The ISOBAR 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

As a pedicle screw system, the ISOBAR 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.

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

Device Description

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

AI/ML Overview

The provided text describes a 510(k) summary for the "ISOBAR Spinal System Additional Components." This document focuses on the mechanical performance and substantial equivalence of the device to existing predicate devices, rather than a clinical study evaluating diagnostic accuracy or a human-AI interaction.

Therefore, many of the requested categories for acceptance criteria and study details (like sample size for test set, number of experts, adjudication methods, MRMC study, standalone performance, training set details) are not applicable or not provided in this type of submission. This 510(k) is for a medical device (spinal implant components), not an AI algorithm or a diagnostic tool.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (from document)	Reported Device Performance (from document)
Mechanical Performance	Static and fatigue compression testing according to ASTM F1717-96.	"static and fatigue compression testing was performed according to ASTM F1717-96." (No specific numerical results or pass/fail stated, just that tests were performed.)
Material Composition	Conformance to ASTM F136 for titanium alloy (Ti-6Al-4V).	"All components are manufactured from titanium alloy (Ti-6Al-4V) that conforms to ASTM F136."

2. Sample size used for the test set and the data provenance

Not applicable/Not provided. This submission is for mechanical device components, not a dataset for an AI algorithm. The performance data refers to material and mechanical testing, not analysis of patient data.

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

Not applicable/Not provided. Ground truth, in the context of an AI algorithm, typically refers to expert labels on a dataset. For this medical device, "ground truth" would relate to engineering standards and material properties, not clinical expert consensus on an image or patient outcome.

4. Adjudication method for the test set

Not applicable/Not provided. Adjudication methods (e.g., 2+1, 3+1) are used for resolving disagreements among multiple expert annotators in AI algorithm studies. This is not relevant to the mechanical testing 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

No. This is a mechanical device, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and human-AI improvement metrics are not relevant.

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

Not applicable. This device is hardware; there is no "algorithm only" performance.

7. The type of ground truth used

Engineering Standards / Material Specifications. For this device, the "ground truth" for acceptance criteria revolves around established ASTM (American Society for Testing and Materials) standards for materials and mechanical performance (e.g., ASTM F136 for titanium alloy, ASTM F1717-96 for static and fatigue compression testing of spinal implant constructs).

8. The sample size for the training set

Not applicable/Not provided. There is no "training set" as this is not an AI/machine learning product.

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

Not applicable/Not provided.

Summary

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510(k) Summary of Safety and Effectiveness JAN 1 5 2002

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

Common or usual name:

Classification name:

(2)

Scient'x Guvancourt, France (512) 834-6255 Joanna Droege October 8, 2001

K013447
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ISOBAR Spinal System Additional Components Trade or proprietary device name: Pedicle screw spinal system Class II

TSRHTM Spinal Implant System (K982990) Sofamor Legally marketed predicate device: (3) Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed.

(4) Subject device description:

Subject device intended use: (ર)

The ISOBAR 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, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion fracture. (pseudarthrosis).

When used as a posterior, non-cervical, non-pedicle screw fixation system, the ISOBAR Spinal System is intended for hook fixation from T1 to the ilium/sacrum. The non-pedicle screw indications are spondylolisthesis, degenerative disc disease (as defined by back pain of discogenic origin with degeneration of the disc confirmed by history patient history and radiographic studies), deformities (scoliosis and lordosis), tumor, pseudoarthrosis, trauma (fracture or dislocation) and/or previous failed fusion surgery.

(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 was performed according to ASTM F1717-96.

(7) Basis for substantial equivalence:

The ISOBAR Spinal System hook components are similar in design, materials and indications as the TSRH™ Spinal Implant System (K982990) Sofamor Danek and the ISOLA® Spinal System (K980485) DePuy AcroMed.

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Image /page/1/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the edge. In the center of the seal is an image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Scient'X c/o Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

K013447 Re:

Trade Name: ISOBAR Spinal System Regulatory Number: 21 CFR 888.3070, 21 CFR 888.3070, 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal System, Spondylolisthesis Spinal Fixation Device System, Spinal Interlaminal Fixation Orthosis, Regulatory Class: II Product Code: MNH, MNI, KWP Dated: October 15, 2001 Received: October 17, 2001

Dear Ms. Droege:

We have reviewed your Section 510(k) notification of intent to market the device referenced We have have determined the device is substantially equivalent (for the indications for use above and we nave determined an marketed in interstate commerce prior to May 28, 1976, the stated in the encrosure) to device Amendments, or to devices that have been reclassified in enacificin date of the Modical Doviet Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general therefore, market the act received to equirements for annual registration, listing of devices, Controls provisions of the heading, 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 (1 Child Kel Approvar), it may of Sallery of Federal Regulations, Title 21, Parts 800 to allecting your device can or route entination assumes compliance with the current Good 097. A substainmin'y equirement, as set forth in the Quality System Regulation (QS) for Manufacturing Praction regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to mspections, the Food and Drag result in regulatory action. In addition, FDA may publish comply with the Grill regarenting your device in the Federal Register. Please note: this response to your premarks contrise your 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. Joanna Droege

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Ro. Mark n. Millman

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

Enclosure

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510(k) Number (if known): ((________________________________________________________________________________________________________________________________________________

K013447

Device Name: ISOBAR Spinal System Additional Components

XO13447
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Indications For Use:

ISOBAR Spinal System Additional Components

Indications For Use

System is a pedicle screw system intended to provide The ISOBAR Spinal 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, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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

Concurrerice of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number K013447
Prescription Use X OR Over-The-Counter Use _
(per 21 CFR 801.109)
(Optional Format 1-2-96)_

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.