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

The Modified Cover is an optional accessory to the CPRmeter™ that is designed to cover the patient contacting side of the CPRmeter™ and provide a larger patient-contact area during use and does not require a patient adhesive. The CPRmeter™ is small, lightweight, and powered by a replaceable battery. The device is approximately 154 mm × 28 mm (6" × 2½" × 1″) and weighs approximately 227 grams (8 ounces) - 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™ is intended for use by responders who have been trained in CPR and use of the CPRmeter™. The CPRmeter™ is used as a guide in administering CPR to a suspected sudden cardiac arrest (SCA) victim at least 8 years old. When placed on the bare chest of a suspected SCA victim, the CPRmeter™ 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.

This document describes the FDA 510(k) summary for the CPRmeter™ CPR Feedback Device with a Modified Cover. It primarily focuses on demonstrating substantial equivalence to a previously marketed device (CPRmeter™ with Predicate Cover) by showing that the new Modified Cover does not raise new questions of safety or effectiveness.

Here’s a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or a direct performance table for each criterion. Instead, it states that "The following tests demonstrate that the Modified Cover met applicable design and performance requirements and support a determination of substantial equivalence." and mentions general outcomes.

Implied Acceptance Criteria & Reported Performance (Based on the text):

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

The document does not specify a sample size for any test set in terms of patient data or a specific number of units tested.
The "Data Used in Determination of Substantial Equivalence" section refers to "Bench testing," "Shelf life testing," and "Biocompatibility analysis." These are likely laboratory or in-vitro tests, not clinical studies with patient data.

• Sample Size: Not specified (refers to bench testing, not human subjects).
• Data Provenance: Not explicitly stated as retrospective or prospective human data. The tests described (bench, shelf life, biocompatibility) are typically performed in a laboratory setting. The device manufacturer, Laerdal Medical AS, is based in Norway.

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

This information is not provided in the document as the tests described are bench tests and material analyses, not studies requiring expert clinical judgment for ground truth establishment.

4. Adjudication Method for the Test Set

This information is not applicable as the tests described are bench tests and material analyses, not studies involving human interpretation or adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not reported. The submission focuses on substantial equivalence of a modified accessory (the cover) through bench testing, not clinical effectiveness studies comparing human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The CPRmeter™ is a physical device that provides real-time feedback during CPR. Its function relies on sensors (accelerometer and force sensor) and internal processing to provide visual feedback to a human rescuer. Therefore, the concept of a "standalone algorithm" acting without human-in-the-loop performance is not directly applicable in the typical sense of AI-driven diagnostic tools.

However, the "bench testing" and "shelf life testing" could be considered as evaluating the device's intrinsic performance (its 'algorithm' for sensing and displaying data) independent of a human rescuer, under controlled, simulated conditions. The document states these tests demonstrated "acceptable performance," implying the device's sensing and feedback mechanism functions correctly.

7. The Type of Ground Truth Used

For the bench testing, the ground truth would likely be known physical parameters (e.g., precisely controlled compression depths, rates, and release) against which the device's reported measurements are compared. For biocompatibility, the ground truth is established by biocompatibility standards and test protocols.

8. The Sample Size for the Training Set

This information is not applicable/not provided. The document describes a 510(k) submission for a physical device with a modified cover, not an AI/ML device that typically requires a training set. The device's functionality is based on established biomechanical principles and sensor technology, not machine learning trained on large datasets.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable/not provided as there is no mention of a training set for an AI/ML algorithm.

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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

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.

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The TrueCPR device is intended to provide feedback to assist rescuers to perform cardiopulmonary resuscitation (CPR). Rescuers must be trained in CPR and use of the device. The TrueCPR device is intended for use on patients eight years of age and older.

The TrueCPR coaching device provides rescuers with real-time feedback on chest compressions during cardiopulmonary resuscitations (CPR) in accordance with current guidelines.

This device is a CPR coaching device, meaning it provides real-time feedback on chest compressions. The provided text, however, focuses on administrative information related to the 510(k) submission and does not contain detailed information about the specific acceptance criteria or the study that demonstrates the device meets these criteria.

Therefore, for aspects related to precise performance metrics, sample sizes for test/training sets, expert qualifications, or comparative effectiveness studies, the information is not available in the provided text. The text states that the 510(k) includes documentation related to verification and validation activities but does not elaborate on their specifics.

Based on the provided snippets, here's what can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly provided in the given text. The submission mentions "Performance Standards" and "verification and validation activities supporting the safe and effective use of TrueCPR," but it does not detail specific quantitative acceptance criteria or the device's reported performance against them (e.g., accuracy of depth measurement, rate measurement, etc.).

2. Sample size used for the test set and the data provenance

This information is not available in the provided text. The document refers to "Bench Testing (Comprehensive verification testing)" and "Simulated Use Testing" but does not specify the sample sizes or data provenance for these 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 available in the provided text.

4. Adjudication method for the test set

This information is not available in the provided text.

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

A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. The device is a "coaching device" to assist rescuers, not an AI-assisted diagnostic tool that would typically involve "human readers." Therefore, the concept of "human readers improve with AI vs without AI assistance" does not directly apply here in the typical sense of interpreting medical images or data.

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

The device is explicitly a "coaching device" intended to "provide feedback to assist rescuers," which inherently implies a human-in-the-loop scenario. The text does not describe any standalone algorithm-only performance testing in the context of interpretation or diagnosis. However, "bench testing" and "simulated use testing" would likely involve evaluating the device's ability to accurately measure and provide feedback on CPR parameters independently, but these are not referred to as a "standalone algorithm performance" in the context of diagnosis.

7. The type of ground truth used

The text does not explicitly state the type of ground truth used for specific performance evaluations. For a CPR coaching device, ground truth would typically refer to accurate measurements of compression depth, rate, recoil, etc., obtained through high-precision sensors or standardized testing apparatus in a laboratory or simulated environment, rather than expert consensus, pathology, or outcomes data, which are more common for diagnostic devices.

8. The sample size for the training set

This information is not available in the provided text.

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

This information is not available in the provided text.

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The CPRmeter 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™ device is small, lightweight (approximately the size and weight of a cell phone), and powered by a replaceable battery. The CPRmeter device is intended for use by responders who have been trained in CPR and use of the CPRmeter device. If in doubt about the appropriateness for use or ability to use. CPR is to be performed without using the CPRmeter device.

When attached to the bare chest of a suspected SCA victim, the CPRmeter device 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 provided text focuses on the device description, indications for use, predicate devices, and general testing criteria for substantial equivalence of the CPRmeter™ CPR Feedback Device. However, it does not contain specific acceptance criteria or detailed study information in the format required for the requested output.

Specifically, the document mentions:

• "Design verification and design validation testing demonstrates that the CPRmeter device meets its functional requirements and performance specifications."
• "Compression depth detection and accuracy have been verified under a wide variety of use or pre-use conditions (e.g., drop testing, temperature and humidity stress, after repeated cleaning)."

But it does not provide:

• A table of specific acceptance criteria (e.g., "accuracy > 90% for depth measurement") and reported performance values.
• Sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth.
• Information about MRMC studies, standalone algorithm performance, or how ground truth was established for training/test sets.

Therefore,Based on the provided text, I cannot complete the requested information, which requires specific acceptance criteria and detailed study parameters. The document states that the device's "functional requirements and performance specifications" and "compression depth detection and accuracy have been verified," but it does not specify what those requirements or accuracy thresholds are, nor does it describe the studies (e.g., sample sizes, ground truth methods, expert involvement) used to verify them.

Missing Information:

1. Table of acceptance criteria and reported device performance: The document only states that the device "meets its functional requirements and performance specifications" and that "compression depth detection and accuracy have been verified." It does not provide specific numerical criteria or reported performance values.
2. Sample size used for the test set and data provenance: Not mentioned.
3. Number of experts used to establish the ground truth for the test set and their qualifications: Not mentioned.
4. Adjudication method for the test set: Not mentioned.
5. Multi-reader multi-case (MRMC) comparative effectiveness study information: Not mentioned. The device is a feedback device for CPR, not an AI diagnostic tool, so an MRMC study in the typical sense wouldn't apply here.
6. Standalone (algorithm-only) performance: Not mentioned.
7. Type of ground truth used: Not explicitly stated how "compression depth detection and accuracy" were verified, so the type of ground truth is unclear (e.g., mechanical test rig, expert measurement).
8. Sample size for the training set: Not mentioned.
9. How the ground truth for the training set was established: Not mentioned.

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PocketCPR Intended Use: To assist users in the performance of effective CPR on a patient 8 years or older.

Effective cardiopulmonary resuscitation (CPR), when administered quickly after the on-set of cardiac arrest, is effective at saving lives and enabling complete neurological recovery, especially when followed by early defibrillation. The PocketCPR® was developed to provide users with real-time feedback during the administration of CPR, to assist CPR instructors during class exercises, and to provide CPR students with verbal instructions and feedback for at-home practice. When the PocketCPR is turned on, the default protocol being driven by the 2010 American Heart Association's (AHA) Guidelines, reminds the user to call for help. Once placed on the patient's chest and chest compressions have begun, PocketCPR generates a metronome at the recommended rate of chest compression, gives verbal and visual feedback on the quality of CPR being delivered and reminds the user to give two breaths after every 30 compressions. Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis.

The provided text describes the PocketCPR® device, an aid for Cardiopulmonary Resuscitation (CPR), and its substantial equivalence to a predecessor device. However, it does not include specific acceptance criteria (e.g., target performance metrics like sensitivity, specificity, accuracy for CPR feedback) or a detailed study proving the device meets such criteria.

The bulk of the "Types of Testing" section lists various bench tests, simulated use on a manikin, usability studies, and biocompatibility, but it doesn't provide performance results against specific, quantifiable acceptance criteria.

Therefore, I cannot fully answer your request based on the provided text for certain points as the information is not present. I will indicate where information is missing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria for CPR Feedback: Specific numerical acceptance criteria (e.g., what percentage accuracy is required for depth, rate, or release feedback) are not explicitly stated in the provided document. The document states the device "generates a metronome at the recommended rate of chest compression, gives verbal and visual feedback on the quality of CPR being delivered and reminds the user to give two breaths after every 30 compressions." This describes the functionality but not the performance targets or the measured performance against those targets.

Reported Device Performance: Similarly, specific quantitative performance data (e.g., measured accuracy of depth detection, rate measurements, or percentage of correct feedback instances) is not reported. The document notes "Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis," but actual performance results are absent.

2. Sample size used for the test set and the data provenance

• Test Set Description: The document mentions "Simulated Use on Computerized Manakin for Data Collection" and "Usability Studies performing CPR using PocketCPR."
• Sample Size for Test Set: The sample size for these tests is not specified.
• Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. Given the mention of "Computerized Manakin" and "Usability Studies," it's highly likely the data was collected prospectively in a controlled environment.

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 type of ground truth used (manikin performance, expert observation) is not detailed, nor is the number or qualifications of any experts involved in assessing performance.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not provided in the document.

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: An MRMC comparative effectiveness study, which typically compares human performance with and without AI, is not described in the document. The device is a direct feedback tool, not an "AI" in the typical sense of interpreting complex diagnostic images or data for a human reader. Its function is to directly guide the user.
• Effect Size: Therefore, effect size related to human reader improvement with AI assistance is not applicable or reported here.

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

• Standalone Performance: The document mentions "Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis." While this implies an internal algorithm for measurement, no standalone performance evaluation of this algorithm's accuracy (e.g., against a gold standard for force or depth measurement) is explicitly detailed with specific metrics. The testing rather focuses on the device's output (feedback) in simulated use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The document implies that the ground truth for the "Simulated Use on Computerized Manakin for Data Collection" and "Usability Studies" likely involves:
  • Manikin-based measurements: Computerized manikins are designed to accurately measure CPR parameters (depth, rate, recoil). This would serve as a form of objective, engineered ground truth.
  • Compliance with AHA Guidelines: The ultimate "ground truth" for the device's feedback is its adherence to the 2010 American Heart Association (AHA) Guidelines for CPR.

8. The sample size for the training set

• The document describes the device as being "programmed to meet the 2010 AHA Guidelines." It does not mention a "training set" in the context of machine learning. The device's "programming" is based on the AHA guidelines rather than learned from a dataset.
• Therefore, a "training set sample size" in the conventional machine learning sense is not applicable or provided.

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

• As above, there is no mention of a "training set" for a machine learning model. The device's operational logic and feedback parameters are derived directly from the 2010 American Heart Association (AHA) Guidelines for CPR. These guidelines represent the accepted "ground truth" for effective CPR practices.

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The Rhythm of Life is a visual and audio timing device assisting individuals trained in CPR to provide effective resuscitation by conforming to the guidelines promoted by the American Heart Association in the field, clinical, and hospital settings. The Rhythm of Life is also intended for use by those in an educational setting who are in the process of learning CPR.

The Rhythm of Life by Rapid Response Solutions, LLC, is a pocket-sized metronome designed to assist both professional rescuers and trained lay rescuers in providing high quality cardiopulmonary resuscitation. This device is designed in accordance with the latest American Heart Association guidelines for CPR. The Rhythm of Life provides three distinctly different tones and visual feedback to prompt the rescuer to compress the patient's chest, ventilate the patient, and reassess the patient's condition every two minutes. The metronome will allow the rescuer to enter the type of patient that is being resuscitated along with other pertinent information, and then outputs proper resuscitation rates and ratios for that specific patient. Both professional and lay rescuers will benefit from additional guidance provided by the Rhythm of Life as it promotes adherence to the American Heart Association's guidelines and therefore improves the quality of patient care. The device is neither life supporting nor life sustaining.

The provided text is a 510(k) summary for the "Rhythm of Life" device, a CPR aid (metronome). It describes the device, its intended use, and indicates that testing was performed to demonstrate substantial equivalence to predicate devices and compliance with applicable standards. However, it does not include specific acceptance criteria or a detailed study report that proves the device meets those criteria in the way typically expected for a medical device's diagnostic or predictive performance.

The document focuses on regulatory compliance for device safety and effectiveness, primarily through demonstrating substantial equivalence to pre-existing devices and adherence to electrical safety and electromagnetic compatibility standards. It does not describe a study to assess the device's clinical performance in terms of improving CPR outcomes, diagnostic accuracy, or similar metrics.

Therefore, for many of your requested items, the information is not present in the provided text.

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

Note: The document states that testing was "performed to demonstrate compliance" and that the device "is as safe, as effective, and performs as well to legally marketed predicate devices." However, it does not provide specific numerical results or performance metrics from these tests beyond the general statement of compliance. The focus is on regulatory and electrical standards, not clinical performance metrics like accuracy, sensitivity, or specificity.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The testing described appears to be engineering/regulatory compliance testing, not a clinical trial with patient data.

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 in the document. The device is a metronome, not a diagnostic tool requiring expert interpretation for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

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

There is no indication that an MRMC or comparative effectiveness study of this nature was conducted. The device is a "CPR Aid (Metronome)" which provides visual and audio timing, not an AI-assisted diagnostic or interpretive tool where "human readers" would be involved in the sense of image or data interpretation.

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

The device itself is a "standalone" metronome; it doesn't involve an algorithm in the sense of AI or complex data processing that would typically be evaluated for standalone performance versus human-in-the-loop. Its primary function is timing and guidance, which is inherently "standalone" in its operation once activated. However, this is not "standalone performance" in the context of diagnostic algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Given the nature of the device (a metronome for CPR), the concept of "ground truth" for clinical performance in the typical diagnostic sense (e.g., against pathology) is not applicable or described. The "ground truth" for this device would relate to the accuracy of its timing signals against established AHA guidelines. The document does not detail how the accuracy of these timing signals was verified beyond stating that it "met all design specifications."

8. The sample size for the training set

This information is not provided and is not applicable for this type of device. The Rhythm of Life is not an AI/machine learning device that requires a training set.

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

This information is not provided and is not applicable for this type of device.

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To assist users in the performance of effective CPR on a victim 8 years or older.

PocketCPR™ is a device that uses voice prompts and visual indicators to assist rescuers in the performance of cardiopulmonary resuscitation (CPR). PocketCPR is designed to be used by a rescuer to perform CPR. PocketCPR provides rescuers with real-time feedback during the administration of CPR.

PocketCPR has two operating modes: Normal and Silent Operating Mode which allows the rescuer to perform CPR in any type of environmental condition. In Normal Operating Mode, PocketCPR operates with all sounds, including voice prompts and metronome beeping. In Silent Operating Mode, PocketCPR operates with visual flashing metronome and chest compression lights "only".

The PocketCPR directly measures acceleration through the use of an integrated accelerometer and The Fookers' It allocaly model is not compressing the chest at least 1.5 inches Instantal. Books are will instruct them to increase compression depth. The rate of compression is (comm), the Fooketer ( will morable non signal, encouraging the rescuer to keep pace with the prompled by the ace of a fiten 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths.

The provided text describes the 510(k) summary for the PocketCPR™ device, but it lacks the detailed information required to fully answer the request regarding acceptance criteria and a specific study proving those criteria are met. The document states that "Extensive performance testing ensures that the PocketCPR meets all of its functional requirements and performance specifications" but does not elaborate on what these specifications are, the methodologies used, or the results of such testing.

Here's an attempt to answer based on the available information, with significant gaps noted:

Acceptance Criteria and Device Performance

The document does not explicitly state acceptance criteria in a quantitative manner, nor does it provide a table of reported device performance against such criteria. It implicitly suggests that the device performs as intended in terms of providing feedback for CPR compression depth and rate.

Implicit Performance Claims from the text:

• Compression Depth: "The PocketCPR will instruct them to increase compression depth" if not compressing at least 1.5 inches. This implies it accurately measures and provides feedback for depths below 1.5 inches.
• Compression Rate: The device "will monitor and signal, encouraging the rescuer to keep pace with the prompt led by the pace" (intended to be about 100 compressions per minute). This implies it accurately measures and provides feedback for compression rate.
• Breaths Prompts: "After 30 compressions or about 18 seconds of chest compressions, PocketCPR will instruct the rescuer to give breaths." This implies accurate counting of compressions or timing.

No explicit acceptance criteria or reported performance data are provided to populate the table.

Detailed breakdown of information requested that is NOT AVAILABLE in the provided text:

1. A table of acceptance criteria and the reported device performance:

   • Not Available. The document does not provide a table with specific acceptance criteria (e.g., "Compression depth accuracy: +/- X mm") nor does it report the device's measured performance against any such criteria. It only makes general statements about "functional requirements and performance specifications."

2. Sample sizes used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Available. The document mentions "Extensive performance testing" but provides no details on sample sizes, study design (retrospective/prospective), or data provenance.

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):

   • Not Available. No information is provided regarding how "ground truth" (if applicable in this context, e.g., for accurate CPR performance) was established for any testing.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not Available. No information on adjudication methods for a test set is provided.

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/Not Available. The PocketCPR is a device providing real-time feedback for CPR, not an AI or imaging diagnostic tool that would typically involve human "readers" or an MRMC study in the traditional sense. While the device assists human rescuers, the text does not describe any study comparing human performance with and without the device, nor does it quantify an "effect size" of improvement.

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

   • Not Available. The device's primary function is to provide real-time feedback to a human rescuer, implying a human-in-the-loop context. No information is given about a standalone algorithm performance test.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not Available. The document does not specify the type of ground truth used for any performance testing. For a CPR feedback device, ground truth might involve objective measurements of compression depth/rate on a manikin, or expert observation of CPR technique.

8. The sample size for the training set:

   • Not Applicable/Not Available. The PocketCPR is described as using an "integrated accelerometer" and having "two operating modes." It is presented more as a real-time sensor-based feedback system rather than a machine learning/AI model that would typically require a "training set" in the conventional sense. If internal calibration or development involved data, it is not mentioned.

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

   • Not Applicable/Not Available. (See point 8).

Conclusion based on Provided Text:

The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices (CPR EZY, ZOLL AEDPLUS®, ZOLL AEDPRO®) rather than detailing specific performance studies with quantitative acceptance criteria and results. It makes general claims about "extensive performance testing" ensuring the device meets "functional requirements and performance specifications" but does not provide the specifics of these tests, the criteria themselves, or the outcomes required to answer your questions comprehensively.

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