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The RMU-1000 ACC is intended for use 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 personnel are available to provide effective CPR).

The RMU-1000 Automated Chest Compression (ACC) System is an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest. The RMU-1000 ACC, when applied to a patient who is unconscious and not breathing, is designed to:

• Provide consistent depth and rate chest compressions.
• Allow for automated chest compressions in both the in-hospital and out of hospital settings, including during patient transport.
• Be applied to the patient with minimal interruption of CPR.

The major elements of the RMU-1000 ACC are the Backboard, Frame and Compression Module. The Backboard is placed under the patient to provide a base for the RMU-1000 ACC system. The Frame is placed over the patient and snaps into the Backboard with two self-locking latches, one on each side of the Frame. The Compression Module mounts into the Frame and contains the user interface, the replaceable lithium ion battery and the piston drive (and motor) used to generate the chest compressions. A replaceable, single-use Patient Interface Pad at the distal end of the Piston contacts the patient's chest and serves to soften the edges of the Piston during compressions.

Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated using a simple three-step operational sequence once the RMU-1000 ACC has been applied to a patient:

• the Compression Module is turned on by pressing the power button;
• the Piston height adjusted for the patient's chest size by pressing the appropriate height adjust button; and
• the appropriate compressions button pushed (either continuous compressions or an automatic pause for breaths).

Additional user interface features include a compression pause function button, service warning indicator, warning mute button, and battery capacity gauge.

The RMU-1000 ACC can be operated using a replaceable, rechargeable lithium-ion battery pack or with an external power supply. A fully-charged, new battery can provide continuous operation for over an hour and can be recharged while in the Compression Module.

A USB port on the Compression Module allows maintenance functions to be performed (outside of emergency use) through a connection to a personal computer.

The RMU-1000 ACC fits in a carry case that holds all the various System elements and accessories, spares (optional) and labeling.

The provided document is a 510(k) Summary for the Defibtech RMU-1000 Automated Chest Compressor (ACC) System. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed acceptance criteria and a study to prove device performance in a clinical sense. Therefore, many of the requested items cannot be definitively answered from this document.

Here's an attempt to extract what is available and note what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a specific table of acceptance criteria with numerical targets. Instead, it broadly states that the device "meets functional and/or performance specifications" and "demonstrates functionally equivalent performance characteristics as the predicate device."

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document. The document refers to "testing" and "performance evaluations" but does not specify the type of test set (e.g., patient data, simulated data), its size, or its provenance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided. The documentation describes a medical device for automated chest compressions, not an AI or diagnostic device that requires expert-established ground truth from a test set like medical images. The "ground truth" for the performance of this device would be its ability to physically deliver compressions according to established standards.

4. Adjudication Method for the Test Set

This information is not applicable and not provided. As noted above, this is not an AI/diagnostic device where adjudication of expert opinions on a test set would be relevant.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, Effect Size of Human Reader Improvement

This is not applicable as the device is an Automated Chest Compressor, not an AI-assisted diagnostic tool that would involve human readers interpreting medical cases. No MRMC study was performed or mentioned.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

This concept is somewhat applicable but presented differently for an automated mechanical device. The document explicitly states the device is "an automated, portable, battery-powered device that provides chest compressions on adult patients who have cardiac arrest." Its performance is evaluated inherently as a standalone system (when in operation) in terms of its ability to deliver consistent compressions. The performance testing mentioned ("hardware verification, software validation, design validation, and compression waveform comparison") would assess its standalone capabilities.

7. The Type of Ground Truth Used

For a mechanical device like an automated chest compressor, the "ground truth" is typically defined by established resuscitative guidelines (e.g., American Heart Association guidelines for compression depth and rate). The device's performance is measured against these objective, quantifiable standards, not against expert consensus, pathology, or outcomes data in the way a diagnostic tool would be. The document notes that "Compression rate and depth, performed according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines, are initiated."

8. The Sample Size for the Training Set

This information is not applicable and not provided. As a mechanical device, there isn't a "training set" in the machine learning sense. The device's design and operation are based on engineering principles and medical guidelines, not data-driven machine learning models.

9. How the Ground Truth for the Training Set was Established

This information is not applicable. As explained above, there is no "training set" for this type of device.

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