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

Device Description

The designs of the Stimulus - Dissection Instruments are similar to existing stainless steel manual surgical instruments. The instruments consist of scissors, retractors, awls, taps, needles, probes, and hooks with biocompatible electrical insulation applied to selected portions, and proximal connectors provided to attach the instruments to a monopolar stimulator. The distal surfaces of the instruments are non-insulated stainless steel to provide for mechanical, manual dissection / resection, and tissue stimulation. The Stimulus - Dissection Instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12. Accessories include monopolar cables available in lengths up to 3 M.

AI/ML Overview

The provided 510(k) summary (K031003) for the Medtronic Xomed "Stimulus - Dissection Instruments" does not contain a detailed study with specific acceptance criteria and reported device performance in the way a clinical trial or algorithm performance study would.

Instead, this 510(k) is a substantial equivalence submission, meaning the manufacturer is demonstrating that their new device is as safe and effective as a legally marketed predicate device, without requiring new clinical performance data in the same way. The "acceptance criteria" here relate to meeting the characteristics of the predicate device and relevant standards.

Here's a breakdown based on the provided text, addressing your points as much as possible within the context of a 510(k) summary for this type of device:

1. Table of Acceptance Criteria and Reported Device Performance

For this specific 510(k), the "acceptance criteria" are not performance metrics in a clinical sense (e.g., sensitivity, specificity for a diagnostic device). Instead, they are the design, material, functional, and safety characteristics that allowed the device to be deemed substantially equivalent to its predicate. The "reported device performance" is implicitly that it meets these characteristics, making it comparable to the predicate.

Acceptance Criteria (Characteristic of Predicate Device)	Reported Device Performance (Proposed Device)
Indications For Use: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.	Meets: Tissue dissection and stimulation of cranial and peripheral motor nerves for location and identification during surgery, including spinal nerve roots.
Construction: Stainless steel	Meets: Yes
Electrical insulation: On all surfaces not intended to provide electrical contact with the patient	Meets: Electrical insulation on all surfaces not intended to provide electrical contact with the patient
Distal patient contact surface: Stainless steel	Meets: Yes
Proximal stimulator connector: Yes	Meets: Yes
IEC 60601-1 Protected Pin design: Yes	Meets: Yes (Meets IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12)
Biocompatible: Yes	Meets: Yes
Use: Single Use, Sterile	Meets: Yes

Implicit Acceptance Criteria (not explicitly in the comparison table but mentioned in device description):

Design: Similar to existing stainless steel manual surgical instruments.
Function: Provide for mechanical, manual dissection/resection, and tissue stimulation.
Safety: The instruments are a protected pin design and meet the requirements of IEC 60601-1:1988 /A1:1991 /A2:1995 Clause 56.3(c) per 21 CFR 898.12.

The "study" that proves the device meets the acceptance criteria is simply the detailed comparison provided by Medtronic Xomed in their 510(k) submission, confirming that their proposed device shares the critical characteristics and intended use of the predicate device (K014165) and adheres to relevant safety standards.

2. Sample Size Used for the Test Set and Data Provenance

This is not applicable in the context of this 510(k) summary. This submission relies on demonstrating substantial equivalence to a predicate device, not on a new clinical performance study with a "test set" of patients or data. The "data provenance" would refer to the technical specifications and design documentation provided by Medtronic Xomed for their new device, comparing it to the specifications of the predicate device.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable. There was no "test set" requiring expert ground truth establishment for this 510(k) submission, as it's not a performance study of a diagnostic or AI device. The "ground truth" for showing substantial equivalence resided in the technical specifications and regulatory clearances of the predicate devices.

4. Adjudication Method for the Test Set

Not applicable, as there was no test set requiring expert adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an MRMC study and does not involve human readers interpreting data. It's for a surgical instrument.

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

No. This device is a manual surgical instrument, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this 510(k) submission is the pre-existing regulatory classification, safety, and effectiveness profile of the predicate devices (Medtronic Xomed Stimulus Dissection Instruments cleared via K014165 and Medtronic Xomed Monopolar Stimulator Probes originally described in K992869). The manufacturer's submission's "truth" is that their new device aligns with these established characteristics and design standards.

8. The Sample Size for the Training Set

Not applicable. This is not an AI or algorithm-based device that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for this device.

Summary

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K031003

510(k) Summary

1.0 Date Prepared

APR 1 1 2003

March 28, 2003

2.0 Submitter (Contact)

Martin D. Sargent Regulatory Affairs Manager Medtronic Xomed Jacksonville, FL (904) 279-7586

3.0 Device Name

Proprietary Name:	Stimulation / Dissection Instruments (Tradenames have not been finalized at this time)
Common Name(s):	Nerve Stimulator / Locator
Classification Name(s):	Surgical Nerve Stimulator / Locator

4.0 Device Classification

Classification Name: Surgical Nerve Stimulator / Locator and accessories
Procode 77ETN	Class II	21 CFR § 874.1820
Procode Various	Class I	-	21 CFR § 874.4420
Procode Various	Class I	21 CFR § 878.4800

5.0 Device Description

6.0 Indications for Use

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510(k) Summary (continued)

7.0 Substantial Equivalence

The design, technology, features, function, and intended use of the Stimulus-Dissection Instrument is substantially equivalent to Medtronic Xomed Stimulus Dissection Instruments cleared via K014165 and Medtronic Xomed Monopolar Stimulator Probes originally described in K992869.

Characteristic	Stimulus - DissectionInstruments[Proposed Device]	Stimulus / Dissection Instruments[K014165]
Indications ForUse	Tissue dissection and stimulationof cranial and peripheral motornerves for location andidentification during surgery,including spinal nerve roots.	Tissue dissection and stimulationof cranial and peripheral motornerves for location andidentification during surgery,including spinal nerve roots.
Stainless steelconstruction	Yes	Yes
Electricalinsulation	Electrical insulation on all surfacesnot intended to provide electricalcontact with the patient	Electrical insulation on all surfacesnot intended to provide electricalcontact with the patient
Distal stainlesssteel patientcontact surface	Yes	Yes
Proximalstimulatorconnector	Yes	Yes
IEC 60601-1Protected Pindesign	Yes	Yes
Biocompatible	Yes	Yes
Single Use,Sterile	Yes	Yes[K992869]

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 11 2003

Medtronic Xomed, Inc. c/o Mr. Martin D. Sargent Regulatory Affairs Manager 6743 Southpoint Drive North Jacksonville, FL 32216

Re: K031003

Trade/Device Name: Stimulus/Dissection Instruments, Ball-Tip Probes Regulation Number: 21 CFR 874.1820 Regulation Name: Surgical nerve stimulator/locator Regulatory Class: Class II Product Code: ETN Dated: March 28, 2003 Received: March 31, 2003

Dear Mr. Sargent:

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.

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. Martin D. Sargent

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 (301) 594-4613. 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/dsma/dsmamain.html

Sincerely vours,

A. halpi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K031003 510(k) Number (if known): Stimulus - Dissection Instruments Device Name: Indications for Use:

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

(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)

Over-the-Counter Use

(Optional Format 1-2-96)

Karen H. Baker
(Division Sign-Off)

Division of Ophthalmic Ear, Nose and Throat Devises

510(k) Number_ K031003

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.