When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
Spondylolisthesis
Spinal Stenosis
Fracture/dislocation
Failed previous fusion
Atlanto/axial fracture with instability
Occipitocervical dislocation
Revision of previous cervical spine surgery
Tumors

The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.

Device Description

The Aesculap® S4 Cervical Occipital Plate Spinal System is an implant system used to facilitate the biological process of spinal fusion. This system is intended to oromote fusion of the cervical and thoracic spine (C1-T3) and occiptio-cervicothoracic junction (occiput-T3). The Aesculap S4 Cervical Occipital Plate Spinal System consists of plates, bone screws, rods, hooks, and connectors. The components are available in a variety of lengths in order to accommodate patient anatomy. The Aesculap® S4 Cervical Occipital Plate Spinal System is manufactured from Titanium Alloy and will be provided non-sterile.

AI/ML Overview

The provided document is a 510(k) summary for the S4 Cervical Occipital Plate Spinal System, which is a medical device for spinal fusion. This type of document focuses on establishing substantial equivalence to previously cleared devices rather than presenting a standalone study with detailed acceptance criteria and performance metrics for an AI/software device.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment, which are typical for software-based medical device submissions, is not present in this document.

Here's an analysis of what can be extracted and what is explicitly not available based on the provided text:

1. A table of acceptance criteria and the reported device performance

Not Available: The document does not provide a table of quantitative acceptance criteria for the device performance, nor does it report specific numerical performance metrics (e.g., accuracy, sensitivity, specificity, precision, recall) in the way a software device would.
Instead, it states: "Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications." and "Testing results demonstrate the Aesculap S4 Cervical Occipital Plate Spinal System is safe and effective comparable to other predicate systems currently on the market." This indicates a qualitative comparison to predicates rather than specific, measurable performance targets.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Available: The document does not describe a "test set" in the context of data for a software device, nor does it refer to human subjects. The testing mentioned is "Biomechanical testing," which typically involves mechanical or cadaveric models rather than patient data. Therefore, data provenance is not applicable in this context.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable/Not Available: This device is a mechanical implant, not an AI/software device that requires expert-established ground truth from medical images or clinical data. "Ground truth" in this context would relate to the physical properties and biomechanical performance of the device itself, which are evaluated through engineering tests, not expert clinical review of data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable/Not Available: As there is no "test set" of clinical data requiring expert review, there is no adjudication method described.

5. 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/Not Available: This device is a physical spinal implant. MRMC studies and "human readers improving with AI assistance" are concepts specific to AI/software diagnostic or assistive devices, not for mechanical implants.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable/Not Available: This is a physical implant, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

Not Applicable/Not Available: The "ground truth" for a mechanical device's performance would be derived from validated engineering standards and testing methodologies (e.g., measuring fatigue life, tensile strength, fixation strength against established biomechanical benchmarks). The document mentions "All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) Applications for Orthopedic Devices-The Basic Elements'" and "'Spinal System 510(k)s'" were completed, implying adherence to these standards for establishing product safety and effectiveness.

8. The sample size for the training set

Not Applicable/Not Available: This device is a mechanical implant; therefore, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

Not Applicable/Not Available: As there is no training set for an algorithm, there is no description of how ground truth for such a set would be established.

In summary: The provided 510(k) summary for the S4 Cervical Occipital Plate Spinal System pertains to a physical orthopedic implant. The information requested aligns with the requirements for software-as-a-medical-device (SaMD) or AI-powered medical devices, which typically involve clinical studies, data sets, and performance metrics like sensitivity and specificity. This document, therefore, does not contain the specific details you've asked for because they are not relevant to the type of device being described. The approval is based on "substantial equivalence" through biomechanical testing against predicate devices.

Summary

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Ko62012

510(k) Summary & Certification B.

510(k) SUMMARY (as required by 21 CFR 807.92) S4 Cervical Occipital Plate Spinal System March 27, 2006

FEB 9 2007

March 27, 2006

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 2916714
----------	--------------------------------------------------------------------------------------------------------------------

Lisa M. Boyle CONTACT: 800-258-1946 (phone) 610-791-6882 (fax)
TRADE NAME: ટેવ
S4 Cervical Occipital Plate Spinal System COMMON NAME:
CLASSIFICATION NAME: Appliance, Fixation Spinal Interlaminal Orthosis, Spinal Pedicle Fixation Orthosis, Spinal Pedicle Fixation, For Degenerative Disc Disease

888.3050/888.3070 REGULATION NUMBER: KWP/MNI/NKB PRODUCT CODE:

SUBSTANTIAL EQUIVALENCE

Aesculap®, Inc. believes that the S4 Cervical Occipital Plate Spinal System is substantially equivalent to Depuy Acromed's Summit Occipito-Cervico-Thoracic (OCT) Spinal Systems and Aesculap's S4 Cervical Spinal System.

DEVICE DESCRIPTION

INDICATIONS FOR USE

When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:

{1}------------------------------------------------

. DDD (neck pain of discogenic origin with degeneration of the disc as confirmed by patient history and radiographic studies
. Spondylolisthesis
. Spinal Stenosis
� Fracture/dislocation
� Failed previous fusion
Atlanto/axial fracture with instability .
. Occipitocervical dislocation
Revision of previous cervical spine surgery .
Rheumatoid Arthritis .
. Tumors

The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation

or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.

TECHNOLOGICAL CHARACTERISTICS(compared to Predicate(s))

The Aesculap® S4 Cervical Occipital Plate Spinal System is considered substantially equivalent to other legally marketed predicate systems. Biomechanical testing of the subject device was found to be similar in performance to previously cleared spinal systems with similar indications.

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 relevant. Testing results demonstrate the Aesculap S4 Cervical Occipital Plate Spinal System is safe and effective comparable to other predicate systems currently on the market.

{2}------------------------------------------------

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 features a stylized eagle with its wings spread, clutching a staff with a snake wrapped around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aesculap, Inc. % Ms. Lisa M. Boyle Regulatory Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

9 2007 FEB

Re: K062012

Trade/Device Name: S4 Cervical Occipital Plate Spinal System Regulation Number: 21 CFR 888.3070 Regulation Name: Pedicle screw spinal system Regulatory Class: III Product Code: NKB, MNI, KWP Dated: January 26, 2007 Received: January 29, 2007

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 such 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); 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

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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,

Barbara Buelund
for

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

Enclosure

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Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number:

Device Name: Aesculap S4 Cervical Occipital Plate System

Indications for Use:

When intended to promote fusion of the cervical spine and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3) and are intended for the following:

DDD (neck pain of discogenic origin with degeneration of the disc as . confirmed by patient history and radiographic studies
Spondylolisthesis .
Spinal Stenosis t
Fracture/dislocation .
Failed previous fusion �
Atlanto/axial fracture with instability �
Occipitocervical dislocation .
Revision of previous cervical spine surgery �
. Tumors

The occipital bone screws are limited to occipital fixation only. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation

or trauma in the cervical/upper thoracic (C1-T3) spine.

The use of the polyaxial screws is limited to placement in T1-T3 in treating thoracic conditions only. Screws are not intended to be place in the cervical spine.

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

sion Sign-Division of General, Restorative,

and Neurological Devices

510(k) Number K06 2012

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.