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.

Device Description

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.

AI/ML Overview

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.

Acceptance Criteria (Interpreted)	Reported Device Performance
Successfully employed in patients	95.7% (45 of 47 patients)
Monitor proper sensory and motor function	93.6% (44 of 47 patients)
Detect neurological dysfunction	Detected in 3 patients (6.4%) and successfully treated
Quick and convenient operational verification	Operator can verify mechanical stimulus, audio tone reset, and cycle timing
Conform to radiated emissions specifications	Passed Electromagnetic compatibility testing
Meet EMI immunity standards	Passed Electromagnetic compatibility testing

Study Details:

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.
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.
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.
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.
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.
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.
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.
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.

Summary

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K961817

510(k) SUMMARY

1.	COMPANY INFORMATION
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JUL 2 3 1997

Hayashi Denki Co., Ltd. Name (Manufacturer) . Name (U.S. Agent) Koven Technology, Inc. . 7-11 Arima, 2-Chome Address (Manufacturer) •• Miyamae-ku Kawasaki 216, Japan Address (U.S. Agent) 300 Brookes Drive, Suite 105 . St. Louis, MO 83042 Telephone (Manufacturer): 011-81-44-877-4361 Telephone (U.S. Agent) : (314) 731-0008 Mr. Paul G. Koven, President Contact Person : Koven Technology, Inc. 300 Brookes Drive, Suite 105 St. Louis, MO 83042 (314) 731-0008 May 8,1996 Date Prepared . Revised October 10, 1996 Revised June 11, 1997 DEVICE NOMENCLATURE. B SMARTTM (Buchbinder Sensory Trade Name .

Motor Activated Response Timer) Common Name Sensory Response Timer . Evoked Response Mechanical Classification Name . • Stimulator [84 GZP, 882.1880]
3 . PREDICATE DEVICE.

Nicolet BiomedicalInstruments Corp.	: Expert Sleep/Wake AnalysisSystem
510(k) Number	: K873535
SE Decision	: October 26, 1987

4 • DEVICE DESCRIPTION.

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 complete system is shown in Figure 1.

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Image /page/1/Picture/0 description: The image shows a white box with the word "BSMART" printed vertically on the left side. To the right of the box, there is a coiled cable with a white connector at the end. The background appears to be a textured surface, possibly a table or countertop.

Figure 1. B SMART System (Control Unit and Finger Attachment)

The Control Unit contains a power supply, a cycle timer, an audio tone generator and speaker, and necessary controls, indicators, and connectors. There are three controls: the power on/ off switch, the stimulus cycle selector switch which is used to set the interval between successive activations of the stimulator, and an audio tone volume control. The indicators are power-on and battery status (an LED indicator). The connector is a 3.5mm mini-tip receptacle for the interconnect cable. A block diagram of the Control Unit is shown in Figure 2 below:

Image /page/1/Figure/3 description: This image is a block diagram of a system. The diagram includes blocks labeled "CLOCK GENERATOR", "TIMER SELECTOR", "OUTPUT DRIVER", "POWER SUPPLY", and "PATIENT STIMULUS (VIBRATOR)". There are also labels for "VOLUME CONTROL", "SPEAKER", "POWER SWITCH", and "RESET SWITCH", which are connected to the blocks via lines and arrows, indicating the flow of signals or power.

Figure 2. Block Diagram of Control Unit

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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 When the patient feels the vibratory stimulus a Velcro band. (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.

For special situations, additional Finger Attachments (up to a total of four) may be connected to a single Control Unit for multiple-site monitoring.

The Stimulus Cycle Selector Switch is a manual slide switch that controls the interval between automatic activations of the patient stimulus test cycle. Any of three intervals may be selected by the operator. The available interval settings are 30, 60, and 120 seconds.

The system is powered by two AA-size 1.5-volt alkaline Total voltage is 3 volts DC. Upon power turn-on, an batteries. LED indicator on the Control Unit flashes on and off for 10 seconds to indicate that battery charge status is adequate for proper operation. If the light fails to come on or no audio tone is heard, the exhausted batteries should be replaced with two AA-size alkaline batteries.

5. INTENDED USES.

6. COMPARISON WITH PREDICATE DEVICE.

The subject device, the B SMART system is a patientactivated stimulus/response system intended for use in monitoring neurological status during carotid endarterectomy and related cerebrovascular surgical procedures performed using local or regional anesthesia. The literature states that adequate monitoring is vital during carotid endarterectomy whether performed under general or regional anesthesia to insure that adequate cerebral perfusion is maintained. In addition to ECG and blood pressure monitoring, many different methods of neurological monitoring are in use to detect evidence of cerebral ischemia early enough so that appropriate counter-measures can be instituted.

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The choice of monitoring methods is partly determined by the type of anesthesia selected. Many of the institutions where local or regional anesthesia is used during carotid surgery employ very simple monitoring techniques. For example, the anesthesiologist will ask the patient to respond to a handgrip or verbal questions at frequent intervals. Some hospitals use squeeze toys, and others have used fluid-filled plastic bags connected to a pressure transducer.

Although the exchange of hand grips between patient and anesthesiologist, squeeze toys, and fluid-filled bags all have
the same intended use as the B Smart system, they are not cleared medical products. It is therefore necessary to compare the B SMART system with more sophisticated equipment capable of being used for the same purpose.

Electroencephalography (EEG) is probably the most widely used form of physiologic monitoring cerebrovascular It's use is virtually standard in those patients surgery. operated on under general anesthesia. Many surgeons who prefer local or regional anesthesia employ EEG monitoring also. Although conventional EEG is often used, many hospitals employ EEG instrumentation equipped with a computer processing accessory as an aid in interpreting results, which can be difficult if personnel with specific EEG training are not available to assist the anesthesiologist.

The predicate device, the Nicolet Expert Sleep/Wake Analysis System, is a computer processing accessory for use in analyzing EEG and other physiologic signals for the evaluation of waking and sleeping states. Although the program is optimized for use in sleep disorder laboratories, the EEG analysis programming incorporated in the Nicolet system is very similar to the several versions of "processed EEG" widely used in carotid endarterectomy monitoring. When used in the awake patient during surgery under local or regional anesthesia, processed EEG systems monitor the neurological status of the patient and detect lapses into unconsciousness signifying the onset of cerebral ischemia. Therefore, an an approved computerized EEG processing accessory, the Nicolet Expert Sleep/Nake Analysis System, was selected as the predicate device for the B SMART system because it is capable of performing the same function in the same type of patient in the same surgical environment as the subject device.

7. PERFORMANCE DATA.

Buchbinder and Melick studied the performance of a prototype version of the B SMART system over a period of three years in 47 patients in whom carotid endarterectomy was performed under regional anesthesia. Results were reported in a scientific exhibit presented at the 81st Clinical Congress of the American College of Surgeons, New Orleans, LA, October 22-27, 1995.

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The B SMART system was employed successfully in 45 of the 47 patients (95.7%). Two patients (4.3%) could not be monitored satisfactorily due to motor impairment caused by partial paralysis from prior cerebral vascular accidents. Monitoring demonstrated proper sensory and motor function during endarterectomy in 44 patients (93.6%). Neurological dysfunction was detected in three patients (6.4%) and was treated successfully by immediate insertion of a temporary shunt.

The B SMART system permits quick and convenient verification of proper operation. Before placement on the patient, the operator can mount the Finger Attachment on his or her own finger and check that the mechanical stimulus is activated and that the cycle reset button turns off the audio tone and that the next stimulus/response cycle occurs at the selected time. A watch may be used to verify performance of the cycle selector switch on the Control Unit.

Electromagnetic compatibility testing was conducted by an independent laboratory. Test results demonstrated that the auditory and vibratory signals produced by the B SMART system conform with specifications for radiated emissions and thus will not cause electromagnetic interference (EMI) with other equipment used in the same environment. The B SMART system was also found to meet EMI immunity standards is that operating integrity is maintained in the presence of electromagnetic signals generated by other emission sources.

8. CONCLUSION .

The intended use of the B SMART Sensory Response Timer is identical to one of the potential diagnostic uses -- monitoring consciousness during carotid endarterectomy under regional anesthesia--for which the predicate device may be employed. The subject device raises no new questions concerning safety or effectiveness. All pertinent product data and all required certifications have been filed with the Food and Drug Administration. Koven Technology, Inc. concludes that the subject device is substantially equivalent to devices of the same classification previously legally introduced into interstate commerce in the United States.

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Image /page/5/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, facing right. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the top and bottom of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Paul G. Koven President and Official Correspondent Koven Technology, Inc. 300 Brookes Drive, Suite 105

Re: K961817 Trade Name: B SMART Buchbinder Sensory Motor Activated Response Timer Regulatory Class: Unclassified Product Code: 84LEL Dated: June 18, 1997 Received: June 19, 1997

Dear Mr. Koven:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The qeneral controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. Paul G. Koven

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radioloqical Health

Enclosure

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Page 1 of 1

K961817 516(k) Number (if known): _

Device Name: B SMART Buchbinder Sensory Motor Activated Response Timer

Indications For Use:

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.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Thomas J. Callahan

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number

Prescription Use X (Per 21 CFR 801.109)

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5050 Biofeedback device.

(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.