(58 days)
The Heartstream XL Defibrillator/Monitor is for use for the termination of ventricular tachycardia and ventricular fibrillation. The device is for use by qualified medical personnel trained in the operation of the device and qualified by training in basic life support, advanced cardiac support, or defibrillation. It must be used by or on the order of a physician. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J. AED Therapy: To be used in the presence of a suspected cardiac arrest on patients of at least 8 years of age that are unresponsive, not breathing and pulseless. Manual Defibrillation: Asynchronous defibrillation is the initial treatment for ventricular fibrillation and ventricular tachycardia in patients that are pulseless and unresponsive. The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor incorporates some user selectable lower energy levels that were not used in the clinical trials. Synchronized defibrillation is indicated for termination of atrial fibrillation. The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation. There are currently no clinical studies related to the use of SMART Biphasic waveform in pediatric applications. 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 XL Defibrillator/Monitor is a full-featured manual defibrillator, designed for use by clinicians trained in Advanced Cardiac Life Support (ACLS) procedures. Manual operation allows users to select biphasic waveform energy levels for external defibrillation, intra-thoracic defibrillation, delivery of synchronized shocks, and noninvasive external pacing.
The provided text describes the Heartstream XL Defibrillator/Monitor and its comparison to predicate devices, but it does not include details about acceptance criteria, a study proving the device meets those criteria, or a detailed breakdown of clinical study parameters as requested.
The document states:
- Nonclinical Tests Used in Determination of Substantial Equivalence:
- Waveform analysis, comparing the performance of the Heartstream XL BTE waveform to the LifePak 12 BTE waveform at various energy and impedance levels typical of intra-thoracic applications.
- Animal test data, comparing the performance of the Heartstream XL BTE to the LifePak 12 BTE in domestic swine.
- Conclusion from Testing: Based on the results of the testing (waveform analysis and animal data), it is concluded that the Heartstream XL BTE waveform for intra-thoracic defibrillation applications does not raise any different questions regarding the safety or effectiveness as compared with the predicate devices. It is considered to be substantially equivalent to the predicate devices.
- Clinical Testing for SMART Biphasic waveform (mentioned briefly in "Indications for Use"): "The SMART Biphasic waveform utilized in the Heartstream XL Defibrillator/Monitor has previously undergone clinical testing in adults. These trials support the waveform's effectiveness for defibrillation of ventricular tachyarrhythmias at 150J." and "The SMART Biphasic waveform utilized in the Heartstream XL has undergone clinical testing demonstrating its safety and effectiveness for cardioversion of atrial fibrillation."
However, none of these descriptions provide the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, or MRMC studies. The submission focuses on demonstrating substantial equivalence through non-clinical and animal testing for the new BTE waveform, and references prior clinical testing for the SMART Biphasic waveform without providing its details.
Therefore, based only on the provided text, I cannot complete most of the requested fields.
Here's a summary of what can be extracted and what is missing:
| Information Requested | Details from the Provided Text |
|---|---|
| 1. Table of acceptance criteria and reported device performance | No explicit acceptance criteria or a dedicated table are provided. The text states that "waveform analysis" and "animal test data" were used to compare the Heartstream XL's BTE waveform to the LifePak 12's BTE waveform, concluding "substantial equivalence" and that it "does not raise any different questions regarding the safety or effectiveness." |
| 2. Sample size and provenance for test set | Not provided for the clinical trials. For non-clinical tests: waveform analysis (no sample size applicable), "domestic swine" for animal test data (specific number not given). Provenance is "nonclinical" and "animal test data". |
| 3. Number/qualifications of experts for ground truth | Not provided. |
| 4. Adjudication method | Not provided. |
| 5. MRMC comparative effectiveness study? Effect size? | No MRMC study is described. The device is a defibrillator, so the concept of human readers improving with AI assistance is not directly applicable in this context. |
| 6. Standalone (algorithm only) performance? | Not explicitly described as a standalone study for the clinical trials. The "waveform analysis" and "animal test data" are standalone comparative tests of the device's waveform. |
| 7. Type of ground truth used | For the clinical trials: Effectiveness for defibrillation of ventricular tachyarrhythmias and cardioversion of atrial fibrillation. The exact method of establishing ground truth (e.g., patient outcomes, expert consensus on rhythm) is not specified. |
| 8. Sample size for training set | Not applicable/Not provided. The text describes clinical testing but does not mention specific training sets in the context of AI/machine learning. |
| 9. How training set ground truth was established | Not applicable/Not provided. |
§ 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.