(57 days)
The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture.
The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. This battery has a shelf life of 4 years from the date of manufacture.
Non-rechargeable battery packs are utilized as a primary direct current (d-c) power source or as a standby or backup d-c power source for portable as well as stationary medical equipment. These devices provide a means of supplying electrical power through chemical reaction. The energy provided depends upon the voltage and capacity rating of a particular pack and the amount of current used by the device into which they are installed. The performance and life span of these batteries depends on operating conditions of temperature, current drain, and the discharge method. These parameters are taken into account in designing such batteries. The goal is to develop battery packs that maintain capacity for as high and as long as possible under a specified range of environmental conditions.
The provided text describes a 510(k) summary for the AMCO Replacement Battery Packs 2L561 and 7L877. This document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than establishing acceptance criteria or reporting on a study that proves a device meets those criteria in the context of, for example, diagnostic accuracy or clinical effectiveness for a novel medical device.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of regulatory submission, which is primarily concerned with demonstrating that a new device is as safe and effective as a legally marketed predicate device.
However, I can extract information relevant to the substantial equivalence claim.
Information Provided in the 510(k) Summary for AMCO Replacement Battery Packs 2L561 and 7L877:
1. A table of acceptance criteria and the reported device performance:
This document does not present a formal table of "acceptance criteria" for a study in the typical sense of a clinical trial or performance evaluation for a diagnostic/therapeutic device. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices. The performance criteria are that the AMCO battery packs are "identical" in key aspects to the predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Claimed by Manufacturer) |
|---|---|
| Indications for Use are the same as predicate. | The AMCO™ 2L561 is intended for the Cardiac Science PowerHeart® AED; the AMCO™ 7L877 is intended for the Cardiac Science PowerHeart® AED G3. These are the same indications as their respective predicate devices. |
| Technological Characteristics are the same as predicate. | "Cell chemistry and type are identical, Sealed (Vented) Lithium Sulfur Dioxide (LiSO2)." |
| Materials are the same as predicate. | (Stated as identical, but no specific material list is provided beyond cell chemistry). |
| Form, Fit, and Function are the same as predicate. | "The design components and functionality of the AMCO™ 2L561 and 7L877 Battery Packs are identical to those of their predicate devices." |
| "The only difference between the devices is that the 7L877 (9146-001) is designed specifically for the PowerHeart® G3 AED. Therefore, the molded plastic case has a stub (key) in order that it cannot be installed in the PowerHeart® AED requiring the 2L561 (9141-001)." (This difference is noted but deemed not to affect equivalence for the intended use). | |
| Safety and Effectiveness is equivalent to predicate. | Demonstrated through "continued evaluation and testing" and similarity in design and function to legally marketed devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The submission refers to "continued evaluation and testing" but does not detail specific sample sizes for performance tests. Given this is a battery pack seeking substantial equivalence, testing likely involves bench testing, environmental stress tests, and cycle life tests as per relevant standards for batteries, but specific numbers are not provided.
- 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 Applicable. This type of information is usually associated with studies involving human interpretation or clinical endpoints (e.g., radiology studies, pathology reviews). For a battery pack demonstrating substantial equivalence, ground truth would be established through engineering specifications and performance testing against those specifications, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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. MRMC studies are used for evaluating diagnostic or interpretive aids, often AI-powered. This submission is for a battery pack, which is a power source, not an interpretive medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI-powered device. The device itself (the battery) is "standalone" in its primary function of providing power.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Performance Standards: The "ground truth" for a battery pack seeking substantial equivalence would be based on verifying that its electrical characteristics (voltage, capacity, current delivery), physical dimensions, chemical composition, and safety features meet design specifications and perform comparably to the predicate device under various operational and environmental conditions, as per relevant industry standards (e.g., for lithium batteries).
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires 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.