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Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator, 510(k) Number 935674. 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 knows the intended use is as a replacement battery.

Replacement battery for Physio-Control 803704-01 Life-Pak 9 Low-Energy Cardiac Monitor/Defibrillator.

The provided documents are a 510(k) clearance letter from the FDA for a replacement battery (LP9) and its "Indications for Use" statement. This type of document does not contain the detailed information necessary to describe acceptance criteria and a study that proves a device meets those criteria, especially for AI/ML devices.

The 510(k) clearance process for this device (a replacement battery) primarily relies on demonstrating substantial equivalence to a legally marketed predicate device. This typically involves:

• Performance testing: Ensuring the battery meets the electrical and safety specifications equivalent to the original battery and the predicate.
• Material compatibility: Ensuring materials are appropriate for the intended use.
• Labeling review: Verifying that the labeling accurately reflects the device's intended use and contraindications.

Here's why the requested information cannot be fully provided from these documents:

• No AI/ML Component: The device is a replacement battery, which does not involve AI or machine learning. Therefore, concepts like "training set," "test set," "ground truth," "MRMC study," "human readers with/without AI assistance" are not applicable.
• Focus on Substantial Equivalence: The letter explicitly states that the device is "substantially equivalent" to predicate devices. This means its performance is compared to an existing device, rather than establishing novel acceptance criteria based on a new technology's performance.
• Lack of Detailed Study Report: The 510(k) clearance letter is an outcome document, not the detailed study report itself. It confirms the clearance but does not provide the specifics of the testing performed, sample sizes, or expert qualifications that would be found in the actual submission.

However, based on the general principles of medical device regulation and what can be inferred for a replacement battery, here's a conceptual outline of what one might expect for such a device, and why it's not present here:

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

Due to the nature of the provided documents (a 510(k) clearance letter), specific numerical acceptance criteria and reported performance values are not detailed. These would be found in the detailed test reports submitted to the FDA.

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not specified in the provided document. For a battery, this would likely involve a statistically significant number of units (e.g., dozens to hundreds) to demonstrate consistent performance and safety.
• Data Provenance: Not specified. Typically, testing would be conducted in a controlled laboratory environment by the manufacturer or a certified testing house.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable: For a battery, "ground truth" isn't established by experts in the same way it is for diagnostic AI/ML. The "ground truth" is typically defined by objective electrical and safety standards (e.g., IEC, UL standards) and the specifications of the original device. Engineers and technicians perform the tests and verify adherence to these objective criteria.

4. Adjudication method for the test set

• Not Applicable: Adjudication is relevant for situations involving subjective interpretation (e.g., image reading). For objective performance tests of a battery, results are directly measured and compared against predefined specifications.

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: This type of study is specifically for AI/ML diagnostic tools that impact human interpretation. A replacement battery has no such AI component.

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

• Not Applicable: The device is a physical battery, not an algorithm.

7. The type of ground truth used

• Objective Standards and Electrical Specifications: For a battery, the "ground truth" would be the documented electrical specifications (voltage, capacity, impedance, etc.) of the original battery and the Life-Pak 9 device, as well as adherence to relevant national and international safety standards (e.g., for lithium-ion batteries if applicable, even though specific chemistry isn't mentioned here).

8. The sample size for the training set

• Not Applicable: There is no "training set" as the device is not an AI/ML algorithm.

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

• Not Applicable: There is no "training set."

In summary, the provided FDA clearance letter for a replacement battery is not the type of document that would contain the detailed technical evaluation information asked for, particularly for AI/ML-related questions. The clearance is based on the battery's substantial equivalence in performance and safety to existing predicate devices, verified through standard engineering and safety testing.

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