When used as a nonpedicle posterior system, the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).

When used as an anterolateral/anterior system the SCS system is indicated for patients with: degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis, kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)

When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients L3 and below who are: having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions using autogenous bone graft only, having the device fixed or attached to the lumbar and sacral spine, having the device removed after the development of a solid fusion mass. Screw fixation is limited to L3 and below.

Posterior pedicle systems are 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: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion (pseudarthrosis).

Device Description

The SCS Claris Extended OmniAxial Connectors are available in two sizes (medium and long) and are used to connect the rods and screws of the SCS Claris Spinal System.

AI/ML Overview

Here's an analysis of the provided FDA 510(k) summary, focusing on your requested acceptance criteria and study information.

It's important to note that the provided document is a 510(k) summary for a medical device (spinal system components), not an AI/software as a medical device (SaMD) submission. Therefore, many of your questions related to AI-specific studies (e.g., sample size for training set, MRMC studies, ground truth for AI) are not applicable to this type of submission. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and intended use for mechanical orthopedic implants.

Acceptance Criteria and Device Performance (Not Applicable for this device type)

For mechanical medical devices like the SCS Claris Spinal System Extended OmniAxial Connectors, the "acceptance criteria" are generally related to demonstrating substantial equivalence to a previously cleared predicate device. This is achieved through comparisons of:

Indications for Use: Must be identical or very similar.
Technological Characteristics: Materials, design principles, manufacturing methods, and fundamental operating mechanisms must be similar.
Performance Data: Often involves mechanical testing (e.g., fatigue, static strength) to show that the new device performs at least as well as, or better than, the predicate device under similar conditions.

The provided 510(k) summary does not explicitly list quantitative acceptance criteria in a table format, nor does it provide a "reported device performance" in the way you might find for a diagnostic or AI device. Instead, it states the conclusion of substantial equivalence. The "study" mentioned is the comparison itself.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Implied from 510(k) Conclusion)
Indications for Use: Identical or substantially similar to predicate device.	"Substantially equivalent... based upon equivalence in indications/intended use." (Identical)
Technological Characteristics:
- Materials: Identical to predicate device.	"manufactured from titanium alloy (ASTM F136 / ISO 5832-3)." (Matches predicate)
- Basic Design: Similar to predicate device.	"basic design" (Similar)
- Manufacturing Methods: Similar to predicate device.	"manufacturing methods" (Similar)
- Interconnection Mechanism: Similar to predicate device.	"interconnection (attachment) mechanism" (Similar)
Performance (Mechanical Testing - inferred): New device performs at least as well as predicate.	Not explicitly detailed in the summary, but implied by the successful 510(k) clearance, meaning testing (if required) showed acceptable performance relative to the predicate.

Detailed Study Information (Where Applicable for K021919 submission):

For this specific 510(k) submission (K021919), the "study" is the demonstration of substantial equivalence.

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

Sample Size: Not applicable in the context of clinical "test sets" for diagnostic or AI devices. For mechanical performance testing, the "sample size" would refer to the number of devices tested to demonstrate mechanical equivalence. This detail is not provided in the summary but would have been part of the full 510(k) submission.
Data Provenance: Not applicable in the context of clinical "data provenance." Mechanical testing data is generated in a lab setting.

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

Not Applicable: This submission does not involve clinical ground truth established by experts for a diagnostic or predictive task. The "ground truth" for a mechanical device is its physical properties and mechanical performance.

4. Adjudication Method for the Test Set

Not Applicable: There is no "adjudication method" in the clinical sense for this type of device submission.

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 mechanical device, not an AI/SaMD.

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

Not Applicable: This is a mechanical device, not an AI/SaMD.

7. The Type of Ground Truth Used

Mechanical Properties and Performance: The "ground truth" for this device is its material composition (titanium alloy as per ASTM F136 / ISO 5832-3) and its mechanical performance characteristics (e.g., fatigue strength, static strength) as demonstrated through engineering testing. This "ground truth" is compared against industry standards and the predicate device's established performance.

8. The Sample Size for the Training Set

Not Applicable: This is a mechanical device, not an AI/SaMD. There is no "training set" in the machine learning sense. The "training" for such a device is its design, engineering specifications, and manufacturing process.

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

Not Applicable: Similar to point 8, there's no "training set" or "ground truth for a training set" as understood in AI/SaMD. The "ground truth" for the device's design and manufacturing is based on established engineering principles, material science, and regulatory standards for spinal implants.

Summary

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ບັນເມຣິເນນນາ

K021919 - -

510(k) SUMMARY of Safety and Effectiveness

page I of 1

Sponsor:	OrthoTec, LLC9595 Wilshire Blvd. Suite 502Beverly Hills, CA 90212Phone: (310) 557-2000 & (310) 273-1500Fax: (310) 843-9500
ContactPerson:	Patrick Bertranou, MD
ProprietaryTrade Name:	SCS Claris Spinal System Extended OmniAxial Connectors (CO05 & CO07)
DeviceDescription:	The SCS Claris Extended OmniAxial Connectors are available in two sizes(medium and long) and are used to connect the rods and screws of the SCSClaris Spinal System.
Intended Use:	When used as a nonpedicle posterior system, the SCS system is indicated forpatients with: degenerative disk disease defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis).When used as an anterolateral/anterior system the SCS system is indicatedfor patients with: degenerative disk disease defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographicstudies, spondylolisthesis, fracture, spinal stenosis, deformities (i.e., scoliosis,kyphosis, lordosis), tumors, failed previous fusion (pseudarthrosis)When used as a posterior pedicle system, the SCS system is indicated for usein skeletally mature patients L3 and below who are: having severespondylolisthesis (Grades 3 and 4) at the L5-S1 joint, receiving fusions usingautogenous bone graft only, having the device fixed or attached to the lumbarand sacral spine, having the device removed after the development of a solidfusion mass. Screw fixation is limited to L3 and below.Posterior pedicle systems are intended to provide immobilization andstabilization of spinal segments in skeletally mature patients as an adjunctto fusion in the treatment of the following acute and chronic instabilities ordeformities of the thoracic, lumbar, and sacral spine: degenerativespondylolisthesis with objective evidence of neurologic impairment, fracture,dislocation, scoliosis, kyphosis, spinal tumor, failed previous fusion(pseudarthrosis).
Materials:	The SCS Claris Spinal System Extended OmniAxial Connectors (CO05 &CO07) are manufactured from titanium alloy (ASTM F136 / ISO 5832-3).
SubstantialEquivalence:	Documentation was provided which demonstrated the SCS Claris ExtendedOmniAxial Connectors (CO05 & CO07) to be substantially equivalent to thepreviously cleared SCS OmniAxial Connector (CO04). The substantialequivalence is based upon equivalence in indications/intended use,manufacturing methods, interconnection (attachment) mechanism, basic designand materials.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a caduceus, a staff with two snakes entwined around it, which is often associated with medicine and healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 3 2002

OrthoTec. LLC c/o Ms. Karen E. Warden, MEBE 8202 Sherman Road Chesterland, OH 44026-2141

Re: K021919

Trade/Device Name: SCS Claris Spinal System - Extended OmniAxial Connectors Regulation Number: 21 CFR 888.3050, 888.3060, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; Spinal intervertebral body fixation orthosis, Pedicle screw spinal system Regulatory Class: Class II Product Code: KWP, KWQ, MNH, MNI Dated: May 29, 2002 Received: June 11, 2002

Dear Ms. Warden:

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. Karen E. Warden

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 and additionally 21 CFR Part 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 vour 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

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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Indications for Use Statement

510(k) Number (if known): KO2 19 | 9

Device Name: SCS Claris Spinal System

Indications for Use:

When used as a nonpedicle posterior system, the SCS system is indicated for patients with:

degenerative disk disease defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies spondylolisthesis fracture spinal stenosis deformities (i.e., scoliosis, kyphosis, lordosis) tumors failed previous fusion (pseudarthrosis)

When used as an anterolateral/anterior system the SCS system is indicated for patients with:

When used as a posterior pedicle system, the SCS system is indicated for use in skeletally mature patients who are:

having severe spondylolisthesis (Grades 3 and 4) at the L5-S1 ioint

receiving fusions using autogenous bone graft only having the device fixed or attached to the lumbar and sacral soine having the device removed after the development of a

solid fusion mass. screw fixation is limited to L3 and below.

degenerative spondylolisthesis with objective evidence of neurologic impairment fracture dislocation scoliosis kyphosis spinal tumor failed previous fusion (pseudarthrosis)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use >> (Per 21 CFR 801.109)

Over-the-Counter Use

Sty Ruda

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

KOL 919 510(k) Number -

Regulation Number and Section

N/A