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The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron 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. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.

The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is intended for use in photon and electron radiation therapy to monitor and validate radiation dose during External Beam Therapy and HDR Brachytherapy to the surface of the skin or the rectal wall. 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 the 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 is a 510(k) Summary of Safety and Effectiveness for the OARtrac® System. It outlines the device's indications for use, its technical characteristics, and how it compares to a predicate device to demonstrate substantial equivalence.

Based on the information provided, here's a breakdown of the acceptance criteria and the study (non-clinical performance data) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the OARtrac® System are primarily based on demonstrating substantial equivalence to its predicate device (RadiaDyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954) and meeting relevant safety and performance standards. While the text doesn't explicitly list "acceptance criteria" as a separate table, the "Dose Accuracy" row in Table 1 functions as a key performance criterion, with other general and specific tests confirming safety and effectiveness.

Here's a table derived from the provided information:

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

The document explicitly states: "10. Clinical and Animal Performance Data - Not Conducted" (Page 6).
This means there was no human or animal test set/data in the traditional sense for this 510(k) submission. The data provenance is therefore entirely from non-clinical (laboratory/bench) testing, which includes validation against standards and previous predicate device data. The data provenance would be from the manufacturer (RadiaDyne) through their internal testing and third-party lab certifications for standards.

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

Since no clinical or animal performance data was collected, there was no expert adjudication for a ground truth derived from clinical cases. The "ground truth" for the non-clinical tests would have been established by the engineering specifications and the established standards (e.g., IEC, ISO, ASTM) against which the device performance was measured. These standards were developed and validated by relevant expert bodies in the field.

4. Adjudication Method for the Test Set

As no clinical test set was used, there was no adjudication method applied to clinical data. The evaluation was based on compliance with pre-defined engineering and safety standards.

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

No MRMC comparative effectiveness study was done. The document explicitly states "Clinical and Animal Performance Data - Not Conducted." The purpose of this submission was to demonstrate substantial equivalence through non-clinical data, not to show improvement over human readers.

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

This device is a radiation dose verification system, not an AI/algorithm for diagnosis or image interpretation. While it contains software, its core function is to measure physical radiation dose. Therefore, the concept of "standalone algorithm only performance" as typically applied to AI/ML devices for medical image analysis does not directly apply in this context. The device's performance was evaluated based on the accuracy of its dose measurements. The software processes these measurements, but it's not a standalone diagnostic algorithm.

7. The Type of Ground Truth Used

The ground truth for this device's performance evaluation was primarily physical measurements against established radiation dosimetry standards and validated test procedures. This is analogous to physical/engineering ground truth rather than clinical ground truth (like pathology, expert consensus, or outcomes data). For example, a known dose from a calibrated radiation source served as the "ground truth" for the device's dose accuracy measurements.

8. The Sample Size for the Training Set

Since this is not an AI/ML device that requires a training set in the typical sense of machine learning algorithms for pattern recognition (e.g., image classification), the concept of a "training set" is not applicable. The device's calibration and design would rely on physical principles and potentially pre-calibrated sensors, but not a data-driven training set like an AI model.

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

As there is no training set in the AI/ML context, this question is not applicable. The "ground truth" for the device's development and calibration would be derived from the fundamental physics of radiation detection and dosimetry, using highly calibrated and traceable radiation sources and measurement standards.

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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 OARtrac® System is specifically indicated for male prostate cancer treatment to measure photon beam therapy as an adjunct to treatment planning permitting measurement of in-vivo radiation dose received on the anterior surface of a modified Prostate Immobilization Endorectal Balloon (ERB) device to monitor and verify the surrounding organs at risk, specifically the protatic rectal interface.

The OARtrac® System provides radiation oncologists with near real- time, in-vivo, multipoint radiation-dose information obtained from two (2) Radiatrac® Plastic Scintillating Detectors (PSD) sensors located on the anterior surface of a modified clinically accepted OARtrac® prostate Endorectal Balloon (ERB) to monitor dose photon based radiation therapy for prostate cancer treatment. This information allows the physician to monitor the dose at the rectal prostatic interface, compare the actual dose relative to the planned dose, and provides graphs and dose information for both the current treatment as well as a log of dose from five previous treatments. The OARtrac® System also provides dose rate during actual treatment.

The function of the OARtrac® prostate ERB is to immobilize the prostate while at the same time positioning the Radiatrac® PSD sensors so that measurement of in-vivo radiation received on the anterior surface of the balloon can be monitored to verify the radiation dose to surrounding organs at risk, specifically the protatic rectal interface. 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 that are further addressed in the remainder of this section.

The OARtrac® System is designed to provide near real-time, in-vivo, multipoint radiation-dose information during prostate cancer treatment. It measures photon-based radiation therapy using two Plastic Scintillating Detector (PSD) sensors located on the anterior surface of a modified Endorectal Balloon (ERB). The system monitors the dose at the rectal prostatic interface, compares it to the planned dose, and provides graphs and dose information for current and past treatments. The ERB also immobilizes the prostate and positions the sensors.

Here's a breakdown of the acceptance criteria and study information:

Acceptance Criteria and Reported Device Performance

Study Information

1. Sample Size and Data Provenance:

   • The document indicates that no human clinical testing was required. The "Non-Clinical Performance Data" section mentions "controlled phantom data" was used to obtain the radiation dose accuracy for the OARtrac® System.
   • No specific sample sizes for test sets (e.g., number of phantom measurements) or the data provenance (e.g., country of origin, retrospective/prospective) are explicitly provided in the provided text.

2. Number of Experts and Qualifications for Ground Truth (Test Set):

   • Not applicable, as no human clinical testing was performed for the test set. Ground truth for the non-clinical tests would be established through a controlled phantom setup and precise dose delivery.

3. Adjudication Method (Test Set):

   • Not applicable, as no human clinical testing requiring expert adjudication was performed.

4. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

   • No MRMC comparative effectiveness study was mentioned. The device is a dosimeter aimed at objectively measuring radiation dose, not interpreting images or aiding human readers in decision-making in a way that an MRMC study would typically evaluate.

5. Standalone Performance Study:

   • Yes, a standalone performance study was done. The "Non-Clinical Performance Data" section details a series of tests, including "Dose Range Verification Testing," "Calibration Testing," and "Dose Accuracy" measurements using controlled phantom data. This implicitly demonstrates the algorithm's (or system's) standalone performance in measuring radiation dose.

6. Type of Ground Truth Used:

   • For the non-clinical testing, the ground truth was established through controlled phantom data and presumably the known, precisely delivered radiation doses from a calibrated source.

7. Sample Size for Training Set:

   • The document does not explicitly mention a separate "training set" or its sample size. For device calibration and verification, data would typically be collected from controlled experiments, but the text doesn't differentiate between training and testing data in a machine learning context.

8. How Ground Truth for Training Set was Established:

   • Ground truth for calibration and verification would be established using calibrated radiation sources and dosimetric standards applied to phantoms. The document mentions the device is "Pre-Calibrated (Cobalt-60)," indicating that Cobalt-60 sources were used in establishing foundational calibration.

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Intended Use: The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.

Indications for Use: The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.

The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.

The provided text does not contain specific acceptance criteria or an analytical study proving the device meets those criteria. Instead, it describes a 510(k) submission for the DVS (Dose Verification System) focusing on its substantial equivalence to predicate devices and the modifications made.

However, based on the text, we can infer some general acceptance criteria and the type of study conducted, though not its detailed results.

Inferred Acceptance Criteria and Device Performance (based on general statements in the document):

Study Information Based on the Text:

Since the provided text is a 510(k) summary, it details the submission for substantial equivalence rather than a detailed clinical or performance study with raw data and statistical analysis. The text states:

"Furthermore, verification and validation testing based on the risk analysis, provided information sufficient to determine that the modifications did not have an effect on safety or efficacv and demonstrated that the device met acceptance criteria based on performance specifications. The testing demonstrated that the modified device is substantially equivalent to the predicate device and performs as well as the predicate device. The verification and validation results are provided within the 510(k)."

This indicates that internal verification and validation testing was performed. However, the document does not provide the specific details requested for the study, such as:

1. Sample size used for the test set and the data provenance: Not mentioned.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
4. 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 mentioned. The device is a dosimeter, not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not explicitly stated as a "standalone" study in the context of an algorithm, but the "verification and validation testing" would have assessed the device's inherent performance.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned. For a dosimeter, ground truth would typically refer to highly accurate reference dosimetry measurements (e.g., from ion chambers or calibrated phantoms).
7. The sample size for the training set: Not mentioned. Dosimeters are typically calibrated, not "trained" in the machine learning sense.
8. How the ground truth for the training set was established: Not mentioned. Calibration would be against known radiation doses from a calibrated source.

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The DVS (Dose Verification System) is intended for use in radiation therapy to verify treatment planning and radiation dose to tissue and organs in or near the irradiated areas of a patient.

The DVS system is specifically indicated for breast and prostate cancer to measure photon beam therapy and as an adjunct to treatment planning to permit measurement of the in vivo radiation dose received at the tumor periphery, tumor bed and/or surrounding normal tissues for validation of the prescribed dose.

The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosimeter for measuring radiation dose in vivo, the DVS Insertion Tool for implanting the dosimeter during percutaneous procedures, the DVS Reader System (Wand and Base Station) for powering the dosimeter and providing a user interface when taking dose measurements, and the DVS Data System (Plan and Review Software and Dosimetery Database) for storing and reporting patient data and for storing dosimeter information. The dosimeters use a MOSFET, Metal Oxide Semiconductor Field Effect Transistor, as a sensing mechanism. The dosimeter is factory calibrated and powered by the Reader Wand utilizing electromagnetic energy. The dosimeter contains a transmitter, to transmit threshold voltage readings to the reader. It is radioopaque and thus registers on computed tomography scans as a point of interest whereby a point dose may be determined. Patients are implanted prior to radiotherapy. Information on the patient's therapy, dose planning, point dose at the dosimeter, dosimeter serial number and calibration files are entered into the Plan and Review software and stored in the Dosimetry Database. At each therapy fraction the dosimeter is read pre- and post-therapy using the Reader Wand and Base Station. This translates into a daily fractional dose. The patient's daily and cumulative dose may be reviewed via the Plan and Review software. Because the Plan and Review software and Dosimetry Database are designed to be stored on a server, multiple users may be logged into the system at any one time. Reports on the patient's daily and cumulative dose history may be printed using the Plan and Review software.

The provided text is a 510(k) summary for the DVS (Dose Verification System) and discusses its substantial equivalence to a predicate device. It does not contain detailed information about specific acceptance criteria, device performance metrics (other than stating "the dosimeter performance specifications are the same and have not changed"), sample sizes for testing, ground truth establishment, or clinical study designs (such as MRMC studies).

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

Here is what can be inferred or stated about the information requested:

1. Table of acceptance criteria and the reported device performance:

2. Sample sized used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective). The document mentions "verification and validation testing" but does not detail the nature of the test set.

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

• Not specified. The document does not describe the establishment of a "ground truth" using human experts for the test set.

4. Adjudication method for the test set:

• Not specified, as no expert adjudication of a test set is mentioned.

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 comparative effectiveness study is mentioned. This device is a hardware/software system for dose verification, not an AI-assisted diagnostic tool for human readers.

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

• This device is not an algorithm-only system. It's a physical dosimeter and reader system with accompanying software. The document states "verification and validation testing... demonstrated that the device met pre-determined acceptance criteria based on performance specifications," which implies standalone testing of the system's performance.

7. The type of ground truth used:

• The document implies that the device's measurements are validated against established physical dosimetry principles and potentially against existing clinical dose measurement standards (given its use for "verification of the prescribed dose"). However, the specific type of ground truth (e.g., gold standard phantom measurements, comparison to other validated dosimetry systems) is not explicitly detailed.

8. The sample size for the training set:

• Not applicable. This device is not an AI/ML model that requires a training set in the typical sense. It is a measurement device.

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

• Not applicable, as there is no training set for an AI/ML model for this device.

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