The ISOBAR Semi-rigid Spinal System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

Device Description

The ISOBAR Semi-rigid System consists of pedicle screws, rods, nuts and crosslink members. It can be used for single or multiple level fixation. All components are manufactured from titanium allov (Ti-6Al-4V) that conforms to ASTM F136.

This system consists of pedicle screws that require rod attachment directly over the top of the screw (U-Line Screws) and a combination of screws and clamps that allow the rod to be offset from the screw (Hemispherical Headed Screws).

AI/ML Overview

The provided text is a 510(k) summary for the ISOBAR Semi-rigid Spinal System. It details the device's description, intended use, and states its substantial equivalence to a previously cleared device (ISOBAR Spinal System K990118).

However, the summary does not contain the information requested regarding specific acceptance criteria, a detailed study proving device performance against those criteria, sample sizes for test/training sets, data provenance, expert qualifications, or adjudication methods for ground truth establishment.

Instead, it explicitly states:
"The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the U-Line Screws was performed according to ASTM F1717-96."

This indicates that while some testing was conducted to a recognized standard (ASTM F1717-96), it was not against FDA-established performance standards or specific acceptance criteria provided within this document. The primary basis for clearance is substantial equivalence to an existing device, not a new comparative effectiveness study or standalone performance evaluation against predefined criteria as would be typical for an AI/CADe device.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as the provided document does not contain this information in the level of detail requested for a typical AI/CADe device submission.

Summary

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(2)

510/k) Summary of Safety and Effectiveness

Submitter's name: (1) Submitter's address: Submitter's telephone number: Contact person: Date summary prepared:
Common or usual name:

Trade or proprietary device name:

Encore Orthopedics, Inc. 9800 Metric Blvd. Austin, TX 78758 (512) 834-6237 Debbie De Los Santos November 5, 1998

ISOBAR Semi-rigid Spinal System Pedicle screw spinal system Class II

ISOBAR Spinal System (K990118) Legally marketed predicate device: (3)

Subject device description: (4)

Classification name:

(ર) Subject device intended use:

The ISOBAR Semi-rigid System is a pedicle screw system intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, spinal tumor, and failed previous fusion (pseudarthrosis),

As a pedicle screw system, the ISOBAR Semi-rigid Spinal System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the LS-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

(6) Performance data:

The Food and Drug Administration have established no performance standards applicable to pedicle screw spinal systems. However, static and fatigue compression testing of the U-Line Screws was performed according to ASTM F1717-96.

(7) Basis for substantial equivalence:

The ISOBAR Semi-rigid Spinal System is equivalent to the ISOBAR Spinal System cleared on K990118.

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Image /page/1/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling an abstract symbol in the center. The symbol consists of three stylized, curved lines that resemble a person's profile, with the lines overlapping to create a sense of depth and movement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 8 1999

Ms. Debbie De Los Santos Requlatory/Clinical Specialist Encore Orthopedics, Inc. 9800 Metric Boulevard Austin, Texas 78758

K991326 Re: ISOBAR Semi-Rigid Spinal System Requlatory Class: II Product Codes: MNI and MNH Dated: August 10, 1999 Received: August 11, 1999

Dear Ms. De Los Santos:

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 The general controls provisions of the Act 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 In addition, FDA may publish further announcements action. 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 requlations.

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Page 2 - Ms. Debbie De Los Santos

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,

James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): _ K 9 9 1 3 ص 2 2 2

Device Name: __ ISOBAR Semi-rigid Spinal System

Indications For Use:

ISOBAR Semi-rigid Spinal 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 (per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)_

Regulation Number and Section

N/A