(140 days)
The X Series is intended for use by trained medical personnel who are familiar with basic monitoring, vital sign assessment, emergency cardiac care, and the use of the X Series, The X Series is also intended for use by (or on the order of) physicians at the scene of an emergency or in a hospital emergency room, intensive care unit, cardiac care unit, or other similar areas of a hospital. The usage may be in an ambulance or at the scene of an emergency. It is also intended to be used during the transport of patients. The X Series will be used primarily on patients experiencing symptoms of cardiac arrest or in post trauma situation. It may also be used whenever it is required to monitor any of those functions that are included (as options) in the device. The X Series unit can be used on pediatric patients (as described in the following table) and on adult patients (21 years of age or older) with and without heart dysfunction.
The predicate X Series is a lightweight, portable device designed to be used by trained medical personnel who are familiar with vital signs monitoring and emergency cardiac care. As in its previously cleared configuration, the modified X Series combines the functions of a Semi-automatic (AED)/ manual defibrillator, external transcutaneous pacer and patient monitors (including ECG, SpO2, SpCO, SpMet, CO2, NIBP, IBP, temperature and respiration monitoring).
With the current application, we are proposing to revise the X Series communication processor software to create a web page with a graphical trend format and countdown timer for ventilations that consolidates the existing SBP (systolic blood pressure from the NIBP monitoring), SpO2, EtCO2 data and the timer on the display of the X Series. The access to this web page will be marketed as the Traumatic Brain Injury (TBI) Dashboard. This TBI Dashboard assists the operator who is ventilating a patient to follow recommendations in the TBI guidelines. Through an encrypted and password protected communications protocol, a suitable separate device with touchscreen, web browser capability and Bluetooth communications can display the TBI Dashboard.
As described above, the proposed software change impacts only the communication aspects of the X Series device. Therapeutic and monitoring capabilities of the X Series device as cleared under K133269 have remained unchanged and are not impacted by the proposed change. The X Series therapeutic and monitoring functionality is entirely controlled by access directly through the X Series device, itself, and not through the TBI Dashboard. TBI Dashboard is intended to supplement and not replace any part of the device monitoring.
The provided text describes the ZOLL X Series, a multi-function medical device that includes capabilities such as defibrillation, ECG monitoring, CPR monitoring, pacing, and various physiological monitoring functions (NIBP, temperature, SpO2, respiration, CO2, invasive pressure). The 510(k) submission (K141774) is specifically for a revision to the X Series communication processor software to add a "TBI Dashboard" functionality.
However, the document does not explicitly state specific acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy, error rates) for the device's various functions, nor does it provide detailed descriptions of studies proving these criteria are met. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.
The "Performance Testing" section states: "Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." This is a general statement about the type of testing performed, not a detailed report of the results against specific criteria.
The 510(k) summary focuses on the TBI Dashboard functionality, which is a software revision. For this new feature, the document asserts substantial equivalence to two predicate devices:
- ZOLL RescueNet Link (K111296) for collecting and displaying data in a web page format.
- L770-CPR Resuscitation Timer (K062080) for ventilation rate timer functionality.
Given this, I will infer what the "acceptance criteria" likely are based on the substantial equivalence claims and the general nature of medical device clearances. The "reported device performance" will be based on the general statements made about meeting requirements.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| For all existing X Series functions (e.g., Defibrillation, ECG, NIBP, SpO2, etc.): Maintains performance as previously cleared predicate (ZOLL X Series K133269) and meets functional requirements and performance specifications. | "Features and functions cleared with the ZOLL X Series (K133269) device has remained unchanged ... ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." |
| For TBI Dashboard (Data Display/Web Console): Functionality is equivalent to ZOLL RescueNet Link (K111296) for displaying physiological data and user-entered data via web page. | "The proposed TBI Dashboard functionality and RescueNet Link (K111296) both collect and display data... in the form of a web page that can be accessed by the authorized users through standard web browser technology." "TBI Dashboard is intended to supplement and not replace any part of the device monitoring." |
| For TBI Dashboard (Ventilation Rate Timer): Functionality is equivalent to L770-CPR Resuscitation Timer (K062080) for providing a visual aid for ventilation rate. | "Ventilation rate timer functionality in the TBI Dashboard is substantially equivalent to the the L770-CPR Resuscitation Timer (K062080). Both the devices are visual aids for a rescuer trained in the protocol they support..." |
| Safety: Device complies with applicable recognized industry and safety standards. | "Safety testing assures that the device complies with applicable sections of recognized industry and safety standards." |
| Software Verification & Validation: Software operates as intended and meets design specifications. | "Extensive performance testing in the form of the software verification and system level validation ensures that the ZOLL X Series performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications." |
2. Sample size used for the test set and the data provenance
The document does not provide details on specific sample sizes for test sets or data provenance (e.g., country of origin, retrospective/prospective) for the software verification and system-level validation. The nature of the submission (a software update for a display feature) suggests that these tests would primarily involve engineering and software validation rather than clinical data from a "test set" in the traditional sense of patient data. For the original X Series functions, such data would have been part of the K133269 submission, but not detailed here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/provided. The submission relies on demonstrating substantial equivalence to predicate devices and general software verification/system validation, rather than a clinical study requiring expert-established ground truth for a novel diagnostic or treatment outcome.
4. Adjudication method for the test set
Not applicable/provided for the reasons stated above.
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
No MRMC comparative effectiveness study was done or reported. This submission is for a device update adding a dashboard, not a novel diagnostic AI algorithm. The TBI Dashboard is described as a "supplement and not replace any part of the device monitoring," and the ventilation timer as a "visual aid," implying it supports human users rather than being an AI system that improves human "reading" performance in a diagnostic context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a patient monitor/defibrillator with software features, not a standalone algorithm. The TBI Dashboard is a display feature for existing data.
7. The type of ground truth used
For the software revision adding the TBI Dashboard, the "ground truth" would likely be the correct functioning of the software according to its design specifications, accuracy in displaying data from the device sensors, and adherence to accepted communication protocols for web page display. This would be established through software unit testing, integration testing, and system validation against known correct values or predicate device behavior. No external expert consensus, pathology, or outcomes data is mentioned for this particular update.
8. The sample size for the training set
Not applicable. The X Series and its TBI Dashboard are not described as machine learning or AI-based systems that require a "training set" for model development.
9. How the ground truth for the training set was established
Not applicable for the reasons stated above.
§ 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.