The SynEx™ Spacer 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 SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynEx™ Spacer System can be packed with bone. The SynEx™ Spacer is designed to provide anterior spinal column support even in the absence of fusion for a prolonged period.

Device Description

The SynEx device is a cylindrically-shaped titanium vertebral implant with a hollow core; the walls and endplates have a plurality of holes. Each implant consists of two telescoping end pieces and a locking ring. The plurality of holes and hollow core allow for the use of grafting materials to help achieve solid fusion. To resist expulsion, the implant endplates have teeth and small spikes to grip the endplates of the adjacent vertebrae. The implant can be expanded vertically using the self-locking ratchet mechanism. A shoulder on the inner telescoping piece will not pass through the locking ring, preventing over-expansion of the implant. The SynEx device is available in a variety of geometries and sizes. This enables the surgeon to choose the configuration suited to the individual pathology and anatomical condition. Only one SynEx device is to be implanted per spinal level. The interior of the spacer is open and can be packed with bone graft material. The Synex Spacer implant is intended only for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Synex™ Spacer implant include SYNTHES plate and rod systems (e.g., ATLP, VentroFix, USS).

AI/ML Overview

The document provided is a 510(k) Premarket Notification for the Synthes SynEx™ Spacer, a medical device. This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving device performance through clinical studies with specific acceptance criteria as you would typically find for a novel device or in a clinical trial setting.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details cannot be fully provided from the given document. This document focuses on demonstrating substantial equivalence through a comparison to existing devices and mechanical testing.

Here's an analysis based on the provided text, highlighting what is available and what is not:

Synthes SynEx™ Spacer 510(k) Premarket Notification Analysis

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

Acceptance Criteria (Implied)	Reported Device Performance	Comments
Material Composition	Titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11	Meets standard for implantable materials.
Mechanical Performance	Mechanical testing in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000 was presented.	The specific results and acceptance values are not detailed in this summary document. It only states that testing was performed according to a recognized guidance.
Substantial Equivalence to Predicate Devices	Similar to components of previously cleared spinal systems (K990148 & K001340) with respect to certain technical characteristics.	This is the primary "acceptance criterion" for a 510(k). The FDA concurred with the substantial equivalence.
Intended Use	Thoracolumbar spine (T1-L5) to replace collapsed, damaged, or unstable vertebral body due to tumor or trauma (fracture), used with supplemental internal fixation, and can be packed with bone. Provide anterior spinal column support even in absence of fusion for prolonged period.	The device's intended use aligns with the predicate devices and is deemed acceptable by the FDA.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The document describes a premarket notification based on substantial equivalence and mechanical testing, not a clinical study with a "test set" of patients or data in the typical sense. Data provenance would refer to the origin of the mechanical test data, which is implied to be from the manufacturer's internal testing.

3. 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. Ground truth in the context of clinical expert review is not relevant for this 510(k) submission, which relies on mechanical testing and comparison to predicate devices, not diagnostic or image-based assessment.

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

Not applicable. See point 3.

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 device is a physical spinal implant, not an AI or image analysis device that would involve human readers or AI assistance.

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

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

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

The "ground truth" for this 510(k) involves adherence to recognized material standards (ASTM, ISO) and mechanical testing guidance (FDA Guidance for Spinal System 510(k)s). For substantial equivalence, the "ground truth" is the performance and design characteristics of the predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this 510(k); it's not a machine learning model.

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

Not applicable. See point 8.

Summary of what the document does provide regarding "proof" of meeting criteria:

The "study" that proves the device meets the acceptance criteria is the mechanical testing performed in accordance with the "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s", September 27, 2000. This testing would have specific benchmarks for strength, durability, and other biomechanical properties. The summary states that this testing was presented to the FDA, and the FDA determined the device to be substantially equivalent. This substantial equivalence is the primary basis for market clearance for this type of device under a 510(k). The document also highlights the use of standardized materials (titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11) as a key characteristic satisfying material requirements.

Summary

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Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

MAY 2 9 2001 Summary of Safety and Effectiveness Information SPONSOR: Synthes Spine Company, L. P. 1690 Russell Road Paoli, PA 19301 (610) 647-9700 Contact: Jonathan Gilbert Synthes Synex™ Spacer System DEVICE NAME: 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: Depuy AcroMed Stackable Cage System - K001340 - K990148 The SynEx device is a cylindrically-shaped titanium vertebral implant DEVICE with a hollow core; the walls and endplates have a plurality of holes. DESCRIPTION: Each implant consists of two telescoping end pieces and a locking ring. The plurality of holes and hollow core allow for the use of grafting materials to help achieve solid fusion. To resist expulsion, the implant endplates have teeth and small spikes to grip the endplates of the adjacent vertebrae. The implant can be expanded vertically using the self-locking ratchet mechanism. A shoulder on the inner telescoping piece will not pass through the locking ring, preventing over-expansion of the implant. The SynEx device is available in a variety of geometries and sizes. This enables the surgeon to choose the configuration suited to the individual pathology and anatomical condition. Only one SynEx device is to be implanted per spinal level. The interior of the spacer is open and can be packed with bone graft material. The Synex Spacer implant is intended only for use with supplemental internal fixation. The supplemental internal fixation systems that may be used with the Synex™ Spacer implant include SYNTHES plate and rod systems (e.g., ATLP, VentroFix, USS). INTENDED USE: The SynExTM Spacer 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 SynEx™ Spacer is intended to be used with Synthes supplemental internal fixation systems, e.g., ATLP, VentroFix and USS. The interior of the spacer component of the SynExTM Spacer System can be packed with bone. Confidential 13 March 6, 2001

KOO 3836

Place 2

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Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

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

All components of the Synex™ Spacer are manufactured from MATERIAL: titanium alloy Ti6A17Nb (ASTM F1295) / ISO 5832-11.

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 Synthes Synex™ Spacer implants are similar to the components of previously cleared spinal systems (K990148 & K001340) with respect to certain technical characteristics. The supplemental fixation devices intended for use with the Synthes Synex™ Spacer are currently cleared for use in patients with either tumor, trauma or fractures.

Date revised: 2/21/01

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or feathers.

Public Health Service

MAY 2 9 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Jonathan Gilbert Senior RA Associate Synthes Spine 1690 Russell Road Paoli, Pennsylvania 19301-1262

Re: K003836 Trade Name: SynEx™ Spacer Product Code: MQP Regulation: 888.3060 Class: II Dated: March 7, 2001 Received: March 9, 2001

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 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 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,

Bismillahi Rahmani Ra

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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Synthes Spine 510(k) Premarket Notification Synthes SynEx™ Spacer

Indications for Use Statement

Page 1 of 1

K003836 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Synthes SynEx™ Spacer Device Name:

INDICATIONS:

The SynEx™ Spacer 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) X

Over-The-Counter Use

MMMMMMMMMMMM

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

510(k) NumberKOQ3836

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.