The Santis Pedicle Screw System is intended for immobilization of the spine. The Santis Pedicle Screw System is indicated for posterical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Device Description

The Santis™ Pedicle Screw System is comprised of: straight and pre-curved rods, pedicle screw assemblies with both cannulated and non-cannulated screws, compression retaining assemblies, cross connectors and a set screw. Various forms and sizes of these implants are available so that adaptations can be utilized to take into account the unique pathology of individual patients. The Santis™ Pedicle Screw System can be implanted either by an open procedure or percutaneous MIS approach, or a combination of both during the same procedure. Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.

AI/ML Overview

This document describes a 510(k) premarket notification for the Santis™ Pedicle Screw System. The primary purpose of this submission is to gain clearance for previously cleared devices as sterile, packaged products. The device is a Class III Pedicle Screw Spinal System.

Here's an analysis of the provided text in relation to acceptance criteria and the study that proves the device meets the criteria:

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

Performance Test	Acceptance Criteria (Standard)	Reported Device Performance
Package integrity	ASTM F1886-09, F1929-12, D3078, F2096	Passed
Gamma sterilization	ANSI/AAMI/ISO 11137 and 11607	Passed
Shelf life	ASTM F1980	Passed
Shipping validation	ASTM D4169	Passed

Detailed Explanation of Performance (as per the document):

The performance testing listed above primarily focuses on the packaging and sterilization processes of the device, rather than the clinical performance of the pedicle screw system itself. This is because the submission's purpose is "to gain clearance of previously cleared devices as sterile, packaged products" (page 3). The core device (Santis™ Pedicle Screw System) was presumably cleared in a previous 510(k) (K133063), and this submission addresses the new aspects of packaging and sterilization.

The technical characteristics of the subject device (Santis™ Pedicle Screw System) are stated to be the "Same as predicate" for:

Indications for Use
Surgical Technique
Screw Options and sizes
Cross Connectors
Rod sizes
Materials

This indicates that no new performance studies related to clinical efficacy or safety of the pedicle screw's function (e.g., bone fixation strength, fatigue life under physiological loads) were necessary, as these aspects were already established for the predicate device. The performance criteria here are entirely focused on demonstrating that the sterilization and packaging of the device maintain its safety and effectiveness.

2. Sample sizes used for the test set and the data provenance:

The document does not specify sample sizes for the individual tests (package integrity, sterilization, shelf life, shipping validation). These types of tests typically involve a defined number of samples to statistically demonstrate compliance with the standards, but the exact numbers are not provided in this summary.

The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective/prospective. However, given that these are laboratory validation tests for manufacturing processes (sterilization, packaging), they would be conducted in a controlled environment, likely at the manufacturer's facility or a certified testing lab.

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

This information is not applicable to the type of studies described. The "ground truth" for package integrity, sterilization, shelf life, and shipping validation is established by adherence to recognized international and national standards (ASTM, ANSI/AAMI/ISO). The tests involve objective measurements and established protocols to determine if the device meets these pre-defined standards, not subjective expert assessment of clinical outcomes or images.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This is not applicable. Adjudication methods are typically used in clinical studies or studies involving human interpretation of data (e.g., reading medical images) to resolve discrepancies among experts. The tests performed here are objective laboratory evaluations against published standards.

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:

This is not applicable. The device is a physical pedicle screw system, not an AI-powered diagnostic or assistive tool. MRMC studies and the concept of "human readers improve with AI" are not relevant to this type of medical device submission.

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

This is not applicable. The device is a physical pedicle screw system, not an algorithm.

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

The "ground truth" for the tests performed (package integrity, sterilization, shelf life, shipping validation) is defined by the specific requirements and acceptance criteria outlined in the referenced technical standards (e.g., ASTM F1886-09, ANSI/AAMI/ISO 11137). These standards describe validated methods and numerical or qualitative criteria for determining compliance. For example, a sterilization validation would involve demonstrating a sterility assurance level (SAL) of $10^{-6}$ in accordance with ISO 11137.

8. The sample size for the training set:

This is not applicable. There is no training set for a pedicle screw system. Training sets are typically used in machine learning or AI development.

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

This is not applicable, as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human profiles.

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

April 3, 2015

Lanterna Medical Technologies % Rich Jansen, Pharm.D. Silver Pine Consulting, LLC 11821 Bramble Cove Drive Fort Myers, Florida 33905

Re: K150507

Trade/Device Name: Santis™ Pedicle Screw System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: March 23, 2015 Received: March 24, 2015

Dear Dr. Jansen:

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

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Page 2 - Rich Jansen, Pharm.D.

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 vours.

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) K150507

Device Name Santis Pedicle Screw 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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510(k) Summary

Date Prepared:Submitter	March 10, 2015Lanterna Medical TechnologiesHorace Hale, PresidentPostfach 231Rorschacherstrasse 294St. Gallen, Switzerland, 9016Phone: +41 79 600 7724Fax: +41 71 370 0522
Regulatory Contact:	Rich Jansen, Pharm. D.Silver Pine Consultingrichj@s-pineconsulting.com
Device:Product Class:Classification:Common Name:Product Codes:Panel Code:	Santis™ Pedicle Screw SystemClass III21 CFR §888.3070 Pedicle Screw Spinal SystemPedicle Screw SystemNKB, MNI, MNH87

Purpose: The purpose of this submission is to gain clearance of previously cleared devices as sterile, packaged products.

Predicate Device(s): The primary predicate device is the Santis™ Pedicle Screw System (K133063)

Device Description:

Components are made of Ti6Al4V ELI, a titanium based alloy, which complies with ASTM F136, or cobalt chrome per ASTM F1537.

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Indications for Use:

The Santis™ Pedicle Screw System is intended for immobilization and stabilization of the spine. The Santis™ Pedicle Screw System is indicated for posterior, noncervical pedicle fixation as an adjunct to fusion in skeletally mature patients using autograft and/or allograft for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion.

Technological Characteristics:

The technological characteristics of the subject device and the predicate device are summarized below.

	Subject Device
Indications for Use	Same as predicate
Surgical Technique	Same as predicate
Screw Options and sizes	Same as predicate
Cross Connectors	Same as predicate
Rod sizes	Same as predicate
Materials	Same as predicate

Performance Standards:

Performance testing includes:

Validation	Standard	Pass/Fail
Package integrity	F1886-09, F1929-12, D3078 and F2096	Passed
Gamma sterilization	ANSI/AAMI/ISO 11137 and 11607	Passed
Shelf life	ASTM F1980	Passed
Shipping validation	ASTM D4169	Passed

Conclusion:

Lanterna Medical Technologies concludes that the Santis™ Pedicle Screw System is substantially equivalent to the previously cleared Santis™ Pedicle Screw System. The packaging and sterilization processes have been validated and raise no new questions of safety or effectiveness.

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.