When used as a pedicle screw fixation system of the non-cervical posterior spine in skeletally mature patients using allograft and/or autograft, the Erisma™ Spinal System is indicated as an adjunct to fusion for one or more of the following:

Degenerative disc disease( Discogenic pain with degeneration of the disc confirmed . by history and radiographic studies)
. Degenerative spondylolisthesis with objective evidence of neurologic impairment.
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) ◆ vertebral joint
Fracture.
Dislocation, ●
. Scoliosis.
Kyphosis, .
Spinal tumor.
Failed previous fusion (pseudarthrosis). .

Device Description

The Erisma™ LP instrumentation is designed for the surgical treatment of spinal pathologies. The treatment consists of the fusion of two or several vertebrae in order to restore spinal stability, with or without any other endocanalar concomitant surgical procedure.

AI/ML Overview

The provided document, K120469, is a 510(k) summary for a medical device called CLARIANCE Erisma-LP, a Noncervical Pedicle Spine System. This type of device is a physical medical implant, meaning its performance is primarily evaluated through non-clinical testing (e.g., mechanical, material, and biocompatibility testing) rather than clinical studies involving human patients for effectiveness claims in the way a diagnostic algorithm or a drug would be.

Therefore, the requested information regarding acceptance criteria and studies that prove the device meets those criteria will be focused on the non-clinical testing performed rather than traditional clinical comparative effectiveness studies or standalone algorithm performance.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for performance in the typical sense of metrics like sensitivity, specificity, or AUC, as these would apply to diagnostic or AI-driven devices. Instead, the "acceptance criteria" for a spinal implant are adherence to recognized industry standards for mechanical and material performance.

Acceptance Criterion (Standard Adherence)	Reported Device Performance
ASTM F1717 - 01	Conforms to the standard, indicating validated design
ASTM F1717 - 09	Conforms to the standard, indicating validated design
ASTM F1798 - 97 (Reapproved 2008)	Conforms to the standard, indicating validated design
ISO 14971 (Risk Management)	Rigorous application of the standard, eliminating or mitigating known health hazards

The "reported device performance" is a statement of conformance to these standards, implying that the device successfully met the test requirements outlined within them for aspects like static and fatigue properties of spinal implant constructs and interconnection mechanisms.

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

Sample Size for Test Set: Not applicable in the context of clinical data for performance evaluation. Non-clinical testing involves specific numbers of physical test specimens (implants, constructs) as defined by the ASTM standards, but these details are not provided in this summary.
Data Provenance (country of origin, retrospective/prospective): Not applicable, as this device's substantial equivalence was determined based on non-clinical testing against standards and comparison to predicate devices, not clinical data collection.

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

Number of Experts: Not applicable. Ground truth for non-clinical testing refers to the established standards themselves, which are developed by expert committees within organizations like ASTM. The specific number and qualifications of individuals involved in the testing itself are not detailed here.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert interpretations (e.g., image readings). For non-clinical device testing, results are objective measurements against predetermined physical criteria within the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Was an MRMC study done? No. MRMC studies are typically performed for diagnostic devices (especially those involving image interpretation by multiple readers) to assess the impact of software or AI on human performance. This device is a physical implant.
Effect size of human readers improve with AI vs without AI assistance: Not applicable.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? No. This concept applies to diagnostic algorithms or AI systems, not physical implants. The "performance" of the Erisma-LP device is its mechanical integrity and biocompatibility, as demonstrated through non-clinical laboratory tests.

7. Type of Ground Truth Used

Type of Ground Truth: The "ground truth" for this device's performance evaluation lies in the established performance criteria and test methodologies within recognized industry standards (ASTM F1717-01, ASTM F1717-09, ASTM F1798-97) and the principles of risk management (ISO 14971). For a physical implant, demonstrating conformance to these standards is how "ground truth" of safety and basic effectiveness (e.g., mechanical stability) is established for 510(k) clearance.

8. Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is not an AI algorithm, so there is no "training set."

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

How Ground Truth for Training Set was Established: Not applicable. As there is no training set for an AI algorithm, this question does not apply.

Summary

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510(k) Number: 120469

Date: July 5, 2012

Page 1 of 3

510(k) Summary

Introduction

This summary is intended to comply with requirements of the SMDA and 21CFR $807.92. FDA may make this summary available to the public within 30 days following a finding of substantial equivalence.

510(k) Holder

CLARIANCE 17 rue James WATT - 2A F-62000 Dainville, FRANCE Tel: +33 (0)3 2116 1215 / Fax: +33 (0)3 2115 5073

510(k) Correspondent

William (Bill) Jackson W. F. Jackson Associates, LTD. 3101 Neal Ct., Cumming, GA.30041-6111 Tel: 678-341-9581

Date Prepared

July 5, 2012

Trade Name of Device

CLARIANCE Erisma-LP

Common Name of Device

Noncervical Pedicle Spine System

Classification Name

Noncervical, Pedicle System

510(k) Classification

Class II under regulation 21 CFR 888.3070 for Product Code MNH and MNI along with Class III for Product Code NKB

Predicate Devices

K052131 Expedium Spine System manufactured by Johnson & Johnson

K030840 Horizon Spinal System manufactured by Medtronic Sofamor Danek, Inc.

K001272 Xia Spine System manufactured by Howmedica Osteonics Corp.

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Device Description

Intended Use

Degenerative disc disease( Discogenic pain with degeneration of the disc confirmed . by history and radiographic studies)
. Degenerative spondylolisthesis with objective evidence of neurologic impairment.
Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (LS-S1) ◆ vertebral joint
Fracture.
Dislocation, ●
. Scoliosis.
Kyphosis, .
Spinal tumor. �
Failed previous fusion (pseudarthrosis). .

Clinical Evaluation

CLARIANCE did not conduct, nor rely upon, clinical tests to determine substantial equivalence.

Non-Clinical Testing

Non-clinical testing was performed in order to validate the design against the company's specified design requirements, and to assure conformance with the following voluntary standards:

ASTM F1717 - 01 ASTM F1717-09 , Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model.

ASTM F1798 - ASTM F1798-97(Reapproved 2008), Standard Guide for Evaluating the Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.

Risk Management

This device has been designed to either completely eliminate or mitigate known health hazards associated with the use of the device. Health hazard risk reduction has been accomplished by rigorous application of a risk management program according to standard ISO 14971.

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Substantial Equivalence

CLARIANCE believes that the Erisma-LP is safe and effective when used as instructed by knowledgeable and trained personnel, and is substantially equivalent to the legally marketed predicate device(s).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

AUG 1 3 2012

Clariance % Mr. William Jackson 3101 Neal Court Cumming, Georgia 30041

Re: K120469

Trade/Device Name: Erisma-LP Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III · Product Code: NKB, MNH, MNI Dated: July 05, 2012 Received: July 09, 2012

Dear Mr. Jackson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

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Page 2 - Mr. William Jackson

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Mark A. Wilkins

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

Enclosure

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Indications for Use

510(k) Number (if known): K120469

Device Name: Erisma-LP

Indications for Use:

Degenerative disc disease (Discogenic pain with degeneration of the disc confirmed by history and radiographic studies)
Degenerative spondylolisthesis with objective evidence of neurologic impairment, .
. Severe spondylolisthesis (Grades 3 and 4) of the fifth lumbar-first sacral (L5-S1) vertebral joint
. Fracture,
Dislocation, .
Scoliosis, �
. Kyphosis,
Spinal tumor. .
Failed previous fusion (pseudarthrosis). ●

Prescription Use X (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Diysion Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________ K120469

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.