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 document is a 510(k) summary for the ISOBAR Spinal System Additional Components. This document pertains to a medical device (pedicle screw spinal system) and its mechanical performance, not an AI/ML-based device. Therefore, many of the requested elements for AI/ML device studies (such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) are not applicable or cannot be extracted from this type of documentation.

However, I can extract the acceptance criteria and the study performed based on the information provided, focusing on the mechanical aspects of the device.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance
Static and fatigue compression testing	Performed according to ASTM F1717-96
(No specific thresholds or values	(Details of results against specific thresholds are not
are explicitly stated in this summary.	provided in this summary, only that testing was "performed
The 510(k) typically implies	according to" the standard, implying compliance for
compliance with the standard's	substantial equivalence.)
requirements.)
Material Compliance	Manufactured from titanium alloy (Ti-6Al-4V) that conforms to
	ASTM F136.

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

Sample Size: Not specified in the document. Testing according to ASTM F1717-96 would involve a specific number of samples, but this summary does not provide that detail.
Data Provenance: The testing was "performed according to ASTM F1717-96." This implies laboratory testing of the physical device components. Data provenance in terms of country of origin or retrospective/prospective is not applicable for this mechanical testing.

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

Not applicable. This is mechanical performance testing against an engineering standard, not clinical data requiring expert human review or ground truth establishment.

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

Not applicable. This refers to consensus methods for clinical assessment, which is not relevant for mechanical testing.

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. This is a medical device for spinal fixation, not an AI-based diagnostic or assistive technology.

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

Not applicable. This is not an algorithm.

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

The "ground truth" for this device's performance is compliance with the ASTM F1717-96 standard for static and fatigue compression testing, and the ASTM F136 standard for material composition. These are engineering standards, not clinical ground truths.

8. The sample size for the training set:

Not applicable. This is mechanical performance testing, not an AI/ML model that requires a training set.

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

Not applicable. There is no training set for this type of device and study.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study performed to demonstrate the device meets acceptance criteria involved mechanical testing of the ISOBAR Spinal System Additional Components. The specific standard cited for this testing is ASTM F1717-96, which covers static and fatigue compression testing of metallic spinal implant ensembles. Additionally, the material used, titanium alloy (Ti-6Al-4V), was confirmed to conform to ASTM F136, a standard specification for wrought titanium-6aluminum-4vanadium alloy for surgical implant applications.

The 510(k) submission states that these tests were "performed according to" the specified standards. This implies that the device and its components successfully met the performance requirements and material specifications outlined in those ASTM standards, thus establishing its substantial equivalence to predicate devices (Moss Miami Polyaxial Screw and ISOBAR U-Line Spinal System) that also rely on compliance with such standards for their mechanical integrity. The document does not provide a detailed report of the exact numerical results or the pass/fail thresholds for these tests, as is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full engineering report.

Summary

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510(k) Summary of Safety and Effectiveness

KD1344

(1) Submitter's name:	Scient'x
Submitter's address:	Guyancourt, France
Contact telephone number:	(512) 834-6255
Contact person:	Joanna Droege
Date summary prepared:	October 8, 2001
(2) Trade or proprietary device name:	ISOBAR Spinal System Additional Components
Common or usual name:	Pedicle screw spinal system
Classification name:	Class II
(3) Legally marketed predicate device:	Moss Miami Polyaxial Screw (K992168)DePuy AcroMed, Inc.ISOBAR U-Line Spinal System (K990118), Scient'x.

Subject device description: (4)

NOV 1 6 2001

(5) Subject device intended use:

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 (1.3 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 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.

Basis for substantial equivalence: (7)

The ISOBAR Spinal System polyaxial screw is similar in design, materials and indications as the Moss Miami Polyaxial Screw (K992168).

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes extending upwards and to the right.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Joanna Droege Regulatory/QA Manager Encore Orthopedics 9800 Metric Boulevard Austin, Texas 78758

NOV 1 6 2001

Re: K013444 Trade Name: ISOBAR Spinal System Regulatory Number: 21 CFR 888.3070. 21 CFR 888.3050 Regulation Name: Pedicle Screw Spinal 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 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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This letter will allow you to begin marketing your device as described in your 510(k) This letter will anow yourse bogan finding of substantial equivalence of your device to a premarket nothers and in a classification for your device 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. ad vertibing or you the regulation entitled, "Misbranding by reference to premarket Also, prease note the roganalism other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (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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NOV 1 6 2001

1(0)34/40

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: __ ISOBAR Spinal System Additional Components

Indications For Use:

ISOBAR Spinal System Additional Components Indications For Use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	for	Mark N Mellen
	(Division Sign-Off)
	Division of General, Restorative
	and Neurological Devices
510(k) Number	K013444

Prescription Use (per 21 CFR 801.109)	X	OR	Over-The-Counter Use (Optional Format 1-2-96)
---------------------------------------	----------	----	-----------------------------------------------

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.