(16 days)
Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing Electrode is intended for use on adults. Not for use on children or infants.
A pre-gelled conductive elecrode consisting of a means of attaching the electrode to the cable, an insulating layer of vinyl, a layer of metal foil, a conductive adhesive hydrogel. a pressure sensitive adhesive ring and a release liner. Device is packaged in pairs in a heat sealed pouch, 10 pouches are packaged into one shelf-box/shipper
This 510(k) summary describes a medical device, the Medi-Trace® 1510M Combination Defibrillation, Monitoring and Pacing Electrode, and its performance against established standards. However, it does not describe an AI device. The document predates widespread AI in medical devices and focuses on physical and electrical device performance rather than algorithmic performance.
Therefore, many of the requested criteria related to AI/algorithm performance (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this submission.
Here's an analysis based on the provided text, focusing on what is available:
Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (from relevant standards) | Reported Device Performance (as stated in the document) |
|---|---|
| AAMI DF-39, 3.3.19 (Electrical Tests) | Met the specifications. |
| Energy Throughput Testing | Met the specifications. |
| AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (multiple defibrillation shocks) | Met the specifications. |
| AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (maximum current pacing) | Met the specifications. |
| AAMI DF-39 (for self-adhesive electrodes for monitoring, defibrillation and pacing) - Simulated Use Testing (ECG monitoring) | Met the specifications. |
| Biocompatibility (ISO-10993, Part 1) | Found to be non-irritating, non-cytotoxic, and non-sensitizing. |
| Shelf Life (Accelerated Shelf Life Studies) | Data substantiated the claimed shelf life. |
Study Details (where applicable to a non-AI device):
- Sample size used for the test set and the data provenance: Not explicitly stated as this is a physical device. The testing was done on the device and its predicate. The provenance would be the manufacturing facility, Graphic Controls Corporation, in Buffalo, New York, USA. The testing would be prospective, as new devices were manufactured and tested.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for physical device performance is typically established by established engineering standards and validated test methods, not expert clinical consensus in the way an AI algorithm might be.
- Adjudication method for the test set: Not applicable. The "ground truth" for electrical and physical performance is defined by the AAMI DF-39 standard specifications. A pass/fail determination against these specifications would be direct, not requiring expert adjudication in the classic sense.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not applicable. This is not an AI device.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, not applicable. This is not an AI device.
- The type of ground truth used: Engineering standards (AAMI DF-39) and established biocompatibility testing protocols (ISO-10993).
- The sample size for the training set: Not applicable. This is not an AI device, so there is no "training set."
- 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.