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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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The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is a restricted medical device intended for use by qualified, trained personnel under the direction of a physician. Specifically, the ventilator is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• Assist/Control, SIMV, or CPAP modes of ventilation. ●
• Breath types including Volume, Pressure Control and Pressure Support. ●
  The ventilator is suitable for use in institutional, home, or transport settings.

The LTV 1000 ventilator is intended to provide continuous or intermittent ventilatory support for the care of individuals who require mechanical ventilation. The ventilator is suitable for use in institutional, home and transport settings, and is applicable for adult and pediatric patients weighing at least 5 kg (11 lbs.), who require the following types of ventilatory support:

• Positive Pressure Ventilation, delivered invasively (via ET tube) or non-invasively (via . mask).
• . Assist/Control, SIMV, or CPAP modes of ventilation.
• Breath types including Volume, Pressure Control and Pressure Support. .
  The modification intended to be cleared by this submission is:
• The addition of Spontaneous Breathing Trial (SBT) function allowing the clinician to . more easily determine a patient's ability to be weaned from ventilation.

The provided 510(k) summary for the Pulmonetic Systems LTV 1000 Ventilator (K051767) primarily focuses on demonstrating substantial equivalence to predicate devices, particularly regarding a new "Spontaneous Breathing Trial (SBT)" function. This type of submission, for a ventilator modification, does not typically include detailed performance studies with acceptance criteria in the same way an AI/ML device would.

Based on the provided document, here's an analysis concerning acceptance criteria and study information:

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

The document doesn't present a table of quantitative acceptance criteria and reported 'performance' in the sense of a diagnostic or predictive device. Instead, it compares characteristics of the modified LTV 1000 Ventilator with its predicate devices to demonstrate equivalence.

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

This submission is for a modification to a medical device (ventilator software feature), not a diagnostic or AI/ML device that would typically involve a "test set" of patient data for performance evaluation in the way a clinical study would. Therefore, there is no specific sample size, test set, or data provenance mentioned in relation to proving the SBT function's performance. The evaluation is based on engineering design, comparison to predicate devices, and potentially internal validation/verification testing which is not detailed in this public summary.

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. As this is not a diagnostic device relying on expert interpretation for ground truth, there's no mention of experts establishing ground truth for a test set. The statement about "Longer time duration is provided at the request of clinicians" suggests input from medical professionals informed the feature design, but not for establishing ground truth in a performance study.

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

Not applicable. There is no test set or adjudication method described in the context of this submission.

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-assisted diagnostic device, and therefore, no MRMC study or AI assistance effect size is mentioned.

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

Not applicable. The device is a ventilator with a software function. The "performance" is inherent to the function's design and operation, not an algorithm providing a diagnostic output independently.

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

Not applicable in the traditional sense of a diagnostic performance study. The "ground truth" for the SBT function would be its adherence to engineering specifications, correct implementation of the defined parameters (e.g., timing, mode switching), and safe operation in a simulated or actual clinical environment. This type of validation is typically conducted through internal engineering testing, which is not detailed here but implied by regulatory compliance.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that would require a 'training set'.

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

Not applicable. This is not an AI/ML device.

Summary:

The 510(k) summary for K051767 focuses on demonstrating "substantial equivalence" of a modified ventilator with a new Spontaneous Breathing Trial (SBT) function to previously cleared predicate devices. The "acceptance criteria" here are implicitly tied to ensuring the new function is safe, effective, and performs comparably or superiorly without introducing new risks compared to existing methods or devices. The "study" proving this largely relies on design comparison, engineering assessment of the software modification, and the assertion that it does not introduce new technology or patient risk. It does not involve a clinical performance study with patient data, ground truth establishment, or human reader evaluations as would be expected for a diagnostic or AI/ML device.

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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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