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IISIS is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station and to provide remote monitoring and alarm surveillance. IISIS is intended to supplement and not replace any part of the current device monitoring procedures.

IISIS software provides continuous display of ventilator data at a central station and remote workstations. IISIS utilizes wireless technology to interface with most critical care and home care ventilators that have RS-232, Ethernet, or nurse call. IISIS is accessed and displays ventilator data and waveforms through web-based technology. IISIS provides real-time alarm annunciation, displays and stores ventilator settings, parameters, and ventilator waveforms as a secondary tool to the primary ventilator alarm and data display.

The provided document describes the IISIS software, an accessory to continuous ventilators, and its 510(k) premarket notification. The focus of the document is on establishing substantial equivalence to a predicate device, the Bernoulli Ventilator Management System, rather than on detailed performance metrics as would typically be found in direct medical device performance studies.

Therefore, many of the requested categories for acceptance criteria and study details cannot be fully satisfied from this document alone because it pertains to software validation rather than a clinical effectiveness study.

Acceptance Criteria and Reported Device Performance

Study Details (as inferable from the document):

1. Sample size used for the test set and the data provenance:

   • The document mentions "Validation testing was provided" for software functions. This refers to software verification and validation activities rather than testing with patient data. It does not specify a "test set" in the context of clinical data or patient samples. Therefore, not applicable for patient/clinical data.
   • Data Provenance: Not specified, as it's a software validation claim.

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

   • Not applicable. This information is for software functional validation, not clinical ground truth establishment. Software requirements are established by a team (likely including subject matter experts) and validated against those requirements.

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

   • Not applicable. This refers to software functional validation, not clinical case adjudication.

4. 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 document describes a software system as an accessory for continuous ventilators that provides a secondary display and alarm annunciation. It is not an AI-assisted diagnostic tool for which MRMC studies would typically be conducted.

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

   • The device, IISIS V 1.0, is inherently a "standalone" software system in the sense that it operates independently to collect, display, and annunciate ventilator data. Its function is to supplement existing procedures and provide secondary information, not to make diagnostic or therapeutic decisions on its own. While it provides "real-time alarm annunciation," it explicitly states it is "intended to supplement and not replace any part of the current device monitoring procedures." Therefore, its performance is evaluated in its functional display and alarm capabilities. The "validation testing" confirms the algorithm's performance of its intended functions.

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

   • Functional Requirements and Specifications. The "ground truth" for the validation of IISIS V 1.0 is adherence to its "functional requirements specified in the Software Requirements Specification" and "User Requirements." This isn't a clinical ground truth but a validation against predefined software behavior.

7. The sample size for the training set:

   • Not applicable. The document describes a software system that displays data and annunciates alarms, not a machine learning or AI model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. No training set is mentioned or implied, as it's not an AI/ML device.

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