Search Results

The RMU-2000 Automated Chest Compression System (ACC) is to be used for performing external cardiac compressions on adult patients who have acute circulatory arrest defined as absence of spontaneous breathing and pulse, and loss of consciousness.

The RMU-2000 must only be used in cases where chest compressions are likely to help the patient.

The RMU-2000 ACC is intended for use as an adjunct to manual cardiopulmonary resuscitation (CPR) on adult patients 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-2000 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-2000 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 components of the RMU-2000 ACC are the Backboard, the Frame and the Compression Module. The Backboard is placed under the patient to provide a base for the ACC system. After a single-use Suction Cup is pre-installed onto the Frame, the Compression Module is then mounted into the Frame, causing the Suction Cup to attach to the Compression Module's piston drive. The Compression Module and Frame assembly is then placed over the patient and snaps into the Backboard with self-locking latches. The Compression Module contains the user interface, a replaceable Battery Pack, and the piston drive and is used to generate the chest compressions.

The RMU-2000 ACC can be operated using a replaceable, rechargeable Battery Pack or with an external power adapter used in conjunction with the battery. A fully-charged, new Battery Pack can provide continuous operation for at least an hour and can be recharged in the Compression Module.

Once the RMU-2000 ACC has been powered on and applied to the patient, compressions are initiated by adjusting the piston to the patient's chest and pressing either of the Run Compressions buttons. Additional user interface features include a pause function, a warning indicator to notify the operator for possible misuse or malfunction, and a Battery Pack capacity gauge.

A Bluetooth® technology ON/OFF button on the user control panel allows the Compression Module to be wirelessly connected to a personal computer and for ACC data retrieval and event reporting when used in conjunction with utility software available at www.defibtech.com. A USB port on the underside of the Compression Module also allows connection to a personal computer when a wired connection is preferred or when a Bluetooth® connectivity is not possible or desired.

The provided text describes a 510(k) premarket notification for the Defibtech RMU-2000 Automated Chest Compression System, asserting its substantial equivalence to the predicate device, the LUCAS Chest Compression System. This document focuses on demonstrating that the RMU-2000 functions safely and effectively, similar to an already cleared device. As such, it does not contain details about a study evaluating AI performance, specifically the acceptance criteria or device performance in the context of AI. The device described is a mechanical system, not an AI or software algorithm.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving an AI device meets these criteria because the document does not pertain to an AI device.

However, I can extract the information related to the performance testing and safety/effectiveness claims made for this non-AI mechanical device:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided text, specific numerical acceptance criteria and a direct comparison table for the RMU-2000 against pre-defined performance thresholds (as would be typical for an AI study) are not detailed. Instead, the submission relies on demonstrating substantial equivalence to a predicate device. The performance claims are primarily comparative:

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

This information is not provided in the document. The text mentions "hardware verification, software validation, design validation and compression waveform comparison" and "Performance testing summaries, including waveform comparison testing," but does not explicitly detail sample sizes for any test sets or data provenance (e.g., country of origin, retrospective/prospective).

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

This information is not provided as the submission is for a mechanical device, not an AI system requiring expert-adjudicated ground truth.

4. Adjudication Method:

This information is not provided as it's not relevant to the type of device and submission described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This is not applicable as the document describes a mechanical chest compression system, not an AI diagnostic or assistive device that would involve human readers.

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

This is not applicable as the document describes a mechanical chest compression system, not an AI algorithm.

7. The type of ground truth used:

This is not explicitly stated in terms of a "ground truth" for a dataset, as would be relevant for an AI study. For this mechanical device, "ground truth" would be related to biomechanical measurements, physical parameters (rate, depth), and safety standards. The document mentions "resuscitation guideline recommendations" (e.g., American Heart Association Guidelines) as a reference point for desired performance. Compliance with these guidelines and functional equivalence to the cleared predicate device serve as the basis for evaluation.

8. The sample size for the training set:

This information is not provided as the device is mechanical and does not involve an AI training set.

9. How the ground truth for the training set was established:

This information is not provided as the device is mechanical and does not involve an AI training set.

Ask a specific question about this device