The E9000 System functions as a powered instrument system consisting of drills, saws, and associated handpieces to perform cutting of soft tissue and bone. The fields of application include: Orthopedic, Arthroscopic, Otolaryngological, Oral/Maxillofacial, Hand, Foot, Neuro, Medial Sternotomy, Spinal and Plastic/Reconstructive surgical procedures.

Device Description

The E9000 System is a combination drive system and irrigation console, which consists of an AC powered drive/pump console, a power cord, a footswitch, a sterilizable handpiece cord, various motorized handpieces, associated shavers, blades, burs, bur guards, routers, irrigation tubing sets, and bur tips.

AI/ML Overview

This document is a 510(k) summary for the Linvatec E9000 System, a surgical power tool. It establishes substantial equivalence to previously marketed devices rather than presenting a study with specific acceptance criteria and performance data in the format typically used for AI/software-based medical devices.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of regulatory submission for a hardware device.

Here's an attempt to answer based on the provided document, addressing the relevant sections and indicating where information is not available:

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

The document does not specify quantitative "acceptance criteria" or "reported device performance" in the manner typically seen for diagnostic or AI-driven devices (e.g., sensitivity, specificity thresholds, AUC). Instead, substantial equivalence for this surgical system is based on similarities in design, function, and intended use with predicate devices.

Acceptance Criteria (Implied)	Reported Device Performance
Safety and Effectiveness	"Testing has been done to prove safety and effectiveness of the devices." (No specific metrics provided.)
Similar Intended Use	The E9000 System's intended use matches or is comparable to predicate devices for cutting soft tissue and bone in various surgical procedures. (Detailed in Section F and the comparison chart).
Similar Design/Function	The E9000 System is a combination drive system and irrigation console, with motorized handpieces, shavers, blades, etc., similar to the predicate devices. (Detailed in Section E and the comparison chart).
Predicate Device Equivalence	Found "substantially equivalent" to the Hall E9000 Integrated Drive/Pump System, MicroChoice Universal Drive System, and Hall Sternum Saw.

2. Sample sized 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 as it is a 510(k) summary for a hardware device, not a clinical study on a diagnostic algorithm. The "testing" mentioned is likely engineering and performance testing (e.g., mechanical, electrical, sterilization) rather than clinical efficacy studies with human subjects.

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 provided and is not applicable to a 510(k) submission for a surgical instrument. There is no concept of "ground truth" expert review in this context.

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

This information is not provided and is not applicable for this type of device submission.

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

An MRMC comparative effectiveness study is not applicable as this is a surgical power tool, not an AI-assisted diagnostic or interpretation device that "improves human readers." Therefore, no effect size is reported.

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

This concept is not applicable as the E9000 System is a physical surgical power device operated by a human surgeon, not an algorithm.

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

This is not applicable. The "ground truth" for a surgical device like this would be its ability to perform its intended mechanical function safely and effectively (e.g., cutting bone, oscillating saws) as demonstrated through engineering tests and historical performance of similar devices.

8. The sample size for the training set

This information is not provided and is not applicable to this type of device submission. There is no "training set" in the context of an AI/ML algorithm.

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

This information is not provided and is not applicable to this type of device submission.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Linvatec. The logo consists of a geometric shape on the left and the word "Linvatec" in bold, black letters on the right. The geometric shape is a square with three smaller squares inside, each rotated 45 degrees relative to the outer square. The word "Linvatec" is written in a sans-serif font.

Largo, FL 33773-4908 727-392-6464 11311 Concent Boule

JUL 15 1999

June 28, 1999

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR 807.92, Linvatec Corporation is hereby submitting the 510(k) Summary of Safety and Effectiveness for the E9000 System, 510(k) Number K990524.

Submitter A.

Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Company Contact B.

Laura Seneff Manager, Regulatory Affairs

Device Name c.

Trade Name:	:	E9000 System
Common Name	:	Integrated Drive/Pump System
Classification Name	:	Surgical, ENT (electric orpneumatic), includinghandpiece - 874.4250Electric cranial drill motor -882.4360Infusion Pump - 880.5725Surgical instrument motors andaccessories/attachments - 878.4820Bone cutting instrument andaccessories - 872.4120

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Summary of Safety and Effectiveness E9000 System 510(K)# K990524 June 28, 1999 Page 2 of 4

D. Predicate/Legally Marketed Devices

Integrated Drive/Pump System (Hall E9000 System) Linvatec Corporation

Universal Drive System (MicroChoice System) Linvatec Corporation

Hall Sternum Saw Linvatec/Hall Surgical

E. Device Description

F. Intended Use

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Summary of Safety and Effectiveness E9000 System 510(K)# K990524 June 28, 1999 Page 3 of 4

Substantial Equivalence G.

The E9000 System is substantially equivalent in design, function and intended use to the Hall E9000 Integrated Drive/Pump System (Linvatec Corporation), the MicroChoice Universal Drive System (Linvatec Corporation) and the Hall Sternum Saw (Linvatec/Hall Surgical).

Testing has been done to prove safety and effectiveness of the devices.

The similarities/dissimilarities to the predicates are shown in the attached table.

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Summary of Safety and Effectiveness E9000 System 510 (K) # K990524 June 28, 1999 Page 4 of 4

HALLE 9000 SYSTEM DEVICE E9000 SYSTICM MIGROGHOIGE दिसम्मान आमिश्रम्बद्धा देतु (ENTERMARASEN) IDEADHD Crassiste SA STICIM INTENDED Resection of tissue and bone during Resection of soft tissue and Resection of soft tissue and bone Cutting of bone beginning USE arthroscopic, orthopedic, bone during orthopedic, cutting during arthroscopic, the suprasternal notch or t otolaryngological, otololaryngological, orthopedic, oral/maxillofacial, xiphoid process during a oral/maxillofacial, hand, foot, neurological and spinal medial sternotomy. otoloaryngological, hand, foot, neurological, spinal, surgical procedures. neurological and plastic/reconstructive and medial plastic/reconstructive surgical sternotomy surgical procedures. procedures. K990254 510(K) K981636 & K981637 K971059 K862474 NUMBER ACCESSORIES Blades, Burs, Routers, Attachments, Blades, Burs, Routers, Blades, Battery Pack Blades, Burs, Attachments, Foot Bur Guards, Bur Tips, Irrigation Attachments, Bur Guards, Bur Control Tubing Sets, Foot Control, Shaver Tips, Irrigation Tubing Sets, Adapter, Universal Cord Foot Control, Shaver Adapter, Universal Cord Drive/Pump Console, High DEVICE Drive/Pump Console, Cranial Universal Drive Console, Micro Handpiece COMPONENT Perforator, High Speed Drill Speed Shaver Handpiece, High Joint Handpiece, Standard Medium Speed Drill, Reciprocating Speed Drill, Cranial Handpiece, Full-Function Saw, Oscillating Saw, Low Speed Perforator, Micro Handpiece, Handpiece, Low Speed Drill, Drill, Modular Handpiece, Sagittal Saw Medium Speed Drill, High Speed Wiredriver, Large Shaver Drill, Oscillating Saw, Sagittal Handpiece, Full-Function Saw, Reciprocating Saw, Handpiece, Small Shaver Wiredriver Handpiece, Micro Handpiece MATERIAL Aluminum, Stainless Steel Aluminum, Stainless Steel Aluminum, Stainless Steel Stainless Steel

CHART OF SIMILARITIES AND DISSIMILARITIES

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three horizontal lines representing its wings or feathers.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 15 1999

Ms. Laura Seneff Manager Regulatory Affairs Linvatec Corporation 11311 Concept Boulevard Largo, Florida 33773-4908

Re: K990524 Trade Name: E9000 System Regulatory Class: II Product Code: HRX Dated: May 27, 1999 Received: May 28, 1999

Dear Ms. Seneff:

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 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. 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 (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 requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, 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.

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Page 2 - Ms. Laura Seneff

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 our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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/dsmamain.html".

Sincerely yours,

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

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June 28, 1999

Page 1 of 1

510(k) Number (if known): K990524

Device Name: E9000 System

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ L

Over-the-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

(Division Sign-Off)
Division of General Restorative Devices K990524
510(k) Number __

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.