The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Device Description

The Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps are sterile single use devices for use in electrosurgery. The forceps are a bayonet style and include a cord at the proximal end which allows for connection to a Malis bipolar electrosurgical generator.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps), a submission for regulatory clearance in the US. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study with defined acceptance criteria and performance metrics in the way one might for a novel diagnostic algorithm or drug.

Therefore, the information requested, particularly regarding "acceptance criteria," "study that proves the device meets the acceptance criteria," "sample size for the test set," "number of experts," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how ground truth for training set was established," is not applicable in the context of this 510(k) submission. These questions are more relevant to studies for AI/ML-driven diagnostic devices or clinical trials for drugs.

However, I can extract the relevant information regarding the device's technical characteristics comparison and regulatory testing, which serves a similar purpose of demonstrating safety and effectiveness for substantial equivalence.

Here's a breakdown based on the provided text, addressing the closest equivalents to your questions:

Device: Synergetics™ Disposable Spetzler™ Malis® Standard Bipolar Forceps

1. Table of Acceptance Criteria and Reported Device Performance

For a 510(k) substantial equivalence determination, "acceptance criteria" are generally interpreted as demonstrating equivalent functional and safety characteristics to a legally marketed predicate device. The "performance" is the new device exhibiting these equivalent characteristics through non-clinical testing.

Criteria (for Substantial Equivalence to Predicate Device K110924)	Predicate Device Performance	Applicant Device Performance (Reported)
Intended Use	Sterile single use, for coagulation and irrigation.	Sterile single use, for coagulation of tissue.
For Use With	Electrosurgical generators, irrigation modules, tubing.	Electrosurgical generators.
Forceps Design	Bayonet Style	Bayonet Style
Patient Contact Material	Biocompatible Silver plated Aluminum base with PVDF insulation	Biocompatible Silver plated Aluminum base with PVDF insulation
Electrical Safety Testing	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2	IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2
Latex Free	Yes	Yes
Single Use	Yes	Yes
Sterilization Method	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Packaging	Rigid PETG Tray, Tyvek lid	Rigid PETG Tray, Tyvek lid

Summary of Non-clinical Testing:
Bench testing and comparative performance testing were conducted to demonstrate substantial equivalence to the predicate device. This included relevant electrical safety testing to IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2. The non-clinical testing indicated that the device performance is substantially equivalent to the predicate, and the slight differences (primarily the lack of irrigation feature) raise no new issues of safety and effectiveness.

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

Sample Size: Not specified for individual tests. The document refers to "bench testing" and "comparative performance testing," implying physical testing of the device. The sample size for these engineering tests would typically be determined by internal quality standards and statistical power requirements for specific tests (e.g., tensile strength, insulation integrity) but is not detailed in this summary.
Data Provenance: The document implies the data comes from internal testing conducted by Synergetics, Inc., related to the manufacturing and design verification of the new device and comparison to the predicate. This is prospective testing performed for regulatory submission. Country of origin not explicitly stated, but the applicant's address is O'Fallon, MO, USA.

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

Not Applicable. This device is a physical electrosurgical tool, not an AI/ML diagnostic system or imaging device requiring expert interpretation for ground truth. "Ground truth" in this context would be engineering specifications and validated performance metrics (e.g., electrical resistance, material integrity).

4. Adjudication Method for the Test Set

Not Applicable. See point 3. Tests would be based on objective measurements against engineering specifications and industry standards rather than expert adjudication.

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

Not Applicable. This is a surgical instrument, not an AI/ML diagnostic aid. No human reader or AI assistance is involved in its direct function.

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

Not Applicable. This is a physical device, not an algorithm.

7. The Type of Ground Truth Used

For the "tests" performed (bench testing, comparative performance, electrical safety), the "ground truth" would be engineering specifications, industry standards (e.g., IEC 60601 series, ISO 11135, ISO 14971, ISO 11607-1), and the established performance characteristics of the legally marketed predicate device. The goal is to show the new device meets safety and performance standards and is substantially equivalent to the predicate.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device, not a machine learning algorithm that requires a training set.

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

Not Applicable. See point 8.

Summary

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510 (k) Summary of Safety and Effectiveness Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps Submitted in accordance with the requirements of 21 CFR 807.92

Applicant's Name and Address:	Synergetics, Inc.3845 Corporate Centre DriveO'Fallon, MO 63368	JUL 10 2012
Contact Person:	Gary OliverosSynergetics, Inc.Senior Regulatory Affairs SpecialistTelephone Number: (636) 794-5107Fax Number: (636) 794-5120Email: goliveros@synergeticsusa.com
Date Prepared:	May 11, 2012
Device Trade Name:	Synergetics™ Disposable Spetzler™ Malis® Standard BipolarForceps
Common Name:	Single Use Bipolar Forceps
Device Classification:	21 CFR Part 878.4400, Electrosurgical Cutting and CoagulationDevices and Accessories are Class II devices
Classification Name:	Electrosurgical, Cutting and Coagulation and Accessories
Product Code:	GEI
FDA Panel:	General and Plastic Surgery
Predicate Device:	Synergetics Disposable Spetzler Malis Dual Irrigating BipolarForceps, K110924

Device Description:

Intended Use:

The Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Page 11 of 449

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Image /page/1/Picture/1 description: The image shows the logo for "Synergetics". The logo consists of a geometric shape resembling a diamond made up of smaller squares on the left, followed by the word "Synergetics" in bold, black font. The letters are connected, and there is a curved line above the "i" in "Synergetics", and the letters "TM" are in the upper right corner of the word.

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Comparison of Technical Characteristics:

Criteria	Predicate Device - SynergeticsSingle Use Dual IrrigatingBipolar Forceps, K110924	Synergetics DisposableStandard Bipolar Forceps
Intended Use	Sterile single use, for use inelectrosurgery for coagulation andirrigation of tissue.	Sterile single use, for use inelectrosurgery for coagulation oftissue.
For Use With	Electrosurgical generators,irrigation modules and irrigationtubing	Electrosurgical generators
Forceps Design	Bayonet Style	Bayonet Style
Patient Contact Material	Biocompatible Silver platedAluminum base with PVDFinsulation	Biocompatible Silver platedAluminum base with PVDFinsulation
Electrical Safety Testing	IEC 60601-1IEC 60601-1-2IEC 60601-2-2	IEC 60601-1IEC 60601-1-2IEC 60601-2-2
Latex Free	Yes	Yes
Single Use	Yes	Yes
Sterilization Method	Ethylene Oxide (EO)	Ethylene Oxide (EO)
Packaging	Rigid PETG Tray, Tyvek lid	Rigid PETG Tray, Tyvek lid
Note 1: Synergetics packaging configuration has been validated in accordance with ISO 11607-1:2006. Packagingfor Terminally Sterilized Medical Devices- Part 1: Requirements for Materials, Sterile Barrier Systems andPackaging Systems

Risk Management:

Risk Management has been implemented and complies with ISO 14971, Medical Devices - Application of Risk Management to Medical Devices.

Sterilization Method:

Synergetics Disposable Spetzler Malis Standard Bipolar Forceps are sterilized in accordance with AMINSO 11135 Medical Devices - Validation and routine control of ethylene oxide sterilization (EtO), Overkill Method.

Summary of Non-clinical Testing:

Bench testing, comparative performance testing to the predicate device, and relevant electrical safety testing to IEC 60601-1, Medical Electrical Equipment Part 1: General Requirements for Safety, IEC 60601-1-2, Medical Electrical Equipment Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility, and IEC 60601-2-2, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of High Frequency Surgical Equipment was performed on the Synergetics Disposable Spetzler Malis Standard Bipolar Forceps. The non-clinical testing indicates the device performance is substantially equivalent to the predicate and the slight differences raise no new issues of safety and effectiveness.

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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 stylized eagle or bird-like figure with outstretched wings, positioned to the right of a circular emblem. Encircling the emblem are the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in capital letters.

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

Synergetics, Incorporated % Mr. Gary Oliveros Senior Regulatory Affairs Specialist 3845 Corporate Centre Drive O'Fallon, Missouri 63368

JUL 10 2012

Re: K121426

Trade/Device Name: Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: May 11, 2012 Received: May 17, 2012

Dear Mr. Oliveros:

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.

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Page 2- Mr. Gary Oliveros

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 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/CDRH0ffices/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.

Edward V. Carey.

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

Enclosure

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Image /page/4/Picture/0 description: The image shows the word "Synergetics" in a bold, sans-serif font. To the left of the word is a geometric shape that looks like a diamond made up of smaller squares. The letters are black, and the geometric shape is outlined in black. There is a trademark symbol to the right of the word.

K121 426

Synergetics™ 510 (k) Submission Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps Section 4 - Indications for Use

510(k) Number (if known):

Device Name:

Synergetics Disposable Spetzler-Malis Standard Bipolar Forceps

Indications for Use:

The Synergetics Disposable Speztler-Malis Standard Forceps are single use devices sold sterile and are intended for use in electrosurgery for coagulation of tissue.

Prescription Use X (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

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

' AND/OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

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

510(k) Number K121426

Section 4 - Page 1 of 1

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Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.