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The HVT 2.0 system provides high velocity nasal insufflation (HVNI) with simultaneous warmed and humidified respiratory gas delivery to augment breathing of spontaneously breathing adult and pediatric patients (5 kg and up) suffering from respiratory distress and/or hypoxemia in the hospital setting, via a small bore nasal cannula. HVT 2.0 is not intended to provide total ventilatory requirements of the patient and not for use during field transport. The flow rates may be from 5 to 45 liters per minute (BTPS).

The HVT 2.0 System is comprised of hardware containing software, and single use disposables that are designed to deliver the same High Velocity Nasal Insufflation (HVNI) as the Vapotherm Precision Flow HVNI.

The HVT 2.0 system consists of the HVT 2.0 hardware containing software, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows 5 to 45 L/min (BTPS) to spontaneously breathing patients, without the need of wall air or any pressurized air source. The addition of an external oxygen source (wall or tank for QAV indication) enables FiO2 delivery from 21% to 100%. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently.

The HVT 2.0 main hardware device contains all the electrical and electronic components including the electronic blender and flow controllers, and sensors to monitor the disposable patient circuit. The main hardware device has no water pathways and the gas pathway only contains dry gas at room temperature, and therefore does not require internal cleaning or disinfection.

The available text does not describe an acceptance criteria and a study proving the device meets said criteria in the format requested. The document is a 510(k) summary for the HVT 2.0 device, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study against predefined acceptance criteria for AI or automated system performance.

Here's why the requested information cannot be extracted and what is provided instead:

• 1. A table of acceptance criteria and the reported device performance: This is not present. The document includes a comparison table between the predicate and subject device (HVT 2.0) for various characteristics like Indications for Use, Patient Population, Flow Range, etc. While it lists "Temperature Accuracy" as "±2°C" and "Oxygen Accuracy" as "±2%", these are device specifications and not explicitly presented as "acceptance criteria" for a study in the context of an AI/algorithm performance. It then states "SAME" for the subject device, implying it meets these for equivalence.
• 2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable. The document discusses "bench / performance testing" and "comparative performance testing" but does not detail sample sizes for these tests in a way that would be relevant to a "test set" for an algorithm. There is no mention of data provenance (e.g., country of origin, retrospective/prospective).
• 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. This document does not describe the use of experts to establish a "ground truth" for a test set, as it does not involve the evaluation of an algorithm's diagnostic or predictive performance.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for the same reasons as point 3.
• 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 summary does not describe any MRMC studies or AI assistance for human readers. The device (HVT 2.0) is a high-flow humidified oxygen delivery device, a physical medical device, not an AI or software-as-a-medical-device (SaMD) that typically undergoes such evaluations.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is not an algorithm. Its software is mentioned for verification and validation but not as a standalone performance entity.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc.): Not applicable.
• 8. The sample size for the training set: Not applicable, as there is no mention of a training set for an algorithm.
• 9. How the ground truth for the training set was established: Not applicable.

Summary of what is provided:

The document describes the HVT 2.0, a High Flow Humidified Oxygen Delivery Device, and its comparison to a predicate device (Precision Flow HVNI). The main point is to demonstrate "substantial equivalence" of the HVT 2.0 to the predicate device, not to prove algorithm performance against specific criteria.

The "studies" mentioned are non-clinical performance and bench testing, including:

• Biocompatibility testing (leveraged from prior testing, compliant with ISO 10993-1)
• Electrical safety and electromagnetic compatibility (compliant with IEC 60601-1 and IEC 60601-1-2)
• Alarms testing (compliant with IEC 60601-1-8)
• RFID testing (compliant with AIM 7351731)
• Software verification, validation, and hazard analysis (compliant with FDA guidance for software and ISO 14971:2019)
• Bench/Performance Testing, including:
  • Precision Flow and HVT 2.0 Comparison Testing (to demonstrate same HVNI technological characteristics and performance)
  • Oxygen accuracy/Blender Performance
  • Temperature accuracy/Thermal Stability
  • Flow rate accuracy
  • Humidification output (ISO 80601-2-74)
  • Patient contacting surface temperature/Thermal Safety
  • Volume of liquid exiting the humidification chamber outlet
  • Continuous use (Use Lifespan)
  • Operating environment
  • Nurse call compatibility
  • Usability/Human Factors
  • Cleaning Validation (for hardware)

The conclusion is that "Any differences in technological characteristics of the devices do not raise different questions of safety and effectiveness based on the performance testing, further supported by the prior clearance of the Reference Device HVT 2.0, cleared under K203357. The devices are substantially equivalent."

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The Vapotherm Aerosol Adapter AAA-2 is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT 2.0 and the Aerogen Solo Nebulizer.

The Vapotherm Aerosol Adapter AAA-2 is an accessory that is intended to facilitate the connection between Vapotherm High Velocity Therapy HVT® 2.0, cleared under K203357, and the Aerogen Aeroneb® Solo Nebulizer System, cleared under K133360, and more recently with K143719. which is intended to aerosolize solutions for inhalation. The AAA-2 facilitates the connection between the noted devices, and therefore aerosolization use is dictated by the Aerogen Aeroneb Solo Nebulizer System labeling.

The provided text describes the Vapotherm Aerosol Adapter AAA-2 (subject device) and its equivalence to a predicate device. However, it does not contain the detailed acceptance criteria or the specific numerical results of a study that directly proves the device meets those criteria in a tabular format as requested.

Instead, the document outlines the types of non-clinical performance testing conducted and generally states that the device passed these tests or demonstrated similar performance to the predicate device.

Here's an attempt to extract and infer the information based solely on the provided text, while noting where information is missing:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not specified for any of the individual tests. The text describes "testing" and "running" the device but doesn't quantify the number of units or repetitions.
• Data Provenance: Not explicitly stated. The tests were performed by Vapotherm Inc. or a contracted lab. It's bench testing, not clinical data, so country of origin of data (patients) is not applicable. This is retrospective bench testing on the device itself.

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

This section is not applicable. This document describes physical and performance bench testing of a medical device accessory, not an AI or diagnostic system that requires expert consensus for ground truth. Biocompatibility and performance standards (like ISO 10993-1, ISO 18562-1, ISO 5356-1) serve as the "ground truth" or accepted standards that the device performance is measured against.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review processes for clinical data, especially in AI studies, to establish ground truth. As this is bench testing against established engineering and material standards, such methods are not used. The device's performance is either within the specified limits or it is not.

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 section is not applicable. This document describes an accessory product (an adapter for a nebulizer) and its bench testing, not an AI system, diagnostic tool, or a product that interacts with human readers/interpretations. Therefore, an MRMC study and AI-assisted human reader improvement are not relevant.

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

This section is not applicable. The device is a hardware accessory; it does not involve any algorithm or AI component.

7. The type of ground truth used

The ground truth for the various tests described is based on:

• Established engineering specifications and performance limits for flow rates, rain-out, connection integrity.
• International standards for medical device safety and performance (e.g., ISO 10993-1 for biocompatibility, ISO 18562-1 for breathing gas pathways, ISO 5356-1 for connections).
• The performance of the predicate device (Aeroneb Solo Adapter) for aerosolization comparison.

8. The sample size for the training set

This section is not applicable. The device is a hardware accessory and does not involve AI/machine learning, so there is no training set.

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

This section is not applicable. As there is no training set for an AI/ML algorithm, the establishment of ground truth for such a set is not relevant.

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The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility, and home-use settings.

The HVT 2.0 system is intended to deliver warmed and humidified high-flow respiratory gases to spontaneously breathing adult patients and pediatric patients (5 kg and up). The device is intended to be used in hospital, sub-acute facility and home-use settings.

The HVT 2.0 system is intended to be used by qualified medical professionals, such as physicians, nurses, respiratory therapists and by patients in a home-use setting under the supervision of qualified medical professionals.

The HVT 2.0 system consists of the HVT 2.0 main device, a Disposable Patient Circuit (DPC), and a patient interface (nasal cannula). The HVT 2.0 system utilizes an integrated internal blower to deliver warmed and humidified breathing gas at flows up to 45 L/min to spontaneously breathing patients, without the need of wall air or any pressurized air source. The device incorporates a blender and flow sensors that allow the oxygen percentage and total gas flow to be set independently. The addition of an external oxygen source (wall, tank, or oxygen concentrator) enables FiO2 delivery from 21% to 100%, dependent on the oxygen source.

The HVT 2.0 main device contains all the electrical and electronic components including the electronic blender and flow controllers, and remote sensors to monitor the disposable patient circuit. The main device has no water pathways, and the gas pathway only contains dry gas at room temperature, and consequently does not need internal cleaning or disinfection.

The provided text describes the HVT 2.0 respiratory gas humidifier and its review by the FDA for substantial equivalence to a predicate device. However, the document primarily focuses on regulatory approval, device description, and non-clinical performance testing. It does not contain information about acceptance criteria and a study proving the device meets those criteria, particularly within the context of artificial intelligence (AI) or machine learning (ML) performance.

Therefore, I cannot provide the requested table and details because the input text does not contain that information. The document focuses on the HVT 2.0 being "substantially equivalent" to a predicate device based on non-clinical performance testing, not on meeting specific, reported performance metrics with acceptance criteria, especially not in the context of an AI/ML study.

Specifically, the document does not include:

1. A table of acceptance criteria and reported device performance related to a diagnostic or analytical function. The testing described is for physical characteristics and safety of the humidifier.
2. Sample size for a test set, data provenance, ground truth establishment, or expert involvement. These are typically relevant for AI/ML performance studies.
3. Adjudication method.
4. Multi-Reader Multi-Case (MRMC) comparative effectiveness study information.
5. Information about standalone (algorithm-only) performance.
6. Type of ground truth used (pathology, outcomes data, etc.) relevant to AI/ML or comparative diagnostic performance.
7. Sample size for a training set or how ground truth for a training set was established.

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