The Spineology Palisade™ Pedicular Fixation System is intended for posterical 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 Spineology Palisade Pedicular Fixation System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy) devices to allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Palisade screws are available with or without a hydroxyapatite coating. The system is intended to provide immobilization 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. The screws can be placed in the pedicles in a variety of trajectories ranging from the standard anatomic transpedicular path projected medially toward the ventral vertebral body, to a caudocephalad path sagittally and a laterally directed path in the transverse plane.

AI/ML Overview

This document is a 510(k) premarket notification decision letter from the FDA for the Spineology Palisade™ Pedicular Fixation System. It grants clearance for the device based on its substantial equivalence to a legally marketed predicate device.

The document does not contain any information about a study that proves the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, accuracy, or any other quantifiable performance measure that would be typically established for an AI-powered device or for clinical outcome studies.

The "acceptance criteria" and "device performance" discussed in this document relate to the substantial equivalence of a modified medical device to a previously cleared predicate device. This is a regulatory pathway, not a clinical performance study against specific, pre-defined outcome metrics.

Here's why the requested information cannot be fully provided based on the given text:

No acceptance criteria for performance: The document confirms the device meets regulatory requirements for substantial equivalence, but it doesn't define specific performance criteria (e.g., "sensitivity > 90%") or report quantitative performance results from a study designed to measure clinical effectiveness or diagnostic accuracy.
No study to prove device performance in a clinical context: The "Non-Clinical Testing" section describes verifications and adoptions for new instruments and rods (e.g., Sawbones Verification Lab, Drawing Verification, Sterilization Adoption). These are engineering and material compatibility tests, not studies assessing clinical outcomes or diagnostic performance.
No AI component: The device described is a pedicular fixation system, which is a physical implant, not an AI-powered diagnostic or therapeutic device. Therefore, questions related to AI performance, ground truth, expert consensus, and MRMC studies are not applicable.

Therefore, many parts of your request are not applicable or cannot be answered from the provided text.

However, I can extract the relevant information regarding the basis for its regulatory clearance:

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

Acceptance Criteria (for Regulatory Clearance via Substantial Equivalence)	Reported Device Performance / Justification
Intended Use: Same as predicate	Met: "the modified Palisade System has the same: Intended Use"
Indications for Use: Same as predicate	Met: "the modified Palisade System has the same: Indications for Use" (Specifically mentioned in A. Purpose of Submission and D. Comparison to Predicate - "posterior, non-cervical fixation as an adjunct to fusion in skeletally mature patients for... degenerative disc disease, spondylolisthesis, trauma, spinal stenosis, curvatures, tumor, pseudoarthrosis, and/or failed previous fusion.")
Fundamental Scientific Technology: Same as predicate	Met: "the modified Palisade System has the same: Fundamental Scientific Technology"
Principle of Operation: Same as predicate	Met: "the modified Palisade System has the same: Principle of Operation"
Device Design: Similar to predicate (for added components)	Met: Non-clinical verifications and product adoptions performed for additional surgical instruments and 4.75mm Straight Rods (e.g., Sawbones Verification Lab, Drawing Verification, Implant/Inserter Interface Verification).
Materials of Construction: Similar/Same as predicate	Met: System consists of screws (titanium alloy), curved and straight rods (cobalt chrome), adjustable Connex Cross Connector (titanium alloy), and fixed ConneX Rod Connector (titanium alloy). Materials are consistent with those typically used in predicate devices.
Primary Method of Access: Similar to predicate	Met: "Primary Method of Access (Percutaneous)" is the same. The submission adds an optional alternative percutaneous method.
Safety and Effectiveness: Demonstrated through non-clinical testing	Met: "Spineology conducted a risk assessment for the additional surgical instruments and 4.75mm Straight Rod devices. Based on the risk assessment, the following non-clinical verifications and product adoptions were performed: Modified Surgical Technique (Instruments) - Sawbones Verification Lab, Drawing Verification, Sterilization Adoption, Surgical Technique Guide Update; Straight Rods (Implants) - Implant/Inserter Interface Verification, Drawing Verification, Sterilization Adoption, Packaging and Shelf Life Adoption."

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

Not applicable. This device is a physical pedicular fixation system. The "testing" involved non-clinical engineering verifications (e.g., Sawbones lab, drawing verification) and regulatory adoptions (sterilization, packaging). There was no "test set" in the context of clinical data or AI performance evaluation.

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. No clinical ground truth was established from expert review for this type of device and submission.

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

Not applicable. No test set requiring expert 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 not an AI device.

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

Not applicable. This is not an AI device.

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

Not applicable. As a physical implant, the "ground truth" for regulatory clearance is based on engineering specifications, material properties, and comparison to the predicate device's established safety and effectiveness.

8. The sample size for the training set

Not applicable. No training set was used as this is not an AI device.

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

Not applicable. No training set or ground truth in this context.

Summary

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

June 2, 2017

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

Re: K171438

Trade/Device Name: Palisade™ Pedicular Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral pedicle screw system Regulatory Class: Class II Product Code: NKB Dated: May 15, 2017 Received: May 16, 2017

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 Part 801); medical device reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set 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,

Vincent J. Devlin -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) K171438

Device Name Palisade™ Pedicular Fixation 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:	May 31, 2017
Submitter:	Spineology Inc.7800 3rd Street NorthSuite 600Saint Paul, MN 55128Establishment Registration Number: 2135156
Contact Person:	Jacqueline A. HaugeRegulatory Affairs ManagerPhone: 651.256.8534Fax: 651.256.8505Email: jhauge@spineology.com

Device Name and Classification

Trade Names:	Palisade™ Pedicular Fixation System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification Name:	Orthosis, Spinal Pedicle Fixation
Product Codes:	NKB
Regulatory Class:	Class II
Regulation Number:	21 CFR 888.3070
Panel:	Orthopedic

Predicate Device

Primary: K170266 Palisade™ Pedicular Fixation System (Spineology Inc.)

A. Purpose of Submission

The purpose of this submission is to obtain FDA clearance for the addition of non-sterile, reusable surgical instrumentation to allow an optional alternative percutaneous method of access to the spine. Currently, the Palisade System incorporates surgical instrumentation which facilitates percutaneous access to the spine via placement of a guidewire to maintain surgical trajectory for the introduction of a pedicle screw. The additional surgical instrumentation allows the option to omit use of a guidewire for percutaneous placement of a pedicle screw.

This submission also seeks FDA clearance for the addition of 4.75mm cobalt chrome Straight Rods in lengths of 100mm to 200mm to the Palisade System.

B. Device Description

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C. Indications for Use

The Spineology 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, kyphosis and/or lordosis); tumor; pseudoarthrosis; and/or failed previous fusion.

D. Comparison to Predicate

When compared to the predicate device, the modified Palisade System has the same:

Intended Use
Indications for Use
Fundamental Scientific Technology
. Principle of Operation
E. Non-Clinical Testing
Device Design
Materials of Construction
Primary Method of Access (Percutaneous)
Spineology conducted a risk assessment for the additional surgical instruments and 4.75mm Straight Rod devices. Based on the risk assessment, the following non-clinical verifications and product adoptions were performed:

Modified Surgical Technique (Instruments)

Sawbones Verification Lab
Drawing Verification
Sterilization Adoption
Surgical Technique Guide Update ●

Straight Rods (Implants)

Implant/Inserter Interface Verification
Drawing Verification
Sterilization Adoption
Packaging and Shelf Life Adoption

F. Conclusion

Based on the same indications for use, similar technological characteristics, and comparison to the predicate device, the modified Palisade System has been shown to be substantially equivalent to the legally marketed 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.