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The Newport HT70 family of ventilators is intended to provide continuous or intermittent positive pressure mechanical ventilatory support for the care of individuals who require mechanical ventilation through invasive or non-invasive interfaces. Specifically, the Newport HT70 family of ventilators is applicable for infant, pediatric and adult patients greater than or equal to 5 kg (11 lbs).

The Newport HT70 is suitable for use in hospital, sub-acute, emergency room, and home care environments, as well as for transport and emergency response applications.

The Newport HT70 is a state of the art ventilator that combines ruggedness, exceptional mobility, and ease of use with clinical proficiency to provide ventilatory support for infant, pediatric and adult patients. It has a durable exterior and robust overall design that stands up to the harsh environments found in emergency response, transport and homecare environments. The HT70's unique design provides maximum mobility and safety for short or long distance transport of critically ill patients and also for patients who are going about their normal activities of daily life.

The HT70 is user friendly with all controls easily found on the front touchscreen and panel; there are no complicated menus or difficult sequences to follow in order to make necessary adjustments for common operations. It may be operated from AC or DC external power sources or from the "hot-swappable" Integrated Battery System. Any time the ventilator is connected to external power, the Integrated Battery System is charged, including while the ventilator is in use.

The Newport HT70™ Family of Ventilators is a device intended to provide continuous or intermittent positive pressure mechanical ventilatory support.

Here's an analysis based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests. The document refers to "a series of tests" but does not quantify the number of units or test iterations.
• Data Provenance: The tests are non-clinical and would have been conducted by the manufacturer, Newport Medical Instruments, Inc., likely at their facilities in Costa Mesa, CA, USA. The data is retrospective in that it's prior to the 510(k) submission, but it's new data generated for this specific device.

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

• This information is not applicable to this 510(k) submission. The Newport HT70 Ventilator is a medical device designed to perform a physical function (mechanical ventilation) and its performance is evaluated against engineering, electrical, and software specifications, rather than against an expert-derived ground truth based on interpretation (e.g., image analysis for disease detection).

4. Adjudication Method for the Test Set

• Not applicable. As the performance assessment is based on objective measurements against predefined specifications, an adjudication method for reconciling expert opinions is not relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of human readers improving with AI vs. without AI assistance

• No. An MRMC study is not applicable here. This device is a ventilator, not an AI-assisted diagnostic or decision-support tool where human readers interact with AI.

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

• Not applicable in the context of AI algorithms. While the ventilator's software and hardware perform functions independently of continuous human-in-the-loop operation, this is not an "algorithm-only" performance as understood in AI/ML contexts. The device's performance is tested as a complete system of hardware and software.

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests were the engineering design specifications, performance requirements, and safety standards (e.g., electromagnetic compatibility standards, electrical safety standards, internal performance metrics for ventilation parameters). For substantial equivalence, the "ground truth" was the performance and operating principles of the legally marketed predicate devices.

8. The Sample Size for the Training Set

• Not applicable. This submission is for a conventional medical device (ventilator) and does not involve AI/Machine Learning, therefore there is no "training set."

9. How the Ground Truth for the Training Set was Established

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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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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