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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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