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The TEMPUS LS - MANUAL is a multi-function, portable of providing defibrillation therapy, noninvasive external pacing, displaying ECG, and CPR feedback in hospital settings. It is to be used by qualified medical health care professionals trained in the use and operation of the device and qualified by training in advanced cardiovascular life (ACLS) support.

Manual Defibrillation: In Manual Defibrillation mode, the TEMPUS LS - MANUAL is indicated for 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 terminating ventricular fibrillation and ventricular tachycardia. Defibrillation is indicated for adult and pediatic patients. When a victim is less than 8 years of age, or weighs less than 55 lbs. (25kg), the TEMPUS LS - MANUAL should be used with the Tempus Pediatric Electrodes or in the device's pediatic mode with the Tempus Adult Electrodes. Therapy should not be delayed to determine the patient's exact age or weight.

Cardioversion: The TEMPUS LS - MANUAL may be used for synchronized cardioversion to terminate atrial fibrillation (AF) or ventricular tachycardia (VT) by using the R-wave of the patient's ECG as a timing reference. A qualified user trained in the operation of the device must decide when synchronized cardioversion is appropriate. Cardioversion is indicated for adult and pediatric patients.

External Pacing: The TEMPUS LS - MANUAL is indicated 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. External pacing is indicated for adult and pediatric patients.

ECG Display: The TEMPUS LS - MANUAL is intended to display a patient's ECG from a 3- or 4- lead wire ECG patient cable. It is indicated for use in adult or pediatric for attended monitoring of the patient's ECG signal (e.g., before starting demand pacing or after successful defibrillation).

CPR Feedback: The TEMPUS LS - MANUAL may be supplied with an optional CPR feedback sensor, which is intended to provide visual and audio feedback to encourage rescuers to perform CPR in accordance with AHA/ERC guidelines for chest compression rate and depth. It is indicated for use on adult and pediatric patients ≥ 8 years of age or weighing ≥ 25 kg / 55 lbs. CPR Feedback is not indicated for use on neonatal and pediatric patients under 8 years of age or weighing less than 25 kg/55 lbs.

The TEMPUS LS – MANUAL is a compact, lightweight, portable electromedical device that contains a direct current (DC) defibrillator capable of delivering up to 200 joules of electrical energy to a patient through selfadhesive external electrode pads. The device is intended for use by advanced cardiac life support (ACLS) trained health care professionals in hospital settings to provide defibrillation therapy, non-invasive external pacing, cardiopulmonary resuscitation (CPR) feedback, and non-alarming electrocardiograph (ECG) monitoring. The device is intended for prescription-use only. The unit is powered by a rechargeable lithium-ion battery which is recharged when connected to a mains power supply. The unit incorporates a color LCD display that displays information related to a clinical intervention. The trained user may select an energy level between 1 - 200 ioules and deliver a shock in either an asynchronous mode of delivery or through synchronized cardioversion using the patient's R-wave as a timing reference for the shock. The device provides non-invasive transcutaneous pacing in either fixed or demand modes of operation through the same self-adhesive pads used in manual defibrillation. In addition, the device incorporates an audible metronome to quide a user as to the correct rate at which chest compressions should be administered in accordance with current American Heart Association (AHA) resuscitation guidelines. The device may be supplied with an optional cardiopulmonary resuscitation (CPR) feedback sensor which assists caregivers during CPR in delivering chest compressions at a rate and depth in compliance with current AHA guidelines. The device may also be paired to a compatible external device via a secure wireless communications protocol called Tempus Data Link (TDL) to export event data (without patient identifiers) at the convenience of the user.

This is a 510(k) summary for the TEMPUS LS - MANUAL, a multi-function defibrillator. The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparisons and non-clinical performance testing. It does not contain information about a clinical study with acceptance criteria in the typical sense of metrics like sensitivity or specificity for an AI algorithm.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The document describes "pre-established acceptance criteria" but does not explicitly list them or quantify performance metrics in a table. Instead, it states that various tests "met requirements" or "met the requirements of the standard," implying that the acceptance criteria were compliance with specific industry standards and successful operation in bench testing.

2. Sample size used for the test set and the data provenance

The document does not detail a "test set" in the context of an AI algorithm's performance. The closest analogous information is for the Human Factors validation testing:

• Sample size: 15 participants
• Data provenance: Not specified, but given the manufacturer is UK-based and the test was for usability, it's likely the participants were located in a similar context. It was a prospective study to evaluate usability.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided as the document describes non-clinical testing and human factors usability, not a clinical study requiring expert-established ground truth for diagnostic accuracy.

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

This information is not provided as the document does not describe a process that would involve expert adjudication of a test set for diagnostic performance.

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, a MRMC comparative effectiveness study was not done with human readers and AI assistance. This document describes a medical device (defibrillator) primarily relying on hardware and embedded software functionality, not an AI-powered diagnostic tool that assists human readers.

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

This concept is not directly applicable to the device described. The "algorithm" here refers to the device's operational functions (defibrillation waveform generation, pacing parameters, CPR metronome, etc.) rather than a diagnostic algorithm generating an output for review. Bench testing was performed for these functionalities, which could be considered "standalone" in the sense that the device's technical specifications were verified against standards.

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

For the non-clinical performance testing, the "ground truth" was the pre-established acceptance criteria derived from recognized consensus standards (e.g., IEC 60601-1, IEC 60601-2-4). For the human factors study, the ground truth was the successful and safe use of the device by participants, evaluated against predefined usability metrics.

8. The sample size for the training set

The document does not mention a "training set" as it is not for an AI/ML algorithm that undergoes a training phase with a dataset.

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

Not applicable, as there is no mention of a training set for an AI/ML algorithm.

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