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.

AI/ML Overview

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:

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."
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.
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.
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.
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.
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.
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.
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.
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.

Summary

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K07/321

Image /page/0/Picture/1 description: The image shows the logo for BIO-DETEK INCORPORATED. The logo consists of two parts: a symbol on the left and the company name on the right. The symbol is made up of four mirrored "B" shapes arranged in a square. The company name is written in bold, uppercase letters, with "BIO-DETEK" on the top line and "INCORPORATED" on the bottom line.

SEP 1 2 2007

510(k) Summary:

Submitter's Name and Address:

Bio-Detek Incorporated

A Division of ZOLL Medical Corporation

525 Narragansett Park Drive

Pawtucket, RI 02861-4323 (401) 729-1400

Contact Person:

Robert Morse

(401) 729-1400 ext. 224

Date Summary Prepared:

July 31, 2007

Device:

PocketCPR™

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

Description:

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

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Indications for Use:

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

Substantial Equivalence:

PocketCPR is substantially equivalent to CPR EZY and uses the technology substantially equivalent to CPR feedback in the ZOLL AEDPLUS® and ZOLL AEDPRO®. The features and equivalent to OF N Toubable in the same technology as that found in the ZOLL AEDPLUS® and ZOLL AEDPRO®.

Performance Testing:

Extensive performance testing ensures that the PocketCPR meets all of its functional requirements and performance specifications.

Conclusion

Testing of the PocketCPR demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed device with regard to performance, safety and effectiveness.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name arranged in a circular pattern around a stylized eagle-like symbol. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 1 2 2007

Bio-Detek Incorporated c/o Mr. Robert Morse QA/QC Manager 525 Narragansett Park Drive Pawtucket, Rhode Island 02861

Re: K071321

Pocket CPR™ Regulation Number: 21 CFR 870.5200 Regulation Name: External Cardiac Compressor Regulatory Class: Class III (three) Product Code: LIX Dated: August 8, 2007 Received: August 24, 2007

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.

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

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Page 2 - Mr. Robert Morse

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); 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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

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

Enclosure

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Section 4 - Indications for Use

510(k) Number (if known): K071321_________________________________________________________________________________________________________________________________________

PocketCPR™ Device Name:

PocketCPR Function:

、

. .

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

and the country of the county of

Rev 6

Prescription Use(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use	X(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF
NEEDED)
Concurrence of Office of Device Evaluation (ODE)
4071321

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.