The ISOBAR Spinal System is 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; spinal tumor; and failed previous fusion.

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 solid fusion.

The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.

Device Description

The ISOBAR Spinal System consists of pedicle screws, rigid rods and crosslink members (K990118, K013444, K020245, K031290 and K051063), semi-rigid rods (K991326) and hooks (K013440 & 013447). The Isobar Semi-rigid Dual Dampener Rod is an addition to the ISOBAR Spinal System family. The semi-rigid rod allows a very small amount of compression, torsion and bending. The components in this submission are fabricated from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.

AI/ML Overview

The provided text is a 510(k) summary for the "ISOBAR Spinal System." It details the device's indications for use, description, and states its substantial equivalence to predicate devices. However, it does not contain the specific information required to answer your questions regarding acceptance criteria, study details, sample sizes, expert involvement, or grand truth establishment for performance evaluation.

Here's an explanation of why the requested information is not present in the given document:

Acceptance Criteria and Reported Device Performance: The document only states that "Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices." It does not provide specific acceptance criteria (e.g., specific thresholds for mechanical strength, fatigue life) or the quantitative results of the tests performed against such criteria.
Sample Size for Test Set and Data Provenance: This document is a regulatory submission for a spinal implant system. Performance testing for such devices typically involves benchtop mechanical testing (e.g., fatigue, static strength), not studies on human data or medical images. Therefore, concepts like "test set," "data provenance," or "country of origin of the data" in the context of medical imaging or clinical study data do not apply here. The "sample size" would refer to the number of devices or components tested mechanically, which is not disclosed.
Number of Experts and Qualifications: As the evaluation is based on mechanical performance and substantial equivalence to predicate devices, there isn't a need for medical experts to establish "ground truth" or to adjudicate observations in the way they would for, say, an AI-powered diagnostic device analyzing medical images.
Adjudication Method: Not applicable for a mechanical device substantial equivalence submission.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This type of study is used for diagnostic devices, particularly those involving human interpretation of medical data, to assess how a new technology (like AI) affects reader performance.
Standalone Performance: While the device is "standalone" in the sense that it's an implantable device, the concept of "algorithm only without human-in-the-loop performance" is typically relevant to AI/ML software devices.
Type of Ground Truth: The "ground truth" for a spinal implant system's performance would generally be established by adherence to recognized ASTM or ISO standards for mechanical testing (e.g., fatigue strength, pull-out strength). The document only mentions conformity to ASTM F136 and ISO 5832-3 for material properties, but not specific performance test standards or their results.
Sample Size for Training Set: Not applicable. This pertains to AI/ML models.
How Ground Truth for Training Set was Established: Not applicable.

In summary, the provided document is a 510(k) summary primarily focused on demonstrating substantial equivalence to predicate devices based on indications for use, design, function, and materials, rather than detailed performance study results against specific acceptance criteria. For mechanical devices like spinal implants, "performance standards" typically refer to adherence to recognized test methods and successful completion of those tests, rather than clinical studies with human participants. The document indicates that testing was performed to show substantial equivalence, but it does not elaborate on the specific tests, their results, or the acceptance criteria used.

Summary

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510(k) Summary

APR 1 7 2008

Contact:	John SandersScient'x USA, Inc.1015 Maitland Center Commons, Suite 106AMaitland, FL 32751407.571.2550
Device Trade Name:	ISOBAR Spinal System
Manufacturer:	Scient'xBatiment Calypso Parc Ariane 378284 Guyancourt, France
Classification:	21 CFR §888.3070; Pedicle screw spinal system21 CFR §888.3050; Spinal interlaminal fixation orthosis
Class:	II
Product Code:	KWP, MNH, MNI, NOP

Indications For Use:

The ISOBAR Spinal System is 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 degenerative spondylolisthesis with objective evidence of neurological spine: impairment; fracture; dislocation; scoliosis; spinal tumor; and failed previous fusion.

The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.

Device Description:

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from Ti6A14V alloy, conforming to ASTM F136 and ISO 5832-3, which is known to be biocompatible.

Predicate Device(s):

The ISOBAR Spinal System was shown to be substantially equivalent to previously cleared devices and has the same indications for use, design, function, and materials.

Performance Standards:

Testing performed indicates the ISOBAR Spinal System is substantially equivalent to predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The eagle is depicted in a simple, black and white design.

APR 17 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Scient'x USA, Inc. % Mr. John Sanders Quality Assurance Regulatory Affairs Manager 1015 Maitland Center Commons Suite 106A Maitland, FL 32751

Re: K071261 Trade/Device Name: ISOBAR Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: II Product Code: NQP, MNI, MNH, KWP Dated: April 4, 2008 Received: April 7, 2008

Dear Mr. Sanders:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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 and the limitations described below. 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.

The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:

The safety and effectiveness of this device for the indication of spinal stabilization without fusion have not been established.

Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.

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Page 2- Mr. John Sanders

The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International, and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

NocetM

Donna-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071261

Indications for Use

510(k) Number (if known): K071261

Device Name: ISOBAR Spinal System

Indications for Use: The ISOBAR Spinal System is 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; spinal tumor; and failed previous fusion.

The Semi-Rigid Rod and Dual Dampener Rod should only be used at levels (one and two levels, respectively) that will be fused.

Prescription Use イ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Neil R.P. Oglsb for mxn

Division of General, Restorative. and Neurological Devices

510(k) Number K071261

Regulation Number and Section

§ 888.3070 Thoracolumbosacral pedicle screw system.

(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when 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 the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.