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510(k) Data Aggregation
(72 days)
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
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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(57 days)
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
The 2L561 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED; specifically Cardiac Science Model / Part Number 9141-001. This battery has a shelf life of 4 years from the date of manufacture.
The 7L877 Lithium Sulfur Dioxide (LiSO2) AMCO battery is a disposable replacement battery pack for use in the Cardiac Science PowerHeart® AED G3; specifically Cardiac Science Model / Part Number 9146-001. 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 describes a 510(k) summary for the AMCO Replacement Battery Packs 2L561 and 7L877. This document focuses on demonstrating substantial equivalence to previously approved predicate devices, rather than establishing acceptance criteria or reporting on a study that proves a device meets those criteria in the context of, for example, diagnostic accuracy or clinical effectiveness for a novel medical device.
Therefore, many of the requested items (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, adjudication methods, MRMC studies, standalone performance) are not applicable to this type of regulatory submission, which is primarily concerned with demonstrating that a new device is as safe and effective as a legally marketed predicate device.
However, I can extract information relevant to the substantial equivalence claim.
Information Provided in the 510(k) Summary for AMCO Replacement Battery Packs 2L561 and 7L877:
1. A table of acceptance criteria and the reported device performance:
This document does not present a formal table of "acceptance criteria" for a study in the typical sense of a clinical trial or performance evaluation for a diagnostic/therapeutic device. Instead, the "acceptance criteria" are implied by the claim of substantial equivalence to predicate devices. The performance criteria are that the AMCO battery packs are "identical" in key aspects to the predicate devices.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Claimed by Manufacturer) |
|---|---|
| Indications for Use are the same as predicate. | The AMCO™ 2L561 is intended for the Cardiac Science PowerHeart® AED; the AMCO™ 7L877 is intended for the Cardiac Science PowerHeart® AED G3. These are the same indications as their respective predicate devices. |
| Technological Characteristics are the same as predicate. | "Cell chemistry and type are identical, Sealed (Vented) Lithium Sulfur Dioxide (LiSO2)." |
| Materials are the same as predicate. | (Stated as identical, but no specific material list is provided beyond cell chemistry). |
| Form, Fit, and Function are the same as predicate. | "The design components and functionality of the AMCO™ 2L561 and 7L877 Battery Packs are identical to those of their predicate devices." |
| "The only difference between the devices is that the 7L877 (9146-001) is designed specifically for the PowerHeart® G3 AED. Therefore, the molded plastic case has a stub (key) in order that it cannot be installed in the PowerHeart® AED requiring the 2L561 (9141-001)." (This difference is noted but deemed not to affect equivalence for the intended use). | |
| Safety and Effectiveness is equivalent to predicate. | Demonstrated through "continued evaluation and testing" and similarity in design and function to legally marketed devices. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated. The submission refers to "continued evaluation and testing" but does not detail specific sample sizes for performance tests. Given this is a battery pack seeking substantial equivalence, testing likely involves bench testing, environmental stress tests, and cycle life tests as per relevant standards for batteries, but specific numbers are not provided.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This type of information is usually associated with studies involving human interpretation or clinical endpoints (e.g., radiology studies, pathology reviews). For a battery pack demonstrating substantial equivalence, ground truth would be established through engineering specifications and performance testing against those specifications, not expert consensus in the diagnostic sense.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See point 3.
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:
- Not Applicable. MRMC studies are used for evaluating diagnostic or interpretive aids, often AI-powered. This submission is for a battery pack, which is a power source, not an interpretive medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is not an algorithm or AI-powered device. The device itself (the battery) is "standalone" in its primary function of providing power.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Specifications and Performance Standards: The "ground truth" for a battery pack seeking substantial equivalence would be based on verifying that its electrical characteristics (voltage, capacity, current delivery), physical dimensions, chemical composition, and safety features meet design specifications and perform comparably to the predicate device under various operational and environmental conditions, as per relevant industry standards (e.g., for lithium batteries).
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. See point 8.
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(102 days)
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
The 6L785 Sealed Manganese Dioxide (MnO2) life+cel (or lifecel) is a replacement disposable battery pack, for use in the Philips Medical Systems FR2 Series AED, specifically OEM Part Number M3863A. 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. The Amco 6L785 battery chemistry is Manganese Dioxide (MnO2) based and is non rechargeable.
This document describes the acceptance criteria and the study conducted for the Amco International Manufacturing & Design, Inc. Replacement Battery Pack 6L785.
The information primarily focuses on the technical testing and performance of the battery pack, not on a medical device with AI components or human-in-the-loop performance studies. Therefore, many of the requested categories (e.g., MRMC studies, effect size of human readers with AI, ground truth for training set) are not applicable to this submission.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Incoming Inspection: Cells inspected for correct specification, visible damage, voltage. Cases inspected for form, fit, function, and aesthetics. | All cells are inspected and randomly voltage tested prior to acceptance. Lot numbers are recorded. Cases are also inspected. Failed items are rejected. |
| CADEX Testing (Non-Rechargeable Packs): Tested to depletion. Target capacity must meet or exceed a required threshold of 90% of nominal capacity. | Non-Rechargeable packs are tested to depletion on a random lot sample basis using a Cadex Electronics Battery Analyzer Model C7400ER in "Auto Mode" with custom test parameters (C-Rates, delta V, volts-per-cell). The target capacity threshold is stated as 90% or higher. Samples not meeting the criteria are rejected, and the entire lot is subsequently tested. |
| Voltage Testing - Completed Packs: 100% testing for correct voltage/polarity. | All Battery Packs are tested 100% for correct voltage/polarity prior to shipment. Devices that fail are rejected and quarantined. |
| Defibrillator Testing: Meet the expected number of shocks as specified by the OEM. | Independent testing (Beta Tests) and random tests on finished packs are performed using NETECH Model Delta 2000 Defibrillator Analyzers to ensure they meet the expected number of shocks as specified by the OEM's. |
| Life Cycle: Replacement battery must provide as many or more charge and discharge cycles as the original (for rechargeable). | Stated that this is an "ongoing process and is not part of the standard QC final inspection protocol" for replacement batteries. (Note: The product 6L785 is non-rechargeable, so this criterion is framed generally for battery packs. For the specific non-rechargeable 6L785, shelf life is based on the original cell manufacturer's specification sheets and Certificates of Conformance. The stated shelf life is 5 years from the date of manufacture). |
| Temperature Performance: Function correctly over the same temperature range as the original. | Testing is done at 0, 25, and 50℃ (32, 77, and 122°F respectively) to ensure correct function over the specified temperature range. |
| Mechanical & Electrical Component Integrity: Withstand drop tests, no case cracks, cell separation, or component damage. | Normal testing involves 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 damage. Root cause analysis is performed for any damage. If no visible damage, the battery is tested for form, fit, and function. Active Safety devices are inspected and tested before use and after installation. |
| Overall Performance & Safety: Replacement devices must meet or exceed OEM benchmark results consistently. | Comparison Analysis: OEM Battery Packs set the benchmark, and replacement devices must meet or exceed these benchmark results consistently to ensure safety and performance meet all functional requirements and performance specifications. The Amco 6L785 is stated to be "identical to those of their predicate devices" in design components and functionality. It is designed to maintain capacity for as high and as long as possible. The Amco 6L785 battery chemistry (Manganese Dioxide) is non-rechargeable and cell specifications are included. |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size:
- CADEX Testing (Non-Rechargeable): "random lot sample basis" for testing to depletion. No specific number is provided, but it implies a statistical sampling approach for batches. If a sample from a lot fails, the entire lot is tested.
- Defibrillator Testing: "random tests on finished packs." No specific number provided.
- Voltage Testing: 100% of completed packs are tested.
- Temperature & Mechanical Testing: Not specified as lot-based; implies testing of representative samples during development and quality control.
- Data Provenance: Not explicitly stated, but the company is based in the USA. The testing is conducted internally by Amco International Manufacturing & Design, Inc. (and Phoenix Technology), and involves external independent testing ("Beta Tests") for defibrillator performance. This is prospective testing performed on manufactured battery packs.
- Test Set Sample Size:
-
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)
- Not Applicable. This is a battery component, not a diagnostic medical device that requires expert interpretation for ground truth. The "ground truth" is established by technical specifications and performance benchmarks of the OEM battery pack.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This is a technical product testing, not a clinical study involving human judgment that requires adjudication. Pass/fail criteria are based on defined technical specifications and measurements.
-
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
- Not Applicable. This device is a battery pack, not an AI-enabled diagnostic system. No human reader or AI assistance is involved.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a battery pack, not an algorithm or AI system.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the battery pack's performance is established by technical specifications and performance benchmarks of the legally marketed predicate devices' OEM batteries. The goal is for the replacement battery to "meet or exceed OEM benchmark results consistently." Key aspects include voltage, capacity, number of defibrillator shocks, temperature range, and mechanical integrity, all compared to the original specifications.
-
The sample size for the training set
- Not Applicable. This is traditional product manufacturing and testing, not a machine learning or AI-based system that requires a "training set."
-
How the ground truth for the training set was established
- Not Applicable. As above, no training set for an AI/ML algorithm is involved.
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(132 days)
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
The 5L500 Lithium life+cel or lifecel is a replacement battery pack for the Medtronic LifePak 500 AED.
Since non-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.
The replacement battery pack in this submission, Amco Part Number 5L500, is to be provided by prescription only.
The AMCO 5L500 life+cel™ Non-rechargeable battery pack is 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.
The provided documents are a 510(k) premarket notification and subsequent administrative change letter for the Amco International Manufacturing & Design, Inc. Life+cel Or Lifecel Battery Pack, Model 51500. This device is a replacement battery pack for the Medtronic LifePak 500 AED.
The information provided primarily focuses on the substantial equivalence argument, comparing the replacement battery pack to its predicate device (the battery pack used in the Medtronic LifePak 500 AED cleared under 510(k) notification K052057). It outlines the general testing protocols used for quality control and provides some information regarding safety and performance testing for the replacement battery pack itself, aiming to meet or exceed OEM battery pack benchmarks.
However, the document does not contain a detailed "study that proves the device meets the acceptance criteria" in the format of a clinical trial or a formal comparative effectiveness study as would be seen for a new diagnostic or therapeutic device. Instead, it describes internal testing procedures to ensure the replacement battery pack functions comparably to the original.
Based on the available information, here's a breakdown of what can be extracted and what is missing:
1. Table of Acceptance Criteria and the Reported Device Performance
The document describes general testing protocols and targets, rather than specific, quantified acceptance criteria with corresponding performance metrics for clinical outcomes. The "acceptance criteria" appear to be internal quality control thresholds.
| Acceptance Criteria (Internal QC/Benchmark) | Reported Device Performance (Internal QC/Benchmark) |
|---|---|
| Incoming Inspection: | |
| - Correct cell specification | - Cells inspected for correctness |
| - No visible damage | - Cells inspected for visible damage |
| - Random voltage test acceptance | - Random voltage tested prior to acceptance |
| Cadex Testing (Non-rechargeable): | |
| - Target capacity ≥ 90% of nominal capacity | - Batteries meet or exceed 90% threshold |
| Voltage Testing (Completed Packs): | |
| - 100% correct voltage/polarity | - Packs tested 100% for correct voltage/polarity |
| Defibrillator Testing (Random): | |
| - Meet expected number of shocks (OEM spec) | - Tests performed to ensure meeting OEM shock specs |
| Life Cycle (Ongoing process): | |
| - As many or more charge/discharge cycles than original | - Stated goal; "ongoing process," not part of standard QC final inspection. Shelf life based on original cell manufacturer's specs. |
| Temperature Functionality: | |
| - Correct function at 0, 25, 40°C | - Testing done at 0, 25, and 40°C |
| Mechanical Integrity (Drop Tests): | |
| - No case cracks, cell separation, electrical/electronic component damage after drop from 2-3 feet | - Battery packs inspected for damage; root cause analysis if damage occurs. |
| Form, Fit, Function (After Drop Test if no visible damage): | - Battery tested for form, fit, and function |
| Active Safety Devices: | |
| - Inspected and tested before use and after installation | - Inspected and tested |
Note: The performance described is primarily based on internal quality control and bench testing, aiming to match or exceed the predicate device's characteristics. There are no clinical performance metrics reported.
2. Sample Size Used for the Test Set and the Data Provenance
- Test Set Description: The "test set" in this context refers to batches of manufactured battery packs undergoing internal quality control and bench testing, not a clinical trial test set.
- Sample Size:
- Cadex Testing: "Non-Rechargeable packs are tested to depletion on a random lot sample basis." If samples do not meet criteria, "the entire lot is tested in this manner."
- Defibrillator Testing: "Independent testing (Beta Tests), as well as random tests on finished packs, are performed."
- Voltage Testing: "All Battery Packs are tested 100% for correct voltage / polarity prior to shipment."
- Incoming Inspection: "All cells are inspected," "randomly voltage tested."
- Data Provenance: The data provenance is internal to Amco International Manufacturing & Design, Inc. and its contracted testing facilities (like Phoenix Technology for the 510(k) summary). There is no mention of country of origin of the data or whether it's retrospective or prospective in a clinical sense. It's prospective in a manufacturing quality control sense.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This section is not applicable in the traditional sense for this type of device and submission. The "ground truth" for the performance characteristics of a replacement battery pack is its ability to power the intended medical device (Medtronic LifePak 500 AED) according to original equipment manufacturer (OEM) specifications, which are established engineering and performance criteria. No human experts are described as establishing "ground truth" in the way radiologists establish cancer diagnoses. The "experts" would be the engineers and technicians performing the quality control and bench testing, comparing to established OEM and internal specifications.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is typically used in clinical studies, particularly for subjective assessments where multiple readers provide independent interpretations.
For this device, the "adjudication" is essentially based on:
- Pre-defined engineering specifications and thresholds (e.g., ≥90% capacity, correct voltage, meeting OEM shock count).
- Pass/fail criteria based on objective measurements from instruments like the Cadex Electronics Battery Analyzer and NETECH Model Delta 2000 Defibrillator Analyzers.
- Visual inspections for damage after mechanical stress tests.
There is no mention of a formal adjudication process involving multiple human reviewers for subjective assessments.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic aids that assist human readers (e.g., radiologists interpreting images). The submitted device is a replacement battery pack, which is a hardware component, not an AI diagnostic tool. Therefore, the concept of "human readers improve with AI vs without AI assistance" does not apply.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone performance study in the context of an algorithm or AI system was not done. The device is a battery pack, a physical component, not an algorithm. Its performance is inherent in its electrical and mechanical properties, not in an "algorithm only" mode.
7. The type of ground truth used
The "ground truth" for the battery pack's performance is tied to engineering specifications, OEM performance benchmarks, and industry standards for battery characteristics (voltage, capacity, life cycle, temperature range, mechanical integrity). This is primarily objective, measurable physical and electrical properties.
8. The sample size for the training set
This device does not involve a "training set" in the context of machine learning or AI. As a manufactured hardware component, it does not learn or get trained from data. The manufacturing process involves quality control, testing, and adherence to design specifications.
9. How the ground truth for the training set was established
Since there is no training set for this hardware device, this question is not applicable. The "ground truth" for manufacturing a battery pack is defined by its design specifications and the performance requirements of the device it powers (Medtronic LifePak 500 AED).
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(225 days)
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC.
To power the functions of various devices for which batteries or battery packs are configured.
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.
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.
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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