Search Results

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.

Ask a specific question about this device

The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System is intended to be used for preparation of intact skin to lower skin impedance. The supplied electrodes are intended to be used for ECG monitoring.

The Sontra Medical Corporation SonoPrep™ Impedance Diagnostics (IDx) System consists of a microprocessor controlled ultrasonic skin prep generator, a reusable handpiece, a reusable handheld contact electrode, coupling media and ECG electrodes used for ultrasonically treating intact skin in order to lower the skin impedance for the application of ECG electrodes for monitoring heart rates.

The provided document is a 510(k) summary for the Sontra Medical Corporation's SonoPrep™ Impedance Diagnostics (IDx) system. This document is a premarket notification to establish substantial equivalence to a legally marketed predicate device, rather than a detailed study report with specific acceptance criteria and performance metrics typically found in clinical trials for new drug or device approvals.

Therefore, the information about acceptance criteria and detailed study results is very limited in this document. Based on the provided text, here's what can be extracted:

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

The document does not explicitly state numerical acceptance criteria in a table format. However, it implies that the device's performance was evaluated against the predicate device (Quinton, Inc. QuikPrep Electrode System, K782079) regarding ECG waveform morphology, long-term impedance, and safety (skin irritation).

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

• Sample Size: Not explicitly stated. The document only mentions "Clinical studies" and "Some patients."
• Data Provenance: Not specified (e.g., country of origin). The document indicates "Clinical studies," suggesting prospective data collection. It does not mention retrospective data.

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

This information is not available in the provided text. The evaluation method described focuses on comparison to a predicate device and direct observation of physiological effects (ECG morphology, impedance, skin reaction), rather than expert-derived ground truth for diagnostic accuracy.

4. Adjudication method for the test set:

This information is not available in the provided text.

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:

This is not applicable to this device. The SonoPrep IDx System is for preparing skin for ECG monitoring, not an AI-assisted diagnostic tool that would involve human readers interpreting images or data.

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

This is not applicable to this device. The SonoPrep IDx System is a physical device that preconditions the skin, not an algorithm.

7. The type of ground truth used:

The ground truth or reference standard implicitly used for this device's performance evaluation was a comparison to a legally marketed predicate device (Quinton, Inc. QuikPrep Electrode System). The "ground truth" for showing effectiveness involved measuring physiological parameters (ECG waveform morphology, long-term impedance) and observing clinical outcomes (skin irritation) in patients treated with both the new device and the predicate.

8. The sample size for the training set:

There is no mention of a training set. This type of device (skin preparation for ECG) would typically involve clinical testing rather than machine learning training.

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

Since there is no mention of a training set, this information is not applicable.

Ask a specific question about this device