The Bionicare® Stimulator System Model BIO-1000™ is indicated for use as an adjunctive therapy in reducing the level of pain and symptoms associated with osteoarthritis of the knee and for overall improvement of the knee as assessed by the physician's global evaluation (see clinical studies).

Device Description

The Bionicare® Stimulator, Model BIO-1000 is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 + 5 Hertz. Electrodes are applied to the knee and thigh using a standard electrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08), The signal is applied across the cathodic knee electrode and the anodic thigh electrode.

AI/ML Overview

Here's an analysis of the Bionicare Stimulator System, Model BIO-1000, based on the provided 510(k) summary, structured to address your specific points:

K971437: Bionicare® Stimulator System, Model BIO-1000 Analysis

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes a clinical study to demonstrate the device's effectiveness. However, it does not explicitly state pre-defined acceptance criteria in terms of specific thresholds for statistical significance or clinical relevance that the device needed to meet. Instead, it reports the findings of the study.

Acceptance Criteria (Implied)	Reported Device Performance
Safety: Device must not cause unanticipated adverse effects.	No unanticipated adverse effects reported. Skin rash (39% active, 27% placebo) was observed, similar to literature findings for TENS, transient, resolved with intervention, and attributed to electrode gel.
Effectiveness: Must provide "significant improvement" in patients' self-evaluation of pain and physicians' global evaluation of the treated knee in osteoarthritis.	Daily treatment with Bionicare resulted in a clinically relevant and statistically significant reduction in signs and symptoms of osteoarthritis of the knee. Significant improvements in the Bionicare active device group vs. placebo group for:
	* Physician's global evaluation of the treated knee (statistically significant, both absolute and percentage change).
	* Patient's evaluation of pain in the treated knee (statistically significant, both absolute and percentage change).
	* Patient's self-evaluation of knee function showed trends favoring the active device group (not statistically significant).
	* Secondary efficacy outcomes (morning stiffness, knee tenderness, knee circumference) showed trends favoring the active device group.

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

Sample Size: The document does not explicitly state the total number of participants in the clinical study. It refers to it as a "multi-center, prospective, parallel, double-blinded, randomized, placebo device controlled clinical study."
Data Provenance:
- Country of Origin: Not specified in the provided text.
- Retrospective or Prospective: Prospective. The study design is explicitly stated as "multi-center, prospective, parallel, double-blinded, randomized, placebo device controlled clinical study."

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

Number of Experts: Not explicitly stated. The study involved a "physician's global evaluation," implying multiple physicians across the multi-center study.
Qualifications of Experts: The document refers to "physician's global evaluation," implying licensed medical doctors. Specific specializations (e.g., orthopedic surgeon, rheumatologist) or years of experience are not provided.

4. Adjudication Method for the Test Set

The document does not describe an adjudication method for establishing ground truth or resolving discrepancies among experts. Given the subjective nature of "physician's global evaluation" and "patient's self-evaluation of pain," a formal adjudication process may not have been deemed necessary or may not have been reported. The ground truth appears to be based on the individual assessments of the participating physicians and patients themselves.

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

Done?: No, a traditional MRMC study as understood in medical imaging for comparative effectiveness of human readers with vs. without AI assistance was not done. This device is an electrical stimulator, not an AI-powered diagnostic tool interpreting medical images. The comparative effectiveness study was between the active device and a placebo device.
Effect Size of AI assistance: Not applicable.

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

Done?: Yes, in a sense. The clinical study evaluated the Bionicare Stimulator as a standalone intervention (the "active device group") compared to a "placebo device group." The device itself does not involve an AI algorithm that performs a diagnostic or assistive function requiring a "human-in-the-loop" assessment. Its performance is measured by its direct effect on patient symptoms and physician evaluation.

7. Type of Ground Truth Used

The ground truth for effectiveness was established through:

Expert Consensus/Opinion: The "physician's global evaluation of the active device treated knee." This represents the subjective clinical judgment of the treating physician(s).
Patient-Reported Outcomes: The "patient's self evaluation of pain in the treated knee" and "patient's self evaluation of knee function."
Clinical Measurements/Observations: Secondary efficacy outcomes included "morning stiffness, knee tenderness and knee circumference," suggesting objective or semi-objective clinical assessments.

8. Sample Size for the Training Set

Not Applicable. The Bionicare Stimulator System is an electrical medical device and does not involve an AI algorithm that requires a "training set" in the context of machine learning. The clinical study served as a validation (test) set for its effectiveness, not a training set.

9. How Ground Truth for the Training Set Was Established

Not Applicable. As explained in point 8, there is no AI algorithm training set for this device.

Summary

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K971437

JUL 2 2 1997

510(k) SUMMARY Bionicare® Stimulator System, Model BIO-1000 April 15, 1997

This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR & 807,87 and the SMDA.

Submitter of 510(k) and Manufacturer 1.0

Murray Electronics 260 Schilling Circle Hunt Valley, MD 21031

Attention:	Kent C. Hoffman
Telephone:	410 771-0380 extension 231
Facsimile:	410 771-5576

2.0 Name of Device

2.1 Trade/Proprietary Name

Bionicare® Stimulator System, Model BIO-1000

2.2 Common/Usual Name

TENS (Transcutaneous Electrical Nerve Stimulator)

2.3 Classification Name

Transcutaneous electrical nerve stimulator for pain relief (21CFR§ 882.5890, class II).

3.0 Reason for Submitting the 510(k)

We are submitting this 510(k) to notify FDA of our desire to commercially distribute for the first time the Bionicare® Stimulator System, Model BIO-1000.

4.0 Device Description

The Bionicare® Stimulator, Model BIO-1000 is a rechargeable battery operated TENS stimulator that utilizes a voltage regulated output circuit to generate a spike-

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shaped pulse with an adjustable amplitude of 0-12 volts peak and repeating at a single fixed frequency of 100 + 5 Hertz. Electrodes are applied to the knee and thigh using a standard electrode gel, Spectra 360 (Parker Laboratories NDC 341-0012-08), The signal is applied across the cathodic knee electrode and the anodic thigh electrode.

5.0 Indications for Use

The Bionicare Stimulator, Model BIO-1000, is indicated for use in relief of signs and symptoms of osteoarthritis of the knee based on scientific evidence from a multi-center. prospective, parallel, double-blinded, randomized, placebo device controlled clinical study that demonstrated significant improvement in the patient's self evaluation of pain and the physician's global evaluation of the active device treated knee.

6.0 Substantial Equivalence

The Bionicare is substantially equivalent to legally marketed predicate TENS devices. The indications for use and technological characteristics of the Bionicare® Stimulator System, Model BIO-1000 and the three legally marketed predicate devices cited below are substantially equivalent. As summarized in Table A, all the devices are electrical stimulators operating in substantially equivalent output ranges with comparable specifications. Each of the devices is battery powered and has adjustable output amplitudes. The output signals are all monophasic waveforms. The BIO-1000 has a single channel that has a fixed frequency and fixed pulse width in comparison to the predicate single and dual channel stimulators that have variable frequency and variable pulse width. Each device is capable of operating at a frequency of 100 Hertz. The electrical characteristics and the maximum charge of the output pulse of the Bionicare meet the safety and effectiveness requirements of the American National Standards Institute Standard for Transcutaneous Electrical Nerve Stimulators ANSI/AAMI NS4-1985, items 3.1 - 3.1.2.1, 3.2.2 - 3.2.4, 4.2.2 - 4.2.4.

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Table A
Technological Characteristics
Bionicare vs. Predicate Devices

	Applicant Device	Predicate Device	Predicate Device	Predicate Device
Manufacturer	Murray Electronics	Verite	Medgeneral	Medgeneral
Device	Bionicare Stimulator	Veri/PPR	Miniceptor	Miniceptor
Model No.	BIO-1000	#800	I	II
OutputVoltage	0-12 volts	0-67 volts	0-100 volts	0-90 volts
Frequency	100 Hertz	1-125 Hertz	25-100 Hertz	25-100 Hertz
Pulse Width	.64 ms1	.05 - .50 ms2	.04 - .10 ms3	.04 - .10 ms3
Waveform	monophasicspike-pulse	monophasicsloped-pulse	monophasicsquare-pulse	monophasicsquare-pulse
Pulse ChargeMax	20 $ μ C $	NA5	NA	NA
ANSI NS44	Meets	NA	NA	NA
Channels	single	dual (single control)	single	dual
Battery Power	12 v rechargeable	67.5 v	rechargeable	rechargeable
Dimensions	13.2 x 8.5 x 4.5 cm	10.8 x 6.4 x 3.2 cm	10.2 x 5.1 x 2.6 cm	10.2 x 5.1 x 2.6 cm
Weight(Less Battery)	235 grams	237 grams	176 grams	179 grams
Charger	yes	no	yes	yes

1 Pulse width fixed, measured at 50% pulse amplitude

2 Pulse width variable, range in product literature

3 Pulse width adjustable, range in product literature

4 The maximum charge per pulse meets the safety and effectiveness requirements of ANSI/AAMI NS4-1985, items 3.1-3.1.2.1, 3.2-3.2.5, 4.1-4.2.3.2

5 NA - Not Available from the data found.

The descriptive characteristics presented were precise enough to ensure the substantial equivalence of the Bionicare to legally marketed predicate devices. The descriptive characteristics included the data provided in the device comparison table above, as well as, the findings of performance and clinical testing. In particular, the performance data provides greater detail regarding the Bionicare's electrical characteristics, its conformance with voluntary standards and its safety and efficacy, as reported in a double-blinded, placebo device controlled study.

The findings of this multi-center, prospective, parallel, double-blinded, randomized, placebo device controlled study demonstrate that the Bionicare Stimulator when used daily is safe and effective in the treatment of the signs and symptoms of osteoarthritis of the knee. These findings are summarized below.

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Safety

There were no reports of unanticipated adverse effects in this study. As anticipated, skin rash appeared in both the active and placebo device group, 39% and 27% respectively. The rash was transient and completely resolved after stopping or changing the electrode gel. The rash appears to be due to the sustained use of the electrode gel. The observed frequency of skin reactions reported herein appear similar to those reported in the literature for studies of TENS and muscle stimulator devices using comparable gels. Propylene glycol, a common ingredient in approved gels, is a skin irritant that may be in part the cause of these reactions.

Effectiveness

Daily treatment with the Bionicare stimulator resulted in a clinically relevant and statistically significant reduction in the signs and symptoms in the knees of patients affected by osteoarthritis. A repeated measures analysis of the primary clinical outcome data collected in this study demonstrated significant improvements in the Bionicare active device group compared to the placebo device group for the physician's global evaluation of the treated knee and the patient's evaluation of pain in the treated knee. The significant improvements for these clinical outcomes were reported both in terms of the absolute change and their percentage of change. The patient's self evaluation of knee function was not statistically significant, but showed trends favoring the active device group. Secondary efficacy outcome measures showed trends favoring the active device group. In particular, the trends in the measure of morning stiffness, knee tenderness and knee circumference favored the active device group.

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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the circumference. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

JUN - 8 2006

Mr. Kent C. Hoffman Director, Research and Development Murray Electronics 260 Schilling Circle Hunt Valley, MD 21031

K971437 Bionicare Stimulator System Model BIO-1000 Regulatory Class: II Product Code: NYN Dated: July 18, 1997 Received: July 21, 1997

Dear Mr. Hoffman:

This letter corrects our substantially equivalent letter of July 22, 1997.

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general 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 (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Eederal Register.

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Page 2 - Mr. Kent C. Hoffman

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good minned to: 10g.stration and institute (s as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to continue marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark McMillan

Mark N. Melkerson, M.S Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

Image /page/5/Picture/7 description: The image shows a circular logo for the FDA Centennial. The logo features the letters "FDA" in a bold, sans-serif font, stacked on top of the word "Centennial". Above the letters "FDA" are the numbers "1906-1906". Below the word "Centennial" are three stars. The entire logo is surrounded by a circular border with text that is difficult to read due to the image quality.

Protecting and Promoting Public Health

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Device Name

Bionicare® Stimulator System, Model BIO-1000™

Indications For Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109)

Thomas J. Callahon

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

510(k) Number _

(Optional Format 1-2-96)

Regulation Number and Section

§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.

(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).