The Spine 360 Talon Spinal 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 following acute and chronic instabilities or deformities of 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 (pseudoarthrosis).

Device Description

The Talon Spinal Fixation System was cleared for use via K071824, and is comprised of polyaxial screws, locking plugs, spinal rods and rod to rod connectors. The Talon System can be used for single or multiple level fixations. All components are manufactured from titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136. Spine 360 proposes to add new smaller diameter (4.5mm) screws in various lengths, cannulated screws in various diameters and lengths, pedicle screw spacers as well as the minimally invasive surgical technique for use with the Spine 360 Talon Spinal System. The new components are based upon the same fundamental scientific technology and do not alter the indications for use as compared to the existing system.

AI/ML Overview

This excerpt focuses on the Spine 360 Talon Spinal System, a medical device, and the documentation provided does not include the detailed information about acceptance criteria and a study design that you are requesting for a typical AI/software-as-a-medical-device (SaMD) submission.

The provided document is a 510(k) Summary for a Premarket Notification (K102995) for a Spinal Fixation System. This is a physical medical device (implants for spinal fusion) and the regulatory submission heavily relies on non-clinical (mechanical) testing and demonstration of substantial equivalence to predicate devices, rather than clinical performance studies with acceptance criteria based on human or AI-assisted performance metrics.

Therefore, I cannot directly extract the following information from the provided text:

A table of acceptance criteria and the reported device performance: The acceptance criteria for this device are related to mechanical properties (e.g., strength, stiffness, fatigue) and functional equivalence to predicate devices, not diagnostic performance metrics like sensitivity, specificity, or AUC.
Sample size used for the test set and the data provenance: Not applicable in the context of this device's testing. Mechanical tests involve test specimens, not patient data.
Number of experts used to establish the ground truth for the test set and the qualifications: Not applicable. Ground truth for mechanical testing would be direct measurements from the tests themselves.
Adjudication method: Not applicable.
If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable, as this is not a diagnostic device involving human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical implant.
The type of ground truth used: For this device, the "ground truth" for non-clinical testing refers to the physical properties measured during mechanical tests against established ASTM standards and against predicate device performance.
The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set.
How the ground truth for the training set was established: Not applicable.

What is present in the document is:

1. Acceptance Criteria (implied through non-clinical test summary and substantial equivalence justification):

The acceptance criteria for this type of device are primarily based on:

Meeting or exceeding the performance standards of recognized ASTM standards (e.g., ASTM F1717-09 for Static Compression Bending, Dynamic Compression Bending).
Demonstrating equivalence or better performance (in terms of compression bending performance, stiffness, and dynamic compression bending fatigue strength) compared to the predicate devices.
Providing stability greater than tolerated thresholds in range of motion and stiffness limits of the human lumbar spine, and adequately stabilizing a fusion site.

2. Reported Device Performance (Summary):

The document states:

"The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed."
"The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced."
"The Spine 360 Spinal Fixation System including the smaller 4.5 screws, cannulated screws and spacers will provide stability greater than the tolerated thresholds in range of motion and stiffness limits of the human lumbar spine and will adequately stabilize a fusion site."

In summary, the provided document describes a medical device undergoing a 510(k) clearance process based on substantial equivalence and mechanical testing, not a software or AI device requiring the type of clinical validation study details you've requested.

Summary

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KIO2995

Image /page/0/Picture/1 description: The image shows a logo with the word "SPINE" in bold, sans-serif font. To the right of the word "SPINE" are the numbers "360" in a stylized font. The numbers are made up of concentric circles, giving them a three-dimensional appearance. The logo appears to be for a product or service related to spinal health or a 360-degree view of the spine.

FEB - 2 2011

510(k) SUMMARY

Spine 360 Talon Spinal System

Premarket Notification

SUBMITTED BY Spine 360 CONTACT PERSON 5000 Plaza on the Lake, Suite 305 Dave Lamb Austin, Texas 78746 Quality and Regulatory Affairs Phone: 512-364-6400 ext 5 Fax: 800-640-6045

ESTABLISHMENT REGISTRATION NUMBER 3005841736

DATE PREPARED October 1, 2010 COMMON NAME Spinal Fixation System PROPRIETARY NAME Talon Spinal Fixation System CLASSIFICATION NAME and product code CLASS II, MNI 888.3070 - Pedicle Screw Spinal System CLASS II, MNH 888.3070 - Pedicle Screw Spinal System PREDICATE DEVICE Talon Spinal Fixation System(K071824)

Acme System (K0010044)

The Spine 360 Talon Spinal Fixation System(K102995) is substantially equivalent to the above devices.

DEVICE DESCRIPTION

NONCLINICAL TEST SUMMARY

The following tests were conducted:

. Static Compression Bending and Torsion ASTM F1717-09

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Image /page/1/Picture/0 description: The image shows a sequence of handwritten alphanumeric characters. The sequence starts with the letters 'K1', followed by the numbers '02995'. The handwriting style appears casual, with some variation in the size and spacing of the characters.

Dynamic Compression Bending ASTM F1717-09 �

INTENDED USE

The intended use for the device is the same as the referenced system cleared K071824. The Spine 360 Talon Spinal Fixation 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 following acute and chronic instabilities or deformities of 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 (pseudoarthrosis).

SUBSTANTIAL EQUIVALENCE

The Spine 360 Spinal Fixation System proposed additional 4.5 screws, cannulated screws and spacers demonstrated equivalence or better in compression bending performance and stiffness to the predicate device listed. The dynamic compression bending fatigue strength for the Spine 360 Spinal Fixation System had already demonstrated a greater endurance strength than predicates referenced.

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS

Spine 360 Spinal Fixation System is substantially equivalent to the predicate devices in terms of indications for use, design, material, and function.

CONCLUSIONS

The Spine 360 Spinal Fixation System including the smaller 4.5 screws, cannulated screws and spacers will provide stability greater than the tolerated thresholds in range of motion and stiffness limits of the human lumbar spine and will adequately stabilize a fusion site.

Pg 2 of 2

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with three wing-like shapes, symbolizing health and human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

Spine 360 % Mr. Dave Lamb Quality and Regulatory Affairs 5000 Plaza on the Lake, Suite 305 Austin, Texas 78746

FEB -- 2 201

Re: K102995

Trade/Device Name: Talon Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system * Regulatory Class: Class II Product Code: MNI, MNH Dated: December 16, 2010 Received: January 11, 2011

Dear Mr. Lamb:

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

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Page 2 - Mr. Dave Lamb

(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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A. B. R. d.
for

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:

Spine 360 Talon Spinal System

Indications for Use:

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)

Signature

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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Regulation Number and Section

N/A