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.

AI/ML Overview

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.

Feature/Metric	Acceptance Criteria (As stated in document)	Reported Device Performance (As stated in document)
CPR Depth Feedback Accuracy	Not explicitly stated (Implied: "gives verbal and visual feedback on the quality of CPR being delivered" meeting AHA 2010 Guidelines)	Not reported quantitatively. States "Measurement of actual chest wall movement is made by a state-of-the-art accelerometer micro-chip and microprocessor performing continuous analysis."
CPR Rate Feedback Accuracy	Not explicitly stated (Implied: "generates a metronome at the recommended rate of chest compression" meeting AHA 2010 Guidelines)	Not reported quantitatively.
Full Release Detection Accuracy	Not explicitly stated (Implied: "allow for 'Full Release' on 'UP' stroke" feedback)	Not reported quantitatively.
Breaths Prompt Accuracy	Not explicitly stated (Implied: "reminds the user to give two breaths after every 30 compressions" meeting AHA 2010 Guidelines)	Device "maintains communicating 'Open Airway - Give Two Breaths' after each sequence of 30 compressions."
Orientation Guidance Accuracy	Not explicitly stated (Implied: "assist the caregiver in selecting proper orientation")	Device "will also prompt 'Analysis Halted' if improper orientation has occurred and will stay silent awaiting proper orientation."

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.

Summary

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N C O R P O R

510(k) Summary: K112660

Rev. 3

Submitter's Name and Address: Bio-Detek, Inc. A Subsidiary of ZOLL® Medica! Corporation 525 Narragansett Park Drive Pawtucket, RI 02861 (401) 729-1400

Contact Person: Robert Morse (866) 639-0060 x.224 bmorse@bio-detek.com

Date Summary Prepared: April 4, 2012

Device Name: PocketCPR® (Part #2132)

Classification Name: Cardiopulmonary Resuscitation Aid; Class III (21 CFR 870.5200)

Device Description: 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 predicate PocketCPR (2047) in K071321 is compliant to the AHA 2005 Guidelines while the proposed PocketCPR (2132) in this submission is compliant to the AHA 2010 Guidelines in the default "Normal Operating Mode" when tumed "On".

525 Narragansett Park Drive, Pawtucket, Rhode Island 02861-4323, Tel. (401) 729-1400 or (800) 729-1408

MAY 1 0 2012

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A plus "4" feature has been added to the Normal Operating Mode to address the caregiver that tums the unit "On", places the device on the patient's chest and commences directly into chest compressions. During the initial power-on protocol the device intuitively monitors for compression recognition of 1.2" or greater. The verbal prompt "Call for Help" will be dropped to allow advancement to the "Start CPR" prompt. This "+" feature will automatically go into chest compression assistance, same as predicate, giving instructions for "Push Harder" as needed and "Good Compressions" when done to correct depth. It also maintains communicating "Open Airway - Give Two Breaths" after each sequence of 30 compressions, same as predicate.

Another plus "+" in the proposed device is an additional guidance source to assist the caregiver in selecting proper orientation of the device when placed on a patient's chest. To best take advantage of the LED's visual cadence and prompting of one LED flashing for "Push Harder" and all four flashing for "Good Compressions" the proper or upright orientation of the device allows the caregiver maximum visual assistance. We have added a "Patient Side" label to the center of the bottom outer surface to direct the caregiver to apply that surface on the patient's chest. The device will also prompt "Analysis Halted" if improper orientation has occurred and will stay silent awaiting proper orientation, hence "Patient Side" label, which when proper orientation occurs the device will then prompt "Start CPR and proceed into CPR assistance sequences.

"Silent Mode" is an operational optional mode both in the predicate PocketCPR and the proposed in this submission for use in training sessions where multiple units are in-play.

NORMAL OPERATING MODE

Start-Up

1. Power On the device by pressing the rubber power button on the side of PocketCPR (marked with a circle and vertical line in the middle).
1. Allow device to Power Up and perform its system checks.
1. Place device in the center of the chest as shown on label.
1. Follow the verbal prompts to:
- · "STAY CALM"
- · "CHECK RESPONSIVENESS"
- · "CALL FOR HELP"
- "OPEN AIRWAY" "+" .
- "CHECK BREATHING" "+" .
- "START CPR" .
1. Place the heel of one hand on the device and the second hand on top so both hands are overlapped.
1. Begin chest compressions, allow for "Full Release" on "UP" stroke.
1. In the Normal Operating Mode "+" feature, the verbal prompts identified with a "+" are over-ridden to advance into chest compression assistance earlier for those caregivers commencing directly into chest compressions.

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1. Begin chest compressions, allow for "Full Release" on "UP" stroke.
1. After 18 seconds, representing 30 compressions, follow the verbal prompts to:
- "OPEN AIRWAY" .
- "GIVE TWO BREATHS" .
1. Continue CPR chest compressions following the metronome and light prompts to ensure proper depth and rate. Cycles of 30 compressions and 2 ventilations are recommended or continuous chest compressions if you are unwilling or unable to provide ventilations, or if an advanced airway has been secured.

SILENT MODE Start-Up

1. Power On the device by pressing and holding in the power button on the side of the device. After hearing the verbal prompt, "STAY CALM.", wait a full second before releasing the power button.
1. The device metronome will begin to flash, indicating that the device is ready for CPR to begin, allow for "Full Release" on "UP" stroke.

Substantial Equivalence:

Part Number (P/N) 2132 for PocketCPR, which represents the version in this submission, is substantially equivalent to its predecessor, PocketCPR P/N 2047, cleared on 510/k) K071321. which incorporated the 2005 AHA Guidelines. The 2132 version of PocketCPR is programmed to meet the 2010 AHA Guidelines as the default mode. The core technology is the same as its predecessor utilizing an Analog Devices accelerometer, presently an ADXL322 versus the earlier submission which had an ADXL311 accelerometer from the same manufacturer. The Indications for Use are the same as the Predicate.

Indications for Use

PocketCPR Intended Use:

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

PocketCPR Types of Testing

. Bench Testing
- General Safety o
- Electromagnetic Compatibility o
- Software Performance o
- o Water Ingress
- o Vibration Effects
- Sound Levels of Verbal Prompts & Metronome o
Simulated Use on Computerized Manakin for Data Collection .
Usability Studies performing CPR using PocketCPR .
Biocompatibility of Skin Contact Materials .

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Conclusion

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 device 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.

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Image /page/4/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, facing to the right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The text is in all capital letters.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 1 0 2012

Bio-Detek Incorporated c/o Mr. Robert Morse Director, Regulatory Affairs 525 Narragansett Park Drive Pawtucket, RI 02861-4323

Re: K112660

PocketCPR Regulation Number: 21 CFR 870.5200 Regulation Name: Cardiopulmonary Resuscitation Aid Regulatory Class: Class III Product Code: LIX Dated: May 1, 2012 Received: May 2, 2012

Dear Mr. Morse:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be

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Page 2 - Mr. Robert Morse

found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman, M.D. Director L Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known): __K112660

Rev 3

Device Name: PocketCPR™

PocketCPR Intended Use:

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

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of DRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number_KII2

Regulation Number and Section

§ 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.