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 TI-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 radios, 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 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.

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 Perla® system can also be linked to the cleared Spineart Romeo®2 spinal system (K151695) using the specific Perla® Axial and Parallel Rod to Rod connectors 3.5/5.4mm or the Perla® Transition Rods 3.5/5.4mm which are part of this submission.

AI/ML Overview

The provided document is a 510(k) summary for the PERLA® Posterior Cervico-Thoracic Fixation System. It details the device's indications for use, technological characteristics, and performance data to demonstrate substantial equivalence to predicate devices. However, the document does not contain information about the acceptance criteria or a study proving the device meets specific acceptance criteria in the context of an AI/ML device.

The information provided describes a traditional medical device (implantable fixation system for spinal segments) and its FDA clearance process. It does not involve AI or algorithms, and therefore, the requested information about AI/ML device performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable or present in this document.

Therefore, the table below will be filled with "Not Applicable" or "Information Not Provided" as the document pertains to a physical medical device and not an AI/ML system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for AI/ML device)	Reported Device Performance (from document, if applicable to AI/ML)
Not Applicable (no AI/ML device)	Not Applicable (no AI/ML device)

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

Test Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)
Data Provenance: Information Not Provided (Not applicable to a physical spinal fixation system)

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

Number of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)
Qualifications of Experts: Information Not Provided (Not applicable to a physical spinal fixation system)

4. Adjudication method for the test set

Adjudication Method: Information Not Provided (Not applicable to a physical spinal fixation system)

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

MRMC Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML system for image interpretation or diagnosis by human readers.)
Effect Size: Not Applicable

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

Standalone Study Conducted?: No (Not applicable; this is a physical spinal fixation system, not an AI/ML algorithm.)

7. The type of ground truth used

Type of Ground Truth: Information Not Provided (Not applicable to a physical spinal fixation system. For this device, "ground truth" would refer to manufacturing specifications, material properties, and mechanical testing results, which are detailed in the document but not in the context of diagnostic "ground truth" for AI.)

8. The sample size for the training set

Training Set Sample Size: Information Not Provided (Not applicable to a physical spinal fixation system)

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

Ground Truth Establishment: Information Not Provided (Not applicable to a physical spinal fixation system)

Summary of Device Performance (from the document, relevant to a physical device):

The document states that "Published literature and bench testing per ASTM F1717 demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to the predicate devices."

The following non-clinical tests were conducted:

Static Compression Bending, Static Torsion, and Dynamic Compression Bending according to ASTM F1717.
Static flexion-extension testing, Static axial gripping, and Static torsion gripping according to ASTM F1798.
Axial pullout strength and Torque to failure according to ASTM F543.

The conclusion is that "Design comparisons and non-clinical performance testing demonstrate that the PERLA® posterior cervico-thoracic fixation system is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties and function."

These tests and their results are used to establish substantial equivalence for a traditional spinal implant, not to evaluate the performance of an AI/ML algorithm against predefined acceptance criteria for diagnostic accuracy or similar metrics.

Summary

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

January 25, 2016

SPINEART Mr. Franck Pennesi Director of Industry & Quality International Center Cointrin 20 route de pré-bois - CP 1813 1215 Geneva 15 SWITZERLAND

Re: K153386

Trade/Device Name: PERLA® Posterior Cervico-Thoracic Fixation System Regulatory Class: Unclassified Product Code: NKG, KWP Dated: November 19, 2015 Received: November 23, 2015

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. 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 Parts 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mark N. Melkerson -S

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) K153386

Device Name

PERLA® Posterior Cervico-Thoracic Fixation System

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

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FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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TRADITIONAL 510k PERLA® POSTERIOR CERVICO-THORACIC FIXATION SYSTEM

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510(k) SUMMARY

	SPINEART
Submitted by	International Center Cointrin
	20 route de pré-bois
	CP1813
	1215 GENEVA 15
	SWITZERLAND
Contacts	Franck PENNESI Director of Industry & Quality
	Phone : +41 22 570 1246 Fax : +41 22 799 40 26
	Mail : fpennesi@spineart.com
	Regulatory contact : Dr Isabelle DRUBAIX (Idée Consulting)
	Mail : idrubaix@nordnet.fr
Date Prepared	January 14th 2016
Trade Name	PERLA® Posterior Cervico-Thoracic Fixation System
Common Name	Orthosis, Cervical Pedicle Screw Spinal Fixation
	Posterior Cervico-Thoracic Fixation system
Classification Name	Appliance, Fixation, Spinal Interlaminal
Product Code / ClassCFR section	Primary: NKG, Unclassified
	CFR Section: Unclassified
	Subsequent: KWP, Class II
	CFR Section: 888.3050 Spinal Interlaminal fixation orthosis
Device panel	Orthopedic
Legally marketedpredicate devices	Primary predicate: Vertex Reconstruction System (K143471) manufactured by
	Medtronic Sofamor Danek USA, Inc
	Reference devices: Vertex Reconstruction System (K003780) manufactured by
	Medtronic Sofamor Danek, Inc Synthes Cervifix/Axon (K023675) manufactured
	by Synthes (USA); Synthes Cervifix System (K991089) manufactured by Synthes
	Spine; Mountaineer OCT Spinal System (K110353) manufactured by Depuy
	Spine, Inc
Indications for use	The PERLA® posterior 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 cervical spine (C 1 to C7)
	and the thoracic spine from TI-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 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.
	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.
Descriptionofthedevice	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
	Perla® system can also be linked to the cleared Spineart Romeo®2 spinal
	system (K151695) using the specific Perla® Axial and Parallel Rod to Rod
	connectors 3.5/5.4mm or the Perla® Transition Rods 3.5/5.4mm which are
	part of this submission
TechnologicalCharacteristics	The multi-axial screws are available with diameters 3.5mm and 4.0mm with
	lengths ranging from 8 mm up to 52mm.
	The 3.5mm diameter rods come in various lengths and have straight or pre-
	bent designs. The Perla® system comprises also transition rods with dual
	diameters of 3.5/5.4mm, a range of hooks and connectors.
	The implantable components of the PERLA® posterior cervico-thoracic fixation
	system are made of medical grade titanium alloy and cobalt chromium
	conforming to standards ASTM F136 and F1537, respectively.
	The implantable components of the PERLA® posterior cervico-thoracic fixation
	system are delivered sterile (gamma sterilization).
	The PERLA® posterior cervico-thoracic fixation system is supplied with all the
	surgical instruments required for its installation.
	Published literature and bench testing per ASTM F1717 demonstrate that the
Performance Data	PERLA® posterior cervico-thoracic fixation system is substantially equivalent to
	the predicate devices.
	The following non-clinical tests were conducted:
	✓ Static Compression Bending, Static Torsion and Dynamic Compression
	Bending according to ASTM F1717
	✓ Static flexion-extension testing, Static axial gripping and Static torsion
	gripping according to ASTM F1798
	✓ Axial pullout strength and Torque to failure according to ASTM F543
	Design comparisons and non-clinical performance testing demonstrate that
Conclusion	the PERLA® posterior cervico-thoracic fixation system is substantially
	equivalent to its predicate devices in terms of intended use, material, design,
	mechanical properties and function.

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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.