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® Deformity Spinal System is indicated as an adjunct to fusion for the following indications:

Degenerative disc disease (Define as back pain of discogenic origin 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 lumbarfirst sacral (L5-S1) vertebral joint; deformities (Scoliosis); spinal tumor; failed previous fusion (pseudarthrosis).

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® LP Spinal System is indicated as an adjunct to fusion for the following indications: 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)

Device Description

The Erisma® Deformity Spinal System device is designed for use in the surgical treatment of spinal pathologies as outlined in the device's indications for use, which remains the same from the cleared Erisma® Lp Spinal Fixation System device (K170163). 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. The Erisma® Deformity Spinal System device is an extension of the already cleared Erisma® Lp Spinal Fixation System.

The cleared Erisma® Lp Spinal Fixation System are composed of cannulated and non-cannulated monoaxial and polyaxial screws, crosslinks, rods, screw sets and associated instruments. Further, the implants used in both the cleared Erisma® Lp Spinal Fixation System device and Erisma® Deformity Spinal System are made of Ti6Al4V allov per ASTM F136.

The subject of this submission is the extend to the Erisma® Lp Spinal Fixation System, with the addition new components 'Closed Offset Connectors' and commercialization of the 'Open Offset Connectors' provided in the Erisma® Deformity Spinal System range.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: The provided FDA 510(k) clearance letter and its associated summary are for a spinal fixation system, which is a physical medical device. This document does not describe a software algorithm or AI device. Therefore, many of your requested points regarding AI/algorithm performance criteria, sample sizes for training/test sets, expert ground truth, MRMC studies, and standalone performance are not applicable to the information provided.

The document focuses on demonstrating substantial equivalence of a modified physical device (Erisma® Deformity Spinal System) to a legally marketed predicate device, primarily the Erisma® Lp Spinal Fixation System (K170163). This is achieved through engineering performance testing, not clinical studies involving patient data or AI analysis.

Analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test Standard)	Device Performance (Test Type)
ASTM F1798 (Static axial load gripping)	Performed to characterize subject modification
ASTM F1798 (Static axial torque gripping)	Performed to characterize subject modification

Explanation: The document states that "Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification." While specific numerical acceptance criteria and precise performance values are not detailed in this summary, the conclusion indicates that these tests were sufficient to demonstrate substantial equivalence in terms of safety and effectiveness. This implies that the device met the performance expectations set by the standard for these tests.

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

Not applicable. This is a physical device clearance based on mechanical testing, not a study involving patient data or an algorithm's performance on a dataset. The "test set" would refer to the physical units subjected to the mechanical tests, but the quantity is not specified in this summary.

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

Not applicable. Ground truth, in the context of device performance, typically refers to expert interpretation of data for diagnostic or prognostic devices. For a spinal fixation system, "ground truth" relates to the fundamental mechanical properties and performance under stress, evaluated against established engineering standards (ASTM F1798). This does not involve clinical experts establishing ground truth in the way it would for an AI diagnostic tool.

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

Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth in image analysis, neither of which are described here. The evaluation is based on engineering test results against a standard.

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 clearance for a physical spinal implant, not an AI or software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable. This is a clearance for a physical spinal implant, not an AI or software device.

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

For this physical device, the "ground truth" for demonstrating substantial equivalence is based on:

Adherence to established international and national standards for medical device materials and mechanical testing (e.g., ASTM F136 for Ti6Al4V alloy, ASTM F1798 for static gripping tests).
Demonstrating that the modified device's performance aligns with, or is equivalent to, the performance of the legally marketed predicate devices. The acceptance of the test results by the FDA is based on this engineering comparison.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device.

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

Not applicable. This is not an AI/machine learning device.

Summary of the K240872 Submission:

The K240872 submission is for the Erisma® Deformity Spinal System: Erisma® Lp Spinal Fixation System. It's classified as a Class II medical device (Thoracolumbosacral Pedicle Screw System, 21 CFR 888.3070).

The core of the submission is to demonstrate substantial equivalence to existing predicate devices, primarily the Erisma® LP Spinal Fixation System (K170163) manufactured by CLARIANCE SAS. The current submission extends the previously cleared system by adding new components: 'Closed Offset Connectors' and commercializing 'Open Offset Connectors'.

The study mentioned to prove the device meets acceptance criteria is the Performance Data section, which states:

"Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification."

The conclusion then asserts:

"Performance data demonstrate that the subject devices have a substantially equivalent safety and effectiveness profile compared to the Erisma® Lp Spinal Fixation System (K170163). Thus, the modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System are substantially equivalent."

Therefore, the "acceptance criteria" were the performance requirements stipulated by the ASTM F1798 standard, and the "study" was the mechanical testing conducted according to that standard. The successful performance in these tests, demonstrating similarity to the predicate device, led to the conclusion of substantial equivalence and FDA clearance.

Summary

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April 26, 2024

Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring a stylized depiction of a human figure. To the right of the HHS logo is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

Clariance % Magalie Hennequin Quality & Regulatory Affairs & Clinical Director Clariance 42547 Farrington Street Dallas. Texas 75207

Re: K240872

Trade/Device Name: Erisma® Deformity Spinal System: Erisma® Lp Spinal Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB Dated: March 18, 2024 Received: March 29, 2024

Dear Magalie Hennequin:

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 (the 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Eileen
Digitally signed
by Eileen Cadel -
S
Cadel -S Date: 2024.04.26
09:58:28 -04'00'
for

Colin O'Neill, MBE Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

Submission Number (if known)

K240872

Device Name

Erisma® Deformity Spinal System :

Erisma® Lp Spinal Fixation System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Erisma® Deformity Spinal System Erisma® LP Spinal Fixation System

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

CLARIANCE 18, rue Robespierre 62217 Beaurains, France

Phone: +33(0)3 2116 1215 Facsimile:+33(0)3 2115 5073

Contact Person: Magalie HENNEQUIN, Quality & Regulatory Affairs & Clinical Director. Consultant: Magalie HENNEQUIN, Quality & Regulatory Affairs & Clinical Director Clariance Inc. 42547 Farrington Street Dallas, Texas 75207

Date Prepared: March 19th, 2024

Name of Device:

Erisma® Deformity Spinal System Erisma® LP Spinal Fixation System

Common or Usual Name:

Thoracolumbosacral pedicle screw system

Classification Name:

Class II, 21 CFR 888.3070 - NKB

Predicate Devices

Erisma® LP Spinal Fixation System manufactured by CLARIANCE SAS (K170163) primary predicate.

XIA® 4.5 Spinal System, XIA® 4.5 Cortical Trajectory, XIA® 3 Spinal System, Serrato® Spinal System, XIA® Growth Rod Conversion Set, XIA® II Spinal System, XIA® Precision System, XIA® Anterior, Diapason® Spinal System, Opus™ Spinal System, Radius® Spinal System, Mantis® Spinal System, Mantis® Redux manufactured by Stryker Spine (K222684).

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Device Description

Intended Use / Indications for Use

Degenerative disc disease (Define as back pain of discogenic origin 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 lumbarfirst sacral (L5-S1) vertebral joint; deformities (Scoliosis, spinal tumor; failed previous fusion (pseudarthrosis).

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® LP Spinal System is indicated as an adjunct to fusion for the following indications: Degenerative Disc Disease (discogenic pain with deqeneration 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)

Technological Characteristics

The proposed modification to the 510(k) cleared Erisma® LP Spinal System (K170163) consist in the addition new components 'Closed Offset Connectors' and commercialization of the 'Open Offset Connectors' provided in the Erisma® Deformity Spinal System range. The proposed offset connectors are made from the same material as the primary predicate device. These offset connectors are available in several sizes. The proposed modification is present in the reference device and does not raise different types of safety or effectiveness questions.

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Performance Data

Static axial load gripping tests and static axial torque gripping tests per ASTM F1798 was performed to characterize the subject modification addressed in this notification.

Conclusions

The modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System devices are substantially equivalent to the Erisma® Lp Spinal Fixation System (K170163) and additional predicate. The modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System have the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. Performance data demonstrate that the subject devices have a substantially equivalent safety and effectiveness profile compared to the Erisma® Lp Spinal Fixation System (K170163). Thus, the modified Erisma® Lp Spinal Fixation System and Erisma® Deformity Spinal System are substantially equivalent.

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.