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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 therefore know that the intended use is as a replacement battery.

Rechargeable batteries and 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 cquipment.

The provided text describes the 510(k) summary for Access Battery, Inc.'s Rechargeable Battery Packs. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than an independent study proving the device meets specific acceptance criteria in the context of a new medical diagnostic or therapeutic algorithm.

Therefore, many of the requested categories for acceptance criteria and study details are not applicable or cannot be extracted from this type of documentation. This document is for a battery, not an AI/ML algorithm or a diagnostic device that would typically have performance metrics like sensitivity/specificity.

Here's an attempt to answer the questions based only on the provided text, indicating where information is not present or not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size: Not applicable. The document describes "bench test comparison analysis" against predicate devices, but does not specify a "test set" in the context of patient data or algorithm evaluation. It refers to "various rechargeable battery packs" and "replacement devices."
• Data Provenance (country of origin, retrospective/prospective): Not applicable. This is not a study involving human data. The testing is described as "safety and performance testing" and "bench test comparison analysis" of battery packs.

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

• Number of Experts: Not applicable. Ground truth in the context of expert consensus is not relevant for a battery pack. The comparison is against predicate device specifications and performance.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. No adjudication method described as this is not a diagnostic or AI study requiring such a process.

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

• MRMC Study Done: No. This is a battery, not a diagnostic imaging or algorithm device.
• Effect size of human readers improvement: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

• Standalone Study Done: Yes, in a way. The "Testing" section describes "Safety and performance testing of these battery packs" and "bench test comparison analysis" where "the replacement devices must meet or exceed these benchmark results consistently." This implies the battery itself, as a standalone product, was tested against performance metrics derived from predicate devices, without human interaction influencing the battery's inherent performance.

7. Type of Ground Truth Used

• Type of Ground Truth: The "ground truth" for the battery performance appears to be established by the specifications and reported performance of the legally marketed predicate devices. The new battery packs "must meet or exceed these benchmark results consistently."

8. Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This device is a physical product (battery pack), not an AI algorithm that undergoes a training phase with a dataset.

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

• Ground Truth for Training Set: Not applicable. No training set is involved.

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Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power.

Rechargeable batteries are utilized in portable medical equipment as a primary d-c power source or as a stand-by or backup d-c power source for portable as well as stationary medical equipment with a-c providing the primary power. These devices are copies of Original Equipment Manufacturer (OEM) or After-Market battery packs currently on the market. A sample is generally submitted by Hospitals, Medical Centers, and Biomedical or Clinical Engineering Service Professionals for duplication. Battery packs are "device specific" and are designed to operate and fit into those OEM devices for which they were manufactured.

The provided document is a 510(k) premarket notification letter from the FDA regarding a rechargeable battery (Models: MLA6153, MNC 847L) for perinatal monitoring systems. This document does not contain the acceptance criteria or a study proving the device meets those criteria, nor does it typically include clinical study details as it concerns a battery, an accessory for a medical device.

The letter states that the device is substantially equivalent to legally marketed predicate devices. The "Indications for Use Statement" (Page 2) describes how the rechargeable batteries are utilized in portable medical equipment as a primary or stand-by/backup DC power source. It also mentions that "The end-user provides feedback and assists in qualifying the device as to its performance, form, fit or function although we incorporate all available resources to assist us in producing a device that meets or exceeds OEM specifications." This statement suggests that acceptance criteria would likely relate to battery performance metrics (e.g., voltage, current, duration, cycle life, safety standards) and would be compared against the original equipment manufacturer's (OEM) specifications or industry standards for similar batteries.

Therefore, I cannot provide the specific information requested in the prompt based on the provided document. The document is a regulatory approval letter, not a study report.

To answer your request, I would need a different type of document, such as a test report, a clinical investigation report, or a detailed technical specification document for the battery and its performance evaluation.

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