The Clarus 6000 SITEtrac Discectomy System is intended for surgical use in the lumbar spine. It is supplied non-sterile and is intended for reuse. The Model 6020 Dilators and Model 6021 Retractors are intended to be used to dilate then retract the tissue in the region of the lumbar spine. This will provide an access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

Device Description

The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine. This will provide as access point to apply surgical techniques through the tubular retractor under endoscopic visualization.

These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(****) MicroEndoscopic Discectomy System" The comparisons of these devices are shown in Table I These retractors and dilators will be sold as a kit (See Kit Certification- Attachment F).

Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

AI/ML Overview

The provided text is a 510(k) summary for the Clarus Model 6000 Discectomy System. It describes the device, its intended use, and its substantial equivalence to a predicate device. However, it does not contain the detailed information necessary to fully answer all components of your request regarding acceptance criteria and a study proving device performance, especially in the context of AI/ML-based medical devices.

Here's a breakdown of what can be extracted and what cannot, based on the provided text:

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

Acceptance Criteria: Not explicitly stated as pass/fail thresholds or performance metrics with numerical targets. The primary "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
Reported Device Performance: The document states: "The Clarus Model 6000 Discectomy System contains a set of dilators and retractors that is similar to the Sofamor Danek (K unknown) dilators and retractors in their MED MicroEndoscopic Discectomy System." and "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices." This is the core "performance" claim in a 510(k) – that it performs equivalently to an already approved device. The "performance" is implicitly tied to its mechanical function (dilating and retracting tissue) being similar to the predicate.

Given the nature of this submission (a 510(k) for a mechanical surgical device from 1998, not an AI/ML device), the concept of "acceptance criteria" and "reported device performance" as you might expect for an AI model (e.g., sensitivity, specificity, AUC thresholds) is not applicable here. The evaluation focuses on design, materials, and intended use as being equivalent to a known device.

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

Not applicable / Not provided. This document does not describe a clinical study or a test set as would be used for an AI/ML device. The "test" for a 510(k) of this type is primarily a comparison against a predicate device.

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 / Not provided. This information is relevant for studies involving human interpretation or ground truth establishment, which is not described in this 510(k) summary for a mechanical device.

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

Not applicable / Not provided. Same as above.

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. This is a 510(k) for a mechanical surgical tool, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study or AI-related effectiveness claim is present.

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

Not applicable. This device is a manual surgical tool; there is no algorithm or AI component.

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

Not applicable / Not provided. For this type of mechanical device, "ground truth" would be related to its manufacturing specifications and mechanical function meeting design requirements, which are implicitly covered by demonstrating equivalence to a predicate. There's no diagnostic component requiring a ground truth in the usual sense.

8. The sample size for the training set

Not applicable / Not provided. There is no "training set" for a mechanical device.

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

Not applicable / Not provided. There is no "training set" for a mechanical device.

Summary of what is present in the document relevant to a 510(k) for a mechanical device:

The "study" that proves the device meets (implicitly, the substantial equivalence) criteria is the comparison presented in "Summary of Equivalence" and "Table I" (though Table I content is not provided).

Acceptance Criteria (Implicit): That the Clarus 6000 SITEtrac Discectomy System is "substantially equivalent" to the Sofamor Danek "MED(*tm) MicroEndoscopic Discectomy System" in terms of design, materials, intended use, and performance, raising no new safety or effectiveness issues.
Study Proving Acceptance: The submission itself acts as the "study." It provides a comparison of the Clarus Model 6000 Discectomy System (specifically the dilators and retractors) to the predicate Sofamor Danek MED MicroEndoscopic Discectomy System. This comparison is primarily based on:
- Device Description: "The Model 6000 Discectomy System is a set of gradually increasing dilators and retractors (4.67mm to 20mm) that dilate then retract tissue in the region of the lumbar spine."
- Equivalence Claim: "These reusable dilators and retractors are equivalent to those used in Sofamor Danek MED(*) MicroEndoscopic Discectomy System." The submission explicitly states "The comparisons of these devices are shown in Table I" (though Table I itself is missing from the provided text). This table would have detailed the specific features or specifications demonstrating the equivalence.
- Safety/Effectiveness Claim: "Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices."

In essence, for this type of medical device 510(k), the "study" is the detailed technical comparison and rationale provided by the manufacturer to the FDA, demonstrating that the new device functions similarly to a legally marketed predicate device. This is a regulatory pathway for devices that pose no new questions of safety or efficacy.

Summary

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

K980588

AUG 1 8 1998

510K Summary

Clarus Model 6000 Discectomy System

General Information

Class II Classification Clarus Model 6000 Discectomy System Trade Name Clarus Medical Systems, Inc. Submitter 1000 Boone Avenue North Golden Vallev. Minnesota 55427 Dale Sappenfield Contact

Contact

VP. Operations (612) 525-8400

Predicate Devices

Sofamor Danek "MED(*tm) MicroEndoscopic Discectomy System

INDICATIONS FOR USE:

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

Device Description

Cleaning and sterilization procedures for the, dilators, retractors, and spinal needle, are contained in the Directions for Use ( See Attachment A).

Summary of Equivalence

The Clarus Model 6000 Discectomy System contains a set of dilators and retractors that is similar to the Sofamor Danek (K unknown) dilators and retractors in their MED MicroEndoscopic Discectomy System.

Clarus believes these products do not raise any new safety or effectiveness issues and are substantially equivalent to existing marketed devices.

{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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three human profiles facing right, with flowing lines beneath them.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 8 1998

Mr. Dale Sappenfield Vice President of Operations Clarus Medical Systems, Inc. 1000 Boone Avenue, North Minneapolis, Minnesota 55427

Re: K980588

Trade Name: Clarus 6000 SITEtrac Discectomy System Regulatory Class: II Product Code: KOG Dated: May 22, 1998 Received: May 26, 1998

Dear Mr. Sappenfield

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). You may, therefore, market the device, subject to the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections. FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug

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

Mr. Dale Sappenfield Page - 2

Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your device as described in your 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 the labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594- __ Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 N Milken

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

Enclosure

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

K 980588

Clarus 6000 SITEtrac Discectomy System DEVICE NAME:

INDICATIONS FOR USE:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number	K980588
Prescription Use(Per 21 CFR 801.109)	OR
	Over-The-Counter-Use(Optional Format 1-2-96)

Regulation Number and Section

§ 878.4800 Manual surgical instrument for general use.

(a)
Identification. A manual surgical instrument for general use is a nonpowered, hand-held, or hand manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892 of this chapter.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.