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The pediatric device for induction of anesthesia (PeDIA) is an alternative to a face mask for the inhalation induction of anesthesia, and is intended for the delivery of nitrous and/or anesthetic gases to children age three years and older. It is intended to be used prior to IV insertion, LMA/endotracheal intubation, and/or conversion to a standard mask induction.

The Pediatric Device for Induction of Anesthesia (PeDIA) is a single-use, disposable, mask-free anesthetic delivery system and method used for children 3 years and older. The balloon is a standard, legally marketed reservoir bag that is modified by the addition of a whistle at the opposite end of the connector (which is a closed end on standard balloons). This balloon is used in place of the initial application of anesthesia gasses. Once the child is sedated the product is removed and replaced with a standard pediatric mask for the duration of anesthesia.

When analyzing the provided text for acceptance criteria and a study proving device performance, it's important to note that this FDA 510(k) clearance document is for a Class I medical device (a reservoir bag with a modification), not typically a device that requires extensive clinical studies with human participants to demonstrate performance or to assess diagnostic accuracy in the way that, for example, an AI-powered diagnostic imaging device would.

The "performance data" discussed here focuses on engineering, biocompatibility, and regulatory compliance rather than diagnostic performance metrics like sensitivity, specificity, or reader improvement.

Therefore, many of the requested points related to AI/MRMC studies, expert ground truth, and training data will not be present in this document, as they are not applicable to the type of device and regulatory pathway involved.

Here's a breakdown based on the provided text:

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

The document doesn't provide a direct table of acceptance criteria with corresponding performance numbers in the way one might expect for a diagnostic AI device. Instead, it describes general compliance and testing outcomes.

• Cytotoxicity
• Sensitization
• Irritation
• Acute Toxicity
• Pyrogenicity |
  | Risk Management | All identified risks were reduced to acceptable levels by mitigation (design, labels, biocompatibility). All residual risks post-mitigation were deemed acceptable. |
  | Standard Compliance | Confirmed compliance with:
• ISO 5362 (Anesthetic Reservoir bags)
• ISO 5356-1 (Anesthetic and respiratory equipment – conical connectors – Part 1: Cones and Sockets).
  This includes requirements for connectivity, capacity, leakage, disconnection, resistance to pressure, and design. |
  | Verification Testing | All requirements (other than those addressed by standardized testing) were confirmed against specifications, labeling, and instructional requirements via a pre-approved protocol. |
  | Overall Conclusion | "Tests were successfully performed and all acceptance criteria were met, thus confirming that the PeDIA device satisfactorily meets requirements. There were no different questions of safety and effectiveness identified..." |

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

• Sample Size: Not specified in terms of clinical study sample size. The tests appear to be laboratory and bench testing on the device prototypes/samples. No patient "test set" in the diagnostic sense is mentioned.
• Data Provenance: Not applicable in the context of diagnostic data. The "data" refers to engineering test results and biocompatibility assays.

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

• Not applicable. This device does not generate diagnostic outputs requiring expert interpretation for ground truth. The "ground truth" here is compliance with engineering standards and safety/biocompatibility profiles.

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

• Not applicable. There are no diagnostic interpretations to adjudicate.

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/diagnostic device, and no MRMC study was performed or required.

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

• No. Not an AI device.

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

• The "ground truth" for this device's performance is adherence to established international standards (ISO 5362, ISO 5356-1) and FDA guidance for biocompatibility (ISO 10993-1), along with internal design specifications. There is no clinical "ground truth" in the diagnostic sense.

8. The sample size for the training set

• Not applicable. This is not an AI device that requires a "training set."

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

• Not applicable.

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