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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 Caddy is a transportable / foldable electric scooter. The Caddy Scooter has been developed especially for those people with Mobility problems are generally problems with walking or with the stamina. wanting or was as a suite for the use of elderly persons and physically disabled persons. The Caddy scooter was developed especially for use in and around the house and to be taken along for trips. For this purpose the scooter can be folded and disassembled easily and the separate parts can be handled with ease.

The Caddy is a transportable / foldable electric scooter.

The provided text is a 510(k) premarket notification letter from the FDA regarding a powered wheelchair named "CADDY." This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The letter explicitly states: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

Substantial equivalence (SE) is a regulatory pathway that allows a new device to be marketed if it is as safe and effective as a legally marketed predicate device. It does not typically require the submission of clinical trials with specific acceptance criteria and detailed study results as would be the case for a premarket approval (PMA) application or certain novel devices.

Therefore, I cannot provide the requested information based on the given text. The text does not describe:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for any test set.
3. Number or qualifications of experts for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study or its effect size.
6. Standalone (algorithm-only) performance.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

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The intended medical application of MRI-Caddy with three 2000-Series syringe pumps is to produce controlled movement of the plunger of a syringe to inject a set amount of therapeutic fluid into a patient within a hospital setting at a set rate and at set times. The MRI-Caddy is designed for use in an MR-environment at a maximum magnetic field strength of 20mT.

The MRI-Caddy® is a cart with an integrated chassis, which is equipped with three Medex syringe pumps and a power supply. The MRI-Caddy's mechanical construction makes it possible to position the system with the MR-room. For this purpose the system was equipped with adequate screening following the principle of a Faraday cage. The function principle corresponds to that of the Medex syringe pumps already on the market.

The provided 510(k) summary for the MRI-Caddy Infusion Pump does not contain information about specific acceptance criteria for device performance or a study demonstrating that the device meets those criteria.

Instead, the submission focuses on demonstrating substantial equivalence to predicate devices (Medex syringe pumps Model 3001 and Medfusion Model 2001) based on design, materials, chemical composition, and operational principles, as well as compliance with a general safety standard.

Here's an breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided document. The submission does not define specific performance metrics or acceptance criteria for the MRI-Caddy beyond compliance with a general safety standard. It asserts that the function principles correspond to existing Medex syringe pumps.

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

No test set or clinical data is mentioned. The submission explicitly states: "The company did not conduct, nor depend on, clinical studies in order to establish substantial equivalence."

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

Not applicable, as no test set or clinical studies were conducted.

4. Adjudication method for the test set

Not applicable, as no test set or clinical studies were conducted.

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. This device is an infusion pump, not an AI-based diagnostic tool, so an MRMC study is not relevant.

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

Not applicable. The equivalence is primarily based on device design and manufacturing, not clinical performance data with ground truth.

8. The sample size for the training set

Not applicable, as no AI model or training was performed.

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

Not applicable, as no AI model or training was performed.

Summary of the Study and Basis for Equivalence (as reported in the document):

The submission for the MRI-Caddy Infusion Pump relies on two key aspects to establish substantial equivalence to legally marketed predicate devices:

• Non-Clinical Testing and Standards Compliance: The company cites compliance with EN 60601-1 / IEC 601-1 "Medical Electrical Equipment - Part 1: General Requirements for Safety" including its amendments. This suggests that the device underwent engineering and safety testing to meet general electrical and medical device safety standards.
• Design and Functional Equivalence to Predicate Devices: The core argument for substantial equivalence is that "The basic design, material, chemical composition of the Medex pump series 2000 used in the MRI-Caddy are the same as for the current corresponding Medex Medfusion model pumps. They are identical in operation, features, and form as their predicate devices, and represent no technological differences." The MRI-Caddy essentially integrates pre-existing, legally marketed Medex syringe pumps into a new housing designed for an MR-environment, with appropriate screening (Faraday cage).

Conclusion:

The K030323 submission does not involve specific acceptance criteria or a performance study as would be seen for a novel diagnostic or therapeutic device. Instead, it leverages the substantial equivalence pathway by demonstrating that the MRI-Caddy is fundamentally the same in design, materials, and operation as existing, cleared infusion pumps, with the added feature of an MR-compatible housing that meets safety standards. No clinical studies were conducted or relied upon for this submission.

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