(150 days)
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."
| Acceptance Criteria Category | Specific Acceptance Criteria (from text) | Reported Device Performance |
|---|---|---|
| ASTM Tests | Ventilator meets ASTM F 1100-90 Standard Specification for Ventilators for Use in Critical Care. | |
| Ventilator meets ASTM F 1246-91 Standard Specification for Electrically Powered Home Care Ventilators. | "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." (Implies general compliance, with specific deviations addressed and mitigated). | |
| Performance Tests | Ventilator meets performance specifications, including tolerance and accuracy issues. (Example: Set Tidal Volume function tested over its entire range (50-2000 ml) and worst-case combinations of patient compliance, patient resistance, temperature/humidity of breathing gas, and ventilator operating temperature). | "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." (Implies general compliance, with specific deviations addressed and mitigated). The example specifically mentions testing "over the entire range of operation while varying other relevant parameters." |
| Functional Tests | Ventilator meets behavioral specifications (Primarily Software). | "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." (Implies general compliance, with specific deviations addressed and mitigated). |
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 originof 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.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).