Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
. Spondylolisthesis
. Trauma (fracture or dislocation)
. Spinal stenosis
Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
. Tumor
. Pseudarthrosis
. Failed previous fusion

Device Description

The Sintea Plustek Anterior Cervical Plate system is made of medical grade titanium alloy Ti-6Al-4V according to ASTM-F136 and consists of plate and screws of various lengths to accommodate single or multilevel fusion and various patients' anatomy. All of the plates have 2.5mm thickness. One level plates are available from 18-38mm, two level plates from 34-56mm, three level plates from 68-112mm and 4 level plates from The screws are available in three configurations: 4mm diameter self 103-128mm. tapping screws in lengths of 10, 12, 14, 16 and 18mm. 4.5 diameter self tapping screws in lengths of 10, 12, 14, 16, and 18mm, 4mm diameter self drilling screws in lengths of 10, 12, 14, 16 and 18mm. The plates have an anti-backout feature based on an elastic ring The elastic ring is inserted into a (made titanium alloy Ti-6AI-4V as well). circumferential slot in the holes present on the plates. The ring can be deformed by the screw during the insertion in order to allow the screw to fit the hole of the plate. Once the screw it is completely inserted the ring return elastically to its original shape in order to prevent screw backout.

AI/ML Overview

The provided text describes a medical device, the Sintea Plustek Anterior Cervical Plate System, and its 510(k) summary for FDA clearance. It focuses on the device's physical properties, indications for use, and a comparison to predicate devices, but does not describe an AI/ML-driven device or study parameters related to AI/ML performance.

Therefore, I cannot extract the information required to answer your prompt, as the prompt's questions pertain to acceptance criteria and studies for an AI/ML device, which are not present in the provided document.

The document only states:

1. Acceptance Criteria and Device Performance (Mechanical Testing):
The study for this device was a mechanical performance test to demonstrate substantial equivalence, not an AI/ML performance study.

Acceptance Criteria	Reported Device Performance
Performance equal to or better than predicate device (Sintea Biotech's Anterior Cervical Plate System, K041989) based on ASTM F1717-09 standards for:	The test results for the Sintea Plustek Anterior Cervical Plate System showed "equal or better performance" when compared to the predicate device.
- Static compression bend
- Static tension
- Dynamic compression bend

2. Sample size and data provenance (for AI/ML test set): Not applicable, as this is a mechanical medical device, not an AI/ML device.

3. Number of experts and qualifications (for AI/ML ground truth): Not applicable.

4. Adjudication method (for AI/ML test set): Not applicable.

5. Multi-reader multi-case (MRMC) comparative effectiveness study (for AI/ML): Not applicable.

6. Standalone performance (for AI/ML algorithm): Not applicable.

7. Type of ground truth used (for AI/ML): Not applicable. The "ground truth" in this context refers to established mechanical testing standards (ASTM F1717-09) and performance of legally marketed predicate devices.

8. Sample size for the training set (for AI/ML): Not applicable.

9. How ground truth for the training set was established (for AI/ML): Not applicable.

Summary

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K112861

Sintea Plustek, LLC, 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312

FEB 2 4 2012

Image /page/0/Picture/3 description: The image contains the text "sinteaPLUSTEK" in a simple, sans-serif font. The text is slightly curved, following the shape of a partial oval that surrounds it. The oval is thicker on the left side and thins out as it curves around the text.

Anterior Cervical Plate System 510(k) Summary November 2011

Sintea Plustek, LLC. Company: 407 Lincoln Rd. Suite 10L Miami Beach, FL 33139 (305) 673-6226

II.	Proprietary Trade Name:	Anterior Cervical Plate System
	Regulation Number:	888.3060
	Regulation Name:	Spinal Intervertebral Body Fixation Orthosis
	Product Code:	KWQ

III. Product Description

IV. Indications for Use

The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

Degenerative Disc Disease (defined as neck pain of discogenic origin with . degeneration of the disc confirmed by history and radiographic studies)
. Spondylolisthesis
. Trauma (fracture or dislocation)
. Spinal stenosis
Deformities or curvatures (scoliosis, kyphosis, lordosis) ●
. Tumor
. Pseudarthrosis
. Failed previous fusion

,
.

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Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312

Image /page/1/Picture/1 description: The image shows the logo for "sinteaplustek". The logo is in a simple, sans-serif font, with the two words joined together. The logo is enclosed in a thin, oval border. The text is in black and the background is white.

V. Predicate Devices

The Sintea Plustek Atnerior Cervical Plate is substantially equivalent to the Sintea Biotech Anterior Cervical Plate (K041989), the Synthes CSLP Variable Angle Plate (K000536) and the DePuy Skyline ACP (K103491).

Performance Data - Overview VI.

The testing completed for the device under review was performed according to ASTM F1717-09 "Standard Test Methods for Spinal Implant Constructs in a Vertebrectomy Model." (Orthopaedics) including static compression bend, static tension, static tension, and dynamic compression bend. The test results were compared to the predicate device Sintea Biotech's Anterior Cervical Plate System (K041989) and showed equal or better performance.

VII. Substantial Equivalence Conclusion

Sintea Plustek, LLC believes that the additions to the Anterior Cervical Plate System are substantially equivalent to the Sintea Biotech's Anterior Cervical Plate Spinal System (K041989) with respect to functional design, indications for use, principles of operation, performance, and materials.

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Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services (HHS). The seal features the HHS logo, which is a stylized caduceus, a symbol of medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the logo.

Public Health Service

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

FEB 2 4 2012

Sintea Plustek, LLC % Ms. Danielle Wernikowski 407 Lincoln Road, Suite 10L Miami Beach, Florida 33139

Re: K112861

Trade/Device Name: Anterior Cervical Plate System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWO Dated: January 23, 2012 Received: January 27, 2012

Dear Ms. Wernikowski:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Danielle Wernikowski

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.

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 A Milheim

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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K112861

Sintea Plustek, LLC. 407 Lincoln Rd, Suite 10L Miami Beach, FL 33139 P. 305-673-6226 F. 305-673-3312

Image /page/4/Picture/2 description: The image shows the logo for Sintea Plustek. The logo is in black and white and features the company name in a stylized font. The text is surrounded by a partial oval shape on the left side of the text.

Indications for Use

510(k) Number (if known): ___K112861

Device Name: Anterior Cervical Plate System

Indications for Use:

The Sintea Plustek Anterior Cervical Plate systems in indicated for use in the cervical spine (C3-C7) for the following conditions:

Degenerative Disc Disease (defined as neck pain of discogenic origin with . Degeneration of the disc confirmed by history and radiographic studies)
Spondylolisthesis .
Trauma (fracture or dislocation) .
Spinal stenosis t
Deformities or curvatures (scoliosis, kyphosis, lordosis) .
Tumor .
Pseudarthrosis
Failed previous fusion

× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)
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Signature

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

K112861 510(k) Number

Regulation Number and Section

N/A