Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondylolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

In addition. 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).

When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine System Evolution is intended for hook fixation from T1 to the ilium / sacrum. The non-pedicle screw indications are degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (fracture or dislocation), spinal stenosis, deformities or curvatures (scoliosis, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

Device Description

Spine System Evolution is a multiple component system comprised of a variety of single-use, non-sterile implants (Ti6Al4V acc. to ISO 5832/3) that allow the surgeon to build a spinal construct in order to stabilize and promote fusion in the thoracic, lumbar and sacral spine. It is a low-profile, top-loading system that utilizes one connection (conical nut) for all implants, such as standard and polyaxial pedicle screws, sacral plates and screws, rods and rod connectors, linking plates, lateral connectors, and various hook styles and configurations.

AI/ML Overview

The provided text does not contain specific acceptance criteria, reported device performance metrics, or details about a study designed to prove the device meets acceptance criteria in the way typically seen for AI/ML-driven medical devices.

Instead, the document is a 510(k) summary for a spinal implant system, the "Spine System® Evolution," seeking to expand its current product line with new and modified components. The focus of this type of submission is on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative criteria through a clinical study.

Here's a breakdown based on the information provided and what is missing:

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

Acceptance Criteria: Not explicitly stated in terms of measurable performance metrics (e.g., sensitivity, specificity, accuracy, precision, etc.). The acceptance criterion for a 510(k) is "substantial equivalence" to a predicate device.
Reported Device Performance: No specific quantitative performance data is provided in the document. It generally states: "The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." No results from these tests are given.

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

Sample Size: Not applicable/not provided. This is not a diagnostic device undergoing a clinical performance study with a test set of images or patient data in the context of AI/ML evaluation. The "tests" mentioned are likely mechanical or material tests of the physical implant components.
Data Provenance: Not applicable.

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

Not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for diagnostic devices (especially AI/ML-driven ones), not for mechanical spinal implants in a 510(k) submission focused on substantial equivalence for material and design changes.

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

Not applicable. Adjudication methods are used in clinical studies for diagnostic accuracy, which is not the type of study 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. This is not an AI-assisted diagnostic device.

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

Not applicable. This is not an AI algorithm.

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

Not applicable in the context of diagnostic "ground truth." For a spinal implant, the "ground truth" for its safety and efficacy would be established through mechanical testing, material compatibility, and potentially long-term clinical follow-up for predicate devices, demonstrating the materials and design meet engineering and biomechanical standards. The document refers to "ISO / ASTM standards" which would define testing methods to ascertain performance (e.g., fatigue life, strength) against established material and design requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable.

Summary of the "Study" (as described in the document):

The document describes the submission as seeking to expand the product line for an existing device. The "study" or evidence provided to meet the regulatory requirements is built on the concept of substantial equivalence.

Evidence for Substantial Equivalence: The new and modified components are compared to:
- Aesculap's current Spine System Evolution (K980484, K982914)
- Competitor spinal systems: ISOBAR®, ISOLOCK® Spinal System, ISOLA / VSP System, Mirage™ Spinal System, Xia™ Spinal System.
Basis of Equivalence: The document explicitly states: "The new and modified components described in this premarket notification are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to those in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems."
Performance Data Mentioned: "The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy." This implies that engineering and material performance tests (not clinical studies with patient data or expert reviews) were conducted to ensure the new components perform similarly to the existing ones and meet relevant biomechanical standards. No specific results from these tests are included in this summary.

In essence, for this specific 510(k) submission, the "acceptance criteria" were met by demonstrating that the modifications to an existing device (Spine System® Evolution) and the new components were substantially equivalent to legally marketed predicate devices, supported by appropriate engineering and material testing against recognized standards. There is no mention of an AI/ML component or a clinical study involving human readers or a labeled test set for diagnostic performance.

Summary

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Spine System® Evolution

JUN 2 9 2000

Koo1080

Page 1 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

SPINE SYSTEM® EVOLUTION

April 3, 2000

Aesculap®, Inc. COMPANY: 1000 Gateway Blvd. So. San Francisco, CA 94080
Lia S. Jones, Regulatory Associate CONTACT: 650-624-5073 (phone) 650-589-3007 (fax) lia.jones@aesculap.com (email)
Spine System® Evolution TRADE NAME:
COMMON NAME: Posterior Spinal Fixation System
DEVICE CLASS: Class II
PRODUCT CODE(S): KWP, MNH, MNI
CLASSIFICATION(S): 888.3050 Spinal Interlaminal Fixation Orthosis 888.3070 - Spondylolisthesis Spinal Fixation Device System 888.3070 - Pedicle Screw Spinal System
Orthopedic Devices Branch REVIEW PANEL: Division of General and Restorative Devices

DEVICE DESCRIPTION

PURPOSE OF PREMARKET NOTIFICATION

This submission seeks to expand the current product line for Aesculap's Spine System Evolution (K980484, K982914) with new and modified components. There are no changes to the intended use, material composition or fundamental scientific technology.

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Spine System® Evolution

K001080

Page 2 of 2

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

in Accordance with SMDA of 1990

SPINE SYSTEM® EVOLUTION

April 3, 2000

INDICATIONS FOR USE

Spine System Evolution is a pedicle screw system indicated for the treatment of severe spondvlolisthesis (Grades 3 and 4) of the L5-S1 vertebra in skeletally mature patients receiving fusion by autogenous bone graft having implants attached to the lumbar and sacral spine (L3 to sacrum) with removal of the implants after the attainment of a solid fusion.

PERFORMANCE DATA

No performance standards have been promulgated under Section 514 of the Food, Drug and Cosmetic Act for this device system. The implants presented in this 510(k), however, were put through various test methods in accordance to applicable ISO / ASTM standards in order to establish their safety and efficacy.

SUBSTANTIAL EQUIVALENCE

The new and modified components described in this premarket notification are substantially equivalent in their intended use, material composition, labeling, design and basic operating principles to those in Aesculap's current Spine System Evolution (K980484, K982914), as well as the following competitor spinal systems:

ISOBAR®, ISOLOCK® Spinal System (K992738, K990118, K990721) .
ISOLA / VSP System (K984350) .
Mirage™ Spinal System (K951846) .
Xia™ Spinal System (K992792, K984251) .

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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 consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, represented by three curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 9 2000

Ms. Lia S. Jones Regulatory Associate Aesculap, Incorporated 1000 Gateway Boulevard South San Francisco, California 94080-7028

Re: K001080

Trade Name: Spinal System® Evolution Regulatory Class: II Product Code: KWP, MNH and MNI Dated: April 3, 2000 Received: April 4, 2000

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 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 requirement, 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- Ms. 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Rene M. Jujan

Say Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and 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

510(k) Number (if known):

K001080

Device Name:

Spine System® Evolution

Indication for Use:

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When used as a posterior, non-cervical, non-pedicle screw fixation system, Spine When used as a postenor, non och fixation from T1 to the illium / sacrum. The System Evolution is Inchart for need maalth in the disease (defined as back pain non-peatcle screw indication of the disc confirmed by first confirmed by first and of useogenic studies), spondylolisthesis, trauma (fracture or dislocation), spinal radiographic studies), Spondylolistics, kyphosis and lordosis), tumor, pseudoarthrosis, and/or failed previous fusion.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Ninel Vang
(Division Sign-Off)

or Over-the-Counter Use

Division of Seral Restorative Devices 510(k) Numb:: 100 1080

(per 21 CFR 801.109)

(Optional Format 3-10-98)

Regulation Number and Section

§ 888.3050 Spinal interlaminal fixation orthosis.

(a)
Identification. A spinal interlaminal fixation orthosis is a device intended to be implanted made of an alloy, such as stainless steel, that consists of various hooks and a posteriorly placed compression or distraction rod. The device is implanted, usually across three adjacent vertebrae, to straighten and immobilize the spine to allow bone grafts to unite and fuse the vertebrae together. The device is used primarily in the treatment of scoliosis (a lateral curvature of the spine), but it also may be used in the treatment of fracture or dislocation of the spine, grades 3 and 4 of spondylolisthesis (a dislocation of the spinal column), and lower back syndrome.(b)
Classification. Class II.