When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis).

It is also intended for the treatment of severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra in skelatally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine with removal of the implants after the attainment of a solid fusion. Levels of pedicle screw fixation for this indication are from L3-S1.

When used as a non-pedicle screw system, Aesculap's Spine System® Evolution is indicated for use in patients with degenerative disc disease (defined as back pain of discongenic origin with degeneration of the disc confirmed by history and radiographic studies), kyphosis, spondylolisthesis, neurological scoliosis, spine tumors and fractures. It is intended for posterior fixation from levels T1 through S1.

Device Description

Spine System® Evolution is a multiple component system comprised of a variety of single use devices that allow the surgeon to build a spinal implant construct in order to stabilize the thoracic and lumbar vertebrae and promote spinal fusion. Spine System® Evolution consists of pedicle screws (monoaxial and polyaxial), rods, linking plates, lateral connectors, and other implant components used to lock the desired construct in place. The spinal implants are manufactured from titanium alloy (Ti6Al4V) in accordance to ISO 5832/III. The specialized instrumentation used to implant and explant the Spine System® Evolution implants are made from surgical grade stainless steel in accordance to ISO 7153/1.

AI/ML Overview

The acceptance criteria for the Aesculap Spine System® Evolution are not explicitly stated in terms of quantitative metrics suitable for a table format as might be seen for AI/ML device performance. Instead, the "acceptance criteria" for this traditional medical device are implicitly linked to its substantial equivalence to predicate devices and its ability to withstand specific mechanical tests, without failure, under certain conditions.

The study proving the device meets these criteria is a mechanical testing study.

Here's the information broken down based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence in design, material, function, and intended use as current marketed spinal implant systems.	Device components are substantially equivalent to: Spine System® by Aesculap (K962757, K953599, K935113), CD Horizon™ Spinal System by Sofamor Danek (K964159, K962708, K961633), Mirage™ Spinal System by Alphatec (K951846), Moss® Miami Titanium Spinal System by Depuy Motech™(K980447, K955348), Synergy™ Posterior Spinal System by Cross® Medical Products, Inc. (K973836, K950099, K940631).
Device components must withstand mechanical testing according to ASTM Standard F 1717-96 without failure (implied).	"The components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model)." The text implies successful completion, as it led to 510(k) clearance.

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

Sample Size: Not explicitly stated as a number of patients or cases. The "test set" consists of the physical device components (pedicle screws, rods, linking plates, lateral connectors) that were subjected to mechanical testing. The number of individual components tested is not specified but would be a representative sample for mechanical validation.
Data Provenance: The device components themselves (manufactured from titanium alloy (Ti6Al4V) in accordance with ISO 5832/III) are tested. The test methodology is an internationally recognized standard (ASTM F 1717-96). This is a prospective test conducted on manufactured device units. No information on country of origin of data, as it's a mechanical test of components, not patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This question is not applicable in the context of this device. The "ground truth" for mechanical testing is established by recognized engineering standards (ASTM F 1717-96) and the physical properties of the materials and device design. There are no human experts "establishing ground truth" in the way clinical studies use them for diagnoses or interpretations.

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically used in clinical studies involving human interpretation or subjective assessments. Mechanical testing involves objective measurements against predefined 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

This is not applicable. This is a traditional spinal implant device, not an AI/ML-driven diagnostic or assistive device, and therefore no MRMC studies involving human readers or AI assistance were performed.

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

This is not applicable. The device is a physical spinal implant system, not a software algorithm.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The ground truth for this device is based on engineering standards and material science properties. Specifically, the ability of the device components to withstand static and fatigue loads as defined by ASTM Standard F 1717-96 is the "ground truth" for its mechanical performance.

8. The Sample Size for the Training Set

This is not applicable. There is no concept of a "training set" for a traditional mechanical medical device. The design process involves engineering principles and prior knowledge of materials, but not structured data "training" in the AI/ML sense.

9. How the Ground Truth for the Training Set was Established

This is not applicable, as there is no training set mentioned for this type of device.

Summary

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OCT 2 1998

Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

AESCULAP SPINE SYSTEM® EVOLUTION

September 25, 1998

Company

Contact

Aesculap®, Inc. 1000 Gateway Blvd. So. San Francisco, CA 94080 Lia S. Jones, Regulatory Associate Phone: 650-876-7000 x 350 650-589-3007 FAX:

Trade Name

Aesculap Spine System® Evolution

Common Name

Spinal Fixation System

Product Code and Regulatory Classification

MNI:	888.3070	Pedicle Screw Spinal Fixation Orthosis
MNH:	unclassified	Spondylolisthesis Spinal Fixation Device System
KWP:	888.3050	Spinal Interlaminal Fixation Orthosis

Product Classification

Class II

Intended Use

0002

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

AESCULAP SPINE SYSTEM® EVOLUTION

Device Description

Performance Data

No applicable performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for these devices. However, the components that comprise Spine System® Evolution were subjected to mechanical testing according to the ASTM Standard F 1717-96 (Static and Fatigue Test Methods for Spinal Implant Constructs in a Corpectomy Model).

Substantial Equivalence

Aesculap believes that the Spine System® Evolution additional components presented in this submission are substantially equivalent in design, material composition, function and intended use to currently marketed spinal implant systems, such as:

Spine System® .
bv Aesculap (K962757, K953599, K935113)
CD Horizon™ Spinal System . bv Sofamor Danek (K964159, K962708, K961633)
. Mirage™ Spinal System by Alphatec (K951846)
Moss® Miami Titanium Spinal System . by Depuy Motech ™(K980447, K955348)
Synergy™ Posterior Spinal System . by Cross® Medical Products, Inc. (K973836, K950099, K940631)

0003

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized caduceus symbol. The caduceus is depicted with a modern, abstract design, consisting of three intertwined figures. The text is arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2 1998 OCT

Ms. Lia S. Jones Regulatory Associate Aesculap®, Inc. 1000 Gateway Boulevard South San Francisco, California 94080-7030

Re: K980484 Spine System® Evolution Regulatory Class: II Product Codes: MNI, KWP, and MNH Dated: August 20, 1998 Received: August 21, 1998

Dear Ms. Jones:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Lia S. Jones

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General
and Restorative Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

i 11 ll

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INDICATION FOR USE STATEMENT

510(k) Number (if known):

K980484

Device Name:

Aesculap Spine System® Evolution

Indication for Use:

When used as a pedicle screw fixation system, Aesculap's Spine System® Evolution is 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: degenerative spondylolisthesis with objective evidence of neurological impairment, fracture, dislocation, scoliosis, spinal tumor, and failed previous fusion (pseudarthrosis).

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

	(Division Sign-Off)
	Division of General Restorative Devices
510(k) Number	K980484

Prescription Use (per 21 CFR 801.109)	X
---------------------------------------	---

Over-the-Counter Use
----------------------	--

(Optional Format 1-2-96)

0001

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.