(90 days)
Heartstream Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
Heartstream External Defibrillation Pads with Preattached Electrode Adapter: For use with Heartstream Defibrillators or Manual Defibrillators with a Quick-Combo® Connection System. For Defibrillation, Monitoring and Pacing.
Heartstream electrode adapters serve as an interface to allow Heartstream electrodes to be connected to various manual defibrillators for external cardiovascular pacing as well as monitoring and delivery of defibrillation shocks up to 360J.
Heartstream electrode adapters are made of rigid thermoplastic material (or equivalent), with varying configurations depending upon the manual defibrillator for which they are designed. The adapters will be provided as reusable stand-alone accessories (to be used in conjunction with standard Heartstream electrodes) or preattached to a Heartstream electrode set, for single use.
The provided text describes Heartstream Electrode Adapters and their substantial equivalence to predicate devices, focusing on their intended use and technological characteristics. However, it does not contain the specific information required to answer all parts of your request regarding acceptance criteria and a study proving device performance.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample size used for a test set, its provenance, or details about the experts involved in establishing ground truth.
- Adjudication methods.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study or standalone algorithm performance.
- Details about the training set's size or how its ground truth was established.
What is provided is a summary of the device's characteristics and a claim of compliance with relevant medical device standards, which demonstrated certain functionalities. This suggests that some level of testing was performed, but the details of that testing, in the format you requested, are absent.
Here's a breakdown of what can be extracted based on the provided text, and where information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied from standards/description) | Reported Device Performance (Implied from text) |
|---|---|
| Compliance with IEC 601-1, 601-2-4, 601-2-25, ANSI/AAMI DF39-1993 | "demonstrated that the Heartstream electrodes effectively deliver defibrillation energy up to 360J, allow for external transcutaneous cardiac pacing, demonstrate mechanical and electrical compatibility with manual defibrillators, and minimize safety risks to the user and patient." |
| Interface with manual defibrillators | Allows connection of Heartstream electrodes to "various manual defibrillators" |
| Facilitate external cardiovascular pacing | Device allows for "external transcutaneous cardiac pacing" |
| Facilitate monitoring | Device allows for "monitoring" |
| Facilitate delivery of defibrillation shocks up to 360J | Device allows for "delivery of defibrillation shocks up to 360J" |
| Minimize safety risks to user and patient | Device designed to "minimize safety risks to the user and patient" |
| Firm seating of connectors | Connectors "firmly seated when in use" |
| No exposure to accidental electrical contact | Connectors "do not expose a user to a risk of accidental electrical contact" |
| No adverse effects on pacing/monitoring/defibrillation | "designed to ensure that all pacing, monitoring and/or defibrillation functions are not adversely affected by their placement" |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The text mentions "Testing per these standards demonstrated..." but does not specify sample size, data provenance, or whether the tests were on actual patient data or conducted in a lab environment.
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)
- Not provided. Ground truth experts or specific adjudication processes are not mentioned.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided.
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
- Not applicable / Not provided. This device is an electrode adapter, a hardware interface, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable / Not provided. This device is a hardware component.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not explicitly stated in terms of ground truth. The "testing" mentioned refers to compliance with safety and performance standards (e.g., IEC, ANSI/AAMI). "Ground truth" in this context would likely be defined by the physical/electrical parameters specified in those standards and confirmed through engineering tests, rather than clinical outcomes or expert consensus on a diagnostic task.
8. The sample size for the training set
- Not applicable / Not provided. This is a hardware device, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- Not applicable / Not provided. This is a hardware device and does not involve a training set.
§ 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.