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 turnor, 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), 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-6AI-4V) that conforms to ASTM F136.

AI/ML Overview

Here's an analysis of the provided text regarding the ISOBAR Spinal System, focusing on acceptance criteria and supporting studies:

It's important to note that the provided document is a 510(k) summary for a medical device submitted to the FDA in 2001. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical efficacy studies as would be required for a Class III device or for certain novel technologies today. Therefore, many of the typical elements you'd find in a modern AI/software as a medical device (SaMD) study are not present in this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Must meet fatigue test requirements as per ASTM F1717-96.	Fatigue Tensile Testing: - Performed according to ASTM F1717-96. - Specific performance values (e.g., cycles to failure, stress levels) are not provided in this summary.
Material Composition: - Manufactured from titanium alloy (Ti-6AI-4V) conforming to ASTM F136.	Material Composition: - All components manufactured from titanium alloy (Ti-6AI-4V) that conforms to ASTM F136.
Indications for Use: - Must be for immobilization and stabilization of spinal segments as an adjunct to fusion for specified acute and chronic instabilities/deformities (pedicle screw and non-pedicle screw indications).	Indications for Use: - Stated as intended for 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, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis), and severe spondylolisthesis (Grade 3 and 4) of L5-S1. Also for hook fixation (non-pedicle screw) for spondylolisthesis, degenerative disc disease, deformities, tumor, pseudoarthrosis, trauma, and/or previous failed fusion surgery.
Substantial Equivalence: - Must be substantially equivalent in design, materials, and indications to predicate devices (TSRH™ Spinal Implant System and ISOLA® Spinal System).	Basis for Equivalence: - The ISOBAR Spinal System hook components are similar in design, materials, and indications to the TSRH™ Spinal Implant System (K982990) and the ISOLA® Spinal System (K980485).

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not discuss a "test set" in the context of performance data from patient outcomes or clinical trials. The "test set" mentioned in the modern context of AI/SaMD studies (i.e., a dataset used to evaluate an algorithm's performance) is not applicable here.

The performance data mentioned relates to mechanical testing (fatigue tensile testing) of the device components. The sample size for this mechanical testing is not specified in the summary. Data provenance is also not applicable as it's a lab-based mechanical test, not clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

This information is not applicable to the provided document. The device is a physical implant, not a diagnostic algorithm that requires expert-established ground truth from clinical images or data.

4. Adjudication Method for the Test Set

This information is not applicable to the provided document, for the same reasons as point 3.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. The ISOBAR Spinal System is a surgical implant, not a diagnostic tool, and the submission predates widespread AI in medical devices requiring such studies.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone algorithm performance study was not done. This concept is completely irrelevant to a physical spinal implant device.

7. The Type of Ground Truth Used

For the mechanical performance data (fatigue tensile testing), the "ground truth" is defined by the acceptance criteria established by the ASTM F1717-96 standard. This standard specifies how the test should be conducted and what constitutes a passing performance. It's an engineering ground truth, not a clinical one.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical product, not an algorithm that undergoes "training" on a dataset. The design and manufacturing processes are informed by engineering principles and existing medical knowledge, not a training set in the AI sense.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable, for the same reasons as point 8.

Summary of Key Findings from the 510(k) for K013440:

Device Type: Physical spinal implant system (pedicle screws, rods, nuts, crosslink members, hooks).
Approval Basis: Substantial Equivalence to predicate devices (TSRH™ Spinal Implant System and ISOLA® Spinal System).
Performance Data: Primarily focused on mechanical testing (fatigue tensile testing according to ASTM F1717-96) and demonstrated material conformity (Ti-6AI-4V to ASTM F136).
Clinical Studies: No clinical studies with human subjects are described in this 510(k) summary. The FDA's review for substantial equivalence at the time did not require such studies for this type of device if mechanical performance and material equivalence were demonstrated to predicate devices.
Absence of AI/SaMD Concepts: The concepts of "test set," "training set," "expert ground truth," "adjudication," and "MRMC studies" are entirely out of scope for this 2001 510(k) submission for a physical implant.

Summary

{0}------------------------------------------------

K613440

510(k) Summary of Safety and Effectiveness

(1) Submitter's name: Submitter's address: · . Contact telephone number: Contact person: Date summary prepared:
Scient'x Guyancourt, France (512) 834-6255 Joanna Droege October 8, 2001

NOV 1 6 2001

(2) Trade or proprietary device name: ISOBAR Spinal System Additional Components Pedicle screw spinal system Common or usual name: Classification name: Class II

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

Subject device description: (4)

(ર) Subject device intended use:

The ISOBAR Spinal System is a pedicle screw system intended to provide immobilization 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 (pseudarthrosis).

As a pedicle screw system, the ISOBAR 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.

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), turnor, 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, fatigue tensile 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.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of an eagle or bird with three wing-like shapes, suggesting movement or flight.

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

K013440 Re: 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.

{2}------------------------------------------------

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 tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,
for Mark N. Melkman

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

{3}------------------------------------------------

NOV 1 6 2001

KARYYO ³10(k) Number (if known):

1013440

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)


(Division Sign-Off)
Division of General, Restorative and Neurological Devices
510(k) Number	K013440

Prescription Use X(per 21 CFR 801.109)	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.