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The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.

The OARtrac® System with Skin Sensors provides Radiation Oncologists with near real-time, multi-point radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) located on the surface of the patient's skin to monitor dose photon based radiation therapy for cancer treatment. This information allows the physician to monitor the dose at the skin surface, compare the actual dose relative to the planned dose, and provides graphs and dose information for the current treatment as well as a log of the dose from five previous treatments. The actual verification of the dose radiation is accomplished by the other main components of the OARtrac® System, those being the Clinical Detector Unit (CDU) with its Charged Coupled Device (CCD) camera and the system's own proprietary dose management software.

The provided document, a 510(k) summary for the OARtrac® System with Skin Sensors, focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study proving those criteria are met for a standalone device. The device is a radiation dose verification system that measures photon beam therapy on the surface of the skin.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the format typically used for a standalone effectiveness study. Instead, it relies on demonstrating equivalence to a predicate device through various non-clinical tests.

However, based on the description of performance testing, we can infer some implied acceptance criteria and reported "performance" in the context of equivalence:

2. Sample Size used for the test set and the data provenance

• Sample Size for Test Set: The document does not specify a "test set" in the context of a dataset of patient images or outcomes for evaluating an AI algorithm. The testing described is primarily non-clinical, involving laboratory-based simulations and physical testing of the device. Therefore, a sample size of "patients" or "cases" is not applicable in this context.
• Data Provenance: Not applicable. The testing is described as being performed in a laboratory setting, simulating radiation treatments.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The device measures radiation dose, and its accuracy is assessed against established physical standards and the performance of a predicate device, not through expert consensus on medical images or diagnoses.

4. Adjudication method for the test set

Not applicable, as there is no test set requiring expert adjudication for 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 MRMC study was done. This device is a measurement tool for radiation dose, not an AI-assisted diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document does not describe the device as containing an "algorithm" in the AI sense. It is a measurement system. The "standalone" performance was assessed through non-clinical laboratory testing to verify its measurement capabilities. The performance referred to is the device itself performing its measurement function.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for the non-clinical performance data appears to be:

• Physical standards and engineering specifications: For aspects like biocompatibility, electrical safety, EMC, software verification, risk analysis, and package shelf-life, the ground truth is adherence to established national and international standards (e.g., ISO, IEC, ASTM).
• Established accuracy of the predicate device: For dose range verification, the ground truth is the established accuracy of the original OARtrac® System (K141154) and "current clinical standards" for simulating treatments from LINAC and CyberKnife machines.

8. The sample size for the training set

Not applicable. This device is not described as utilizing machine learning or AI that requires a "training set."

9. How the ground truth for the training set was established

Not applicable, as there is no training set for the device's functionality.

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