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The Impulse 7010 is used to determine that a defibrillator is performing within its operating specifications by providing multiple loads of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. The Impulse 7010 is used in conjunction with the Impulse 7000DP Defibrillator Analyzer.

The Impulse 7010 Defibrillator Selectable Loads is an optional accessory to the Impulse 7000DP to simulate 25 to 200 Ohm thoracic impedance. Four 50 Ohm resistors are switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms. Defibrillator output energy is measured by the Impulse 7000DP Defibrillator Tester.

The provided text is a 510(k) summary for the Impulse 7010 Defibrillator Selectable Loads, which is an accessory to a defibrillator tester. The document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than detailing a study with acceptance criteria and device performance evaluation in the manner typically found for AI/ML medical devices or diagnostic tools.

Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this regulatory submission for a simple accessory device. The device is a physical component (resistance box) for testing other medical devices, not a diagnostic or AI-powered system that would undergo extensive performance validation against a clinical ground truth.

However, I can extract the relevant information where available and explain why other sections are not applicable.

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

This information is not explicitly provided in the 510(k) summary. For a device like the Impulse 7010, acceptance criteria would typically relate to the accuracy of the selectable resistance values it provides. The summary states that the device "simulates 25 to 200 Ohm thoracic impedance" and consists of "Four 50 Ohm resistors switched in combinations to make series or parallel circuits of 25, 50, 75, 100, 125, 150, 175 and 200 Ohms." The implication is that the accuracy of these resistance values is critical for its function as a defibrillator tester accessory, but specific numeric tolerances or performance data are not reported in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This device is an accessory that provides fixed resistance loads for testing other equipment. Its performance validation would involve electrical engineering tests (e.g., measuring the actual resistance output) rather than a clinical "test set" of data or patients. No clinical data or patient data is mentioned or relevant for this device.

3. 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 device does not generate diagnostic outputs or interpretations that require a "ground truth" established by medical experts. Its "ground truth" is based on fundamental electrical engineering principles.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No "test set" or clinical adjudication is described or relevant for this device.

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 is not an AI/ML device, nor is it a diagnostic tool that involves human readers interpreting cases.

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

Not applicable. This is a hardware accessory, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable in the clinical sense. The "ground truth" for this device would be established by fundamental electrical measurement standards (e.g., a high-precision ohmmeter to verify the resistance values provided).

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable for the same reason as above.

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