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Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. This battery is shipped only to customers who request a replacement battery for a particular device or to replace a competitor's replacement battery. The biomedical equipment technician therefore the intended use is as a replacement battery.

Rechargeable Battery Part Number MS3030P

This is a 510(k) clearance letter for a replacement battery, not an AI/ML medical device. Therefore, the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not applicable. The document confirms that the Alexander Manufacturing Company's Rechargeable Battery Part Number MS3030P is substantially equivalent to legally marketed predicate devices.

Here's how the provided information relates to the request, and why it doesn't fit the AI/ML device study format:

1. A table of acceptance criteria and the reported device performance: Not applicable. For a replacement battery, "performance" would relate to electrical characteristics and compatibility, which are demonstrated through testing to ensure the device meets specified standards and functions equivalently to the original or predicate battery. This document doesn't detail those specific tests or acceptance criteria as it's a clearance letter, not a test report.

2. Sample size used for the test set and the data provenance: Not applicable. For a battery, testing involves physical and electrical measurements, not data sets.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. "Ground truth" in the context of AI/ML refers to accurately labeled data. For a battery, validation relies on engineering specifications and laboratory testing by qualified technicians/engineers.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. This method is used to reconcile differing expert opinions in AI/ML performance evaluation.

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 specific to evaluating diagnostic systems used by human readers, often involving radiological or pathological images.

6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable. This concept applies to AI/ML algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a battery.

8. The sample size for the training set: Not applicable. Batteries are tested, not trained like an AI model.

9. How the ground truth for the training set was established: Not applicable.

Summary from the provided document:

• Device Name: Alexander Manufacturing Company Rechargeable Battery Part Number MS3030P
• Regulatory Class: II
• Product Code: MRZ
• Indications for Use: Replacement battery for Corpak 415A R200, VTR300D Enteral Pump, 510(k) Number K832167. Intended for customers requesting a replacement for a particular device or to replace a competitor's replacement battery.
• Substantial Equivalence: The FDA determined the device is substantially equivalent to devices marketed prior to May 28, 1976, or reclassified devices. This implies that the battery's design, materials, and performance characteristics are comparable to a predicate device, ensuring it functions safely and effectively for its intended use as a replacement.

The document is a clearance letter indicating that the battery has met the regulatory requirements for market entry based on substantial equivalence, which primarily involves demonstrating that it performs equivalently to a legally marketed predicate device. The detailed testing and acceptance criteria would have been part of the 510(k) submission, but are not explicitly detailed in this clearance letter.

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