The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device. The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the "Symmetry Kerrison Disposable Tip Rongeurs":

The provided document is a 510(k) Summary for a medical device that introduces disposable tips to an existing rongeur design. It focuses on demonstrating substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic accuracy or a specific performance metric against a defined acceptance criterion the way AI/ML devices typically would.

Therefore, many of the requested fields are not applicable to this type of submission. I will fill in what can be inferred and explicitly state when information is not available or not applicable.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) for a mechanical surgical instrument, the "acceptance criteria" are not reported as numerical thresholds for sensitivity, specificity, etc., but rather as functional performance. The performance data section vaguely states that the devices perform according to their description and intended use.

Acceptance Criteria (Implied)	Reported Device Performance
Ability to cut bony tissue (as intended use)	Demonstrated through "cut testing"
Structural integrity and function under intended use	Demonstrated through "foot load plate testing" and "cycle testing"
Resistance to degradation (e.g., rust)	Demonstrated through "corrosion resistance"
Conformance to design specifications	Conforms to design specifications.
Substantial equivalence to predicate devices in function	"Substantial equivalence is based on intended use, performance characteristics, materials, and principle of operation."
Safety and effectiveness (overall)	"Demonstrates the proposed devices perform according to its description and intended use and supports the safety and effectiveness of the device."

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

Sample Size for Test Set: Not explicitly stated. The document refers to "Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance." The number of devices or components tested in these non-clinical tests is not provided.
Data Provenance: Not applicable in the context of clinical data for diagnostic or AI/ML devices. The testing is internal non-clinical performance testing.

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

Number of Experts: Not applicable. This is not a study requiring expert interpretation or ground truth establishment in the traditional sense of a clinical or image-based diagnostic study. The "ground truth" here is the physical performance of the device against engineering specifications.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This is not a study requiring subjective interpretation or adjudication. The performance tests are objective mechanical or material tests.

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

MRMC Study: No. This is a surgical instrument, not a diagnostic imaging device, and does not involve AI assistance or human readers.

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

Standalone Performance: Not applicable. This is a manual surgical instrument, not an algorithm or AI device.

7. The Type of Ground Truth Used

Type of Ground Truth: The "ground truth" in this context would be the engineering specifications and performance benchmarks derived from the predicate devices or industry standards for similar instruments. The tests performed ("cut testing, foot load plate testing, cycle testing and corrosion resistance") are designed to verify that the device meets these physical and functional requirements.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.

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

Ground Truth for Training Set: Not applicable. There is no machine learning or AI component requiring a training set.

Summary

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K130541

510(k) Summary of Safety and Effectiveness

(Per 21 CFR 807.92)

General Company Information

Company Name:	Symmetry Surgical
Company Address:	3034 Owen DriveNashville, TN 37013	AUG 0 5 2013
Company Telephone:	615-964-5558
Contact:	Dalene T. Binkley, MS, RAC
Contact Addressand Telephone:	1927 N. Arthur DriveColumbia City, IN 46725260-244-4189
Date:	February 24, 2013
Device Trade Name:	Symmetry Kerrison Disposable Tip Rongeurs
Common Name:	Manual Rongeurs
Classification Nameand Reference:	HAE - Class II (21 CFR 882.4840)
Predicate Device:	Codman Kerrison Laminectomy Rongeurs,PreamendmentIntegra Kerrison Rongeurs, K092227, cleared 2/17/1

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Device Description: The Symmetry Kerrison Disposable Tip Rongeurs are manually operated instruments, provided with a non-sterile reusable handle and a set of sterile, disposable tips, indicated for cutting bony tissue of the spine. They represent a design modification to the predicate devices, the Codman Kerrison Laminectomy Rongeurs and the Integra Kerrison Rongeurs, introducing disposable tips to the device.

The Symmetry Kerrison Disposable Tip Rongeurs handles are comprised of stainless steel, and operate with a cup and ball assembly for smooth motion of the footplate when the handle is squeezed. The handles and disposable tips are provided in various sizes to help provide the surgeons with more options.

Intended Use: The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue in the area of the spine. This intended use is similar to that of our predicate devices.

Technological Characteristics: The technological characteristics of the proposed device are similar or the same as those of the predicate devices. The design modification introduces disposable tips to the device providing the surgeon with a disposable option while assuring the sterility and sharpness of the tips. This design modification does not impact the safety and effectiveness of the device. The Symmetry Kerrison Disposable Tip Rongeurs are substantially equivalent to their predicate devices Codman Kerrison Laminectomy Rongeurs and Integra Kerrison Rongeurs. Substantial equivalence is based on intended use, performance characteristics, materials, and principle of operation.

Performance Data (Nonclinical and/or Clinical): Performance testing consisting of cut testing, foot load plate testing, cycle testing and corrosion resistance demonstrates the proposed devices perform according to its description and intended use and supports the safety and effectiveness of the device. The Symmetry Surgical Disposable Tip Rongeurs conform to their design specifications and are substantially equivalent to the commercially distributed devices for the same intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with its wings spread, symbolizing protection and service. The seal is in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 5, 2013

Symmetry Surgical % Dalene T. Binkley, MS, RAC Regulatory Affairs Consultant 1927 N. Arthur Drive Columbia City, IN 46725

Re: K130541

Trade/Device Name: Symmetry Kerrison Disposable Tip Rongeurs Regulation Number: 21 CFR 882.4840 Regulation Name: Manual Rongeur Regulatory Class: Class II Product Code: HAE Dated: June 18, 2013 Received: June 25, 2013

Dear Ms. Binkley:

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 Eederal 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

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Page 2 - Ms. Dalene T. Binkley

(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 contact 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.goy/MedicalDevices/ResourcesforYou/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,

Joyce M. Whang -S

for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): _K130541

Device Name: Symmetry Kerrison Disposable Tip Rongeurs

Indications For Use:

The Symmetry Kerrison Disposable Tip Rongeurs are indicated for cutting bony tissue of the spine.

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)

Joyce M. Whang -S

(Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number K130541

Page 1 of 1

Regulation Number and Section

§ 882.4840 Manual rongeur.

(a)
Identification. A manual rongeur is a manually operated instrument used for cutting or biting bone during surgery involving the skull or spinal column.(b)
Classification. Class II (performance standards).