The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral body due to tumor or trauma/fracture, to achieve anterior decompression of the spinal cord and neural tissues, and to restore the height of a collapsed vertebral body.

The SeaSpine VBR System is designed to restore the biomechanical integrity of the anterior, middle, and posterior spinal column, even in the absence of fusion for a prolonged period. Additionally, the SeaSpine VBR System is intended for use with bone graft.

Device Description

The SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are manufactured out of PEEK OPTIMA® polymer with tantalum wires and/or beads. All VBR configurations will be offered in numerous lengths and sizes. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The SeaSpine VBR System will offer a wide variety of instruments that range from paddle scrapers to inserters. These various instruments will be made primarily from stainless steel with handles made from Radel or Pomalux. These items are supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The SeaSpine VBR System is a medical device for vertebral body replacement, and its acceptance criteria and the study proving it meets these criteria are outlined in the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the SeaSpine VBR System are based on demonstrating "substantial equivalence" to its predicate devices. This is not about specific numerical performance metrics in the way a diagnostic AI might have, but rather about demonstrating that the new device is as safe and effective as existing legally marketed devices with similar intended use and technological characteristics.

Feature	Acceptance Criteria (Substantial Equivalence to Predicate Devices)	Reported Device Performance (SeaSpine VBR System)
Intended Use	The intended use should be substantially equivalent to predicate devices for spinal disorders and fusion.	"The intended use of the SeaSpine VBR System is as a vertebral body replacement to correct spinal disorders and provide stabilization of the spine to permit the biological process of spinal fusions to occur." (Determined "Yes" to be substantially equivalent to predicates)
Indications for Use	Indications for use (Trauma/fracture, Tumor) should be substantially equivalent to predicate devices.	"• Trauma/fracture • Tumor" (Determined "Yes" to be substantially equivalent to predicates)
Design	Design (PEEK implants with tantalum markers, multiple shapes) should be substantially equivalent.	"• PEEK implants with tantalum markers • Multiple shapes" (Determined "Yes" to be substantially equivalent to predicates)
VBR Shapes/Sizes	Straight, Curved, Round, and Trapezoidal VBRs in various sizes should be substantially equivalent.	"Various sizes" for each shape (Determined "Yes" to be substantially equivalent to predicates)
Material	Material (PEEK and Tantalum) should be substantially equivalent.	"PEEK and Tantalum" (Determined "Yes" to be substantially equivalent to predicates, acknowledging predicate devices use Titanium per ASTM F-1108)
Sterile	Sterilization status (Non-sterile) should be substantially equivalent.	"Non-sterile" (Determined "Yes" to be substantially equivalent to predicates which included both sterile and non-sterile options)
Mechanical Testing	Conducted according to recognized standards, results substantially equivalent to predicate devices.	"Conducted according to recognized standards" (Determined "Yes" to be substantially equivalent to predicates)
Method of Sterilization	(High-temperature steam) should be substantially equivalent.	"High-temperature steam" (Determined "Yes" to be substantially equivalent to predicates)

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

This document describes a 510(k) premarket notification for a medical device (spinal implant), not an AI/ML algorithm. Therefore, there is no "test set" in the context of diagnostic performance data, nor is there data provenance (e.g., country of origin, retrospective/prospective) related to patient data or diagnostic images. The "study" mentioned refers to the mechanical testing and comparison of the device's characteristics to already legally marketed predicate devices.

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

Not applicable. As this is a 510(k) for a physical medical device (spinal implant) and not an AI/ML diagnostic system, there is no "ground truth" established by experts in the context of diagnostic accuracy for a test set. The "ground truth" for the device's safety and effectiveness is established by its similarity to predicate devices that have already been cleared by the FDA and have a history of safe use.

4. Adjudication Method for the Test Set

Not applicable. No test set requiring expert adjudication for diagnostic performance is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC comparative effectiveness study is designed for evaluating the diagnostic performance of AI-assisted systems versus human readers. This submission is for a physical medical device (spinal implant) and does not involve such a study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is the established safety and effectiveness profile of legally marketed predicate devices. The SeaSpine VBR System demonstrated its "ground truth" by showing substantial equivalence in design, materials, intended use, indications for use, and mechanical testing results to these predicate devices.

8. The Sample Size for the Training Set

Not applicable. This submission is not for an AI/ML algorithm. There is no concept of a "training set" in the context of device design and mechanical testing for spinal implants.

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

Not applicable. As there is no training set, there is no process for establishing its ground truth.

Summary

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K052170 p/3

CONFIDENTIAL

DEC 2 1 2005

SeaSpine VBR System

510(K) SUMMARY

Pursuant to 510(i) of the Federal Food, Drug, and Cosmetic Act, as amended, and in accordance with 21 CFR § 807.92.

Submitter Information:	SeaSpine, Inc.Contact: Diana Smith2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Company Registration Number:	2032593
Submission Correspondent:	SeaSpine, Inc.Contact: Diana Smith, Manager ofRegulatory Affairs and Quality Assurance2302 La Mirada DriveVista, CA 92081-7862Phone: 760-727-8399 Fax: 760-727-8809
Date Summary Prepared:	August 5, 2005
Classification Name:	Spinal Intervertebral Body FixationOrthosisMQP (Class II) - 888.3060
Common/Usual Name:	Straight Vertebral Body Replacement(VBR), Curved VBR, Round VBR,Trapezoidal VBR, and Instruments
Device Trade Name:	SeaSpine VBR System

The devices used for comparison in this summary are the Alphatec Manufacturing NOVEL VBR Spinal System (K050553 and K042201), the Interpore Cross GEO VBR Spinal System (K010530, K020048, and K040168), the Quantum Vertebral Body Replacement (K050449), and Spinal Concepts Cadence and Traxis (K033517).

Intended Use: (The statements of intended use are identical.)

The intended use of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs is substantially equivalent to the intended use of the predicate devices.

The SeaSpine VBR System is intended for use in the thoracolumbar spine (T1 to L5) to replace a collapsed, diseased, damaged or unstable complete or partial vertebral

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Image /page/1/Picture/0 description: The image shows a handwritten string of characters, "K052170. P2/3", written in black ink on a white background. Below the string of characters, the word "CONFIDENTIAL" is printed in a serif font. The handwriting is somewhat stylized, with some characters being more distinct than others.

SeaSpine VBR System

body due to tumor or trauma/fracture, to achieve anterior decompression of the spiral cord and neural tissues, and to restore the height of a collapsed vertebral body.

2. Description:

3. Technological Characteristics:

The straight, curved, round, and trapezoidal VBRs and instruments in this notification are components of a new stand alone system called the SeaSpine VBR System. The devices in this submission have substantially equivalent technological characteristics to the predicate devices. The devices in this submission also underwent appropriate mechanical testing and those results were found to be substantially equivalent to those of the predicate devices. Refer to Table 1 on the following page, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, material, and testing.

4. Comparison Analysis:

The overall designs of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs are substantially equivalent to the predicate devices. See Table 1 on the following page for a comparison of the SeaSpine VBR System straight, curved, round, and trapezoidal VBRs to the predicate devices.

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13 K052 1 CONFIDENTIAL

A STATUS FOR COLLECT PRODUCTS AND AN AND AN AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AN

SeaSpine VBR System

ﺎ ﻓﻲ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ

Feature	SeaSpine VBRSystem	AlphatecNOVEL VBRSpinalSystem	InterporeCross GEOVBR SpinalSystem	QuantumVertebralBodyReplacement	SpinalConceptsCadenceandTraxis	SubstantiallyEquivalent
Intended Use	The intended use ofthe SeaSpine VBRSystem is as avertebral bodyreplacement tocorrect spinaldisorders andprovide stabilizationof the spine to permitthe biologicalprocess of spinalfusions to occur.	Similar	Similar	Similar	Similar	Yes
Indicationsfor Use	• Trauma/fracture• Tumor	Similar	Similar	Similar	Similar	Yes
Design	• PEEK implants withtantalum markers• Multiple shapes	Similar	• Titaniumimplants• Multiple shapes	Similar	Similar	Yes
Straight VBR	Various sizes	Similar	Similar	Similar	Similar	Yes
Curved VBR	Various sizes	Similar	Similar	Similar	Similar	Yes
Round VBR	Various sizes	Similar	Similar	NA	NA	Yes
TrapezoidalVBR	Various sizes	Similar	Similar	NA	NA	Yes
Material	PEEK and Tantalum	Similar	Titanium (perASTM F-1108)	Similar	Similar	Yes
Sterile	Non-sterile	Similar	Sterile and Non-Sterile	Similar	Similar	Yes
MechanicalTesting	Conducted accordingto recognizedstandards	Similar	Similar	Similar	Similar	Yes
Method ofSterilization	High-temperaturesteam	Similar	Similar	Similar	Similar	Yes

Table 1: Summary of Design Comparison

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" are arranged in a circular pattern around the symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 2 1 2005

Ms. Diana Smith Manager of Regulatory Affairs & Quality Assurance SeaSpine, Inc. 2302 La Mirada Drive Vista, California 92081-7862

Re: K052170

Trade/Device Name: SeaSpine Vertebral Body Replacement (VBR) System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: MOP Dated: December 1, 2005 Received: December 2, 2005

Dear Ms. Smith:

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 mav 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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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) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson,

ﮨﮯ Acting 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

510(k) Number (if known): 1052170

Device Name: SeaSpine VBR System

Indications for Use:

2100-1 Niin

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

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

(Division Sign-Off) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of General, Restorative,

and Neurological Devices

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.