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The device is designed for using suction to remove nasal secretion and mucus in Children (age 2~12 years old) at home environment.

The additional spray/irrigation function helps moisten and loosen/soften nasal secretions in Children (over 3 years old), making them easier to aspirate.

This AViTA nasal aspirator (Model NS13) consists of a pump that can generate negative pressure suction, a silicone tip for contacting the nostrils, a collecting nasal mucus, a sprayer head module for moistening the nasal cavity, and two buttons that activate suction and sprayer functions. This nasal aspirator is powered by two AAA batteries. The accessories are the batteries, silicone tips.

The provided text describes the performance testing and validation for the AViTA Nasal Aspirator (Model NS13). However, it does not contain the specific details required to fully address all parts of your request, particularly regarding acceptance criteria for a "device" in the context of an AI/ML medical device. This document describes a physical medical device (nasal aspirator), not an AI/ML algorithm. Therefore, many of your questions related to AI/ML specific criteria (such as "sample size for the training set," "number of experts used to establish ground truth," "MRMC comparative effectiveness study," etc.) are not applicable to the information provided.

Based on the provided text, here's what can be extracted and inferred:

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

The document lists performance specifications for the device and indicates that testing was conducted to demonstrate these specifications were met. While it doesn't provide a direct "acceptance criteria vs. reported performance" table for each specific parameter, it states that "The results of those testing show that the required limits for mean difference and standard deviation are fulfilled by the subject device."

• Irritation and skin sensitization (ISO 10993-10)
• Systemic toxicity (ISO 10993-11)
• Irritation (ISO 10993-23) | "The biocompatibility evaluation and testing of the Product name was conducted in accordance with the following standards and guidance... [and passed]." |
  | Cleaning and Disinfecting | - 1000 times cleaning verification with mild non-abrasive soap and 70℃ water and soft dry cloth wiping | "This product has passed the cleaning verification... confirming that the product can be used continuously without any functional abnormalities." |
  | Safety (Electrical/Medical Device Standards) | - IEC 60601-1:2005+A1:2012 (Medical electrical equipment - General requirements for basic safety and essential performance)
• IEC 60601-1-11:2010 (Medical electrical equipment - Requirements for medical electrical systems used in the home healthcare environment) | "the subject device has passed the relevant tests of IEC 60601-1" and "has passed the relevant tests in accordance with IEC 60601-1-11" |
  | Software Verification and Validation | - "Basic documentation" level of concern | "Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance..." |

In the comparison table on page 8, the subject device's performance specifications are listed, which can be interpreted as its target acceptance criteria for technical performance:

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

The document does not specify "sample size" in terms of patient data or clinical study cohorts, as this is a K510 submission for a physical device, not an AI/ML algorithm. The performance testing refers to engineering and laboratory tests on the device itself.

• Data Provenance: Not applicable in the sense of patient data. The tests are conducted on the device hardware and software.

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

Not applicable. Ground truth as typically defined for AI/ML (e.g., expert labels on medical images) is not relevant for the testing of this physical nasal aspirator. The "ground truth" here is the adherence to established technical standards and engineering specifications.

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

Not applicable. This is not a study involving human adjudication of results in the context of an AI/ML algorithm.

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-assisted diagnostic device. The document explicitly states "Clinical Studies None."

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 AI algorithm.

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

The "ground truth" for this device's performance is adherence to established international standards (e.g., ISO, IEC) for biocompatibility, electrical safety, and general performance, as well as the manufacturer's own internal specifications (e.g., vacuum pressure, sound level).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The document states that the AViTA Nasal Aspirator (Model NS13) meets its acceptance criteria through a series of non-clinical performance tests, biocompatibility tests, cleaning and disinfecting tests, and safety tests (electrical and general).

• Non-Clinical Performance Testing: Implied to include assessments of vacuum pressure, sound level, spray capacity, and operating/storage conditions. The document states these tests "show that the required limits for mean difference and standard deviation are fulfilled."
• Biocompatibility Testing: Conducted in accordance with recognized ISO 10993 standards (Parts 5, 10, 11, and 23) for cytotoxicity, irritation, skin sensitization, and systemic toxicity. The device "passed" these evaluations.
• Cleaning and Disinfecting Test: The device underwent "1000 times" of cleaning verification, confirming its ability for continuous use without functional abnormalities.
• Safety Testing: Compliance with IEC 60601-1 and IEC 60601-1-11 for basic safety and essential performance, particularly for home healthcare environments, was verified. The device "passed" these relevant tests.
• Software Verification and Validation: Performed according to FDA guidance for "Basic documentation" level of concern software in medical devices, demonstrating the software performs as intended.

The overall conclusion is that these non-clinical data support the device's safety and effectiveness, and its comparable performance to predicate devices already on the market.

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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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This device is designed for using intermittent suction to remove nasal secretion and mucus in Children (age 2-12 years old) at home environment.

AVITA NS1 Nasal Aspirator is a portable, DC powered device intended to provide the suction function to aspirate children's nasal secretion. The device consist of a pump that is driven by Two (2) 1.5V AA size alkaline batteries , soft aspiration tip , collection cup and Music IC with 12 Chord Melody.

The provided text describes a 510(k) summary for the AVITA Nasal Aspirator, Model NS1 Series. However, it does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The document focuses on:

• Device Identification: Submitter, device name, classification, predicate devices.
• Intended Use: For intermittent suction to remove nasal secretions in children aged 2-12 at home.
• Device Description: Portable, DC-powered, uses AA batteries, soft aspiration tip, collection cup, and music IC.
• Performance Requirements: States conformance to IEC 60601-1 and IEC 60601-1-2 for operating specifications, safety, and EMC. This is a general statement of conformance to standards, not specific acceptance criteria or a study demonstrating achievement.
• Conclusion: Declares substantial equivalence to predicate devices based on "same intended use and similar technological characteristics" and "bench testing contained in this submission demonstrates that any differences in their technological characteristics do not raise any new questions of safety or effectiveness."
• FDA Correspondence: A letter from the FDA confirming substantial equivalence and outlining regulatory requirements.

Therefore, I cannot populate the requested table or provide details about the study as the information is not present in the provided text.

To provide the requested information, the document would need to include:

1. Specific quantifiable acceptance criteria (e.g., minimum suction pressure, maximum noise level, battery life, mucus removal efficiency).
2. Details of a performance study conducted to measure these criteria. This would typically include:
   • Study design (e.g., bench test, clinical trial).
   • Methodology for measuring performance.
   • Results of the measurements.
   • Comparison of results against the acceptance criteria.

Without this information, I can only state that the document indicates the device conforms to IEC 60601-1 and IEC 60601-1-2 requirements and that "bench testing" was performed to demonstrate substantial equivalence, but it does not elaborate on the specific criteria, the test results, or the study details.

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The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device 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 crust secretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis. It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

The Aardvark device is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of salinc into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can bc used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement mancuver. The device consists of a hand held battery opcrated unit with a disposable tip portion. A charger is provided with the device.

This document states the device went through "verification testing under the company's Design Control Process" which "confirmed the device's conformance with specifications." However, it does not include details about specific acceptance criteria for performance, nor does it describe a study that provides objective performance data or establishes a ground truth.

Therefore, for many of the requested categories, the information is not present in the provided text.

Here's a breakdown based on the input document:

1. A table of acceptance criteria and the reported device performance
   This information is not provided in the document. The document only states: "The Aardvark device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicates." This indicates performance was assessed against internal specifications, but the specific criteria and results are not reported.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   This information is not provided in the document. The document mentions "verification testing" but gives no details about sample size or data provenance for any test set.

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)
   This information is not provided in the document. There is no mention of a "test set" in the context of expert review or ground truth establishment.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   This information is not provided in the document. There is no mention of a "test set" in the context of adjudication.

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
   This information is not applicable/not provided. The device described is a powered nasal irrigator and aspirator, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   This information is not applicable/not provided. The device described is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   This information is not provided in the document. There is no discussion of ground truth as it pertains to performance evaluation of the device against a gold standard for a specific diagnostic task. The "verification testing" mentioned would typically refer to engineering and functional performance, not clinical diagnostic accuracy.

8. The sample size for the training set
   This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm that requires a training set.

9. How the ground truth for the training set was established
   This information is not applicable/not provided. The device is a physical medical device, not a machine learning algorithm.

Summary of what is stated regarding performance:

• Acceptance Criteria/Performance Goal: The device was tested for "conformance with specifications." These specifications were considered "substantially equivalent" to those of the predicate devices. No specific quantitative criteria or performance metrics are listed in the document.
• Study Description: The document refers to "verification testing under the company's Design Control Process." No details about the study design, methodology, or results are provided beyond the statement that it confirmed conformance.

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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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