The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

Device Description

The NuVasive Stimulation/Dissection Instruments are similar to existing Class I exempt manual surgical instruments described in 21 CFR 88.4540 Orthopedic Manual Surgical Instruments. The instruments consist of retractors, dilators (expanding set of cannula), a stimulating electrode, taps, drills, probes, needles, and screw drivers with proximal connectors to attach the instruments to a monopolar stimulator, and insulating sheaths to provide biocompatible electrical insulation to selected portions of the instruments. The distal surfaces of the instruments are selectively noninsulated and manufactured from durable biocompatible materials to provide for mechanical, manual dissection/resection, probing, and tissue stimulation.

AI/ML Overview

The provided text describes the 510(k) summary for the NuVasive® Stimulation/Dissection Instruments. It focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study of device performance against specific acceptance criteria.

Therefore, many of the requested elements for a study proving acceptance criteria cannot be extracted because the document primarily discusses comparison to predicate devices and non-clinical testing.

Here's an attempt to answer based on the available information:

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

The document does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is qualitative, stating that the device "meets or exceeds the performance of the predicate device."

Feature	Acceptance Criteria (Implied by Predicate Equivalence)	Reported Device Performance
Indications for Use	Same as predicate: Tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.	The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots. (Matches)
Product Code	ETN	ETN (Matches)
Regulation Number	874.1820	874.1820 (Matches)
Electrical Insulation	Electrical insulation on all surfaces not intended to provide electrical contact with the patient and connection.	Some instruments have electrical insulation on surfaces not intended to provide electrical contact with the patient and connection while others are used with an insulating accessory that provides electrical insulation on surfaces not intended to provide electrical contact with the patient and connection. (Equivalent functionality achieved through instruments or accessories)
Biocompatibility	Biocompatible materials.	Biocompatible: Anodized Aluminum, Stainless Steel, Radel (Materials listed are biocompatible)
Sterilization	Sterile for single use.	Some instruments are provided sterile for single use only while others are provided as non-sterile reusable instruments. (Different sterilization statuses, but within acceptable parameters for different instrument types)
Stimulation and Insulation Impedance	Meets or exceeds predicate device's performance.	Results showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device.
Current Density Determination	Meets or exceeds predicate device's performance.	Results showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device.

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 "nonclinical testing" but does not detail sample sizes for these tests, nor the 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 applicable as the document describes non-clinical testing and comparison to predicate devices, not studies involving human experts establishing ground truth for a test set.

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

This information is not applicable as the document describes non-clinical testing, not a study involving adjudication of a test set by human readers.

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 information is not applicable. The device is a physical surgical instrument (Nerve Stimulator/Locator), not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study comparing human readers with and without AI assistance is irrelevant to this device.

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

This information is not applicable. The device is a physical surgical instrument, not an algorithm. Standalone performance for an algorithm is not relevant.

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

For the non-clinical testing (Stimulation and Insulation Impedance, Current Density Determination, Biocompatibility, Sterilization Validation), the "ground truth" or reference would be established engineering standards, specifications, and regulatory requirements (e.g., ISO 10993-1 for biocompatibility, ISO 11135-1 for sterilization validation, and internal performance specifications derived from predicate device performance).

8. The sample size for the training set

This information is not applicable. The device is a physical surgical instrument, not an AI model that requires a training set.

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

This information is not applicable. The device is a physical surgical instrument, not an AI model.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete circle on the left, followed by the word "NUVASIVE" in capital letters. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

510(k) Summary

In accordance with Title 21 of the Code of Federal Regulations. Part 807, and in particular 21 CFR §807.92. the following summary of information is provided:

Submitted by: A.

Elias Ketchum Senior Associate. Regulatory Affairs NuVasive, Incorporated 7475 Lusk Blvd. San Diego, California 92121 Contact: (858) 320-4588

Date Prepared: September 2, 2011

B. Device Name

Trade or Proprietary Name:	NuVasive ® Stimulation/Dissection Instrument
Common or Usual Name:	Nerve Stimulator/Locator
Classification Name:	Surgical Nerve Stimulator/Locator

Device Class:	Class II
Classification:	21 CFR § 874.1820
Product Code:	ETN

C. Predicate Devices

The subject Stimulation/Dissection Instruments are substantially equivalent to the following predicate devices currently distributed commercially in the U.S .:

K031003 Medtronic Stimulation/Dissection Instruments �
K111597 NuVasive Disposable Stimulating Electrode .

D. Device Description

E. Intended Use

The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

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hnological Characterist ت

wa established in this subject Similation Instruments are substantaly equivalent to ol
dicate devices de the PDA for commercial distribution in the subject device was shown a

Predicate Device	Subject Device	SubstantiallyEquivalent
Stimulation/Dissection InstrumentsK031003	NuVasive® Stimulation/Dissection InstrumentsK112709
The Stimulation/Dissection Instruments areindicated for tissue dissection and stimulation ofcranial and peripheral motor nerves for locationand identification during surgery, includingspinal nerve roots.	The Stimulation/Dissection Instruments are indicatedfor tissue dissection and stimulation of peripheralmotor nerves for location and identification duringsurgery, including spinal nerve roots.	Yes
ETN	ETN	Yes
874.1820	874.1820	Yes
Electrical insulation on all surfaces not intendedto provide electrical contact with the patient andconnection	Some instruments have electrical insulation on surfacesnot intended to provide electrical contact with thepatient and connection while others are used with aninsulating accessory that provides electrical insulationon surfaces not intended to provide electrical contactwith the patient and connection.	Yes
Yes	Yes	Yes
Biocompatible	Biocompatible:Anodized AluminumStainless SteelRadel	Yes
Sterile for single use	Some instruments are provided sterile for single useonly while others are provided as non-sterile reusableinstruments.	Yes

Predicate and Subject Device Comparison 1

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Image /page/2/Picture/0 description: The image shows the logo for Nuvasive. The logo consists of a stylized, incomplete circle on the left, followed by the word "NUVASIVE" in a sans-serif font. Below the word "NUVASIVE" is the tagline "Speed of Innovation" in a smaller font.

G. Performance Data

Nonclinical testing was performed to demonstrate that the subject Stimulation/Dissection Instruments are substantially equivalent to other predicate devices. The following testing was performed:

. Stimulation and Insulation Impedance
. Current Density Determination
. Biocompatibility testing per ISO 10993-1
. Sterilization validation per ISO 11135-1

The results of these studies showed that the subject Stimulation/Dissection Instruments meets or exceeds the performance of the predicate device, and the device was therefore found to be substantially equivalent.

Conclusions H.

Based on the indications for use, technological characteristics, performance testing, and comparison to predicate devices, the subject Stimulation/Dissection Instruments has been shown to be substantially equivalent to legally marketed predicate devices, and do not raise new questions of safety or effectiveness.

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Image /page/3/Picture/0 description: The image is a logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird-like figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

NuVasive, Inc. c/o Mr. Elias Ketchum Senior Associate, Regulatory Affairs 7475 Lusk Blvd. San Diego, California 92121

FEB - 9 2012

Re: K112709

Trade/Device Name: NuVasive Stimulation/Dissection Instruments Regulation Number: 21 CFR 874.1820 Regulation Name: Nerve Stimulator/Locator Regulatory Class: Class II Product Code: ETN Dated: January 6, 2012 Received: January 9, 2012

Dear Mr. Ketchum:

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 application (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. 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.

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Page 2 - Mr. Elias Ketchum

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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

signature

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K112709

Indications for Use

510(k) Number (if known): K112709

Device Name: NuVasive® Stimulation and Dissection Instruments

Indications For Use:

The Stimulation/Dissection Instruments are indicated for tissue dissection and stimulation of peripheral motor nerves for location and identification during surgery, including spinal nerve roots.

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

Over-The-Counter Use (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)

R. Mathe

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number	K112709
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Prescription Use (Per 21 CFR 801.109)

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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.