The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture). The Vertebral Spacer Ti is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Ti Spacer System can be packed with bone.

The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of:

vertebral body replacement devices comprised of a variety . of fixed heights and cross-sections.
supplemental fixation currently cleared for use in treating . patients for tumor, trauma or fractures of the vertebral body and
manual surgical instrumentation used to prepare the . anatomy and implant the Vertebral Spacer Ti.

There are no unique surgical instruments required for implantation of the submitted device system.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Synthes Vertebral Spacer Ti:

The provided document is a 510(k) premarket notification for a medical device. These types of submissions typically focus on demonstrating substantial equivalence to a predicate device rather than comprehensive clinical trials with detailed acceptance criteria and standalone performance studies for novel devices.

Based on the provided text, the information available is limited regarding explicit acceptance criteria and a detailed study report. However, we can extract some relevant points.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance
Mechanical Stability/Strength	"Mechanical testing in accordance with the 'Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s', September 27, 2000 was presented."
Material Biocompatibility	"All components... manufactured from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295)." (Implies meeting ASTM standards for biocompatible materials)
Substantial Equivalence to Predicate Device	"The Vertebral Spacer Ti implants are similar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) with respect to technical characteristics and performance."
Anterior Spinal Column Support	"The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period." (This is a design intent rather than a measured performance metric in the document)
Intended Use Compliance	The device is intended for use in "thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to tumor or trauma (i.e., fracture)." The 510(k) cleared this indication.

Explanation: In 510(k) submissions, acceptance criteria are often framed implicitly by the substantial equivalence argument and adherence to recognized standards. For mechanical devices like spinal implants, the "Guidance for Spinal System 510(k)s" would outline specific mechanical tests (e.g., compression, fatigue, subsidence) and acceptable performance limits, likely referencing ASTM or ISO standards. The document only confirms that such testing was presented, not the specific results or the predefined acceptance values.

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

This information is not provided in the document. The document refers to "Mechanical testing," which implies laboratory-based, non-clinical tests. There is no mention of a human test set or clinical data for this specific device.

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

This information is not applicable/not provided. As "mechanical testing" was performed, the "ground truth" would be established by engineering standards and measurements, not medical expert consensus.

4. Adjudication Method for the Test Set

This information is not applicable/not provided. Adjudication methods are relevant for studies involving human interpretation or clinical outcomes.

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 information is not applicable. The device is a physical spinal implant, not an AI-assisted diagnostic or therapeutic tool.

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

This information is not applicable. The device is a physical spinal implant, not an algorithm.

7. The Type of Ground Truth Used

For the "Performance Data" section, the ground truth was based on engineering standards and measurements from mechanical testing. The document states that testing was "in accordance with the 'Guidance for Spinal System 510(k)s', September 27, 2000." This guidance would specify the appropriate methods for determining the mechanical properties and performance (e.g., strength, stiffness, fatigue life) of spinal implants.

8. The Sample Size for the Training Set

This information is not applicable/not provided. This device is not an AI/ML product that requires a "training set."

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

This information is not applicable/not provided.

Summary of the Study Mentioned:

The primary "study" mentioned for the Vertebral Spacer Ti is mechanical testing. This testing was conducted:

In accordance with: "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000.
Purpose: To demonstrate the device's mechanical performance and support the claim of substantial equivalence to the predicate device (Synthes SynMesh System, K003275).
Basis of Substantial Equivalence: The filing argues that the new device's "technical characteristics and performance" are similar to the predicate device. This implies that the mechanical testing results were comparable or met the same performance expectations as the predicate device and the relevant guidance.

It's crucial to understand that for a 510(k) substantial equivalence submission for a physical implant, the focus is largely on non-clinical performance (like mechanical testing, material biocompatibility, and sterilization) and a comparison of design and indications for use to a previously cleared device. Extensive clinical studies with defined acceptance criteria for patient outcomes, expert consensus on images, or AI performance metrics are typically not required for this regulatory pathway unless the device presents novel technology or significant differences from a predicate.

Summary

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APR 1 6 2002

Premarket Notification - Vertebral Spacer Ti

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3.0 Summary of Safety and Effectiveness Information

SPONSOR:

Synthes Spine Company, L. P. 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Jonathan Gilbert

DEVICE NAME: Synthes Vertebral Spacer Ti

CLASSIFICATION: Per CFR 21, §888.3060: Implant, fixation, spinal intervertebral body fixation orthosis devices. Class II. Product code is MQP. The Panel code is 87.

PREDICATE DEVICE:

Vertebral body replacement device: Synthes SynMesh System: K003275 SE date: April 23, 2001.

DEVICE DESCRIPTION: The Vertebral Spacer Ti is a titanium vertebral body replacement device used in conjunction with supplemental internal fixation to provide structural stability in skeletally mature individuals following corpectomy or vertebrectomy and consists of:

vertebral body replacement devices comprised of a variety . of fixed heights and cross-sections.
supplemental fixation currently cleared for use in treating . patients for tumor, trauma or fractures of the vertebral body and
manual surgical instrumentation used to prepare the . anatomy and implant the Vertebral Spacer Ti.

There are no unique surgical instruments required for implantation of the submitted device system.

INTENDED USE: The Vertebral Spacer Ti is a vertebral body replacement device intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due to turnor or trauma (i.e., fracture). The Ti Spacer System is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix, USS and Small Stature USS. The interior of the spacer component of the Vertebral Spacer Ti can be packed with bone.

The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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Premarket Notification - Vertebral Spacer Ti

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MATERIAL:

All components of the Vertebral Spacer Ti are manufactured from commercially pure titanium (ASTM F67) or titanium alloy Ti6Al7Nb (ASTM F1295).

PERFORMANCE DATA:

Mechanical testing in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.

BASIS OF SUBSTANTIAL EQUIVALENCE: The Vertebral Spacer Ti implants are similar to the predicate Synthes SynMesh vertebral body replacement device(s), (K003275) with respect to technical characteristics and performance. The supplemental fixation devices intended for use with the Vertebral Spacer Ti implants are currently cleared for use in patients with either tumor, trauma or fractures.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle.

Food and Drug Administrațion 9200 Corporate Boulevard Rockville MD 20850

Jonathan Gilbert Regulatory Affairs Project Manager Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301

APR 1 6 2002

Re: K020152

Trade Name: Vertebral Spacer Ti Regulation Number: 21 CFR 888.3060 Regulation Name: Vertebral Body Replacement Regulatory Class: II Product Code: MQP Dated: January 16, 2002 Received: January 17, 2002

Dear Mr. Gilbert:

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 – Mr. Jonathan Gilbert

This letter will allow you to begin marketing your device as described in your 510(k) premarket I mis letter will and it your dine of substantial equivalence of your device to a legally marketed predication: "The PDF monty of its a classification for 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 toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

for Mark A. Mellers

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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Indications for Use Statement 2.0

Page 1 of 1

510(k) Number (if known):

K020152

Device Name:

Synthes Vertebral Spacer Ti

Indications:

The Vertebral Spacer Ti is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use

for
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices

510(k) Number __ K020152

Regulation Number and Section

§ 888.3060 Spinal intervertebral body fixation orthosis.

(a)
Identification. A spinal intervertebral body fixation orthosis is a device intended to be implanted made of titanium. It consists of various vertebral plates that are punched into each of a series of vertebral bodies. An eye-type screw is inserted in a hole in the center of each of the plates. A braided cable is threaded through each eye-type screw. The cable is tightened with a tension device and it is fastened or crimped at each eye-type screw. The device is used to apply force to a series of vertebrae to correct “sway back,” scoliosis (lateral curvature of the spine), or other conditions.(b)
Classification. Class II.