The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to provide immobilization of spinal segments in skeletally mature patients as an adjunct to fusion in the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: degenerative disc disease; spondylolisthesis; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). When used for posterior noncervical pedicle screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-lumbar Fixation System is indicated as an adjunct to fusion to treat adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-lumbar Fixation System is intended to be used with autograft. Pediatric pedicle screw fixation is limited to a posterior approach.

Device Description

The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the PERLA® TL Posterior Thoraco-lumbar Fixation System. This submission is an "Extension of the range" and an "MRI update" for an already cleared device.

Crucially, the document explicitly states that this is an extension of an existing device and focuses on mechanical testing of new components (rods, rod connectors) and MRI safety evaluations. It does NOT describe a study evaluating the clinical performance or diagnostic accuracy of an AI or software device. Therefore, many of the requested points related to AI performance, such as sample sizes for test and training sets, expert ground truth, adjudication methods, and MRMC studies, are not applicable to this submission.

However, I can extract the relevant information regarding the acceptance criteria and the studies performed for this specific device extension.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Study Type)	Standard/Criteria	Reported Device Performance
Mechanical Testing	ASTM F1798	Results demonstrate that no new worst case has been added into the range for the added components (rod connectors and Z-rods).
MRI Safety Evaluation	ASTM F2052-2021	MR Conditional (Magnetically Induced Displacement Force)
	ASTM F2213-17	MR Conditional (Magnetically Induced Torque)
	ASTM F2119-07	Evaluation of MR Image Artifacts from Passive Implants conducted. Result: MR Conditional.
	ASTM F2182-19e2	Measurement of Radio Frequency Induced Heating conducted. Result: MR Conditional.
Material/Manufacture	ASTM F136	Medical grade titanium alloy conforms to standard.
	ASTM F1537	Medical grade cobalt chromium conforms to standard.
	USP standard	Bacterial endotoxin testing meets pyrogenicity standard (Endotoxin limit of 20 EU / device).

Explanation: The acceptance criteria for this device extension are primarily focused on the safety and performance of the added mechanical components and their compatibility with MRI environments, as well as adherence to material and manufacturing standards.

Regarding the points not applicable to this specific submission (as it's a hardware extension and MRI update, not an AI/software performance study):

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. This document describes mechanical and MRI safety testing, not clinical data analysis. For mechanical testing, samples are typically physical devices.
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. No expert ground truth was established as this is not a diagnostic AI device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No adjudication method was used as this is not a diagnostic AI device.
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 not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done: Not applicable. This is a medical implant, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. Ground truth for diagnostic accuracy is not relevant here. The "ground truth" for mechanical testing is adherence to established engineering standards (ASTM).
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable. This is not an AI/ML device requiring a training set.

Summary

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October 25, 2023

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Spineart SA Franck Pennesi Chief Technical Officer 3 Chemin du Pré-Fleuri Plan-les-Ouates. Geneve 1228 Switzerland

Re: K231069

Trade/Device Name: Perla® TL Posterior Thoraco-lumbar Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: September 19, 2023 Received: September 21, 2023

Dear Franck Pennesi:

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 (OS) 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 820.70) 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,

Image /page/1/Picture/6 description: The image shows the name "Eileen Cadel" in large, bold font on the left side of the image. To the right of the name, there is a digital signature that reads "Digitally signed by Eileen Cadel" followed by the date "2023.10.25 13:27:19 -04'00'". The word "for" is at the bottom right of the image.

Colin O'Neill, M.B.E. 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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Form Approved: OMB No. 0910-0120

Expiration Date: 06/30/2023

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K231069

Device Name

PERLA® TL Posterior Thoraco-lumbar Fixation System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Traditional 510k PERLA® TL Extension Line

510(k) SUMMARY

510k	TRADITIONAL
Basis for submission	Extension of the range of PERLA® TL Posterior Thoraco-lumbar Fixation
	System and MRI update for Spineart PERLA® TL Posterior Thoraco-
	lumbar Fixation System
Submitted by	SPINEART
	3 Chemin du Pré-Fleuri
	1228 PLAN LES OUATES
	GENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical Officer
	Phone : +41 22 570 1200 Fax : +41 22 594 8306
	Mail : fpennesi@spineart.com
	Regulatory contact : Estelle LEFEUVRE elefeuvre@spineart.com
Date Prepared	April 11th, 2023
Common Name	Pedicle screw spinal system
Trade Name	PERLA® TL Posterior Thoraco-lumbar Fixation System
Classification Name	Thoracolumbosacral pedicle screw system
Class	II
Product Code	NKB, KWP
CFR section	888.3070
Device panel	ORTHOPEDIC
	Primary predicate: PERLA® TL Posterior Thoraco-lumbarFixation
Legally marketedpredicate devices	System manufactured by Spineart (K193396, K203222)
	Additional predicates:
	ROMEO® 2 Posterior Osteosynthesis System manufactured by
	Spineart (K172101),
	- SeaSpine® Daytona® Small Stature Spinal System manufactured by
	SeaSpine Orthopedics Corporation (K163604, K180686)
	- SeaSpine Mariner Pedicle Screw System manufactured by SeaSpine
	Orthopedics Corporation (K173882)
	Mariner Outrigger Revision System manufactured by SeaSpine
	Orthopedics Corporation (K183639)
Indications for use	The PERLA® TL Posterior Thoraco-lumbar Fixation System is 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 disc disease; spondylolisthesis;
	fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous
	fusion (pseudarthrosis). When used for posterior non-cervical pedicle
	screw fixation in pediatric patients, the PERLA® TL Posterior Thoraco-
	lumbar Fixation System is indicated as an adjunct to fusion to treat
	adolescent idiopathic scoliosis. The PERLA® TL Posterior Thoraco-
	lumbar Fixation System is intended to be used with autograft and/or
	allograft. Pediatric pedicle screw fixation is limited to a posterior
	approach.
Description of the device	The PERLA® TL Posterior Thoraco-lumbar Fixation System consists of a range of screws, rods, set screws, hooks, rod connectors and cross-connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The PERLA® TL Posterior Thoraco-lumbar Fixation System is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® TL Posterior Thoraco-lumbar Fixation System implants are delivered sterile (gamma sterilization) and supplied with dedicated surgical instruments. Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Technological characteristics compared to the predicate devices	The subject product line extension of the PERLA® TL Posterior Thoraco-lumbar Fixation System manufactured by Spineart (K193396) consists of addition of- Rod connectors (Parallel Open/Open (W-Shape), Parallel Open/Open (T-Shape), Parallel Open/Close, Parallel Close/Close),- Rods (Z-Rods – pre-bent)As it was established in this submission, the PERLA® TL Posterior Thoraco-lumbar Fixation System added components are substantially equivalent and have the same technological characteristics to predicate devices in areas including indications for use, function, material composition, design, range of sizes and mechanical performance.

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Mechanical testing: Axial gripping and static torsion testing were conducted in conformance with ASTM F1798 to determine if the range extensions introduce new worst case into the range. Results demonstrate that no new worst case has been added into the range. MRI Safetv Evaluation: In accordance with the FDA guidance "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (Issued May 2021), testing has been completed on the worst case implants. The following testing has been completed and provided a determination that the subject Spineart PERLA® TL Posterior Thoraco-lumbar Fixation System in this 510(k) submission has been determined to be MR conditional: Discussion of Testing - ASTM F2052-2021: Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment ASTM F2213-17: Standard Test Method for Measurement of i Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment - ASTM F2119-07: Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants - ASTM F2182-19e2: Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Maqnetic Resonance - ASTM F2503-20:"Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment" Mechanical testing: Based on the design features, technological characteristics, feature comparisons, indications for use, and non-clinical performance testing, the PERLA® TL Posterior Thoraco-lumbar Fixation System added components have demonstrated substantial equivalence to the identified predicate devices. Conclusion MRI Safety Evaluation: The Spineart PERLA® TL Posterior Thoraco-lumbar Fixation System has been labeled as MR Conditional in accordance with ASTM F2503-20 "Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment"

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.