The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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.

The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
trauma (i.e., fracture or dislocation),
spinal stenosis, ·
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.

Device Description

The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.

AI/ML Overview

The Malibu™ Spinal System with the Daytona™ Deformity System is a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as ground truth, training set, test set, effect size, etc.) are not applicable.

This device is a Pedicle Screw Spinal System and a Spinal Interlaminal Fixation Orthosis, which are hardware components (spinal rods and pedicle screws) used in spinal fusion procedures. The submission is a "Special 510(k)" for line extensions.

Here's the information based on the provided document:

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

Acceptance Criteria (What the device needs to achieve)	Reported Device Performance (How the device performed in testing)
Substantially equivalent to predicate devices in terms of technological characteristics.	The spinal rod product line extension increases the ultimate strength of the existing cobalt alloy spinal rods while the varying uni-planar pedicle screws combine the features of the current pedicle screws including cannulated and non-cannulated with variable and limiting angles. These line item extensions to the system do not alter the fundamental scientific technologies of the previously cleared system; these devices have substantially equivalent technological characteristics as the predicate devices.
Compliance with ASTM F1717 (Static and Fatigue Compressive Bending, Static Torsion).	The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM F1717 (static compressive bending, fatigue compressive bending, static torsion) and found to be equivalent.
Compliance with ASTM F1798 (Static AP testing).	The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM F1798 (static AP) testing and found to be equivalent.
Compliance with design control procedure requirements as specified in 21 CFR §820.30.	The manufacturing facility is in conformance with the design control procedure requirements as specified in 21 CFR §820.30 and the records are available for review.
Reduced sterilization time for Malibu implants within the Daytona™ Deformity System is validated.	Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System. A re-validation to updated standards is included.

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

Sample Size: Not explicitly stated as a numerical sample size for a "test set" in the context of clinical data. The performance testing was based on mechanical testing of the devices themselves, comparing them to predicate devices.
Data Provenance: The testing was mechanical/bench testing according to ASTM standards (F1717 and F1798) comparing the new device designs to existing predicate devices. This is laboratory-based data, not human patient data in this context.

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 medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring expert consensus for image or clinical data.

4. Adjudication method for the test set:

Not applicable. This is a medical device (spinal hardware) that undergoes mechanical testing, not an AI/ML device requiring adjudication of clinical or image data.

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 medical device (spinal hardware), not an AI/ML device.

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

Not applicable. This is a medical device (spinal hardware), not an AI/ML algorithm.

7. The type of ground truth used:

For mechanical performance, the "ground truth" is established by the performance characteristics of legally marketed predicate devices and the requirements of recognized industry standards (ASTM F1717 and F1798). The new devices are shown to be "equivalent" in these mechanical tests to their predicates.

8. The sample size for the training set:

Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

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

Not applicable. This is a medical device (spinal hardware), not an AI/ML device.

Summary

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Malibu Spinal System with the Daytona Deformity System Special 510(k)

Special 510(k) Summary			DEC 12 2012
Company Name:	SeaSpine, Inc.An Integra Life Sciences Company2302 La Mirada DriveVista, CA 92081
Contact person:	Nicholas M. CordaroDirector, Engineeringe-mail: nick.cordaro@integralife.comPhone: (760) 216-5603, Fax: (760) 477-8260
Date prepared:	December 11, 2012
Trade name:	Malibu™ Spinal System with the Daytona™ Deformity System
Common name:	Pedicle Screw System
Classification name:	Pedicle Screw Spinal SystemMNH (Class II) - 888.3070(b)(1)MNI (Class II) - 888.3070(b)(1)NKB (Class III) - 888.3070(b)(2)Spinal Interlaminal Fixation OrthosisKWP (Class II) - 888.3050
Predicate Device:	Previously cleared Malibu Spinal System 510(k)'s K072605, K061342, K051942, K051663, Xia Spinal System 510(k) K060979, UCR Spinal System 510(k) K021623 and the IST Pedicle Screw System 510(k) K053276.
Device Description:	The Malibu Spinal System contains titanium alloy and cobalt alloy implants and surgical tools. This submission is intended to address line extensions for spinal rods of identical material composition and dimensional specifications but with a higher tensile strength and varying uni-planar pedicle screws. Additional documentation is submitted for a reduced sterilization time for the Malibu implants within the Daytona™ Deformity System.
Intended use:	The intended use for the Malibu Spinal System remains unchanged by the addition of the product line extension and remains as:The intended use of the Malibu System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System, is 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

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chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
trauma (i.e., fracture or dislocation),
spinal stenosis, ·
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.
The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:
degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.

Technological Characteristics:

The spinal rod product line extension increases the ultimate strength of the existing cobalt alloy spinal rods while the varying uni-planar pedicle screws combine the features of the current pedicle screws including cannulated and non-cannulated with variable and limiting angles. These line item extensions to the system do not alter the fundamental scientific technologies of the previously cleared system; these devices have substantially equivalent technological characteristics as the predicate devices. These Malibu rods and pedicle screws are housed within the Daytona™ Deformity sterilization tray. A re-validation to updated standards is included.

Performance Testing:

The subjective devices were compared to legally marketed predicated devices in regards to an array of testing per ASTM 1717 (static compressive bending, fatigue compressive bending, static torsion) and ASTM 1798 (static AP) testing and found to be equivalent.

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. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

100 - 100 - 100 -

Declaration ofSubstantial Equivalence:	All verification and validation activities related to the design features,conducted risk analysis, and mitigation activities (e.g. performance testing)showed that the submitted devices are substantially equivalent to predicatedevices.
	The manufacturing facility is in conformance with the design controlprocedure requirements as specified in 21 CFR §820.30 and the records areavailable for review.

and the comments of the comments of

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all capital letters and is oriented to follow the curve of the circle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Letter dated: December 12, 2012

SeaSpine, Incorporated % Mr. Nicholas M. Cordaro Director, Engineering 2302 La Mirada Drive Vista, California 92081

Re: K122571

Trade/Device Name: Malibu™ Spinal System with the Daytona™ Deformity System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH, KWP Dated: November 1, 2012 Received: November 19, 2012

Dear Mr. Cordaro:

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 - Mr. Nicholas M. Cordaro

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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

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 Statement

510(k) Number: K122571

Device Name: Malibu™ Spinal System with the Daytona™ Deformity System

Indications for Use:

The indications for use are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
: severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusions by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion (indication for use only when used as a Spondylolisthesis Spinal Fixation Device System),
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
spinal tumor,
pseudoarthrosis, and/or
failed previous fusion.

Prescription Use

AND/OR

Over-The-Counter-Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K122571

Page 1 of 2

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510{k} Number: K122571

Device Name: Malibu™ Spinal System with the Daytona™ Deformity System

Indications for Use (Continued):

The intended use and indications of the Malibu™ Spinal System, when used as a Spinal Interlaminal Fixation Orthosis or Hook Spinal System, are limited to T1-L5 and are as follows:

degenerative disc disease (DDD) as defined by back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies,
spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudarthosis, and/or
failed previous fusion.

Prescription Use

AND/OR

Over-The-Counter-Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED).

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald P. Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Summary: K122571

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.