The Palisade Pedicular Fixation System is intended for posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for the following indications: degenerative disc disease (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 and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

Device Description

The Palisade Pedicular Fixation System consists of titanium screws and cobalt chrome rods which allow a surgeon to build a spinal implant construct to accommodate the anatomical and physiological needs of the patient. The system 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 the thoracic, lumbar, and sacral spine.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the "Palisade Pedicular Fixation System." It is primarily focused on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving the device meets specific acceptance criteria in terms of clinical performance or diagnostic accuracy.

Therefore, many of the requested elements (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, ground truth for training set) are not applicable to this type of submission. This document describes a mechanical device used in spinal surgery, not an AI/diagnostic device.

However, I can extract the relevant information from the document regarding the performance testing that was conducted to demonstrate the substantial equivalence of the device.

Here's an interpretation of the provided document in the context of your request, focusing on what is available:

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

The document does not explicitly state "acceptance criteria" in a quantitative, pass/fail manner for clinical performance, as it is a mechanical device. Instead, it relies on demonstrating mechanical equivalence to predicate devices through various ASTM standard tests. The "reported device performance" is essentially that the device passed these tests in accordance with applicable standards.

Acceptance Criteria (Implied by Standards)	Reported Device Performance (Summary)
Endurance, Strength, Durability	Device "passed" tests according to applicable ASTM standards.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample size: Not explicitly stated for each mechanical test. However, typically mechanical testing involves a specific number of samples (e.g., 6 or more) per test configuration as defined by the ASTM standards. This is for product samples, not patient data.
Data provenance: Not applicable. The data is generated from laboratory mechanical testing of the device components, not from human or animal subjects.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This is mechanical testing, not a diagnostic or clinical study requiring expert ground truth.

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

Not applicable. This is mechanical testing.

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 fixation system, not an AI or diagnostic device.

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

Not applicable. This is a mechanical device.

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

Not applicable in the sense of clinical ground truth. The "ground truth" for these tests are the established performance requirements and methodologies outlined in the ASTM standards for spinal implant mechanical testing.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

Not applicable.

Summary of the Study Discussed in the Document (Performance and Biological Testing):

The document reports on performance tests conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System.

Tests Performed:
- ASTM F1798
- ASTM F1717
- Static Compression Bending
- Flexural Grip
- Axial Grip
- Static Torsion
- Torsional Grip
- Dynamic Compression Bending
Conclusion regarding these tests: Spineology states that the device "passed" these tests and demonstrated substantial equivalence to the predicate devices. The exact quantitative results (e.g., specific load values, cycles to failure) are not provided in this summary document but would have been submitted to the FDA separately.
Biological Safety Testing: "Not required as there was no change in materials from the predicate device." This implies that the materials used in the Palisade system are identical to those of legally marketed predicate devices, for which biological safety has already been established.
Packaging and Sterilization Testing: "Not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device." This indicates that these aspects of the device delivery are the same as those previously cleared predicate devices.

In essence, this document demonstrates substantial equivalence of a new mechanical spinal fixation device to existing, legally marketed devices by showing it has the same intended use, indications for use, fundamental scientific technology, biological safety, packaging, and sterilization method, supported by mechanical testing that confirms similar performance characteristics as defined by international standards.

Summary

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

February 23, 2016

Spineology, Incorporated Ms. Jacqueline A. Hauge Regulatory Affairs Manager 7800 3rd Street North, Suite 600 Saint Paul, Minnesota 55128

Re: K153323

Trade/Device Name: Palisade Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNI, MNH Dated: December 3, 2015 Received: December 4, 2015

Dear Ms. Hauge:

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/ResourcesforYou/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)

K153323

Device Name Palisade Pedicular Fixation System

Indications for Use (Describe)

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

☑ Prescription Use (Part 21 CER 801 Subpart D)
□ Over-The-Counter Use (21 CER 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the word "Spineology" in a bold, sans-serif font. To the right of the word is a graphic of a cluster of purple dots arranged in a circular pattern. The word "Spineology" is the main focus of the image, and the purple dots serve as a visual element that complements the text.

Date Prepared:	November 17, 2015
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128
Establishment Registration Number:	2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs Manger
Phone:	651.256.8534
Fax:	651.256.8505
Email:	jhauge@spineology.com

Device Name and Classification

Trade Name:	Palisade Pedicular Fixation System
Common Name:	Pedicle Screw System
Classification Name:	Orthosis, Spinal Pedicle Fixation
Product Codes:	NKB, MNI, MNH
Regulatory Class:	MNI, MNH: Class II NKB: Class III
Regulation Number:	MNI, MNH: 888.3070(b)(1) NKB: 888.3070(b)(2)
Panel:	Orthopedic

Predicate Devices

Primary:	K143403	Threshold Pedicular Fixation System
Additional:	K140010 K122901	Fortress Pedicle Screw SystemFirebird Spinal Fixation System, PhoenixMIS Spinal Fixation System

Device Description

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Image /page/4/Picture/1 description: The image shows the word "Spineology" in a bold, sans-serif font. The word is black and is followed by a registered trademark symbol. To the right of the word is a graphic of a cluster of purple dots arranged in a circular pattern.

Indications for Use

Comparison to Predicate

When compared to the predicate devices, the Palisade Pedicular Fixation System has the same:

Intended Use
Indications for Use
Fundamental Scientific Technology ●
· Biological Safety
Packaging System
Sterilization Method

Summary of Performance and Biological Testing

The following performance tests were conducted in accordance with applicable standards and test methods to determine the endurance, strength, and durability of the Palisade Pedicular Fixation System:

ASTM F1798

ASTMF1717
· Static Compression Bending
Flexural Grip

• Axial Grip

· Static Torsion
Torsional Grip
Dynamic Compression Bending

Packaging and sterilization testing was not required as there was no change to the sterile barrier system, sterilization method, sterilization parameters, or sterility assurance level (SAL) from the predicate device.

Biological safety testing was not required as there was no change in materials from the predicate device.

Conclusion

Spineology has demonstrated that the Palisade Pedicular Fixation System is substantially equivalent to the predicate devices. The fundamental scientific principle, primary technological characteristics, and intended use are unchanged from the predicate device.

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.