(106 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 1008 is a pneumatically-powered, electronically controlled external cardiac compressor used on adult patients in a state of clinical death and in immediate need of respiratory and circulatory support. The Thumper® Model 1008 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 that is compatible with a facemask or advanced airway 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 Cardiopulmonary Resuscitation ("CPR") according to contemporary American Heart Association ("AHA") CPR guidelines for manual CPR. The Thumper® Model 1008 delivers standard AHA compliant CPR in two modes. The first is a 30:2 compression-ventilation ratio with a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute. The second is a continuous compressions mode having a compression duration that is 50% of the cycle length at a rate of 100 compressions per minute with nine asynchronous breaths per minute.
The provided text is a 510(k) summary for the Michigan Instruments Inc.'s Thumper® Model 1008, a mechanical cardiopulmonary resuscitation device. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study cannot be extracted from the provided text.
The document states: "Appropriate testing was conducted to evaluate conformance to product specifications and substantial equivalence to the predicate devices." and "Performance data demonstrates that the Thumper® Model 1008 is as safe and effective as the predicate devices." However, it does not provide the specifics of these "product specifications," "performance data," or the studies conducted to generate this data.
The 510(k) summary implicitly indicates that the device has met internal design and performance specifications to demonstrate substantial equivalence to the Thumper® Model 1007 and ZOLL® AutoPulse® based on similar principles of operation and technological characteristics. The "performance data" mentioned is likely related to engineering and bench testing to ensure the device performs CPR according to AHA guidelines (e.g., compression rate, depth, ventilation ratio), rather than a clinical trial with human subjects and clinical endpoints against explicit acceptance criteria as would be expected for diagnostics or other therapeutic devices.
Without further information from the full 510(k) submission, it is impossible to populate the table or answer the specific questions about clinical study methodology and results.
§ 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.