Internal fixation implants are load-sharing devices intended to stabilize and maintain alignment until normal healing occurs. Implants are not intended to replace normal body structures or bear the weight of the body in the presence of incomplete bone healing.

The ARX™ Spinal System, when properly used, is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, the ARXTM Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Device Description

The ARX™ Spinal System includes various types and sizes of single use implantable components. When assembled, the components create a rigid structure providing stabilization and promoting spinal fusion. The system is comprised of bone screws and rods. Class I surgical instruments are utilized for the installation of the implant.

AI/ML Overview

The provided text describes a medical device submission (K061600) for the ARX™ Spinal System. It details the device, its intended use, materials, and substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria for device performance in a clinical study, nor does it provide results of such a study from which "reported device performance" could be extracted.

Instead, this is a 510(k) summary submission to the FDA, where the manufacturer demonstrates substantial equivalence to legally marketed predicate devices primarily through biomechanical testing and comparison of indications for use, design, function, and materials.

Here's what can be extracted and what is missing based on your request:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a clinical study from this document. The "criteria" for FDA clearance here is demonstrating substantial equivalence to predicate devices. This is achieved by comparing indications for use, design, function, and materials, and through biomechanical testing to ASTM F1717.
Reported Device Performance: The document states: "Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalency." It then concludes: "The ARX™ Spinal System was shown to be substantially equivalent to previously cleared devices..." No specific numerical performance metrics are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size: Not applicable in the context of a clinical test set from this document. Biomechanical testing (ASTM F1717) would involve a sample of the manufactured device components rather than patient data. The sample size for the biomechanical tests is not specified.
Data Provenance: Not applicable for patient data. The biomechanical testing would have been conducted in a lab setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is not a study involving expert assessment of patient data to establish ground truth.

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

Not applicable. This is not a study involving expert assessment of patient data.

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, an MRMC comparative effectiveness study was not done. This device is a spinal implant, not an AI diagnostic tool.

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 device is a spinal implant.

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

For the purpose of substantial equivalence, the "ground truth" is established by the performance characteristics and indications for use of the predicate devices. For the biomechanical testing, the "ground truth" would be the engineering standards defined by ASTM F1717.

8. The sample size for the training set

Not applicable. This device does not involve a training set for an algorithm.

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

Not applicable. This device does not involve a training set for an algorithm.

In summary, the provided document is a 510(k) premarket notification for a Class II medical device (spinal implant). It demonstrates substantial equivalence primarily through adherence to established material specifications and biomechanical testing against an ASTM standard, rather than a clinical study with detailed acceptance criteria and performance metrics for patient outcomes.

Summary

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Image /page/0/Picture/0 description: The image shows the words "Life Spine" in a bold, sans-serif font. The word "Life" is on the left, and the word "Spine" is on the right. There is a curved line underneath the word "Spine". There is a registered trademark symbol next to the word "Spine".

AUG 2 2 2006

K061600 pg 1 of 2

510(k) Summary of Safety and Effectiveness

510(k) Summary - ARXTM Spinal System

Submitted By:	Life Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60195
	Telephone: 847-884-6117Fax: 847-884-6118
510(k) Contact:	Erin MalloyLife Spine2400 Hassell Road, Suite 370Hoffman Estates, IL 60195
Date Prepared:	June 7, 2006
Trade Name:	ARX TM Spinal System
Common Name:	Appliance, Fixation, Spinal Interlaminal
Classification:	888.3070 Pedicle screw spinal system
Device Product Code:	MNH, CFR 888.3070, Class IIMNI, CFR 888.3070, Class II
Predicate Device:	DePuy AcroMed TM Moss® Miami Spinal SystemStryker Spine TRIO® Spinal Fixation System

Device Description:

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K061600 ps 2 of 2

Intended Use of the Device:

When used as a posterior spine thoracic/lumbar system, the ARX™ Spinal System is indicated for one or more of the following: (1) degenerative disc disease (is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), (2) trauma (i.e. fracture or dislocation), (3) curvatures (scoliosis, kyphosis, and/or lordosis), (4) spinal tumor, (5) failed previous fusion (6) pseudarthrosis, (7) spinal stenosis, (8) spondylolisthesis.

Material:

The ARX™ Top-Loading Thoracolumbar Spinal System is manufactured from medical grade titanium alloy described by ASTM F136.

Performance Data:

Biomechanical testing in accordance with ASTM F1717 was conducted to demonstrate substantial equivalency.

Substantial Equivalence:

The ARX™ Spinal System was shown to be substantially equivalent to previously cleared devices, the DePuy AcroMedTM Moss® Miami Spinal System and the Stryker Spine TRIO® Spinal Fixation System, in indications for use, design, function, and materials used.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with three figures instead of one.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 2 2006

Life Spine % Ms. Erin Malloy Project Engineer 2400 Hassell Road, Suite 370 Hoffman Estates, Illinois 60195

Re: K061600

Trade/Device Name: ARX Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class II Product Code: MNH, MNI Dated: June 7, 2006 Received: June 8, 2006

Dear Ms. Malloy:

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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 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.

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Page 2 - Ms. Erin Malloy

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara buchlun
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K∅616∅∅

Life S

Indications for Use

510(k) number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: ARX™ Spinal System

Prescription Use x x (Part 21 CFR 801 Subpart D) And/Or

Over-the-Counter Use _ (21 CFR 807 Subpart C)

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

Barbave Buehns

Division of General. Restorative. and Neurological Devices

510(k) Number K061600

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.