(28 days)
Use of the E Series products in the Manual mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation as indicated by these three conditions:
- Unconsciousness
- Absence of breathing, and
- Absence of pulse.
This product should be used only by qualified medical personnel for converting ventricular fibrillation and rapid ventricular tachycardia to sinus rhythm or other cardiac rhythms capable of producing hemodynamically significant heart beats.
In Manual mode, the E Series unit may also be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardias (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified physician must decide when synchronized cardioversion is appropriate.
The Advisory function should be used to confirm ventricular fibrillation and wide complex ventricular tachycardia (greater than 150 beats per minute) in patients meeting the three conditions indicating lack of circulation (previously listed).
The E Series AED unit is designed for use by emergency care personnel who have completed training and certification requirements applicable to the use of a defibrillator where the device operator controls delivery of shocks to the patient.
They are specifically designed for use in early defibrillation programs where the delivery of a defibrillator shock during resuscitation involving CPR, transportation, and definitive care are incorporated into a medically-approved patient care protocol.
Use of the device in the Semiautomatic mode for defibrillation is indicated on victims of cardiac arrest where there is apparent lack of circulation.
The CPR monitoring function provides visual and audio feedback designed to encourage rescuers to perform chest compressions at the AHA/ERC recommended rate of 100 compressions per minute. Voice and visual prompts encourage a minimum compression depth of at least 1.5 (3.8 cm) or 2.0 inches (5.0 cm), depending on the configuration, for adult patients.
This product may be used for temporary external cardiac pacing in conscious or unconscious patients as an alternative to endocardial stimulation.
The purposes of pacing include: - Resuscitation from standstill or bradycardia of any etiology
- As a standby when standstill or bradycardia might be expected
- Suppression of tachycardia
The ZOLL E Series, reviewed and cleared under 510(k) K042007 and K062177, is a portable device designed to be used by trained emergency care personnel in both the hospital and pre-hospital arenas. The ZOLL E Series is designed for all emergent care situations and provides multi-parameter monitoring of patients in critical care and transport. The E Series combines defibrillation, ECG monitoring, noninvasive transcutaneous pacing, pulse oximetry, end tital CO2 12-Lead ECG monitoring, noninvasive blood pressure measurement, data printing and recording and CPR feedback in a single instrument.
The ZOLL E Series software, which currently supports the American Heart Association's (AHA) Guidelines for CPR 2005, has been revised to optionally support the AHA's Guidelines for CPR 2010. The specific changes include:
- Adding support, in the form of a configuration option, for a minimum CPR target compression depth of at least 2.0 inches (AHA Guidelines for CPR 2005 specified a minimum compression depth of at least 1.5 inches.) as described in Section 7 of the Operator's Guide included in Attachment 11-1.
- Modifying the reference markers associated with the displayed CPR compression bargraph when the CPR target compression depth is configured for 2.0 inches.
- Adding an optional informational message to remind the user to release their hands from the chest between compressions in order to allow the chest to recoil. When the E Series is configured to display this new message, the message FULLY RELEASE will be displayed every 45 seconds, for 5 seconds, as long as CPR compressions are detected.
The E Series products contain a DC defibrillator capable of delivering up to 200 joules of energy. It may be used in synchronized mode to perform synchronized cardioversion by using the R-wave of the patient's ECG as a timing refer-ence. The unit uses paddles or disposable, pre-gelled, MFE Pads for defibrillation.
Some E Series products may include an optional transcutaneous demand pacemaker consisting of a pulse generator and ECG sensing circuitry.
The provided document is a 510(k) summary for the ZOLL E Series with a 2010 AHA Guidelines Software Update. It describes the device, its intended use, and substantial equivalence to previously cleared devices. However, the document does not contain specific information about acceptance criteria, detailed study designs, sample sizes for test or training sets, expert qualifications for ground truth establishment, or adjudication methods for performance testing. It only broadly states that "Extensive performance testing ensures that the ZOLL E Series Defibrillator meets all of its functional requirements and performance specifications" and "Performance testing of the ZOLL E Series Defibrillator demonstrates that its features and functions are substantially equivalent".
Therefore, I cannot provide a detailed answer to your request based on the provided text. The document focuses on regulatory clearance based on substantial equivalence rather than presenting a performance study with detailed acceptance criteria and results.
Here's a summary of what can be extracted and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated or organized into a table in the provided document. The document implies compliance with the 2010 AHA Guidelines for CPR regarding compression depth and full chest recoil.
- Reported Device Performance: The document only states that "Performance testing... demonstrates that its features and functions are substantially equivalent to that of the indicated commercially distributed predicate devices with regard to performance, safety and effectiveness." No specific metrics (e.g., accuracy, precision, sensitivity, specificity) for the CPR monitoring function or other features are provided. The key change is the software update to support a minimum CPR target compression depth of at least 2.0 inches, up from 1.5 inches.
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set:
- Adjudication Method: Not specified.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- MRMC Study: No mention of an MRMC study. The document focuses on device performance and substantial equivalence, not comparative effectiveness with human readers.
- Effect Size of Human Readers with vs. without AI Assistance: Not applicable, as no MRMC study or AI assistance comparison is presented. The device provides feedback, but it's not described as an "AI assistance" in the context of improving human reader interpretation of data.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:
- The document implies standalone testing of the device's functions, as it refers to "performance testing" of the defibrillator's features and functions. However, detailed results of such standalone testing with specific metrics are not provided. The CPR monitoring function is an algorithm-driven feature that provides feedback, which is a form of standalone function before human-in-the-loop interaction.
7. The Type of Ground Truth Used:
- Not specified. Given the nature of the device (defibrillator with CPR feedback), ground truth for performance testing would likely involve simulated CPR scenarios with controlled compression depths and rates, or potentially data from actual CPR events where precise measurements of depth and rate are obtained through external sensors.
8. The Sample Size for the Training Set:
- Not applicable as the document describes a software update to an existing device, implying a rule-based or algorithm update rather than a machine learning model that requires a "training set" in the conventional sense. The "training" here refers to meeting the new AHA guidelines, likely through parameter adjustments in the existing software.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable for the same reason as point 8, as it's not a machine learning model. The "ground truth" for the software update would be the 2010 AHA Guidelines recommending at least 2.0 inches compression depth and full chest recoil.
In summary, the provided text serves as a regulatory submission for a software update rather than a detailed scientific and performance study report. It confirms the device's substantial equivalence to existing cleared devices after the software modification, but lacks the specific details of performance testing requested.
§ 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.