(553 days)
The Life Support for Trauma and Transport (LSTAT) is a portable system to provide in a single platform, Intensive Care Unit (ICU) functionality for adult patients. Its use is to provide physiological monitoring, upper airway or gastrointestinal drainage suction, automated external defibrillation, IV fluid and drug administration, ventilation and oxygen delivery for use in hospitals, aircraft, ambulances, field hospitals and extended care facilities. It is for use on any adult patient weighing more than 90 pounds. Operating power is applied to unconscious, pulseless and apneic patients from internal rechargeable batteries.
The LSTAT Model 9601 is used to support resuscitation, stabilization, and transport of adult trauma victims or patients needing physiological monitoring and treatment capabilities of a hospital intensive care unit or trauma care unit for pre-operative, intraoperative, and post operative support during pre, intra, and post-transport phases.
The indications for use of selected subsystems/capabilities are dictated by medical protocol, but in general LSTAT use may be anticipated for victims of: combat/civilian casualty, trauma, respiratory distress, pneumothorax, severe fluid loss, cardiac emergency, or unstable clinical presentation.
The LSTAT Model 9601 is a portable individualization intensive care unit that incorporates resuscitative and life-sustaining medical devices within a single composite structure assembly.
Physically, the LSTAT Model 9601 is a highly instrumented patient transport platform (interfaced to a NATO litter) with medical devices incorporated within its composite structure assembly. Figure 16-2 shows the appearance of the LSTAT assembly whose unique outer moldline and low profile are defined for military transport compatibility (height = 13.2 inches, length = 86.8 inches, and width = 23.0 inches without patient). Device interfaces are colocated to favor awareness and controls in the "anestheologist position" during intra-operative procedures.
The LSTAT incorporates six portable patient monitoring/treatment subsystems/ capabilities and five utilities/support subsystems as identified below.
The LSTAT Medical Subsystems include:
- Physiological Monitoring
a. ECG
b. NIBP
c. Invasive Blood Pressure (BP) (two channels)
d. Temperature - Blood Chemistry Assessment (in vitro)
- Suction
- Automated External Defibrillator (AED)
- IV Fluid Administration (and IV drugs)
- Ventilator
a. On-board compressor (for medical air only)
b. Oxygen-air blending
c. Patient ventilation (controllable: mandatory or assist)
d. Ventilation assessment: airway pressure, airway pCO2 and EtCO2, airway flow and tidal volume, and oxygen saturation (pulse oximeter)
The LSTAT Utilities/Support Subsystems include:
7. Structure (including NATO litter)
8. Oxygen
9. Electrical Power
10. Environmental Control Subsystem (ECS)
11. Data Logging and Display Subsystem (DDLS) including a secondary display
Here's a summary of the acceptance criteria and study information for the Northrop Grumman Life Support for Trauma and Transport (LSTAT) device, based on the provided text:
Acceptance Criteria and Device Performance
The provided document does not explicitly present a table of numerical acceptance criteria or reported device performance metrics in the format typically seen for algorithm-based devices (e.g., sensitivity, specificity, AUC). Instead, it focuses on the LSTAT's ability to integrate existing, FDA-cleared medical devices and provide a functional ICU platform in severe environments.
The overarching "acceptance criteria" can be inferred as:
- Maintaining the safety and efficacy of integrated medical devices.
- Providing necessary utilities and support for their operation.
- Withstanding severe military/transport environments (vibration, shock, thermal, altitude, EMI/EMS).
- Performing continuous data logging and display.
- Ensuring structural integrity and patient/component support.
- Providing oxygen and power management.
The "device performance" is described through the successful integration of these systems and the extensive testing program designed to validate these aspects.
| Acceptance Criterion (Inferred from text) | Reported Device Performance/Study Findings |
|---|---|
| Integration of existing legally marketed medical devices (without compromising functionality, capability, controls, interfaces). | Explicitly stated as a core design principle. "The LSTAT integration design has not changed any of the supplier's circuitry or patient/operator interfaces." |
| Provision of utilities and support (power, oxygen, environmental control) meeting device requirements. | "Provision of utilities and support which meet the requirements of each device's operation." Centralized power system supports all devices, provides uninterruptible backup, and stand-alone operation (at least 30 minutes). Compressed and regulated oxygen provided. Environmental control (cooling, temperature, EMI/EMS protection) accommodated. |
| Continuous data logging and display (patient data, system/device data, alarms, waveforms) for post-treatment analysis and redundant messaging. | "Continuous logging of both patient data and system/device data and alarms for redundant messaging of alarms and for support of post-treatment analysis of any event or observation (24 hours operations before down-load required with continued monitoring during down-load)." A secondary display (portable computer) provides real-time data/alarms at any location. |
| Aerospace designs for structure, severe environment operations, and airworthiness qualifications. | "Aerospace designs for structure, severe environment operations, and airworthiness qualifications." The structure is lightweight composite, accommodates NATO litter, and designed to accommodate vibration, shock, and rugged environments. Monitoring of tilt, acceleration, humidity, ambient temperature, and altitude. Comprehensive test program includes stress characterization (vibration, shock, thermal, altitude), component/system EMI/EMS. Several incorporated devices have undergone airworthiness qualification testing at USAARL. "The design to operating temperature ranges for many pieces of equipment and parts are -26°C to +49°C." |
| Safe Design: No created or impacted hazards. | "Aerospace qualified safety engineers provide analysis and acceptance validation...Supplier hazard analyses were included to ensure no modification created or impacted existing device hazard mitigation, and NGC hazard analysis and mitigation assured that no NGC design or implementation produced unacceptable patient or operator hazard." |
Study Information
The document describes a comprehensive test program rather than a single, specific clinical study with a defined test set and ground truth in the traditional sense for diagnostic/AI devices. The LSTAT is an integrated system of existing medical devices, and its validation focuses on the system's ability to perform as intended in challenging environments while maintaining the functionality of its components.
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: The document mentions "LSTAT #1, LSTAT #2, LSTAT #3, and LSTAT #4" as "completed items ready for government tests" (Figure 16-6). This suggests at least four physical units were part of the final system-level validation. However, the testing also involved individual components and 'brassboard' assemblies before these final units. The specific "data provenance" in terms of patient data is not detailed as this is primarily an engineering and integration validation, rather than a clinical efficacy trial on a patient cohort for a new diagnostic. The test program involves "in vitro subsystem acceptance testing," "stress characterization," "EMI/EMS," "manufacturing acceptance tests," and "usability tests." The document states "U.S. Government Laboratories (WRAIR, USAARL, and Brooks AFB) are participating with Northrop Grumman engineers/technicians in the validation/verification of safety and efficacy." This implies some prospective testing in a controlled environment.
- Data Provenance: United States (U.S. Government Laboratories involved). The testing appears to be prospective in terms of verifying the integrated system's performance and robustness.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- The concept of "experts establishing ground truth" for clinical outcomes is not explicitly described in the context of this device, as it is an integration platform. However, the evaluation involved:
- "Aerospace qualified safety engineers" for hazard analysis and validation of modification designs.
- "Northrop Grumman engineers/technicians" and "U.S. Government Laboratories (WRAIR, USAARL, and Brooks AFB) personnel" for validation/verification of safety and efficacy.
- The qualifications mentioned are "aerospace qualified safety engineers" and implicitly, the expertise within the U.S. Government Laboratories (Walter Reed Army Institute of Research, U.S. Army Aeromedical Research Laboratory, and Brooks Air Force Base) which would include medical and engineering specialists.
- The concept of "experts establishing ground truth" for clinical outcomes is not explicitly described in the context of this device, as it is an integration platform. However, the evaluation involved:
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable in the typical sense for a diagnostic device. The validation process appears to be a collaborative effort between Northrop Grumman and government laboratories, implying a consensus-driven approach based on established engineering and medical device testing standards.
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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, an MRMC comparative effectiveness study was not done. The LSTAT is a portable ICU platform, not an AI-assisted diagnostic or imaging interpretation device. There is no mention of AI or "human readers" in the context of improving performance with or without AI assistance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The LSTAT is a medical device system, not an algorithm. Its operation inherently involves human operators. The emphasis is on how the integrated system supports human medical professionals in delivering care.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device relates to engineering specifications, regulatory compliance, and functional performance objectives under specified environmental conditions, rather than a clinical diagnostic ground truth. This includes:
- Compliance with supplier's directions for in vitro subsystem acceptance.
- Meeting stress characterization parameters (vibration, shock, thermal, altitude).
- Meeting EMI/EMS standards.
- Verification against hazard analyses.
- Airworthiness qualifications.
- The "safety and efficacy" of the system as a whole are "asserted by the U.S. Government and tracked with analysis of the extensive data logging capability of each device." This suggests an ongoing monitoring and verification process as part of real-world use.
- The "ground truth" for this device relates to engineering specifications, regulatory compliance, and functional performance objectives under specified environmental conditions, rather than a clinical diagnostic ground truth. This includes:
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The sample size for the training set
- Not applicable. The LSTAT is an integrated hardware system, not a machine learning algorithm that requires a "training set."
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How the ground truth for the training set was established
- Not applicable as there is no "training set" for this device.
§ 870.5310 Automated external defibrillator system.
(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.