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The bellavista 1000/1000e ventilator is intended to provide positive pressure ventilatory support to adult and pediatric patients and optionally infant and neonatal patients by qualified, trained personnel under the direction of a physician.

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

When used on neonatal patients: The environment of use is the Neonatal Intensive Care Unit (NICU).

bellavista is an electronically controlled pneumatic ventilation system. It is powered by AC or DC and also provided with an internal battery. The bellavista pneumatic system supplies respiratory gas whilst the electrical systems control the pneumatics and provides the power supply.

The user can enter values or parameters in the bellavista via the touch screen. These inputs entail instructions for bellavista's pneumatic system to ventilate the patient with a precisely controlled gas mixture. bellavista gathers readings from the proximal flow sensor within the ventilator.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) clearance letter and summary for a medical device (ventilator). It describes the device, its intended use, a comparison to predicate devices, and the basis for substantial equivalence.

However, it does not include details about acceptance criteria, specific device performance numerical results, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, or any details about a multi-reader multi-case (MRMC) study or standalone algorithm performance, as these are typically part of a clinical validation study and not usually found in a 510(k) summary for a ventilator.

The document discusses the ventilatory support capabilities and patient populations for which the device is intended, but not the kind of detailed performance metrics usually required for AI/algorithm-based diagnostic devices.

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The Puritan Bennett 980 Series Ventilator System is designed for use on patient population sizes from Neonatal (NICU) through Adult who require respiratory support or mechanical ventilation and weigh a minimum of 0.3kg (0.66lb). It is suitable for service in hospital (institutions) and intra-hospital transport to provide continuous positive pressure ventilatory support using medical oxygen and compressed medical air from either an internal air compressor or external air sources to deliver oxygen concentrations of 21% to 100%. Ventilatory support can be delivered invasively or non-invasively to patients who require the following types of ventilator support

• Positive Pressure Ventilation, delivered invasively (via endotracheal tube or tracheotomy tube) or noninvasively (via mask or nasal prongs)
• Assist/Control, SIMV, or Spontaneous modes of ventilation

The Puritan Bennett 980 Series Ventilator System is a dual-microprocessor-based, touch-screen controlled; critical care ventilator intended to provide continuous ventilation for neonate to adult patients who require either invasive ventilation or non-invasive ventilation. It can be used in hospitals and institutions and for intra –hospital transport applications with access to the appropriate services.
The ventilator system offers features for patient comfort while delivering sensitive, precise breaths to critically ill patients. The product ventilates Neonatal, Pediatric, and Adult patients with predicted body weights from 0.3 kg, and with tidal volumes for mandatory volume controlled breaths from 2 mL to 2500 mL.

The provided text is a 510(k) summary for the Puritan Bennett 980 Ventilator System. It details the device's characteristics, indications for use, and a comparison to predicate devices, primarily focusing on non-clinical evidence for substantial equivalence.

Based on the provided information, I can only provide limited answers to your request as the document does not contain details about acceptance criteria, device performance metrics, or a study that would involve a test set with ground truth, experts, or MRMC studies. This is because the submission is for a ventilator, not an AI/CADe device.

Here's an attempt to answer based on the available information, noting when the information is not available in the provided document:

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

This information is not available in the provided document. The document focuses on demonstrating substantial equivalence through non-clinical verification and validation, rather than specific performance metrics against acceptance criteria for an AI/CADe system.

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

This information is not applicable and not available in the provided document. The submission is for a ventilator, which does not typically involve a "test set" of data for performance evaluation in the way an AI/CADe device would. The "test sets" mentioned relate to engineering tests (e.g., electrical safety, EMC) rather than clinical data for AI model evaluation.

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 applicable and not available in the provided document. As it's a ventilator, there isn't a "ground truth" establishment by medical experts for image interpretation or diagnosis.

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

This information is not applicable and not available in the provided document.

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

This information is not applicable and not available in the provided document. MRMC studies are typically used for assessing the impact of AI/CADe systems on human performance in diagnostic tasks, which is not relevant to a ventilator submission.

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

This information is not applicable and not available in the provided document. A ventilator's performance is not typically evaluated as a "standalone algorithm" in this context.

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

This information is not applicable and not available in the provided document.

8. The sample size for the training set

This information is not applicable and not available in the provided document. The ventilator has software, but it is not described as an AI or machine learning system that requires a "training set" in the context of image analysis or diagnostic tasks.

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

This information is not applicable and not available in the provided document.

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The bellavista 1000 ventilator is intended to provide positive pressure ventilator support to adults and pediatrics (IBW greater than 6 kg).

Environment of use: hospitals, sub-acute care facilities and intra-hospital transfer

It is intended for use by qualified, trained personnel under the direction of a physician.

The bellavista 1000 ventilator (hereafter referred to as "bellavista") is designed for continuous ventilation of adult and pediatric patients.

The bellavista ventilator is a positive pressure ventilator for intubated patients and patients with mask ventilation. Its pneumatic power is provided by an internal turbine. Supplemental oxygen is provided by an auxiliary oxygen source.

The following modes of ventilation are available

• Adults: CPAP, PCV, P-A/C, PC-SIMV, PSV, S, S/T, T, beLevel, APRV, VCV, ● V-A/C, VC-SIMV.
• Pediatrics the following modes of ventilation are available: CPAP, PCV, P-A/C, ● PC-SIMV, S, T, beLevel, APRV, VCV, V-A/C, VC-SIMV

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the "bellavista 1000" ventilator. It is a letter confirming the device's substantial equivalence to legally marketed predicate devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves the device meets the acceptance criteria in the way you are asking.

The 510(k) process for substantial equivalence (SE) reviews a new device against a predicate device. It demonstrates that the new device is as safe and effective as a legally marketed device, not that it independently "meets acceptance criteria" through clinical trials for novel devices.

Therefore, many of the specific points you requested (e.g., sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) are not applicable to this type of regulatory submission because clinical performance studies, as you've outlined, are generally not required for a 510(k) unless significant differences or new questions of safety/effectiveness arise.

The document states:

• "No clinical testing was conducted or required in support of this premarket notification." (Page 17)
• The comparison is primarily against a predicate device (HAMILTON-C2, K121225) and some reference devices (HAMILTON-G5, COVIDIEN-PB 840, DRAEGER-Oxylog 3000 plus).

Instead of clinical study data, the document relies on:

• Performance Testing:
  • Tests according to IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2007, ISO 80601-2-12:2011, IEC 60601-1-8:2006+A1:2012, ISO 80601-2-55:2011.
  • Reliability testing as described in ASTM F1100-90.
  • Validation testing with "wide range of System Acceptance Tests (SAT)".
  • Biocompatibility testing according to ISO 10993-1, with certain scientific methodologies within ISO 18562-3.
• Comparison of Technical Specifications: Detailed tables comparing settings, alarms, monitoring parameters, and accuracy controls with the predicate device.
• Usability: Summative usability tests performed with a user group of respiratory therapists.

Given this, I will answer the applicable parts of your request based on the provided document and clarify why other points are not present.

Acceptance Criteria and Device Performance (Based on Substantial Equivalence to Predicate)

The "acceptance criteria" in this context are primarily demonstrating equivalence to the predicate device (HAMILTON-C2, K121225) and compliance with relevant performance standards. The "reported device performance" is presented through detailed comparisons.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This is a 510(k) premarket notification relying on technical specifications and performance testing against standards and a predicate device, not a clinical study with patient samples.
• Data Provenance: The document does not specify the country of origin for the internal testing data, but the submitter is IMTMEDICAL AG, Switzerland. The testing is non-clinical (laboratory/bench testing) rather than retrospective or prospective patient data.

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

• Not Applicable. Ground truth in the context of clinical expert consensus would be relevant for devices involving image interpretation or diagnosis. For a ventilator, "ground truth" for performance is established through internationally recognized performance standards (e.g., ISO, IEC, ASTM) and physical measurements using test lungs and calibrated sensors.
• The usability testing was conducted with a user group reported as "respiratory therapists," but no number or detailed qualifications are provided.

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

• Not Applicable. This is a method used in clinical studies, particularly for diagnostic devices where subjective interpretation (e.g., by radiologists) needs consensus. It does not apply to the technical performance testing of a ventilator.

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 study is a type of clinical study for diagnostic devices, especially those using AI, to assess the impact of AI on human reader performance. This document concerns a ventilator, which is a therapeutic device, and explicitly states "No clinical testing was conducted or required."

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

• Yes, in spirit, for certain aspects. The performance testing (e.g., accuracy of controls, alarm limits, monitoring parameters) represents the "standalone" or "algorithm only" performance of the ventilator's internal systems against engineering specifications and international standards. This is not "AI algorithm only" but "device functionality only." The document does not detail specific "algorithms" for AI, as this is a traditional ventilator.

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

• The "ground truth" for the device's technical performance is the relevant international performance standards (e.g., IEC, ISO, ASTM) and the measured performance of the legally marketed predicate device. These standards define acceptable ranges for parameters like accuracy, flow, pressure, etc.

8. The sample size for the training set

• Not Applicable. This is a traditional medical device (ventilator). The document does not describe the use of machine learning or AI models requiring a "training set" of data. Its design and validation rely on engineering principles, known predicate device performance, and adherence to established standards.

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

• Not Applicable. See point 8.

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