The Comet Anterior Cervical Plate System is intended for anterior fixation. immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.

The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of disogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

Device Description

Multi-level anterior cervical plates and fixation screws are being added to the previously cleared single-level Comet Anterior Cervical Plate System. The multi-level device additions consist of duallevel plate lengths ranging from 24mm through 48mm and triple-level plate lengths ranging from 36mm through 72mm. Similarly to the single-level devices, the multi-level devices contain barbed plate fixation pins that are permanently affixed to the plate. Plate fixation screws are used to secure the plate to each vertebrae. An additional plate fixation screw diameter is being added in a 3.3mm diameter in 14mm, 16mm and 18mm lengths.

AI/ML Overview

The provided text describes a medical device, the "Comet Anterior Cervical Plate System," and its performance testing in support of a 510(k) premarket notification. However, it does not contain information about a study involving AI, human readers, or image analysis.

Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (General)	Reported Device Performance
Substantial equivalence to predicate single-level devices.	"multi-level device additions ... are substantially equivalent to the predicate single-level devices of the Comet Anterior Cervical Plate System"
Meeting pre-determined acceptance criteria for safety and effectiveness.	"met pre-determined acceptance criteria." and "meet all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness"
Acceptable risks evaluated by FMEA.	"The risks associated with use of the new devices were found acceptable when evaluated by FMEA."
Performance in static and dynamic axial compression bending.	Bench tests performed in accordance with FDA Guidance and ASTM F1717-04 included "assessments of static and dynamic axial compression bending."
Performance in static torsion.	Bench tests performed in accordance with FDA Guidance and ASTM F1717-04 included "static torsion."

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

The document describes bench tests for the device, not clinical studies with patient data. Therefore, there is no "test set" in the context of human or imaging data, nor data provenance (country of origin, retrospective/prospective). The tests were performed in a standardized vertebral body model.

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

Not applicable. This was a mechanical engineering bench test, not an evaluation of diagnostic accuracy requiring expert consensus on images.

4. Adjudication Method for the Test Set

Not applicable. (See #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

No. The provided text describes the mechanical testing of a medical implant, not an AI-powered diagnostic device. Therefore, no MRMC study or AI-related effectiveness assessment was conducted or reported here.

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

No. This is not an AI algorithm.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be the established engineering standards and specifications against which the device's mechanical performance was measured (e.g., specific load endurance, displacement limits).

8. The Sample Size for the Training Set

Not applicable. This is not an AI algorithm requiring a training set.

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

Not applicable. (See #8)

Summary

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Comet Anterior Cervical Plate System Apollo Spine, Inc.

K090751

K090551

Attachment IV.2 - 510(k) Summary (revised)

General Information

OCT 2 8 2009

Owner's Name:	Apollo Spine
Address:	307 Placentia Ave, Suite 111Newport Beach CA 92663
Telephone Number:	(949) 645-7746
Fax Number:	(949) 645-7749
Contact Person:	Kamran Aflatoon
Subject Device Name:	Comet Anterior Cervical Plate System
Trade Name:	Comet Anterior Cervical Plate System
Common/Usual Name:	Anterior Cervical Plate System
Classification Name:	KWQ - Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3060; Class II
Predicate Device Name:	Comet Anterior Cervical Plate System
Trade Name:	Comet Anterior Cervical Plate System
Common/Usual Name:	Anterior Cervical Plate System
Classification Name:	KWQ - Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3060; Class II
Premarket Notification:	K082504, SE date January 27, 2009
Predicate Device Name:	Synthes Anterior Cervical Plate System
Trade Name:	Synthes Anterior Cervical Plate System
Common/Usual Name:	Anterior Cervical Plate System
Classification Name:	KWQ - Spinal Intervertebral Body Fixation Orthosis21 CFR 888.3060; Class II
Premarket Notification:	K926453, SE date Oct. 12, 1993

Device Description

Indications for Use

The indications for use for the multi-level device additions are the same as those for the previously cleared single-level devices of the Comet Anterior Cervical Plate System. The indications are as follows:

The Comet Anterior Cervical Plate System is intended for anterior fixation, immobilization and stabilization of adjacent cervical vertebral bodies as an adjunct to intervertebral fusion by autogenous and/or allogenic bone graft.

The Comet Anterior Cervical Plate System is indicated for anterior cervical fixation (levels C2-C7) for the following indications: degenerative disc disease (defined as neck pain of discogcnic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e., fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.

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Performance Testing

Performance data demonstrated that the multi-level device additions to the Comet Anterior Cervical Plate System are substantially equivalent to the predicate single-level devices of the Comet Anterior Cervical Plate System and/or met pre-determined acceptance criteria. The risks associated with use of the new devices were found acceptable when evaluated by FMEA.

Bench tests performed in accordance with FDA's May 2004 Guidance for Industry and Staff Spinal System 510(k)s and ASTM F1717-04 Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model included assessments of static and dynamic axial compression bending and static torsion.

No biocompatibility testing was conducted; all materials used in the manufacture of the Comet Anterior Cervical Plate System device have been previously cleared for similar devices.

Conclusion

The Comet Anterior Cervical Plate System multi-level device additions mect all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Comet Anterior Cervical Plate System multi-level device additions are substantially equivalent to the predicate device, the single-level devices of the Comet Anterior Cervical Plate System.

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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" arranged around the perimeter. Inside the circle is a stylized image of an eagle or other bird with outstretched wings, rendered in a simple, modern design.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002

Apollo Spine % STD MED, Inc. Ms. Christie Santagate 75 Mill Street Stoughton, Massachusetts 02072

OCT 2 3 2009

Re: K090751

Trade/Device Name: Comet Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: II Product Code: KWQ Dated: October 19, 2009 Received: October 22, 2009

Dear Ms. Santagatc:

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 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. Christie Santagate

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark M. Milliman

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

Enclosure

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Comet Anterior Cervical Plate System Apollo Spine, Inc.

Attachment IV.1 - Indications for Use Statement (revised)

510(k) Number (if known): K090751

Device Name: Comet Anterior Cervical Plate System

Indications for Use:

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

Page 1 of

510(k) Number K090751

34 年来

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.