The Sonoma Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to T1 during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

Device Description

The Sonoma Anterior Cervical Plate System includes titanium alloy anterior cervical plates and bone screws. The anterior cervical plates will be available in levels 1 through 4 and in 31 sizes that range from 12.0 to 84.0mm. The cervical plate bone screws will be offered in 4.0mm and 4.5mm fixed and variable angles and come in sizes ranging from 10mm to 20mm. All screws will also be available with a single or double lead. The product is supplied "NON-STERILE" and must be sterilized prior to use.

The Sonoma Anterior Cervical Plate System also utilizes a variety of instruments to assist in placement of the devices. These instruments include a cervical awl, removal tool, tap, plate bender, driver, standard fixed/variable drill guide, and drills. The instruments will be fabricated from stainless steel and Radel. The product is supplied "NON-STERILE" and must be sterilized prior to use.

AI/ML Overview

The provided text describes the Sonoma™ Anterior Cervical Plate System, a medical device for spinal fixation. It is a 510(k) submission, meaning it aims to demonstrate substantial equivalence to a legally marketed predicate device rather than undergoing a new PMA (Premarket Approval) process based on extensive clinical trials.

Therefore, the documentation does not include a study demonstrating the device meets a specific set of acceptance criteria in terms of diagnostic performance (e.g., sensitivity, specificity, accuracy) using a defined test set, expert ground truth, or comparative effectiveness studies with human readers.

Here's an analysis based on the information provided, addressing your specific questions:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the provided document, there are no acceptance criteria for diagnostic or clinical performance (e.g., sensitivity, specificity, accuracy) or a corresponding reported device performance. The 510(k) submission focuses on demonstrating substantial equivalence to predicate devices for mechanical strength and intended use.

The closest to "acceptance criteria" are the characteristics compared in Table 1 for substantial equivalence, specifically "Mechanical Strength." The document states "See test results" under Sonoma ACPS for Mechanical Strength, implying these results were used to show substantial equivalence to the predicate devices, but the specific criteria or results are not detailed in this summary.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (Implied)
Intended Use: Substantial equivalence to predicate devices	"See Insert" (stated as similar to predicates)
Indications for Use: Substantial equivalence to predicate devices	"See Insert" (stated as similar to predicates)
Design: Substantial equivalence to predicate devices (Level 1-4 plates with fixed and variable screws)	"Similar" to predicates
Sizes: Substantially equivalent to predicate devices	"Similar" to predicates
Material: Titanium	"Same" as predicates
Sterile: Non-sterile	"Same" as predicates
Mechanical Strength: Substantially equivalent to predicate devices	"See test results" (implied to meet equivalence)

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

Not applicable. This device is a mechanical implant, and the submission is a 510(k) claiming substantial equivalence. It does not involve a "test set" of patient data or images in the way a diagnostic AI device would. The performance evaluation would have primarily involved mechanical bench testing to demonstrate similar strength and durability to the predicate devices. The document explicitly states: "A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration."

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

Not applicable. As no clinical studies or diagnostic test sets were used, there was no need for experts to establish ground truth in this context. The "ground truth" for mechanical testing would be established by engineering standards and comparative analyses with predicate device specifications and performance.

4. Adjudication Method for the Test Set:

Not applicable. There was no diagnostic "test set" requiring adjudication.

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 spinal implant, not an AI-assisted diagnostic tool. No MRMC study was performed.

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

Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used:

For the purpose of the 510(k) submission, the "ground truth" implicitly used was the established characteristics and performance of the predicate devices (Synthes Anterior Cervical Vertebrae Plates and Howmedica Osteonics' Reflex Anterior Cervical Plate System). The submission aims to show that the Sonoma system is substantially equivalent in terms of intended use, indications for use, design, materials, and mechanical strength to these legally marketed devices.

8. The Sample Size for the Training Set:

Not applicable. There is no "training set" in the context of an AI device.

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

Not applicable.

In summary: The provided document is a 510(k) summary for a physical medical device (spinal implant). It focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, and mechanical performance, rather than clinical or diagnostic performance evaluated through studies involving patient data or AI algorithms. As such, many of the questions related to AI device evaluation are not applicable to this submission.

Summary

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K03 23 68

Sonoma™ Anterior Cervical Plate System

CONFIDENTIAL

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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: Kirt Stephenson6276 River Crest Drive, Suite ERiverside, CA 92507-0754Phone: 909-656-4850 Fax: 909-656-5530
Company Registration Number:	2032593
Submission Correspondent:	The Regulatory Affairs CompanyContact: Diana Smith727 Park BoulevardSan Diego, CA 92101Phone: 619-251-9132 Fax: 619-696-9883
Date Summary Prepared:	July 11, 2003
Classification Name:	Spinal Intervertebral Body Fixation Orthosis(Class II) - KWQ 888-3060
Common/Usual Name:	Anterior Cervical Plate System andInstruments
Device Trade Name:	Sonoma™ Anterior Cervical Plate System

The primary devices used for comparison in this summary are Synthes' Synthes Anterior Cervical Vertebrae Plates and Howmedica Osteonics' Reflex Anterior Cervical Plate System.

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

The intended use of the Sonoma anterior cervical plates and their components is substantially equivalent to the intended use of the predicate devices. The Sonoma Anterior Cervical Plate System is intended for anterior interbody screw fixation of the cervical spine. This system is indicated for use in the temporary stabilization of the anterior spine from C2 to T during the development of cervical spinal fusions in patients with: degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies); trauma (including fractures); primary and metastic malignant tumors; deformity (defined as kyphosis, lordosis, or scoliosis); pseudarthrosis; failed previous fusions; and/or spinal cord stenosis and cervical myelopathy.

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2. Description:

3. Technological Characteristics:

The Sonoma Anterior Cervical Plate System has substantially equivalent technological characteristics to the predicate devices. Refer to Table 1 in the following section, entitled Comparison Analysis, for a summation of technological characteristics such as design, dimensional specifications, and material.

4. Comparison Analysis:

The overall design of the Sonoma Anterior Cervical Plate System is substantially equivalent to the predicate devices. See Table 1 below for a comparison of the Sonoma Anterior Cervical Plate System and the predicate devices.

PREDICATE DEVICE COMPARISON SUMMARY TABLE
Feature	Sonoma ACPS	SynthesACVP	Reflex ACPS	SubstantialyEquivalent
Intended Use	See Insert	Similar	Similar	Yes
Indications for Use	See Insert	Similar	Similar	Yes
Design	Level 1-4 plates withfixed and variablescrews	Similar	Similar	Yes
Sizes	See prints	Similar	Similar	Yes
Material	Titanium	Same	Same	Yes
Sterile	Non-sterile	Same	Same	Yes
Mechanical Strength	See test results	Similar	Similar	Yes

Table 1: Summary of Design Comparison

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Sonoma™ Anterior Cervical Plate System

K03236Y

CONFIDENTIAL
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A financial certification or disclosure statement or both, as required by part 54 (i) of this chapter:
A financial certification and/or disclosure statement is not needed for this submission as no clinical studies have been undertaken in regards to the products under consideration.
For submission claiming substantial equivalence to a device which has been (j) classified into class III under section 513(b) of the act:
- (1) Which was introduced or delivered for introduction into interstate commerce for commercial distribution before December 1, 1990: and
- (2) For which no final regulation requiring premarket approval has been issued under section 515(b) of the act, a summary of the types of safety and effectiveness problems associated with the type of devices being compared and a citation to the information upon which the summary is based (class III Summary). The 510(K) submitter shall also certify that a reasonable search of all information known or otherwise available about the class III device and other similar legally marketed devices has been conducted (Class III Certification), as described in Sec. 807.94.

A class III Certification and Summary is not needed for this submission as the products under consideration are class II.

(k) A statement that the submitter believes, to the best of his or her knowledge, that all data and information submitted in the Premarket notification are truthful and accurate and that no material fact has been omitted.
A Premarket Notification Truthful and Accurate Statement is included on the following page.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is enclosed within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.

OCT - 9 2003

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SeaSpine, Inc. C/o Ms. Diana Smith The Regulatory Affairs Company 727 Park Boulevard San Diego, CA 92101

Re: K032368

Trade/Device Name: Sonoma™ Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: July 29, 2003 Received: August 1, 2003

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 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 - Ms. Diana Smith

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

l. Mark N. Millman

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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Sonoma™ Anterior Cervical Plate System

Indications for Use Statement

510(k) Number (if known):

Device Name: Sonoma™ Anterior Cervical Plate System

Mark N Milken

(Division Sign-Off Division of General Destorative and Neurological Del rees

Number K032368

(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

632368

ONFIDENTIAL

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.