The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

Device Description

The PlasmaBlade™ X 3.0S LIGHT is a single-use, monopolar RF device. It is designed to be used with the qualified Generator as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S LIGHT consists of a single bendable blade and telescoping shaft that can be configured in both standard and extended length. The finger grip also incorporates a suction lumen for the evacuation of smoke and fluids. The device also has integrated LED-based illumination.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the PlasmaBlade X 3.0S LIGHT. This document outlines the regulatory approval process and includes summaries of non-clinical testing conducted to demonstrate substantial equivalence to previously cleared predicate devices.

It is important to note that this document describes a conventional electrosurgical device, NOT an AI/Algorithmic Decision Support (ADS) device. Therefore, the specific questions regarding acceptance criteria and studies that prove an AI device meets those criteria (e.g., sample size, expert consensus for ground truth, MRMC studies, standalone performance, training set details) are not applicable to the content provided.

The document demonstrates a different type of substantial equivalence claim, which is based on demonstrating that the new device has the same intended use, technological characteristics, and performs as safely and effectively as a legally marketed predicate device, with any differences not raising new questions of safety or effectiveness.

However, I can extract the closest analogous information from the provided text to answer the spirit of your request as it pertains to this type of medical device submission.

Here's an interpretation of the requested information based on the provided 510(k) summary for the PlasmaBlade X 3.0S LIGHT:

Acceptance Criteria and Device Performance (Analogous to a non-AI device submission):

For this conventional medical device, "acceptance criteria" are not defined as statistical metrics for an AI algorithm's performance (e.g., sensitivity, specificity, AUC). Instead, they relate to demonstrating that the new device's performance characteristics are equivalent to its predicate devices and meet established safety and performance standards for electrosurgical devices. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench and animal) testing conducted.

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

Acceptance Criteria Category (Analogous to performance metrics)	Reported Device Performance (Summary from submission)
Functional Equivalence to Predicates	- The PlasmaBlade X 3.0S LIGHT shares the same operational characteristics as the predicate platforms (RF-based cutting and coagulation).- Bench testing was completed to ensure the new blade geometry did not affect the performance of the blade compared to predicates.- Updated blade coating incorporates material from a previous generation predicate (K093695).- All design features (including new ones like geometry and coating) were met, demonstrating performance equivalent to predicates.
Power Output	- Max power: 50W +/- 20% (Cut 8, Cut 10 and Coag 10)- Min power: ~0.5W +/- 1W (Cut 1)- Acceptance: "Same" as predicate devices.
Biocompatibility	- External communicating device <24 hours, tested to ISO 10993-1. - Compliance with ISO 10993-5 (in vitro cytotoxicity), ISO 10993-10 (irritation and skin sensitization), and ISO 10993-11 (systemic toxicity).- Acceptance: Demonstrated compliance with recognized standards.
Sterilization	- EtO sterilization.- Compliance with ISO 11135 (Ethylene Oxide sterilization requirements).- Acceptance: Demonstrated compliance with recognized standards.
Electrical Safety & EMC	- Compliance with IEC 60601-1 (General requirements for basic safety and essential performance), IEC 60601-2-2 (Particular requirements for high frequency surgical equipment), and IEC 60601-1-2 (Electromagnetic Disturbances).- Acceptance: Demonstrated compliance with recognized standards.
Thermal Damage Profile	- Thermal damage testing completed on muscle, skin, and liver (porcine model) in accordance with FDA guidance for electrosurgical devices.- Acceptance: Testing concluded the subject device was substantially equivalent to predicate devices regarding thermal damage.
LED Light Performance (New Feature)	- Allowable activation amounts, lux ranges (minimum and maximum), and light diameter at extension and collapse were tested.- Acceptance: "All light specifications were met." (Specific numerical acceptance criteria and measured performance not detailed in this summary, but confirmed as "met".)
Design Verification	- Design Verification was completed to guarantee all new design features functioned appropriately.
Overall Equivalency	- The device's "indications for use, technology and performance characteristics...are equivalent to the predicate devices. Therefore, the PlasmaBlade X 3.0S LIGHT is substantially equivalent to the predicates." This is the ultimate "performance" metric for a 510(k) submission.

2. Sample size used for the test set and the data provenance

Test Set (Non-Clinical):
- Bench Testing: The document states "Bench testing was completed" across various parameters (blade geometry, coating effect on performance, LED light specifications). Specific sample sizes (N of devices tested) are not provided in this summary.
- Animal Testing: "Thermal damage testing was completed on a porcine model." It mentions "muscle tissue testing was completed in-vivo, while the skin and liver tissue testing was completed ex-vivo." The exact number of animals or tissue samples is not specified.
- Data Provenance: The testing appears to be prospective as it was conducted specifically for this submission. The country of origin of the data is not explicitly stated, but it would have been conducted by Medtronic Navigation, an entity based in Louisville, Colorado, USA.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable: For this type of device, "ground truth" as it relates to expert medical evaluation of images/data for AI performance is not relevant. The "ground truth" for performance is established through physical measurements (bench testing) and biological responses (animal tissue reactions) against established engineering and biological standards, and comparison to predicate device performance. This does not involve human expert consensus on medical findings.

4. Adjudication method for the test set

Not Applicable: No adjudication method as understood for AI model evaluation (e.g., 2+1 radiologist review) was used. Testing results were presumably analyzed by qualified engineers and scientists.

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 device is an electrosurgical instrument, not an AI/ADS system. MRMC studies are not relevant for demonstrating the substantial equivalence of such a device. The device does not assist human "readers" in interpreting diagnostic information.

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

Not Applicable: This is an electrosurgical instrument, not an AI algorithm. Its performance is evaluated through its physical and biological effects, independent of human interpretation of a digital output.

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

Analogous "Ground Truth":
- Bench Testing: Engineering specifications, physical measurements, and established performance parameters for electrosurgical cutting and coagulation.
- Animal Testing: Histopathological analysis of tissue damage, visual assessment of surgical effects, and comparison to documented effects of predicate devices. This is a form of scientific and empirical "ground truth."
- Standards Compliance: Ground truth is defined by the technical requirements and limits specified in recognized consensus standards (e.g., ISO 11135, ISO 10993 series, IEC 60601 series).

8. The sample size for the training set

Not Applicable: This is not an AI/machine learning device. There is no "training set." The device's design is based on engineering principles and existing predicate device designs, not on data-driven algorithmic training.

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

Not Applicable: As there is no training set, this question is not relevant. The "ground truth" for the device's design and validation is derived from established medical device standards, regulatory guidance, and scientific understanding of electrosurgical principles.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 24, 2020

Medtronic Navigation Gina Cunsolo Regulatory Affairs Specialist 826 Coal Creek Circle Louisville, Colorado 80027

Re: K193579

Trade/Device Name: PlasmaBlade X 3.0S LIGHT Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 20, 2019 Received: December 23, 2019

Dear Gina Cunsolo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Long Chen, Ph. D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K193579

Device Name PlasmaBlade X 3.0S LIGHT

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

Submitter:	Medtronic Navigation826 Coal Creek CircleLouisville, CO
Contact Person:	Gina CunsoloRegulatory Affairs SpecialistPhone: (603) 842-6210Fax: (603) 742-1488Email: gina.m.cunsolo@medtronic.com
Date Summary Prepared:	March 19, 2020
Device Trade Name:	PlasmaBlade X 3.0S LIGHT
Common Name:	Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device andaccessories (21 CFR 878.4400)
Product Code:	GEI
Predicate Devices:	PlasmaBlade X 3.0S (K181257)PlasmaBlade 3.0S (K093695)
Reference Device:	PhotonBlade (K162053)
Device Description:	The PlasmaBlade™ X 3.0S LIGHT is a single-use,monopolar RF device. It is designed to be used with thequalified Generator as part of the Surgery System. Itcan be operated with the integrated hand switch or aqualified Footswitch. The PlasmaBlade™ X 3.0S LIGHTconsists of a single bendable blade and telescopingshaft that can be configured in both standard andextended length. The finger grip also incorporates asuction lumen for the evacuation of smoke and fluids.The device also has integrated LED-based illumination.
Indications for Use:	The Surgery System is indicated for cutting and coagulation of soft tissue during General, Plastic and Reconstructive (including but not limited to skin incisions and development of skin flaps), ENT, Gynecologic, Orthopaedic, Arthroscopic, Spinal and Neurological procedures.

{4}------------------------------------------------

Substantial Equivalence Comparison Two predicate devices (cleared by Medtronic Advanced Energy) were used for substantial equivalence comparison to the subject device.

Attribute	PlasmaBlade X 3.0SLIGHT (Subject -K193579)	PlasmaBlade X3.0S (K181257)	PlasmaBlade3.0S (K093695)
IntendedUse/Indicationsfor Use	The Surgery System isindicated for cuttingand coagulation ofsoft tissue duringGeneral, Plastic andReconstructive(including but notlimited to skinincisions anddevelopment of skinflaps), ENT,Gynecologic,Orthopaedic,Arthroscopic, Spinaland Neurologicalprocedures.	Same	Same
Mechanism ofaction/principleod operation	RF Monopolar Energy	Same	Same
Power Output	Max power: 50W +/-20% 9Cut 8, Cut 10and Coag 10)Min power: ~0.5W +/-1W at (Cut 1)	Same	Same
Sterilization	EtO	Same	Same
Biocomp	Externalcommunicating device<24 hours, tested toISO 10993-1	Same	Same
Blade Material	Coated Stainless Steel	Same	Same
IntegratedSuction	Yes	Same	Same
LED Light	Yes	No	No

{5}------------------------------------------------

TechnologicalCharacteristics:	The predicate PlasmaBlade devices and subject PlasmaBlade X 3.0S LIGHT device are intended for RF-based cutting and coagulation. The PlasmaBlade X 3.0S LIGHT device shares the same operational characteristics as the predicate platforms, comprised of a radio-frequency generator which supplies RF power to disposable electrode devices for electrosurgical procedures. The differences between the subject and predicate devices are:The PlasmaBlade X 3.0S LIGHT contains an LED light source located at the blade end of the handpiece. Bench testing was completed in order to ensure all light specifications were met. An updated blade geometry to the subject device Bench testing was completed to ensure the new geometry did not affect performance of the blade. Updated blade coating to incorporate material utilized in the previous generation of the PlasmaBlade 3.0S device (K093695). Similar to other devices in the field (i.e. PhotonBlade K162053), the PlasmaBlade X 3.0S LIGHT contains an LED-light source to assist in illuminating the field.
Summary of Non-Clinical Testing:	The design and performance of the new features of the PlasmaBlade X 3.0S LIGHT were verified and validated through bench testing. Medtronic product development processes and the finalized FDA Guidance Document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff," issued on August 15, 2016, were utilized to determine applicable bench testing requirements.

TechnologicalCharacteristics:

The predicate PlasmaBlade devices and subject PlasmaBlade X 3.0S LIGHT device are intended for RF-based cutting and coagulation. The PlasmaBlade X 3.0S LIGHT device shares the same operational characteristics as the predicate platforms, comprised of a radio-frequency generator which supplies RF power to disposable electrode devices for electrosurgical procedures. The differences between the subject and predicate devices are:The PlasmaBlade X 3.0S LIGHT contains an LED light source located at the blade end of the handpiece. Bench testing was completed in order to ensure all light specifications were met. An updated blade geometry to the subject device Bench testing was completed to ensure the new geometry did not affect performance of the blade. Updated blade coating to incorporate material utilized in the previous generation of the PlasmaBlade 3.0S device (K093695). Similar to other devices in the field (i.e. PhotonBlade K162053), the PlasmaBlade X 3.0S LIGHT contains an LED-light source to assist in illuminating the field.

Summary of Non-Clinical Testing:

The design and performance of the new features of the PlasmaBlade X 3.0S LIGHT were verified and validated through bench testing. Medtronic product development processes and the finalized FDA Guidance Document, "Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery Guidance for Industry and Food and Drug Administration Staff," issued on August 15, 2016, were utilized to determine applicable bench testing requirements.

Sterilization, Biocompatibility, IEC and EMC Testing were conducted in compliance with the following FDA recognized consensus standards:

Standard	Title
ISO 11135 2nd Ed 2014	Sterilization Of Health-CareProducts - Ethylene Oxide -Requirements For TheDevelopment, Validation AndRoutine Control Of ASterilization Process ForMedical Devices
10993-5 Third Edition2009-06-01	Biological Evaluation Of Medical Devices - Part5: Tests For In Vitro Cytotoxicity

{6}------------------------------------------------

10993-10 Third Edition2010-08-01	Biological Evaluation Of Medical Devices - Part10: Tests For Irritation And Skin Sensitization
10993-11 Third Edition2017-09	Biological Evaluation Of Medical Devices - Part11: Tests For Systemic Toxicity
ES60601-1:2005/(R)2012 AndA1:2012,	Medical electrical equipment - Part 1: Generalrequirements for basic safety and essentialperformance (IEC 60601-1:2005, MOD)
60601-2-2 Edition 6.02017-03	Medical electrical equipment - Part 2-2:Particular requirements for the basic safetyand essential performance of high frequencysurgical equipment and high frequency surgicalaccessories
60601-1-2 Edition 4.02014-02	Medical Electrical Equipment - Part 1-2:General Requirements For Basic Safety AndEssential Performance - Collateral Standard:Electromagnetic Disturbances - RequirementsAnd Tests

Bench Testing

Test	Description
Design Verification	Design Verification was completed toguarantee all new design features functionedappropriately.

In comparison to the predicate devices, the subject PlasmaBlade X 3.0S LIGHT device was evaluated via bench testing to ensure all features performed in an equivalent manner to the predicates. Bench testing included consideration of the geometry change as well as the addition of the blade coating. All design features were met. In addition, the subject device was tested for multiple light performance specifications, which included allowable activation amounts, lux ranges (minimum and maximum), and light diameter at extension and collapse. All light specifications were met.

Animal Testing

Test	Description
Tissue Testing	Thermal damage testing was completed onmuscle, skin, and liver in accordance with theguidance entitled, "Premarket Notification(510(k)) Submissions for Electrosurgical Devicesfor General Surgery," issued August 2016, toensure substantial equivalence to predicate.

{7}------------------------------------------------

Similar to the predicate devices, thermal damage testing was completed on a porcine model to ensure the subject device was substantially equivalent to the predicates. The muscle tissue testing was completed in-vivo, while the skin and liver tissue testing was completed ex-vivo. Testing concluded the subject device was substantially equivalent.

Summary of ClinicalTests:	Clinical Testing was not required for these products.
Conclusion:	The indications for use, technology and performance characteristics ofthe PlasmaBlade X 3.0S LIGHT devices are equivalent to the predicatedevices. Therefore, the PlasmaBlade X 3.0S LIGHT is substantiallyequivalent to the predicates.

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.