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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.

Device Description

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.

AI/ML Overview

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.

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K Number

K972525

Device Name

THUMPER

Manufacturer

MICHIGAN INSTRUMENTS, INC.

Date Cleared

1997-10-02

(87 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

K851139

Intended Use

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.

Device Description

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.

AI/ML Overview

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.