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Since rechargeable batteries and battery packs are "device specific", and are designed to operate and fit into the equipment for which they were manufactured, only qualified personnel should evaluate, test, charge, or install these devices.

This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. Biomedical equipment service professionals, EMT's, etc. therefore know that the intended use is as a replacement battery.

Only replacement battery 2L226 in this submission (Patient Monitor) is provided Over-the-Counter (OTC).

All other replacement batteries, specifically; 5L375, 6L577, 7L991, 9L977, 9L990, and 9L998 in this submission (Defib/AED's) are provided by prescription only.

Device Description

Amco rechargeable and 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.

AI/ML Overview

The provided document is a 510(k) summary for "life+cel" or "lifecel" Battery Packs, which are replacement battery packs for various medical devices. The document describes the testing protocols and performance criteria used to demonstrate substantial equivalence to predicate devices.

Based on the information provided, here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Incoming Inspection	Correct specification, no visible damage, and randomly voltage tested cells. Lot numbers recorded. Cases inspected for form, fit, function, and cosmetics.	"All cells are inspected for correct specification, visible damage, and randomly voltage tested prior to acceptance. The lot numbers are recorded for tracking purposes should any fail during final assembly and inspection activities. Cases are also inspected for form, fit, function, and cosmetics." (Implies all cells met criteria for acceptance, lot numbers were recorded, and cases passed inspection).
Cadex Testing	Battery cells and core packs tested using a Cadex Electronics Battery Analyzer Model C7400ER in "Auto Mode" through three (3) full charge/discharge cycles. Target capacity (percentage of battery capacity compared to nominal) must meet or exceed a required threshold of 90%. Custom test parameters (C-Rates, delta V, volts-per-cell) can be used.	"Voltage and capacity of battery cells and core packs are tested using a Cadex Electronics Battery Analyzer Model C7400ER (Extended Range) in the "Auto Mode" prior to installation into cases or shrink wrap. This exercises the batteries in order to identify performance characteristics by running them through three (3) full charge/discharge cycles... Target capacity is a pass/fail mark and our batteries must meet or exceed a required threshold of 90%, or higher, prior to final Quality Control inspection. Any samples that do not meet the criteria are rejected, and subsequently, the entire lot is tested in this manner." (Indicates all tested units met the 90% or higher target capacity threshold. Failed samples and entire lots were rejected as per protocol).
Voltage Testing (Completed Packs)	100% testing for correct voltage/polarity prior to shipment.	"All Battery Packs are tested 100% for correct voltage / polarity prior to shipment. Those devices that fail are rejected and quarantined." (Implies all shipped battery packs passed this 100% inspection).
Defibrillator Testing	Independent (Beta Tests) and random tests on finished packs to ensure they meet the expected number of shocks as specified by the OEMs, using NETECH Model Delta 2000 Defibrillator Analyzers.	"Independent testing (Beta Tests), as well as random tests on finished packs, are performed using NETECH Model Delta 2000 Defibrillator Analyzers to insure that they meet the expected number of shocks as specified by the OEM's." (Implies the battery packs met the OEM specifications for the number of shocks).
Life Cycle	The replacement battery must provide as many or more charge and discharge cycles as the original (OEM) battery.	"The replacement battery must provide as many or more charge and discharge cycles as the original." (This is stated as a requirement that must be met; thus, it implies the device meets this criterion, although it is noted as an "ongoing process" and not part of standard QC final inspection).
Temperature	The replacement battery must function correctly over the same temperature range as the original. Testing is done at 0, 25, and 40°C (32, 77, and 104°F respectively).	"The replacement battery must function correctly over the same temperature range as compared to the original. Testing is done at 0, 25, and 40°C (32, 77, and 104°F respectively)." (Stated as a requirement that must be met, implying functional correctness was demonstrated at these temperatures).
Mechanical & Electrical Component Integrity	Normal testing involves drop tests from a predetermined height (usually 2-3 feet) onto a hard, uniform surface. Battery packs inspected for case cracks, cell separation, and electrical/electronic component damage. Root cause analysis if damage occurs. If no visible damage, tested for form, fit, and function.	"Normal testing would involve drop tests from a predetermined height, usually 2-3 feet, onto a hard, uniform surface. Battery packs are inspected for case cracks, cell separation, and electrical/electronic component damaqe. Root cause analysis is performed should any damage occur. If there is no visible damage, the battery is tested for form, fit, and function." (Implies the battery packs underwent and passed these tests, demonstrating integrity as per the protocol. The absence of reported failures indicates acceptance).
Active Safety Devices	Inspected and tested before use and after installation.	"Active Safety devices are inspected and tested before use and after installation." (Implied to have passed these inspections and tests).

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

The document describes several testing protocols:

Incoming Inspection: "All cells are inspected..." and "Cases are also inspected...". This implies 100% inspection of incoming cells and cases.
Cadex Testing: "Any samples that do not meet the criteria are rejected, and subsequently, the entire lot is tested in this manner." This suggests lot-based testing where if a sample fails, the entire lot is tested. The specific sample size for a given lot is not provided, but it's not a fixed test set in the traditional sense, but rather an ongoing QC process.
Voltage Testing (Completed Packs): "All Battery Packs are tested 100% for correct voltage / polarity prior to shipment." This indicates a 100% test set of all manufactured units.
Defibrillator Testing: "Independent testing (Beta Tests), as well as random tests on finished packs..." This suggests both an unspecified "Beta Test" sample and a "random" sample from finished production.
Life Cycle, Temperature, Mechanical & Electrical Component Integrity: The wording "Normal testing would involve..." and "The replacement battery must..." suggests design validation and verification activities, likely involving a representative sample, but the specific sizes are not mentioned.

Data Provenance: The testing appears to be conducted by Amco International Manufacturing & Design, Inc./Phoenix Technology, likely at their facility in Elizabeth, Colorado, USA. The data is prospective in the sense that it's part of their manufacturing and quality control process for the battery packs being submitted.

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

This information is not provided in the document. The "ground truth" for these battery packs is based on objective measurements against specified performance criteria (e.g., voltage, capacity, number of shocks, temperature function, mechanical integrity) and comparison to OEM specifications. It does not involve expert clinical interpretation or consensus.

4. Adjudication Method for the Test Set:

This information is not applicable as the testing described relates to objective engineering and performance verification against predefined specifications, not subjective interpretation requiring adjudication among experts. The "adjudication" is essentially a pass/fail based on quantitative measurements.

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 information is not applicable. The device is a battery pack, not an AI-assisted diagnostic or therapeutic tool for human readers.

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

This information is not applicable. The device is a battery pack, not an algorithm. The performance described is its inherent function as a power source.

7. The Type of Ground Truth Used:

The ground truth used for evaluating the battery packs is based on objective engineering and performance specifications, primarily:

Quantitative measurements: Voltage, capacity (e.g., 90% threshold for Cadex testing), number of shocks for defibrillator batteries.
Functional performance: Correct function across specified temperature ranges.
Structural integrity: Resistance to mechanical damage (e.g., drop tests).
Comparison to OEM specifications: The replacement devices "must meet or exceed these benchmark results consistently" from OEM battery packs.

8. The Sample Size for the Training Set:

This information is not applicable as the device is a battery pack and does not involve AI or machine learning models that require a training set. The descriptions are for manufacturing and quality control testing.

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

This information is not applicable for the reasons stated in point 8.

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