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The Navina Systems are indicated for use for children (2 -

The subject Navina Smart System is an electronically controlled, trans-anal irrigation system. The subject Navina Smart System consists of an electronic control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set and the regular (size) rectal balloon catheter utilized with the Navina Smart System are identical to the same components cleared under the original clearance of the predicate Navina Classic System in premarket notification, K170487.

With the Navina Smart control unit, the user controls water volume, irrigation speed, and rectal catheter balloon inflation. The Navina Smart system includes a mobile application in which users can save treatment data and rate their irrigation. The Navina Smart mobile application facilitates tracking of TAI treatment data (e.g., treatment duration, water volume used, rectal balloon size, etc.) but does not function in any way to control the function of the Navina Smart System itself.

The Navina Classic System is a manually operated trans-anal irrigation (TAI) system. The Navina Classic System, as subject of this "bundled" 510(k), consists of a manual control unit, a water container and tubing set for water instillation, single-use, disposable rectal balloon catheters in two sizes (regular or small), and a disposable rectal cone catheter. The water container, tubing set, and regular (size) rectal balloon catheter are identical to the same Navina Classic System components that were cleared under the system's original clearance in the predicate premarket notification, K170487.

This document describes the Dentsply Sirona Navina Smart System and Navina Classic System, trans-anal irrigation (TAI) systems. The submission is a 510(k) premarket notification (K190977) for the introduction of the Navina Smart System and modification of the Navina Classic System.

Here's a breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present acceptance criteria in a table format with corresponding reported device performance values. Instead, it lists the types of performance tests conducted and states that "The results of the testing conducted in conformity with applicable standards support substantial equivalence." This implies that the devices met the performance requirements defined by these standards.

Here's an organized view of the performance testing categories:

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

The document describes non-clinical performance testing and does not provide details on the sample sizes for these tests. It states that the testing was conducted to support substantial equivalence and addressed new components not part of the original clearance (K170487).

Regarding data provenance, the testing appears to be internal performance testing conducted by the manufacturer, Dentsply Sirona. The tests are for device components and software, not human subject data. Therefore, notions of "country of origin of the data" or "retrospective/prospective" studies are not directly applicable in the sense of clinical trials.

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

This information is not provided in the document. The performance testing described is non-clinical, focusing on engineering and safety standards for the device itself. Therefore, the concept of "ground truth" as established by medical experts for a diagnostic or clinical outcome is not directly relevant here.

4. Adjudication Method for the Test Set

This information is not provided in the document. Given that the performance testing is non-clinical and related to engineering standards, an adjudication method in the context of human interpretation or clinical endpoints would not typically be applicable. The tests likely have objective pass/fail criteria based on measured parameters and compliance with stated standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The Navina Smart System and Navina Classic System are trans-anal irrigation devices, not diagnostic AI systems that assist human readers in interpreting medical images or data. The Navina Smart system includes a mobile application for tracking data, but it does not function to control the device or provide AI assistance to human readers for diagnostic interpretation.

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

The Navina Smart System includes an "electronically controlled, trans-anal irrigation system" with a control unit that manages water volume, irrigation speed, and balloon inflation. It also has a mobile application for tracking treatment data.

While the control unit operates with programmed logic (an "algorithm"), the performance testing described (Control of air leakage, Complete deflation of balloon, Ability to instantly stop waterflow, Control of water flow rate, Control of water back flow, Setting of balloon size) represents a form of standalone testing for the functions controlled by the device's embedded software. This is not "algorithm only" in the sense of an AI model making a recommendation, but rather the functional performance of the electromechanical system. The mobile application facilitates tracking but does not function in any way to control the function of the Navina Smart System itself. So, the core function of water instillation and balloon inflation is a standalone device operation.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the non-clinical performance testing described, the "ground truth" would be the engineering specifications and applicable international standards (e.g., IEC 60601 series, IEC 62304, IEC 62133, IEC 62366-1, ISO 10993-12). The devices are tested against physical and functional requirements defined by these standards and the manufacturer's design specifications.

8. The Sample Size for the Training Set

This information is not provided as there is no mention of a "training set" in the context of machine learning or AI model development. The Navina Smart System and Navina Classic System are medical devices with electromechanical components and software, not AI algorithms that are trained on large datasets.

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

This information is not applicable as there is no "training set" for an AI model mentioned in the document.

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The Navina Classic System is indicated for adults who suffer from fecal incontinence, chronic constipation, and/or time consuming bowel management.

The Navina Classic System is intended to promote evacuation of the colon and rectum by instilling water into the lower part of the colon through a rectal catheter which incorporates an inflatable balloon.

The Navina Classic System is composed of a single use rectal catheter with an inflatable balloon, a water container, a control unit for manual control of instillation water flow and manual balloon inflation and deflation, and tubing with integral connectors for connection of the device components.

The Navina Classic System is intended to promote evacuation of the contents of the colon and rectum by instilling water into the lower part of the colon through the rectal catheter which incorporates an inflatable balloon.

The provided document is a 510(k) premarket notification for the Dentsply Sirona Navina Classic System. It focuses on demonstrating substantial equivalence to a predicate device (Peristeen Anal Irrigation System), rather than detailing original clinical performance studies with specific statistical acceptance criteria for a novel AI/device.

Therefore, many of the requested details, such as those related to AI model acceptance criteria, ground truth establishment for test sets, MRMC studies, and standalone algorithm performance, are not applicable or not available in this document because the device itself is a mechanical medical device, not an AI/ML product.

However, I can extract information related to the performance testing that was conducted:

Acceptance Criteria and Reported Device Performance

The document describes non-clinical performance testing against "requirements." While specific numerical acceptance criteria are not explicitly stated in a table format with corresponding reported values, the text indicates that the device met these requirements.

Note: The document states, "The performance of the Navina Classic System satisfactorily met the requirements of the non-clinical bench testing conducted to support substantial equivalence." This implies that internal acceptance criteria were established and met for each test.

Study Details

As the document is a 510(k) for a physical medical device, not an AI/ML product study, many of the requested fields are not applicable (N/A).

1. 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 explicitly quantified in terms of "samples" in a clinical or data sense for bench testing. It refers to the physical units tested to verify performance. The document does not specify the number of units or iterations for each non-clinical test.
   • Data Provenance: N/A for bench testing. These are laboratory tests conducted on the device components.

2. 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):

   • N/A. Ground truth in the context of AI/ML device performance (e.g., image annotation) is not relevant here. For a mechanical device, performance is evaluated against engineering specifications and industry standards. There is mention of "consensus expert review (Emmanuel et al)" for the contraindications and precautions, referencing a published paper by medical professionals, but this is for clinical context, not for establishing ground truth for a test set in the AI sense.

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

   • N/A. This concept applies to human review of data, typically in AI/ML performance studies.

4. 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 mechanical device, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

   • N/A. Not an algorithm-only device.

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

   • For the non-clinical performance data, the "ground truth" or reference for acceptance is against pre-defined engineering specifications, international standards (e.g., ISO 10993 for biocompatibility), and relevant regulatory requirements.

7. The sample size for the training set:

   • N/A. This device does not involve a "training set" in the machine learning context.

8. How the ground truth for the training set was established:

   • N/A. This device does not involve machine learning or a training set.

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