The Proliant 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 acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

Device Description

The ChoiceSpine Proliant Posterior Pedicle Screw and Hook Fixation System is a toploading spinal fixation system including screws, rods, and connectors for fixation to the thoracic, lumbar, and sacral spine. Components are manufactured from titanium alloy (Ti-6AI-4V ELI per ASTM F136) and Cobalt Chrome (Co-28Cr-6Mo per ASTM F1537) in various sizes. The system components are provided clean and non-sterile. The products must be steam sterilized by the hospital prior to use.

AI/ML Overview

This document is a 510(k) premarket notification for a Class II medical device, the ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System. It explicitly states that the device is substantially equivalent to a legally marketed predicate device (Exactech, Inc.'s Proliant® Pedicle Screw System, K102870).

A 510(k) submission primarily relies on demonstrating substantial equivalence to a predicate device rather than conducting de novo clinical performance studies or establishing new acceptance criteria based on human reading performance. Therefore, the provided text does not contain the information requested in your prompt regarding acceptance criteria, human reader studies, or detailed AI/ML performance metrics.

The study described is a non-clinical mechanical and biomechanical performance test designed to show the physical properties of the new device are comparable to the predicate.

Here's a breakdown of why this document doesn't fit your prompt's scope and what it does provide:

Why the Document Does Not Contain the Requested Information:

Device Type: This is a pedicle screw and hook fixation system, which is a physical implant, not an AI/ML diagnostic or image analysis device. Therefore, concepts like "multireader multi-case (MRMC) comparative effectiveness study," "standalone (algorithm only) performance," "ground truth establishment based on expert consensus," or "effect size of human readers improving with AI assistance" are not applicable.
Regulatory Pathway: A 510(k) typically relies on demonstrating substantial equivalence to an existing legally marketed device. This means the primary evidence revolves around comparing the new device's design, materials, indications for use, and non-clinical performance (e.g., mechanical testing) to a predicate, rather than generating new clinical performance data against specific acceptance criteria for a diagnostic task.
Absence of AI/ML: There's no mention of any AI or machine learning component in this device.

What the Document Does Provide (Mapped to Closest Relevant Concepts where possible, but not a direct match to your prompt):

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit via Substantial Equivalence): The implicit acceptance criterion is that the new device's mechanical and biomechanical performance must be comparable or superior to the predicate device to demonstrate substantial equivalence for its intended use. The document states: "The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices."
- Reported Device Performance (Test Modes):
  - Static axial compression bending per ASTM F1717-14
  - Static torsion per ASTM F1717-14
  - Dynamic axial bending per ASTM F1717-14
  - No specific numerical results are provided in this summary, only the types of tests performed and a general conclusion of sufficiency.
Sample sizes used for the test set and the data provenance:
- Sample Size: Not explicitly stated (for mechanical tests, this would refer to the number of test specimens).
- Data Provenance: Not applicable in the context of human data. These are laboratory mechanical tests, not clinical studies with patient data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth in this context refers to the physical properties measured in a lab, not expert consensus on medical images or diagnoses.
Adjudication method for the test set:
- Not applicable. This refers to mechanical testing, not a human reader study.
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:
- No, not done. This is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, not applicable. This is a physical implant, not an algorithm.
The type of ground truth used:
- Physical measurement of material properties and mechanical integrity. The "ground truth" is established by adherence to recognized industry standards (e.g., ASTM F1717-14) for testing the strength and durability of spinal implants.
The sample size for the training set:
- Not applicable. This is a physical device, not an AI/ML model that requires training data.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

In summary, the provided document details a 510(k) submission for a physical medical device (spinal fixation system) and demonstrates substantial equivalence through non-clinical mechanical testing, rather than addressing AI/ML performance metrics, human reader studies, or associated acceptance criteria.

Summary

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

Choice Spine, LP % Jim Banic Senior Regulatory Affairs Specialist 2320 NW 66th Court Gainesville, Florida 32653

June 8, 2017

Re: K170821

Trade/Device Name: ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System Regulation Number: 21 CFR 888.3070 Regulation Name: Thoracolumbosacral Pedicle Screw System Regulatory Class: Class II Product Code: NKB, KWP Dated: March 17, 2017 Received: March 20, 2017

Dear Mr. Banic:

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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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.

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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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known)	K170821
Device Name	Choice Spine™ Proliant® Posterior Pedicle Screw and Hook Fixation System
Indications for Use (Describe)	The Proliant 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 acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).
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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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FORM FDA 3881 (8/14)	Page 1 of 1
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ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System Traditional 510(k)

510(k) Summary

Company:	Choice Spine, LP400 Erin DriveKnoxville, TN 37919
Date:	May 19, 2017
Contact Person:	Jim BanicSr. Regulatory Affairs Specialist
	Phone: (352) 327-4673Fax: (352) 378-2617
Proprietary Name:	ChoiceSpine™ Proliant® Posterior Pedicle Screw andHook Fixation System
Common Name:	Thoracolumbosacral Pedicle Screw System
Classification Name:	21 CFR 888.3070, Orthosis, Spinal Pedicle Fixation21 CFR 888.3070, Orthosis, Spondyloisthesis SpinalFixation21 CFR 888.3050, Appliance, Fixation Interlaminal
	Class II
Product Codes:	NKB and KWP

Legally Marketed Devices to Which Substantial Equivalence Is Claimed:

Name	Manufacturer	510(k) Number
Proliant® Pedicle Screw System(Primary Predicate)	Exactech, Inc.	K102870
	Expedium Spine System	DePuy Synthes

Device Description

Indications for Use

The Proliant System is intended to provide immobilization and stabilization of spinal

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segments in skeletally mature patients as an adjunct to fusion in the treatment of the acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.

The Proliant system is intended for posterior, noncervical pedicle and non-pedicle fixation for the following indications: (DDD) degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis including severe spondylolisthesis (Grades 3 & 4) of L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e., scoliosis, kyphosis, and/or lordosis); tumor; and failed previous fusion (pseudoarthrosis).

Submission Purpose

The purpose of this 510(k) submission is to all line extensions to the existing Proliant Pedicle Screw System, and to change the name from the Exactech Proliant Pedicle Screw System to the ChoiceSpine Proliant Pedicle Screw System

Summary of Technological Characteristics

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use/Indications for Use.

Proliant Polyaxial Pedicle Screw and Hook Fixation System have similar indications for use and intended uses as its predicate device.

. Materials

Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Polyaxial Pedicle Screw System are composed of titanium alloy (Ti-6Al-4V) per ASTM F136 and cobalt chrome per ASTM F1537, biocompatible materials conforming to a recognized industry standard for permanent implants.

Design Features .

Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System have similar design features.

. Dimensions

Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant System are dimensionally comparable.

. Packaging and Sterilization

Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System are provided non-sterile, for single use only, and will be steam sterilized by the hospital prior to use in the operating room using the same sterilization method.

Device Shelf Life ●

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ChoiceSpine™ Proliant® Posterior Pedicle Screw and Hook Fixation System K170821 Traditional 510(k) Page 3 of 3

Neither Proliant Posterior Pedicle Screw and Hook Fixation System and the predicate Proliant Pedicle Screw System have shelf life expiration dating.

. Performance specifications

The proposed Proliant System line extensions have been tested in the following test modes.

Static axial compression bending per ASTM F1717-14 o
0 Static torsion per ASTM F1717-14
o Dynamic axial bending per ASTM F1717-14

The results of this non-clinical testing show the strength of the Proliant Posterior Pedicle Screw and Hook Fixation System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices.

Substantial Equivalence Conclusion

Results from mechanical tests and biomechanical assessment demonstrate the proposed Proliant Posterior Pedicle Screw and Hook System is substantially equivalent to the predicate Proliant Pedicle Screw System.

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.