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The Steri-Lub Lubricating Gel is intended to be used in procedures requiring a sterile product (surgical and urological). The Lubrication Gel is intended to be used to lubricate a body orifice to facilitate entry of a diagnostic or therapeutic device.

The Steri-LubTM Lubrication Gel is a sterile, single patient use, disposable instrument that is substantially equivalent to the predicate device and other pre-filled syringes. All Steri-Lubrication Gel syringes are designed for lubrication of a body orifice to facilitate entry of a diagnostic or therapeutic device only and are intended for single patient use.

This document is a 510(k) Pre-market Notification for a device modification, specifically for AVAIL MEDICAL PRODUCTS, INC.'s Steri-Lub™ Lubrication Gel. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study performing to acceptance criteria in the typical sense of a clinical trial or performance study for a diagnostic AI device.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, MRMC studies, standalone performance, training set details) is not applicable to this type of regulatory submission.

This document describes a modification to an existing device (Steri-Lub™ Lubrication Gel) and seeks to demonstrate its "substantial equivalence" to its predicate device (Steri-Lub™ Lubrication Gel, K944060). The focus is on the similarity of materials and intended use, rather than a quantifiable performance metric for a and diagnostic or therapeutic AI device.

Here's a breakdown of what can be extracted and why other points are not applicable:

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

   • Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics because this is a substantial equivalence submission for a physical device modification, not a performance study for, for example, an AI diagnostic algorithm. The implicit acceptance criterion is "substantial equivalence" to the predicate device in terms of materials, intended use, and technological features.
   • Reported Device Performance: No specific quantitative performance data is provided as this is not a study assessing performance against a benchmark. The document states that the modified device and predicate device "contain similar materials of construction" and share the same "intended use."

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

   • Not Applicable. This document does not describe a performance study involving a "test set" of data or patients. It's a regulatory submission for a physical device.

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. There is no "ground truth" establishment in the context of a performance study for this type of device modification submission.

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

   • Not Applicable. No test set or adjudication process is described.

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 device is a lubrication gel, not an AI-assisted diagnostic tool.

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

   • Not Applicable. This is not an algorithm or AI device.

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

   • Not Applicable. No ground truth measurement is relevant for this device modification.

8. The sample size for the training set:

   • Not Applicable. This is not an AI/machine learning device requiring a training set.

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

   • Not Applicable. No training set is used.

Summary based on the provided document:

This document is a 510(k) Summary for a device modification of a sterile lubrication gel. The core of this submission is to demonstrate "substantial equivalence" to a legally marketed predicate device (Steri-Lub™ Lubrication Gel, K944060). It is not a performance study for a diagnostic or therapeutic AI device, which typically involves the detailed performance metrics, sample sizes, and ground truth methodologies outlined in your request. The "proof" is the comparison of technological features (similar materials of construction) and identical intended use between the modified device and its predicate.

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