The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for irrigation and aspiration. These channels are connected to medical tubing designed to operate in the bipolar model. The handpiece is ABS plastic and incorporates a stainless steel probe of low energy output control. The special production of the device model is supplied when connected to a compatible electrosurgical generator of the handpiece to standard irrigation and aspiration devices.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the NeoMedix Corporation's NMX-1000™ electrosurgical device. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials with detailed acceptance criteria and performance data like those typically seen for AI/ML devices. Therefore, much of the requested information about acceptance criteria, study design, and performance metrics for a novel device is not available or applicable in this context.

However, I can extract the relevant information that is present in the document.

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

Since this is a 510(k) submission for a non-AI/ML device demonstrating substantial equivalence to a predicate, explicit "acceptance criteria" in the sense of predefined thresholds for diagnostic performance (e.g., sensitivity, specificity) for a novel AI algorithm are not provided. Instead, the device's "performance" is demonstrated by its equivalency to a predicate device and compliance with relevant safety standards.

Category	Acceptance Criteria (Demonstration)	Reported Device Performance
Technological Characteristics Comparison	Identical design and function to predicate device (NeoMedix MicroSurgical Bipolar Handpiece and Storz Maumenee Goniotomy Knife Cannula).	The NMX-1000™ probe is "identical in design" to the currently marketed NeoMedix MicroSurgical Bipolar Handpiece regarding the application of radio frequency current at the probe tip. Irrigation and aspiration capabilities are "the same as those of the Storz Maumenee Goniotomy Knife Cannula."
Material Safety	Use of materials with an established history of safe use in similar medical devices.	"materials used have an established history of safe use in similar medical devices."
Biocompatibility	Demonstration of biological safety of patient contact materials in accordance with standards.	"biological safety of the device has been demonstrated by biocompatibility studies of all patient contact materials in accordance with the Standards outlined in ISO 10993-1."
Electrical Safety	Compliance with IEC 60601-1 for leakage current and ANSI/AMI HF-18 for handpiece dielectric voltage.	"Electrical safety has been demonstrated by compliance to applicable requirements as outlined in IEC 60601-1 for leakage current and ANSI/AMI HF-18 for handpiece dielectric voltage."
Manufacturing/Sterility	Assurance of connector integrity, tip bend resistance, and sterility (SAL of 10⁻⁶).	"Hydroblister testing at critical tissues has been performed to assure connector integrity, tip bend resistance and nature is supplied sterile and sterility will confirm to a Sterility Assurance Level (SAL) of 10⁻⁶."
Indications for Use	Same indications for use as predicate device.	"Since the device indications are a subset of only glaucoma. Since the device is our modification of a that of a Goniotomy knife, there are no new safety or effectiveness issues related to this device."

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

Not applicable. This is not a study involving a "test set" of patient data for evaluating an algorithm's performance. The evaluations were engineering tests, biocompatibility studies, and comparisons to predicate devices.

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 applicable. Ground truth as typically understood for an AI/ML diagnostic device (e.g., expert consensus on medical images) is not relevant here. The "ground truth" for this device's safety and performance is based on engineering standards, material science, and regulatory compliance.

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

Not applicable. No "adjudication method" for interpreting data is mentioned as it's not a diagnostic study.

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. This is a non-AI/ML electrosurgical device.

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

Not applicable. This is a non-AI/ML electrosurgical device.

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

The "ground truth" or basis for affirming the device's safety and effectiveness relies on:

Compliance with recognized standards: IEC 60601-1, ANSI/AMI HF-18, ISO 10993-1.
Engineering testing: Hydroblister testing for integrity, tip bend resistance.
Material history: "established history of safe use in similar medical devices."
Substantial equivalence: Direct comparison to legally marketed predicate devices (NeoMedix MicroSurgical Bipolar Handpiece (K024304) and Storz Maumenee Goniotomy Knife Cannula).

8. The sample size for the training set

Not applicable. This is a non-AI/ML electrosurgical device. There is no "training set."

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

Not applicable. This is a non-AI/ML electrosurgical device.

Summary

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APR 2 2 2004

NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

K 040584

Page 1 of 2

SECTION 2 - 510 (K) SUMMARY

SUMMARY OF SAFETY AND EFFECTIVENESS

Date Prepared: February 9, 2004

Manufacturer and Submitter

NeoMedix Corporation 27452 Calle Arroyo San Juan Capistrano, California 92675 Phone: (949) 248-7029 Fax: (949) 248-7119

Contact Person

Dr. Soheila Mirhashshemi

Common, Classification and Proprietary Names

Common Name:	Electrosurgical electrode
Classification Name:	Radio frequency cautery device (21 CFR section 886.4100)
Proprietary name:	NMX-1000™

Predicate Devices

The NeoMedix NMX-1000™ is identical to the NeoMedix Microsurgical Bipolar Handpiece (K024304; GEF and The Neowedix NW/F 1000" Is ruenical to the noonthalmic surgery. The NeoMedix NMX
HQR) in general indications, materials, design and features for other Caristery knife [610K] HQR) in general indications, materials, design and leatures for opinisms con- , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , , ,

Indications for Use

The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

Device Description

The NMX-1000™ is a sterile single use device that consists of a bipolar probe and channels for inigation and The NMX- IDO0™ Is a stellie Single dse device that ochalist of a special production of the device model aspiration. These chames are connected to modical group designed to operate in the bipolar model. nandplece is ABS plastic incorporates a stamess stor proble of low energy output control. The supplied when connected to a companible electrosurgical generator of the handless to standard irrigation and aspiration devices.

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NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

Page 2 of ②

Technological Characteristics Comparison

The probe is identical in design to the currently marketed NeoMedix MicroSurgical Bipolar Handpiece in that The probe is identical in design to the canciny hidriced rroand occurs at the probe tip . The irigation and the application of fadio trequency current is opplical in Rater to the Storz Maumenes aspiration capabilities are the as those of the never electrosurgical devices is well known and
Goniotomy knife cannula. The cutting capability of radio frequency an ostopli Goniotomy Knile Cannula. The Gotting Capability of Tadio Requestion materials used have an established history of safe use in similar medical devices.

Performance and Safety

The biological safety of the device has been demonstitility studies of all patient The bloodical salety of the device has been demonstitution the some of . Electrical safety has been a contact materials in accordance with the Standards out.infalled in IEC 60601-1 for leakage current and demonstrated by compliatic to applicable requirements as litem was performed to assure connector ANSI/AMI HF-18 Tor namplece dicience voltage. " Hyoldar costing at urinal tissues of himal tissues integrity, tip bend resistance and nature is supplied sterile and sterlier and sterlity will confirm to a Sterlily Assurance Level (SAL) of 10". The supplied instructions for use provide the user with the applicable a Sterlity Assurance Level (SAL) of 10 . The Supplied instructions of only glaucoma. Since the device warnings and caulons during use. The device is our annuisation of a that of a Gonotomy knife, there are no new safety or effectiveness issues related to this device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

APR 2 2 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Neomedix Corporation c/o Mr. Marc M. Mouser Underwriters Laboratories, Inc. 2600 N.W. Lake Road Camas, Washington 98607

Re: K040584

Trade/Device Name: NMX-1000TM Regulation Number: 21 CFR 878.4400, 886.4100 Regulation Name: Electrosurgical cutting and coagulation device and accessories; Radiofrequency electrosurgical cautery apparatus Regulatory Class: II Product Code: GEI, HQR Dated: April 6, 2004 Received: April 8, 2004

Dear Mr. Mouser:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass stated in the encrobate) to togens and the Medical Device Amendments, or 10 commence prior to May 20, 1970, the enaoudance with the provisions of the Federal Food, Drug. devices mat have been recuire approval of a premarket approval application (PMA). and Cosmithe Ace (ree) that do noverpal controls provisions provisions of the Act. The 1 ou may, dicierore, market the Act include requirements for annual registration, listing of general controls provisions of the rice, 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 If your device to such additional controls. Existing major regulations affecting your device can thay be subject to suble additional connections, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peaces announceming your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I Dri 3 issuation of a receivice complies with other requirements of the Act that i DA has made a dolorimations administered by other Federal agencies. You must of any I cocolar surches and regarants, including, but not limited to: registration and listing (21 comply with an the 7ter 31equirements, mercess, and manufacturing practice requirements as set CITK Fart 607), labeling (21 OF R Part 820); and If applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Marc M. Mouser

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis icter will anow you to begin finding of substantial equivalence of your device to a legally premarket notification. The PDF interessification 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 If you desire spocente acreouser - at (301) 594-4659. Also, please note the regulation entitled, Comace the Other of Compullier in (set notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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NeoMedix Corporation 510(k) Premarket Notification February 9, 2004

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

K 040584

Device Name:

NMX-1000™

Indications for use: The NMX-1000™ is designed to surgically remove a strip of the Trabecular meshwork for surgical management of infantile and adult glaucoma.

Prescription Use: X (Part 21 CFR 801 Subpart D) AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Muriam C. Provost

(Divis Division of General, Restorative. and Neurological Devices

510(k) Number K040584

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.