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The S10 Kirra is indicated to provide CPAP and Bi-level therapy for the treatment of obstructive sleep apnea (OSA) in patients (female patients with mild to moderate OSA when using AfH treatment mode) weighing more than 66 lb (30 kg). ASV and ASVAuto modes are also indicated for the treatment of central and/or mixed apneas, or periodic breathing. It is intended for home and hospital use.

The S10 Kirra is a prescription only Positive Airway Pressure (PAP) ventilator device intended to treat individuals that are diagnosed with sleep apnea conditions. The S10 Kirra uses a micro-processor controlled blower, along with pressure and flow sensors, to achieve pressure, flow and time regulation of air delivery. It includes optional humidification, with air delivery to the patient via heated or non-heated breathing circuits. The device provides both therapeutic (e.g. tidal volume) and technical data (e.g. system fault), and a user interface allowing adjustment of device parameters. The device uses an external AC power supply, and allows the addition of low flow supplemental oxygen.

The provided text describes the S10 Kirra, a non-continuous ventilator, and its substantial equivalence to predicate devices, but it does not contain the detailed information necessary to answer all parts of your request about acceptance criteria and a specific study proving the device meets them.

The document focuses on demonstrating substantial equivalence to previously cleared predicate devices (S9 Greenhills, S9 Wanda, S9 Elouera), rather than detailing a new study with acceptance criteria for a novel device.

Here's a breakdown of what can be extracted and what is missing:

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

The document states:
"Verification confirmed the S10 Kirra met the predetermined acceptance criteria as defined in the relevant compliance standards and as defined in the system verification protocols."

However, it does not provide a table listing specific acceptance criteria values and the reported performance for each criterion. It broadly mentions areas of testing:

• Pressure performance
• Breath events (flow limitations, snore, apneas)
• Response to periodic breathing
• Humidification

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

This information is not available in the provided text. The document refers to "verification bench testing" and "comparative predicate testing" but does not specify sample sizes for test sets or data provenance (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)

This information is not available. The document focuses on bench testing and comparison to predicate devices, not human expert evaluations for ground truth.

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

This information is not available. Adjudication methods are typically relevant for studies involving human interpretation or subjective assessments, which are not detailed here.

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

The document explicitly states:
"Clinical performance data is not required as the subject device uses established therapeutic technology and bench testing is sufficient to demonstrate substantial equivalence."

Therefore, no MRMC comparative effectiveness study was done as the device relies on established technology, and its performance was evaluated through non-clinical bench testing.

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

The entire non-clinical data section describes performance of the device itself (hardware and software), which can be considered a standalone performance assessment in a bench testing environment. The listed performance areas (pressure, breath events, humidification) are intrinsic to the device's function.

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

For the non-clinical bench testing, the "ground truth" would be established by engineering specifications, compliance standards, and the performance characteristics of the predicate devices. The tests evaluate if the S10 Kirra performs according to these pre-defined, measurable engineering and physiological parameters. It is not based on expert consensus, pathology, or outcomes data in the way these terms are typically used for clinical evaluations.

8. The sample size for the training set

This information is not applicable/available. The S10 Kirra is a medical device (ventilator) with microprocessor control, not an AI/machine learning algorithm that requires a "training set" in the computational sense. The device's "training" involves design, engineering, and calibration to meet its specifications, rather than data-driven model training.

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

This information is not applicable/available for the same reason as point 8.

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