The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back;
Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed Back Syndrome;
Post Laminectomy Pain;
Unsuccessful Disk Surgery;
Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and surgical interventions;
Peripheral Causalgia;
Epidural Fibrosis;
Arachnoiditis or Lumbar Adhesive Arachnoiditis;
Complex Regional Pain Syndtome (CRPS) or Reflex Sympathetic Dystrophy (RSD) or Causalgia; and,
Multiple Back Surgenes

Additional Contraindication: The Medtronic Models 3873 1 x 8 and the 3874 1 x 8 Compact Test Stimulation Leads are contraindicated for long-term implantation. The lead MUST BE REMOVED within ten (10) days of implant.

Device Description

The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact are test stimulation lead kits. A test stimulation lead is a thin wire covered by an insulative coating, which is intended to be connected to a screening cable and an external neurostimulator (ENS). The lead has small metal electrodes near its tip through which the ENS delivers electrical stimulation to an area where pain signals will be blocked.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the Medtronic Model 3873 and 3874 Test Stimulation Leads:

The provided document is a 510(k) summary and an FDA clearance letter from 2005 for the Medtronic Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads. This type of regulatory submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria as might be seen for novel devices requiring PMA (Premarket Approval).

Therefore, some of the requested information (like specific numerical acceptance criteria, data provenance, expert ground truth establishment, MRMC studies, or detailed standalone performance data) is not explicitly present in this document. The focus is on in-vitro testing and material biocompatibility to show similarity to an already approved device.

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

Acceptance Criteria (Implied/General)	Reported Device Performance
Substantial equivalence to predicate device (Model 3862 Verify Temporary Screening Lead)	"Medtronic, Inc. considers the Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits to be substantially equivalent to legally marketed predicate devices." And FDA confirmed: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent..."
Meet all specified design and performance requirements (for in-vitro testing)	"The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits met all specified design and performance requirements."
Sterilization process effectiveness consistent with predicate device	"The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits will be sterilized using the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device."
Biocompatibility consistent with ISO-10993	"All materials were found to be biocompatible and in compliance to ISO 10993-1."

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

Sample Size: Not specified for the in-vitro tests mentioned. Since it's in-vitro testing of medical devices (leads), it would typically involve a certain number of units of the device being tested for physical and electrical parameters.
Data Provenance: The document does not specify the country of origin of the data as these are in-vitro studies/tests. It's retrospective in the sense that the testing was completed before the submission to show equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable and not provided in this type of 510(k) submission, as it focuses on device safety and performance characteristics through engineering tests, not on diagnostic accuracy requiring expert interpretation.

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

This information is not applicable and not provided. Adjudication methods are relevant for studies involving human interpretation or clinical endpoints, which are not the focus of this 510(k) summary.

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

No, an MRMC comparative effectiveness study was not done. This document pertains to physical medical devices (test stimulation leads), not an AI-powered diagnostic or assistive tool for human readers. Therefore, these metrics are not relevant or present.

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

This concept is not applicable to the device described. This is a physical lead, not an algorithm.

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

The "ground truth" for the tests performed (in-vitro, sterilization, biocompatibility) would be defined by the engineering specifications, regulatory standards (like ISO 10993), and the performance characteristics of the predicate device. For example:
- In-vitro testing: Ground truth would be adherence to pre-defined engineering specifications (e.g., tensile strength, electrical resistance, insulation integrity).
- Sterilization: Ground truth would be the validated sterility assurance level (SAL).
- Biocompatibility: Ground truth would be the established safety profiles for materials based on ISO 10993.

8. The sample size for the training set

This information is not applicable as there is no "training set" in the context of this device's evaluation. This is not an AI/machine learning device.

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

This information is not applicable for the same reason as above.

Summary

{0}------------------------------------------------

JUL 2 8 2005

July 2005

051973

Appendix A: 510(K) Summary

Submitter

Medtronic, Inc. 710 Medtronic Parkway NE Minneapolis, MN 55432

Contact:	Paula Cordero, Regulatory Affairs Specialist
Telephone:	(763) 505-0238
Fax:	(763) 505-0258
E-Mail:	paula.cordero@medtronic.com
Date Prepared:	July 1st, 2005

Name of Device

Trade Name:	Medtronic Model 3873 1 x 8 and Model 38741 x 8 Compact Test Stimulation Leads
Common Name:	Trialing Leads
Classification:	Class II
Product Code:	GZB

Predicate Devices

The predicate device for the Medtronic Model 3873 1 x 8 Test Stimulation Leads and the Model 3874 1 x 8 Compact Test Stimulation Leads is the currently available Model 3862 Verify Temporary Screening Lead.

Device Description

Intended Use

The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid is indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back; ●
Image /page/0/Picture/16 description: The image shows the Medtronic logo. The logo consists of a symbol on the left and the word "Medtronic" on the right. Below the word "Medtronic" is the word "Confidential".

{1}------------------------------------------------

Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to . Failed Back Syndrome;
Post Laminectomy Pain; ●
Unsuccessful Disk Surgery; ◆
Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative . and surgical interventions;
Peripheral Causalgia; .
Epidural Fibrosis; .
Arachnoiditis or Lumbar Adhesive Arachnoiditis; .
Complex Regional Pain Syndrome (CRPS) or Reflex Sympathetic Dystrophy . (RSD) or Causalgia; and,
Multiple Back Surgeries .

Summary of Studies

In Vitro testing was performed to support substantial equivalence to the predicate device. The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits met all specified design and performance requirements.

Sterilization

The Medtronic Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits are labeled STERILE. The Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits will be sterilized using the same 100% Ethylene Oxide (EtO) sterilization process as the predicate device.

Biocompatibility

All device materials / components were assessed for biocompatibility consistent with ISO- 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing". All materials were found to be biocompatible and in compliance to ISO 10993-1.

Conclusion

Through data and information presented, as well as similarity to legally marketed devices, Medtronic, Inc. considers the Model 3873 1 x 8 and the Model 3874 1 x 8 Compact Test Stimulation Lead Kits to be substantially equivalent to legally marketed predicate devices.

Image /page/1/Picture/20 description: The image shows the Medtronic logo with the word "Medtronic" in bold, black letters. Below the logo, the word "Confidential" is written in a smaller, non-bold font. To the left of the word "Medtronic" is a graphic of a person with outstretched arms.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 8 2005

Ms. Paula Cordero Regulatory Affairs Specialist Medtronic, Inc., Neurological Division 710 Medtronic Parkway NE Minneapolis, Minnesota 55432-5604

Re: K051773

Trade/Device Name: Medtronic® Model 38731 x 8 and Model 38741 x 8 Compact Test Stimulation Leads Regulation Number: 21 CFR 882.5880 Regulation Name: Implanted spinal cord stimulator for pain relief Regulatory Class: II Product Code: GZB Dated: June 30, 2005 Reccived: July 5, 2005

Dear Ms. Cordero:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved 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 for use stated in the encreations of the enactment date of the Medical Device Amendments. Or to commerce provise that have been reclassified in accordance with the provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). and Cosmetic Ace (. 10.) that the device, subject to the general controls provisions of the Act. The r ou may, morely williams of the Act include requirements for annual registration. Iisting of general controlo proficturing 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 If your device is elabsition it controls. Existing major regulations affecting your device can may oe subject to back as a sateral 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 r lease be devised that i bring that your device complies with other requirements of the Act that + Dr Are I statutes and regulations administered by other Federal agencies. You must or any I vath 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Ms. Paula Cordero

This letter will allow you to begin marketing your device as described in your Section 510(k) rms letter will and wyours organism diagrof substantial equivalence of your device to a legally prematter nedicate 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 n Joa abon's 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/dsma/dsmamain.html

Sincerely yours,

Mark McMullen

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

Enclosure

{4}------------------------------------------------

4. Indications for Use

510(k) Number (if known): N/A

Device Name: Medtronic® Model 3873 1 x 8 and Model 3874 1 x 8 Compact Tcst Stimulation Leads

Indications For Use: The Model 3873 1 x 8 and Model 3874 1 x 8 Compact Test Stimulation Leads are indicated as an aid in the management of chronic, intractable, unilateral or bilateral pain associated with the following:

Failed Back Syndrome or Low Back Syndrome or Failed Back; �
Radicular Pain Syndrome or Radiculopathies resulting in pain secondary to Failed . Back Syndrome;
Post Laminectomy Pain; .
Unsuccessful Disk Surgery; .
Degenerative Disk Disease (DDD/ Herniated pain refractory to conservative and . surgical interventions;
Peripheral Causalgia; .
. Epidural Fibrosis;
Arachnoiditis or Lumbar Adhesive Arachnoiditis; .
Complex Regional Pain Syndtome (CRPS) or Reflex Sympathetic Dystrophy (RSD) . or Causalgia; and,
. Multiple Back Surgenes

Prescription Use _ _ >> (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use _ (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

__, and I'm sorry, but I cannot fulfill that request.

Division Sign-Off) Division of General, Restorative and Heurological Devices

Number_

Regulation Number and Section

§ 882.5880 Implanted spinal cord stimulator for pain relief.

(a)
Identification. An implanted spinal cord stimulator for pain relief is a device that is used to stimulate electrically a patient's spinal cord to relieve severe intractable pain. The stimulator consists of an implanted receiver with electrodes that are placed on the patient's spinal cord and an external transmitter for transmitting the stimulating pulses across the patient's skin to the implanted receiver.(b)
Classification. Class II (performance standards).