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The Pediatric Energy Reducer product is intended to be used to treat patients in cardiopulmonary arrest. It should only be used on patients who are unconscious, without a pulse and not breathing spontaneously. It is intended for use in either inhospital or out-of-hospital arrests. The Pediatric Energy Reducer is to be used only in conjunction with Automatic External Defibrillator (AED) and disposable electrode products marketed by Welch Allyn, or as formerly marketed by Medical Research Laboratories (MRL). The AED 10™ was formerly marketed as the MRL JumpStart and AED 20™ was formerly marketed as the MRL LifeQuest AEDefibrillator.

The Pediatric Energy Reducer product is intended to be used to treat infants and children up to approximately 8 years of age or 25 kg (55 lbs) weight; therapy should not be delayed to determine the child's exact age or weight.

It is intended to be used with normal (non-attenuating) adult electrodes on patients who are sufficiently large for the electrodes to be applied (in the anterior / posterior position), or with normal (non-attenuating) pediatric electrodes on smaller patients.

The reusable Pediatric Energy Reducer products are small, lightweight, passive accessory devices for use with Welch Allyn automatic external defibrillators (AED). The Pediatric Energy Reducer product is inserted between the AED and suitable size non-attenuating defibrillation electrodes. The Pediatric Energy Reducer product attenuates the energy from the defibrillator by a factor of four, making the energy delivered to the electrodes suitable for use on pediatric patients. The Pediatric Energy Reducer product only affects the amplitude of the delivered waveform; the wave shape and arrhythmia detection algorithms are not affected by device use. The device consists of a resistive voltage divider circuit encapsulated in a protective plastic housing. Suitable connectors are provided to engage the Pediatric Energy Reducer to the AED and the electrodes to the Pediatric Energy Reducer.

The provided document is a 510(k) Premarket Notification Summary for the Welch Allyn Pediatric Energy Reducer for AED 10TM and AED 20TM. It describes the device, its intended use, and its equivalence to a predicate device. However, it does not contain information regarding detailed acceptance criteria or a study proving the device meets those criteria in the format requested.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Medtronic Physio-Control Infant/Child Reduced Energy Electrodes, K022732) based on the same technology for energy attenuation. While it states that the Pediatric Energy Reducer "attenuates the energy from the defibrillator by a factor of four, making the energy delivered to the electrodes suitable for use on pediatric patients," it does not provide specific performance metrics, a study design, or results in terms of sensitivity, specificity, accuracy, or other quantitative measures typically found in clinical or performance studies for diagnostic or AI-enabled devices.

Therefore, many of the requested sections cannot be filled based on the provided text.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information in this table:

• Specific numerical thresholds or targets for "suitable" energy delivery.
• Quantitative measurements for how wave shape and algorithm performance are unaffected (e.g., specific deviation tolerances).
• Any other performance metrics typically associated with device testing (e.g., durability, electrical safety, impedance, etc., though these may be covered by different sections of a full 510(k) submission not provided here).

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

• Not specified. The document does not describe a clinical study or a specific test set of patient data. It is a device modification (accessory) focusing on electrical characteristics rather than diagnostic performance on patient data.

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 / Not specified. This device is an energy attenuator for a defibrillator, not a diagnostic device requiring expert interpretation of results to establish ground truth for a test set.

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

• Not applicable / Not specified. 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

• No. This is not an AI-enabled device. Therefore, no MRMC study comparing human readers with or without AI assistance was performed or described.

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

• Not applicable. This device is a passive accessory (resistive voltage divider circuit) that modifies the energy output of an existing AED. It does not have an "algorithm" in the sense of a standalone diagnostic or decision-making component. Its performance is based on its electrical properties.

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

• Not applicable in the typical sense for diagnostic devices. The "ground truth" for this device would likely be derived from engineering specifications and electrical measurements demonstrating that the energy reduction is by a factor of four and that the waveform and existing AED algorithms are unaffected. This is inferred from the description of the device as a "resistive voltage divider circuit."

8. The sample size for the training set

• Not applicable. This is not a machine learning or AI-based 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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