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Northstar System is indicated for the administration of lidocaine hydrochloride to provide local dermal anesthesia on normal intact skin. This system is an alternative to hypodermic injection or topical application of lidocaine hydrochloride.

Northstar System is indicated for use on patients 5 years of age and older.

The Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System) is composed of the Controller and the pre-medicated Patch. The Controller is fitted with a unique interconnect device, mating only with the Northstar Patch.

The Northstar System delivers drugs through a process known as iontophoresis. It is based on the principle that a soluble salt or drug can be transported across the skin barrier as a part of an electric current induced in the skin.

The quantity and distribution of delivered drug(s) is dependent on; ion charge, molecular weight, the intensity of the electric current and the time the current is present. In most iontophoretic systems the delivery is measured in terms of milliampere-minutes (mA-min).

It has been shown that the efficacious delivery of anesthetic levels of lidocaine hydrochloride can be made to local dermal areas through iontophoresis.

The Northstar Controller-D uses a combination of discrete analog circuitry to control the delivery current and an embedded microprocessor to monitor the delivery.

The Northstar System utilizes a solid-state electronic controller and a pre-medicated drug delivery patch to form a simplified iontophoretic drug delivery system. As a result of this product design coordination, the Northstar System requires no special patch preparation or delivery parameter selection in the controller. An ON button actuation turns on an LCD (Liquid Crystal Display) indicating the number of deliveries available, starts the delivery and two LED's (Light Emitting Diodes) on the controller indicate the delivery status to the user.

The Northstar System has been specifically designed for the delivery of a proprietary preparation containing 10.0% Lidocaine hydrochloride and 1.0% Epinepherine packaged in a pre-filled patch. The delivery is done over a 10 minute interval. The user simply applies the patch to the patient, connects the controller and patch then depresses the ON button to start the delivery.

The provided text describes the Northstar Lidocaine Iontophoretic Drug Delivery System (Northstar System), which gained 510(k) clearance. The focus of the provided document is on the device itself (the controller) and its substantial equivalence to a predicate device, rather than a detailed clinical study report with acceptance criteria and specific performance metrics.

Therefore, the following information is extracted and inferred from the given text.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for the device performance but rather focuses on its ability to deliver the electrical current required for the intended use and its safety and efficacy as a system.

2. Sample Size Used for the Test Set and Data Provenance

The document states that Phase III clinical studies were conducted, but does not specify the sample size for these studies.

• Data Provenance: The studies were prospective Phase III clinical studies conducted to provide safety and efficacy data for a New Drug Application (NDA) (N21-504) to CDER at the FDA. The country of origin of the data is not specified in this document.

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

The document does not provide information regarding the number of experts or their qualifications used to establish ground truth for the test set. Given that it's a drug delivery system for local anesthesia, ground truth would likely be based on objective measures of pain reduction or numbness, potentially reported by patients and assessed by clinicians.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or reported in this document. The study described focuses on the efficacy of the device-drug system itself, not on human readers interpreting outputs or improving with AI assistance, as there is no AI component mentioned.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable as the described device is an iontophoretic drug delivery system, not an algorithm or AI system. The "performance" refers to the system delivering the drug and achieving local anesthesia in patients.

7. Type of Ground Truth Used

The ground truth for the clinical studies would be related to the patient's response to local dermal anesthesia, likely assessed through clinical observations, patient-reported pain scales, or objective measures of numbness. The document refers to "safety and efficacy data" from the Phase III clinical studies supporting the indication of local dermal anesthesia.

8. Sample Size for the Training Set

The document does not specify a training set in the context of an algorithm. The term "training set" is typically used in machine learning. For a medical device, there would be development and testing phases, but not a "training set" in the AI sense.

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

This is not applicable as there is no mention of an algorithm training set. The clinical studies establish the safety and efficacy of the system as a whole.

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