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The Respironics Trilogy100 system provides continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. Trilogy100 is intended for pediatric through adult patients weighing at least 5 kg (11 lbs.).

The device is intended to be used in home, institution/hospital, and portable applications such as wheelchairs and gurneys, and may be used for both invasive and non-invasive ventilation. It is not intended to be used as a transport ventilator.

The Respironics Trilogy 100 Ventilatory Support System is a microprocessor controlled blower based pressure support, pressure control or volume controlled ventilator intended for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in the institutional, home and transport settings and is applicable for adults and pediatric patients weighing at least 5 kg (11 lbs) who require the following types of ventilatory support.

CPAP – Continuous Positive Airway Pressure
S Spontaneous Ventilation
S/T Spontaneous and Timed Ventilation
T Timed Ventilation
PC Pressure Control Ventilation
PC-SIMV Pressure Controlled Synchronized Intermittent Mandatory Ventilation
AC Assist Control Ventilation
CV Control Ventilation
SIMV Synchronized Intermittent Mandatory Ventilation

A user interface displays clinical data and enables the operator to set and adjust certain clinical parameters.

The Trilogy 100 Ventilator is fitted with alarms to alert the user to changes that will affect the treatment. Some of the alarms are pre-set (fixed), others are user adjustable.

The Trilogy 100 Ventilator can deliver invasive (via ET tube) or non-invasively (via a mask)

The provided text is a 510(k) premarket notification for the Respironics Trilogy 100 Ventilator. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing extensive clinical trials to establish new acceptance criteria and prove performance against those criteria. Therefore, the document does not contain the detailed information typically found in a study designed to establish and meet novel acceptance criteria for a new device.

However, based on the information provided, I can infer the "acceptance criteria" as demonstrating substantial equivalence to predicate devices, and the "study" proving this as the compilation of technical characteristics and bench testing results comparing the Trilogy 100 to its predicates.

Here's a breakdown of the available information, addressing as many of your points as possible:

Acceptance Criteria and Reported Device Performance

• Environment of Use
• Physical Characteristics of Design, Manufacturing, Energy Delivery, Materials, Anatomical Sites, Energy Source
• Rise Time, Ramp, Triggering, Pressure Regulation method
• Alarm/Power Control Indicators, Patient Alarms, System Error Alarms
• Device Settings (Tidal Volume, Pressure, Rate), Inspiratory Time Setting, Rise Time Setting
• Protection against electric shock and patient applied part
• Therapy features (Bi-Flex and AVAPS, where applicable to specific predicates)
• Data Storage, Serial Interface, User Interface, Real-Time Pressure Display, Humidifier, Oxygen Safety Valve, Modem |
  | Compliance with specific standards (ASTM F1100-90, F1246-91, ISO 10651-2, ISO 10651-6, IEC 60601-1-2) and FDA guidance documents. | "Bench testing has confirmed that the Trilogy 100 Ventilator performs equivalently to the cited device predicates. Performance testing was conducted per the applicable sections of ASTM F1100-90, F1246-91, ISO 10651-2 and ISO 10651-6. EMC testing was performed per IEC 60601-1-2. Electrical, mechanical and environmental testing was performed in accordance with the FDA Draft Reviewers Guidance for Pre-market Notification Submission (1993). Software validation testing was performed per FDA's Guidance for the Content of Premarket Submissions for Software contained in Medical Devices (2005). The results of all testing demonstrate that all design and system requirements for the Trilogy 100 have been met." |

Detailed Study Information (as much as can be inferred from the document):

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

   • Test Set Sample Size: Not explicitly stated as a "sample size" in the context of patient data. The "test set" here refers to the extensive bench testing and engineering verification and validation activities. The document implies a comprehensive set of tests covering various performance parameters and safety aspects according to industry standards.
   • Data Provenance: The nature of the testing (bench testing, EMC testing, electrical, mechanical, environmental testing, software validation) suggests the data was generated in a controlled laboratory environment. No country of origin for specific data is mentioned beyond Respironics, Inc. being in Monroeville, PA, USA. The testing is prospective in the sense that it was performed specifically for this submission to verify the device's design and performance.

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

   • Not applicable in the sense of medical experts establishing "ground truth" for patient data. The "ground truth" for this type of submission is defined by the technical specifications and performance requirements derived from predicate devices and applicable standards. The "experts" involved would be the engineers, quality assurance personnel, and regulatory affairs specialists at Respironics responsible for designing, testing, and documenting the device's compliance. Their qualifications are not detailed.

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

   • Not applicable as this is not a study involving human interpretation of medical data. Performance was measured against predefined technical specifications and standards, likely through automated or manual measurements by testing engineers.

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 MRMC comparative effectiveness study was done. This device is a ventilator, not an AI-assisted diagnostic tool for human readers.

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

   • This is not an AI algorithm. The device itself (the ventilator) underwent standalone performance testing. The detailed bench testing and compliance with standards are the standalone performance evaluation of the device's functions.

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

   • For this 510(k) submission, the "ground truth" is primarily based on:
     • Standard Specifications: Requirements outlined in ASTM F1100-90, F1246-91, ISO 10651-2, ISO 10651-6, IEC 60601-1-2.
     • Predicate Device Performance: Documented performance characteristics and safety profiles of the legally marketed predicate devices.
     • FDA Guidance Documents: Benchmarking against relevant FDA guidance for ventilators and software.

7. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI algorithm where a "training set" (implying data used to teach an algorithm) is relevant. The "design phase" and prior knowledge from predicate devices inform the design of the Trilogy 100.

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

   • Not applicable for the reason stated above.

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The V60 ventilator is an assist ventilator and is intended to augment patient breathing. It is intended for spontaneously breathing individuals who require mechanical ventilation: patients with spontaneous respiratory failure, chronic respiratory insufficiency, or obstructive sleep apnea in a hospital or other institutional settings under the direction of a physician.

The Ventilator is intended to support pediatric patients weighing 20kg (44 lbs) or greater to adult patients. It is also intended for intubated patients meeting the same selection criteria as the noninvasive applications. The Ventilator is intended to be used by qualified medical professionals, such as physicians, nurses, and respiratory therapists.

The ventilator is intended to be used only with various combinations of Respironics recommended patient circuits, interfaces (masks), humidifiers and other accessories.

The V60™ ventilator is a microprocessor controlled positive pressure ventilatory assist system incorporating a user interface with multifunction keys, real-time graphic displays, and integral patient and system alarms. The ventilator provides noninvasive and invasive ventilatory support for spontaneously breathing adult and pediatric patients.

The provided text describes a 510(k) submission for the Respironics V60 Ventilator. The summary states that "Bench performance testing was performed comparing the new V60 and the predicate devices, and was found to be substantially equivalent." and "Performance testing and human factors testing demonstrate that the device is as safe, as effective and performs as well as or better than the predicate device."

However, the document does not provide specific acceptance criteria, reported device performance metrics, detailed study designs, sample sizes, information on ground truth establishment, or any details about multi-reader multi-case (MRMC) comparative effectiveness studies.

Therefore, I cannot populate the table or answer most of the questions based on the provided text. The document focuses on demonstrating substantial equivalence to predicate devices through general performance and human factors testing, rather than presenting a detailed clinical study with quantitative acceptance criteria.

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

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

The document mentions "Bench performance testing" and "human factors testing" but does not specify sample sizes for any test sets, nor does it provide details about data provenance (e.g., country of origin, retrospective or prospective nature).

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 specified in the provided text. The document does not describe the establishment of a "ground truth" using experts for the performance testing.

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

Not specified in the provided text.

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 MRMC study is mentioned. The device is a ventilator, and the testing described is performance and human factors testing of the device itself, not a study evaluating human reader performance with or without AI assistance.

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

This question is not applicable in the context of a ventilator. The described "Performance testing" is inherently standalone in the sense that it tests the device's functionality.

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

The concept of "ground truth" as typically defined for diagnostic AI studies using expert consensus or pathology is not applicable to the performance testing of a ventilator as described in this document. The "ground truth" for a ventilator's performance would be engineering specifications and established physiological parameters it is designed to achieve.

8. The sample size for the training set

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.

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

Not applicable. The document describes a medical device, not an AI/ML algorithm that requires a training set.

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