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The Went™ 201 is a portable, computer controlled, electrically powered ventilator intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Specifically, the ventilator is applicable for adult and pediatric putients weight 10 kg (22 lb.), who require the following general modes of ventilatory support, as prescribed by an attending physician:

• Assist/Control (Pressure Controlled or Volume Controlled) .
• SIMV (Pressure Controlled or Volume Controlled) .
• CPAP/PSV .
  The iVent™ 201 ventilator with Non-invasive Puise Oximeter is suitable for intra-hospital use, home and alternate-site use, transport and emergency use. The Non-invasive Pulse Oximeter is intended for non-invasive monitoring of oxygen saturation and pulse rate.
  The iVent™ 201 ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician and within the technical specification limits.

The iVent201 is a compact, portable, fully featured, microprocessor-controlled ventilator offering the versatility and capability of larger and coptivessor vontilators. A turbine-powered air source and a rechargeable internal battery provide freedam from wall air and power outlets. An intuitive turn-and-click control knob, quick-choice pushbuttons, and a bright, well-organized, easy-to-read screen allow rapid control and continuous real-time monitoring of patient ventilation. Alam settings are fully adjustable. Optional Waveform and Diagnostic Software package displays pressure and flow waveform data, loops, trends, and logged totals in a full array of time slices and presentation modes.
Description of Non- invasive Pulse Oximeter (Cleared under K 021981): The Noninvasive Pulse Oximeter connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interfor. The iVent 201 systems provide DC power and isolation to the board from the mains power and ground.
The Non-invasive Pulse Oximeter board is mounted internal to the iVent 201 unit and is part of the electronic configuration of the unit. Connection of the Pulse Oximeter accessories is via a connector on the back panel of the unit.
Description of remote Alarm Adaptor (cleared under K 011957): The adapter connects between a Remote Alarm outlet on the iVent 201 Ventilator and the Central Remote Alarm unit of the Hospital. The adapter consists of a relay circuit, which meets activating requirements of the Central Remote Alarm unit.The iVent 201 Ventilator with Remote Alarm Adapter will activate the Central Remote Alarm unit for any major or medium priority alarm event that occurs on the unit.

The provided text is a Fragment of a 510(k) premarket notification and an FDA clearance letter for a medical device (iVent™ 201 Portable Ventilator). It does not contain the kind of detailed study information (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.) that would typically be found in a clinical study report or a more comprehensive technical summary.

The document focuses on demonstrating substantial equivalence to predicate devices and adherence to voluntary performance standards, rather than providing the results of a specific performance study against defined acceptance criteria for the device itself.

Therefore, I cannot provide a table of acceptance criteria and reported device performance or answer most of the requested questions based on the provided text. The document states that "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act," but it does mention compliance with voluntary standards like ASTM and ISO. However, it doesn't specify what the acceptance criteria derived from these standards were, nor does it provide the results of testing against those criteria in a format suitable for the requested table.

Here's what can be extracted and what cannot:

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

• Cannot provide. The document states "No performance standards have been established for such devices under Sections 514 of the Federal Food, Drug, and Cosmetic Act." While it lists voluntary standards (e.g., ASTM F 1100-90, ISO 10651-1/2/3), it does not detail specific acceptance criteria derived from these standards or present test results against them. Compliance with these standards is mentioned as a general statement rather than specific performance data.

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

• Cannot provide. The document does not describe a specific performance test or clinical study with a test set. It focuses on substantial equivalence based on design, intended use, and technology rather than clinical performance data.

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 / Cannot provide. No test set or ground truth establishment process is described in the provided text.

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

• Not applicable / Cannot provide. No test set or adjudication process is described in the provided text.

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. This device is a ventilator, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned.

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

• Not applicable. This device is a physical medical device (ventilator), not an algorithm or AI. Performance would be assessed through engineering and bench testing, as well as potentially clinical trials for safety and effectiveness, but not in the "standalone algorithm" sense. The document does not detail specific performance studies.

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

• Not applicable / Cannot provide. No ground truth establishment is described as part of a performance study.

8. The sample size for the training set

• Not applicable. This device is a mechanical ventilator; there is no "training set" in the context of machine learning or AI models with the provided information.

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

• Not applicable. See point 8.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to predicate devices and compliance with voluntary standards for a physical medical device (ventilator). It does not contain the detailed performance study data, acceptance criteria, or ground truth information typical of a submission for an AI/algorithm-based device.

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