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The LIFEPAK 35 AC power adapter is an optional accessory intended to connect to the LIFEPAK 35 monitor/defibrillator to provide auxiliary power. The bracket and screws provided are intended to attach the power adapter to a wall or shelf.

The LIFEPAK 35 AC power adapter is intended for indoor environments and for fixed installation in ground transportation vehicles.

The LIFEPAK 35 AC Power Adapter is an optional accessory for use with only the LIFEPAK 35 monitor/defibrillator. This accessory contains: AC power adapter with output cable, mounting bracket, bracket screws, region-specific AC power cord (packed separately). The power adapter:

• Provides operating power to the monitor/defibrillator without batteries installed.
• Provides power to charge batteries installed in the monitor/ defibrillator.

The LIFEPAK 35 AC Power Adapter operates on 100 to 240 VAC line power. Installed batteries are charged whenever the power adapter is connected to the LIFEPAK 35 monitor/defibrillator. To help manage and maintain battery charge, the power adapter should be kept plugged into the defibrillator whenever possible.

This document is a 510(k) premarket notification for a medical device: the LIFEPAK® 35 AC Power Adapter. It does not describe a study involving an algorithm or AI.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types cannot be found in this document. This document pertains to a physical hardware accessory for a defibrillator.

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The HighPak-12 rechargeable lithium battery is intended for use in the LifePak-12 defibrillator.

The HighPak -2 is a lithium manganese rechargeable battery. The outer case is molded plastic and is identical in shape and size to the predicate LifePak-12 NiCd battery. The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life. It is charged in the same manner as the predicate battery and is "Smart Battery" system compatible.

The provided text focuses on the 510(k) summary for the HighPak-12 Smart Battery, a rechargeable lithium battery intended for use in the LifePak-12 defibrillator. It primarily discusses the device's description, materials, and testing in the context of establishing substantial equivalence to predicate devices. However, it does not provide detailed acceptance criteria or a comprehensive study plan with the specific performance metrics requested.

Based on the provided information, I can extract the following:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states "Product testing was conducted to evaluate conformance to product specification." However, it does not provide a specific table of acceptance criteria with numerical targets or the detailed reported device performance against such targets.

It mentions the following testing categories:

• Electromagnetic Compatibility (EMC)
• Charging
• Discharging
• Proper fit and operation in the LifePak-12 Defibrillator

The statement "The lithium manganese cell technology offers the same voltage but an increased in amp hours resulting in longer life" suggests a performance improvement in terms of amp-hours, but no specific acceptance criterion or quantitative measurement for "longer life" is given.

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify the sample size used for testing (e.g., number of batteries tested).
It also does not mention data provenance (e.g., country of origin of the data, retrospective or prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not applicable to a battery performance test. Ground truth established by experts is typically relevant for diagnostic or image interpretation devices.

4. Adjudication Method for the Test Set:

This information is not applicable to a battery performance test, as there would be no subjective interpretation requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

This information is not applicable to a battery performance test. MRMC studies are used to evaluate human reader performance, often with AI assistance, for diagnostic tasks.

6. Standalone Performance Study (Algorithm Only):

This information is not applicable to a battery, which is a hardware component and not an algorithm. The testing described (EMC, charging, discharging, fit/operation) evaluates the physical device's performance.

7. Type of Ground Truth Used:

For the testing mentioned (EMC, charging, discharging, proper fit and operation), the "ground truth" would be the engineering specifications and functional requirements of the battery and the LifePak-12 defibrillator. For instance, for "charging," the ground truth would be that the battery charges successfully and within expected parameters according to its design and the defibrillator's charging mechanism. For "fit and operation," the ground truth would be seamless physical integration and successful power delivery to the defibrillator.

8. Sample Size for the Training Set:

This information is not applicable. Battery performance testing does not typically involve a "training set" in the context of machine learning or AI algorithms. The testing is for verifying hardware performance.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable for the reasons stated above.

In summary, the provided K062331 document for the HighPak-12 Smart Battery outlines its intended use, design similarity to predicate devices, and general categories of testing performed (EMC, charging, discharging, fit/operation). However, it does not detail specific acceptance criteria with numerical values, sample sizes for testing, or information relevant to AI/algorithm performance studies, as these are not relevant for the type of device being described.

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