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The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.

The SonoPrep® Ultrasonic Skin Permeation System is a portable battery operated reusable device that disrupts the stratum corneum layer of the skin by means of cavitation of a fluid with ultrasonic energy. The result of the treatment allows the rapid onset of topical OTC lidocaine 4%.

Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal acceptance criteria in a quantitative or tabular format. However, based on the study described, the implied performance criterion is the ability to produce a "rapid dermal anesthetic effect" using topical OTC lidocaine 4%, with no significant adverse events or skin irritation.

2. Sample Size for Test Set and Data Provenance

• Sample Size for Test Set: 320 subjects.
• Data Provenance: The study was a "randomized, controlled study." The country of origin is not explicitly stated, but the submission is to the FDA in the USA, suggesting the study was likely conducted there or in a location compliant with US regulatory standards. It was a prospective study, as subjects were treated and then their pain and adverse events were assessed.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications of Experts

The document does not mention the use of experts to establish a "ground truth" for the test set in the traditional sense of diagnostic accuracy. Instead, pain was assessed by the subjects themselves using an "accepted pain evaluation scale." The clinical observations for adverse events were likely made by clinical staff involved in the study, but their number and specific qualifications are not detailed.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for the test set. Pain scores were self-reported by subjects, and clinical observations for adverse events were analyzed. There's no indication of multiple reviewers or an adjudication process for these outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The study focused on the effectiveness of the device in facilitating anesthesia, not on human readers' performance with or without AI assistance.

6. If a Standalone Study (Algorithm Only Without Human-in-the-Loop Performance) was Done

This question is not applicable as the device is a physical system (SonoPrep® Ultrasonic Skin Permeation System) that is used in conjunction with a topical anesthetic, not a diagnostic algorithm. Therefore, there's no "algorithm only" performance to evaluate.

7. The Type of Ground Truth Used

The "ground truth" in this context is based on:

• Subjective Patient Outcomes: Pain scores reported by the subjects using an accepted pain evaluation scale.
• Clinical Observations: Assessment of adverse events and skin irritation by clinical personnel.

8. The Sample Size for the Training Set

The document does not describe a "training set" as this is a medical device for facilitating drug delivery, not a machine learning algorithm requiring training data. The "evaluations" mentioned (Laboratory and bench top) refer to engineering and design verification, not algorithm training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable for the reasons stated in point 8.

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