The HeartStart FR2+ is intended to be used with disposable defibrillation pads applied to a person who is experiencing the symptoms of sudden cardiac arrest (SCA): unresponsiveness and absence of breathing.

If in doubt, apply the pads.

When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information.

The HeartStart FR2+ is intended for use by personnel who have been trained in its operation. The user should be qualified by training in basic life support (BLS), advanced life support (ALS), or other physician-authorized emergency medical response.

At the discretion of emergency care personnel, the M3860A FR2+ with ECG display enabled can also be used with the FR2+ ECG assessment module to display the rhythm of a responsive or breathing patient, regardless of age. The FR2+ and ECG assessment module system provides a non-diagnostic display for attended patient monitoring. While connected to the FR2+ ECG assessment module, the FR2+ evaluates the patient's ECG and disables its shock capability.

Device Description

The HeartStart FR2+ is an automated external defibrillator available in two models, including one with ECG display and manual shock capability. Features include self-testing, impedance-compensating biphasic truncated exponential waveform, multi-parameter Patient Analysis System (PAS), and human factor designs to facilitate use by lay responders.

A non-rechargeable lithium manganese dioxide battery powers the FR2+ with a typical capacity of 300 shocks or 12 hours of operating time.

Except for specific programmed periods when a responder needs to deliver uninterrupted CPR, the FR2+ continuously and automatically analyzes the ECG and alerts the responder when the ECG changes to a possible shockable rhythm. Analysis continues even after the FR2+ advises a shock and arms - if the ECG spontaneously converts to a non-shockable rhythm prior to a responder pressing the shock button, the FR2+ disarms.

If significant artifact is detected in the ECG, FR2+ suspends further analysis until reliable data is available. When a shockable rhythm is detected, the FR2+ directs the responder to press the shock button to deliver a biphasic shock to the patient.

Event and incident data can be recorded during FR2+ use with an optional data card having a recording capacity of four hours of event and ECG data (or at least thirty minutes with voice recording).

The FR2+ has an optional Training and Administration Pack that is used for device training and for customizing FR2+ set-up options. The FR2+ is highly configurable, with over 10 possible parameters. Use of the Training and Administration Pack converts the FR2+ to a training device with ten training "scripts" that simulate different SCA scenarios.

The FR2+ also has an infrared communication port to facilitate communication of set-up parameters.

An optional reusable ECG Cable can be inserted into the AED's connector port to permit the viewing of lead II ECG and heart rate on the FR2+'s main liquid crystal display screen. Three lead wires, connected to standard disposable ECG electrodes, are labeled according to AAMI or IEC conventions. If a potentially shockable rhythm is detected (using the existing FR2+ algorithm) or if the heart rate drops below 30 beats per minute, voice and text prompts are issued.

AI/ML Overview

The provided text is a 510(k) summary for the Philips HeartStart FR2+ AED with modifications. It declares substantial equivalence of the modified device to a previously marketed device (Philips/Heartstream HeartStart FR2+ AED). However, it does not contain detailed information about specific acceptance criteria or the study data that "proves the device meets the acceptance criteria" in the format requested.

The document states: "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria." but it does not elaborate on what those criteria were or present the results of any specific study in a way that allows for a comprehensive answer to your questions.

Therefore, I cannot fulfill your request for a table of acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information based solely on the provided text.

Here's what I can extract and what is explicitly missing:

Acceptance Criteria and Device Performance

Acceptance Criteria (What was measured & threshold)	Reported Device Performance (Result & conclusion)
MISSING: Specific performance metrics for the modified features (e.g., sensitivity, specificity for rhythm analysis, energy delivery accuracy) are not explicitly stated.	General Statement: "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria."

Study Details (Based on the provided text)

Sample size used for the test set and the data provenance:
- Test Set Sample Size: MISSING (Not specified in the document).
- Data Provenance: MISSING (No information regarding country of origin or whether it was retrospective or prospective is provided).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: MISSING (Not specified).
- Expert Qualifications: MISSING (Not specified).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: MISSING (Not specified).
If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- MRMC Study Done: No, the document does not mention any MRMC study. The submission focuses on device modifications and substantial equivalence, not human-AI comparative effectiveness.
- Effect size of human readers improve with AI vs without AI assistance: N/A (No MRMC study was mentioned).
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Standalone Study Done: The document implies that the device's "Patient Analysis System (PAS)" continuously and automatically analyzes the ECG, and that "Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria." This suggests an assessment of the algorithm's performance, but specific details or results of a standalone study are MISSING.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: MISSING (Not specified).
The sample size for the training set:
- Training Set Sample Size: MISSING (Not specified).
How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: MISSING (Not specified).

Summary of what is present:

The document describes modifications to the Philips HeartStart FR2+ AED.
It claims substantial equivalence to the predicate device.
It states that testing was performed and the modified device performance is acceptable and meets predefined criteria, but does not provide those criteria or the detailed results of the testing.

Summary of what is missing from the provided text:

Almost all the specific details about the study, acceptance criteria, ground truth establishment, and sample sizes that you requested are absent from this 510(k) summary. These details would typically be found in the actual testing reports or design validation documentation referenced in such a submission, but not usually in the summary itself.

Summary

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OCT 5 - 2005

510(k) Summary for the Philips HeartStart FR2+ AED with Modifications

1. 510(k) Submission Number

#K051632

Date Summary Prepared 2.

October 3, 2005

3. Submitter's Name and Address

Philips Medical Systems Heartstream 2301 Fifth Avenue, Suite 200 Seattle, WA 98121

4. Contact Person

Tamara Yount Philips Medical Systems Heartstream Telephone: (206) 664-5000 Facsimile: (206) 664-5001

5. Device Name

Proprietary Name: Philips HeartStart FR2+ AED Common Name: Automated external defibrillator Classification Name: Low-Energy Defibrillator

6. Predicate Device

The legally marketed device to which Philips Medical Systems, Heartstream claims equivalence for the Philips HeartStart FR2+ AED with modifications is the Philips/Heartstream HeartStart FR2+ AED.

The design and intended use of the modified FR2+ AED is substantially equivalent in safety and performance to the device named above.

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7. Device Description Summary

A non-rechargeable lithium manganese dioxide battery powers the FR2+ with a typical capacity of 300 shocks or 12 hours of operating time.

Event and incident data can be recorded during FR2+ use with an optional data card having a recording capacity of four hours of event and ECG data (or at least thirty minutes with voice recording).

The FR2+ also has an infrared communication port to facilitate communication of set-up parameters.

page 2 of 3

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8. Intended Use

If in doubt, apply the pads.

When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information.

9. Comparison of Technology Characteristics

The modified Philips HeartStart FR2+ employs the same fundamental scientific technologies as the currently available Philips HeartStart FR2+.

10. Data Used in Determination of Substantial Equivalence

The FR2+ employs most the same technologies as the predicate device used for comparison.

Testing demonstrated the performance of the modified FR2+ is acceptable and meets predefined criteria.

11. Conclusion

The modifications proposed do not present new issues of safety or effectiveness.

LAST PAGE

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right. The profiles are stacked on top of each other, with the bottom profile having a wavy line extending from the chin. The profiles are surrounded by a circular border with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" written around it.

OCT & - 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems Heartstream c/o Ms. Tamara Yount Senior Regulatory Specialist 2301 Fifth Avenue, Suite 200 Seattle. WA 98121

Re: K051632 Trade Name: Philips HeartStart FR2+ AED Regulation Number: 21 CFR 870.5310 Regulation Name: Automated External Defibrillator Regulatory Class: Class III Product Code: MKJ Dated: September 22, 205 Received: September 23, 205

Dear Ms. Yount

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 - Ms. Tamara Yount

Please be advised that FDA's issuance of a substantial equivalence determination docs 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 20); 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours,

Bhimuma for

Bram D. Zuckerman, MD Director 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): #K051632

Device Name: Philips FR2+ Automated External Defibrillator (AED)

Indications For Use:

If in doubt, apply the pads.

When the patient is under 8 years or weighs less than 55 pounds (25 kg), apply FR2 infant/child reduced-energy defibrillator pads, if available.

WARNING: Performance of the SMART CPR AUTO1 and AUTO2 settings has not been established in patients under 8 years or 55 lb (25 kg). See Appendix E for more information.

Prescription Use x (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bhimma

on Slan-C Division of Cardiovascul : 10(k) Number

page 1 of 1

Regulation Number and Section

§ 870.5310 Automated external defibrillator system.

(a)
Identification. An automated external defibrillator (AED) system consists of an AED and those accessories necessary for the AED to detect and interpret an electrocardiogram and deliver an electrical shock (e.g., battery, pad electrode, adapter, and hardware key for pediatric use). An AED system analyzes the patient's electrocardiogram, interprets the cardiac rhythm, and automatically delivers an electrical shock (fully automated AED), or advises the user to deliver the shock (semi-automated or shock advisory AED) to treat ventricular fibrillation or pulseless ventricular tachycardia.(b)
Classification. Class III (premarket approval)(c)
Date PMA or notice of completion of PDP is required. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED that was in commercial distribution before May 28, 1976. A PMA will be required to be submitted to the Food and Drug Administration by April 29, 2015, for any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976, or that has, by April 29, 2015, been found to be substantially equivalent to any AED accessory described in paragraph (a) that was in commercial distribution before May 28, 1976. Any other AED and AED accessory described in paragraph (a), shall have an approved PMA or declared completed PDP in effect before being placed in commercial distribution.