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The Perifix Pediatric Epidural Kit is designed to provide pediatric patients, who are undergoing a surgical procedure, with regional anesthesia below the level of the tenth thoracic vertebrae.

The Perifix Pediatric Epidural Kit is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.

This submission is for a Class II medical device, the Perifix Pediatric Epidural Kit. The provided text, a 510(k) summary, focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study with specific acceptance criteria and performance data in the way one would for a novel AI/software device. Therefore, much of the requested information regarding acceptance criteria, study design, ground truth, and expert involvement is not applicable or cannot be extracted from this document.

Here's an attempt to answer the questions based on the provided text, indicating where information is not available:

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

   • Acceptance Criteria: Not explicitly stated in terms of objective performance metrics (e.g., sensitivity, specificity, accuracy). The acceptance criteria are implicitly that the device "meets all required release specifications" and performs equivalently to predicate devices in "materials, form, and intended use."
   • Reported Device Performance: Not quantified with specific metrics. The reported "performance" is that it "is equivalent in materials, form, and intended use" to the predicate devices.

   Acceptance Criteria (Implicit from provided text)	Reported Device Performance
   Materials are suitable for intended use (in accordance with Tripartite Guidance)	Materials tested and determined suitable.
   Equivalent in materials to predicate devices (K813186, K893766, K953467)	Device is equivalent in materials to predicate devices.
   Equivalent in form to predicate devices	Device is equivalent in form to predicate devices.
   Equivalent in intended use to predicate devices	Device is equivalent in intended use to predicate devices.
   Meets all required release specifications (physical testing, visual examination)	All finished products are tested and must meet all required release specifications before distribution.
   Raises no new issues of safety or effectiveness	No new issues of safety or effectiveness raised by the Perifix Pediatric Epidural Kit.

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

   • Sample Size for Test Set: Not applicable. This submission describes testing for manufacturing release (physical testing, visual examination) for its own products, not a clinical study on a "test set" in the context of diagnostic performance.
   • Data Provenance: Not applicable. The "testing" refers to internal quality control and release procedures, not data collected from patients or a specific study.

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. Ground truth as typically understood for a diagnostic algorithm is not relevant here. The ground truth for "meeting specifications" would be defined by the established Quality Control Test Procedure documents and the parameters conforming to product design specifications. These are internal company procedures, not expert-derived ground truth from a clinical setting.

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

   • Not applicable. There is no "test set" in the context of diagnostic performance or clinical outcomes requiring expert adjudication.

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 or software device.

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

   • Not applicable. This is not an AI or software device.

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

   • The "ground truth" for this device's "performance" is conformance to engineering design specifications, material compatibility standards (Tripartite Guidance for Plastics), and established quality control procedures. It is not clinical ground truth derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

   • Not applicable. This is not an AI or software device that undergoes "training."

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

   • Not applicable. This is not an AI or software device.

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