The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 ioin: b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or attached to the lumbar or sacral spin; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum.

The S4 Spinal System is a pedicle screw system 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 spin: degenerative spondyloisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies). idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/illac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

Device Description

The S4 Spinal System consists of polyaxial screws and monoaxial screws of varying diameters and lengths, various hook styles, rods of varying lengths, and fixed and adjustable rod to rod connectors. All implant components are top loading and top tightening. The S4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

AI/ML Overview

The provided document is a 510(k) summary for the S4 Spinal System and does not contain information about acceptance criteria for a study, nor does it describe a study proving the device meets specific acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy.

Instead, the document focuses on:

Substantial Equivalence: It states that the S4 Spinal System additions are substantially equivalent to existing components of the S4 Spinal System. This is the primary claim for 510(k) submissions, not a demonstration of meeting specific performance criteria through clinical studies.
Device Description: Details the components and materials of the S4 Spinal System.
Indications for Use: Specifies the medical conditions and patient populations for which the device is intended.
Technological Characteristics: Compares the new components to predicate devices, noting similar shapes, sizes, and materials.
Performance Data: This section broadly states: "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements' were done where applicable. In addition, testing per the 'Spinal System 510(k)s' was completed where applicable."

This statement on "Performance Data" refers to non-clinical (e.g., mechanical, biocompatibility) testing required by guidance documents for orthopedic devices, not clinical studies assessing diagnostic accuracy or performance against specific acceptance criteria for AI or diagnostic devices. There is no mention of:

A table of acceptance criteria and reported device performance (in terms of clinical metrics).
Sample sizes for test sets, data provenance, or ground truth.
Numbers or qualifications of experts.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Training set details.

Therefore, I cannot fulfill the request as the essential information related to acceptance criteria and a study proving device performance (in the context implied by the questions, i.e., clinical or AI performance) is absent from the provided text. The document is for a spinal implant system, and the "performance data" mentioned would typically refer to mechanical and material safety, not diagnostic or AI performance.

Summary

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S4 Spinal System
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510(k) SUMMARY (as required by 21 CFR 807.92) B. APR 2 0 2009 S4 Spinal System March 11, 2009 Aesculap Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Reqistration Number: 3005673311 CONTACT: Lisa M. Bovle 610-984-9274 (phone) 610-791-6882 (fax) lisa.boyle@aesculap.com (email) TRADE NAME: ਟੇਖ COMMON NAME: S4 Spinal System DEVICE CLASS: Class III PRODUCT CODE: NKB, MNI, MNH, and KWP REGULATION NUMBER: 888.3070 - Orthosis, Spinal Pedicle Fixation For Degenerative Disc Disease 888.3070 - Orthosis, Spinal Pedicle Fixation 888.3070 - Orthosis, Spondyloisthesis Spinal Fixation 888.3050 - Appliance, Fixation, Spinal Fixation Orthopedics REVIEW PANEL:

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, Inc. believes that the S4 Spinal System additions are substantially equivalent to the existing components of the S4 Spinal System (K071945/K062085/K032219).

DEVICE DESCRIPTION

INDICATIONS FOR USE

The S4 Spinal System, when used as a pedicle screw fixation system, is indicated for use in patients: a) having severe spondylolisthesis (Grade 3 and 4) at the L5-S1 join; b) who are receiving fusion using autogenous graft only; c) who are having the device fixed or

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SPECIAL 510(k) Premarket Notification

54 Spinal System

Page 2 of 2

attached to the lumbar or sacral spine; and d) who are having the device removed after the development of a solid fusion mass may not go above the L5-S1 joint, the levels of pedicle screw fixation may span from L3 to the sacrum,

When used as a hook and sacral screw system (other than pedicle screw fixation system for high grade spondylolisthesis), the S4 Spinal System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with the degeneration of the disc confirmed by a history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture of dislocation, pseudoarthrosis, and previous failed spinal surgery/fusion. When used for this indication, screws of the S4 Spinal System are intended for sacral/iliac attachment only. Hooks and transverse connectors of the system are intended for posterior throracic and/or lumbar use only. The levels of use for hook and sacral screw fixation of this system are T1 to the sacrum.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The new components of the S4 Spinal System are offered in similar shapes and sizes as the predicate devices. All the components are manufactured from Titanium and Titanium Allov, which is the same material as the predicate devices.

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements" were done where applicable. In addition, testing per the "Spinal System 510(k)s" was completed where applicable.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is an abstract image of an eagle.

Food and Drug Administration 200 Corporate Boulevard Rockville MD 20850

Aesculap Implant Systems % Lisa M. Boyle 3773 Corporate Parkway Center Valley, Pennsylvania 18034

APR 2 0 2009

Re: K090657

Trade/Device Name: S4 Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle Screw Spinal System Regulatory Class: Class III Product Code: NKB, MNI, MNH and KWP Dated: April 14, 2009 Received: April 15, 2009

Dear Ms. Boyle:

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.

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 (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.

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Page 2 - Ms. Lisa M. Boyle

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Darbere BrienD to mken

Mark N. Melkerson Director Division of General, Restorative, And Neurological Devices Office of Device Evaluation Center for Devices and Radiological.Health

Enclosure

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S4 Spinal System
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K090657
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A. INDICATIONS FOR USE STATEMENT

K090657 510(k) Number:

Device Name: S4 Spinal System

Indications for Use:

X Prescription Use______________________________________________________________________________________________________________________________________________________________

and/or Over-the-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANQTHER PAGE IF NEE Concurrence of CDRH, Office of Device Evalualis

Division of General, Restorative,
and Neurological Devices 002

510(k) Number K090057

Regulation Number and Section

N/A