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The B SMART Sensory Response Timer is indicated for use in evaluating neurological status during surgery under regional anesthesia by monitoring the capability of the patient to detect and to respond to a timed series of mechanical and auditory stimuli.

The B SMART Sensory Response Timer system consists of two components connected by an electrical cable. These components are a Control Unit and a Finger Attachment. The Control Unit contains a power supply, a cycle timer, an audio tone generator and speaker, and necessary controls, indicators, and connectors. The Finger Attachment contains a vibratory tactile stimulus mechanism and an impedance-pad-type cycle reset button housed in a small case which is attached to the patient's finger using a Velcro band. When the patient feels the vibratory stimulus (or hears the speaker tone), he or she presses the cycle reset button to terminate the stimuli. Cessation of the audio tone informs the attending physician or nurse that the patient is awake and able to respond. If the audio tone does not cease, the anesthesiologist is alerted that intervention may be needed due to impairment of neuromuscular responsiveness.

Here's a breakdown of the acceptance criteria and study information for the B SMART system, based on the provided 510(k) summary:

Acceptance Criteria and Device Performance

The provided document describes the performance of the device rather than explicit, pre-defined acceptance criteria in a quantifiable table format. However, the study results implicitly define the device's acceptable performance. For clarity, I will interpret the reported outcomes as the de facto acceptance criteria demonstrated by the study.

Study Details:

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

   • Sample Size: 47 patients.
   • Data Provenance: The study was conducted by Buchbinder and Melick over a period of three years. The information does not explicitly state the country of origin, but the 81st Clinical Congress of the American College of Surgeons was held in New Orleans, LA, suggesting a U.S.-based study. The study appears to be prospective in nature, as it describes monitoring patients during actual surgical procedures.

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

   • The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience").
   • However, the study involved monitoring patients during carotid endarterectomy under regional anesthesia, where anesthesiologists and surgeons would be the primary clinicians overseeing patient neurological status and making decisions based on the device's feedback and their clinical judgment. "Neurological dysfunction was detected in three patients (6.4%) and was treated successfully by immediate insertion of a temporary shunt," suggesting clinical expert judgment was involved in confirming and acting on detected issues.

3. Adjudication method for the test set:

   • The document does not specify a formal adjudication method (e.g., 2+1, 3+1). The nature of the study seems to be direct clinical observation and intervention based on the device's output and the operating team's assessment.

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, an MRMC comparative effectiveness study was not done. The B SMART system is a "patient-activated stimulus/response system" that monitors neurological status, not an AI-assisted diagnostic imaging tool with "human readers." The study focuses on the device's ability to monitor patient responsiveness during surgery.

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

   • The B SMART system is inherently a human-in-the-loop device. It relies on a patient's volitional response (pressing a button) to a stimulus. Therefore, a standalone "algorithm only" performance would not be applicable or clinically meaningful for this device's intended use. The device's function is to assess patient response, which requires the patient's active participation.

6. The type of ground truth used:

   • The ground truth appears to be clinical outcome/patient responsiveness during surgery, as assessed by the medical team. The detection of "neurological dysfunction" and subsequent "successful treatment by immediate insertion of a temporary shunt" indicates that actual clinical events and interventions served as the reference for the device's effectiveness in identifying issues.

7. The sample size for the training set:

   • The document does not mention a separate training set. The study cited (Buchbinder and Melick) describes the performance of a "prototype version" of the B SMART system, which suggests this was an evaluation of the device in its near-final or tested form, rather than a separate training phase. As a relatively simple mechanical/electrical device assessing a physiological response, it's unlikely to have relied on a "training set" in the way an AI/ML algorithm would.

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

   • Since no separate training set is described for an AI/ML algorithm, this question is not applicable.

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