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The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body, and indicated for use when adhered to the skin with a bolus, or inserted into the rectum to measure the rectal prostatic interface via a specifically designed endorectal balloon device.

The OARtrac® System with patient specific, reusable, pre-calibrated PSD sensors is intended for use in photon radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal prostatic interface. This dose verification information obtained during the treatment is then used to compare with the planned dose that the Radiation Oncologists expect to provide to their patient. The OARtrac® System itself does not stop the radiation treatment to the patient, or change the radiation delivery, but only provides dose data which a trained Radiation Oncologist can decipher and use to adjust a patient's treatment plan accordingly.

The provided text does not contain information about an Artificial Intelligence (AI) device or a study proving its performance against acceptance criteria in the context of AI. The document is a 510(k) premarket notification for a medical device called the "OARtrac® System with Patient Specific Reusable PSD Sensors," which is a radiation dose verification system.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices, primarily through non-clinical performance data related to material, electrical safety, EMC, software, package shelf-life, risk analysis, dose range verification, and importantly, cleaning and disinfection validation for reusability.

Therefore, I cannot provide the requested information regarding AI device acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies, as these concepts are not addressed in the provided text.

Specifically:

1. A table of acceptance criteria and the reported device performance: The document lists "Key Performance Specifications/Characteristics" for the device, which includes:

   • Photon Energy Based Therapies: Energy Range .37-18 MeV
   • Dose Rate Range: 1.3-17.3 cGy/s
   • Dose Range: 27-1200 cGy
   • Dose Accuracy: +/-6%, 2 σ
     It states that the subject device meets these requirements, and that "all the testing" was passed. However, it does not provide detailed performance results in a table format comparing acceptance criteria to reported performance for each specific test item in the same way an AI model's performance metrics (e.g., sensitivity, specificity, accuracy) would be presented against pre-defined thresholds. The key focus of this submission is on the reusability validation.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as this is a non-AI device. The testing described is primarily laboratory-based non-clinical performance validation (e.g., electrical safety, EMC, cleaning/disinfection validation). Specific sample sizes for these types of engineering tests are not detailed in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in the context of expert consensus is relevant for AI diagnostic or prognostic devices. For this device, "ground truth" would relate to verifiable physical measurements in a laboratory setting for dose accuracy, cleaning efficacy, etc. The document does not specify experts for establishing such ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a non-AI device's non-clinical performance testing.

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: Not applicable, as this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the non-clinical tests mentioned, the "ground truth" would be established by standard engineering and scientific methodologies (e.g., calibrated reference instruments for dose measurement, laboratory testing protocols for cleaning/disinfection efficacy, an accredited laboratory for biocompatibility).

8. The sample size for the training set: Not applicable, as this is not an AI device and thus has no training set in that context.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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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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The RadiaPak™ Brachytherapy Applicator Balloon Device is a single use, non-sterile, disposable, inflatable, non-powered positioning device, manufactured without the use of latex, intended to be used on a daily treatment basis to position and stabilize the brachytherapy radiation delivery applicator within the vagina or rectum during brachytherapy radiation therapy procedures, x-ray, or computed tomography (CT) exam. The placement of the balloon device requires a physician directed healthcare professional.

The RadiaPak™ Device is designed to position and stabilize the brachytherapy applicator and to space the applicator surface from the targeted vaginal or rectal mucosa during computed tomography and brachytherapy procedures. The proposed device is a latex free balloon and can be inflated with either air or saline, is provided non-sterile, and is intended for single use.

The provided text describes a 510(k) submission for the RadiaPak™ Brachytherapy Applicator Balloon Device. This document does not include detailed acceptance criteria or a study proving the device meets specific acceptance criteria in the way typically seen for AI/software-as-a-medical-device (SaMD) clearances.

Instead, this is a traditional medical device submission based on substantial equivalence to predicate devices. For such devices, the "acceptance criteria" are primarily related to general safety and effectiveness characteristics, and the "study" is a comparison to legally marketed predicate devices, along with performance testing and biocompatibility testing.

Here's an attempt to answer your questions based on the provided text, recognizing that it's not a SaMD-style submission with AI performance metrics:

1. Table of Acceptance Criteria and Reported Device Performance

For this type of device (a physical medical device cleared via substantial equivalence), the "acceptance criteria" are implied by the characteristics of the predicate devices and general regulatory requirements for safety and effectiveness. The "reported device performance" demonstrates that the new device meets these implied criteria.

• Inflatable and Deflatable
• Balloon Fill Volume and Pressure
• Flexible
• Expands | - Inflatable: Yes
• Deflatable: Yes
• Performance testing to determine balloon fill volume and fill pressure completed.
• Flexible: Yes
• Expands: Yes |
  | Treatment Area: Vaginal or rectal mucosa compatibility. | Vaginal or rectal mucosa compatibility. |
  | Body Contact Area: Mucosal Membrane. | Mucosal Membrane. |
  | Procedure Time: Approx. ≤ 90 minutes. | Approx. ≤ 90 minutes. |
  | Single Use: Designed for single use. | Yes, single use. |
  | Inflation Medium: Compatibility with air, saline, or water. | Pressurized with air, saline, water. |
  | Connection Type: Functioning connection mechanism. | Stopcock valve. |
  | Sterility: Whether supplied sterile or non-sterile is a characteristic, not an acceptance value. | Supplied non-sterile. |
  | Latex-free: If aiming for latex-free status. | Manufactured without the use of latex. |
  | No new questions of safety or effectiveness. | Differences to predicates do not raise new questions of safety/effectiveness. |

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size: Not applicable. This submission relies on non-clinical testing (biocompatibility and performance) and comparison to predicate devices, not clinical data from a test set of patients in the way an AI/SaMD product would.
• Data Provenance: Not applicable for a clinical test set. The data provenance for biocompatibility and performance testing would be from in vitro or in vivo (animal) lab studies, but the document does not specify the country or whether it was retrospective/prospective.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. There was no clinical test set requiring expert ground truth in this 510(k) submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical test set.

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. This is a physical medical device, not an AI/SaMD. No MRMC study was performed.

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

• No. This is a physical medical device.

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

• Not applicable for a clinical ground truth. For the non-clinical performance and biocompatibility testing, the "ground truth" would be established by validated test methods and passing criteria defined by relevant industry standards (e.g., ISO 10993 for biocompatibility) and engineering specifications.

8. The sample size for the training set

• Not applicable. This device is not an AI/machine learning model and therefore does not have a "training set."

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

• Not applicable. As there is no training set for an AI model.

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