The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the crania-cervical junction. the cervical spine (Cl to C7) and the thoracic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.

The PERLA® posterior occipito-cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (Cl to C7) and the thoracic spine (Tl to T3).

In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA® TL Posterior Osteosynthesis Systems with rod connectors. Transition rods mav also be used to connect the PERLA® posterior occipito-cervico-thoracic fixation system to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for a list of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indications of use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated for skeletally mature patients.

Device Description

The PERLA® 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® system is manufactured from medical grade titanium alloy and medical grade cobalt chromium conforming respectively to standards ASTM F136 and ASTM F1537. The PERLA® implants are delivered either non sterile or sterile (gamma sterilization) and supplied with dedicated surgical instruments (reusable - provided non-sterile except for the drill supplied as sterile or not sterile). Bacterial endotoxin testing on final, finished devices as specified in USP standard is used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the PERLA® Posterior Occipito-Cervico-Thoracic Fixation System.

Important Note: This document is a 510(k) summary for a medical device. It describes the device as "substantially equivalent" to predicate devices based on non-clinical testing. It does not contain information about software performance, AI algorithms, clinical study outcomes for human readers, or ground truth establishment in the ways typically expected for AI/ML device submissions. The questions asked are highly relevant for AI/ML medical devices, but the provided text describes a traditional orthopedic implant. Therefore, many of your questions cannot be answered from this document.

Explanation of Device: The PERLA® Posterior Occipito-Cervico-Thoracic Fixation System is a surgical implant designed to provide immobilization and stabilization of spinal segments. It consists of various components like screws, rods, and connectors, made of medical-grade titanium alloy and cobalt chromium. The 510(k) submission is for a line extension of the PERLA® system to include components for occipital fixation.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a hardware orthopedic implant and not an AI/ML device, the "acceptance criteria" and "device performance" are related to mechanical and material properties, rather than diagnostic accuracy metrics (e.g., sensitivity, specificity).

Acceptance Criteria (Study Type)	Reported Device Performance
Static Compression Bending per ASTM F2706-18	Results demonstrate comparable mechanical properties to the predicate devices.
Static Torsion per ASTM F2706-18	Results demonstrate comparable mechanical properties to the predicate devices.
Dynamic Compression Bending per ASTM F2706-18	Results demonstrate comparable mechanical properties to the predicate devices.
Dynamic Torsion per ASTM F2706-18	Results demonstrate comparable mechanical properties to the predicate devices.
Bacterial Endotoxin Testing	Achieved Endotoxin limit of 20 EU / device (as specified in USP standard for pyrogenicity testing).
Material Composition	Medical grade titanium alloy and medical grade cobalt chromium conforming to standards ASTM F136 and ASTM F1537, respectively.
Sterilization	Delivered non-sterile or sterile (gamma sterilization).

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

The study described is non-clinical bench testing (mechanical and material testing), not a clinical study involving patient data. Therefore, the concepts of "test set sample size" and "data provenance" (country of origin, retrospective/prospective) are not applicable in the context of this device. The "test set" would refer to the physical samples of the device components subjected to the mechanical tests. The document does not specify the number of individual components tested but states that "non-clinical tests were conducted on the PERLA® components for occipital fixation."

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

This question is not applicable to an orthopedic implant submission based on non-clinical bench testing. "Ground truth" in this context would be the measured physical properties of the materials and constructs, determined by laboratory equipment and standard mechanical testing protocols, not by expert human interpretation.

4. Adjudication Method for the Test Set

Not applicable. As explained above, the "test set" is physical device components, and the "adjudication method" does not apply to non-clinical mechanical testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

No, this type of study was not done. An MRMC study is relevant for AI/ML diagnostic devices where human readers interpret medical images or data. The PERLA® system is a surgical implant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical surgical implant, not an algorithm.

7. The Type of Ground Truth Used

For the non-clinical testing:

Mechanical Performance: The "ground truth" is the quantitative results (e.g., load to failure, fatigue life) obtained from standardized mechanical tests (ASTM F2706-18). This is based on objective physical measurements according to established engineering standards.
Material Composition: The "ground truth" is that the materials conform to specific ASTM standards (F136, F1537) for medical-grade titanium alloy and cobalt chromium, verified through material characterization tests.
Pyrogenicity: The "ground truth" is that the device meets the endotoxin limit of 20 EU/device, as measured by bacterial endotoxin testing following USP standards.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML model or "training set" for this physical implant device.

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

Not applicable. As there is no training set, the establishment of ground truth for it is irrelevant.

Summary

{0}------------------------------------------------

May 1, 2020

Image /page/0/Picture/1 description: The image contains two logos. On the left is the Department of Health & Human Services logo, which features a stylized depiction of human figures. To the right is the FDA U.S. Food & Drug Administration logo, with the FDA acronym in a blue square and the full name of the agency in blue text.

SPINEART Mr. Franck Pennesi Chief Technical Officer 3 Chemin du Pre Fleuri 1228 Plan Les Quates Geneva, Switzerland

Re: K200571

Trade/Device Name: PERLA® Posterior Occipito-Cervico-Thoracic Fixation System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior Cervical Screw System Regulatory Class: Class II Product Code: NKG, KWP Dated: March 3, 2020 Received: March 4, 2020

Dear Mr. 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 (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 located 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.

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 803) for

{1}------------------------------------------------

devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 medical devices and radiation-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.

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

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K200571

Device Name

PERLA® posterior occipito-cervico-thoracic fixation system

Indications for Use (Describe)

The occipital bone screws are limited to occipital fixation only. The use of the multi-axial screws is limited to placement in the cervical spine (Cl to C7) and the thoracic spine (Tl to T3).

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

*DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW."

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

PSC Publishing Services (301) 443-6740

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{3}------------------------------------------------

Traditional 510k

Image /page/3/Picture/2 description: The image shows the word "PERLA" in bold, black font. To the right of the word, there is a circled "R" symbol, indicating that the word is a registered trademark. The word and symbol are centered in the image and set against a white background.

Image /page/3/Picture/3 description: The image shows the logo for Spineart. The logo consists of the word "spineart" in a stylized font, with a purple butterfly above the word. The "a" in "spineart" is a lighter shade of purple than the rest of the word.

510(k) SUMMARY

510k	TRADITIONAL
Basis for submission	New devices
Submitted by	SPINEART3 Chemin du Pré Fleuri1228 PLAN LES OUATESGENEVA SWITZERLAND
Contacts	Franck PENNESI Chief Technical OfficerPhone: +41 22 570 1200 Fax: +41 22 594 8306Mail: fpennesi@spineart.comRegulatory contact: Dr Isabelle DRUBAIX (Idée Consulting) idrubaix@nordnet.fr
Date Prepared	February 27, 2020
Common Name	Pedicle screw spinal system
Trade Name	PERLA® Posterior Occipito-Cervico-Thoracic Fixation System
Classification Name	Posterior cervical screw system
Class	II
Product Code	NKG, KWP
CFR section	888.3075
Device panel	ORTHOPEDIC
Legally marketed predicate devices	Primary predicate: Mountaineer OCT, Summit SI OCT Spinal Fixation System manufactured by Depuy Synthes, Inc (K110353, K151885)Additional predicates: Neon3T™ Universal OCT Spinal Stabilization manufactured by Ulrich Gmbh & CO. KG (K161032); Vertex Reconstruction System manufactured by Medtronic Sofamor Danek USA, Inc (K143471); Tiger Occipital-Cervical-Thoracic Spinal Fixation System manufactured by Corelink LLC (K132504); Pioneer Posterior Occipito-Cervico-Thoracic (OCT) System manufactured by Pioneer Surgical Technology, Inc (K121725); Oasys Spinal System manufactured by Stryker Spine (K111719)
Indications for use	The PERLA® posterior occipito-cervico-thoracic fixation system is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following acute and chronic instabilities of the crania-cervical junction, the cervical spine (C1 to C7) and the thoracic spine (T1 to T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervical spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability.The PERLA® posterior occipito-cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical

{4}------------------------------------------------

spine in whom life expectancy is of insufficient duration to permit achievement offusion.
The occipital bone screws are limited to occipital fixation only. The use of themulti-axial screws is limited to placement in the cervical spine (C1 to C7) and thethoracic spine (T1 to T3).
In order to achieve additional levels of fixation, the PERLA® posterior occipito-cervico-thoracic fixation system may be connected to the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems with rod connectors. Transition rods may alsobe used to connect the PERLA® posterior occipito-cervico-thoracic fixation systemto the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems. Refer to theROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems packages inserts for alist of the ROMEO®2 and PERLA®TL Posterior Osteosynthesis Systems indicationsof use. PERLA® posterior occipito-cervico-thoracic fixation system is indicated forskeletally mature patients.
Description of thedevice	The PERLA® system consists of a range of screws, rods, set screws, hooks, rodconnectors and cross-connectors. These connecting components can be rigidlylocked to the rod in a variety of configurations to be adapted for the individualcase. The PERLA® system is manufactured from medical grade titanium alloy andmedical grade cobalt chromium conforming respectively to standards ASTM F136and ASTM F1537. The PERLA® implants are delivered either non sterile or sterile(gamma sterilization) and supplied with dedicated surgical instruments (reusable- provided non-sterile except for the drill supplied as sterile or not sterile).Bacterial endotoxin testing on final, finished devices as specified in USP standardis used for pyrogenicity testing to achieve the Endotoxin limit of 20 EU / device.
Technologicalcharacteristicscompared tothepredicate devices	The subject product line extension of the PERLA® Posterior Cervico-ThoracicFixation System (K153386, K190071) consists of implants for occipital fixation. Theline extension includes occipital plates, occipital screws, occipital rods, occipitaladjustable rods, transition rods and rod to rod connectors. As was established inthis submission, the PERLA® components for occipital fixation are substantiallyequivalent and have the same technological characteristics to predicate devices inareas including indications for use, function, material composition, design, rangeof sizes and mechanical performance.
Discussion of Testing	The following non-clinical tests were conducted on the PERLA® components foroccipital fixation: Static Compression bending, Static Torsion, DynamicCompression bending and Dynamic Torsion per ASTM F2706-18. Resultsdemonstrate comparable mechanical properties to the predicate devices.
Conclusion	Based on the design features, technological characteristics, feature comparisons,indications for use, and non-clinical performance testing, the PERLA® componentsfor occipital fixation have demonstrated substantial equivalence to the identifiedpredicate devices.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.