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The iVent™ 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 patients weighing at least 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 Portable Oximeter is suitable for intrahospital use, home and alternate-site use, transport and energy 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 speqification, limits.

The Non-invasive Pulse Oximeter board, MS-5, connects to sensors and provides oxygen saturation, pulse rate, pulse waveform, and other output information via a serial digital interface. The iVent201 provides DC power and isolates the board from the mains power and ground.

The provided text describes the regulatory filing for the iVent™ 201 Portable Ventilator with Pulse Oximeter, but it does not contain the detailed information required to fill out the table and answer all the questions regarding acceptance criteria and the study that proves the device meets them.

Specifically, the text mentions "Acceptance criteria for compliance with the standards is detailed in Section 3, part E (Compliance)" but this section is not provided. It also discusses risk analysis for hardware and software but doesn't explicitly link these to performance claims or specific studies with sample sizes, ground truth, or expert qualifications.

Here's what can be extracted and what is missing:

Information Present:

• Device Name: iVent™ 201 Portable Ventilator with Pulse Oximeter
• Predicate Device (for Pulse Oximeter): MASIMO CSD-1050, Masimo Set 2000, cleared under K990966
• Voluntary Standards:
  • ISO 9919 Pulse Oximeters for Medical Use Specifications
  • UL 544 Standard for Medical and Dental Equipment
  • Council Directive -93/42/EEC
  • IEC 601-1-4 Medical Electrical Equipment Programmable electrical medical systems
  • EN 865 Pulse Oximeters Particular Specifications
  • IEC 60601-1 (for medical safety)
• Risk Analysis Areas: Leakage current, SpO2 power source failure, SpO2 Alarms, EMC interference (ventilator on oximeter, oximeter on ventilator, integrated unit on external devices and vice versa), loss of communication, out of range inputs.
• Mention of Testing (but no details):
  • "interference of the Ventilator on the Pulse Oximeter, which is checked by Masimo"
  • "interference of the Pulse Oximeter on the Ventilator which is checked Versamed's software validation procedure"
  • "interference of the integrated unit on external devices and vise versa, which is checked by an independent accredited testing agent."
  • "The software risks addressed are loss of communication and out of range inputs. These are checked as part of Versamed's Software Test Procedure for validation of the software."
• Indications for Use (Pulse Oximeter): Non-invasive monitoring of oxygen saturation and pulse rate of adult and pediatric patients.

Missing Information (Crucial for the Request):

• Specific Acceptance Criteria: While standards are listed, the document does not provide specific numerical or qualitative acceptance criteria (e.g., SpO2 accuracy within +/-X%, pulse rate accuracy within +/-Y bpm).
• Reported Device Performance: No actual performance data (e.g., measured accuracy values) is given.
• Study Details:
  • Sample size for test set
  • Data provenance (country, retrospective/prospective)
  • Number of experts
  • Qualifications of experts
  • Adjudication method
  • MRMC study details (effect size)
  • Standalone algorithm performance
  • Type of ground truth used
  • Sample size for training set
  • How ground truth for training set was established

Table of Acceptance Criteria and Reported Device Performance:

Answers to Specific Questions:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
* Information not provided. The document vaguely mentions "Versamed's software validation procedure" and "an independent accredited testing agent" for EMC, but no details on sample size or data provenance.

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 / Information not provided. For a pulse oximeter, ground truth for SpO2 and pulse rate is typically established through direct measurement or comparison with a gold standard device, not expert consensus on interpretations. No details are given on how the ground truth was established for any performance testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
* Not applicable / Information not provided. This method is typically used for subjective evaluations where multiple readers/experts interpret images or data. For objective measurements like SpO2 and pulse rate, it's not relevant.

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, an MRMC comparative effectiveness study was not done. This type of study is for AI-assisted human interpretations, which is not relevant to a standalone medical device like a ventilator and pulse oximeter that provide direct measurements.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
* Yes, implicitly. A pulse oximeter is a standalone measurement device. However, the document does not provide the specific performance data from such a standalone evaluation. It references compliance with standards like ISO 9919, which would necessitate standalone performance testing.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
* Information not provided. For pulse oximetry, the ground truth for oxygen saturation and pulse rate is typically obtained from a reference method (e.g., arterial blood gas analysis, electrocardiogram) for accuracy testing, but this is not explicitly stated.

8. The sample size for the training set
* Not applicable / Information not provided. The device described is a hardware medical device with integrated software for control and measurement. It's not an AI/machine learning device that would typically involve a "training set" in the common sense.

9. How the ground truth for the training set was established
* Not applicable / Information not provided. (See answer to #8).

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