The NIM™ surgeon control probes are indicated to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.

Device Description

The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (NIM™ 35cm long Surgeon Control Probe). It describes the device, its intended use, and why it is considered substantially equivalent to a predicate device. However, it does not contain information about a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device, as implied by the detailed questions (e.g., sample size for test/training sets, experts for ground truth, MRMC study, standalone performance, etc.).

The "Performance Testing Discussion" section (Page 6) details typical engineering verification and validation tests for a physical medical device, such as electromechanical performance, sterilization validation, electrical safety, biocompatibility, stability, packaging performance, and usability testing. These are standard tests for hardware devices, not for assessing the performance of an AI model's diagnostic or predictive capabilities.

Therefore, I cannot provide a table of acceptance criteria for AI performance or answer most of the specific questions about the study proving the device meets AI-related acceptance criteria, as this information is not present in the provided document.

Here's what I can infer from the document regarding the performance testing that was conducted:

Acceptance Criteria & Reported Performance: The document states that "Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria." It also notes that "This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device." While specific numerical performance values against acceptance criteria are not provided, the conclusion is that the tests yielded "passing results" and demonstrated the device is "safe and effective."

The performance tests listed are:
- Electromechanical, dimensional, and visual design performance
- Sterilization validation to ISO 11135:2014
- Electrical safety & EMC testing to IEC 60601
- Biocompatibility testing and risk analysis to ISO 10993-1:2018
- Stability testing of proposed shelf life
- Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
- Usability testing to IEC 62366-1:2015
Sample Size for Test Set and Data Provenance: The document states "Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data." It does not specify the exact number of samples. Data provenance is not applicable in the sense of patient data; it's product performance testing.
Number of Experts Used to Establish Ground Truth and Qualifications: This information is not relevant to the type of device and testing described. The "ground truth" for this device is established by engineering specifications, international standards, and physical measurements/tests.
Adjudication Method: Not applicable for engineering performance testing of a physical device.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is for evaluating human performance, often with AI assistance, in interpreting medical images/data. This device is a surgical nerve stimulating probe, not an image analysis or diagnostic AI.
Standalone (algorithm only) Performance: Not applicable. There is no algorithm in the described function that operates standalone for diagnostic or predictive purposes. The "algorithm" here would literally be the electrical stimulation function itself, which is a physical property.
Type of Ground Truth Used: For this device, the ground truth is based on engineering specifications, applicable international standards (e.g., ISO, IEC, ASTM), and established physical principles.
Sample Size for Training Set: Not applicable. This document describes the validation of a physical medical device, not the training of an AI model.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is for a physical medical device (a surgical nerve stimulating probe) seeking 510(k) clearance based on substantial equivalence to a predicate device, supported by standard engineering performance and usability testing. It does not involve AI or an algorithm in the sense that would require the detailed AI-specific study information requested in your prompt.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

August 30, 2023

Medtronic Xomed, Inc. Alexandra Oliver Senior Regulatory Affairs Specialist 6743 Southpoint Drive North Jacksonville, Florida 32216

Re: K231580

Trade/Device Name: NIM™ 35cm long Surgeon Control Probe, 1mm Ball-Tip (NIMDTP35) Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: May 30, 2023 Received: May 31, 2023

Dear Alexandra Oliver:

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 app roval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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): medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrl-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Shuchen Peng -S

Shu-Chen Peng, Ph.D. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K231580

Device Name NIM™ 35cm long Surgeon Control Probe

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - K231580

I. SUBMITTER

Company (submitter):	Medtronic Xomed, Inc.6743 Southpoint Drive NorthJacksonville, Florida 32216 USATelephone Number: (904) 296-9600
Date Prepared:	May 19, 2023

Contact Person: Alexandra Oliver Senior Regulatory Affairs Specialist Telephone: (904) 332-8936 Email Address: Alexandra.j.oliver@medtronic.com

II. DEVICE

Proprietary (Trade) Name:	NIM™ 35cm long Surgeon Control Probe
Common Name:	Stimulator, nerve
Regulation Name:	Surgical nerve stimulator/locator
Regulation Number:	21 CFR 874.1820
Product Code:	ETN
Classification:	II
Panel:	77 (Ear, Nose, & Throat)

III. PREDICATE DEVICE(s)

The 35cm long NIM™ Surgeon Control Probe is substantially equivalent in intended use and technological characteristics to the following predicate device:

510(k) Number	510(k) / DeviceName	510(k) ClearanceDate
K213246	NIMTM SurgeonControl Probes	March 21, 2022

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IV. DEVICE DESCRIPTION

Device Description

Intended Use

The NIMTM surgeon control probes are intended for use as intraoperative nerve stimulators.

V. INDICATIONS FOR USE

Indications for Use

The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots via minimally invasive Transoral endoscopic thyroidectomy via vestibular approach - TOETVA.

VI. SUBSTANTIAL EQUIVALENCE

Substantial Equivalence/Device Comparison (Subject Device(s) to Predicate Devices)

Feature/Attribute	35cm long Surgeon Control Probe(Subject Device(s))	Surgeon Control Probes, K213246(Predicate Device)	Comparison
Product Code	ETN	ETN	SAME
Regulation Number	21 CFR 874.1820	21 CFR 874.1820	SAME
Regulation Description	Surgical nerve stimulator/locator	Surgical nerve stimulator/locator	SAME
Classification	Class II	Class II	SAME
Common Name	Nerve Stimulator	Nerve Stimulator	SAME
Device Description	The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.	The NIM™ surgeon control probes carry stimulation current from the patient interface to the patient. It also enables the user to adjust stimulation current and key functions from the surgical site. All probes are single use devices.	SAME
Intended Use	The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators	The NIM™ surgeon control probes are intended for use as intraoperative nerve stimulators	All probes are intended for the SAME use, as an intraoperative nerve stimulator.
Indications for Use	The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including	The NIM™ surgeon control probes are intended to stimulate cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots	The subject device's extended length is to accommodate TOETVA as a minimally invasive approach. The
Feature/Attribute	35cm long Surgeon Control Probe(Subject Device(s))	Surgeon Control Probes, K213246(Predicate Device)	Comparison
	spinal nerve roots viaminimally invasive Transoralendoscopic thyroidectomy viavestibular approach -TOETVA		usability study on theNIM 35cm long probeshows this probelength is suitable foruse in a TOETVAapproach.
Contraindications	The NIM™ surgeon controlprobes are contraindicated foruse with paralyzing anestheticagents when monitoring amotor nerve as these mayreduce or eliminate thepatient's EMG response.	The NIM™ surgeon controlprobes are contraindicated foruse with paralyzing anestheticagents when monitoring amotor nerve as these mayreduce or eliminate thepatient's EMG response.	SAME
OperatingPrinciple	Electrical stimulation	Electrical stimulation	SAME
Design	Offered in a ball-tipconfiguration with insulatedshaft and permanently moldedincrementing (stim) handle foruse in the sterile field	Offered in prass-tip or ball-tipconfigurations; both withinsulated shaft andpermanently moldedincrementing (stim) handle foruse in the sterile field	SAME
Probe tip (exposedarea) tissuecontact surfacegeometry	1mm ball	1mm ball	SAME (for ball-tipgeometriesrespectively)
Probe workinglength	13.78" [35.0 cm]	3.76" [9.6cm]	The 35 cm Ball Tipprobe has a longerlength for extendedreach. The patientcontacting surfacesand stimulationperformance isunaffected by thismodification to thelength.
Patient-contactingMaterials	303 Stainless Steel with TeflonPolytetrafluoroethylene(PTFE) coating insulation	303 Stainless Steel withXylamed coating insulation orTeflon Polytetrafluoroethylene(PTFE) coating insulation	SAME (for ball-tipmaterials respectively)
Patient contact	Direct	Direct	SAME
Biocompatible	Yes	Yes	SAME
Sterile	Yes	Yes	SAME
Single-UseDisposable	Yes	Yes	SAME
Duration of Use	Limited (<24 hours)	Limited (<24 hours)	SAME

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Substantial Equivalence Discussion

A comparison of technological characteristics was provided in the submission to establish substantial equivalence. Both the subject device and the predicate device(s) share the same design,

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materials, operating principle, energy source, and performance characteristics, in addition to identical intended use to stimulate cranial and peripheral motor nerves for location and identification during surgery. Furthermore, NIM™ surgeon control probes ball-tip geometry and biocompatibility mirror the predicate device(s). The subject device differs from the predicate device to accommodate TOETVA as a minimally invasive approach. The subject device probe working length is 35cm (vs 9.6cm for the predicate), and the indications for use explicitly provide for TOETVA. Usability testing performed on the 35cm long probe demonstrated that the subject device is suitable for its intended use and does not compromise the safety or performance of the subject device relative to the predicate. Therefore, the NIM™ 35cm long Surgeon Control Probe is substantially equivalent to its legally marketed predicate device.

VII. PERFORMANCE DATA

Performance Testing Discussion

Design performance testing was completed to ensure the functionality and intended use of the NIM™ 35cm long surgeon control probe was met in accordance with external standards, and device specifications via pre-defined acceptance criteria. Bench engineering test samples were subjected to simulated real-life conditions during functional testing to establish baseline data and accelerated aging data. The testing included in this submission provides objective evidence through passing results that key technological characteristics such as the ones listed below are proven to be safe and effective. This performance testing was used to support substantial equivalence, proving the subject device is as safe and effective as its predicate device.

Electromechanical, dimensional, and visual design performance
Sterilization validation to ISO 11135:2014
Electrical safety & EMC testing to IEC 60601
Biocompatibility testing and risk analysis to ISO 10993-1:2018
Stability testing of proposed shelf life
. Packaging performance of environmental conditioning to ISTA 3A and distribution simulation to ASTM D4169
Usability testing to IEC 62366-1:2015 ●

VIII. CONCLUSION

Conclusion

Utilizing FDA's Guidance for Industry and Food and Drug Administration Staff, "Format for Traditional and Abbreviated 510(k)s" issued on September 13, 2019, a comparison of key performance characteristics demonstrates that the subject device, the 35cm long NIM™ Surgeon Control Probe is substantially equivalent to the predicate device(s). The 35cm long NIM™ Surgeon Control Probe has been proven to be as safe and effective as its legally marketed predicate device. The design performance testing has demonstrated that the NIM 35cm long Surgeon Control

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Probe is equivalent to the predicate for delivering current for nerve stimulation. The usability study on the NIM 35cm long probe shows this probe length is suitable for use in a TOETVA approach.

Regulation Number and Section

§ 874.1820 Surgical nerve stimulator/locator.

(a)
Identification. A surgical nerve stimulator/locator is a device that is intended to provide electrical stimulation to the body to locate and identify nerves and to test their excitability.(b)
Classification. Class II.