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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 Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen Anal Irrigation System is indicated for use by children (2 years -

The Peristeen™ Anal Irrigation (PAI) System is a Class II device intended for intermittent use that facilitates emptying of the colon/bowel in patients with neurogenic bowel dysfunction. The PAI system consists of a single-use irrigation catheter that incorporates an inflatable balloon to keep the catheter in place during the procedure and retain the water that flows into the colon. The rectal catheter is non-sterile, intended for single-use, and packaged and labeled accordingly. The other components may be used multiple times; usage guidelines are detailed in the labeling. All System components are also provided separately in various accessory packages.

The provided document is a 510(k) premarket notification for the Peristeen™ Anal Irrigation System. It states that no changes have been made to the device design, materials, components, technological characteristics or manufacturing processes of the subject device compared to the predicate. The only change being effected is the release of an updated Instructions For Use (IFU).

Therefore, the document explicitly states: "As such, testing for Performance, Shelf Life and Biocompatibility was not deemed necessary to support substantial equivalence. No clinical testing was performed, referenced, or relied on in the 510(k) for a determination of substantial equivalence."

Because no new performance testing was conducted for this submission, the document does not contain the information required to answer the questions about acceptance criteria and a study proving the device meets those criteria.

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The Peristeen™ Anal Irrigation System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote evacuation of the contents of the lower colon. The Peristeen™ Anal Irrigation System is indicated for use by children (2 years -

The Peristeen™ Anal Irrigation system is a Class II device, consisting of a single-use irrigation catheter with balloon for retention; a control unit with a manual switch that allows for addition of pressure to the water bag, and inflation and deflation of the balloon on the catheter; a bag with a lid to hold water, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system is provided with a nylon storage case. The rectal catheter is single-use, but the other components may be used multiple times.

The provided FDA 510(k) summary for the Peristeen™ Anal Irrigation System (K112860) does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device.

This document describes a medical device (a rectal catheter system) that underwent biocompatibility and mechanical testing. It does not mention any AI/ML components or algorithms, nor does it discuss performance metrics like sensitivity, specificity, or AUC, which are typically found in studies validating AI/ML devices.

Therefore, I cannot provide the requested information. The document explicitly states:

• SUMMARY OF CLINICAL TESTS SUBMITTED (AS APPLICABLE): Not applicable

This means no clinical trials were conducted or submitted as part of this 510(k) to evaluate the device's performance in human subjects, let alone an AI/ML component. The "nonclinical tests" listed are bench tests related to the physical properties and biocompatibility of the catheter.

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The Peristeen™ Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter-which incorporates an inflatable balloon-inserted into the rectum to promote revacuation of the contents of the lower colon. The PAI System is indicated for use by Children (2 years -

The Peristeen™ Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI system does not contain natural rubber latex components.

The provided text is a 510(k) summary for the Peristeen™ Anal Irrigation System, which is a medical device. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the typical sense of a clinical performance study with statistical metrics.

The document states that the Peristeen™ Anal Irrigation System is substantially equivalent to a previously cleared device (K083770). The equivalence is supported by a comparison of design, materials, intended use, and acceptable results from functional performance and biocompatibility testing. This indicates that the "acceptance criteria" here are likely related to engineering specifications, safety standards, and material compatibility, rather than clinical performance metrics like sensitivity, specificity, or reader agreement.

Since the document focuses on substantial equivalence for a physical medical device, not an AI/algorithm-based diagnostic tool, most of the requested information (like sample size for test sets, expert ground truth, MRMC studies, standalone performance, training set details) is not applicable or not provided in this specific type of regulatory filing.

However, I can extract the relevant information that is present:

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

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

• Not Applicable/Not Provided. The submission relies on functional performance and biocompatibility testing and substantial equivalence to a predicate device, not clinical performance data from a patient test set in the context of diagnostic accuracy.

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

• Not Applicable/Not Provided. This information is relevant for diagnostic accuracy studies, which are not detailed in this 510(k) summary for a physical irrigation system.

4. Adjudication method for the test set:

• Not Applicable/Not Provided.

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-based diagnostic device.

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

• No. This is not an AI/algorithm-based diagnostic device.

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

• For functional performance and biocompatibility testing, the ground truth would typically be established by established engineering standards, material science testing protocols, and biological safety evaluations.
• For substantial equivalence, the ground truth is the performance, design, and indications for use of the predicate device.

8. The sample size for the training set:

• Not Applicable/Not Provided. This information is relevant for AI models, not for a physical medical device like the Peristeen™ Anal Irrigation System.

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

• Not Applicable/Not Provided.

Summary of the "study" that proves the device meets acceptance criteria:

The "study" referenced in the document is a comparison to a legally marketed predicate device (K083770) combined with functional performance and biocompatibility testing.

• Comparison to Predicate: The report states: "Substantial equivalence of the Peristeen™ Anal Irrigation System is supported by a comparison of the design, materials, and intended use compared to the predicate..." This comparison essentially serves as the primary "study" for establishing regulatory acceptance based on the 510(k) pathway. If the new device is sufficiently similar to an already cleared device in terms of safety and effectiveness, it can be cleared.
• Functional Performance and Biocompatibility Testing: The document mentions "acceptable results from functional performance and biocompatibility testing." While the details of these tests are not provided in this summary, they would involve engineering tests to ensure the device operates as intended (e.g., proper water flow, balloon inflation/deflation, pressure control) and material tests to ensure the components are safe for human contact (e.g., ISO 10993 series of standards). The "acceptance criteria" for these would be specific engineering and biocompatibility thresholds defined prior to testing.

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InsertEase™ is to be used as a device for the insertion of prescription and over the counter suppositories into the rectum

The rectal suppository applicator, to be called, InsertEase™, is a plastic, non sterile, single use device for the insertion of prescription and over the counter suppositories into the rectum. The design of InsertEase™ is substantially equivalent to a vaginal applicator used for inserting vaginal suppositories, creams and tampons. One piece, the plunger, will be movably coupled within a second piece, the barrel. The barrel has an open end to receive and hold a suppository, which is then inserted into the anus. The plunger is then pushed into the barrel and places the suppository within the rectum. InsertEase™ functions in the same way and manner that vaginal applicators insert vaginal suppositories and tampons.

The provided text describes a 510(k) submission for a rectal suppository applicator called "InsertEase™". The core of the submission revolves around demonstrating substantial equivalence to already legally marketed predicate devices, primarily vaginal applicators.

Here's an analysis of the acceptance criteria and the study as described in the document, keeping in mind that the primary "study" is a comparison to predicate devices rather than a traditional clinical trial:

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are not quantitative performance metrics like sensitivity or specificity. Instead, the acceptance criteria are met if the device demonstrates equivalent:

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

• Sample Size for Test Set: Not applicable in the context of a 510(k) based on substantial equivalence to a physical device. There wasn't a "test set" of performance data generated, but rather a comparison of technical characteristics and intended use.
• Data Provenance: The "data" primarily comes from the established regulatory classifications and descriptions of existing predicate devices marketed in the United States (implied by FDA regulation). This is retrospective in the sense that it relies on the known characteristics and regulatory history of pre-existing devices.

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 the sense of expert review of performance, was not established for InsertEase™ using a test set. The "ground truth" for the substantial equivalence claim relies on the established regulatory framework and common understanding of how such applicators function, and their safety/effectiveness as previously determined by the FDA for similar devices.

4. Adjudication method for the test set

Not applicable, as there was no test set or expert adjudication process described for performance evaluation.

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 is a medical device for physical application, not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study was conducted or relevant to this submission.

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

Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for this submission is based on:

• Predicate Device Characteristics: The established design, materials, intended use, and functional principles of legally marketed vaginal applicators (Product Code: 884.4520(7)) and other relevant devices like Enema Kits (876.5210) and Rectal Dilators (876.5450), and the precedent set by the FDA regarding the Rectal Speculum vs. Vaginal Speculum.
• Regulatory Precedent: The FDA's prior determination of substantial equivalence for devices with similar function but different anatomical sites (e.g., vaginal vs. rectal speculums).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

Not applicable, as there is no training set for this type of device submission.

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The Peristeen Anal Irrigation (PAI) System is intended to instill water into the colon through a rectal catheter - which incorporates an inflatable balloon - inserted into the rectum to promote evacuation of the contents of the lower colon. The PAI System is indicated for use by adolescent (12 years -

The Peristeen Anal Irrigation system consists of a single-use irrigation catheter with a balloon for retention; a control unit with a manual switch to add pressure to the water bag, inflate and deflate the balloon on the catheter; a bag with a lid to hold water or isotonic saline solution, leg straps that may be used to fasten the control unit and tubing to the thigh, and tubes with connectors. The system may be purchased with a carrying case (toilet bag). The rectal catheter is single-use, but the other components may be used multiple times. Accessory kits are available for the components. The PAI System is provided nonsterile and is latex free. It is intended for single patient use only.

The provided text describes a medical device, the Peristeen™ Anal Irrigation System, and its substantial equivalence to predicate devices based on design, materials, intended use, and functional performance and biocompatibility testing. However, the document does not contain specific acceptance criteria or a detailed study description with performance metrics that would allow for the complete fulfillment of your request.

The document primarily focuses on obtaining 510(k) clearance by demonstrating substantial equivalence to existing devices. This type of submission often relies on a comparison of technical characteristics and safety data rather than a detailed comparative effectiveness study with specific performance thresholds.

Therefore, I cannot provide the requested table or detailed study information because it is not present in the provided text. The summary and conclusions from the nonclinical tests only state "acceptable results from functional performance and biocompatibility testing" without quantifying these results or defining acceptance criteria.

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AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON.

AMSure® Cleansing Enema Set

This document, K974042, is a 510(k) premarket notification decision letter for the AMSure® Cleansing Enema Set. It declares the device substantially equivalent to legally marketed predicate devices.

The information provided does not contain the details typically sought when describing acceptance criteria and a study to prove a device meets those criteria in the context of a new, potentially AI-driven, medical device. This is largely because the document pertains to a Class I medical device (a cleansing enema set) cleared in 1997, which would not involve the complex performance studies, statistical analysis, or AI-specific criteria requested in the prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria development, study design, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth establishment, or sample sizes related to a performance study for this device based on the given text.

The closest information provided is:

• Device Name: AMSure® Cleansing Enema Set
• Indications For Use: "AMSure CLEANSING ENEMA SET IS A DEVICE INTENDED TO INSTILL WATER INTO COLON THROUGH A NOZZLE INSERTED INTO THE RECTUM TO PROMOTE EVACUATION OF THE CONTENTS OF THE LOWER COLON."
• Regulatory Class: I (21 CFR §876.5210/Product Code: 78 FCE)

For Class I devices like this, substantial equivalence is often based on fundamental design, materials, and intended use being similar to existing legally marketed devices, rather than extensive clinical performance studies as would be required for higher-risk devices or novel AI/software as a medical device. The "acceptance criteria" here implicitly refer to meeting the general controls provisions of the Act and demonstrating substantial equivalence to a predicate device, which would involve showing that the device is as safe and effective as the predicate.

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