(419 days)
The CPR RsQ Assist is intended to assist the rescuer in performing chest compressions at the recommended American Heart Association (AHA) rate of 100 compressions/minute on a victim 8 years or older.
The CPR RsQ Assist consists of a rigid plastic top with an integrated plastic support collar, a flexible plastic bellows filled with foam, and a removable silicone base platform. LED lights and a speaker component provide visual and audio cues, respectively, to the user during manual CPR compressions. The CPR RsQ Assist is provided non-sterile.
The provided 510(k) summary for AvanTech, Inc.'s CPR RsQ Assist describes performance data based solely on bench testing. It does not include clinical studies involving human subjects or extensive AI/algorithm-based performance assessments typically associated with the detailed criteria requested.
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance |
|---|---|---|
| Mechanical Strength | Mechanical test to failure | "functions as intended and meets all of its performance specifications" |
| Structural Integrity | Structural integrity "drop" test | "functions as intended and meets all of its performance specifications" |
| Simulated Use (CPR Manikin) | Chest displacement depth and rate | "performs appropriately for its intended use" |
| Simulated Use (CPR Manikin) | Chest compression force | "performs appropriately for its intended use" |
| User Interface | Low battery indicator | "functions as intended and meets all of its performance specifications" |
| Electromagnetic Compatibility (EMC) | EMC testing according to IEC 60601-1-2 | "functions as intended and meets all of its performance specifications" |
| Electromagnetic Immunity | ESD Immunity Test (IEC 61000-4-2) | "functions as intended and meets all of its performance specifications" |
| Electromagnetic Immunity | RF Electromagnetic Field Immunity Test (IEC 61000-4-3) | "functions as intended and meets all of its performance specifications" |
| Biocompatibility | Testing according to ISO 10993-1 | "established based on testing" |
| Primary Functional Goal | Assist rescuer in performing chest compressions at AHA recommended rate of 100 compressions/minute | "functions as intended and meets all of its performance specifications" and "performs appropriately for its intended use." |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states "bench testing" and "simulated use on conventional CPR manikin."
- Sample Size: Not specified for any of the tests. It is likely a small number of devices or test cycles typical of bench testing.
- Data Provenance: Not human data. Derived from in-house bench testing and simulated use experiments. No country of origin for data as it's not clinical. Retrospective or prospective is not applicable as it is not human data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Number of Experts: Not applicable. The ground truth for bench testing is typically derived from engineering specifications, industry standards (e.g., AHA guidelines for CPR rate/depth), and recognized test methodologies. There's no mention of human expert consensus for these physical and functional tests.
- Qualifications of Experts: Not applicable. The "ground truth" here is the expected performance based on design and standards, not expert interpretation of data.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where multiple human readers assess the same cases and their disagreements need to be resolved. This document describes physical, electrical, and functional bench tests where outcomes are objective measurements against defined standards.
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
- MRMC Study: No. The device is a "Cardiopulmonary Resuscitation Aid" providing real-time feedback (visual and auditory cues), not an AI-driven image analysis tool or diagnostic algorithm that would typically be evaluated in an MRMC study. There is no mention of "AI" in the document.
- Effect Size: Not applicable as no MRMC study was conducted.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable in the context of typical AI algorithm evaluation. The device itself is designed to work as an assist with a human in the loop (a rescuer). Its "standalone" performance would be its ability to accurately measure and report compressions, which is what the bench tests on the manikin assessed. However, this is not an "algorithm-only" performance in the sense of a diagnostic or predictive AI.
7. The Type of Ground Truth Used
- Ground Truth Type:
- Engineering Specifications: For mechanical strength, structural integrity, low battery indication, and EMC/EMI.
- Industry Standards/Guidelines: Specifically, the American Heart Association (AHA) recommended rate of 100 compressions/minute for simulated use on the manikin (chest displacement depth and rate, chest compression force).
- ISO Standards: For biocompatibility (ISO 10993-1).
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device is described as a mechanical and electronic aid, not a machine learning or AI system that undergoes training with a "training set." Its functionality is based on pre-programmed logic for measurements and feedback, not learned from data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable, as there is no mention of a training set or machine learning involved. The device functions based on established engineering principles and AHA guidelines.
§ 870.5210 Cardiopulmonary resuscitation (CPR) aid.
(a)
CPR aid without feedback —(1)Identification. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
CPR aid with feedback —(1)Identification. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use.
(ii) Labeling must include the clinical training, if needed, for the safe use of this device and 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).(iii) 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.
(iv) For devices containing software, software verification, validation, and hazard analysis must be performed.
(v) Components of the device that come into human contact must be demonstrated to be biocompatible.
(vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user.
(3)
Premarket notification. The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (e.g., is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in § 870.9.