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The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use non-powered inflatable positioning device intended to be used for temporary positioning of the rectal wall and adjacent structures in the male human anatomies and to assist in positioning the prostate in a more predictable and reproducible location.

The purpose of the DxTx Medical Pro-Tx Endorectal Balloon is to stabilize the rectal wall and surrounding anatomy during all phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. Only trained healthcare professionals are intended to operate this device.

The DxTx Medical Pro-Tx Endorectal Balloon is a disposable, single use device for immobilization and localization of the rectal wall and surrounding anatomy on a daily basis for radiation therapy treatment. The Pro-Tx Endorectal Balloon includes the shaft and inflatable balloon with a gas venting feature. The Pro-Tx Endorectal Balloon is capable of being filled with air or fluid. The intended contact duration of the device is less than 60 minutes.

No components of this device contain medicinal substances, tissues or blood products.

The device component materials are PVC, Polycarbonate, Polyethylene, Polypropylene, Copolyester, Liquid Silicone Rubber (balloon), and brass (the radiopaque marker).

This FDA 510(k) summary describes the Pro-Tx Endorectal Balloon (PROT-25) and its equivalence to a predicate device, the RadiaDyne Prostate Immobilizer Rectal Balloon.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list "acceptance criteria" for each performance test in a quantitative manner. Instead, it states that the performance tests were completed "to demonstrate performance equivalent to the predicate device and in compliance with 21 CFR 892.5720." This implies that the acceptance criteria are met if the new device performs at least as well as the predicate device across these specific tests, or adheres to regulatory standards where applicable.

Based on the "Effectiveness" section in the comparison table and the "Performance Verification (Bench Testing)" section, here's a reconstructed table reflecting the tests performed:

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

• Sample Size for Shelf-life: A box of 25 Pro-Tx devices was subjected to accelerated aging for the shelf-life study.
• Sample Size for other Bench Tests: Not explicitly stated for individual bench tests (Axial pull, inflation integrity, burst strength, occlusion, drop test, flexure test). Typically, such tests would involve a representative sample size from a production lot.
• Data Provenance: The accelerated aging study was conducted by an "independent ISO 17025-certified lab." Other bench test data are implied to be from internal testing by DxTx Medical, Inc. or associated labs. The predicate device's performance data likely came from its original De Novo study and post-market surveillance. The biocompatibility assessment references the design lineage from MEDRAD/Bayer Healthcare and its post-market performance.

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

This information is not applicable as the studies presented are primarily non-clinical bench and biocompatibility tests, not clinical performance studies requiring expert ground truth for classification or diagnosis. The "ground truth" for these tests relates to engineering specifications and material properties.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. Adjudication methods are typically used in clinical studies involving multiple expert readers.

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

An MRMC comparative effectiveness study was not done. This device is a physical medical device (an endorectal balloon) for positioning and stabilization during radiation therapy, not an AI-powered diagnostic or assistive tool. Therefore, the concept of human readers improving with AI assistance is not relevant to this submission.

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

This information is not applicable as the device is a physical, non-powered positioning device and does not involve any algorithm or AI for standalone performance evaluation.

7. The type of ground truth used

The "ground truth" for the performance tests is based on engineering specifications, material properties, and regulatory standards (21 CFR 892.5720). For biocompatibility, the ground truth refers to established biocompatibility guidelines and the absence of adverse events from the legacy device over a long period. For shelf-life, the ground truth is the maintenance of performance specifications after accelerated aging.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The design was based on a previously marketed device (MEDRAD/Bayer Healthcare Pro-Tekt Endorectal Balloon).

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

This information is not applicable for the same reason as point 8.

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The RectalPro™15 Endorectal Balloon device is a single-use disposable, inflatable, non-powered positioning device intended for us 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 RectalPro™ 75 Endorectal Balloon (ERB) is single use, disposable, inflatable, non-powered rectal device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery. The RectalPro75 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 ERB 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 ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The RectalPro ERB is designed with a slim curved, extended shaft and balloon. The device is provided non-sterile to the end user, is not intended to be sterilized by the end user. It is packaged in a kit configuration, consisting of three primary components: 1. ERB shaft This is the shaft with attached balloon and attached clear plastic tubing for filling the balloon with air / water. The end of the tubing has a female luer lock. There are white markings on the side of the ERB shaft as insertion depth markings. 2. Stopper This is the circular plastic piece with one flat side, and one side containing four prongs. There is a hole in the middle of the stopper for placement onto the ERB shaft. 3. Air / water valve This is the small plastic valve on the air tube connected to the ERB shaft. The clamp on the air / water tube stops the air / water flow by squeezing the tube closed. This component stops air / water from releasing out of the balloon after it has been filled. The kit also includes a standard 100 cc syringe with male luer lock connector, for connecting to the female luer connection of the ERB tubing, and is used to deliver the water or air to the ERB.

The provided text describes the RectalPro™75 Endorectal Balloon, a device intended for prostate immobilization during radiation therapy planning. It is a 510(k) submission, meaning the manufacturer is claiming substantial equivalence to a legally marketed predicate device, not necessarily proving novel safety and effectiveness through extensive clinical trials.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily derived from the performance of the predicate device and relevant international standards. The reported device performance is presented as meeting these criteria.

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The Myriad Prostate Caddy™ Immobilization 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 Xray, 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 Myriad Prostate Caddy™ Immobilization 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 Immobilization 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. Myriad'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 (PVC); Syringe (optional accessory to the device); Locking Stopper (accessory to the device) and the Instructions for Use. The balloon consists of a single lumen shaft with a blow molded balloon attached to the distal end of the shaft. The balloon is bonded to the shaft at the proximal end of the balloon. The shaft extends into the balloon but it is not attached at the end with a rounded atraumatic tip. Several eye holes are provided to inflate/deflation of the balloon. The main section of the device consists of a balloon and single lumen tubing which are made of PVC. The remainder of the device is made of other medical grade materials consisting of the following components shown below in Table 1. 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 (or offered as an option) 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.

The provided text describes a 510(k) premarket notification for the Myriad Prostate Caddy™ Immobilization Rectal Balloon, which aims to demonstrate substantial equivalence to a predicate device, the RadiaDyne Prostate Immobilizer Rectal Balloon RB Classic Series (K132194). This document focuses on non-clinical/bench studies to assess the device's performance, rather than a clinical study involving human subjects or AI algorithms. As such, information typically found in studies for AI/CADe devices (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable or available in this document.

However, the document does detail the acceptance criteria and performance of the device based on bench testing.

1. A table of acceptance criteria and the reported device performance:

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

This document describes bench and biocompatibility testing, not a clinical study on a test set of patient data. Therefore, concepts like “test set,” “data provenance,” and “retrospective/prospective” are not applicable in this context. The samples used are devices themselves or animal models for biocompatibility.

• Biocompatibility testing: Conducted at NAMSA, 6750 Wales Road, Northwood, Ohio 43619.
  • Cytotoxicity: Not specified individual sample count, but "data presented" supported safety.
  • Rectal Irritation: Rabbit model. Not specified sample count.
  • Sensitization: Guinea pig model. Not specified sample count.
  • Acute Systemic Toxicity: Mice. Not specified sample count.
• Performance Testing - Bench:
  • Bioburden Testing: The testing process was repeated 3 times. The average of 75 CFU and maximum of 168 CFU suggests multiple device samples were used.
  • Leakage Testing: "A statistically appropriate number of devices" were tested, and "100 % of the Balloons are inflated" for final QC.
  • Tensile-strength and Burst-strength: Not specified individual sample count, but performed on "the Balloons."
  • Stopper Resistance Testing: Not specified individual sample count, but "All of the units passed the test."

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. This device is a physical medical device, not an AI or imaging diagnostic tool. "Ground truth" in the sense of expert consensus on medical images is not relevant to its evaluation. Biocompatibility tests were conducted by a testing facility (NAMSA) according to established standards.

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

Not applicable. There is no test set in the context of expert adjudication. Performance was evaluated based on physical measurements and biological responses in laboratory settings.

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. No MRMC study was performed as this is not an AI/CADe device.

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

Not applicable. This is not an AI algorithm.

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

The "ground truth" for this device's performance is established by:

• Biocompatibility standards: International Organization for Standardization (ISO) 10993 series for biological evaluation of medical devices.
• Microbial limits: USP and USP for Total Aerobic Count and Fungi.
• Physical performance derived from engineering specifications and literature: For example, the 7.1 Lbs force for tensile/burst strength and 3.57 Lbs for stopper resistance are described as simulating worst-case usage per literature with a safety factor.

8. The sample size for the training set

Not applicable. This device does not use a training set for machine learning.

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

Not applicable. This device does not use a training set for machine learning.

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The ERB is a single use, inflatable, non-powered positioning device placed in the rectum to immobilize the prostate in patients undergoing radiation therapy. The device is intended to be used during all the phases of radiation therapy, including treatment planning, image verification, and radiotherapy delivery.

The ERB is designed as an immobilizer to assist in positioning the prostate in a more predictable and reproducible location during Computed Tomography (CT) exam and Xray, when these imaging techniques are used for Radiation Therapy (RT) planning. The ERB 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 ERB is deflated and removed after each individual scan or therapy procedure is complete, and a new balloon is used in the next therapy session. The ERB is designed for single use, is provided non-sterile to the end user, and is not intended to be sterilized by the end user. The ERB consists of a balloon and tubing can be inflated with either water or air. The device can be locked into place once inserted into the rectum with a locking stopper.

The provided text is a 510(k) summary for the ERB Endorectal Balloon, a Class II medical device. The document primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study of the device's performance against specific acceptance criteria.

However, it does mention "Non-Clinical Testing" and "Performance Data" in a general sense. Based on the provided text, a detailed table of acceptance criteria and reported device performance with specific metrics cannot be fully populated. The document only states that "Product testing was completed and met all of the acceptance criteria. Testing included dimensional, visual, mechanical and performance." and "All necessary verification and validation testing has been performed for the ERB to assure substantial equivalence to the predicate devices."

Here's an attempt to extract the information requested, with limitations due to the nature of the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The provided document does not list specific quantitative acceptance criteria or detailed performance metrics. It generally states that testing was completed and met all acceptance criteria, and that the device's performance attributes are equivalent to the predicate. Therefore, the "Reported Device Performance" column reflects generalized statements from the document.

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

The document does not specify the sample size used for the test set in non-clinical testing. It only mentions "Product testing" and "All necessary verification and validation testing."

Data Provenance: The testing appears to be non-clinical (laboratory/bench testing) rather than clinical studies on human subjects. The document does not specify the country of origin for the data or if it was retrospective or prospective, beyond stating that Edge Medical, LLC performed the testing.

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

This information is not applicable and not provided in the document. The testing described is non-clinical (dimensional, visual, mechanical, performance, biocompatibility) of a physical device, not an AI/software device that would require expert-established ground truth for a test set.

4. Adjudication Method for the Test Set

This information is not applicable and not provided in the document for the reasons stated in point 3.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for imaging interpretation devices, often involving AI assistance for human readers. The ERB Endorectal Balloon is a physical medical device for prostate immobilization during radiation therapy.

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

No, a standalone (algorithm-only) performance study was not done, as the ERB is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing mentioned (dimensional, visual, mechanical, performance), the "ground truth" would be established by engineering specifications, material standards, and benchmark measurements against known properties of the device and its predicate. For biocompatibility, the ground truth is established by adherence to ISO10993 standards.

8. The Sample Size for the Training Set

This information is not applicable and not provided in the document. The ERB is a physical medical device, not an AI/machine learning algorithm that requires a training set.

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

This information is not applicable and not provided in the document for the reasons stated in point 8.

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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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