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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

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I am sorry, but the provided FDA 510(k) Clearance Letter for the "Baby Nasal Aspirator" does not contain information about acceptance criteria and a study proving the device meets those criteria.

This document is a formal clearance letter issued by the FDA, confirming that the device is substantially equivalent to legally marketed predicate devices. It focuses on regulatory aspects such as:

• Device Identification: Trade name, regulation number, product code, regulatory class.
• Substantial Equivalence Determination: The FDA's finding that the device is equivalent to existing legal devices.
• Regulatory Requirements: Information about general controls (registration, listing, GMP, labeling, misbranding, adulteration), additional controls for Class II/III devices, Quality System (QS) regulation, medical device reporting, Unique Device Identification (UDI) system, and contact information for regulatory advice.
• Indications for Use: The stated purpose and target user group for the device.

The letter explicitly states: "We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

The letter does not include details on:

• Specific performance acceptance criteria for the device itself (e.g., suction pressure, battery life, noise levels).
• Any studies or test results demonstrating the device meets such criteria.
• Information about test set sample sizes, data provenance, expert ground truth establishment, or clinical study methodologies (like MRMC studies) as these are typically associated with performance data for more complex or AI/imaging devices, not simple mechanical devices like a nasal aspirator.

For a device like a baby nasal aspirator, the "acceptance criteria" and "proof of meeting them" would typically involve:

• Bench testing: Measuring suction pressure, flow rate, durability, material biocompatibility, and safety (e.g., absence of sharp edges, proper battery compartment sealing).
• Biocompatibility testing: To ensure materials are safe for contact with human tissue.
• Electrical safety testing: If powered, to ensure it meets relevant electrical safety standards.
• Usability testing: To ensure it can be safely and effectively used by the intended users (parents or caregivers).

However, none of these specific test results or their underlying methodologies are detailed in the provided FDA clearance letter. The letter signifies regulatory clearance based on a review of the submitted documentation, which would have included these types of test reports, but it does not reproduce them within the letter itself.

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The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.

Electric Nasal Aspirator consists of silicone nozzle which has three models (conical nozzle, flat nozzle, angled nozzle), collection cup, air tube, tweezers, charging cable-USB and aspirator body. The Electric Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line.

The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

The provided text is a 510(k) clearance letter and summary for an Electric Nasal Aspirator. It details the device's characteristics and its comparison to a predicate device, along with the performance data submitted to demonstrate substantial equivalence.

However, the nature of this medical device (a nasal aspirator, essentially a suction pump) means the "acceptance criteria" and "study that proves the device meets the acceptance criteria" are focused on engineering performance parameters (e.g., vacuum pressure, flow rate, safety standards) rather than clinical efficacy studies with human subjects that measure the device's ability to diagnose or treat a condition, which is what is typically discussed in the context of "human-in-the-loop performance," "ground truth," "expert consensus," and "MRMC studies" for AI/software-as-a-medical-device (SaMD).

Therefore, the requested information elements related to AI/SaMD (e.g., training set, test set, expert adjudication, MRMC studies, standalone performance, ground truth for image analysis) are not applicable to this specific device submission. The "study" here is a series of bench tests and electrical/biocompatibility assessments.

Below is a breakdown of the applicable acceptance criteria and the "study" (bench testing) as described in the provided text, while explicitly stating when an element is not applicable.

Acceptance Criteria and Device Performance for Electric Nasal Aspirator (K244033)

1. Table of Acceptance Criteria and Reported Device Performance

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The AIRO Suction Unit, Model AIRO-01, is a portable, battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.

The AIRO Suction Unit, Model AIRO-01, is a compact, handheld, portable battery-powered medical suction device intended for use in emergency airway management procedures by professional medical providers such as emergency medical technicians, paramedics, and hospital personnel. The device is not intended for contact with patient tissue during procedures. It is intended for intermittent operation to remove secretions, such as blood or vomit, during airway management procedures and other procedures for which an intermittent suction medical device may be applicable. The device is indicated for the suctioning of adult patients.

The provided FDA 510(k) clearance letter for the AIRO Suction Unit (AIRO-01) is for a powered suction pump. Such devices are typically evaluated based on their physical and functional performance rather than AI/ML algorithm performance.

Therefore, many of the requested categories related to AI/ML specific studies (like MRMC studies, sample sizes for AI training sets, ground truth establishment for AI, number of experts for ground truth, adjudication methods) are not applicable to this type of medical device submission.

Here's a breakdown of the available information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document states the device was tested to ISO 10079-1 and ISO 10079-4, and all applicable clauses were successfully executed, meeting the established criteria. However, the specific quantitative acceptance criteria and detailed performance results are not explicitly provided in the excerpt. We can infer the performance from the device description and the ISO standards it complies with.

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The Electric Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Electric nasal aspirator (model: BC026, BC025 and BC023) consists of main unit, and suction portion working together as one unit. The Electric nasal aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

The differences between BC026, BC025, and BC023 are as follows:

1. BC026 has 5 suction levels, while BC023 and BC025 have 3 suction levels.
2. BC026 and BC023 have "Light" function for distracting and pacifying the child. BC025 does not have this function.
3. BC026 and BC023 can pause suction during the suction process. BC025 does not have this feature.
4. BC026 and BC023 have 4 buttons, BC025 has 2 buttons.
5. In addition, BC026, BC025, and BC023 have different Display, Size, Weight, and Appearance.

The provided FDA 510(k) clearance letter and summary for the Electric Nasal Aspirator do not contain specific acceptance criteria for device performance such as sensitivity, specificity, accuracy, or other diagnostic metrics. This device is a powered suction pump and not a diagnostic device that would typically have such performance criteria. The clearance is based on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical safety and performance testing.

Therefore, many of the requested fields cannot be extracted directly from the provided text as they pertain to clinical performance studies (e.g., sample size for test set, number of experts, adjudication method, MRMC studies, standalone performance, ground truth establishment) that were explicitly not performed.

Here's the information that can be extracted, and an explanation for what cannot:

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

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The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.

The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "ATMOS C 051 Thorax," a powered suction pump for thoracic drainage. While it discusses performance tests and adherence to various standards, it does not contain the detailed clinical study data typically found in a clinical trial report or a comprehensive technical submission.

Therefore, I cannot extract answers for many of your specific questions related to acceptance criteria, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set details from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance bench testing, software validation, biocompatibility testing, human factors validation, and risk management.

However, I can provide information on what is explicitly stated or can be inferred from the document regarding the acceptance criteria and the nature of the study.

Here's what can be extracted:

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

The document mentions that "Performance tests were carried out to ensure that the subject device functions as intended and meet design specifications." and "Risk analysis was carried out based on acceptance criteria established in accordance with ISO 14971." However, the specific numerical acceptance criteria or the direct reported performance values for each criterion are NOT provided in this summary.

The document lists the following categories of performance tests conducted with "no unexpected results or significant deviations":

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes bench testing and validation activities rather than a typical clinical study with a "test set" of patient data. Therefore, the concept of sample size as it applies to patient data is not relevant here. The "tests" refer to engineering and quality assurance activities. No country of origin for data or retrospective/prospective nature is mentioned as it's not a clinical data study.

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 as there is no mention of clinical "ground truth" derived from expert interpretation in this document. The tests performed are technical and engineering-focused (e.g., flow rates, vacuum levels, battery performance), with human factors validation likely involving usability experts or human factors engineers, but their specific qualifications and number are not detailed.

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

This information is not provided as it's relevant for clinical adjudication of medical images or diagnoses, not for the technical bench testing described.

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 MRMC study was conducted or mentioned. This device is a powered suction pump, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical medical device (suction pump), not a software algorithm or AI.

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

The "ground truth" for the tests mentioned are engineering specifications, international standards (IEC, ISO), and regulatory guidance documents (FDA guidance). For example, for flow rate, the "ground truth" would be the measured flow rate compared against the predefined design specification. For human factors, it would be the assessment of safety and effectiveness of use against defined usability goals and risk analysis.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no "training set."

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

This question is not applicable for the reason stated above.

In summary, the provided document details a 510(k) submission for a non-AI medical device (powered suction pump). The "studies" proving it meets acceptance criteria are predominantly non-clinical bench tests and validation activities against established engineering specifications, international standards, and regulatory guidelines, rather than clinical trials that generate patient data and require expert ground truth establishment.

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Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Geon Nasal Aspirator, model S2, is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old). Geon (S2) Nasal Aspirator is intended for over-the-counter (OTC) use at home environment. The main principle of operation is to utilize a pump to generate negative pressure in the suction system, which allows nasal secretions to flow into the device container.

The Geon (S2) Nasal Aspirator is a hand-held, non-invasive, electronic medical device that provides negative pressure to remove nasal secretions and mucus from children (age 2-12 years old) at home environment.

Here's an analysis of the acceptance criteria and the study proving the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a separate "test set" in the context of clinical or comparative studies with a patient population. Instead, the performance evaluations were conducted through verification testing of the device's technical specifications.

• Sample Size: The document doesn't explicitly state the number of units tested for suction vacuum and noise. However, it indicates that "For Model S2, no individual differences exceed the spective tolerance of suction vacuum and noise after the cleaning and disinfection procedure," implying multiple units or multiple measurements were taken to confirm consistency.
• Data Provenance: The document does not provide details on the country of origin of the data or whether it was retrospective or prospective, as the testing described appears to be bench-top engineering verification rather than a clinical study.

3. Number of Experts Used to Establish Ground Truth and Their Qualifications:

Not applicable. The ground truth for this device's performance is based on engineering specifications and direct physical measurements (suction vacuum and noise levels) rather than expert interpretation of clinical findings.

4. Adjudication Method for the Test Set:

Not applicable. As a bench-top engineering verification, there was no subjective judgment from experts requiring an adjudication method. The measurements against the specified tolerances determined success or failure.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not conducted. This type of study is typically used for diagnostic devices where human readers interpret medical images or data. The Geon (S2) Nasal Aspirator is a therapeutic/extraction device, and its performance is evaluated based on physical parameters like suction and noise, not diagnostic accuracy requiring human interpretation.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Yes, the testing described is a standalone performance evaluation of the device. The device's performance (suction vacuum and noise) was measured directly on the device itself without human intervention in operating it beyond standard use, or human interpretation of outputs.

7. Type of Ground Truth Used:

The ground truth used was engineering specifications and direct physical measurements. The device's suction vacuum was measured in kPa and its noise level in dB, and these measurements were compared against pre-defined tolerance ranges established by the manufacturer.

8. Sample Size for the Training Set:

Not applicable. This device is a hardware product, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning.

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

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

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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 Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment.

The Nasal Aspirator consists of silicone tips which has three models (A, B, C), host, tube, mucus collector. The accessory are charging cable-USB, clean brush, clip, sponge. The Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age.

The motor pump provides a negative pressure which removes nasal secretions.The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the exter (not included in this device) through the provided charging line. The user interface consists of buttons and indicator/ display, and the vacuum pressure through the button. Three different shapes of silicone nasal tips are provided to enable easier and more effective removal of the nasal mucus.

The provided text describes the 510(k) summary for the Nasal Aspirator (BC-021, BC-022, BC-023, BC-024, BC-025, BC-026). It does not contain information typically found in acceptance criteria or a study design for evaluating an AI/ML powered device. Instead, it focuses on the substantial equivalence of a medical device (a nasal aspirator) to a predicate device.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and expert involvement are not applicable or cannot be extracted from this document, as it is related to a conventional medical device rather than an AI/ML-powered one requiring such extensive performance studies as described in your prompt.

Here's an attempt to answer the questions based on the limited relevant information:

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

The document does not explicitly present a table of "acceptance criteria" in the context of AI/ML performance metrics (e.g., sensitivity, specificity). Instead, it discusses the equivalence of technological characteristics and performance tests for a physical device.

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

Not applicable. The document describes tests for a physical medical device (Nasal Aspirator), not an AI/ML algorithm requiring a test set of data. The "tests" mentioned are product appearance tests, performance tests, and human factors engineering verification, which typically involve a limited number of physical units or usability testing, not large datasets.

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

Not applicable. This device is not an AI/ML system that requires expert-established ground truth from a test set of data.

4. Adjudication method for the test set

Not applicable. This device is not an AI/ML system that requires adjudication of a test set.

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 not an AI-assisted device, so an MRMC study comparing human readers with and without AI assistance is irrelevant.

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

Not applicable. The device is a physical nasal aspirator, not an algorithm.

7. The type of ground truth used

Not applicable in the context of AI/ML. For a physical device, "ground truth" would be related to physical measurements and compliance with established engineering and safety standards (e.g., the actual vacuum pressure measured, adherence to IEC standards).

8. The sample size for the training set

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

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

Not applicable. This is a physical medical device, not an AI/ML algorithm.

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The Electronic Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2-12 years old). This device is used in a home environment.

Electric nasal aspirator consists of main unit, and the suction portion working together as one unit. The Electronic Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor pump provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The rechargeable battery can be charged from the external power adapter (not included in this device) through the provided charging line. The user interface consists of buttons and LED display, and the user can control the vacuum pressure through the button.

The provided text is a 510(k) summary for an Electric Nasal Aspirator. This document describes its substantial equivalence to a predicate device based on non-clinical testing. It explicitly states that "No clinical test data was used to support the decision of substantial equivalence."

Therefore, the requested information about acceptance criteria, study details, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, and ground truth establishment for a clinical study to prove the device meets acceptance criteria cannot be extracted from this document, as no such clinical study was conducted or presented.

The document focuses on demonstrating substantial equivalence through non-clinical testing, which includes various safety and performance benchmarks.

However, based on the non-clinical tests mentioned, we can infer the acceptance criteria and reported performance for those specific tests:

1. Table of Acceptance Criteria and Reported Device Performance (Based on Non-Clinical Tests)

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The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is ued in a home environment.

The Baby Nasal Aspirator is intended for intermittent removal of nasal secretions and mucus from children (age 2~12 years old). This device is used in a home environment. It consists of main unit, and suction working together as one unit. The Baby Nasal Aspirator is a portable device which is intended for suction of nasal passages in children 2-12 years of age. The motor provides a negative pressure which removes nasal secretions. The motor pump operates on a rechargeable battery. The recharged from the external power adapter(not included in this device) through the provided charging line. The user interface consists of buttons and the user can control the vacuum pressure through the button.

The provided text is a 510(k) summary for a Baby Nasal Aspirator. It describes the device, its intended use, and a comparison with a predicate device to establish substantial equivalence. However, it does not include acceptance criteria, performance data in a table format, or details about a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device.

Here's an analysis based on the information provided, highlighting what's present and what's missing in relation to your request about acceptance criteria and a study:

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

• Missing. The document states: "In order to verify and assure the performance of the Baby Nasal Aspirator, we have conducted the product appearance test (color, dimension, weight, etc.), product performance test (vacuum pressure, noise level, flow rate, etc.), and verification on lithium battery power indication."
• It mentions "vacuum pressure (52 - 60 Kpa) is the same as the predicate device" but does not explicitly state this as an acceptance criterion with a numerical target and then present the measured performance in a table. It also refers to compliance with IEC 60601-1 and IEC 60601-1-2 which are standards for medical electrical equipment, indicating safety and essential performance criteria were met, but details are not provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Missing. This device is a physical medical device (a nasal aspirator), not an AI/ML or software device that processes data. Therefore, there is no "test set" in the context of data for an algorithm. The "tests" performed were physical product performance tests. The document does not specify the number of units tested for appearance, vacuum pressure, noise level, or flow rate.

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)

• Not applicable. As this is a physical device and not an AI/ML algorithm requiring expert opinion for ground truth, this information is not relevant or provided.

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

• Not applicable. No adjudication method is described as this is not a study assessing interpretations of data by multiple experts.

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 standalone nasal aspirator, not an AI-assisted diagnostic or interpretive tool for "human readers." No MRMC study was conducted or is relevant.

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 (expert consensus, pathology, outcomes data, etc.)

• Not applicable. For a physical device like a nasal aspirator, "ground truth" would relate to objective measurements against engineering specifications and safety standards (e.g., measured vacuum pressure against a specified range, noise levels against acceptable limits, compliance with electrical safety standards). These are typically verified through direct measurement and testing rather than expert-derived ground truth as in AI/ML applications.

8. The sample size for the training set

• Not applicable. This refers to AI/ML algorithms. There is no concept of a "training set" for a physical device like a nasal aspirator.

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

• Not applicable. See point 8.

Summary based on the provided document:

The document describes the regulatory clearance for a physical medical device, a Baby Nasal Aspirator. The "study" mentioned for demonstrating substantial equivalence consisted of non-clinical performance tests.

• Acceptance Criteria (Implicit/Inferred from the text):

  • Vacuum pressure: 52 - 60 Kpa (same as predicate device).
  • Compliance with safety standards: IEC 60601-1 and IEC 60601-1-2.
  • Product appearance: Conformance to design (color, dimensions, weight).
  • Noise level: Within acceptable limits ( implied by "product performance test").
  • Flow rate: Conformance (implied by "product performance test").
  • Lithium battery power indication: Verification conducted.

• Reported Device Performance:

  • "The vacuum pressure (52 - 60 Kpa) is the same as the predicate device."
  • "The device complies with IEC 60601-1 and IEC 60601-1-2 requirements."
  • Other tests (appearance, noise level, flow rate, battery indication) were "conducted to verify and assure the performance" and "demonstrate substantial equivalence," implying they met their respective criteria, although specific numerical results are not detailed.

• Study Description:

  • Type of Study: Non-clinical bench testing.
  • Tests Performed: Product appearance test (color, dimension, weight), product performance test (vacuum pressure, noise level, flow rate), and verification on lithium battery power indication.
  • Sample Size: Not specified for any of the individual tests. This is common for bench testing of physical devices where a small representative sample is typically used to confirm design specifications.
  • Data Provenance: Not applicable in the sense of patient data. The testing was conducted on manufactured device units.
  • Ground Truth: Objective measurements against engineering specifications and recognized safety standards (IEC 60601-1, IEC 60601-1-2).
  • No clinical data: The document explicitly states, "Not applicable, there is no clinical data."

In conclusion, the request is largely framed for an AI/ML device or a diagnostic device involving human interpretation, which does not align with the nature of the Baby Nasal Aspirator described in the provided FDA 510(k) summary. The document confirms that the device underwent non-clinical performance testing to demonstrate substantial equivalence to a predicate device, meeting relevant safety and performance standards.

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