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The 5L318 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream ForeRunner AED; specifically Philips Medical battery part number BT1. This battery has a shelf life of 4 years from the date of manufacture.

The AM5070 Lithium/Manganese Dioxide (Li/MnO2) AMCO battery is a disposable replacement battery pack for use in the Philips Medical / HeartStream FRx and HeartStart Home AED; specifically Philips Medical battery part number AM5070A. 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 pertains to a 510(k) summary for replacement battery packs (AMCO™ 5L318 and AM5070) for Automated External Defibrillators (AEDs). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with specific acceptance criteria and detailed device performance metrics typically found in clinical trials for diagnostic algorithms or medical devices with measurable outputs.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment is not available in the provided document. The 510(k) summary explicitly states that equivalence was demonstrated through "continued evaluation and testing," but it does not detail these tests or present specific results against pre-defined acceptance criteria.

The key points from the provided text relevant to the request are:

• Device Type: Replacement battery packs for AEDs.
• Demonstration of Equivalence: The submission aims to show substantial equivalence to legally marketed predicate devices (Philips Medical replacement batteries).
• Basis of Equivalence: "The design components and functionality of the AMCO™ 5L318 and AM5070 battery packs are identical to those of their predicate devices. Cell chemistry and type are identical, Sealed (Vented) Lithium / Manganese Dioxide (Li/MnO2)." (Page 2).
• Conclusion: "Amco International Manufacturing and Design, Inc. has demonstrated through its continued evaluation and testing of the AMCO™ 5L318 and AM5070 replacement battery packs, that these devices are equivalent to the HeartStream / Philips Medical / Agilent battery packs, as outlined in this submission." (Page 3).

In summary, a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study are not present in this 510(k) summary, as it focuses on demonstrating technological equivalence to existing devices rather than new performance claims.

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