(293 days)
The Heartstream XLT Defibrillator/Monitor is to be used for the termination of ventricular tachycardia and ventricular fibrillation.
This device is for use by emergency personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac life support, defibrillation, or other physician-authorized emergency medical response. It must be used by or on the order of a physician.
The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J.
In the manual mode operation, the Heartstream XLT Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials.
AED Therapy:
To be used in the presence of a suspected cardiac arrest on patients that are unresponsive, not breathing and pulseless.
Pacing:
Noninvasive pacing is one method of treating patients with symptomatic bradycardia. It can also be helpful in patients with asystole, if performed early.
SpO2 Monitoring:
SpO2 monitoring is indicated for use when it is beneficial to assess a patient's oxygen saturation level.
The Heartstream XLT Defibrillator/Monitor has two modes of operation: AED and manual. Non-invasive external pacing, as well as SpO2 and 3/5-wire ECG monitoring are also available.
The Heartstream XLT defibrillator uses the Heartstream SMART biphasic waveform for defibrillation, the same waveform utilized in the Heartstream ForeRunner AED.
ECG data and events can be stored on a Data Card by the Heartstream XLT for Jater downloading and reporting with the Heartstream CodeRunner data management system.
The provided text describes a 510(k) summary for the Heartstream XLT Defibrillator/Monitor and its comparison to predicate devices, but it does not contain the specific acceptance criteria or a detailed study proving the device meets those criteria in the format requested.
The document primarily focuses on demonstrating substantial equivalence to existing predicate devices based on technological characteristics and repetition of previous testing. It mentions a "Conclusion from Testing" that the device "does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices," but this is a high-level summary, not a report of specific acceptance criteria and performance data.
Here's an breakdown of what can and cannot be extracted from the provided text according to your request:
1. A table of acceptance criteria and the reported device performance
This information is not present in the provided text. The document states: "For each function on the Heartstream XLT that is leveraged from previous HP products, such as the CodeMaster 100 or the Heartstream ForeRunner, the testing done for the previous product was repeated in order to demonstrate equivalence, although in some cases, more stringent procedures and/or acceptance criteria were required for the XLT." However, neither these "more stringent procedures and/or acceptance criteria" nor the specific performance results are described.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not explicitly stated for the non-clinical tests.
For the clinical testing of the SMART Biphasic waveform, it states: "The SMART Biphasic waveform utilized in the Heartstream XLT Defibrillator/Monitor has undergone clinical testing in adults." However, it does not provide the sample size, country of origin, or whether it was retrospective or prospective.
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)
This information is not present in the provided text. The document mentions tests but not the use of experts to establish a ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not present in the provided text.
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
This information is not present in the provided text. The device is a defibrillator/monitor, not an AI-assisted diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document mentions "algorithm and software testing" for nonclinical tests, but it does not provide details about standalone performance metrics or if it was conducted without human intervention in the context of defibrillation effectiveness.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not explicitly stated. For the "clinical testing in adults" of the SMART Biphasic waveform, it implicitly suggests that the ground truth would be successful termination of ventricular tachyarrhythmias (outcomes data), but this is not definitively stated. For the other non-clinical tests, the ground truth would likely be established in accordance with engineering standards and predicate device performance.
8. The sample size for the training set
This information is not present in the provided text. Since the document primarily describes reuse of existing algorithms and technologies from predicate devices rather than a newly trained AI model, the concept of a "training set" in the context of machine learning might not be directly applicable to the described evaluation.
9. How the ground truth for the training set was established
This information is not present in the provided text.
Summary of available information:
The document describes the Heartstream XLT Defibrillator/Monitor and asserts its substantial equivalence to predicate devices (HP CodeMaster 100, HP Heartstream ForeRunner AED, HP CodeMaster XL, HP Viridia Telemetry System).
- Nonclinical Tests: Bench testing (hardware, algorithm, software) and animal testing were performed. The animal testing evaluated the safety and effectiveness of the Heartstream SMART biphasic waveform up to 200J.
- Clinical Testing (for waveform): The SMART Biphasic waveform underwent clinical testing in adults, supporting its effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. No further details on this study (sample size, methodology, acceptance criteria, specific results) are provided.
- Equivalence Approach: The core approach was to repeat tests performed on predicate devices, sometimes with more stringent procedures/acceptance criteria, to demonstrate that the Heartstream XLT does not raise new safety or effectiveness concerns.
To fulfill your request completely, significantly more detailed study reports would be required than what is provided in this 510(k) summary.
§ 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.