The Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.

Device Description

The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.

AI/ML Overview

The provided text is a 510(k) Summary for the Aesculap ENNOVATE Cervical Spinal and Occiput System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (performance data).

The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI/algorithm-based device. The original document does not describe an AI/algorithm-based device. It describes a physical implant system (screws, rods, plates, etc.) for spinal stabilization. Therefore, the questions related to AI/algorithm performance studies (such as MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, training set sample size, expert consensus, etc.) are not applicable to this submission.

The "Performance Data" section solely lists ASTM standards that the physical device was tested against. These standards evaluate the mechanical properties of the implant system (e.g., strength, fatigue, static properties) to ensure it performs as safely and effectively as the predicate device.

Given that the request is for an AI/algorithm device study and the provided document is for a physical orthopedic implant, I can only address the "acceptance criteria" and "device performance" in the context of the mechanical and material testing described for this specific physical device.

Acceptance Criteria and Device Performance (Based on the provided document for a physical implant):

The acceptance criteria for this physical device are implicitly tied to the successful completion of the listed ASTM standard tests, demonstrating equivalence in mechanical performance to the predicate device. The performance is stated to be "as safely and effectively" as the predicate device based on these tests.

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

Acceptance Criteria Category (Implied by Standards)	Reported Device Performance (Implied Statement)
Spinal Implant Constructs in a Vertebrectomy Model (ASTM F1717-18)	Successfully met standards, performing "as safely and effectively as the primary predicate."
Static and Fatigue Properties of Interconnection Mechanisms and Subassemblies (ASTM F1798-13)	Successfully met standards, performing "as safely and effectively as the primary predicate."
Components Used in Surgical Fixation of the Spinal Skeletal System (ASTM F2193-18a)	Successfully met standards, performing "as safely and effectively as the primary predicate."
Metallic Medical Bone Screws (ASTM F543-17)	Successfully met standards, performing "as safely and effectively as the primary predicate."
Overall Safety and Effectiveness (compared to predicate)	"substantially equivalent in design, materials, intended use, and performs as safely and effectively as the primary predicate currently on the market."

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. For physical device testing, this typically refers to the number of implants or components tested according to the ASTM standards.
Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, since it's bench testing, the "data" originates from the physical tests performed on the device samples in a laboratory setting.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This is a physical device, and its performance is evaluated against engineering standards, not by expert interpretation of images or data. Ground truth here is based on the objective measurements from the mechanical testing.

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

Not Applicable. Adjudication methods are relevant for human interpretation or complex data analysis, not for direct physical property measurements against engineering standards.

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. This is not an AI/algorithm-based device. An MRMC study would not be performed for a physical implant.

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

Not Applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used:

Mechanical Performance Standards: The ground truth for this physical device is the set of mechanical and material properties defined by the ASTM standards (e.g., tensile strength, fatigue life, torque limits) which are universally accepted engineering benchmarks for such implants. Compliance with these quantitative standards serves as the "ground truth."

8. The sample size for the training set:

Not Applicable. This is a physical device, not an algorithm that requires a training set.

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

Not Applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" and "study proving device meets criteria" are based on a series of bench tests against pre-defined ASTM engineering standards to demonstrate substantial equivalence to an existing predicate device, primarily in terms of mechanical and material performance. The questions related to AI/algorithm studies are not relevant to this specific premarket notification.

Summary

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July 1, 2022

Aesculap Implant Systems, LLC Paul Amudala Senior Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K213871

Trade/Device Name: Ennovate Cervical Spinal and Occiput System Regulation Number: 21 CFR 888.3075 Regulation Name: Posterior cervical screw system Regulatory Class: Class II Product Code: NKG. KWP Dated: June 1, 2022 Received: June 3, 2022

Dear Paul Amudala:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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542 of the Act); 21 CFR 1000-1050.

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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Colin O'Neill, M.B.E. Assistant Director DHT6B: Division of Spinal Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K213871

Device Name

Ennovate Cervical Spinal and Occiput System

Indications for Use (Describe)

In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

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

AESCULAP ENNOVATE Cervical Spinal and Occiput System Jun 01, 2022

COMPANY:	Aesculap Implant Systems, LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Paul AmudalaSr. Regulatory Affairs Specialist610-984-9303/610-417-0839 (phone)610-791-6882 (fax)
TRADE NAME:	ENNOVATE® Cervical Spinal and Occiput System
COMMON NAME:	Posterior Cervical Screw System, Spinal Interlaminal FixationOrthosis
REGULATION NUMBER:	21 CFR 888.3075 – Posterior cervical screw system21 CFR 888.3050 – Spinal interlaminal fixation orthosis
PRODUCT CLASS:	Class II
PRODUCT CODE:	NKG, KWP
REVIEW PANEL:	Orthopedics

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems, LLC believes that the ENNOVATE Cervical Spinal and Occiput System is substantially equivalent to the Primary Predicate K151938 S4C Cervical Spinal and Occiput Systems.

DEVICE DESCRIPTION

INDICATIONS FOR USE

The Aesculap ENNOVATE Cervical Spinal and Occiput System is intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion for the following

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acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous fusions (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radiculopathy and/or myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap ENNOVATE Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap ENNOVATE Cervical Spinal and Occiput System using connectors and rods.

TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s))

The components of the ENNOVATE Cervical Spinal and Occiput System are offered in similar configuration as the predicate device. All of the implants are made from a Titanium Alloy (Ti-6Al-4V) and CoCr. The instruments are made of medical grade stainless steel, aluminum, titanium alloy, PEEK and silicone which are the same materials as the Primary Predicate device and other Aesculap spine products distributed currently on the market.

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 guidance "Spinal System 510(k)s May 3, 2004" was completed where applicable.

ASTM F1717-18 Standard Test Methods for Spinal Implant Constructs in a ● Vertebrectomy Model.
ASTM F1798-13 Standard Test Method for Evaluating the Static and Fatigue Properties . of Interconnection Mechanisms and Subassemblies Used in Spinal Arthrodesis Implants.
ASTM F2193-18a Standard Specifications and Test Methods for Components Used in ● the Surgical Fixation of the Spinal Skeletal System.
ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone ● Screws.

CONCLUSION:

Aesculap believes that based on the completed testing, the Ennovate Cervical Spinal and Occiput System presented in this submission is substantially equivalent in design, materials, intended use, and performs as safely and effectively as the primary predicate currently on the market.

Regulation Number and Section

§ 888.3075 Posterior cervical screw system.

(a)
Identification. Posterior cervical screw systems are comprised of multiple, interconnecting components, made from a variety of materials that allow an implant system to be built from the occiput to the upper thoracic spine to fit the patient's anatomical and physiological requirements, as determined by preoperative cross-sectional imaging. Such a spinal assembly consists of a combination of bone anchors via screws (i.e., occipital screws, cervical lateral mass screws, cervical pedicle screws, C2 pars screws, C2 translaminar screws, C2 transarticular screws), longitudinal members (e.g., plates, rods, including dual diameter rods, plate/rod combinations), transverse or cross connectors, interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors), and closure mechanisms (e.g., set screws, nuts). Posterior cervical screw systems are rigidly fixed devices that do not contain dynamic features, including but not limited to: non-uniform longitudinal elements or features that allow more motion or flexibility compared to rigid systems.Posterior cervical screw systems are intended to provide immobilization and stabilization of spinal segments in patients as an adjunct to fusion for acute and chronic instabilities of the cervical spine and/or craniocervical junction and/or cervicothoracic junction such as: (1) Traumatic spinal fractures and/or traumatic dislocations; (2) deformities; (3) instabilities; (4) failed previous fusions (
e.g., pseudarthrosis); (5) tumors; (6) inflammatory disorders; (7) spinal degeneration, including neck and/or arm pain of discogenic origin as confirmed by imaging studies (radiographs, CT, MRI); (8) degeneration of the facets with instability; and (9) reconstruction following decompression to treat radiculopathy and/or myelopathy. These systems are also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.(b)
Classification. Class II (special controls). The special controls for posterior cervical screw systems are:(1) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(2) Nonclinical performance testing must demonstrate the mechanical function and durability of the implant.
(3) Device components must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(5) Labeling must include the following:
(i) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(ii) Intended use and indications for use including levels of fixation;
(iii) Device specific warnings, precautions, and contraindications that include the following statements:
(A) “Precaution: Preoperative planning prior to implantation of posterior cervical screw systems should include review of cross-sectional imaging studies (
e.g., CT and/or MRI) to evaluate the patient's cervical anatomy including the transverse foramen, neurologic structures, and the course of the vertebral arteries. If any findings would compromise the placement of these screws, other surgical methods should be considered. In addition, use of intraoperative imaging should be considered to guide and/or verify device placement, as necessary.”(B) “Precaution: Use of posterior cervical pedicle screw fixation at the C3 through C6 spinal levels requires careful consideration and planning beyond that required for lateral mass screws placed at these spinal levels, given the proximity of the vertebral arteries and neurologic structures in relation to the cervical pedicles at these levels.”
(iv) Identification of magnetic resonance (MR) compatibility status;
(v) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user, and;
(vi) Detailed instructions of each surgical step, including device removal.