The MANTIS® Spinal System and MANTIS® Redux Spinal System is intended for percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the following indications:

Degenerative disc disease (DDD) (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
Failed previous fusion.
The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are intended to be used with the other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

Device Description

This 510(k) is intended to introduce a line extension to the existing MANTIS® Redux Spinal System. The line extension consists of additional sizes of the MANTIS® Redux Long Arm Polyaxial Screws. The additional sizes include the 7.5 mm and 8.5 screw diameter, ranging 30 - 90 mm in length for the MANTIS Redux Spinal System. No modifications were made to the MANTIS Spinal System.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Stryker Spine MANTIS® Spinal System and MANTIS® Redux Spinal System). It focuses on demonstrating substantial equivalence to predicate devices for a line extension. It does not contain information on acceptance criteria, a study proving device performance against acceptance criteria, or any of the detailed study parameters you've requested (sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth types, or training set details).

This type of submission typically relies on non-clinical (bench) testing to show that the new components meet established performance standards and are comparable to existing, legally marketed devices. It does not involve clinical studies with human participants or the assessment of AI algorithm performance as described in your prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and a study proving device performance because that information is not present in the provided document.

The document discusses:

Device Modification: Additional sizes (7.5 mm and 8.5 mm diameter, 30-90 mm length) for MANTIS® Redux Long Arm Polyaxial Screws.
Intended Use: Percutaneous, posterior, non-cervical pedicle and non-pedicle fixation of the spine for immobilization and stabilization as an adjunct to fusion in skeletally mature patients for various indications (e.g., DDD, spondylolisthesis, trauma).
Technological Characteristics: Substantial equivalence in terms of material, design, and indications for use to predicate devices.
Testing: Static Compression Bending testing, Static Torsion testing, and Fatigue Compression Bending testing per ASTM F1717 were conducted on the subject components and compared to a predicate system to demonstrate substantial equivalence.

In summary, the provided text describes a regulatory submission for a medical device line extension, not a study evaluating AI performance or clinical efficacy against specific acceptance criteria for diagnostic or therapeutic accuracy.

Summary

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K10 2235 Page 1 of 2

AUG 2 4 2010

STRYKER SPINE Special 510(k) Summary of Safety and Effectiveness:

Line Extension

Proprietary Name:	MANTIS® Spinal System and MANTIS® Redux Spinal System
Common Name:	Spinal Fixation Appliances
Classification Name andReference:	1) Spinal Intervertebral Body Fixation Orthosis, 21 CFR §888.30602) Pedicle Screw Spinal System, 21 CFR §888.3070 (b) (1) & (b) (2)
Device Product Code:	NKB, MNH, MNI, KWQ
Proposed Regulatory Class:	Class III
For Information contact:	Curtis TruesdaleRegulatory Affairs Project Manager2 Pearl CourtAllendale, NJ 07401Telephone: (201) 760-8296Fax: (201) 760-8496Email: Curtis.Truesdale@Stryker.com
Date Summary Prepared:	August 6, 2010
Predicate Devices	Stryker Spine MANTIS® Spinal System and MANTIS® Redux Spinal System, K092631; Stryker Spine Xia® II Spinal System, K063428; Stryker Spine Xia Spinal System, K002858, K013823, K043473; Stryker Spine Osteonics Spinal System, K951725

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K102235

Description of Device Modification

Intended Use

u Degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies);
Spondylolisthesis;
트 Trauma (i.e., fracture or dislocation);
Spinal stenosis;
Curvatures (i.e., scoliosis, kyphosis, and/or lordosis); ■
Tumor: .
. Pseudoarthrosis; and
. Failed previous fusion.

The Titanium and Vitallium® rods from the Stryker Spine RADIUS® Spinal System are intended to be used with the other components of MANTIS® Spinal System and MANTIS® Redux Spinal System.

Summary of the Technological Characteristics

The Stryker Spine MANTIS® Redux Spinal System, with the incorporation of the subject components, is substantially equivalent to the predicate devices in terms of material, design, and indications for use. Static Compression Bending testing, Static Torsion testing and Fatigue Compression Bending testing per ASTM F1717 were conducted on the subject components. The results obtained from these tests were compared to those of a predicate system to demonstrate substantial equivalence, as recommended by the "Guidance for Industry & FDA Staff Spinal System 510(k)s, May 3, 2004."

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, with three distinct lines forming the body and wings.

Public Health Service

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

Stryker Spine % Mr. Curtis Truesdale Regulatory Affairs Project Manager 2 Pearl Court Allendale, New Jersey 07401

AUG 2 4 2010

Re: K102235

Trade/Device Name: MANTIS® Spinal System and MANTIS® Redux Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: Class III Product Code: NKB, MNH, MNI, KWQ Dated: August 06, 2010 Received: August 09, 2010

Dear Mr. Truesdale:

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. Curtis Truesdale

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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Barbara Buettner

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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1112235

Indications for Use

510(k) Number (if known): K102235

Device Name: MANTIS® Spinal System and MANTIS® Redux Spinal System

Indications for Use:

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 .
. failed previous fusion.

The Titanium and Vital!ium rods from the Stryker Spine RADIUS® Spinal System are also intended to be used with other components of the MANTIS® Spinal System and MANTIS® Redux Spinal System.

AND/OR

Prescription Use (21 CFR 801 Subpart D) Over-The-Counter Use _

(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

K102235 510(k) Number_

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.