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The ZP9141 is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9100 and 9200, or Survivalink Non-G3 9100 and 9200 AED's and is designed to replace the Cardiac Science Model / Part Number 9141-001 battery pack. This battery pack has a shelf life of 5 years from the date of manufacture.

The ZP9146Y (or W) is a disposable non-rechargeable battery pack for use in the Cardiac Science PowerHeart® Non-G3 Model 9300E AED's and is designed to replace the Cardiac Science Model / Part Number 9146-001 battery pack. This battery pack has a shelf life of 5 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 Zeller Power Products ZP9141 / ZP9146 battery packs utilize Saft LO26SHX, 3.0 Vdc / 7.5 Ah (amp-hour) primary lithium sulfur dioxide (Li-SO2) D- size spiral cells wired in series (4 cells) which produces a total maximum output of 12Vdc @ 7.5Ah. Two (2) additional cells in the ZP9146 provide 6Vdc for auxiliary functions.

Diodes are included to prevent recharging by blocking current into the cells while allowing current out of the cells. Thermal fuses (thermistors) are utilized to cut-off current flow should the battery packs overheat. Ceramic slow-blow fuses protect the pack from short circuits.

A proprietary IC is utilized as an Identification (ID Sensor) chip which signals the appropriate Cardiac Science AED that the battery pack is the correct model.

The only difference between the ZP9146Y and ZP9146W is the case color and label in order to accommodate end user preference.

The document pertains to the 510(k) premarket notification for Zeller Power Products' ZP9141, ZP9146Y, and ZP9146W Non-Rechargeable Battery Packs. The submission aims to demonstrate substantial equivalence to legally marketed predicate devices, specifically Cardiac Science battery packs 9141-001 and 9146-001.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state "acceptance criteria" in a formal table with pass/fail thresholds. Instead, it describes performance characteristics that the replacement batteries must meet or exceed compared to the predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state a specific sample size used for the "test set" in terms of number of units. It mentions "All Battery Packs are tested 100% for voltage prior to shipment" and that "Those devices that fail are rejected and quarantined." This implies a 100% inspection for voltage for production units rather than a specific test set for regulatory submission.

The general performance testing involving capacity and electrical characteristics seems to be done on representative units, but the quantity is not specified. The data provenance is internal to Zeller Power Products / Battery Beast, LLC, as indicated by "internal testing" and "feedback from end users" in the conclusions. No information is provided regarding the country of origin of the data or whether it was retrospective or prospective, though it would likely be prospective testing conducted for the submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to this device. The device is a non-rechargeable battery pack for AEDs, not a diagnostic or AI-driven medical imaging device. There is no concept of "ground truth" established by experts in the context of electrical and physical performance of a battery. The performance is objectively measured by instruments.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable for the reasons stated above. There is no subjective assessment requiring adjudication for this type of device.

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

This section is not applicable as the device is a battery pack, not an AI or diagnostic tool requiring human interpretation or a comparative effectiveness study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable for the same reasons as above. The device is a battery, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This section is not applicable as there is no "ground truth" in the clinical or diagnostic sense for a battery pack. The "truth" for its performance is based on direct electrical and physical measurements against engineering specifications and industry standards.

8. The sample size for the training set

This section is not applicable. As a physical medical device (battery pack), there is no concept of a "training set" like there would be for an AI algorithm. The performance is assessed through direct testing and comparison with the predicate device's known characteristics.

9. How the ground truth for the training set was established

This section is not applicable for the same reasons as above. There is no training set or clinical ground truth involved.

Summary of the Study Proving Acceptance:

The study proving the device meets the described performance characteristics is primarily a bench testing program and comparison to predicate device specifications.

• Bench Testing: The document states, "The predicate and replacement battery packs are tested using a Cadex Electronics Battery Analyzer Model C7000 in the 'Auto Mode'. This exercises both devices in order to identify performance characteristics." This includes measuring nominal Amp-hour rating, minimum voltage maintained during discharge, and demonstrating "Target capacity...of 80%."
• Safety Features: Internal components like diodes, thermistors (thermal fuses), and ceramic slow-blow fuses are included and are stated to be "Identical" or "Equivalent" to the predicate.
• Physical/Mechanical Equivalence: The cell case material, connector location, internal PC board, and contacts are declared "Equivalent" or "Identical" to the predicate.
• Shelf Life: The replacement battery packs are designed to have a 5-year shelf life, based on data sheets from the cell manufacturer, similar to the predicate.
• 100% Voltage Testing: All battery packs are "tested 100% for voltage prior to shipment" as a final quality control step.
• Additional Testing: "Additional battery pack testing included drop, temperature vs. energy, and life cycle as outlined under the Performance Testing - Bench section."

The conclusion states that Zeller Power Products "has demonstrated through its continued evaluation and testing...that these devices are substantially equivalent to the current Cardiac Science AED non-rechargeable battery packs, as outlined in this submission and indicated by internal testing, comparison analysis, and feedback from end users."

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