(87 days)
The SVL-9130 electrodes are single use and intended to be used in conjunction with semi-automatic external defibrillators (AED) to monitor and deliver defibrillation energy to the patient. The electrodes are intended to be used with AEDs that specify the use of disposable electrodes that meet AAMI DF-39 standards. These AEDs must have compatible electrode connectors. The VivaLink AED and the V2 are examples of such AEDs.
The electrodes are intended for short term use and must be used before the expiration date listed on the packaging.
The AEDs are used for emergency treatment of cardiac arrest patients who weigh more than 90 pounds. The user assesses the patient's condition and confirms that the patient is unconscious, pulseless and is not breathing prior to applying the electrodes to the skin.
The SVL-9130 electrodes consists of a pair of hydrogel polymeric self-adhesive electrode pads of equal dimension. The electrode are packaged in such a way that the two conductive areas are in electrical contact.
The provided document is a 510(k) summary for a medical device called the SVL-9130 Defibrillation Electrode. It details the device's administrative information, predicate devices, intended use, and a brief statement about its performance.
However, the document does not contain the detailed information required to fill out a table of acceptance criteria and reported device performance. Specifically, it states:
"The SVL-9130 electrodes meet all the specifications for single use hydrogel electrodes of the AAMI DF-39 specifications and SurVivaLink's internal specifications. In all instances, the SVL-9130 electrodes functioned as intended."
This is a general statement of compliance, but it does not provide:
- Specific acceptance criteria: The document refers to "AAMI DF-39 specifications" and "SurVivaLink's internal specifications" but does not list or describe them.
- Reported device performance: It doesn't present any quantitative results (e.g., impedance measurements, defibrillation efficacy rates, adhesion strength, etc.) that would demonstrate how the device "functioned as intended" against those specifications.
- Details about the study: There is no information regarding sample sizes, data provenance, ground truth establishment, expert involvement, or any form of comparative effectiveness study (MRMC) or standalone performance study.
Therefore, based solely on the provided text, I cannot complete the requested tables and information. The document focuses on demonstrating substantial equivalence to predicate devices and adherence to existing standards rather than presenting detailed study results.
Here's what I can extract from the document regarding studies and performance, but it's very limited:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (from AAMI DF-39 and SurVivaLink internal specifications) | Reported Device Performance |
|---|---|
| Not specified in the document (e.g., impedance, adhesion, current delivery efficacy) | "met all the specifications" |
| Not specified in the document | "functioned as intended" |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified.
- Data provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not specified. The document indicates adherence to technical specifications, not human interpretation-based ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This typically applies to studies where human interpretation of data (like medical images) is involved, which is not the case described here.
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, an MRMC study was not done or reported. This device is an electrode, not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable in the context of an algorithm. The "standalone" performance here would refer to the physical and electrical performance of the electrode itself, which they state "met all the specifications" but provide no specific data.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the electrodes appears to be defined by the technical specifications of AAMI DF-39 and SurVivaLink's internal specifications, which likely include physical, electrical, and biocompatibility standards. No biological or clinical ground truth (like pathology or outcomes) is mentioned in relation to specific performance data.
8. The sample size for the training set:
- Not applicable/Not specified. This device is not an AI algorithm that undergoes "training."
9. How the ground truth for the training set was established:
- Not applicable.
§ 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.