The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and
failed previous fusion.

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, fixed and adjustable cross-connectors, and various styles of 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 text describes a 510(k) premarket notification for the Aesculap® Implant Systems S4 Spinal System, specifically focusing on a line extension to include additional rod connectors. The evaluation largely relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing.

Here's an analysis of the acceptance criteria and study described, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Mechanical Performance (Non-Clinical):
Static Axial Compression Bending (ASTM F1717-11a)	Results showed that the subject Aesculap S4 Rod Connectors meet or exceed the performance of the predicate devices.
Dynamic Axial Compression Bending (ASTM F1717-11a)	Results showed that the subject Aesculap S4 Rod Connectors meet or exceed the performance of the predicate devices.
Static Torsion (ASTM F1717-11a)	Results showed that the subject Aesculap S4 Rod Connectors meet or exceed the performance of the predicate devices.
Material Equivalence:	Manufactured from Titanium and Titanium Alloy, which is the same material as the predicate devices.
Dimensional & Design Equivalence:	Components are offered in similar shapes and sizes as the predicate devices.
Indications for Use Equivalence:	Intended for the same indications for use as the predicate devices (anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation, for skeletally mature patients as an adjunct to fusion for various spinal instabilities/deformities).

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not specify a "sample size" in the context of clinical test subjects or datasets as would be common for AI/diagnostic device studies. Instead, it refers to non-clinical testing of the physical device components. The sample size for these non-clinical tests (e.g., number of rod connectors tested) is not provided.
Data Provenance: Not applicable in the context of clinical data provenance. The "data" here comes from laboratory mechanical testing of physical devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This submission is for a physical spinal implant system, not a diagnostic or AI-driven device requiring expert consensus for ground truth establishment. The "truth" in this context is determined by adherence to ASTM standards and mechanical performance metrics compared to predicate devices.

4. Adjudication Method for the Test Set:

Not applicable. There is no "test set" in the sense of clinical cases requiring expert adjudication. The performance is assessed through standardized mechanical testing methods per ASTM F1717-11a.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a spinal implant, not a diagnostic imaging or AI-assisted interpretation device that would involve human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Not applicable. This submission describes a physical medical device, not an algorithm or software.

7. Type of Ground Truth Used:

For the performance studies, the "ground truth" implicitly refers to the specified performance criteria set by ASTM standards (F1717-11a) for static axial compression bending, dynamic axial compression bending, and static torsion, as well as the performance profiles of legally marketed predicate devices. The device's performance is compared against these benchmarks rather than a clinical ground truth like pathology or outcome data.

8. Sample Size for the Training Set:

Not applicable. This device is not an AI/machine learning model, so there is no training set in the conventional sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. As there is no training set, this question is not relevant.

In summary: The provided document describes the regulatory pathway for a spinal implant system, which primarily involves demonstrating mechanical equivalence to predicate devices through standardized non-clinical testing. It does not involve AI, diagnostic algorithms, or human-in-the-loop performance studies.

Summary

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K123352 Page 1 of 2

в. 510(k) SUMMARY (as required by 21 CFR 807.92)

DEC 1 2 2012

Aescular® Implant Systems S4 Spinal System October 23, 2012

Aesculap®Implant Systems, Inc. COMPANY: 3773 Corporate Parkway Center Valley, PA 18034 Establishment Registration Number: 3005673311 CONTACT: Lisa M. Boyle 610-984-9274 (phone) 610-791-6882 (fax) TRADE NAME: ડવ COMMON NAME: Pedicle Screw System REGULATION NUMBER: 888.3070 - Orthosis. Spinal Pedicle Fixation For Degenerative Disc Disease 888.3070 - Orthosis, Spinal Pedicle Fixation 888.3070 - Orthosis, Spondylolisthesis Spinal Fixation 888.3050 - Appliance, Fixation, Spinal Fixation

NKB, MNI, MNH, and KWP PRODUCT CODE: REVIEW PANEL: Orthopedics

PURPOSE FOR PREMARKET NOTIFICATION

The S4 Spinal System described in this submission represents a line extension to the system. The purpose of the line extension is to include additional rod connectors to the svstem.

SUBSTANTIAL EQUIVALENCE

Aesculap® Implant Systems, Inc. believes that the S4 Spinal System is substantially equivalent to the S4 Spinal System (K112551/K062085), the Aesculap Spine System Evolution (K001080), and the Depuy Spine Expedium Systems (K033901, K063156, K073126, K073364, K081898).

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, fixed and adjustable cross-connectors, and various styles of rod connectors. All implant components are top loading and top tightening. The $4 Spinal System is manufactured from Titanium and Titanium alloy in accordance with ISO 5832/3 and ISO 5832/2.

INDICATIONS FOR USE

The S4 Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and non-pedicle fixation. Fixation is limited to skeletally mature patients and is

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intended to be used as an adjunct to fusion using autograft or allograft. The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

spondvlolisthesis.
trauma (i.e., fracture or dislocation),
spinal stenosis.
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),

1. tumor.

pseudoarthrosis, and
failed previous fusion.

TECHNOLIGICAL CHARACTERISTICS(compared to Predicate(s))

The components of the Aesculap® Implant Systems S4 Spinal System are offered in similar shapes and sizes as the predicate devices. All the components are manufactured from Titanium and Titanium Alloy, which is the same material as the predicate devices.

PERFORMANCE DATA

As recommended by the FDA Guidance for Spinal System 510(k)'s, non-clinical testing was performed to demonstrate that the S4 Rod Connectors are substantially equivalent to other predicate devices. The following testing was performed:

Static Axial Compression Bending per ASTM 1717-11a .
Dynamic Axial Compression Bending per ASTM F1717-11a .
Static Torsion per ASTM 1717-11a �

The results of these studies showed that the subject Aesculap S4 Rod Connectors meet or exceed the performance of the predicate devices, and the device is therefore found to be substantially equivalent.

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Image /page/2/Picture/0 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 design resembling an abstract caduceus or a series of flowing lines. The entire logo is presented in black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 12, 2012

Aesculap Implant Systems, Incorporated % Ms. Lisa Boyle Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K123352

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, KWP Dated: October 26, 2012 Received: November 7, 2012

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. 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 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

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Page 2 - Ms. Lisa Boyle

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 yours,

Image /page/3/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The first name, "Erin," is written in a bold, sans-serif font. The middle initial and last name, "DKeith," are written in a more decorative font with a series of parallel lines forming the letters.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification

S4 Spinal System Modification Axial & Domino Rod Connectors

Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number: K123352

Device Name: S4 Spinal System

Indications for Use:

1 ) degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies)

spondylolisthesis,
trauma (i.e., fracture or dislocation),
spinal stenosis,
deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
tumor,
pseudoarthrosis, and
failed previous fusion.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)

Otot the Sooner 000

(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ronald# Jean -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K123352

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.