The Silhouette™ Spinal System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scoliosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to turnors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for the hook and sacral screw fixation of this system are T1 to the sacrum.

Device Description

The Zimmer Spine Silhouette Spinal Fixation System is a temporary implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for the noncervical posterior use in the thoracic, lumbar and sacral areas of the spine. Implants of this system consist of hooks and/or screws connected to rods and are intended to be removed after solid fusion has occurred. The system includes polyaxial screws of varying diameters and lengths, fixed screws of varying diameters and lengths, rods in varving lengths, hooks in varying designs, fixed and adjustable transverse connectors. All implant components are top loading and top tightening. All the implants in this system are manufactured from titanium alloy (Ti-6A1-4V) conforming to ASTM F-136.

AI/ML Overview

The provided text is a 510(k) summary for a spinal fixation system, not a study evaluating a medical device based on acceptance criteria. Therefore, most of the requested information cannot be extracted from this document, as it pertains to a clinical study or performance evaluation with specific metrics.

Here's a breakdown of why and what little information can be gleaned:

Reasoning for inability to answer most questions:

Type of Document: This is a 510(k) summary, which is a premarket notification for a medical device. Its primary purpose is to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present the results of a detailed performance study against pre-defined acceptance criteria for a novel AI or diagnostic device.
Focus on Equivalence: The document explicitly states "There are no technological differences between the Silhouette Spinal Fixation System and the previously cleared Silhouette Spinal Fixation System" and "The Silhouette Spinal System is substantially equivalent to the original Silhouette Spinal System based on materials, design, function and the supporting information included in the Class III Certification and Summary." This means the "study" is a comparison to a predicate, not a performance study against specific criteria for a new device.
Device Type: The device is a "Spinal Fixation System," which is a physical implant (hooks, screws, rods). The concept of "acceptance criteria" and "device performance" in this context refers to mechanical properties (e.g., strength, fatigue, biocompatibility) rather than diagnostic accuracy metrics (e.g., sensitivity, specificity, AUC) typically associated with AI or imaging devices. This document does not detail those mechanical tests or their results.
Missing Study Details: There is no mention of "test sets," "ground truth," "experts," "adjudication methods," "MRMC studies," "standalone performance," or "training sets," as these are all relevant to the evaluation of AI/diagnostic algorithms, not material equivalence for a physical implant.

Information that can be extracted (with caveats):

A table of acceptance criteria and the reported device performance:
- Cannot be provided directly. The document does not define specific "acceptance criteria" in terms of performance metrics (like sensitivity, specificity, accuracy). Instead, the overall acceptance criterion for 510(k) clearance is "substantial equivalence" to a predicate device.
- Reported Device Performance: The primary "performance" reported is its substantial equivalence to the predicate. The document states:
  - "There are no technological differences between the Silhouette Spinal Fixation System and the previously cleared Silhouette Spinal Fixation System."
  - "The Silhouette Spinal System is substantially equivalent to the original Silhouette Spinal System based on materials, design, function and the supporting information included in the Class III Certification and Summary."
  - This implies that the device performs the same as the predicate. The specific mechanical performance (e.g., strength, fatigue life) that would underpin this substantial equivalence is not detailed in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not applicable. There is no "test set" in the context of an algorithm or diagnostic study. The "test" for this device involved demonstrating equivalence in materials, design, and function to a predicate device, likely through engineering analysis and potentially mechanical testing, not a dataset of patients or images.
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. No ground truth was established for a "test set" as this is not a diagnostic device.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. No test set or adjudication method described.
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 a physical implant, not an AI or diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. No ground truth in the context of an AI/diagnostic study. The "ground truth" for this 510(k) application is essentially adherence to established standards for spinal implants and demonstrating equivalence to a previously cleared device.
The sample size for the training set:
- Not applicable. No training set for an algorithm.
How the ground truth for the training set was established:
- Not applicable. No training set described.

In summary, the provided document is a regulatory filing for a physical medical device (spinal implant) demonstrating substantial equivalence to a predicate device, rather than a clinical or performance study of an AI-powered or diagnostic device. Therefore, the specific questions regarding acceptance criteria, test sets, ground truth, and expert evaluation are not relevant to this document's content.

Summary

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NOV 2 3 2004

510(k) SUMMARY

Submitter:	Zimmer Spine, Inc.7375 Bush Lake RoadMinneapolis, MN 55439
Company Contact:	Tim CrabtreeSenior Regulatory Affairs Specialist
Date Prepared:	November 19, 2004
Device Name:	Trade Name: Silhouette™ Spinal Fixation System
	Common Name: Spinal Fixation System.
Classification Name:	Spinal interlaminal fixation orthosisPedicle screw spinal system
Predicate Devices:	Silhouette™ Spinal Fixation System (K980288)

Description of Device:

Intended Use:

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K042702
Page 2 of 2

When used as a hook and sacral screw system, the Silhouette Spinal Fixation System is intended for use in the treatment of degenerative disc disease (as defined by chronic back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), idiopathic scollosis, spondylolisthesis, kyphotic or lordotic deformity of the spine, loss of stability due to tumors, spinal stenosis, vertebral fracture or dislocation, pseudoarthrosis, and previous failed spinal fusion. When used for this indication, screws of the Silhouette™ Spinal Fixation System are intended for sacral iliac attachment only. Hook and transverse connectors of the system are intended for posterior thoracic and/or lumbar use only. As a whole, the levels of use for the hook and sacral screw fixation of this system are T1 to the sacrum.

Comparison of Technological Characteristics:

There are no technological differences between the Silhouette Spinal Fixation System and the previously cleared Silhouette Spinal Fixation System.

Substantial Equivalence:

The Silhouette Spinal System is substantially equivalent to the original Silhouette Spinal System based on materials, design, function and the supporting information included in the Class III Certification and Summary.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with its wings forming three horizontal lines. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2004

Mr. Tim Crabtree Senior Regulatory Affairs Specialist Zimmer Spine, Inc. 7375 Bush Lake Road Minneapolis, Minnesota 55439

Re: K042702

Trade/Device Name: Silhouette™ Spinal Fixation System Regulation Number: 21 CFR 888.3050, 888.3070 Regulation Name: Spinal interlaminal fixation orthosis; pedicle screw spinal system Regulatory Class: III Product Code: NKB, KWP, MNH, MNI Dated: September 29, 2004 Received: September 30, 2004

Dear Mr. Crabtree:

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 - Mr. Tim Crabtree

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-. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark H. Millenn

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 : K042702

Device Name: Silhouette™ Spinal Fixation System

Indications for Use: The Silhouette™ Spinal System is intended for posterior, noncervical pedicle fixation for the following indications: degenerative disc disease (DDD) (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies); spondylolisthesis; trauma (i.e. fracture and dislocation); spinal stenosis; deformities (i.e. scoliosis, kyphosis and/or lordosis); tumor; pseudoarthrosis; and failed previous fusion. Pedicle screw fixation is limited to skeletally mature patients.

Prescription Use	X	AND/OR	Over-The-Counter Use
(Part 21 CFR 801 Subpart D)			(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative, and Neurological Devices

510(k) Number K042702

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.