(87 days)
This device is used 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 Thumper® Model 1007 is a pneumatically powered external cardiac compressor used on a patient in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1007 uses a gas powered piston assembly with a massager pad and associated backboard to perform the function of a rescuer pressing on the patient's chest with his or her hands. A built-in ventilator to replaces the rescuer's mouth to mouth breathing for the patient. The action of the piston and the action of the associated ventilator have been designed to perform mechanical CPR according to contemporary American Heart Association (AHA) CPR guidelines for manual CPR. The Thumper® Model 1007 delivers standard CPR in a 5:1 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 90 compressions per minute.
The Thumper® Model 1007 is a mechanical cardiopulmonary resuscitator. The device's performance was evaluated through a bench test comparing it to its predicate devices, Thumper® Model 1004 and Thumper® Model 1005.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (AHA Standards for manual CPR) | Thumper® Model 1007 Performance | Compliance |
|---|---|---|
| Compression Rate: 90 compressions per minute | 90 compressive cycles per minute | Complies |
| Compression Duration Duty Cycle: 50% of the cycle | Compression duty cycle of 50% | Complies |
| Ventilation Ratio: 5:1 compression-ventilation | 5:1 compression to ventilation ratio | Complies |
2. Sample Size and Data Provenance
- Test Set Sample Size: One exemplar model of the Thumper® Model 1007, Thumper® Model 1004, and Thumper® Model 1005 was used for comparative testing.
- Data Provenance: The study was a bench test conducted internally by Michigan Instruments, Inc. (MII). The country of origin for the data is implicitly the USA, where MII is located. It is a prospective test specifically designed to evaluate the new device.
3. Number of Experts and their Qualifications
The document does not specify the number of experts or their qualifications for establishing the "ground truth" for the test set. Instead, it relies on objective physical measurements and comparisons against established American Heart Association (AHA) CPR guidelines.
4. Adjudication Method
No explicit adjudication method is mentioned. The evaluation was based on instrumental measurement and comparison to predefined standards.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was done. This study involved a bench test of a mechanical device, not human readers or clinical cases.
6. Standalone Performance
A standalone performance evaluation was conducted for the Thumper® Model 1007 (and its predicate devices) in a bench test setting. The algorithm (or in this case, the mechanical operation) was tested independently of human intervention during the measurement process, against a calibrated spring load and a test lung.
7. Type of Ground Truth Used
The ground truth used was based on:
- Established Physiological Standards: American Heart Association (AHA) CPR guidelines for manual CPR.
- Physical Measurement Devices: A MII calibrated spring load (Model T106, based on a clinical study of human chest elastic properties) for compression measurements, and a calibrated test lung (MII Pneu® View Model 2601i) for ventilation measurements.
8. Sample Size for the Training Set
This information is not applicable. There is no mention of a "training set" in the context of this mechanical device's evaluation. The device is not based on machine learning or AI that requires a training phase.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable, as there was no training set for this mechanical device.
§ 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.