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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 intended use of the PLV Continuum II ventilator is to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The intended patient population includes pediatric and adult patients who weigh at least 5 kg (11 lbs). The PLV Continuum II ventilator is intended for use in home, institutional and portable settings and may be used for invasive as well as non-invasive ventilation.

The PLV Continuum ventilator is a microprocessor controlled, compressor-based, ventilator that provides ventilatory support by delivering room air to the patient. PLV Continuum utilizes an internal compressor to generate compressed air for delivery to the patient. Breath delivery is controlled by software. The PLV Continuum has a membrane keypad with indicator Light Emitting Diodes (LED) for the selection and acceptance of patient settings. The PLV Continuum is capable of providing the following types of ventilatory support:

• Positive Pressure Ventilation, delivered either invasively (via endotracheal or tracheostomy tube) or non-invasively (via mask or mouthpiece).
• Assist Control, Synchronized Intermittent Mandatory Ventilation (SIMV) or Spontaneous Pressure (CPAP) modes of ventilation.
• Volume-Controlled (VC). Available in A/C and SIMV.
• Pressure-Controlled (PC). Available in A/C and SIMV.
• Pressure Support (PS). Available in SIMV and SPONT.

The provided document is a 510(k) Premarket Notification for a modification to the PLV Continuum Ventilator, now referred to as the PLV Continuum II Ventilator. This document concerns a medical device (ventilator) and its regulatory approval process, rather than a clinical study evaluating an AI/ML powered device. As such, many of the requested fields (e.g., sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of submission.

The document primarily focuses on establishing substantial equivalence to predicate devices rather than proving the performance against specific acceptance criteria in the context of an AI/ML algorithm.

However, I can extract information related to the performance testing conducted for the device.

Here's a summary of the information that can be extracted, with notes for the fields that are not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study that proves the device meets the acceptance criteria is described as a series of performance tests, rather than a single clinical study.

• Study Name/Description: "Summary of Performance Testing" (Section 16.5)
• Study Objective: To demonstrate that all design and system requirements for the modified PLV Continuum have been met and to support substantial equivalence to predicate devices.
• Key Finding: "The results of all testing demonstrate that all design and system requirements for the modified PLV Continuum have been met." (Section 16.5) and "The technological characteristics of the modified PLV Continuum ventilator and the results of the performance testing do not raise new questions of safety and effectiveness when compared to the legally marketed predicate devices." (Section 16.6)

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

• Not Applicable. This is a hardware/software medical device modification submission, not an AI/ML study with a distinct "test set" of patient data. The "testing" refers to engineering and regulatory compliance testing of the device itself.

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 Applicable. Ground truth, in the context of patient data adjudicated by experts, is not relevant to this type of device submission. Performance was assessed against engineering standards and specifications.

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

• Not Applicable. See point 3.

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

• Not Applicable. This is not an AI-powered device, nor is it a diagnostic device being evaluated with human readers.

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

• Not Applicable. While the device is microprocessor-controlled with software algorithms, the "standalone" performance requested typically refers to the performance of an AI algorithm in isolation from a human user, which is not the subject of this document. The device's performance was evaluated as a complete system.

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

• Not Applicable as traditionally defined for AI/ML studies. The "ground truth" here is adherence to engineering specifications and regulatory standards (e.g., flow rates, pressure delivery, safety alarms, EMC compliance).

8. The sample size for the training set

• Not Applicable. There is no "training set" in the context of an AI/ML algorithm development described in this document. The software algorithms are described as "equivalent to those used on the currently marketed Respironics PLV Continuum ventilator (K022750)".

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

• Not Applicable. See point 8.

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