When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in skeletally mature patients, the Presidio Surgical Viking Pedicle Screw 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) fracture, (4) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

Device Description

The Presidio Surgical Viking Lumbar Polyaxial Screw System is a polyaxial pedicle screw system with straight or precontoured crosslink to provide optimal supporting structure for the spinal bodies. The pedicle screw system is a surgically implantable device which is intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of thoracic, lumbar, and sacral spine. This premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device, specifically a "Viking Lumbar Polyaxial Screw System." It seeks to demonstrate substantial equivalence to previously cleared devices. The document explicitly states that this premarket notification is to add a new crosslink design to the pedicle screw system that was previously cleared. This means the device in question is a surgical implant for spinal stabilization, not an AI/Software as a Medical Device (SaMD).

Therefore, the requested information regarding "acceptance criteria" related to device performance in diagnosis or treatment, "study that proves the device meets the acceptance criteria" in terms of AI performance metrics, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types are not applicable to this type of device and submission.

The "performance testing" described in the document is mechanical testing to demonstrate the structural integrity of the spinal implant.

Here's the relevant information that can be extracted from the provided text, adapted to the nature of the device:

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

Acceptance Criteria (Mechanical Testing)	Reported Device Performance
Mechanical strength adequate for intended use (presumably defined by ASTM F1717 standards)	"confirmatory mechanical testing to demonstrate that the modifications... provide adequate and substantially equivalent mechanical strength for their intended use."

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

Test Set (for mechanical testing): Not explicitly stated in the provided text. It refers to "confirmatory mechanical testing," which implies testing a certain number of devices or components.
Data Provenance: Not applicable in the context of human data. The testing is described as mechanical testing of the physical implant.

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

Not Applicable. This is a mechanical device, not an AI/SaMD requiring expert ground truth for diagnostic or prognostic performance. The "ground truth" for mechanical testing would be defined by engineering specifications and standards (e.g., ASTM F1717).

4. Adjudication method for the test set

Not Applicable. Mechanical testing results are typically evaluated against predefined engineering specifications, not through human adjudication.

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 mechanical spinal implant, not an AI/SaMD.

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

Not Applicable. This is a mechanical spinal implant.

7. The type of ground truth used

Mechanical Integrity/Performance Standards: The "ground truth" for this device's performance would be compliance with mechanical testing standards (e.g., ASTM F1717 dynamic compression bending) and engineering specifications to ensure structural adequacy for its intended surgical use.

8. The sample size for the training set

Not Applicable. There is no "training set" for this mechanical device.

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

Not Applicable. There is no "training set" for this mechanical device.

In summary: The provided document describes a mechanical spinal implant attempting to gain market clearance through the 510(k) pathway by demonstrating substantial equivalence to predicate devices. The "performance testing" involved is physical, mechanical testing of the device's components (specifically a new crosslink design) against established engineering standards like ASTM F1717. The concepts of AI performance metrics, test/training sets of patient data, expert readers, and ground truth in the context of AI/SaMD are not relevant to this submission.

Summary

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July 13, 2018

Presidio Surgical % Meredith Lee May, MS, RAC Vice President Empirical Consulting 4628 Northpark Drive Colorado Springs, Colorado 80918

Re: K180655

Trade/Device Name: Viking Lumbar Polyaxial Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: April 17, 2018 Received: April 18, 2018

Dear Ms. May:

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 Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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) K180655

Device Name

Viking Lumbar Polyaxial Screw System

Indications for Use (Describe)

When used as a pedicle screw fixation system in the non-cervical posterior spine (T1-S1) in sketally mature patients, the Presidio Surgical Viking Pedicle Screw System is intended to provide immobilization 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: (1) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), (2) degenerative spondylolisthesis with objective evidence of neurologic impairment, (3) dislocation, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), (5) spinal stenosis, (6) curvatures (i.e., scoliosis, and/or lordosis), (7) tumor, (8) failed previous fusion (i.e. pseudarthrosis).

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Submitter's Name	Presidio Surgical
Submitter's Address	1451 Danville Blvd. Suite 204Alamo, CA 94507
Submitter's Telephone	925.400.3010
Contact Person	Meredith Lee May, MS, RACVP, Empirical ConsultingMMay@EmpiricalConsulting.com719-337-7579
Date Summary wasPrepared	05 March 2018
Trade or Proprietary Name	Viking Lumbar Polyaxial Screw System
Common or Usual Name	Thoracolumbosacral pedicle screw system
Classification	Class II per 21 CFR §888.3070
Product Code	NKB
Classification Panel	Orthopedic

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION

INDICATIONS FOR USE

TECHNICAL CHARACTERISTICS

The Viking Lumbar Polyaxial Screw System is made from material that conforms to ASTM F136. The subject and predicate devices have nearly identical technological characteristics and

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the minor differences do not raise any new issues of safety and effectiveness. Specifically the following characteristics are the same between the subject and predicate devices:

Indications for use
Principles of operation
Implant materials of manufacture ●
Sterilization ●

Table 5-1: Predicate Devices

510kNumber	Trade or Proprietary orModel Name	Manufacturer	Predicate
K120091	Pedicle Screw System	R&D Innovation	Primary
K120832	Fortex Pedicle ScrewSystem	X-Spine	Additional
K111940	S 100 Pedicle Screw System	Renovis	Additional

PERFORMANCE TESTING SUMMARY

In support of this Traditional 510(k) Device Modification Premarket Notification, Presidio Surgical has conducted confirmatory mechanical testing to demonstrate that the modifications to the Viking Lumbar Polyaxial Screw System provide adequate and substantially equivalent mechanical strength for their intended use. The testing that was completed was dynamic compression bending per ASTM F1717.

CONCLUSION

The Viking Lumbar Polyaxial Screw System modified subject device is very similar to the previously cleared Viking Lumbar Polyaxial Screw System. The subject device Viking Lumbar Polyaxial Screw System has the same intended uses, indications, technological characteristics, and principles of operation as the predicate devices. The modifications raise no new types of safety or effectiveness questions. The overall technology characteristics and mechanical performance data lead to the conclusion that the Viking Lumbar Polyaxial Screw System is substantially equivalent to the predicate devices.

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.