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The intended use of the Esprit Ventilator Neonatal Option is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes intubated neonatal patients with an ideal body weight range from 0.5 kg to 6.5 kg and an endotracheal tube I.D. range from 2.5 – 4.0 mm.

The Neonatal Option is a software modification to the currently marketed Esprit Ventilator. Once the software is enabled and the neonatal patient type is selected on the Esprit, it provides the following types of ventilatory support to neonatal patients in invasive applications only: Assist/Control, Spontaneous Intermittent Mandatory Ventilation (SIMV) or Continuous Positive Airway Pressure (CPAP) modes of ventilation. Pressure-Controlled (PC). Available in A/C and SIMV. Pressure Support (PS). Available in SIMV and SPONT. Apnea Ventilation

The provided text describes a software modification to the Esprit Ventilator, called the "Neonatal Option," but it does not contain acceptance criteria or a study proving that the device meets specific acceptance criteria in the format requested.

The document is a 510(k) summary for a medical device modification, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance study results against predefined acceptance criteria.

Here's an breakdown of what is and isn't available based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Comment: The document states that "performance testing was successfully completed" and "all design and system level requirements...have been met," but it does not explicitly list what those acceptance criteria (e.g., specific metrics like accuracy, precision, or reliability thresholds) were, nor does it provide the quantitative results of the performance testing against such criteria. It's a high-level statement of success.

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not specified.
• Data Provenance: Not specified. The testing described is "Software verification and validation testing," implying internal testing rather than clinical study data from a specific country or retrospective/prospective collection.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

• Number of Experts: Not applicable. The document is about a ventilator's software modification, not an AI or diagnostic device that typically requires expert-established ground truth from medical images or clinical observations.
• Qualifications: Not applicable.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not applicable. This type of testing (software verification and validation for a ventilator) does not typically involve expert adjudication of results in the way an AI diagnostic tool would.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• MRMC Study: No. This document does not describe an MRMC study. The device is a ventilator, not an imaging or diagnostic AI tool that would typically involve human readers.
• Effect Size of Human Readers: Not applicable.

6. Standalone (Algorithm Only) Performance Study:

• Standalone Study: Yes, indirectly. The "Software verification and validation testing" is conducted on the device's software algorithms to ensure they meet design and system-level requirements. This inherently refers to the algorithm's performance in controlling ventilation parameters. However, specific metrics or a detailed standalone performance study report are not provided. The phrase "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator" suggests that the technical characteristics and performance of these algorithms were deemed equivalent to a previously cleared device.

7. Type of Ground Truth Used:

• Type of Ground Truth: "Design and system level requirements." For a ventilator, ground truth would typically be established based on engineering specifications, physiological models, and regulatory standards for delivering specific pressure, volume, and flow characteristics accurately and safely. It would not typically be pathology, expert consensus on images, or outcomes data in the way an AI diagnostic device would.

8. Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This device is a software modification for a ventilator, not a machine learning or AI model trained on a data set.

9. How Ground Truth for Training Set was Established:

• How Ground Truth was Established: Not applicable, as there is no training set in the context of an AI model for this device.

Summary of what the document does provide regarding performance:

• It states that the Neonatal Option is a software modification to an existing ventilator.
• It claims the addition does not result in the use of any new technological characteristics.
• It explicitly states: "Breath delivery is controlled by software algorithms that are equivalent to those used on the currently marketed Respironics Esprit ventilator."
• It indicates that "Software verification and validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (1998)."
• It concludes that "Performance testing was successfully completed demonstrating that all design and system level requirements for the Esprit Ventilator with Neonatal Option have been met."
• The primary method for determining substantial equivalence relies on the similarity of performance characteristics, intended use, and patient populations to predicate devices, implying that the performance meets expectations set by already approved devices.

In essence, the document serves as a regulatory submission arguing for substantial equivalence based on the software's adherence to established design requirements and equivalency to existing technology, rather than detailing a specific experimental study with statistical results against explicit numerical acceptance criteria.

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