(125 days)
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:
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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."
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
§ 870.5210 Cardiopulmonary resuscitation (CPR) aid.
(a)
CPR aid without feedback —(1)Identification. A CPR aid without feedback is a device that performs a simple function such as proper hand placement and/or simple prompting for rate and/or timing of compressions/breathing for the professionally trained rescuer, but offers no feedback related to the quality of the CPR being provided. These devices are intended for use by persons professionally trained in CPR to assure proper use and the delivery of optimal CPR to the victim.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.(b)
CPR aid with feedback —(1)Identification. A CPR Aid device with feedback is a device that provides real-time feedback to the rescuer regarding the quality of CPR being delivered to the victim, and provides either audio and/or visual information to encourage the rescuer to continue the consistent application of effective manual CPR in accordance with current accepted CPR guidelines (to include, but not be limited to, parameters such as compression rate, compression depth, ventilation, recoil, instruction for one or multiple rescuers, etc.). These devices may also perform a coaching function to aid rescuers in the sequence of steps necessary to perform effective CPR on a victim.(2)
Classification. Class II (special controls). The special controls for this device are:(i) Nonclinical performance testing under simulated physiological or use conditions must demonstrate the accuracy and reliability of the feedback to the user on specific compression rate, depth and/or respiration over the intended duration, and environment of use.
(ii) Labeling must include the clinical training, if needed, for the safe use of this device and information on the patient population for which the device has been demonstrated to be effective (including patient size and/or age limitations,
e.g., adult, pediatric and/or infant).(iii) For devices that incorporate electrical components, appropriate analysis and testing must demonstrate that the device is electrically safe and electromagnetically compatible in its intended use environment.
(iv) For devices containing software, software verification, validation, and hazard analysis must be performed.
(v) Components of the device that come into human contact must be demonstrated to be biocompatible.
(vi) Human factors testing and analysis must validate that the device design and labeling are sufficient for effective use by the intended user.
(3)
Premarket notification. The CPR Aid with feedback device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter if it does not contain software (e.g., is mechanical or electro-mechanical) and is in compliance with the special controls under paragraph (b)(2) of this section, subject to the limitations of exemptions in § 870.9.