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The EpiFinder is intended for use, in between a luer Loss of resistance (LOR) syringe and an epidural needle, to verify the needle tip placement in the epidural space as a secondary indicator adjunctive to the LOR technique.

The EpiFinder is intended to be used in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator, giving the practitioner a clear visual signal that the needle tip has entered the epidural space. The EpiFinder is a sterile, single-use device that is used during epidural procedures. The device works with a standard loss of resistance (LOR) syringe and an epidural needle (18G) to verify that the needle tip placement is in the epidural space in patients ages 18 or older.

The EpiFinder consists of a blunt tip spring-loaded probe that is installed into a standard epidural needle, and a plastic housing that is composed of a linear actuator, a sensor, and a microcontroller that measures the probe spring's contraction. The EpiFinder is attached to a Tuohy needle that has been inserted into the patient. The device has built in "wings" to help advance the needle, if the practitioner wishes to use them. As the needle advances forward, there are LED indicator lights on the housing that give feedback to the operator as to when the epidural space is entered, as input to the user in conjunction with the standard LOR technique.

Here's an analysis of the acceptance criteria and study information for the EpiFinder device, based on the provided text:

Important Note: The provided text does not explicitly list acceptance criteria in a quantitative table format with pass/fail metrics. Instead, it describes various performance evaluations and concludes that the device's performance was "appropriate," "effective," and "similar to standard practice." Therefore, the table below will summarize the reported device performance based on the described studies, indicating what was evaluated and the general outcome.

Acceptance Criteria and Reported Device Performance

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Animal Study (Pigs): "Numerous test sites" (specific number not given) were randomly divided into two groups: Group 1 (EpiFinder + standard LOR technique) and Group 2 (standard LOR technique alone). The study was conducted in compliance with OECD principles of Good Laboratory Practice (GLP) ENV/MC/CHEM (98)17 (except for blood analysis).
   • Human Factors Evaluation: 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs).
   • Clinical Evaluation: 31 adult subjects.
   • Data Provenance: The animal study was noted as GLP compliant, implying a controlled, prospective design. The human factors and clinical evaluations would also be prospective studies. The country of origin for the animal and clinical studies is not explicitly stated, but the company address is in Israel.

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

   • Animal Study: Ground truth was confirmed using X-ray and contrast medium. No specific number of experts or their qualifications are mentioned for interpreting these confirmations.
   • Human Factors: The "experts" were the participating 16 anesthesiologists (physicians) and 10 student resident nurse anesthetists (sRNAs) who evaluated usability. Their feedback contributed to assessing safety and usability.
   • Clinical Evaluation: Ground truth for epidural space identification during the clinical trial is implied to be clinical assessment by the performing physicians, potentially combined with the standard LOR technique used concurrently. The text mentions "The performance of the device was also established, demonstrating that the device is capable of correctly identifying the epidural space during the injection procedure." No specific number of independent experts or their detailed qualifications for establishing ground truth are explicitly stated beyond the clinical team performing the procedures.

3. Adjudication method for the test set:

   • The document does not describe a formal adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth in any of the studies.
   • In the animal study, confirmation was via X-ray and contrast medium, which typically involves interpretation by a radiologist or veterinary specialist, but a specific adjudication process isn't detailed.
   • In the clinical evaluation, the "correctly identifying the epidural space" implies the clinical judgment of the performing physician was the primary determinant, likely corroborated by the LOR technique.

4. 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:

   • No MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is compared. The EpiFinder is a physical device with an indicator (LEDs) and functions adjunctively to the standard LOR technique, rather than being an AI diagnostic tool primarily interpreted by human readers.

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

   • The EpiFinder is designed to be used "in conjunction with a standard epidural LOR technique as an independent secondary confirmatory indicator." It provides a "clear visual signal" via LEDs. Therefore, its performance is inherently "human-in-the-loop" as it provides feedback to the operator. The animal study did evaluate the device's signal in conjunction with the standard LOR technique, and its effectiveness was confirmed against X-ray and contrast.

6. The type of ground truth used:

   • Animal Study: Radiographic confirmation (X-ray and contrast medium).
   • Clinical Evaluation: Clinical identification of the epidural space by performing physicians, presumably leveraging the concurrent standard LOR technique. The device's ability to "correctly identify" the space refers to its agreement with this clinical assessment.

7. The sample size for the training set:

   • The document describes performance evaluation studies (validation studies) for the EpiFinder. It does not provide information about a "training set" as this device is a hardware product with a pre-programmed microcontroller/firmware, not a machine learning (AI) algorithm that undergoes a training phase with a distinct dataset. Software verification and validation were performed, but this typically involves testing inputs/outputs against specifications, not learning from a dataset.

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

   • Not applicable, as there is no mention of a "training set" in the context of an AI/machine learning model. The software is described as "pre-programmed software (firmware)," implying it's deterministic based on its design specifications, not trained on data.

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