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."

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.

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The CPRmeter 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

The CPRmeter 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter 2 is composed of polycarbonate. It is small, lightweight, and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6.0" × 2.5" × 1.0") and weighs approximately 191 g (6.7 oz) excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR. The CPRmeter 2 is intended for use by responders who have been trained in CPR and use of the CPRmeter 2. When placed on the bare chest of a suspected SCA victim, the CPRmeter 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity.

The Silicone Cover is an optional accessory to the CPRmeter 2 that is designed to cover the patient contacting side of the CPRmeter 2 and provide a larger patient-contact area during use. The Silicone Cover does not require a patient adhesive.

The CPRmeter 2 CPR Feedback Device does not appear to be an AI/ML device per the provided text. Therefore, an analysis of the acceptance criteria and study that proves the device meets the acceptance criteria in the context of AI/ML is not applicable. The document describes a traditional medical device (CPR feedback device) and its accessory (a silicone cover) with comparisons primarily based on physical characteristics, materials, and existing functionalities, rather than algorithmic performance.

However, based on the provided text, I can extract the following information regarding the device and its testing:

Device Name: CPRmeter 2 CPR Feedback Device (with Silicone Cover accessory)
Indications for Use: To be used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for the CPRmeter 2 with the Silicone Cover based on its functional indications (e.g., accuracy of depth, rate, or release feedback). Instead, it focuses on verifying that the addition of the Silicone Cover does not negatively impact the existing performance and safety of the CPRmeter 2 device. The acceptance criteria are implied by the nature of the tests performed to demonstrate substantial equivalence, ensuring the accessory does not introduce new safety or effectiveness concerns.

• Adequate physical fit
• Minimal water ingress
• Silicone Cover provides larger patient-contact area
• Textured surface stabilizes the device
• No new safety concerns compared to predicate | - Bench testing demonstrated acceptable performance for:
  • Withstanding changes in ambient pressure
  • Adequate physical fit
  • Minimal water ingress
• The Silicone Cover functions as intended to provide a larger patient contact area and its textured surface stabilizes the device.
• The Silicone Cover does not raise any different questions regarding the safety or effectiveness of the CPRmeter 2. |
  | Biocompatibility | - Materials of the device (specifically the new Silicone Cover) are biocompatible with patient contact. | - Biocompatibility analysis was performed and demonstrated biocompatibility of the materials of the device. |
  | Shelf Life | - Device (with Silicone Cover) performs acceptably at the end of its labeled shelf life. | - Shelf life testing showed that the device could perform acceptably at the end of its labeled shelf life. |
  | Functional Equivalence | - The addition of the Silicone Cover does not change the indications for use.
• Fundamental scientific technology and principle of operation are unchanged. | - The Silicone Cover does not change the indications for use of the CPRmeter 2.
• The materials, fundamental scientific technology, and principle of operation of the CPRmeter 2 are unchanged with the addition of the Silicone Cover. |
  | Adhesive Requirement | - When used with the Silicone Cover, a patient adhesive is not required. | - When the CPRmeter 2 is used with the Silicone Cover, the patient adhesive is not required. |

2. Sample size used for the test set and the data provenance
The document does not specify general "test set" sample sizes in terms of patient data or specific CPR measurements. Instead, it refers to different types of engineering and materials testing:

• Bench testing: Performed to assess physical and mechanical aspects (pressure changes, fit, water ingress). No sample size or data provenance is provided.
• Shelf life testing: Conducted to evaluate performance over time. No specific sample size or provenance is provided.
• Biocompatibility analysis: Performed on the materials. No specific sample size or provenance is provided.

The testing seems to be laboratory-based (bench testing, shelf life, biocompatibility) rather than involving human subjects for performance evaluation in a clinical setting. Therefore, data provenance such as "country of origin" or "retrospective/prospective" is not applicable in the context of these engineering tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the document. The tests described are engineering and material science evaluations, which typically rely on established standards and laboratory procedures rather than expert consensus on clinical ground truth.

4. Adjudication method for the test set
Not applicable, as the tests performed are not clinical evaluations requiring adjudication.

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
Not applicable, as this is not an AI/ML device, and no MRMC study or human reader improvement data is presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is not an AI/ML device. The CPRmeter 2 provides real-time feedback; it's a device for human-in-the-loop performance, not an algorithm performing autonomously.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The concept of "ground truth" in a clinical diagnostic or predictive sense is not directly applicable here. The "truth" for the tests performed (bench, shelf life, biocompatibility) would be defined by engineering specifications, material standards, and regulatory requirements.

8. The sample size for the training set
Not applicable, as this is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established
Not applicable, as this is not an AI/ML device.

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The CPRmeter™ 2 CPR Feedback Device is used as a guide in administering cardiopulmonary resuscitation (CPR) to a suspected sudden cardiac arrest (SCA) victim at least 8 years old.

The CPRmeter™ 2 is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. The housing material of the CPRmeter™ 2 is composed of polycarbonate. It is small, lightweight and powered by a replaceable battery. The device is approximately 153 mm × 64 mm × 25 mm (6"× 2 ½"× 1") and weighs approximately 163 g (5.7 oz), excluding batteries. The device is approximately the size and weight of a cell phone. It is intended to be placed between the responder's hands and the patient's chest during CPR by means of a self-adhesive foam pad. The CPRmeter™ 2 is intended to be used by responders who have been trained in CPR and use of the CPRmeter™ 2. If the responder is in doubt about its appropriateness for use or the ability to use it. CPR is to be performed without using the CPRmeter™ 2 device.

When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 2 provides real-time feedback on CPR compressions in accordance with current CPR guidelines. It displays CPR feedback indicators for depth, rate, and release of chest compressions. It also counts the number of compressions in a series and provides notification of lack of expected CPR activity. The CPRmeter™ 2 may be reused, provided proper cleaning procedures are performed after each patient use.

The CPRmeter™ 2 CPR Feedback Device's acceptance criteria and the study that proves it meets these criteria are detailed below. It is important to note that this device is not an AI-powered diagnostic tool, but rather a feedback device for CPR. Therefore, some of the requested information regarding AI-specific studies (e.g., MRMC studies, training set details, expert ground truth for training) are not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the CPRmeter™ 2 are primarily based on its functionality in providing real-time feedback for CPR compressions according to current guidelines. The reported device performance is demonstrated through various verification and validation tests.

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