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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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The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

The X80 / RADiant / Photoelectric Therapy System (hereafter referred to as the RADiant System) is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

The RADiant System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time-based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the RADiant System.

The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.

The Xstrahl Photoelectric Therapy System (RADiant Aura) is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Here’s an analysis of the provided information regarding its acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria for performance metrics in a clinical study. The "acceptance criteria" here are generally understood as meeting design requirements, mitigating risks, and conforming to relevant standards, which are evaluated through non-clinical testing.

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

• Sample Size for Test Set: Not explicitly stated as a "test set" in the context of clinical data. The testing described largely involves non-clinical (engineering and technical) verification and validation. This means the "sample size" would refer to the number of devices or components tested. The document mentions "Twenty Six independent verification tests and 18 independent validation tests were executed on the RADiant Aura systems." This implies that at least one, but likely a limited number (e.g., prototype or production units), of RADiant Aura systems were subjected to these tests.
• Data Provenance: This information refers to the origin of the data. Since the testing is non-clinical, the data provenance is primarily from internal testing conducted by Xstrahl Ltd. and independent testing by the National Physics Laboratory UK (NPL). The context is purely technical performance evaluation, not clinical outcomes from human patients. The data is prospective in the sense that it was generated specifically for this submission to verify the new design. There is no mention of country of origin of clinical data, as no clinical data is presented.

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

This section is not applicable as the document describes non-clinical performance and safety testing, not a clinical study requiring expert-established ground truth for a test set (e.g., image interpretation or disease diagnosis). The "ground truth" here is adherence to engineering specifications, safety standards, and physical laws, verified by technical measurements and evaluations.

4. Adjudication Method for the Test Set

This is not applicable as the document describes non-clinical performance and safety testing. Adjudication methods are typically used in clinical studies when multiple human readers evaluate data, and their assessments need to be reconciled to establish a ground truth.

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?

No, an MRMC comparative effectiveness study was not done. This device is an X-Ray radiation therapy system, not an AI diagnostic or assistance tool. The submission focuses on the safety and performance of the hardware and software for delivering radiation therapy, not on interpreting medical images or assisting human readers in diagnosis.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

This question is not directly applicable in the context of this device. The "algorithm" in this case refers to the embedded software and control systems of the radiation therapy device. The non-clinical testing described (e.g., software run-through functionality test, dose reproducibility) effectively evaluates the "standalone" performance of these systems in meeting their intended technical specifications, without direct human intervention in the treatment delivery process once programmed. However, the device itself is a treatment device, not a diagnostic algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing, the "ground truth" used was based on:

• Engineering specifications and design requirements: The device was tested against its defined operational parameters and expected performance.
• International and national standards: Compliance with standards like BS EN 60601-2-8, IEC 60601-1, etc., served as the ground truth for safety, electrical performance, usability, and software lifecycle.
• Recognized codes of practice: For output measurements, protocols from AAPM (2001) and IPEMB (1996) were used as the benchmark for accurate dose delivery.

8. The Sample Size for the Training Set

There is no mention of a training set in the document. This is because the device is not an AI/ML-based diagnostic or predictive algorithm that typically requires large datasets for training. The software components mentioned (Concerto, Fisica, TP2) appear to be control software and firmware for the device's operation, not machine learning models.

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

This is not applicable as there is no training set for an AI/ML model mentioned in the context of this device.

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The Xstrahl Photoelectric Therapy System is a low energy X-Ray system intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

Typical applications include treatment for Basal Cell Carcinoma, Squamous Cell Carcinoma, Metatypic Carcinoma, Cutaneous Appendage Carcinoma, Karposi's Sarcoma, Merkel Cell Carcinoma, Lentigo Maligna, Lentigo Maligna Melanoma, Cutaneous Lymphomas (B and T cell) and Keloids.

The Photoelectric Therapy System is a compact and ergonomic superficial X-Ray therapy system operating in the 10kV to 80kV range intended for superficial radiotherapy and surface electronic brachytherapy treatment of primary malignant epithelial neoplasms of the skin and keloids.

The Photoelectric Therapy System is a standalone X-Ray radiation therapy system consisting of the X-Ray Therapy Unit, a TP2 Central Control Unit (CCU), a Control POD (Control POD), and a PC on which user interface software is loaded. The system has a time based control system used with treatment filters and applicators. A range of bespoke treatment applicators and beam filters are available for use with the Photoelectric Therapy System.

The system is freestanding, self-contained, unobtrusive, compact and ergonomic in design, which helps to ensure a reassuring and stress-free patient experience. The system is floor mounted in order to accommodate almost any clinical space, and features ergonomically designed controls ensuring smooth adjustment and safe, simple patient set-up. The system requires connection to the clinical facilities electrical supply and room interlocks.

This document describes a 510(k) premarket notification for the Xstrahl Photoelectric Therapy System, an X-ray radiation therapy system. The notification primarily focuses on demonstrating substantial equivalence to a predicate device (Sensus Healthcare SRT-100 Superficial Radiation Therapy System) through non-clinical testing.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly provide a table of acceptance criteria with corresponding device performance for a clinical evaluation. Instead, it details adherence to various international and national standards for electrical safety, electromagnetic compatibility, usability, and dosimetry for an X-ray therapy system. The "reported device performance" in this context refers to compliance with these standards, not necessarily clinical efficacy.

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

The document describes non-clinical testing for safety, EMC, usability, and dosimetry. Therefore, there is no "test set" of patient data in the context of a clinical study. The "test set" would refer to the physical device prototypes and components subjected to these engineering and physics tests. The data provenance is from non-clinical laboratory settings in the UK (Xstrahl Ltd. and National Physics Laboratory UK). The data is prospective in the sense that the device was specifically manufactured and tested against these standards.

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

Since this document focuses on non-clinical engineering and physics tests, the concept of "ground truth for a test set" established by medical experts (like radiologists) does not apply in the typical sense of a clinical trial.

However, the National Physics Laboratory UK (NPL) is a recognized authority in measurement science, and their involvement in dosimetry verification suggests that their experts (likely medical physicists or similar specialists) were used. The IPEMB Code of Practice and AAPM Task Group 61 Protocol are established by expert bodies in medical physics, and adherence to these protocols reflects an expert consensus on accurate dosimetry.

The "experts" involved in establishing the "ground truth" for these technical tests would be:

• Engineers and physicists at Xstrahl Ltd. involved in the design, development, and internal testing of the device.
• Independent medical physicists/scientists at the National Physics Laboratory UK (NPL) who performed the verification measurements according to recognized professional codes of practice. Their qualifications would typically include advanced degrees in physics, medical physics, or related fields, with expertise in radiation dosimetry and medical device testing.

4. Adjudication Method for the Test Set:

Not applicable in the context of non-clinical engineering and physics testing. Adjudication methods like "2+1" are typically used in clinical studies involving multiple human readers to resolve discrepancies in diagnoses or interpretations. The non-clinical tests described involve objective measurements and compliance verification against predefined technical standards.

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:

No. The document does not describe any MRMC comparative effectiveness study, nor does it mention AI or human-in-the-loop performance. This device is an X-ray radiation therapy system, not an imaging or diagnostic AI-powered device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No. This question is also not applicable. The device is a physical X-ray therapy system. There is no "algorithm only" performance reported in the context of AI or diagnostic interpretation. The "system" operates as a standalone piece of equipment for delivering radiation therapy as intended.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" is defined by:

• Established international and national standards: IEC 60601 series, EN 60601 series, IEC 62366. Compliance with these standards is the "truth" being verified for safety, EMC, and usability.
• Recognized codes of practice for dosimetry: IPEMB Code of Practice and AAPM Task Group 61 Protocol. The physical measurements conducted by NPL are compared against the expected values as defined by these protocols to establish the "ground truth" for radiation output accuracy.
• Manufacturer's own Customer Acceptance Test (CAT) procedure: This internal standard serves as a ground truth for the device's specific manufactured performance characteristics.

8. The Sample Size for the Training Set:

Not applicable. The document describes a medical device, not an AI or machine learning model. Therefore, there is no "training set" in this context.

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

Not applicable. As there is no training set for an AI model, the question of establishing its ground truth is irrelevant to this submission.

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