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The CerroZone Mini is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.

The CerroZone Mini is a medical recirculating air cleaner that uses multiple inactivation processes, including use of reactive oxidizing species (ozone) and ultraviolet radiation, to inactivate bacteria and viruses in the CerroZone Mini may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mini's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 110 cubic feet of air per minute (CFM), or 2.00 air changes per hour (ACH) in a standard 5,600 cubic foot room. The process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction, or 99.99% reduction, of airborne particles in a standard 579 cubic foot room is achieved in 45 minutes or less.

The prompt requests information about a study proving that a medical device meets acceptance criteria. The provided text is an FDA 510(k) clearance letter for the CerroZone Mini, a medical recirculating air cleaner. The document details the device, its indications for use, comparison to a predicate device, and summarizes non-clinical testing.

However, the provided text does not contain the specifics of a study proving device acceptance criteria in the way one might expect for an AI/algorithm-driven medical device, which is what the prompt implies by asking about sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies. The device in question is an air cleaner, and the "studies" mentioned are laboratory tests assessing its ability to reduce airborne biological agents and ozone emissions, not clinical trials or AI performance evaluations involving human-in-the-loop scenarios.

Therefore, many of the requested points are not applicable to the data provided for this specific device. I will address only the points for which information is available in the text.

Here's the analysis based on the provided document:

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

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

The document does not specify exact "sample sizes" in terms of number of runs or specific data points for the biological agent reduction tests, nor does it explicitly state the precise "data provenance" (e.g., country of origin, retrospective/prospective). These are laboratory efficacy and safety tests, not clinical studies with human subjects or large datasets typical for AI model validation. The tests were performed in a controlled laboratory environment.

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 context of this device's testing refers to measured physical/biological parameters (e.g., log reduction of bacteria/viruses, ozone concentration), not expert interpretation of medical images or other data typically associated with AI/diagnostic devices. The results are based on quantitative laboratory measurements.

4. Adjudication method for the test set

Not applicable. There was no need for adjudication as the "ground truth" was established through direct laboratory measurements, not subjective evaluations or consensus processes.

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 an air cleaner, not an AI-assisted diagnostic or decision support tool for human readers. No MRMC study was performed.

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

Not applicable beyond the device's inherent standalone function as an air cleaner. There is no AI algorithm in the traditional sense that performs a diagnostic or interpretive function. The device's performance is its inherent physical and chemical action on airborne particles.

7. The type of ground truth used

The ground truth for the biological agent reduction tests was established through direct quantitative laboratory measurements of the reduction in viable MS2 bacteriophage and Staphylococcus epidermidis concentrations. For ozone emissions, the ground truth was direct measurement of ozone concentration in ppm. For electrical compatibility and safety, the ground truth was compliance with specified international and national standards (EN/IEC 60601-1-2, UL 867, CSA C22.2 No.187), verified through standard engineering tests.

8. The sample size for the training set

Not applicable. This device is an air cleaner with a physical mechanism of action, not a machine learning model that requires a "training set."

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 Airdog X8 Air Purifier is a mobile air cleaner intended to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog X8 has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L5 speed.

The Airdog X8 Air Purifier (X8) is a mobile air cleaner. The air from the room enters the X8 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon filter that captures particular matter and biological agents from the air. The X8 contains multiple PCB modules, device status indicators, power switch and a display panel, it allows user to select between different operation parameters, including auto-mode, sleep mode and wind speed. The Ionization wireframe and the collecting plate can be cleaned routinely and are reusable. X8 is powered from an AC wall outlet. It is intended to be used indoors only. The device is not intended to be connected to other instruments or medical devices.

The provided text is a 510(k) Summary for the Airdog X8 Air Purifier. It lacks the details typically found in a study proving a device meets specific acceptance criteria, especially for an AI/ML-driven device with complex performance metrics like those involving human readers or expert consensus. This document pertains to an air purifier, and its "performance data" is focused on physical and biological filtration capabilities, not on an AI's diagnostic or assistive accuracy.

Therefore, I cannot extract information related to:

• Sample size used for the test set and data provenance (e.g., country of origin, retrospective/prospective)
• Number of experts used to establish ground truth and their qualifications
• Adjudication method for the test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study or effect size
• Standalone (algorithm only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data)
• Sample size for the training set
• How ground truth for the training set was established

However, based on the provided text, I can infer the "acceptance criteria" and "reported device performance" related to the air purifier's function.

Here's a breakdown of what can be extracted:

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

While not explicitly called "acceptance criteria" with pass/fail thresholds in the typical AI/ML sense, the document lists specifications and test results that serve as performance benchmarks.

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The MA-40 and MA-112 are intended for use as room recirculating air cleaner. The systems are used for filtering out and inactivating airborne particles from the air for medical purposes.

The MA-40 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)

The MA-112 has been demonstrated to reduce the following airborne microorganisms by >99.99% in a test chamber of 83ft3 (580 ft3)

Not Found

This document is a 510(k) premarket notification from the FDA, indicating that the device being reviewed is a Medical Recirculating Air Cleaner. Therefore, the device in question is not an AI/ML powered device. The information requested in your prompt (e.g., acceptance criteria for AI algorithms, sample sizes for AI model training/testing, expert adjudication, MRMC studies) is typically associated with the evaluation of AI/ML-driven medical devices.

Since the document provided is for a physical air cleaner and not an AI/ML device, most of the requested information does not apply. However, I can extract what is provided in the document related to acceptance criteria and performance of this physical medical device.

Here's an analysis based on the provided document:

The acceptance criteria for the MA-40 and MA-112 air cleaners are based on their ability to reduce airborne microorganisms. The study proves that the devices meet these criteria by demonstrating a reduction of specific bioaerosol types by >99.99% within certain timeframes in a test chamber.

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

The acceptance criterion for both devices is to reduce airborne microorganisms by >99.99%. The tables provided show the time taken to achieve this reduction for different bioaerosol types and device fan speeds. The device performance (achieving >99.99% reduction) is reported for each scenario.

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

• Sample Size: The test "sample" here refers to the conditions under which the device was tested. The performance was demonstrated "in a test chamber of 83ft³ (580 ft³)". It's not a biological sample size in the sense of patient data. The document does not specify the number of individual tests or replicates run for each bioaerosol type and fan speed.
• Data Provenance: The document does not specify the country of origin of the data or whether the study was retrospective or prospective. It is a report of performance in a controlled test chamber.

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 question is not applicable as this is a physical device being tested for its ability to filter and inactivate microorganisms, not an AI/ML algorithm requiring expert interpretation of medical images or data. The "ground truth" is measured by the reduction of bioaerosols in a controlled environment.

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

Not applicable. This is not an adjudication process for human interpretation or AI output. The performance is based on quantitative measurements in a laboratory setting.

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-powered device, and therefore no MRMC study involving human readers and AI assistance would be conducted.

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

Not applicable, as this is not an AI/ML algorithm. The "standalone" performance is the device's ability to purify air without human intervention beyond turning it on and setting the fan speed.

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

The "ground truth" is the measured reduction of specific bioaerosol concentrations within the test chamber. This is determined through laboratory methods suitable for quantifying microorganisms, which is an objective measurement rather than a subjective expert assessment.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model that requires a training set.

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

Not applicable. There is no training set for this type of device.

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The RIA SafeGuard is intended as a room recirculating air cleaner. The system is used for filtering out airborne particles PM2.5 from the air for medical purposes, and is intended for over-the-counter use.

The RIA SafeGuard has wind speed of 1.3 m/s and airflow of 135 CMH (m3/h). Using the HEPA H13 filter, it provides a 4 log (99.99%) reduction in suspended particulate PM2.5 in 120 minutes within a 29.75 m³ room.

RIA SafeGuard (SG020MS120) is an air purifier that contains the highefficiency HEPA technology and Bi-Polar Ionization (BPI) unit to remove 99.99% of particles as small as 2.5 microns from the air stream. SafeGuard addresses suspended particles with a single wind speed of 1.3 m/s, providing a 4 log reduction in PM2.5 particulates within 120 minutes in a 29.75 m³ space. The airflow is 135 CMH (m3/h). It is intended to be placed in a room such as medical care institutions and hospitals etc. RIA SafeGuard is a product that is designed as one-touch, easy to use, and no contact with patients. RIA SafeGuard has built in a blue LED as the switch-on indicator. All the maintenance should be done by a trained technician. Changing the HEPA is the only recommended maintenance to do by a non-trained technician, recommended renewing every 12 months.

The provided text describes the mechanical and electrical performance of an air purification device, not an AI/ML-enabled medical device. Therefore, the information typically required for an AI/ML device's acceptance criteria, such as details about ground truth, expert adjudication, MRMC studies, or training set data, is not present in this document.

However, I can extract the acceptance criteria and study details relevant to this specific device based on the provided text.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, according to the document:

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

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

• Sample Size: The document does not specify a "sample size" in the context of a test set for an AI/ML model. Instead, it refers to a single device (RIA SafeGuard, Model Number: SG020MS120) that underwent non-clinical testing.
• Data Provenance: The tests were conducted on the subject device, RIA SafeGuard. The exact location or origin of the testing data is not explicitly stated, but the manufacturer is RIA Tech Co., Ltd. located in Taipei City, Taiwan (R.O.C.). The tests were "non-clinical," implying they were conducted in a laboratory or controlled environment, rather than involving patient data (retrospective or prospective).

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

This information is not applicable to this device's testing. "Ground truth" in the context of an AI/ML model usually refers to labeled data verified by human experts. For a physical device like an air cleaner, the "ground truth" is established through direct physical measurements against predefined engineering and safety standards (e.g., measuring particle reduction with sensors, ozone concentration with detectors). No human experts were involved in establishing the "ground truth" for these physical performance metrics.

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

This information is not applicable. Adjudication methods are relevant for subjective interpretations of data, typically in AI/ML model validation where multiple experts might disagree on labels. For the physical performance tests conducted, the results are objective measurements that do not require 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. An MRMC study is relevant for evaluating the impact of an AI/ML system on human performance (e.g., how radiologists improve diagnostic accuracy with AI assistance). The RIA SafeGuard is an air cleaning device, not an AI/ML diagnostic tool, and therefore, an MRMC study was not performed.

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

This information is not applicable. This question pertains to AI/ML algorithm performance. The "Filtration of Particles" test can be considered an analogue to a standalone performance test for the device in that it measures the device's inherent ability to clean air without human interaction determining its efficacy. However, it's not an "algorithm-only" test.

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

The "ground truth" for this device's performance was established through objective physical measurements against established standards and design specifications.

• For "Filtration of Particles": The ground truth was the measured reduction of PM2.5 particulates using scientific instruments.
• For "Ozone Emissions": The ground truth was the measured ozone concentration.
• For "Electrical Safety" and "Electromagnetic Compatibility": The ground truth was compliance with the specified IEC standards determined through testing.

8. The sample size for the training set:

This information is not applicable. This device is a physical product, not an AI/ML model that undergoes training with a dataset.

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

This information is not applicable, as there is no training set for this type of device.

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The Airdog is a mobile air cleaner intended to be used to remove particles from the air for medical purposes. The device is intended for indoor use only. The Airdog has been demonstrated to effectively inactivate H3N2 and reduce Staphylococcus albus by 4 log with L4 speed.

The Airdog X5 Recirculating Air Cleaner is a floor-standing air cleaner with an air quality sensor. The air from the room enters the X5 and passes a pre-filter, ionization frame, ionization field, collecting plates and carbon layer that captures particular matter and virus from the air. The X5 contains multiple PCB modules, air quality sensor, device status indicators, power switch and a display panel it allows user to select between different operation parameter, including auto-mode, sleep mode and wind speed. The Ionization Wireframe and the Collecting Plate can be cleaned routinely and are reusable. X5 is powered from an AC wall outlet. It is intended to be used indoors only.

This document is a 510(k) Pre-market Notification from the FDA regarding the Airdog X5 Recirculating Air Cleaner (model KJ300F-X5). It's a regulatory approval document and thus primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed scientific study report with all the requested specifics.

Based on the provided text, here's the information regarding acceptance criteria and the study that proves the device meets them:

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

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The Qorda QD is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.

The Qorda QD1 has been demonstrated to remove the following organisms under the following exposure conditions:

| Organism | Fan Speed | Average Maximum log
reduction | Exposure Time |
|----------------------------------------|------------|----------------------------------|---------------|
| MS2 bacteriophage | Turbo MODE | 5.6 log reduction | 20 minutes |
| MS2 bacteriophage | Sleep MODE | 4.9 log reduction | 45 minutes |
| Bacillus subtilis
endospores | Turbo MODE | 4.4 log reduction | 20 minutes |
| Bacillus subtilis
endospores | Sleep MODE | 4.3 log reduction | 60 minutes |

Oorda OD1 is a freestanding medical recirculation air cleaner that facilitates movement with wheels. The device includes two pre-filters, two deodorizing filters, two HEPA filters - 3 filters in the front panel and 3 filters in the rear panel), and a manual for users.

The device can adjust the air volume in four stages through manual operation (Level 1, Level3, Turbo) and Sleep mode. When operating in sleep mode, the equipment LED and PlasmaWave are turned off and operated with low noise.

The device contains the following additional functions.

(1)Child lock: Button lock function that prevents children or pets from changing their current motion mode even if they accidentally operate device.

(2)Filter Replacement Guide: The remaining filter life is displayed on the front display of the device and tells you when to replace the filter.

(3)Adjustment of illuminance: You can adjust the illuminance in four stages (100%, 50%, 20%, OFF).

(4)You can turn on or off the PlasmaWave.

(5)The timer allows the equipment to turn off automatically after a certain period of time.

Qorda QD1 inhales air in both directions on the front and rear of the device and purifies it through the four cleaning steps below:

[Pre-Filter]

The air is drawn in through the cover front, passes through the Pre-Filter then moves to two filters stages(CD Carbon Filter, True HEPA Filter). The Pre-Filter protects CD Carbon Filter, True HEPA Filter inside the Pre-Filter.

[CD Carbon Filter]

Reduces any ozone generated as a byproduct of the plasma field. It also prolongs the True HEPA Filter lifespan.

[True HEPA Filter]

True HEPA Filter captures 99.99%* of airborne ultrafine particles as small as 0.003 microns. *Based on independent laboratory test conducted on particles as small as 0.003 microns in size.

[PlasmaWave]

PlasmaWave Technology has been tested by an independent third-party to remove particles from the air for medical purposes.

Here's an analysis of the acceptance criteria and study information for the Qorda QD1 device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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The CerroZone Mobile is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles (i.e., bacteria and viruses) from the air for medical purposes.

The CerroZone Mobile is a medical recirculating air cleaner that uses multiple inactivation processes consisting of reactive oxidizing species (ozone) and ultraviolet radiation to inactivate bacteria and viruses in the air. The CerroZone Mobile may be used in medical facilities. Once turned on, inlet air is passed through CerroZone Mobile's inline flow-through design which inactivates bacteria and viruses in a single pass flow-through. The device generates 220 cubic feet of air per minute (CFM), or 2.36 air changes per hour (ACH) in a standard 5,600 cu. Ft room. This process of air being inlet, purified, then outlet, lasts approximately 1.2 seconds. A 4 LOG reduction of airborne particles in a standard 579 cu. Ft room is achieved in 30 minutes or less. A 5.67 LOG, or 99.9998%, reduction is achieved in 45 minutes or less.

The CerroZone Mobile device is a medical recirculating air cleaner designed to filter out and inactivate airborne bacteria and viruses. The following information summarizes its acceptance criteria and the studies conducted.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample sizes for the biological aerosolization tests (MS2 bacteriophage and MRSE). The studies appear to be laboratory-based non-clinical tests rather than human subject or field trials, so terms like "country of origin" and "retrospective/prospective" might not be strictly applicable in the same way they would be for clinical studies. The context implies these were controlled experiments conducted to assess device performance under specific conditions.

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 "ground truth" for these non-clinical tests would have been established by the direct measurement of reduction in viable microorganisms using standard microbiological techniques, rather than expert interpretation.

4. Adjudication Method for the Test Set:

Not applicable. The tests involved direct measurement of microbial reduction, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. The CerroZone Mobile is a medical device for air cleaning, not an interpretative diagnostic tool, so such a study would not be relevant.

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

These were standalone performance tests of the device itself (algorithm not applicable), evaluating its ability to reduce airborne pathogens directly.

7. The Type of Ground Truth Used:

The ground truth used for the efficacy studies was based on quantitative laboratory measurements of microbial viability (e.g., plaque assays for bacteriophages, colony counts for bacteria) before and after exposure to the device. For ozone emissions, the ground truth was direct quantitative measurement of ozone concentration.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical air cleaner, 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 type of device.

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Bentrio™ is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, animal hair and dust mites.

Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.

Bentrio™ is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives.

The gel formulation of Bentrio™ has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.

The provided text describes the regulatory clearance of a medical device, Bentrio™ Allergy Blocker, and its equivalence to a predicate device, Nasal Ease Allergy Blocker. It focuses on the device's mechanism of action, intended use, and the studies conducted to demonstrate its safety and clinical performance.

However, the document does not contain the kind of information typically found in acceptance criteria and study designs for an AI/ML medical device. Specifically, it does not mention:

• Acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity, AUC) for an AI model.
• Sample sizes for test sets in the context of an AI model's validation.
• Number or qualifications of experts establishing ground truth for AI model training/testing.
• Adjudication methods for AI ground truth.
• MRMC studies for AI assistance.
• Standalone performance (algorithm only) of an AI.
• Ground truth types for AI models (e.g., pathology, outcomes data).
• Training set details for an AI model.

The document describes clinical studies for a physical medical device (nasal spray) to alleviate allergy symptoms. The "performance" discussed relates to the device's ability to reduce symptoms in human subjects, not the performance of an AI algorithm in classification or prediction tasks.

Therefore, I cannot extract the requested information regarding acceptance criteria and study data for an AI/ML device from the provided text. The questions posed in the prompt (1-9) are relevant to the validation of AI/ML medical devices, which is not the subject of this FDA clearance letter.

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AllerBlock Junior is intended for use in adults and children (8 years or older) to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e., mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor environmental pollens, house dust, animal hairs, and dust mites.

Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.

When the powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier -- making it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reducing the intensity of allergic rhinitis (AR) symptoms.

The provided text is a 510(k) summary for AllerBlock Junior, a medical device intended to alleviate mild allergic symptoms. The document focuses on demonstrating substantial equivalence to a predicate device and extending its indications for use to include pediatric patients (8 years or older).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as a set of predefined quantitative thresholds that the device must meet for clearance. Instead, it presents summaries of clinical studies to demonstrate the device's safety and effectiveness, especially for the extended pediatric indication. The "reported device performance" is largely qualitative, focusing on symptom reduction and safety.

• Biocompatibility: Tests (cytotoxicity, sensitization, irritation) showed "no biocompatibility concerns."
• Adverse Effects in Children (5 studies, N=219 total pediatric patients): "reported adverse effects and complications were few in number (2-15%) and mild in level of severity." |
  | Effectiveness (Pediatric) | Alleviation of mild allergic symptoms (nasal irritation, itchy, runny, congested nasal passages). Reduced allergen exposure via mechanical barrier. | - Mechanism: Produces a mucous-like gel barrier that coats nasal membranes, blocking inhaled allergens.
• Study 1 (Mucociliary Clearance): "Significant decrease of clearance observed in children... after treatment (especially those with mean value > 31 minutes) is due to the effect of cellulose." This implies the formation of the barrier.
• Studies 2-5 (AR Symptom Scores): "all showed consistent reductions in AR symptoms including nasal congestion and discharge, sneezing, nasal and ocular itching." This directly supports alleviation of mild allergic symptoms. |
  | Shelf Life/Stability | Device maintains functionality and safety over its intended storage and use duration. | - Stability/Shelf Life Testing: "results support a shelf life of ≥ 3 yrs at 40°C." |
  | Product Formulation | New formulation (strawberry scent, 3%) should maintain safety and effectiveness comparable to predicate. | - Ingredients: HPMC Powder 97%, Strawberry Powder 3%. Strawberry scent recognized as GRAS.
• Particle Size: "Powder particle size remains essentially unchanged."
• Conclusion: "This change continues to support product safety and effectiveness." |

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

• Total Pediatric Patients Across 5 Studies: N=219.
  • Study 1: N=100 children
  • Study 2: N=23 children
  • Study 3: N=25 children
  • Study 4: N=30 children
  • Study 5: N=41 children
• Data Provenance: Not explicitly stated regarding the country of origin for each study. However, the author names (e.g., Aivazis V, Bourli E; Zakharzhevskaya T, Sidorenko I; Aberg N, Dahl A, Benson M; Geppe N, Snegotskaya M; Chen X, Guan WJ, Sun SX) suggest a mix of international (possibly European, Russian, Chinese) origins for the studies. The studies are described as "clinical studies," implying they are prospective, designed trials.

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

• The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation.
• The "ground truth" for these studies is based on clinical outcomes:
  • Mucociliary clearance measurements (Study 1).
  • Patient-reported daily symptom scores for allergic rhinitis (Studies 2-5).
  • Clinical assessment of adverse events by study investigators.
• The qualifications of the clinicians/investigators conducting these studies are not detailed.

4. Adjudication Method for the Test Set:

• Adjudication methods (like 2+1 or 3+1 for discordance resolution) are typically used in studies involving expert interpretation of images or other subjective data to establish a definitive ground truth.
• These clinical studies primarily relied on objective measurements (mucociliary clearance) and patient-reported outcomes (symptom scores). There is no mention of an adjudication method in this context. Adverse events would be reported and managed by the study investigators.

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.
• MRMC studies are typically used to assess the impact of AI on human reader performance, usually in image-based diagnostic tasks. The AllerBlock Junior device is a physical barrier product, not an AI diagnostic tool.
• The comparative effectiveness in the provided studies refers to comparing the device to placebo or standard of care (oral medications, nasal steroids in Study 4 and 5).

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

• This question is not applicable. AllerBlock Junior is a physical device, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is directly tied to its physical application and effect on the user.

7. The Type of Ground Truth Used:

• Clinical Ground Truth:
  • Mucociliary Clearance: An objective physiological measurement.
  • Patient-Reported Outcomes (PROs): Daily symptom scores for allergic rhinitis (e.g., nasal congestion, discharge, sneezing, itching). These are subjective but are standard clinical endpoints for allergy studies.
  • Adverse Event Reporting: Clinical observation and reporting of adverse effects by study participants and investigators.

8. The Sample Size for the Training Set:

• The document does not describe a "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and effectiveness.
• The device's formulation (HPMC with strawberry scent) is based on established knowledge of HPMC as a safe and effective barrier and strawberry as a GRAS flavoring, not derived from training on a dataset.

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

• This question is not applicable as there is no "training set" in the machine learning sense for this device. The underlying principles for the device (HPMC forming a barrier) are based on scientific understanding and prior uses of these materials.

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The Novaerus NV 1050 is intended as a room recirculating air cleaner. The system is used for filtering out and inactivating airborne particles from the air for medical purposes.

The Novaerus NV1050 (NV1050) is a free-standing cabinet of a size that can be maneuvered into position by a single person. The NV1050 is powered from an AC wall outlet. The NV1050 circulates the room air through its cabinet. The air is drawn in through the front of the cabinet, passes through a pre-filter then a Dielectric Barrier Discharge Plasma generator ("plasma generator") stage, and a further two filters (HEPA, Carbon) The cleaned air is exhausted out of the top panel of the cabinet. The device has simple controls: On/Off and fan speed setting from 1 to 5. There is a button to initiate a filter blockage test to check and inform the user if the filters are getting close to requiring changing. The only routine maintenance is a calendar-based filter change schedule indicated in the User Manual; the indicator light on the front panel acts as a reminder that the filters will soon need attention. The airflow path through the NV1050 is: - A general pre- filter to remove particles from the input air flow. . - A bank of three (3) plasma generators, each Plasma Generator consists of ● two (2) plasma Coils. Micro-Organisms, including virus and bacteria, are inactivated by the plasma generator. This occurs through damage by plasma constituents (ions, electrons, reactive oxidizing species, ultraviolet radiation, high electric fields) - A HEPA (High-efficiency Particulate Air) filter to trap the resulting virus/bacteria particulates. - . An activated carbon filter to trap any ozone in the airstream before it is output to the environment.

The provided text describes the Novaerus NV1050 medical recirculating air cleaner and its substantial equivalence to a predicate device. It includes information on non-clinical testing to demonstrate performance against acceptance criteria.

Here's the breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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