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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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The RadiaDyne Prostate Immobilizer Rectal Balloon is a single-use disposable, inflatable, non-powered positioning device intended for use in the temporary positioning of the rectal wall and adjacent structure in the male human anatomies. The purpose of the device is to stabilize the prostate during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The placement of the balloon requires a Physician or a Physician directed healthcare professional, and is performed as a separate procedure apart from the standard CT exam and RT treatment.

The RadiaDyne Prostate Immobilizer Rectal Balloon is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and X-ray, when these imaging techniques are used for Radiation Therapy (RT) planning. The Prostate Immobilizer Rectal Balloon is inserted into the rectum and inflated prior to the start of a CT scan or RT therapy procedure. The device stabilizes the prostate once the device is inflated. The Prostate Immobilizer Rectal Balloon is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. RadiaDyne's device is designed for single use, is provided non-sterile to the end user, is not intended to be sterilized by the end user, and is packaged in a kit configuration. Each kit contains the following items: Rectal Balloon (polyurethane); Syringe (accessory to the device); Lubricant (accessory to the device); Locking Stopper (accessory to the device); and Instructions Manual. The main section of the device consists of a balloon and tubing which are made of polyurethane. The remainder of the device is made from other medical grade materials. The device can be inflated with either air or water, and this process is carried out with the single use disposable syringe that is supplied with the device in the accessory kit. The locking stopper supplied with the Prostate Immobilizer Rectal Balloon controls the depth at which the balloon is inserted into the rectum. The device can therefore be locked into place once inserted into place. RadiaDyne's Prostate Immobilizer Rectal Balloon is offered with a gas release valve (Models GRB) and without a gas release valve (Models: RB). Prior to insertion of the balloon, rectal gas can be removed from the rectum by methods not involving the balloon, such as inserting a pediatric catheter. The gas release model incorporates an open conduit through the balloon stem so that the rectal gas can be released once the balloon is inserted. After inflation, the gas release conduit continues to provide an escape path for any additional gas arriving at the superior end of the balloon, thus preventing gas accumulation during the procedure. The gas release valve is always open and does not require any action to function. If the model without the gas release valve is used, some transient gas may accumulate during the procedure, as is customary when no balloon is inserted. Aside from this feature, the GRB and RB models are identical in materials, construction and function.

This document describes the acceptance criteria and supporting studies for the RadiaDyne Prostate Immobilizer Rectal Balloon.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for the RadiaDyne Prostate Immobilizer Rectal Balloon are primarily based on non-clinical performance testing and literature review. The performance data generally indicate that the device meets these criteria.

• Well-tolerated by patients, with acceptable rates of acute anorectal toxicity.
• No serious complications (e.g., perforations or tissue damage) related to balloon application.
• Effectiveness in releasing bowel gas and decreasing balloon displacement for gas-release models.
• Risks mitigated by applying general and special controls. | - Wachter et al. [1]: Observed maximum prostate AP displacements >5 mm in 2/10 patients with balloons vs. 8/10 without, concluding reduced prostate movements. 252 patients treated, no complications related to balloon application.
• D'Amico et al. [2]: Reduced intrafraction motion (maximum prostate AP displacement from 4 mm to ≤1 mm), well tolerated by all patients.
• Woel et al. [3]: Balloon well tolerated by all patients, none discontinued use. Expected increase in acute toxicities resolved by end of treatment or 3 months after.
• Patel et al. [4]: Significantly reduced rectal wall volume in high-dose region, well tolerated without complications (some needed lidocaine).
• Bastasch et al. [5]: 99.2% (393/396) patients tolerated 100 ml barium-enema type endorectal balloon for entire 35-day course. 0.8% required volume reduction, 4.3% lubricant, 11.6% anal med, 6.8% antidiarrhea med. Clinically acceptable acute anorectal toxicity, no Grade 3 or 4.
• Ronson et al. [6]: 97.6% (3474/3561) patients tolerated balloon throughout treatment. Rectal balloons with fill volumes=120cc were well tolerated. Subject balloon fill volume (60-100ml) is less.
• Both et al. [7]: Daily endorectal balloon placement consistently stabilized prostate, preventing clinically significant displacement (>5 mm).
• Wang et al. [8]: Quantified interafraction prostate motion, showing reduced motion in the subject endorectal balloon group, especially in the anterior-posterior direction.
• Wootton et al. [9]: Gas-release mechanism effectively released bowel gas, decreased balloon displacement. |
  | Labeling | - Adequate instructions for use on proper insertion, positioning, and inflation.
• Appropriate contraindications and warnings.
• Expiration date supported by performance data.
• Statement on sterility (non-sterile). | - Labeling includes detailed instructions, specific warnings, contraindications (e.g., hemorrhoids, recent surgery), and an expiration date (2 years). States non-sterile and for single use. Consistent with clinical data. |

2. Sample Sizes and Data Provenance for Test Set (Clinical Studies)

The document does not detail a single "test set" in the context of a controlled clinical trial for the device's regulatory acceptance. Instead, it relies on a review of published clinical literature (retrospective and prospective studies) that used either similar devices or the subject device. The information below summarizes the sample sizes and provenance from these cited studies.

• Wachter et al. [1]:
  • Sample Size: 10 patients (for initial observation of AP displacements); 252 patients treated with fractionated radiation therapy.
  • Provenance: Not explicitly stated, but likely from a clinical setting where radiation therapy for prostate cancer is performed. Retrospective observations from a treated cohort.
• D'Amico et al. [2]:
  • Sample Size: Not explicitly stated, but implies multiple patients as "all patients" tolerated placement and inflation.
  • Provenance: Clinical setting, "repeated CT-imaging with 1 min time intervals" suggests a prospective measurement during a treatment or simulation session.
• Woel et al. [3]:
  • Sample Size: Multiple patients, as "patients treated with four-field three-dimensional (3D) conformal radiation therapy (CRT)". "all of the patients" tolerated the balloon. Specific number not given.
  • Provenance: Clinical study, evaluating acute toxicity in patients undergoing radiation therapy.
• Patel et al. [4]:
  • Sample Size: Not explicitly stated, but refers to "patients," indicating more than one. "None of the patients in this study..."
  • Provenance: Clinical study, demonstrating rectal dose sparing.
• Bastasch et al. [5]:
  • Sample Size: 396 patients.
  • Provenance: Baylor College of Medicine/Methodist Hospital group, study from 1998 onwards. Retrospective analysis of patient tolerance during IMRT.
• Ronson et al. [6]:
  • Sample Size: 3561 patients.
  • Provenance: Not explicitly stated, but likely a large clinical cohort study.
• Both et al. [7]:
  • Sample Size: Not explicitly stated, but focused on "intrafraction prostate displacements measured with electromagnetic tracking system" in a clinical setting using the subject balloon system.
  • Provenance: Clinical study, using the subject device.
• Wang et al. [8]:
  • Sample Size: Not explicitly stated, comparing "patient groups treated with and without daily endorectal balloons".
  • Provenance: Clinical study, using the subject device.
• Wootton et al. [9]:
  • Sample Size: Not explicitly stated, but was a "retrospectively examined" study.
  • Provenance: Clinical study, using the subject device with a gas-release mechanism.

3. Number of Experts and Qualifications for Ground Truth (Clinical Studies)

The document does not describe a traditional "ground truth" establishment process for a diagnostic device test set involving experts reviewing images. Instead, the "ground truth" for the device's effectiveness and safety is inferred from:

• Clinical Outcomes: Stability of the prostate, reduction in intrafraction motion, reduction in rectal wall volume in high dose regions, patient tolerance, and lack of severe complications (e.g., perforation, tissue damage).
• Clinical Judgement/Observations: The studies cited were conducted by medical professionals in radiation oncology. The "experts" are the physicians and healthcare professionals involved in delivering radiation therapy and assessing patient outcomes. Their qualifications are implicit in the nature of the studies (e.g., oncologists, radiation therapists performing patient care and data collection).

There is no mention of a specific number of independent experts adjudicating ground truth for device performance in the context of AI studies or similar applications.

4. Adjudication Method for Test Set

Not applicable. The regulatory decision hinges on a summation of existing scientific literature and specific bench testing, not a single comparative study with a human-adjudicated test set in the manner of AI/CADe device evaluations (e.g., 2+1 adjudication).

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

No MRMC comparative effectiveness study was mentioned regarding human readers improving with AI vs. without AI assistance. This device is a physical medical device, not an AI or imaging interpretation tool. The studies focus on the physical effect of the balloon on prostate motion and patient tolerance during radiation therapy, not on human interpretive performance.

6. Standalone (Algorithm Only) Performance

Not applicable. The device is a physical medical device, not a software algorithm.

7. Type of Ground Truth Used

The ground truth for the device's effectiveness and safety is derived from:

• Clinical Outcomes Data: This includes measurements of prostate displacement (AP displacement, intrafraction and interafraction motion), assessment of rectal toxicity (acute gastrointestinal, genitourinary, dermatological toxicity), patient tolerance, and observed complications (e.g., perforations, tissue damage).
• Quantitative Imaging Analysis: Studies used repeated CT examinations and electromagnetic tracking systems to quantify prostate motion.
• Biocompatibility Standards: Adherence to established standards for material safety (cytotoxicity, irritation, sensitization, acute systemic toxicity).
• Bench Testing Standards: Verification against engineering specifications for leakage, burst strength, tensile strength, and vent performance.

8. Sample Size for Training Set

Not applicable. This is a physical medical device, not an AI/machine learning algorithm, so there is no "training set." The supporting information is based on literature review and physical bench tests.

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for this physical device.

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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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The ALATUS Vaginal Balloon Packing System is a single use, non-sterile, disposable, flexible, inflatable, non-powered positioning device, intended to be used on a daily treatment basis for the temporary positioning of the vaginal wall and adjacent structural anatomies. The purpose of the device is to displace and stabilize the vaginal wall during computed tomography (CT) exam, x-ray, or radiation treatment (RT) therapy. The placement of the balloon requires a physician or physician directed healthcare professional, and it is performed as a separate procedure outside of the standard (CT) exam and (RT) treatment. This device is not intended to be inserted into the uterine cavity.

The ALATUS Vaginal Balloon Packing System is designed as an immobilizer to assist in positioning and displacing the vaginal wall in a more predictable and reproducible location during computed tomography (CT) exams and radiation treatment (RT) therapy. The proposed device is a latex free balloon made from Polyurethane consisting of the following components:

1. Balloon
2. Catheter tubing
3. Connector
4. Flex tubing
5. 1-way stopcock, 90° turn handle

The provided text is a 510(k) summary for the ALATUS Vaginal Balloon Packing System. It focuses on demonstrating substantial equivalence to predicate devices and does not contain information about acceptance criteria, specific performance studies with sample sizes, expert qualifications, or ground truth establishment relevant for an AI/ML medical device.

Therefore, I cannot fulfill your request for the tables and sections regarding acceptance criteria and performance study details. The document primarily addresses regulatory clearance based on substantial equivalence, rather than a detailed performance study as would be expected for an AI/ML device.

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