When used as an anterior spinal system the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, stenosis, deformities (scollosis, kyphosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

When used as a posterior, non-pedicle spinal system (consisting of hooks and sacral/iliac screws), the Rogozinski Spinal Rod System is intended for the treatement of DDD (degenerative disc disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history or radiographic studies), pseudoarthrosis, deformities (scoliosis, kyphosis, lordosis), spondylolisthesis, fracture, previous failed fusion, or tumor resection. The Rogozinski Spinal Rod System is limited to non-cervical use.

Pedicle Screw Fixation

When used as a pedicle screw system, in the spine of skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the LS-S1 igint: (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral spine. degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

Device Description

The Rogozinski Spinal Rod System consists of stainless steel rods attached to the spinal column through the use of interlaminal hooks and/or screws. Crossbars may be used to connect rods to rods to provide a more rigid construct, as well as screws to rods and hooks to rods.

AI/ML Overview

This is a medical device submission, specifically a Summary of Safety and Effectiveness for the Rogozinski Spinal System (K983904), dated December 22, 1998. This document does not contain information about acceptance criteria or specific study data.

Medical device submissions like this primarily focus on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use. They typically do not include detailed performance studies with acceptance criteria in the way an AI/software device would. The "study" here is more about asserting equivalency to previously cleared devices rather than a performance study measuring metrics like sensitivity, specificity, or accuracy against a ground truth.

Therefore, most of the requested information cannot be extracted from the provided text.

Here is what can be extracted based on the nature of this document:

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

Not applicable / Not present. This document does not describe acceptance criteria in terms of performance metrics (e.g., accuracy, sensitivity, specificity) or report quantitative device performance data against such criteria. The device is a physical spinal fixation system, and its "performance" is generally established through material testing, mechanical testing, and clinical history of predicate devices, not through a statistical study with specific acceptance thresholds for diagnostics.

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 present. This document does not detail a "test set" or clinical study data. It is a substantial equivalence submission for a physical implant.

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 present. No ground truth establishment for a test set is described.

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

Not applicable / Not present. No test set or adjudication process is described.

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

Not applicable / Not present. This is not an AI/software device.

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

Not applicable / Not present. This is not an algorithm.

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

Not applicable / Not present. No ground truth for device performance is defined or used in the context of a "study" here. The "truth" for this device lies in its mechanical properties meeting standards and its clinical use being consistent with predicate devices that have established safety and effectiveness.

8. The sample size for the training set

Not applicable / Not present. This is not a machine learning/AI device, so there is no training set mentioned.

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

Not applicable / Not present. See point 8.

In summary: The provided text is a 510(k) summary for a spinal implant, focusing on its substantial equivalence to previously cleared devices rather than providing performance metrics from a study that would include acceptance criteria, test sets, or ground truth establishment in the context of diagnostic or AI devices.

Summary

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DEC 22 1998	Rogozinski Spinal SystemSummary of Safety and Effectiveness		K983904page 1 of 2
	SUBMITTER:	United States Surgical Corporation150 Glover AvenueNorwalk, CT 06856
	CONTACT PERSON:	Sharon L. Murphy
	DATE PREPARED:	September 29, 1998
	CLASSIFICATION NAME:	Spinal Intervertebral Body Fixation OrthosisSpinal Interlaminal Fixation OrthosisSpondylolisthesis Spinal Fixation Device System
	COMMON NAME:	Spinal Rod System
	PROPRIETARY NAME:	Rogozinski Spinal Rod System
	PREDICATE DEVICES:	USSC's Surgical Dynamics™ Rogozinski Spinal RodSystem - K884263, K896106, K930298, K950865,K954696, K965224
	DEVICE DESCRIPTION:	The Rogozinski Spinal Rod System consists of stainlesssteel rods attached to the spinal column through the use ofinterlaminal hooks and/or screws. Crossbars may be usedto connect rods to rods to provide a more rigid construct,as well as screws to rods and hooks to rods.
	INTENDED USE:	Non-Pedicle Screw Fixation
		When used as an anterior spinal system the RogozinskiSpinal Rod System is intended for the treatement of DDD(degenerative disc disease defined as back pain ofdiscogenic origin with degeneration of the disc confirmedby history or radiographic studies), pseudoarthrosis,stenosis, deformities (scoliosis, kyphosis, lordosis),spondylolisthesis, fracture, previous failed fusion, or tumorresection. The Rogozinski Spinal Rod System is limited tonon-cervical use.
		When used as a posterior, non-pedicle spinal system(consisting of hooks and sacral/iliac screws), theRogozinski Spinal Rod System is intended for thetreatement of DDD (degenerative disc disease defined asback pain of discogenic origin with degeneration of thedisc confirmed by history or radiographic studies),pseudoarthrosis, stenosis, deformities (scoliosis, kyphosis,lordosis), spondylolisthesis, fracture, previous failed fusion,or tumor resection. The Rogozinski Spinal Rod System islimited to non-cervical use.

10/11/2

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Surnmary of Safety and Effectiveness

K983906 Page 2 of 2

Pedicle Screw Fixation INTENDED USE :

When used as a pedicle screw system, in the spine of (continued) skeletally mature patients, the Rogozinski Spinal Rod System is indicated for patients: (a) having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint; (b) who are receiving fusions using autogenous bone graft only; (c) who are having the device fixed or attached to the lumbar and sacral spine (L3 and below); and (d) who are having the device removed after the development of a solid fusion mass.

In addition, when used as a pedicle screw system, in the non-cervical spine of skeletally mature patients, the Rogozinski Spinal Rod System is intended to provide immobilization and stabilization of spinal segments, as an adjunct to fusion, in the treatment of the following acute and chronic instabilities of the thoracic, lumbar, and sacral degenerative spondylolisthesis with objective spine: evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

MATERIALS: The material used is implant grade material that conforms to ASTM F138 standards for stainless steel.

ു.

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Image /page/2/Picture/2 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 top half of the circle. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines beneath them, resembling a bird or a symbol of human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 22 1998

Ms. Sharon L. Murphy Regulatory Affairs Program Manager United States Surgical Corporation 150 Glover Avenue Norwalk, Connecticut 06856

K983899 Re : Thoracolumbar Spinal Rod System (Empower) Trade Name: K983904 Roqozinski Spinal Rod System Trade Name: Requlatory Class: II Product Codes: MNI, MNH, KWQ, and KWP October 30, 1998 Dated: November 3, 1998 Received:

Dear Ms. Murphy:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) 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 devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਜ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General requlation (21 CFR Part 820) and that, Devices: 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 devices in the Federal Register. Please note: this response to your premarket notification submission does

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Page 2 - Ms. Sharon L. Murphy

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 requlations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your devices, 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

Enclosures

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Rogozinski Spinal System

Indications for Use

510(k) Number (if known): K983904

Rogozinski Spinal Rod System Device Name:

Indications For Use:

Non-Pedicle Screw Fixation

Pedicle Screw Fixation

(Please do not write below this line - continue on another page if needed)

	Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:	X
	OR Over-The-Counter
Use:(Per 21 CFR 801.109)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number K983904
A1

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.