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The Naväge Nose Cleaner is intended to help relieve nasal and/or sinus congestion and stuffiness by washing and moisturizing the nasal cavity with a pressure-controlled stream of irrigant rinse.

The Naväge Nose Cleaner ("Naväge") is a powered nasal irrigator intended for OTC use to wash and moisturize the nasal cavity. There are many nasal irrigation devices in commercial distribution in the US, and Naväge is substantially identical to those devices in terms of intended use and indications for use. It is similar in terms of mechanical functionality with the single exception that in addition to using positive pressure, Naväge simultaneously uses negative pressure (suction). That is, the device uses a combination of positive pressure (gravity) to introduce irrigant rinse into the nasal cavity, and negative pressure (powered suction) to aspirate the rinse out of the nasal cavity. The simultaneous use of positive and negative pressure makes it possible for the device to be self-contained so that after washing through the nasal cavity, the irrigant rinse can flow into a removable collection tank attached to the device. This provides an improved nasal irrigation experience resulting from functional simplicity, superior ergonomics, and less mess than currently available devices.

The provided text describes the Naväge Nose Cleaner and its substantial equivalence to predicate devices, focusing on its functional characteristics rather than clinical performance or AI integration. Therefore, many of the requested categories related to acceptance criteria, study design for AI models, ground truth, and expert evaluation are not directly available in this document.

However, I can extract information related to the device's performance specifications and the studies conducted to demonstrate substantial equivalence for certain aspects.

Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the typical sense of a pre-defined threshold for clinical efficacy but rather performance specifications for mechanical operation and demonstrations of equivalence for usability and safety.

Study Details

The document refers to studies conducted to demonstrate substantial equivalence, but it does not detail the methodology for all of them.

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

   • Flow Rate and Pressure Performance Data: No specific sample size or data provenance (country of origin, retrospective/prospective) is provided for the "Performance testing data for flow rate of irrigant and pressure." This likely refers to engineering bench testing rather than human subject data.
   • Comprehension Study: No specific sample size or data provenance is provided for the "comprehension study of the subject device's Instructions for Use."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The performance testing appears to be objective mechanical measurements, not dependent on expert ground truth in a clinical sense. The comprehension study likely involved consumer participants rather than experts establishing a "ground truth."

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable based on the information 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: Not applicable. This device is a physical medical device (nasal irrigator), not an AI diagnostic or assistive technology.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm or AI system.

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

   • For flow rate and pressure: The "ground truth" would be the objective measurements obtained from laboratory equipment.
   • For biocompatibility: Compliance with ISO 10993 parts 5 and 10 constitutes the basis for determining biocompatibility.
   • For electrical safety: Compliance with IEC-60601-1 constitutes the basis for determining electrical safety.
   • For consumer comprehension: The "ground truth" would likely be the scores or performance on consumer comprehension tasks.

8. The sample size for the training set: Not applicable. The device is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

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The RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include:

• Rhinitis (as a symptom of colds, allergies, etc.) .
• . Both Acute and Chronic Sinusitis

RinoFlow Micronized E.N.T. Wash System should be used with a physiological saline solution. "Tap" water is not recommended.

RinoFlow Micronized E.N.T. Wash System is intended to be used by adults and pediatrics (age ≥3) in the home or doctor's office, and is available over-the-counter.

The RinoFlow Micronized E.N.T. Wash System provides aerosol irrigation with positive pressure. The device has two settings that facilitate a two-phase procedure for nasal irrigation and upper respiratory tract humidification. Phase One washes the nasal cavity and nasopharynx by hydrating and softening the mucus with a stream of large-particle aerosol, causing drainage to occur. Phase Two applies the aerosol stream with higher velocity that reaches the paranasal sinuses.

The RinoFlow E.N.T. Wash System consists of a Micronizer-Chamber connected by a length of tubing to a lubricant-free, sealed piston compressor. The compressor incorporates a reciprocating power pump design.

The Micronizer-Chamber , made of synthetic, washable polycarbonate material, is in four essential parts: the body, the inner shell, the outer shell, and the baffle. Tubing is connected at the bottom of the body. At the top of the body is an air injector covered by a baffle. The bell-shaped inner shell surrounds the air injector and baffle and tapers to an outlet at the top for the aerosol stream to exit. The rim at the bottom of the shell fits in a groove at the top of the body. The space inside the inner shell forms the inner chamber, where the liquid is micronized. The outer shell fits over the body, surrounding the inner shell and its contents. The outer shell is cylindrical and tapers to an outlet at the top. The outer shell can be rotated to two different positions, gliding vertically over the body. In the first position, the outer shell's outlet is vertically aligned slightly above that of the inner shell. The space between the outer shell and the inner shell forms the outer chamber, where the drainage is collected. This chamber is sealed at the bottom by an O-ring. The space between the very tops of the inner and outer shells forms an opening for the drainage to descend into the outer chamber during Phase 1. Four holes around the rim at the top of the outer shell provide the primary means for excess nasal drainage to enter the outer chamber. These holes also provide an outlet for patient exhalation.

When rotated to the second position, the outer shell lowers so its outlet meets that of the inner shell, joining the holes to create a single outlet. This configuration increases the velocity of the aerosol stream. The outer chamber is unaffected by this change in shell configuration, and any residual drainage will continue to enter the chamber via the four holes along its rim.

The document provided is a 510(k) premarket notification for the "RinoFlow Micronized E.N.T. Wash System". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study with specific acceptance criteria and performance outcomes in the way a clinical trial for a novel device would.

Therefore, the information typically requested regarding acceptance criteria and a study proving a device meets them (as per the prompt's structured questions) is not directly available in this document. The safety and effectiveness of the RinoFlow system are primarily established through a comparison to a predicate device and performance-related testing to ensure it functions as intended.

Here's an analysis based on the provided text, addressing the prompt's points where applicable, and noting where information is not present:

1. Table of Acceptance Criteria and Reported Device Performance: This document does not contain a table of acceptance criteria and reported device performance in the typical sense of a clinical outcomes study with quantitative metrics. The acceptance criteria for this 510(k) revolve around demonstrating substantial equivalence to the predicate device and compliance with relevant standards.

   The "reported device performance" is summarized conceptually as:

   • Substantial Equivalence: The RinoFlow Micronized E.N.T. Wash System is substantially equivalent to the Ethicare Puls-ator Irrigator Lavage (K821481).
   • Safety and Effectiveness: Verified through "performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing."
   • Compliance: "Tested and found compliant with the standards referenced in the 'Draft FDA Reviewer Guidance for Premarket Notifications,' November 1993."

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

   • Sample Size: Not applicable in the context of a clinical test set. The document refers to "performance-related testing" which typically involves engineering and bench testing, not patient-based data. No patient test set size is mentioned.
   • Data Provenance: Not applicable for a clinical test set. The testing performed was technical (Electrical Safety, EMC, Mechanical, Environmental), likely done in a laboratory setting by the manufacturer or a contracted lab.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications: This information is not provided and is generally not relevant for this type of technical performance testing. Ground truth, in a clinical context, would typically refer to a definitive diagnosis or outcome, which is not being assessed here.

4. Adjudication Method for the Test Set: This is not applicable as there is no human-reader-based test set or ground truth adjudication described.

5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: No MRMC study was mentioned or performed. This type of study assesses human reader performance, usually in diagnostics, which is not the primary focus of this device (a therapeutic/irrigation system).

6. Standalone Performance (Algorithm Only without Human-in-the-Loop): This is not applicable. The RinoFlow system is a physical medical device, not an algorithm, and its performance is inherently tied to its use by a human.

7. Type of Ground Truth Used: The "ground truth" here is compliance with technical specifications and standards (e.g., electrical safety standards, electromagnetic compatibility standards) and functional performance demonstrating that the device operates as intended for its stated use. It's not based on expert consensus, pathology, or outcomes data from a clinical trial, but rather on engineering and performance testing against established benchmarks and the predicate device's function.

8. Sample Size for the Training Set: This is not applicable. The device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established: This is not applicable.

In summary, the 510(k) submission for the RinoFlow Micronized E.N.T. Wash System demonstrates substantial equivalence to a predicate device through engineering and performance testing. It does not present data from a clinical study with outcome-based acceptance criteria or a "test set" in the sense of patient data evaluated by experts, as would be expected for a diagnostic or higher-risk device seeking de novo clearance or PMA approval.

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RinoFlow Micronized E.N.T. Wash System aerosolizes solutions intended for nasal and sinus irrigation and humidification of the upper respiratory tract. RinoFlow is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh, and mucopurulent or crusty secretions. Such conditions and disorders include:

• . Rhinitis
• Both Acute and Chronic Sinusitis .

RinoFlow Micronized E.N.T. Wash System should be used with a physiological saline solution. "Tap" water is not recommended.

The RinoFlow Micronized E.N.T. Wash System provides aerosol irrigation with positive pressure. The device has two settings that facilitate a twophase procedure for nasal irrigation and upper respiratory tract humidification. Phase One washes the nasal cavity and nasopharynx by hydrating and softening the mucus with a stream of large-particle aerosol, causing drainage to occur. Phase Two applies the aerosol stream with higher velocity that reaches the paranasal sinuses.

The RinoFlow E.N.T. Wash System consists of a Micronizer-Chamber connected by a length of tubing to a lubricant-free, sealed piston compressor. The compressor incorporates a reciprocating power pump design.

The provided text describes the RinoFlow Micronized E.N.T. Wash System, a new device for nasal and sinus irrigation and humidification of the upper respiratory tract.

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance

The submission states that:
"The safety and effectiveness of the RinoFlow Micronized E.N.T. Wash System were verified through performance-related testing that consisted of Electrical Safety, Electromagnetic Compatibility, Mechanical and Environmental Testing. The RinoFlow Micronized E.N.T. Wash System was tested and found compliant with the standards referenced in the "Draft FDA Reviewer Guidance for Premarket Notifications," November 1993."

This indicates that the acceptance criteria were based on compliance with specific standards outlined in the mentioned FDA guidance document. However, the exact quantitative acceptance criteria (e.g., specific thresholds for electrical safety, EMI levels, mechanical durability) are not detailed in this document.

Table 1: Acceptance Criteria and Reported Device Performance (Summary based on available information)

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

The document states: "Testing was performed to demonstrate that the performance of the RinoFlow Micronized E.N.T. Wash System in its intended environment is as safe and effective as that of the legally marketed predicate device."

No specific sample size for a test set is mentioned. The "testing" refers to technical performance evaluations (electrical, mechanical, environmental) rather than a clinical study with patient data. Therefore, there is no data provenance (e.g., country of origin, retrospective/prospective) in the context of clinical data for this type of device submission.

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

Since the testing described is primarily technical performance testing of the device itself (electrical safety, mechanical, etc.) and not an assessment of clinical outcomes against a ground truth diagnosis or condition, there were no experts used to establish ground truth for a clinical test set. The "ground truth" for these types of tests are the specifications and standards themselves.

4. Adjudication Method for the Test Set

As there was no clinical test set requiring expert interpretation or diagnosis, no adjudication method was applicable.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or at least not described in this document. The submission focuses on technical performance and substantial equivalence to a predicate device, not on comparing performance with and without AI assistance (as AI is not mentioned in the context of this device).

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

This device, the RinoFlow Micronized E.N.T. Wash System, is a physical medical device (a powered nasal irrigator), not an algorithm or AI system. Therefore, the concept of "standalone algorithm performance" is not applicable to this submission. The device itself operates independently of human interpretation in terms of its function (e.g., aerosolizing solutions).

7. The Type of Ground Truth Used

The "ground truth" for the testing described in this submission is the established engineering standards and specifications for electrical safety, electromagnetic compatibility, mechanical performance, and environmental robustness, as outlined in the "Draft FDA Reviewer Guidance for Premarket Notifications, November 1993." The device was tested for compliance against these technical benchmarks. There is no biological or diagnostic "ground truth" in the typical sense (e.g., pathology, clinical outcomes) mentioned for the verification of this device.

8. The Sample Size for the Training Set

This submission pertains to a physical medical device, not a machine learning model or algorithm. Therefore, the concept of a "training set" and its sample size is not applicable.

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

As explained above, there is no training set for this type of device.

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