analysis.

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

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: The ground truth for dose calculation was established by "hand calculations" and the output of the predicate device "RadCalc (version: 7.3)." This implies that the 'experts' or processes involved in performing these hand calculations or configuring/using RadCalc would be "authorized personnel trained in medical physics" as stipulated in the device's indications for use.

4. Adjudication Method

Not applicable/specified. The validation involves direct comparison of numerical outputs (dose, monitor units) against established calculational methods and physical measurements, rather than assessment by multiple human reviewers requiring adjudication for a "ground truth" establishment in a subjective medical imaging context.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported in this summary. The device is a dose calculation software, not an AI-powered diagnostic image analysis tool that would typically involve human readers interpreting results with and without AI assistance.

6. Standalone Performance Study

Yes, a standalone performance study was done. The summary describes the validation of the XBeam algorithm's output (dose calculations) by comparing it against two independent methods:

1. Hand calculations.
2. The output of the predicate device, RADCalc.
   It also compared XBeam's planned dose to the physically delivered dose using measurement. This demonstrates the algorithm-only performance.

7. Type of Ground Truth Used

The ground truth used for the dosimetric accuracy validation was a combination of:

• Expert Consensus/Established Methods: "Hand calculations" (representing established physics principles and manual computation).
• A Legally Marketed Predicate Device's Output: "RadCalc (version: 7.3)".
• Physical Measurements/Outcomes Data (Indirectly): Comparison of "planned dose" (from XBeam) to "delivered dose" (presumably measured with dosimetry equipment in a controlled setting).

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or "training data." The XBeam software appears to be a dose calculation algorithm based on physics models, rather than a machine learning model that requires a distinct training phase with labeled data. Therefore, the concept of a training set as typically understood in AI/ML is not directly applicable to this description.

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

As noted above, the concept of a training set is not explicitly referred to for XBeam. The data that would inform the development and calibration of such a physics-based dose calculation system would typically come from extensive commissioning data (e.g., PDD curves, absolute dose output, beam profiles) measured for each specific Xstrahl radiotherapy system it supports, established via standard medical physics protocols. These measurements would be considered the "ground truth" for calibrating the physics model within the software. However, the document does not detail this specific process for XBeam's development.

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