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The LTV1000 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 10 kg (22 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.
  The ventilator is suitable for use in institutional, home, and transport settings.

The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional, home, and transport settings. The ventilator is slightly larger than a "laptop computer" and is self-contained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:

• . Modes: Assist/Control, SIMV, CPAP, Apnea Backup
• Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
• . Flow Triggering
• . Oxygen Blending
• . PEEP
• Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real . Time Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
• . Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
  The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
  The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.

Here's a breakdown of the acceptance criteria and study information for the LTV 1000 ventilator, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document outlines a non-clinical performance test program to ensure the LTV 1000 meets its stated specifications and standards. This effectively serves as the acceptance criteria. The reported device performance is that the "ventilator was found to perform to specifications with exceptions as noted in the validation report."

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

• Sample Size: The document states that "Test procedures were written for individual tests specifying: the requirement being tested, the number of units to be tested." However, the exact sample size (the specific number of units tested) is not explicitly provided in the given text. It mentions testing "worst case combinations" for parameters like tidal volume, implying comprehensive testing.
• Data Provenance: The data is retrospective in the sense that it's generated from internal testing of the manufactured device. The country of origin of the data is not explicitly stated but is implicitly the USA, where Pulmonetic Systems, Inc. is located.

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

• The document does not mention the use of experts to establish ground truth for the test set. The ground truth for this device's performance is established through adherence to engineering specifications, industry standards (ASTM), and internal validation procedures, rather than expert consensus on diagnostic interpretations.

4. Adjudication Method for the Test Set

• The concept of an "adjudication method" (like 2+1 or 3+1) is not applicable to this type of device testing. This method is typically used in clinical studies where subjective human interpretation (e.g., image reading) requires consensus from multiple experts. For a mechanical ventilator, the tests are objective, comparing measurements against predefined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret data (e.g., medical images) and their performance with and without AI assistance is evaluated. The LTV 1000 is a therapeutic device, a ventilator, and its performance is assessed against technical specifications, not human interpretive accuracy.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• The entire non-clinical performance testing described is essentially a standalone (algorithm/device only) performance study. The testing validates the ventilator's functional and performance specifications independently, without human intervention as part of the evaluated performance metric. The "human-in-the-loop" would be the clinician operating the device, but the device's inherent performance is assessed on its own.

7. Type of Ground Truth Used

• The ground truth used for validating the LTV 1000 is based on engineering specifications, industry standards (ASTM F 1100-90, ASTM F 1246-91), and internal requirements (System Specification, Software Requirements Specification, System Hazards Analysis). These define the expected or correct behavior and output of the device.

8. Sample Size for the Training Set

• The document does not explicitly mention a "training set" in the context of machine learning or AI. This is a mechanical device, and its design and development likely involved traditional engineering and testing, not machine learning model training.

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

• Since there is no mention of a training set in the context of AI/ML, the question of how its ground truth was established is not applicable to this document. The "ground truth" for the device's design and function would have been established through engineering principles, regulatory requirements, and clinical needs analysis.

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The LTV1000 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 10 kg (22 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.
  The ventilator is suitable for use in institutional and transport settings.

The LTV 1000 is a self-contained mechanical ventilator suitable for continuous life support in institutional and attended transport settings. The ventilator is slightly larger than a "laptop computer" and is selfcontained in that it can be operated without the need for externally supplied compressed air. The unit may be operated from external AC power through the use of an external AC/DC converter, or may be operated for approximately one hour using an internal rechargeable battery pack.
The following major features are included:

• Modes: Assist/Control, SIMV, CPAP, Apnea Backup .
• Breath Types: Volume Control, Pressure Control, Pressure Support, Spontaneous .
• Flow Triggering .
• Oxygen Blending
• PEEP
• Monitors: Calculated Peak Flow, Exhaled Tidal Volume, I:E Ratio, Mean Airway Pressure, Real Time . Airway Pressure, Peak inspiratory Pressure, PEEP, Total Breath Rate, Total Minute Volume
• Alarms: Apnea, High Pressure Limit, Low Peak Pressure, Low Minute Volume, Disconnect, Low & . Lost External Power, Low & Empty Internal Battery, Oxygen Inlet Pressure
  The ventilator uses an internal flow generator to provide the pressurized gas source. All breath types are delivered by an electromechanical inspiratory flow valve. An oxygen blender meters oxygen as required to meet the current setting of the O2% control. Mechanical valves are provided internally for overpressure relief and sub-ambient relief functions.
  The patient circuit is comprised of a single leg inspiratory tube connected to an exhalation system located proximal to the patient connection. The exhalation valve system will consist of a piloted exhalation valve, a PEEP valve, and a flow transducer combined in a compact package. Additional small bore tubing is included to transmit the flow, pressure and exhalation drive signals.

The provided document is a 510(k) premarket notification for a medical device, the LTV 1000 Ventilator. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove acceptance criteria with specific performance metrics. Therefore, several requested elements (e.g., sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable or cannot be extracted from this type of regulatory submission.

Here's an analysis based on the information provided:

Acceptance Criteria and Device Performance

The document doesn't explicitly list "acceptance criteria" in terms of quantitative performance metrics with pre-defined thresholds. Instead, it describes a non-clinical performance testing program designed to ensure the device met its "stated specifications" and demonstrated "functional and technical equivalence" to the predicate device. The "reported device performance" is essentially that the ventilator "was found to perform to specifications."

Note: The document explicitly states: "A validation report was written that summarizes the results of these tests. The ventilator was found to perform to specifications with exceptions as noted in the validation report. If a parameter was found to be non-compliant, a procedure was described in the report to ensure the anomaly does not present a hazard to the patient or user." This suggests that any deviations from specifications were either minor or had a documented mitigation plan.

Study Details

The study described is a non-clinical performance testing program aimed at demonstrating substantial equivalence to a predicate device (TBird Ventilator, K950484).

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

   • Sample Size: The document states that test procedures were written specifying the "number of units to be tested." However, the exact number is not specified in this document. It only mentions "In general, test procedures were written to test each parameter over the entire range of operation while varying other relevant parameters such as patient lung condition and environment."
   • Data Provenance: The testing was retrospective in the sense that it was conducted on the manufactured device to verify its specifications. The data origin is internal testing by Pulmonetic Systems, Inc. There is no mention of external data or patient data from a specific country.

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

   • Not applicable / Not specified. This was a non-clinical technical performance study. "Ground truth" in this context refers to the defined specifications and standards (e.g., ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care). The "experts" involved would be the engineers and quality assurance personnel who designed the tests and evaluated the results against the established specifications. Their specific number and qualifications are not mentioned.

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

   • None specified. As this was a technical validation against specifications, an adjudication method in the clinical sense (e.g., for image interpretation) is not relevant. The validation report would likely have involved review and approval by relevant engineering and quality management personnel.

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. This device is a mechanical ventilator and does not involve AI or human "readers" in the context of diagnostic interpretation. Therefore, an MRMC study is not applicable.

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

   • Yes, analogous to standalone performance. The non-clinical performance testing assesses the device (including its software and mechanical components) in isolation, against its stated specifications and relevant standards. This is essentially a standalone performance evaluation of the device's functional and technical characteristics.

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

   • The "ground truth" for this non-clinical study consists of:
     • System Specifications: Internal design requirements.
     • Software Requirements Specifications: Internal software design requirements.
     • System Hazards Analysis: Requirements derived from risk assessment.
     • ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care: External, recognized industry standard for ventilator performance.

7. The sample size for the training set:

   • Not applicable / Not specified. This device is a mechanical ventilator, not an AI/ML algorithm that requires a "training set" in the conventional sense. The development of the device would have involved engineering design, prototyping, and iterative testing, but not a "training set" for an algorithm.

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

   • Not applicable. As there is no "training set" for an algorithm, this question is not relevant. The ground truth for the testing related to device specifications was established through internal design requirements (System, Software Requirements, Hazards Analysis) and external industry standards (ASTM F 1100-90).

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