(112 days)
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."
| Acceptance Criteria (Inferred from document) | Reported Device Performance (Inferred from document) |
|---|---|
| Provide consistent depth and rate chest compressions | Device provides consistent depth and rate chest compressions according to current American Heart Association (AHA) and other internationally-recognized resuscitation guidelines. |
| Automated chest compressions in various settings | Allows for automated chest compressions in both in-hospital and out-of-hospital settings, including during patient transport. |
| Minimal interruption of CPR during application | Device can be applied to the patient with minimal interruption of CPR. |
| Operation per resuscitation guidelines | Compression rate and depth performed according to current AHA and other internationally-recognized resuscitation guidelines. |
| Functionally equivalent to predicate | Testing, including hardware verification, software validation, design validation, and compression waveform comparison, demonstrates that the DDU-1000 meets functional and/or performance specifications and has functionally equivalent performance characteristics as the predicate device (LUCAS 2 Chest Compression System). The operating principles, basic design, device features (compression mechanism, power sources, deployment, user interface), patient characteristics (adult), and compression parameters are similar/same as the predicate device. |
| Safety Compliance | Complies with IEC 60601-1, IEC 60601-1-2, and IEC 62133 for safety. |
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.
§ 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.