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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 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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