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NeoBeat and NeoBeat Mini are indicated to continuously measure and display the heart rate of neonates using dry electrodes on the torso during transition, stabilization and/or resuscitation. The devices are intended to be used in healthcare facilities. NeoBeat is intended for use on newborns approximately 1.5-5 kg. NeoBeat Mini is intended for newborns approximately 0.5-2 kg.

The NeoBeat Newborn Heart Rate Meter is a battery-powered device placed on the torso of a newborn, indicated to measure the heart rate. NeoBeat does not store, display or output an ECG signal. The device is placed around the torso of the neonate such that the ECG dry electrodes contact the neonate's skin. It can be oriented caudally or cranially. In normal operation, the LED display presents the heart rate in large numerals. The display can also present other information, such as signal quality and error codes. The device comes with a charging stand.

Here's a breakdown of the acceptance criteria and study information for the NeoBeat/NeoBeat Mini device based on the provided text:

Acceptance Criteria and Device Performance

Study Information

1. Sample sizes used for the test set and the data provenance:

   • Test Set Sample Size: 19 clinical cases representing over 4 hours of ECG data.
   • Data Provenance: The 19 cases were randomly selected from a large database containing newborn ECGs from four countries outside the United States.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: 2
   • Qualifications: An ICU physician and a scientific expert in ECG signal processing and analysis.

3. Adjudication method for the test set:

   • Not explicitly stated, but it implies a consensus given "Heart rate based on expert annotation was considered 'ground truth'." This suggests the two experts either agreed directly or their combined annotation formed the ground truth.

4. 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:

   • No MRMC comparative effectiveness study was done. This study focused on the algorithm's standalone performance compared to expert-annotated ground truth, not on human reader improvement with or without AI assistance.

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

   • Yes, a standalone performance study was done. The study compared "Heart rate based on NeoBeat's algorithm" to the "ground truth" heart rate established by experts.

6. The type of ground truth used:

   • Expert consensus (specifically, expert annotation of QRS complexes).

7. The sample size for the training set:

   • Not explicitly stated. The document mentions a "large database containing newborn ECGs from four countries outside the United States" with "over 1000 cases of ECGs" collected from researchers. While this database was used to select the test cases, it is strongly implied that this database would have been used for training/development, but the exact size of the training set is not specified separately from the total database.

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

   • Not explicitly stated for the training set. For the test set, it was established by expert annotation of QRS complexes by an ICU physician and a scientific expert. It is reasonable to infer a similar method for the training set, given the nature of the data and the use of expert annotation for the test set.

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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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