The BioniCare® Stimulator, 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 (clinical studies.)

Device Description

The BioniCare® Stimulator, Model BIO-1000™ consists of the electrodes, the lead wires, and the BioniCare Stimulator. The stimulator is portable, battery operated and rechargeable. The lead wires connect the electrodes to the stimulator. These electrodes complete an electrical circuit allowing current flow. The stimulator produces a pulsed electrical signal through the lead wires and electrodes at the treatment site.

AI/ML Overview

This document is a 510(k) Summary for the BioniCare® Stimulator, Model BIO-1000™, a transcutaneous electrical nerve stimulator for pain relief associated with osteoarthritis of the knee. The document focuses on comparing the new device (Version B) to its predicate device (Version A) regarding technological characteristics and demonstrating substantial equivalence.

Based on the provided text, the complete information regarding acceptance criteria and a study proving the device meets them cannot be fully extracted for the following reasons:

No explicit "acceptance criteria" table is present. The document describes technological characteristics and claims substantial equivalence to a predicate device. It does not define specific performance metrics with target thresholds that the device must meet independently.
No specific study designed to "prove the device meets acceptance criteria" is detailed. The document refers to "clinical studies" in the "Indications for Use" but does not provide details about these studies, their methodology, or their results in relation to specific performance criteria for the new device itself. The focus is on comparing the technological characteristics of the new device (Version B) against the predicate device (Version A).

Therefore, a table of acceptance criteria and reported device performance, and the detailed study information requested, cannot be fully generated from the provided text.

However, I can extract and infer some related information:

1. A table of acceptance criteria and the reported device performance

As mentioned, explicit acceptance criteria (e.g., minimum pain reduction % or specific improvement scores) are not provided for the new device. The document focuses purely on the technological equivalence to the predicate device.

Acceptance Criteria (Implied)	Reported Device Performance (Version B vs. Version A)
Electrical Output (Frequency): Same as predicate device	Same frequency at 100 ± 5Hz, fixed.
Waveform: Same as predicate device	Same monophasic spike shaped pulse.
Voltage Output Range: Same as predicate device	Same 0-12 volts peak.
Voltage Pulse Width: Same as predicate device	Same
Current Output Range: Same as predicate device	Same
Current Pulse Width: Same as predicate device	Same
Maximum Output Change/Channel: Same as predicate device	Same
Compliance with ANSI/AAMI NS-4: 1988: Same as predicate device	Both Version A and Version B comply with the standard ANSI/AAMI NS-4: 1988.
Ability to reduce pain and symptoms associated with OA of the knee and improve overall knee assessment: Implied to be equivalent due to technological equivalence.	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 (clinical studies.)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The document refers to "clinical studies" in its Indications for Use, but offers no details about these studies, including sample size, design (retrospective/prospective), or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. The document doesn't detail any specific "test set" or how its ground truth was established. The clinical context mentioned refers to "physician's global evaluation," implying expert assessment, but the number or qualifications of these physicians are not given.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the document.

5. 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

This is not applicable as the device is a transcutaneous electrical nerve stimulator, not an AI-assisted diagnostic tool for human readers. There is no mention of an MRMC study or AI assistance.

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

This is not applicable as the device is an electrical stimulator, not an algorithm. Its performance is in delivering electrical signals to the body, not interpreting data or making diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "Indications for Use" states that the device is indicated for reducing pain and symptoms and for "overall improvement of the knee as assessed by the physician's global evaluation (clinical studies)." This implies that expert assessment (physician's global evaluation) was a key type of outcome/ground truth in the underlying "clinical studies." However, no details on how "ground truth" was established for any specific "test set" for the new device's performance validation are provided.

8. The sample size for the training set

This information is not provided as the device is a hardware stimulator and not an AI/machine learning algorithm that requires a "training set."

9. How the ground truth for the training set was established

This information is not applicable as the device does not use a "training set."

Summary

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Attachment E

510(k) Summary

Submitter Information:

Kent Hoffman Chief Operating Officer BioniCare Medical Technologies Inc. 47 R. Loveton Circle Sparks, MD 21152 (410) 472-1888

Date Prepared:

January 30, 2003

Name and Classification of Device:

Transcutaneous electrical nerve stimulator for pain relief Class II Regulation - 21 CFR 882.5890 Product Code -- 84GZJ

Device:

BioniCare® Stimulator, Model BIO-1000™

Predicate Device:

Bionicare® Stimulator, Model BIO-1000™

Device Description:

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Statement of Intended Use:

Summary of Technological Characteristics of New device compared to Predicate Device:

The Bionicare Model BIO-1000™ Version A, and the BioniCare® Model BIO-1000 Version B, systems generate the same electrical output. The analog circuit of Version A and the digital circuit of Version B produce the same frequency at 100 ± 5Hz, fixed.

The analog circuit of Version A and the analog circuit of Version B produce the same waveform as a monophasic spike shaped pulse.

The analog circuit of Version A and the digital circuit of Version B produce the same voltage output range which is 0-12 volts peak. Version A has a single channel of output and version B has two channels of output. The voltage pulse width, current output range, current pulse width, and maximum output change/channel are the same for Version A and Version B.

The output of Version A is displayed on red and green LEDs. The output on Version B is displayed on a LCD as numeric values in the range of the 0.0 to 12.0 volt output.

The twelve volt battery of Version A and the nine volt battery of Version B both produce the same output voltage over the range of 0.0 to 12.0 volts. Version A and Version B both comply with the standard ANSI/AAMI NS-4: 1988.)

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville, Maryland 20850

JUN - 8 2006

Mr. Kent Hoffman Chief Executive Officer BioniCare Medical Technologies, Inc. 47 R Loveton Circle Sparks, MD 21152

Re: K030332

Trade/Device Name: BioniCare® Stimulator Model BIO-1000™ Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NYN Dated: May 9, 2003 Received: May 9, 2003

Dear Mr. Hoffman:

This letter corrects our substantially equivalent letter of June 6, 2003.

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 Federal Register.

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Page 2 – Mr. Kent 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 I oderal agencies: " Fou may comply 1 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements 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 This lotter will and w you to comment The FDA finding of substantial equivalence of your device 510(t) promanteeted 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 10 galation onlines, "Thisolation on your responsibilities under the Act 0017777 - Fouring 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 M. Wilkerson

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

Enclosure

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1 Promoting Public . Health

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Attachment C

Indications for Use Statement

Device Name

BioniCare® Stimulator, Model BIO-1000™

Indications for Use

The BioniCare® Stimulator, Model BIO-1000™ is indicated for use as an adjunctive The Diolicate "Stimulator, Model Dro" 1000 - 1000 - 1000 - 1000 - 1000 - 100 - 100 therapy in roducing the lover of the knee as assessed by the physician's global evaluation (clinical studies.)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use: (Per 21 CFR 801.109) OR Over-the-Counter Use

(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).