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Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.

Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. The gel is not sterile. The raw materials comprising the gel have a long and established history as raw materials in cosmetics.

The provided text describes a 510(k) Premarket Notification for "Lubriscan Ultra Scan Gel," an ultrasound coupling gel. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for the device itself.

Therefore, the requested information elements related to detailed acceptance criteria, a study proving performance, sample sizes, ground truth establishment, expert involvement, or MRMC studies for this specific device are not available in the provided document because the submission relies on substantial equivalence.

Here's an overview of what can be extracted and what cannot:

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

• Not Available. The document does not specify quantitative acceptance criteria or detailed performance metrics for the Lubriscan Ultra Scan Gel+. The substantial equivalence argument relies on the established safety and performance of predicate devices for the same intended use.

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

• Not Applicable / Not Available. There is no test set or study described in the document where a sample size would be relevant.

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 / Not Available. No ground truth establishment by experts for a test set is described.

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

• Not Applicable / Not Available. 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 / Not Available. This device is an ultrasound gel, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving AI assistance is not relevant or described.

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

• Not Applicable / Not Available. This device is an ultrasound gel, not an algorithm.

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

• Not Applicable / Not Available. No ground truth data is mentioned or used. The safety and effectiveness are established through the history of its raw materials in cosmetics and its similarity to predicate devices.

8. The sample size for the training set

• Not Applicable / Not Available. There is no "training set" as this is not an algorithm being developed.

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

• Not Applicable / Not Available. No training set or ground truth establishment for a training set is described.

Summary of what is available:

Device Description:
Lubriscan Ultra Scan Gel + is used for coupling ultrasound devices to external surfaces such as skin. It is not sterile. The raw materials have a long and established history in cosmetics.

Intended Use / Indications for Use:
Lubriscan® Ultra Scan Gel + is intended to be used on external, intact skin for short duration as a coupling contact medium for abdominal and OB/GYN diagnostic scanning procedures.

Basis for Approval:
Substantial equivalence to predicate devices (other ultrasound coupling gels) in terms of intended use, materials of construction, and technological characteristics. The safety is also implied by the "long and established history as raw materials in cosmetics." The manufacturing will follow specified process controls and a Quality Assurance Program similar to pharmaceuticals.

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