(116 days)
To perform Cardiopulmonary Resuscitation (CPR) on adult patients and only adult patients in cases of clinical death as defined by a lack of spontaneous breathing and pulse.
The miniaturized compressor (MCC) is an automated, portable chest compressor, which provides continuous chest compressions as an adjunct to performing manual CPR. It is powered by compressed oxygen or air.
The MCC provides consistent CPR support for cardiac arrest patients under conditions, which might otherwise hinder the effectiveness of manual techniques.
Here's an analysis of the provided text to extract the acceptance criteria and details of the supporting study:
The provided document describes a mechanical chest compressor (MCC) and its premarket notification, not an AI/algorithm-based device. Therefore, many of the requested fields related to AI performance, human-in-the-loop, training sets, and expert adjudication are not applicable or cannot be determined from the given text.
The primary study mentioned is a non-clinical animal study comparing the MCC to a predicate device.
Here's the breakdown based on the provided information, indicating when information is not available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Performance Metric | Reported Device Performance | Source of Information |
|---|---|---|
| CPR Effectiveness | MCC is as effective as the predicate device. | Animal Testing |
| Performance during simulated CPR | Results are within the range recommended by CPR guidelines. | Bench Testing |
| Biocompatibility | Successfully completed, meeting ISO 10993 standards. | Biocompatibility Testing |
2. Sample Size for the Test Set and Data Provenance
- Sample Size (Test Set): Not explicitly stated for either bench testing or animal testing. The animal study mentions "animal testing" but doesn't specify the number of animals.
- Data Provenance:
- Bench Testing: Simulated cardiopulmonary resuscitation (simulated environment).
- Animal Testing: Animal models (type of animal not specified).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. The device is a mechanical chest compressor, not an imaging or diagnostic AI device requiring expert ground truth for a test set. The validation relies on objective physical measurements and biological outcomes in animals.
4. Adjudication Method for the Test Set
- Not Applicable. No human adjudication of results is mentioned for the mechanical device performance evaluation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a mechanical device, not an algorithm. Bench testing evaluated its standalone mechanical performance.
7. The Type of Ground Truth Used
- For Bench Testing: "Recommended by the CPR guidelines" implies a standard for mechanical compression parameters (e.g., depth, rate) as ground truth.
- For Animal Testing: "CPR efficacy and ultimately on outcomes after prolonged cardiac arrest" suggests physiological outcomes (e.g., return of spontaneous circulation, survival metrics) were used as "ground truth" to determine effectiveness.
8. The Sample Size for the Training Set
- Not Applicable. This is a mechanical device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. This is a mechanical device, not an AI model that requires a training set.
§ 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.