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The samaritan® Pediatric-Pak (Model SPP 351) is indicated for use to treat patients in cardiopulmonary arrest who are unconscious, without a pulse and not breathing spontaneously. They should only be used by personnel who have been trained in its operation.

The samaritan® Pediatric-Pak is specially designed for use only with the samaritan® PAD (Model SAM 300P). This product allows the samaritan PAD to deliver lower-energy therapy to children from 1 year of age to 8 years or up to 55lbs (25kg). DO NOT DELAY THERAPY IF YOU ARE NOT SURE OF EXACT AGE OR WEIGHT.

The samaritan® Pediatric-Pak is intended as a direct replacement for the Adult Pad-Pak but Tor use with children between the ages of 1 year and 8 years or 55 pounds (25 kilograms) in weight. The clectrodes and lead wires are identical in materials and construction to those used in the adult samaritan® Pad-Pak, cleared under K042088 for use with patient above 8 years old or 55 pounds in weight. They are use in the same way as with the adult samaritan® PAD-Pak. The energy reduction required for children is accomplished by means of purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software. The Pediatric-Pak incorporates a magnet which is sensed, on insertion, by the host PAD which automatically prompts the user "child patient" and, while the Pediatric-Pak is in position, uses the Pediatric look-up table to define the voltage and duration of the therapeutic shock commensurate with the required energy deliverable (50 Joules), taking into account the attenuation by the resistors incorporated into the Pediatric-Pak. The electrodes are sealed inside poly/foil. peelable pouches of the same materials and construction as the current adult PAD-Pak electrodes. The purely resistive attenuator circuit board is enclosed inside the Pediatric-Pak requiring a slightly lengthened version of the current PAD-Pak molded housing. A different color scheme (pink) is used to help differentiate the samaritan Pediatric-Pak from their adult counterparts. The product labeling for the samaritan® Pediatric-Pak indicates a "anterior/posterior" placement to be preferred, while allowing for the typical adult "apex/sternum" placement under some circumstances.

Here's an analysis of the provided text regarding the acceptance criteria and study for the samaritan® Pediatric-Pak (Model SPP 351).

Disclaimer: The provided text is a 510(k) summary, which is a regulatory document. It summarizes the findings and conclusions of studies and does not typically contain exhaustive details about the methodologies of those studies. Therefore, some information requested may not be explicitly present.

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting specific numerical acceptance criteria and a detailed performance table for the new device's efficacy. The core acceptance criteria appear to be implicit in the comparison to the predicate device's established safety and effectiveness.

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

• Sample Size: Not explicitly stated for the "pediatric heart rhythm database" used for validation. The summary only mentions "validation against a pediatric heart rhythm database."
• Data Provenance: Not explicitly stated (e.g., country of origin). The data is described as a "pediatric heart rhythm database," implying it contains recorded heart rhythms from pediatric patients.
• Retrospective or Prospective: Not explicitly stated, however, the phrase "validation against a pediatric heart rhythm database" strongly suggests a retrospective analysis of existing recorded data.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not specified. Given the nature of a "heart rhythm database," it's likely that established medical criteria or a consensus of cardiologists previously annotated the rhythms within the database, but this is not detailed in the summary.

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

• MRMC Study Done: No, an MRMC comparative effectiveness study is not mentioned in the provided 510(k) summary. The comparison is between the new device's technology and performance (as evaluated via bench testing and database validation) against a predicate device, not typically involving human readers.
• Effect Size of Human Readers Improve with AI vs without AI assistance: Not applicable, as no MRMC study involving human readers and AI assistance was reported.

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

• Standalone Study Done: Yes, a standalone evaluation of the device's performance was conducted. The summary states: "The results of bench testing and validation against a pediatric heart rhythm database indicates that the HeartSine Technologies samaritan Pediatric-Pak is substantially equivalent in safety and effectiveness to the predicate devices." This implies that the device's ability to appropriately identify and deliver a shock (or withhold if not required, though the focus is on reduced energy delivery) was evaluated without a human-in-the-loop, against pre-recorded rhythms.

7. Type of Ground Truth Used

• Type of Ground Truth: The ground truth for the standalone performance was based on a "pediatric heart rhythm database." This implies that the rhythms in the database were classified according to their clinical significance (e.g., shockable vs. non-shockable rhythms for pediatric patients, or specific energy requirements for different rhythm types). This would typically be established by expert medical consensus or established diagnostic criteria.

8. Sample Size for the Training Set

• Sample Size: The provided 510(k) summary does not mention a training set or its sample size. This device appears to rely on a fixed resistive attenuation and a "pediatric look-up table" for energy delivery, rather than an adaptive algorithm that would typically require a training set. The "pediatric heart rhythm database" was used for validation, not training.

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

• How Ground Truth Established: Not applicable, as no training set is mentioned for an adaptive algorithm. The device's operation is described as a "purely resistive attenuation in concert with a separate energy look-up table incorporated into the PAD embedded software," indicating a deterministic rather than machine-learning-based approach requiring a training set. The "pediatric look-up table" itself would have been developed based on established medical guidelines for pediatric defibrillation.

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