(269 days)
The AutoPulse NXT Resuscitation System is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The AutoPulse NXT System must be used only in cases where chest compressions are likely to help the patient.
The AutoPulse NXT System is intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
The AutoPulse® NXT Resuscitation System (also referred to as the AutoPulse® Model 200 or AP 200 System) is an automatic, portable, battery-powered chest compressor, which provides chest compressions as an adjunct to performing manual cardiopulmonary resuscitation (CPR). The system can adjust to different patient sizes and can operate in environments with limited space, such as moving vehicles.
The system may be a reasonable alternative to conventional CPR in specific settings where the delivery of high-quality manual compressions may be challenging or dangerous for the provider (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).
The AutoPulse® NXT Resuscitation System (hereinafter referred to as AutoPulse® NXT System) consists of four (4) primary components: a reusable platform (AutoPulse® NXT Platform), a single-use chest compression assembly (AutoPulse® NXT Band), a rechargeable battery (AutoPulse® NXT Battery), and a reusable battery charger (AutoPulse® NXT Battery Charger).
The AutoPulse® NXT Platform contains the mechanical drive mechanism, control system, software, and electronics necessary to generate and control the motion required to perform mechanical chest compressions. User controls and indicators are contained in two (2) identical User Control Panels provided for ease-of-use.
The AutoPulse® NXT Band is a chest compression assembly which consists of a cover plate and two bands integrated with a compression pad with a Velcro fastener. Attached to the AutoPulse® NXT Platform, the NXT Band is automatically adjusted to the patient and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. The band is a single-use component that is attached to the AutoPulse® NXT Platform before each use.
The Lithium-ion (Li-ion) Battery is a removable component that supplies power for operation of the AutoPulse® NXT Platform. It also includes a printed circuit assembly to provide "smart battery" features including cell balancing, state of charge (SOC) reporting, a history archive, and safety circuits.
The AutoPulse® NXT Battery Charger is a reusable, stand-alone unit intended to charge and test-cycle AutoPulse® NXT Batteries. The battery charger has two (2) charging bays, each with its own indicators, and is used to charge and test-cycle up to two (2) AutoPulse® NXT batteries simultaneously. When in use, the battery charger continuously tests itself and any compatible batteries in its ways.
The AutoPulse® NXT System comprises the subject devices included in this 510(k).
The provided document is a 510(k) premarket notification for the AutoPulse NXT Resuscitation System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical study data (such as an MRMC study or detailed analysis of ground truth establishment for AI models). The document primarily presents non-clinical evidence related to software verification and validation, safety testing against recognized standards, and usability testing.
Therefore, the requested information regarding acceptance criteria, study design for proving device performance (especially for AI/ML based devices), and ground truth establishment methods for large datasets is largely not applicable or not detailed in this document, as the device is a mechanical chest compressor and not an AI/ML diagnostic tool.
However, I can extract the information that is present and indicate where the requested details are not provided by this document:
Acceptance Criteria and Device Performance for AutoPulse NXT Resuscitation System
The provided document describes the AutoPulse NXT Resuscitation System, a mechanical chest compressor. The "acceptance criteria" in this context refer to the device's adherence to its design specifications, safety standards, and functional requirements, rather than performance metrics typically associated with AI/ML diagnostic tools (like sensitivity, specificity, or AUC). The study proving the device meets these criteria primarily involves non-clinical testing (software verification, safety standard compliance, and usability testing) rather than clinical trials with patient outcomes or large-scale data analysis for diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The document details a comparison of technological characteristics between the proposed device (AutoPulse NXT System) and its predicate (AutoPulse Resuscitation System Model 100). The "performance" here refers to operational parameters rather than diagnostic accuracy.
| Feature/Functionality | Predicate Device (AutoPulse® Resuscitation System Model 100) | Proposed Device (AutoPulse® NXT System) | Acceptance Criteria Met? |
|---|---|---|---|
| Indications for Use | Intended as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse. | Intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by a lack of spontaneous breathing and pulse. The system must be used only in cases where chest compressions are likely to help the patient. |
Intended for use as an adjunct to manual CPR when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective or consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR). | Yes |
| Target Patient Population | Clinically dead adults as defined by a lack of spontaneous breathing and pulse. | Same | Yes |
| Min. Patient Chest Width | 9.8" | Same | Yes |
| Patient Chest Circumference | Minimum: 30", Maximum: 51.2" | Minimum: Same (30"), Maximum: 56" | Yes (Improved) |
| Maximum Patient Weight | 300 lbs. | 400 lbs. | Yes (Improved) |
| Operating Temperature | 0 – 40° C, 5 – 95% non-condensing relative humidity | 0 – 45° C, 15 – 95% non-condensing relative humidity | Yes (Improved range) |
| Compression Frequency | 80 ± 5 compressions per minute | Same | Yes |
| Compression Depth | Chest displacement equal to 20% reduction in anterior-posterior chest depth, +0.25/-0.5 inches. | Chest displacement equal to 20%, up to 2.1 +0.25/-0.5 inches reduction in anterior-posterior chest depth for each patient. | Yes (Clarified/Slightly adjusted limit) |
| Compression Modes | 30:2; 15:2; Continuous | 30:2; Continuous | Yes (Modified to 2 modes) |
| Physiologic Duty Cycle | 50 ± 5% | Same | Yes |
| Patient Basline/Depth Control | Determined and controlled via load cell. | Determined and controlled via motor current. | Yes (Different mechanism) |
| User Control Panel | One (1) LCD screen with buttons on the side. | Two (2) identical simple non-LCD user interfaces on both sides for glanceability, intuitiveness, and minimizing physical, cognitive, and visual workload. | Yes (Improved design) |
| Band change (patient position)| Patient must be off the platform. | Patient can be either on or off the platform. | Yes (Improved flexibility) |
Note: The "Acceptance Criteria Met?" column is inferred based on the FDA's clearance of the device, indicating that the differences were deemed acceptable and did not raise new questions of safety or effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
This document describes a medical device (mechanical chest compressor), not an AI/ML algorithm. Therefore, the concept of a "test set" in the sense of a data pipeline for AI validation does not directly apply. The "testing" involved here is primarily:
- Software Verification and Validation: Conducted internally by the manufacturer. No specific sample sizes (e.g., number of cases/patients) are mentioned as it relates to software functionality testing, not diagnostic performance on a dataset.
- Safety Testing: Compliance with international standards (e.g., ISO, IEC). This involves device testing under various conditions, not patient data sets.
- Usability Testing: Formalized human factors analyses. While a "Summative Usability Test" was conducted, the document does not specify the number of participants (sample size) or their provenance. The testing was simulated use conditions.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. This device is a mechanical therapeutic device, not an AI/ML diagnostic device requiring expert interpretation for ground truth establishment.
4. Adjudication Method for the Test Set
Not applicable, as there isn't a "test set" as defined for AI/ML diagnostic purposes.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. An MRMC study is relevant for diagnostic imaging AI. This document does not mention such a study, and it's not typically required for a mechanical chest compressor in a 510(k) submission, especially one relying on substantial equivalence to a predicate device. The document explicitly states: "Clinical evidence was not necessary to show substantial equivalence."
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Not applicable. This is not an AI algorithm but a mechanical device. Its performance is inherent to its mechanical and software operation.
7. The Type of Ground Truth Used
Not applicable in the context of diagnostic AI. The "ground truth" for this device's performance would be its ability to mechanically deliver compressions according to its specifications and safely interact with users/patients, as verified by engineering tests, compliance with standards, and usability studies.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set is involved for this type of device.
In summary, the provided document is a regulatory submission for a mechanical medical device, not an AI/ML-driven diagnostic tool. Therefore, many of the questions asked, which are highly relevant to AI/ML device validation, are not applicable or detailed in this context. The "acceptance criteria" are met through adherence to design specifications, safety standards, and documented performance comparison to a predicate device, as demonstrated through engineering tests, software verification, and usability studies rather than clinical data from human subjects or AI model performance metrics.
§ 870.5200 External cardiac compressor.
(a)
Identification. An external cardiac compressor is an externally applied prescription device that is electrically, pneumatically, or manually powered and is used to compress the chest periodically in the region of the heart to provide blood flow during cardiac arrest. External cardiac compressor devices are used as an adjunct to manual cardiopulmonary resuscitation (CPR) when effective manual CPR is not possible (e.g., during patient transport or extended CPR when fatigue may prohibit the delivery of effective/consistent compressions to the victim, or when insufficient EMS personnel are available to provide effective CPR).(b)
Classification. Class II (special controls). The special controls for this device are:(1) Nonclinical performance testing under simulated physiological conditions must demonstrate the reliability of the delivery of specific compression depth and rate over the intended duration of use.
(2) Labeling must include the following:
(i) The clinical training necessary for the safe use of this device;
(ii) Adjunctive use only indication prominently displayed on labels physically placed on the device and in any device manuals or other labeling;
(iii) Information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant); and(iv) Information on the time necessary to deploy the device as demonstrated in the performance testing.
(3) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(4) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user, including an evaluation for the time necessary to deploy the device.
(5) For devices containing software, software verification, validation, and hazard analysis must be performed.
(6) Components of the device that come into human contact must be demonstrated to be biocompatible.