The Katia System is intended for anterior screw fixation to the cervical spine. It is to be used in skeletally mature patients as an adjunct to fixation of the cervical spine (C2 – T1). The system is indicated for use in temporary stabilization of the anterior spine during the development of cervical spinal fusions in patients with: 1) degenerative disc disease (as defined by neck pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), 2) spondylolisthesis, 3) trauma (i.e. fractures or dislocations), 4) tumors, 5) deformity (defined as kyphosis, lordosis, or scoliosis), 6) pseudarthrosis, 7) failed previous fusions, and/or 8) spinal stenosis.

Device Description

The Katia System includes implants that are intended for anterior interbody screw fixation of the cervical spine during the development of a cervical fusion. The Katia system consists of a variety of shapes and sizes of bone plates, screws and associated instruments. Fixation is provided by bone screws inserted into the vertebral body of the cervical spine using an anterior approach. The components are made from titanium alloy.

AI/ML Overview

The provided text describes the Katia System, a medical device for anterior interbody screw fixation of the cervical spine, and its 510(k) summary. However, the document does not contain the specific information required to complete the table and answer all the questions regarding "acceptance criteria" and "device performance" in terms of clinical or algorithmic efficacy. The provided text focuses on regulatory approval, device description, indications for use, and mechanical performance testing against ASTM standards.

Therefore, for aspects related to clinical or algorithmic performance, acceptance criteria, sample sizes for test/training sets, expert qualifications, and ground truth establishment, the information is not available in the given document.

Here's a breakdown of what can be extracted and what cannot:

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

Acceptance Criteria: The text states "Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004." While these documents define acceptance criteria for mechanical performance, the specific criteria (e.g., specific load limits, displacement thresholds) and the device's reported performance against these criteria are not detailed in the provided text. The 510(k) summary typically includes a statement that the device met these standards, but not the raw data or specific values. Without access to the full test report, this information cannot be provided.
Reported Device Performance: As above, specific quantitative performance data for mechanical tests (e.g., cyclic loading, static compression, screw pull-out strength) against the ASTM standard are not included in this summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not available in the provided text. The document refers to mechanical testing, not a clinical study involving a "test set" of patient data in the context of AI/diagnostic device evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided text. This device is a surgical implant, and the approval detailed here is based on substantial equivalence to predicate devices and mechanical performance testing, not on a diagnostic or AI-driven evaluation that would require expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not available in the provided text. (See point 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

This information is not available in the provided text. This type of study is relevant for diagnostic imaging AI, not for a spinal implant like the Katia System.

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

This information is not available in the provided text. (See point 5).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not available in the provided text. The "ground truth" for a spinal implant's approval typically revolves around manufacturing quality, biocompatibility, and mechanical strength/durability demonstrated through laboratory testing, not medical image interpretation or clinical outcomes data in the way an AI diagnostic device would.

8. The sample size for the training set

This information is not available in the provided text. (See point 5).

9. How the ground truth for the training set was established

This information is not available in the provided text. (See point 5).

Summary of available information related to performance testing:

Performance Testing Method: Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.
Device Type: Spinal intervertebral body fixation orthosis (implant).
Approval Basis: Substantial equivalence to predicate devices (K081038, K111132, K031276, K971883) and adherence to mechanical testing standards.

Conclusion:

The provided document details regulatory information and mentions mechanical performance testing standards but does not provide the specific acceptance criteria or reported device performance data for these tests, nor does it contain any information relevant to the evaluation of an AI-driven or diagnostic device (e.g., clinical test/training sets, ground truth establishment, expert adjudication, MRMC studies).

Summary

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7 2013

	510(k) SummaryKATIA SYSTEMJuly 22, 2013	AUG
Company:	Manufacturing Facility and Headquarters:Shanghai Sanyou Medical Co, LTD1988 Jiatang RoadJiading District, Shanghai, 201807, China
	Manufacturing Facility:Shanghai Sanyou Medical Co, LTDRm 101/102/106/107356 Renqing Rd, Building 3-1F,Pudong New District, Shanghai 201201, China
EstablishmentRegistration:	Registration applied; Number not assigned
Primary Contact:	Kimberly StrohkirchPhone: 901-361-2037Fax: 902-318-5380strohkirch@memphisregulatory.com
Company Contact:	David Fan, VP, MarketingPhone: +86 21 58389980Fax: +86 21 38682915david.fan@sanyou-medical.com
Trade Name:	Katia System
Common Name:	Appliance, Fixation, Spinal Intervertebral Body
Classification:	Class II
Regulation Number:	21 CFR 888.3060 (Spinal intervertebral body fixation orthosis)
Panel:	87- Orthopedic
Product Code:	KWO

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Device Description:

Indications for Use:

Substantial Equivalence:

K081038 - Medtronic ATLANTIS® Anterior Cervical Plate System K111132 - Genesys Spine Anterior Cervical Plate System K031276 - Synthes Anterior Cervical Locking Plate (ACLP System) K971883 – Synthes Small Stature Anterior Cervical Vertebrae Plate System

Performance Testing:

Testing was completed according to ASTM F1717-12 and Guidance for Industry and FDA Staff: Spinal System 510(k)s issued May 3, 2004.

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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The text is centered horizontally in the image. The background of the image is white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G60 Silver Spring, MD 20993-0002

August 7, 2013

Shanghai Sanyou Medical Co, Ltd % Memphis Regulatory Consulting Ms. Kimberly Strohkirch 3416 Roxee Run Cove Bartlett, Tennessee 38133

Re: K131512

Trade/Device Name: Katia System Regulation Number: 21 CFR 888.3060 Regulation Name: Spinal intervertebral body fixation orthosis Regulatory Class: Class II Product Code: KWQ Dated: June 19, 2013 Received: June 20, 2013

Dear Ms. Strohkirch:

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 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 - Ms. Kimberly Strohkirch

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Erin I. Keith

For

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

Enclosure

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Traditional 510(k)

Indications for Use Statement

510(k) Number (if known): K131512

Katia System Device Name:

Indications for Use:

Prescription Use X(Part 21 CFR 801 Subpart D)	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation

Anton E. Dmitriev, PhD Division of Orthopedic Devices

CONFIDENTIAL

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.