(268 days)
The CPR BAND is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.
The CPR BAND is a small, lightweight device that uses rechargeable batteries and is worn on the wrist. This device is designed for first aid personnel trained in CPR and use of the CPR BAND. The CPR BAND (Model: CREDO-CB) provides real-time information about chest compression according to the latest CPR guideline when CPR is performed on patient who is estimated a sudden cardiac arrest (SCA). This device displays CPR feedback indicator for the chest compression depth. It guides chest compression rhythm through sound and indicates the total chest compression time and number of chest compression.
The CPR BAND is a device that provides Bluetooth function. It can transmit CPR record and confirm information on the mobile application of the smart device in order to training CPR Skill for user via checking data. In the smart device that provides the wireless communication function by receiving information provided by the CPR BAND, it can display the pressure axis angle, pressure axis average value, compression depth average value, compression rhythm average value, and chest compression graph which are not displayed on the CPR BAND.
The device provides other functions on the user's wrist while waiting without CPR. The time, step count, movement distance and calorie consumption function are displayed.
The provided document, a 510(k) Summary for the CPR BAND (Model: CREDO-CB, CREDO-CB-MO), details the device's technical specifications and the testing conducted to demonstrate its substantial equivalence to a predicate device (CPRmeter 2). However, it does not contain the specific information required to address most of the user's request, as it lacks a detailed description of the acceptance criteria and the comprehensive study report that proves the device meets those criteria for human performance.
The document primarily focuses on non-clinical data, including safety tests (biocompatibility, electrical safety, EMC, RoHS, FCC), performance tests (Compression Depth Indicator, Compression Rate Target, Compression Depth Target, Compression Count Target, Compression Time Target, Dimension Test), usability V&V, and software testing. These are primarily engineering and bench tests, not clinical studies involving human performance or reader studies.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists "Performance Test" items and indicates they were performed according to "Manufacturer SOP." However, it does NOT specify the quantitative acceptance criteria for these tests, nor does it provide the reported performance results other than stating "there are not any problems, which influence safety and performance."
| Acceptance Criteria (Not Explicitly Stated in Document) | Reported Device Performance (Implied as "Met") |
|---|---|
| Compression Depth Indicator: (e.g., Accuracy ±X mm) | Passed (according to Manufacturer SOP, no problems reported) |
| Compression Rate Target: (e.g., Accuracy ±X bpm) | Passed (according to Manufacturer SOP, no problems reported) |
| Compression Depth Target: (e.g., Accuracy ±X mm) | Passed (according to Manufacturer SOP, no problems reported) |
| Compression Count Target: (e.g., Accuracy ±X counts) | Passed (according to Manufacturer SOP, no problems reported) |
| Compression Time Target: (e.g., Accuracy ±X seconds) | Passed (according to Manufacturer SOP, no problems reported) |
| Dimension Test: (e.g., Within specified tolerances) | Passed (according to Manufacturer SOP, no problems reported) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily discusses non-clinical (bench and engineering) tests, not clinical studies or human performance tests. Therefore, it does not provide information on sample sizes for a 'test set' in the context of human data, nor does it mention data provenance (country of origin, retrospective/prospective). The device is manufactured in Republic of Korea.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided as the document does not describe a study involving expert readers or establishment of ground truth for diagnostic purposes. The ground truth for the performance tests would be established by the calibrated instruments used for measurement during bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as there is no mention of a human-reader-based test set or adjudication process.
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
The document does not describe a multi-reader multi-case (MRMC) study. The device, described as a "CPR Aid" providing real-time feedback, assists rather than replaces human action. There's no AI explicitly mentioned or comparative effectiveness study against human readers described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The "Performance Test" section describes testing of the device's ability to measure compression depth, rate, count, and time accurately, which could be considered a form of standalone testing of the device's measurement capabilities. However, these are bench tests, not clinical performance studies. The document states the device "provides real-time information about chest compression" and "measures the chest compression depth...via the built-in accelerometer," implying its core function is the algorithm/sensor. The results are implied as meeting manufacturer SOPs.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Performance Test" section, the ground truth would be measurements from calibrated instruments or reference standards used in the bench testing environment, not expert consensus, pathology, or outcomes data, as this is a device for guiding CPR compressions not for diagnosis.
8. The sample size for the training set
The document does not mention or describe a training set as this is a device cleared via 510(k) substantial equivalence (based on bench testing and comparison to a predicate), not an AI/ML device requiring a distinct training and test set in the traditional sense for diagnostic algorithm development.
9. How the ground truth for the training set was established
As no training set is mentioned or described, this question is not applicable based on the provided document.
Summary of Device and Testing Approach from the Document:
The CPR BAND is a non-invasive device intended to guide CPR compressions by providing real-time feedback on depth, rate, count, and time. It was cleared through the 510(k) pathway, demonstrating substantial equivalence to a predicate device (CPRmeter 2). The testing presented relies on non-clinical (bench) safety and performance tests, usability verification, and software testing, all conducted according to recognized standards (IEC, ISO, FCC, etc.) and the manufacturer's own Standard Operating Procedures (SOPs). The document does not describe a clinical study involving human subjects or readers for evaluating the device's performance in a diagnostic or interventional context that would require the typical data validation outlined in the user's request.
§ 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.