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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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The MBSS charging station is used to charge NiCd or SLA batteries of the Lifepak®, Fastpak® and Fastpak 2® series manufactured by Medtronic - Physio Control.

The MBSS overall dimensions are 30 cm x 20 cm x 10 cm. It is available either as a table top model or wall mount unit. The table top model has a standard power cord which plugs into a 110 volt wall outlet and non-slip rubberized feet. The wall mount model has a bracket for mounting the charger on a vertical surface. For mounting and use in an automobile (ambulance or rescue vehicle), the wall mount bracket is used. Power requirements are either standard mains at 120 volts or standard automotive 12 volts. The charger is only used for charging specific batteries. The batteries are removed from the defibrillator and inserted into the MBSS charging bays. The MBSS is not attached to the defibrillator during operation.

The provided text describes a 510(k) premarket notification for the Mobile Battery Service Station (MBSS), a battery charging station for defibrillator batteries. It focuses on demonstrating substantial equivalence to predicate devices rather than a typical clinical study evaluating a diagnostic or therapeutic AI device.

Therefore, many of the requested categories (like sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or directly derivable from this type of regulatory submission. The document primarily reports engineering and safety testing.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated for specific tests (e.g., how many chargers, how many batteries, how many charge cycles). The testing appears to be product-level validation rather than a statistical sampling of a large population.
• Data Provenance: The testing was conducted by the manufacturer, AD Elektronik GmbH, likely at their facilities or through certified testing laboratories. The country of origin for the testing is implied to be Germany (where the submitter is located). The testing is prospective in the sense that it evaluates the newly manufactured device, but it is not a clinical study on human subjects or patient data.

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

• Not applicable/Not mentioned. This is not a study requiring expert-established ground truth for performance evaluation (e.g., diagnosing a condition). The "ground truth" here is compliance with engineering standards and predefined product specifications.

4. Adjudication Method for the Test Set

• None. This concept is not relevant to the engineering and safety testing described. The tests are pass/fail based on meeting predefined technical specifications.

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

• No. This is not a clinical or diagnostic imaging device studied with human readers.

6. Standalone Performance Study (Algorithm only without human-in-the-loop performance)

• Yes (inherently). The described testing focuses solely on the performance of the MBSS device itself (e.g., charging function, safety compliance) as a standalone unit. There is no human interaction element in the performance evaluation described, beyond technicians operating the test equipment and assessing results against specifications.

7. Type of Ground Truth Used

• Engineering Specifications and Regulatory Standards. The "ground truth" for this device's performance is its ability to meet documented technical specifications (e.g., charge times, impedance) and adhere to established electrical safety (EN60601-1, UL 60950) and electromagnetic compatibility (EN60601-1-2) standards.

8. Sample Size for the Training Set

• Not applicable. This device is a hardware charging station, not an AI/ML algorithm that requires a "training set."

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

• Not applicable. As above, no training set is involved.

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