The PERLA® posterior cervico-thoracic fixation system is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracic spine from Tl-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 cervico-thoracic fixation system is also intended to restore the integrity of the spinal column even in the 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. In order to achieve additional levels of fixation, the PERLA® posterior cervico-thoracic fixation system may be connected to the ROMEO® Posterior Osteosynthesis System with rod connectors. Transition rods may also be used to connect the PERLA® posterior cervico-thoracic fixation system to the ROMEO® Posterior Osteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System package insert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

Device Description

The Spineart Perla® system is a posterior cervico-thoracic fixation system intended to provide stabilization to promote fusion of the cervical spine and the upper thoracic spine. Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws, set screws, rod connectors and transverse connectors. These connecting components can be rigidly locked to the rod in a variety of configurations to be adapted for the individual case. The multi-axial screws are available with diameters 3.5mm and 4.0 mm with lengths ranging from 08 mm up to 52 mm. The purpose of this Special 510(k) application is to introduce an additional range of multi-axial screw with 4.5 mm diameter and lengths ranging from 08 mm up to 52 mm to the Perla® spinal system.

AI/ML Overview

The provided document is a 510(k) summary for the SPINEART Perla® Posterior Cervico-Thoracic Fixation System. It describes a device modification, specifically the introduction of an additional range of multi-axial screws with a 4.5 mm diameter.

Here's an analysis of the acceptance criteria and study information, based solely on the provided text:

Key Takeaway: This 510(k) is for a modification to an existing device (Perla® Posterior Cervico-Thoracic Fixation System, cleared under K153386). The modification is the introduction of a new screw diameter (4.5mm). The submission leverages previous testing and an engineering analysis to demonstrate substantial equivalence, rather than conducting new performance studies for the specific modification. As such, the information you requested regarding acceptance criteria and performance data for a new study is largely not present for this specific submission because it was deemed unnecessary due to the nature of the modification.

1. A table of acceptance criteria and the reported device performance

Based on the provided document, there are no specific numeric acceptance criteria for device performance reported for this specific 510(k) submission (K190071). Instead, the submission relies on the existing performance data and acceptance for the predicate device (Perla® Posterior Cervico-Thoracic Fixation System, K153386).

The document states: "An engineering analysis was performed and determined the new 4.5 mm multi-axial screws do not constitute a new worst-case design in the Perla spinal system. No additional testing has been performed for the Perla® 4.5 mm multi-axial screws."

It then lists non-clinical tests that were conducted on the predicate devices:

Test Type	Standard	Acceptance Criteria (Not explicitly stated for this submission, inferred from standards)	Reported Device Performance (Not explicitly stated for this submission)
Static Compression Bending	ASTM F1717	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Static Torsion	ASTM F1717	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Dynamic Compression Bending	ASTM F1717	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Static flexion-extension testing	ASTM F1798	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Static axial gripping	ASTM F1798	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Static torsion gripping	ASTM F1798	Device should meet specified strength/integrity requirements of the standard	Implied to have met requirements for predicate device
Axial pullout strength	ASTM F543	Device should meet specified strength requirements of the standard	Implied to have met requirements for predicate device
Torque to failure	ASTM F543	Device should meet specified strength requirements of the standard	Implied to have met requirements for predicate device
Bacterial endotoxin testing (Pyrogenicity testing)	USP standard (for Endotoxin limit of 20 EU / device)	Endotoxin limit of 20 EU / device	Implied to have met this limit for predicate device

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

As no new performance testing was conducted for the 4.5 mm multi-axial screws due to the engineering analysis, there is no "test set" and thus no sample size or data provenance specified for this particular modification. The previous testing for the predicate device would have had its own sample sizes, but those are not detailed here.

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

Not applicable, as no new clinical or performance test set (requiring expert ground truth) was performed for this specific 510(k) submission.

4. Adjudication method for the test set

Not applicable, as no new clinical or performance test set (requiring adjudication) was performed for this specific 510(k) 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 device is a mechanical implant (spinal fixation system), not an AI-driven diagnostic or assistive device that would involve human readers.

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

Not applicable. This device is a mechanical implant.

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

Not applicable, as no new performance studies requiring ground truth were conducted for this submission. The "ground truth" for mechanical testing is the physical measurement against the standard.

8. The sample size for the training set

Not applicable, as no AI/algorithm is involved, and no new training set was mentioned for mechanical testing.

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

Not applicable, as no AI/algorithm is involved, and no new training set or corresponding ground truth establishment was discussed.

Summary

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February 25, 2019

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

Re: K190071

Trade/Device Name: Perla® Posterior Cervico-Thoracic Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: January 11, 2019 Received: January 15, 2019

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/cdrl/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

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Ronald P. Jean -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K190071

Device Name

Perla® Posterior Cervico-Thoracic 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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SPECIAL 510k DEVICE MODIFICATION PERLA® POSTERIOR CERVICO-THORACIC FIXATION SYSTEM

510(k) SUMMARY

Type of 510k	510k SPECIAL – DEVICE MODIFICATION
Reason for submission	Extension of the range of Perla® Posterior Cervico-Thoracic Fixation system
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 20, 2019
Common Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
Trade Name	Perla® Posterior Cervico-Thoracic Fixation system
Product Code	NKG / KWP
Class	Unclassified
Device panel	Orthopedic
Legally marketed predicate devices	Primary predicate: PERLA Posterior Cervico-Thoracic Fixation System (K153386)manufactured by SpineartAdditional predicate: None
Indications for use	The PERLA® posterior cervico-thoracic fixation system is intended to provideimmobilization and stabilization of spinal segments as an adjunct to fusion for thefollowing acute and chronic instabilities of the cervical spine (C 1 to C7) and the thoracicspine from TI-T3: traumatic spinal fractures and/or traumatic dislocations; instability ordeformity; failed previous fusions (e.g., pseudarthrosis); tumors involving the cervicalspine; and degenerative disease, including intractable radiculopathy and/or myelopathy,neck and/or arm pain of discogenic origin as confirmed by radiographic studies, anddegenerative disease of the facets with instability. The PERLA® posterior cervico-thoracicfixation system is also intended to restore the integrity of the spinal column even in theabsence of fusion for a limited time period in patients with advanced stage tumorsinvolving the cervical spine in whom life expectancy is of insufficient duration to permitachievement of fusion. In order to achieve additional levels of fixation, the PERLA®posterior cervico-thoracic fixation system may be connected to the ROMEO® PosteriorOsteosynthesis System with rod connectors. Transition rods may also be used to connectthe PERLA® posterior cervico-thoracic fixation system to the ROMEO® PosteriorOsteosynthesis System. Refer to the ROMEO® Posterior Osteosynthesis System packageinsert for a list of the ROMEO® Posterior Osteosynthesis System indications of use.

Description of the device	The Spineart Perla® system is a posterior cervico-thoracic fixation system intended toprovide stabilization to promote fusion of the cervical spine and the upper thoracic spine.Perla® system consists of a variety of shapes and sizes of rods, hooks, multi-axial screws,set screws, rod connectors and transverse connectors. These connecting componentscan be rigidly locked to the rod in a variety of configurations to be adapted for theindividual case.The multi-axial screws are available with diameters 3.5mm and 4.0 mm with lengthsranging from 08 mm up to 52 mm. The purpose of this Special 510(k) application is tointroduce an additional range of multi-axial screw with 4.5 mm diameter and lengthsranging from 08 mm up to 52 mm to the Perla® spinal system.
Technologicalcharacteristics comparedto the predicate devices	The unique aspect of the new 4.5 mm multi-axial screws which differs from the existingPerla® multi-axial screws is the diameter of the bone screw that is enlarged to diameter4.5 mm. All other design features are strictly the same as for existing Perla® multi-axialscrews. Compared with previously cleared predicate multi-axial screws, the subjectmulti-axial screws with 4.5 mm in diameter are made of the same material (Titaniumalloy Ti6Al4V ELI conforming to ASTM F136), available in the same lengths ranging from08 mm up to 52 mm, present the same design and polyaxiality of 60° and use the sameset screw. Both previously cleared and new multi-axial screws are delivered sterile(gamma sterilization) and supplied with the same dedicated surgical instruments(reusable – provided non-sterile).The following non-clinical tests were conducted on predicate devices:- Static Compression Bending, Static Torsion and Dynamic Compression Bendingaccording to ASTM F1717- Static flexion-extension testing, Static axial gripping and Static torsion grippingaccording to ASTM F1798- Axial pullout strength and Torque to failure according to ASTM F543- Bacterial endotoxin testing as specified in USP standard is used for pyrogenicity testingto achieve the Endotoxin limit of 20 EU / device.
Discussion of Testing	An engineering analysis was performed and determined the new 4.5 mm multi-axialscrews do not constitute a new worst-case design in the Perla spinal system. Noadditional testing has been performed for the Perla® 4.5 mm multi-axial screws.
Conclusion	Based on the design features, technological characteristics, feature comparisons, andindications for use, the Perla® 4.5 mm multi-axial screws have demonstrated substantialequivalence to the identified predicate devices.

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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.