The REGENT Anterior Cervical Plate System is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
. Trauma (including fractures)
. Tumors
. Deformities or curvatures (including kyphosis, lordosis or scoliosis)
. Pseudoarthrosis
. Failed previous fusion
. Spondylolisthesis
Spinal Stenosis
THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS
WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

Device Description

The REGENT Anterior Cervical Plate System is composed of various cervical plates and the screws in made from a Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3). The REGENT Anterior Cervical System contains multiple level plates (1 Level, 3 Level, and 4 Level) and various diameter screws that are either fixed or variable in nature. The plates and screws are anodized.

AI/ML Overview

The provided text describes a medical device, the REGENT Anterior Cervical Plate System, and its regulatory submission. It is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a clinical or standalone study.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/device performance study is not available in the provided text.

The document explicitly states "Clinical Testing Not Applicable" and "Animal Testing Not Applicable," indicating that the submission primarily relied on bench testing and comparison to predicate devices for substantial equivalence.

Here's what can be extracted from the text in relation to your request, but with the understanding that it doesn't align with a typical AI device performance evaluation:

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

Acceptance Criteria (Implied by Bench Testing)	Reported Device Performance (Implied by Substantial Equivalence to Predicates)
Mechanical integrity and stability under physiological loads (per ASTM F 1717-04)	The device meets the standards outlined in ASTM F 1717-04 for spinal implant constructs in a vertebrectomy model.
Material compatibility and safety	Manufactured from Titanium alloy (Ti-6Al-V, ASTM F-136/ISO 5832-3), consistent with predicate devices.
Design and indications for use similarity	Same principle of operation, identical indications for use as predicate devices.

Note: The "acceptance criteria" here are inferred from the mention of ASTM F 1717-04 and the substantial equivalence claim. Actual specified criteria are not provided in detail.

2. Sample sized used for the test set and the data provenance:
Not applicable. No test set for device performance as per an AI study is mentioned. The submission refers to "Bench Testing" data, but details about sample size or data provenance for these bench tests are not provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is discussed in the context of an AI/device performance study.

4. Adjudication method for the test set:
Not applicable.

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:
No. The document states "Clinical Testing Not Applicable."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used:
For the bench testing, the "ground truth" would be the engineered specifications and performance standards defined by ASTM F 1717-04.

8. The sample size for the training set:
Not applicable. This is not an AI/algorithm-based device.

9. How the ground truth for the training set was established:
Not applicable.

Summary

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1091134

510(K) SUMMARY

AUG 1 7 2009

Name of Firm

Custom Spine, Incorporated 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 808-0019 Fax: (973) 808-0707

Official Correspondent

Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Blvd, Suite 201 Parsippany, NJ 07054 Phone: (973) 265-5036 Fax: (973) 808-0707 E-mail: saad@customspine.com

Establishment Number 3005129649

Device Name

Legally Marketed Trade Name: REGENT Anterior Cervical Plate System Common Name: Spinal Intervertebral Body Fixation Orthosis. Device Classification: Class II Regulation Number: 21 CFR 888.3060 Device Product Codes: KWQ

Predicate Devices

X-Spine Anterior Compact Plate System (K041469), Synthes CSLP (K030866)

Device Description

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Indications for Use

The Regent Anterior Cervical Plate System is intended for anterior cervical plate system is intended for anterior intervertebral screw fixation of the cervical spine at levels C2-T1. The system is indicated for temporary stabilization of the anterior spine during the development of cervical spine fusions in patients with the following indications:

. Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies)
. Trauma (including fractures)
. Tumors
. Deformities or curvatures (including kyphosis, lordosis or scoliosis)
. Pseudoarthrosis
. Failed previous fusion
. Spondylolisthesis
Spinal Stenosis

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS

WARNING: THIS DEVICE IS NOT INTEDED FOR SCREW ATTACHEMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE

Materials

The Regent Anterior Cervical Plate System contains implants are manufactured from Titanium alloy (Ti-6AI-V, ASTM F-136/ISO 5832-3). The system contains instrument and non-implantable devices manufactured from stainless steel.

Performance Data

Performance data per ASTM F 1717-04, " Standard Test Method For Spinal Implant Constructs in a Vertebrectomy Model", were submitted to characterize the subject Regent Anterior Cervical Plate System

Substantial Equivalence Statement

The Custom Spine Regent Anterior Cervical Plate (ACP) System is equivalent to the previously cleared systems, as they utilize the same principle of operation, and has identical indications for use as the predicates, and materials.

Animal Testing Not Applicable

Bench Testing The data are included in the submission under "Bench Testing", Section 19.

Clinical Testing Not Applicable

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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

AUG 1 7 2009

Custom Spine Inc. % Mr. Saad Attiyah Manager of Regulatory Affairs and Quality Assurance 1140 Parsippany Boulevard, Suite 201 Parsippany, New Jersey 07054

Re: K091134

Trade/Device Name: Custom Spine Regent Anterior Cervical Plate Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal Intervertebral Body Fixation Orthosis Regulatory Class: II Product Code: KWQ Dated: August 10, 2009 Received: August 10, 2009

Dear Mr. Attiyah:

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Saad Attiyah

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Balbare Bavehud
fix

Mark N. Melkerso Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT

Degenerative Disc Disease (as defined by neck pain of discogenic origin with degeneration of the . disc confirmed by history and radiographic studies)
Trauma (including fractures) �
◆ Tumors
Deformities or curvatures (including kyphosis, lordosis or scoliosis) �
� Pseudoarthrosis
Failed previous fusion
Spondylolisthesis ●
Spinal Stenosis .

THIS DEVICE IS ONLY TO BE USED IN SKELETALLY MATURE PATIENTS.

WARNING: THIS DEVICE IS NOT INTENDED FOR SCREW ATTACHMENT OR FIXATION TO THE POSTERIOR ELEMENTS (PEDICLES) OF THE CERVICAL, THORACIC, OR LUMBAR SPINE.

Prescription Use X

AND/OR

Over-The-Counter Use

(Part 21 C.F.R. 801 Subpart D)

(21 C.F.R. 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

E
(EXT for MX,N)

(Division Sign-Off) Division of Surgical, Orthopedic. and Restorative Devices

510(k) Number K091134

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.