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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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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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