The TIGER" Spine System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a pedicle screw system, the TIGER™ Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion 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.

Device Description

The TIGER™ Spine System is comprised of polyaxial pedicle screws, rods and crosslinks. The TIGER™ Spine System can be used for single or multiple level fixations. The pedicle screws are available in various lengths and diameters. The rods are available in straight and pre-iordosed (curved) configurations. The system has variable length cross connectors.

AI/ML Overview

The provided text describes the TIGER™ Spine System, a pedicle screw system, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the context of the requested AI/medical device performance evaluation framework.

The document is a 510(k) summary for a medical device (TIGER™ Spine System), which is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective as a legally marketed predicate device. This process typically relies on demonstrating substantial equivalence rather than meeting pre-defined performance acceptance criteria in the way an AI algorithm might have.

Here's a breakdown of why many of your requested points cannot be answered from the provided text:

Acceptance Criteria & Device Performance: The document outlines the device's characteristics and compares them to predicate devices to establish substantial equivalence. It does not define performance metrics, thresholds, or acceptance criteria in the sense of accuracy, sensitivity, specificity, or other performance measures that would be relevant for an AI device.
- The "performance" described is in terms of the device's physical properties, materials, and intended function, not diagnostic or predictive performance.
Study Details (Sample Size, Data Provenance, Ground Truth, Experts, Adjudication, MRMC, Standalone): The document explicitly states: "No clinical studies were performed." This means there are no details about a test set, training set, experts, ground truth, or any other elements related to performance evaluation studies for an AI/diagnostic device.
Training Set Sample Size & Ground Truth: Since no clinical studies were performed, there is no mention of a training set or how ground truth for such a set would have been established.

Summary based on the provided document:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly defined in terms of measurable performance thresholds for a diagnostic device. The acceptance criteria for its 510(k) approval are based on demonstrating "substantial equivalence" to predicate devices in terms of intended use, design, materials, and function.
- Reported Device Performance: No quantitative performance metrics (e.g., accuracy, sensitivity) are reported. The performance described is its function as a posterior pedicle screw system for temporary stabilization.
Sample sized used for the test set and the data provenance: None, as no clinical studies were performed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: None, as no clinical studies were performed.
Adjudication method for the test set: None, as no clinical studies were performed.
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, as this is a physical spinal implant system, not an AI diagnostic device, and no clinical studies were performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical spinal implant system.
The type of ground truth used: Not applicable, as no clinical studies requiring ground truth for performance evaluation were performed.
The sample size for the training set: Not applicable, as no clinical studies were performed.
How the ground truth for the training set was established: Not applicable, as no clinical studies were performed.

What the document does provide regarding "performance" and "studies":

Non-clinical Test Summary: Mentions "Static and dynamic compression and static torsion per ASTM F1717." These are mechanical tests to ensure the physical integrity and strength of the implant, not performance as a diagnostic or AI device. The results of these tests (e.g., meeting ASTM F1717 standards) would be the "performance" data, but specific numerical outcomes are not detailed in this summary.
Conclusion: States that the TIGER™ Spine System is "substantially equivalent to the predicate devices in terms of indications for use, design, material, and function." This "substantial equivalence" is the primary basis for its acceptance (510(k) clearance).

In essence, the provided document is for a traditional medical device (implant) and not an AI-powered diagnostic tool, therefore the requested information fields related to AI performance evaluation are not relevant or present in this context.

Summary

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K110321

510(k) Summarv for the TIGER™ Spine System

In accordance with 21 CFR 807.92 of the Federal Code of Regulations the following 510(k) summary is submitted for the TIGER™ Spine System

Date Prepared: January 28, 2011

25 2011

1. Submitter:	Corelink, LLC
	10805 Sunset Office Drive, Suite 300
	St. Louis, MO 63127

Contact Person:	J.D. Webb
	The OrthoMedix Group, Inc.
	1001 Oakwood Blvd
	Round Rock, TX 78681

Trade name: TIGER™ Spine System Common Name: pedicle screw system Classification Name: orthosis, spinal pedicle fixation / orthosis, spondylolisthesis spinal fixation MNI/MNH 21 CFR section 888.3070 Class II

Telephone: 512-388-0199

Predicate or legally marketed devices which are substantially equivalent: 3. ISOBAR (Scient'x - K990118/K013444) ZODIAC™ Polyaxial Spinal Fixation System (Alphatec - K042673) Array Spinal System (Biomet - K033312/K061563)

4. Description of the device:

Materials:

Ti-6Al-4V ELI conforming to ASTM F136

Function:

A posterior pedicle screw system designed for temporary stabilization of the anterior spine during the development of spinal fusion.

5. Substantial equivalence claimed to predicate devices

The TIGER™ Spine System is substantially equivalent to the ISOBAR and ZODIAC™ in terms of intended use, design, materials used, mechanical safety and performances. The table below compares the features and characteristics of the TIGER™ Spine System to these predicate devices.

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Device NameItems	TIGER™ Spine System	ISOBAR	ZODIAC™ Polyaxial Spinal Fixation System	Array Spinal System
Sponsor	Corelink LLC	Scient'x	Alphatec Spine Co.	Biomet
510(k) Number	N/A	K990118/K013444	K042673	K033312/K061563
Device Classification Name	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070	orthosis, spinalpedicle fixation perMNI 888.3070orthosis,spondylolisthesisspinal fixation perMNH 888.3070
Product Code	MNI, MNH	MNI, MNH	MNI, MNH	MNI, MNH
Class	Class II per 21 CFR888.3070/888.3050	Class II per 21 CFR888.3070/888.3050	Class II per 21 CFR888.3070/888.3050	Class II per 21 CFR888.3070/888.3050
Straight rods	Yes	Yes	Yes	Yes
Pre-bent rods	Yes	No	Yes	Yes
Rod material	Ti-6Al-4V ELI perASTM F136	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136	CP titaniumTi-6Al-4V per ASTMF136
Screw loading	Tulip top loading	Tulip top loading	Tulip top loading	Tulip top loading
Screw material	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136	Ti-6Al-4V per ASTMF136
Polyaxial	Yes	Yes	Yes	Yes
Crosslinks -length	Yes	Yes	Yes	?
Sterility	None sterile, single use only

The following devices were used as predicates for test result purposes:

. Synergy VLS - open (DePuy)
. Moss Miami SS K000536 (DePuy)
Rogozinski K884263 (Smith & Nephew) .
. ISOLA/MONARCH (DePuy)
Valeo Pedicle Screw System K072022 (Amedica)

6. Intended Use:

The TIGER™ Spine System is intended to provide immobilization 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 thoracic, lumbar, and sacral spine: fracture, dislocation, failed previous fusion (pseudoarthrosis), spinal stenosis, degenerative spondylolisthesis with objective of neurological impairment, spinal deformations such as scoliosis and loss of stability due to tumors.

When used as a pedicle screw system, the TIGER™ Spine System is intended for the treatment of severe spondylolisthesis (Grade 3 and 4) of the L5-S1 vertebrae in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (13 to sacrum) with removal of the implants after the attainment of a solid fusion.

7. Non-clinical Test Summary:

The following tests were conducted:

Static and dynamic compression and static torsion per ASTM F1717.

8. Clinical Test Summary

No clinical studies were performed

்.

ம் Conclusions Nonclinical and Clinical

TIGER™ Spine System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

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Image /page/2/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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

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

Corelink, LLC % The OrthoMedix Group, Inc. Mr. J. D. Webb 1001 Oakwood Boulevard Round Rock, Texas 78681

Re: K110321

Trade/Device Name: TIGER™ Spine System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class II Product Code: MNH, MNI Dated: April 15, 2011 Received: April 19, 2011

MAY 25 2011

Dear Mr. Webb:

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

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Page 2 - Mr. J. D. Webb

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 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. Millman

Mark N. Melkerson Director Division of Surgical, Orthopedic And-Restorative-Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: TIGER" Spine System

Indications for Use:

Prescription Use _ X _ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgeal, Orthopedic, and Restorative Devices

510(k) Number_ K110321

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.