ZOLL M SERIES WITH RECTILINEAR BI-PHASIC OPTION (M SERIES BI-PHASIC) by ZOLL MEDICAL CORP.

The ZOLL M Series Bi-Phasic Defibrillator is to be used only by qualified medical personnel for converting ventricular fibrillation (VF), a cardiac rhythm incompatible with life, and/or Ventricular Tachycardias (VT) to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Atrial Fibrillation (AF) at lower energy and currents than monophasic defibrillators. A qualified physician must decide when synchronized cardioversion is appropriate.

In addition, this product is to be used in the synchronized cardioversion mode only by qualified medical personnel to terminate Ventricular Tachycardias (VT). A qualified physician must decide when synchronized cardioversion is appropriate.

The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices. The M Series Biphasic Option incorporates some user selectable energy settings, which are lower than those used during those dinical trials.

There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatric applications. Or

The M Secies Biohasionalisation for direct defibrillation of the heart during open chest surgical/ (procedures.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in palients meeting the following clinical criteria:

the patient should be unconscious and unresponsive .
the patient should be apneic (not breathing) .
the patient should be pulseless ●

Do not use the unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Warning Cardiopulmonary Resuscitation and AED, 3-5, 1998).

Device Description

Not Found

AI/ML Overview

This looks like a medical device approval document, specifically a 510(k) premarket notification for the ZOLL M Series Bi-Phasic Option. Unfortunately, this type of document typically does not contain the detailed study information required to answer your prompt.

Here's why and what kind of information it does provide:

510(k) Premarket Notifications: These submissions primarily demonstrate "substantial equivalence" to a legally marketed predicate device, not necessarily extensive clinical efficacy trials. While some clinical data might be included, it's usually summarized or referenced, not presented with the granular detail you're asking for about acceptance criteria, sample sizes, expert qualifications, etc.
Focus of this Document: This specific document is the FDA's letter of clearance for the 510(k) submission, along with the "Indications for Use." It confirms the device can be marketed. It refers to past clinical trials (paragraph 4 on page 3) but doesn't describe them in detail.

Based on the provided text, I can extract the following limited information regarding studies:

1. A table of acceptance criteria and the reported device performance:

Does not exist in this document. The document states: "The Rectilinear Biphasic Waveform (RBW) has been successfully tested in multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials, and proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices." This is a summary statement of success, not a table of specific criteria and performance metrics.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified.
Data Provenance: "multi-center, prospective, randomized, transthoracic defibrillator VT/VF and AF clinical trials." No country of origin is mentioned.

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 specified. Clinical trials would have involved physicians, but their roles in "establishing ground truth" are not detailed here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not specified.

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 specified. This device is a defibrillator, not an AI-powered diagnostic tool requiring human readability or interpretation. The document mentions "proven to defibrillate and cardiovert adult patients at lower energies and currents than existing monophasic devices," which implies a comparative effectiveness study against monophasic devices. However, it's not a "human reader" study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable / Not specified. Again, this is a physical medical device (defibrillator), not an algorithm or AI. It functions to deliver an electrical shock. The "AED or advisory function" is mentioned, which implies some automated analysis to confirm VF, but details of its standalone performance are not provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For a defibrillator, ground truth would typically be patient outcomes related to successful termination of VT/VF and AF. The sentence "proven to defibrillate and cardiovert adult patients" directly implies this.

8. The sample size for the training set:

Not specified. The document refers to "clinical trials" which are likely the testing set (or main study data), but no separate training set is mentioned or implied, especially since this is not an AI/ML device in the modern sense of requiring extensive training data.

9. How the ground truth for the training set was established:

Not specified.

In summary, the provided document is a regulatory clearance letter and provides very high-level information about the clinical studies conducted. It does not contain the granular detail about study methodology, acceptance criteria tables, sample sizes, expert qualifications, or adjudication methods that your prompt requests. To get that level of detail, one would typically need to review the full 510(k) submission, the associated clinical study reports, or published peer-reviewed literature related to the device.

Summary

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Image /page/0/Picture/10 description: The image is a black and white circular logo for the Department of Health & Human Services - USA. The logo features the department's emblem, which consists of a stylized caduceus with three intertwined snakes and a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the emblem in a circular fashion.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

3 1999 SEP

Mr. Paul Dias QA Engineer ZOLL Medical Corporation 32 Second Avenue Burlington, MA 01803-4420

Re: K990762 ZOLL M Series Bi-Phasic Option Regulatory Class: III (three) Product Code: 74 MKJ, DRO, LDD, and DPS July 2, 1999 Dated: Received: July 7, 1999

Dear Mr. Dias:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act). The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

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Page 2 - Mr. Paul Dias

devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

On August 16, 1993 the Final Rule for Device Tracking was published in the Federal Register, pages 43442-43455 (copy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirements of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please not the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act, may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosures

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510(k) NUMBER (IF KNOWN): K990762

M Series Bi-Phasic Option DEVICE NAME:

INDICATIONS FOR USE:

There are currently no clinical studies related to the Rectilinear Biphasic Waveform (RBW) in pediatric applications. Or

The M Secies Biohasionalisation for direct defibrillation of the heart during open chest surgical/ (procedures.

The AED or advisory function should only be used to confirm the presence of ventricular fibrillation in palients meeting the following clinical criteria:

the patient should be unconscious and unresponsive .
the patient should be apneic (not breathing) .
the patient should be pulseless ●

Do not use the unit's AED function on patients under 8 years of age. (Per AHA Guidelines for Adult Warning Cardiopulmonary Resuscitation and AED, 3-5, 1998).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter-Use (Optional Format 1-2-96)

Closer
2/2/32

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number

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.