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The Magic3 Go® Intermittent Urinary Catheter is intended for urological use only. It is intended for use by adult and pediatric patients of all ages for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.

The Magic3 Go® Intermittent Urinary Catheter is a ready-to-use silicone intermittent catheter with a self-hydrating over a hydrophilic coating. The device is provided sterile and is for single use.

The device consists of an all silicone single lumen catheter with a polyethylene insertion sleeve (Sure-Grip™) which is not made from natural rubber latex, DEHP and/or other phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The catheter will be offered in multiple French sizes (6 – 20Fr), multiple lengths (10" & 16") and two tip designs (straight and coudé).

The outer surface of the catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating coating is applied. The additional coating does not require activation with water prior to use. The Sure-Grip™ insertion sleeve provides the user with an ergonomically designed area for a secure grip and notouch area with which to insert the catheter.

This document is a 510(k) summary for the Magic3 Go® Intermittent Urinary Catheter and focuses on establishing substantial equivalence to previously cleared predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the manner one might see for a novel AI device or a device requiring extensive clinical trials for efficacy.

However, I can extract the information related to performance testing that serves as the "study" to demonstrate equivalence.

Here's the breakdown based on the provided text:

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

• Cytotoxicity
• Sensitization
• Vaginal Mucosal Irritation |
  | Non-clinical functional performance: In accordance with BS EN 1616:1997 + A1:1999 | Device met the requirements of BS EN 1616:1997 + A1:1999. |
  | Lubricity: Equivalent to predicate device K150345 | Lubricity of the subject device is determined to be equivalent to predicate device K150345. |
  | Substantial Equivalence: Same intended use, similar indications for use, similar technological characteristics, and performance data as predicate devices. | The device was determined to be substantially equivalent. |

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: The document does not specify the exact sample sizes for the biocompatibility or non-clinical functional performance tests. It mentions "The battery of testing included the following:" for biocompatibility and "Non-clinical functional performance testing of the subject device was performed..." without giving numbers of units tested.
• Data Provenance: Not specified. Standard medical device testing is typically conducted in controlled laboratory environments, and the country of origin of the data is not mentioned. The tests are likely prospective for the specific device being submitted.

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 or not provided in the context of this 510(k) submission. For mechanical and biocompatibility testing of a medical device like a catheter, "ground truth" is established by adherence to recognized international standards and laboratory test methods, not by expert consensus on clinical interpretation. The experts are typically laboratory technicians, toxicologists, and engineers who conduct and interpret the results according to the specified standards.

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

• This is not applicable for the type of testing described (biocompatibility and non-clinical functional performance). Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or image interpretation studies where human reviewers independently assess outcomes and disagreeing results need resolution.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is an intermittent urinary catheter, not an AI-powered diagnostic tool, so such a study would not be relevant.

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

• This is not applicable. The device is a physical medical device (catheter), not an algorithm or AI system.

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

• For biocompatibility: Ground truth is established by the results of standardized biological tests evaluated against the acceptance criteria defined in ISO 10993 series and regulatory guidelines.
• For non-clinical functional performance: Ground truth is established by the device meeting the specified parameters and ranges defined in the technical standard BS EN 1616:1997 + A1:1999.
• For lubricity: Ground truth is a comparison to the established lubricity of the predicate device (K150345), as the subject device is identical in material and coatings.

8. The sample size for the training set

• This is not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set.

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

• This is not applicable as there is no training set mentioned for this type of device submission.

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The Magic3 Go™ Intermittent Urinary Catheter is intended for urological use only. If is intended for use by adult female patients for bladder management including urine drainage, collection, and measurement. The device is passed to the urinary bladder via the urethra.

Magic3 Go™ Intermittent Urinary Catheter is a ready-to-use silicone intermittent urinary catheter with a self-hydrating coating over a hydrophilic coating.

The device consists of an all silicone single lumen catheter with a thermoplastic elastomer (TPE) handle which does not contain DEHP and/or phthalates. The catheter has four drainage eyes located in the proximal tip and a tapered funnel located at the distal end. The outer surface of the all silicone catheter has two coatings. The first coating is a hydrophilic coating. Over the hydrophilic coating, a self-hydrating is applied. The additional coating does not require activation with water prior to use. The handle provides the user with an area for a secure grip and no-touch area with which to insert the catheter.

The provided document describes a 510(k) premarket notification for a medical device, the Magic3 Go™ Intermittent Urinary Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new device's effectiveness through clinical trials with specific acceptance criteria like those often seen for AI/ML devices or novel therapies.

Therefore, many of the requested elements (like a multi-reader multi-case study, effect size of AI, number of experts for ground truth, adjudication methods, and sample sizes for training/test sets) are not applicable to this type of regulatory submission for this particular device.

However, I can extract information related to the performance data provided to support substantial equivalence.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a urinary catheter, the "acceptance criteria" are implied by demonstrating equivalence to a predicate device and meeting relevant industry standards. There are no numerical performance metrics (like sensitivity, specificity, accuracy) provided in the document for the device itself against a specific clinical outcome.

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

• Test Set Sample Size: Not applicable/not specified for performance metrics in the context of clinical outcomes. The performance data refers to laboratory testing on device materials and function.
• Data Provenance: Not applicable in terms of country of origin or retrospective/prospective for clinical data, as this is laboratory and material testing.

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

• Not applicable. Ground truth, in this context, would be the results of the laboratory tests based on established ISO and BS EN standards, not expert clinical interpretation.

4. Adjudication method for the test set

• Not applicable. The "test set" here refers to physical/material performance tests, which are objective and do not require expert adjudication in the way clinical diagnostic interpretations would.

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 not an AI/ML device and therefore an MRMC study is not relevant.

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

• No. This is not an AI/ML device.

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

• The ground truth for the performance data (biocompatibility and nonclinical functional performance) is based on established international and national standards (ISO 10993-5, ISO 10993-10, BS EN 1616:1997 + A1:1999) and quantitative measurements (e.g., coefficient of friction). For the substantial equivalence argument, the predicate device's established safety and effectiveness also serves as a "ground truth" reference.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device.

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

• Not applicable. This is not an AI/ML device.

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