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The Synergetics Sterile Adjustable Gas Pressured Infusion Tube Set is intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery.

The Synergetics AGPI Tubing set is a PVC tubing set intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The tubing set consists of a three channel IV spike, for insertion into a bottle of Balanced Salt Solution. The three way spike is designed to deliver air from an air supply unit through the solution; while the dual PVC tubing also administers humidified air (clear lumen) and saline (green stripe lumen); this dual PVC tubing has a three-way stopcock for proper connection.

This document describes the Synergetics Adjustable Gas Pressured Infusion (AGPI) Tube Set, a device intended to deliver forced humidified air or fluid to the eye during ophthalmic surgery. The document is primarily a 510(k) submission, focusing on establishing substantial equivalence to predicate devices, rather than a clinical study report with detailed acceptance criteria and performance metrics in the context of diagnostic accuracy or clinical outcomes.

Therefore, many of the requested sections regarding acceptance criteria, study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment cannot be fully addressed from the provided text, as this information is typically found in performance studies, which are not detailed here. The submission focuses on technical and safety aspects for regulatory approval.

However, I can extract the available relevant information about the device and its compliance.

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity) in the sense of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices by comparing technical characteristics and adherence to regulatory standards.

The primary "acceptance criteria" can be inferred as meeting the technical characteristics and safety/sterilization standards demonstrated by predicate devices and relevant ISO standards.

Study Information (Based on available text)

1. Sample size used for the test set and the data provenance:

   • The document does not describe a "test set" in the context of a clinical performance study with a sample size for human subjects or case data. The "test set" here refers to the device itself being evaluated against technical and regulatory standards.
   • Data provenance is primarily through comparison with existing predicate devices (Peregrine Wet Set, Alcon VGFI Tube Set) and established international standards (ISO 11607-1:2006, AAMI/ISO 11135, ISO 14971, BS EN 13485:2003). This is therefore "retrospective" analysis of existing regulatory and technical standards and comparison to previously approved devices.

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

   • Not applicable in this context. The "ground truth" for this type of submission is adherence to predefined technical specifications and regulatory standards, rather than expert-derived diagnoses or interpretations. The FDA reviewers (e.g., in the Ophthalmic Panel) represent regulatory expertise.

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

   • Not applicable. There's no clinical "test set" requiring adjudication of results. The adjudication process would be the regulatory review conducted by the FDA.

4. 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 device is a medical accessory (tubing set), not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or is relevant.

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

   • Not applicable. This is not an algorithmic device.

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

   • The "ground truth" for this 510(k) submission relates to technical specifications, safety, and performance as defined by engineering standards, manufacturing controls, and the established characteristics of predicate devices. For example, the ground truth for sterilization is adherence to AAMI/ISO 11135, and for packaging, it's ISO 11607-1:2006.

7. The sample size for the training set:

   • Not applicable. There is no concept of a "training set" for this type of medical device submission. The device is not learning from data.

8. How the ground truth for the training set was established:

   • Not applicable.

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