(166 days)
Indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation. Used to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55 Ibs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.
These are single use, non-sterile, self stick defibrillator electrodes packaged in pairs. Effective electrode area = Conductive Area: 92 Sq. cm. They are radiotranslucent. They come in two connector styles to match the specific defibrillator. The construction and materials employed are similar to the predicates. The patient contact material is a conductive adhesive hydrogel identical to the material used in the predicate devices. These pads meet the AAMI Standard ANSI/AAMI DF80:2003 and the connectors meet the FDA performance standard for touch proof ECG connectors.
Here's an analysis of the provided text regarding the Heart Sync Pediatric AED Pad, formatted to describe acceptance criteria and study details.
Please note: The provided text is a 510(k) Summary, which typically focuses on demonstrating substantial equivalence to predicate devices through non-clinical (bench) testing. It does not contain information about clinical trials, human reader studies, or AI performance, as the device is a medical accessory (defibrillator pads) and not an AI algorithm. Therefore, many sections of your requested output will be marked as "Not Applicable" (N/A) or "Not Provided in Document."
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| AAMI Standard ANSI/AAMI DF80:2003 Compliance | All units passed tests for DC offset, offset instability, AC small signal impedance, AC large signal impedance, and defibrillator overload. |
| FDA Performance Standard for Touch-Proof ECG Connectors | Compliance verified by inspection of the connectors. |
| Biocompatibility Testing (patient contact material Hydrogel) | The material passed biocompatibility testing. |
| Accelerated Age Shelf Life Test (42 months) | All units passed relevant AAMI tests after accelerated aging. |
| Attenuator System Performance (compared to predicates) | Testing showed excellent correlation of results with attenuator predicates. |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: "Various different lots containing multiple samples each" were subjected to AAMI tests. No specific numerical sample size is provided.
- Data Provenance: Not explicitly stated, but assumed to be from manufacturing and laboratory testing conducted by Heart Sync, Inc. or its contracted labs. This is retrospective in nature (testing manufactured units). No country of origin of data is specified beyond the submitter's location (Ann Arbor, MI, USA).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- Not Applicable. The "ground truth" for this device's performance is based on established engineering and medical device standards (AAMI, FDA performance standards) and direct measurements from bench tests, not expert interpretation of cases or data.
4. Adjudication Method for the Test Set
- Not Applicable. As the testing is bench-top and objective against defined standards, there is no need for expert adjudication.
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. This device is a passive accessory (defibrillator pad) and does not involve AI or human interpretation for its function. Therefore, no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a medical accessory, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for this device's performance is based on defined technical specifications and validated test methods from standards bodies (AAMI) and regulatory agencies (FDA). For instance, the "ground truth" for impedance is a specific numerical range defined by the standard.
8. The sample size for the training set
- Not Applicable. This device does not use machine learning or AI, and therefore does not have a "training set."
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.