(160 days)
The AutoPulse Resuscitation System Model 100 is intended to be used as an adjunct to manual CPR, on adult patients only, in cases of clinical death as defined by lack of spontaneous breathing and pulse.
The AutoPulse Resuscitation System Model 100 is an automated, portable, batterv powered device that compresses the chest of an adult human as an adjunct to manual CPR. The AutoPulse System consists of 4 primary components, a reusable Platform, a single use chest compression assembly (LifeBand), a rechargeable battery, and a battery charger. The AutoPulse Platform contains the mechanical drive mechanism, control system, software and electronics necessary to generate and control the force required to perform mechanical chest compressions. User controls and indicators are contained in the User Control Panel. The AutoPulse Platform and LifeBand are unchanged. A new battery and battery charger are the subject devices of this 510(k).
The provided documentation is a 510(k) summary for the AutoPulse® Resuscitation System Model 100, focusing on changes related to its battery and charger. It is not a study reporting on the clinical performance of the device in relation to patient outcomes or a diagnostic algorithm's accuracy.
Therefore, many of the requested fields are not applicable to this specific document as it details a submission for a modification to an already cleared device, primarily concerning electrical components, rather than a clinical effectiveness study.
Based on the provided text, here is the information that can be extracted:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Bench Testing) | Reported Device Performance |
|---|---|
| System level compatibility with new Li-Ion battery meets operating parameters in a safe and intended manner. | Data showed that the new battery chemistry did not alter the functioning of the AutoPulse in any way and that it operates identically to the NiMH Battery powered AutoPulse. |
| New multi-chemistry charger capable of safely and consistently charging NiMH battery, testing the battery, and correctly identifying end of life. | Bench testing showed the new charger was capable of safely and consistently charging the NiMH battery, testing the battery, and correctly identifying when the end of life has been reached. |
| New multi-chemistry charger capable of safely and consistently charging, testing, maintaining, and identifying end of life conditions per Li-Ion battery specifications. | The new charger successfully demonstrated its ability to charge, test, maintain, and identify the end of life conditions per the Li-Ion battery specifications. |
| Li-Ion battery meets performance safety specifications (including charging/discharging characteristics, ability to power AutoPulse for specified runtime throughout life, environmental testing, electrical safety, electromagnetic compatibility). | Extensive bench testing was conducted to verify ability of the Li-Ion battery to meet the performance safety specifications. (Specific quantitative results not provided in this summary, but the general statement indicates criteria were met). |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of clinical patient data. The testing was "extensive bench testing" on the device components (new battery and charger).
- Data Provenance: Not applicable as this was bench testing, not human patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable. Ground truth for electrical and mechanical performance is established through engineering specifications and standards, not expert clinical consensus.
- Qualifications of Experts: Not applicable.
4. Adjudication method for the test set
- Adjudication Method: Not applicable. This was bench testing against engineering specifications and international standards, not a study requiring adjudication of clinical findings.
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
- MRMC Study: No. This document is about a mechanical resuscitation device's electrical component update, not an AI-assisted diagnostic tool.
- Effect size: Not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Study: The "standalone" performance here refers to the device's functional integrity with the new battery and charger. The summary states that "the system level compatibility was verified to ensure that the AutoPulse powered with the new Li-lon battery meets the operating parameters in a safe and intended manner" and that "the new battery chemistry did not alter functioning of the AutoPulse in any way and that it operates identically to the NiMH Battery powered AutoPulse." This effectively describes the standalone performance of the modified device meeting its operational specifications.
7. The type of ground truth used
- Ground Truth: Engineering specifications for power output, charging characteristics, battery life, environmental resilience, electrical safety, and electromagnetic compatibility established by relevant international standards (e.g., IEC 60601-1, IEC 60068, CISPR11, IEC 62133).
8. The sample size for the training set
- Sample Size: Not applicable. This is not a machine learning or AI-based device requiring a training set.
9. How the ground truth for the training set was established
- Ground Truth Establishment: Not applicable.
§ 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.