The OrthMon system is intended for use to record, monitor and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Device Description

The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.

The system performs these functions automatically or manually and uses several neurophysiological techniques including: free run and stimulus evoked electromyography (EMG), transcranial electrical motor evoked potentials and train of four.

The main OrthoMon system components include: the console, housing the computer, controller and sensory and motor evoked potential electrical stimulator and patient module located at the OR table to route stimuli to the appropriate sites and electrode preamplifier harness. The electrode harnesses contains 8 recording sites. Each site connects to a quick-apply disposable surface electrode.

A pre-sterilized, disposable, hand-held, microprocessor controlled probe operated by the surgeon, connects to the patient module. The probe directs stimulation to the appropriate site, controls certain test functions and settings and provide visual indication of test results.

The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.

The system is network compatible for data review within the hospital and permits secure information access over the Internet.

Technologically, OrthoMon is similar to the predicate devices. The exceptions are the use of a surgeon controlled probe to select certain test functions and to direct the stimulation: and use of quick-apply disposable surface electrodes.

OrthoMon was tested functionally using accepted laboratory test procedures.

AI/ML Overview

This 510(k) summary does not contain the detailed study results and acceptance criteria typically found in a clinical study report. The document is primarily a premarket notification for a medical device, focusing on substantial equivalence to predicate devices rather than direct performance metrics against predefined acceptance criteria from a standalone study.

However, based on the provided text, we can infer some information about the device's functional testing and claims of effectiveness.

Here's an attempt to answer your questions based solely on the provided text, with many fields explicitly stating that the information is "Not provided in the text" as a detailed study was not presented:

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

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Functionality: System performs intended neurophysiological techniques (EMG, evoked potentials, train of four).	"OrthoMon was tested functionally using accepted laboratory test procedures."
Safety: Device is safe for intraoperative use.	"Based on the technical information provided in this 510(k) and the safety and effectiveness criteria of the design and development process, validated and verified, we claim the OrthoMon to be safe, effective..."
Effectiveness: System effectively records, monitors, and stimulates biopotential signals; assists in localization/assessment of spinal nerves; verifies spinal instrumentation placement.	"...effective and substantially equivalent to the predicate device(s) noted." and "The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots."
Substantial Equivalence: Device is similar in technology and intended use to predicate devices.	"Technologically, OrthoMon is similar to the predicate devices." (and implicitly accepted by FDA clearance)

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

Sample Size for Test Set: Not provided in the text. The document refers to "accepted laboratory test procedures" for functional testing but does not detail a specific clinical test set or its size.
Data Provenance: Not provided in the text. There is no mention of country of origin or whether any data was retrospective or prospective.

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)

Not provided in the text. The document does not describe the establishment of a ground truth for a test set by external experts. The claims of safety and effectiveness are based on "the design and development process, validated and verified" by the manufacturer.

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

Not provided in the text. No adjudication method is mentioned as there's no detailed study describing expert review or consensus for a test set.

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

Not applicable. The OrthoMon system is an intraoperative neural monitoring system, not an AI-assisted diagnostic imaging device that involves "human readers" in the sense of interpreting images. Therefore, an MRMC comparative effectiveness study involving human readers improving with AI assistance is outside the scope of this device's function as described.

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

The device itself is a standalone system for monitoring and stimulating, though it is used by surgeons and OR teams and provides "feedback to the surgeon and OR team." The document states it "performs these functions automatically or manually." While it can operate automatically, the "performance" described isn't an algorithm that independently makes diagnoses or decisions without human interaction on a case. No specific "standalone algorithm performance" study, distinct from its integrated use, is mentioned.

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

Not provided in the text. For the functional testing, ground truth would likely refer to established physiological responses and electrical measurements, but the method for establishing this "ground truth" (e.g., against a gold standard instrument) is not detailed.
- For the claims of assisting in nerve localization and avoiding injury, the "ground truth" in efficacy would ultimately be the actual state of nerve integrity and accurate placement, but no specific method for validating this using pathology or outcomes data is described in this summary.

8. The sample size for the training set

Not applicable/Not provided. The OrthoMon system is described as using neurophysiological techniques for monitoring and stimulation, not as a machine learning or AI algorithm that requires a "training set" in the conventional sense for model development. The "design and development process" implied internal testing and validation.

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

Not applicable/Not provided. As no training set for an AI model is described, there's no mention of how its ground truth would be established.

Summary

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MAY 2 3 2006

: 3

510(k) Summary

This 510(k) summary of safety and effectiveness is being submitted in accordance with the requirements of CFR 807.92.

Summary Date:Submitter'sInformation:	April 14, 2006Howard BailinVice President, C.O.O.Axon Systems, Inc.400-2200 Oser AveHauppauge, NY 11788P: 631 436 5112F: 631 436 5141hbailin@axonsystems.com
Trade Name:	OrthoMon
Common Name:	EMG monitor, Evoked Potential System
ClassificationName:	Evoked Response, Electromyograph
Classification:	Number:882.1870 Electromyograph Monitor, Surgical NerveStimulator/Locator, Diagnostic Electromyograph,Evoked Response Stimulator
Product Codes:	GWF, IKN
Predicate Devices	Axon Systems: Eclipse Neurological Workstation (K050798)NuVasive: Neurovision JJB (K051384)Datex-Ohmeda: M-NMT Neuromuscular TransmissionModule (K955026)

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Description: The Orthomon system provides continuous, 8 channel, monitoring of neural motor pathways intraoperatively and is used to locate and assess spinal nerves, verify placement of orthopedic instrumentation in order to reduce the risk of nerve root injury and to access spinal cord motor function.

The OrthoMon interface is a touch screen with optional keyboard and mouse. A built-in speaker may be used for audible EMG or signal trigger tones.

The system is network compatible for data review within the hospital and permits secure information access over the Internet.

OrthoMon was tested functionally using accepted laboratory test procedures.

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Image /page/2/Picture/0 description: The image shows the logo for Axon Systems. The logo is in black and white and features the word "AXON" in large, bold letters. Below the word "AXON" is the word "SYSTEMS" in smaller letters. To the right of the logo is the text "pg 3:3" in a handwritten font.

The OrthMon system is intended for use to record, monitor Intended Use: and stimulate/record biopotential signals including electromyograph (EMG), evoked response and nerve/muscle potentials and for the intraoperative diagnosis of acute dysfunction in corticospinal axonal conduction.

The system provides feedback to the surgeon and OR team to assist in the localization and assessment of spinal nerves and verification of placement of spinal instrumentation to avoid injury to at risk nerve roots.

Conclusions: Based on the technical information provided in this 510(k) and the safety and effectiveness criteria of the design and development process, validated and verified, we claim the OrthoMon to be safe, effective and substantially equivalent to the predicate device(s) noted.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 3 2006

Axon Systems C/o Mr. Howard Bailin Vice President, C.O.O, 400- 2200 Oser Avenue, Hauppauge, NY 11788.

Re: K061113

Trade Name: Orthomon System Regulation Number: 21 CFR 882.1870 Regulation Name: Evoked Response Stimulator Regulatory Class: II Product Code: GWF, IKN Dated: April 14, 2006 Received: April 21, 2006

Dear Mr. Bailin:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becaren of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreate) is togens actment date of the Medical Device Amendments, or to conninered province way 20, 1976, are excordance with the provisions of the Federal Food, Drug, de nees that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, dictere, mains 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 such 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.

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 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.

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Page 2 - Mr. Howard Bailin

This letter will allow you to begin 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Hubert Lenoir
Carol N. Miller, MS

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

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Cover Letter Executive Summary

Indications for Use Statement

510(k) Number

K0611/3

Device Name

OrthoMon

Indications for Use

Hubert Romero

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

510(k) Number K061113

Prescription Use_ × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

Regulation Number and Section

§ 882.1870 Evoked response electrical stimulator.

(a)
Identification. An evoked response electrical stimulator is a device used to apply an electrical stimulus to a patient by means of skin electrodes for the purpose of measuring the evoked response.(b)
Classification. Class II (performance standards).