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

PlasmaBlade X 4.0: The PlasmaBlade™ X 4.0 is a single-use- only device designed for use with qualified Generators as a System (Surgery System). The PlasmaBlade™ X has integrated hand switch control, or alternatively, may be controlled with a qualified Footswitch, supplied as an optional accessory to the Generator. The PlasmaBlade™ X 4.0 consists of a single bendable shaft and rotatable nose piece that can be adjusted by hand. The system components are designed to be used together and operated as a single unit.

PlasmaBlade X 3.0S: The PlasmaBlade™ X 3.0S is a single-use, monopolar RF device. It is designed to be used with the qualified Generators as part of the Surgery System. It can be operated with the integrated hand switch or a qualified Footswitch. The PlasmaBlade™ X 3.0S 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding Medtronic's PlasmaBlade X 4.0 and PlasmaBlade X 3.0S devices. It does not describe an AI/ML-driven medical device, but rather an electrosurgical cutting and coagulation device. Therefore, the requested information about acceptance criteria for an AI/ML device, including details about test sets, expert ground truth, MRMC studies, and training sets, is not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's an analysis based on the provided document, addressing what information is not applicable and what little can be inferred:

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

Not Applicable in the AI/ML sense. This document doesn't define quantitative performance metrics (like accuracy, sensitivity, specificity) for an AI/ML algorithm.
Implied Acceptance Criteria for an Electrosurgical Device: The acceptance criteria for this device appear to be primarily related to safety and functionality, demonstrating that it performs as intended for cutting and coagulation of soft tissue and that its thermal effect is substantially equivalent to predicate devices.
Reported Device Performance: "The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices." This is a qualitative statement of equivalence, not a specific quantitative performance metric.

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

Not Applicable/Not Provided. The document mentions "comparative performance testing was conducted in an in-vivo/ex-vivo animal model." It does not specify the sample size of animals or the details of the "test set" in an AI/ML context. Data provenance (country, retrospective/prospective) is also not provided.

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)

Not Applicable. "Ground truth" in the AI/ML sense (e.g., expert labels on medical images) is not relevant for an electrosurgical device's performance evaluation as described here. The evaluation seems to be based on physical measurements of thermal effect.

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

Not Applicable. No human interpretation or adjudication of output is described.

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 an electrosurgical device, not an AI-assisted diagnostic tool. No MRMC study was performed or needed.

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

Not Applicable. There is no "algorithm" in the AI/ML sense to test standalone performance. The device itself is the "standalone" item being evaluated for its physical effects.

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

Not Applicable. The "ground truth" for this device's evaluation would be physical measurements of thermal effect in animal tissue, comparing it to predicate devices. It's not a diagnostic or prognostic tool requiring expert consensus or pathology for "ground truth."

8. The sample size for the training set

Not Applicable. This is not an AI/ML device that requires a training set for model development.

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

Not Applicable. There is no training set mentioned or implied.

In summary, this document is a regulatory submission for a physical medical device (electrosurgical) and does not contain the information requested for evaluating an AI/ML-driven device's acceptance criteria and study data.

Summary

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August 2, 2018

Medtronic Advanced Energy Heather Valley Principal Regulatory Affairs Specialist 180 International Drive Portsmouth, New Hampshire 03801

Re: K181257

Trade/Device Name: PlasmaBlade X 3.0S, PlasmaBlade X 4.0 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: May 9, 2018 Received: May 11, 2018

Dear Heather Valley:

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/cfpm/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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) 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 of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely. Jennifer Stevens For Binita S. Ashar, M.D., M.B.A., F.A.C Director Division of Surgical Devices Office of Device Evaluation

Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K181257

Device Name

PlasmaBlade X 4.0 and PlasmaBlade X 3.0S

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)
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Medtronic

510(k) Summary K181257

Submitter:	Medtronic Advanced Energy180 International DrivePortsmouth, NH 03801
Contact Person:	Heather Valley, RACPrincipal Regulatory Affairs SpecialistPhone: (603) 294-5447Fax: (603) 742-1488Email: heather.a.valley@medtronic.com
Date Summary Prepared:	May 09, 2018
Device Trade Name:	PlasmaBlade X 4.0PlasmaBlade X 3.0S
Common Name:	Electrosurgical Instrument
Classification Name:	Electrosurgical cutting and coagulation device andaccessories (21 CFR 878.4400)
Product Code:	GEI
Predicate Devices:	PlasmaBlade 4.0 (K073057 Original Submission, K082786Expanded Indications)PlasmaBlade 3.0S (K093695)
Device Description:	PlasmaBlade X 4.0The PlasmaBlade™ X 4.0 is a single-use- only devicedesigned for use with qualified Generators as a System(Surgery System). The PlasmaBlade™ X has integratedhand switch control, or alternatively, may be controlled with aqualified Footswitch, supplied as an optional accessory to theGenerator. The PlasmaBlade™ X 4.0 consists of a singlebendable shaft and rotatable nose piece that can be adjustedby hand. The system components are designed to be usedtogether and operated as a single unit.PlasmaBlade X 3.0SThe PlasmaBlade™ X 3.0S is a single-use, monopolar RFdevice. It is designed to be used with the qualifiedGenerators as part of the Surgery System. It canbe operated with the integrated hand switch or a qualifiedFootswitch. The PlasmaBlade™ X 3.0S consists of a singlebendable blade and telescoping shaft that can be configured

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in both standard and extended length. The finger grip also
incorporates a suction lumen for the evacuation of smoke and fluids.

Indications for Use:	Device Name: PlasmaBlade X 4.0
	Indications: 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 Name: PlasmaBlade X 3.0S
	Indications: 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.
Technological Characteristics:	The predicate PlasmaBlade devices and proposed PlasmaBlade X family of devices are intended for RF based cutting and coagulation. The proposed devices share 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.
Summary of Non-Clinical Testing:	Design and material changes were verified through bench testing.
	Comparative performance testing was conducted in an in-vivo/ex-vivo animal model to determine thermal effect of the X series against the predicates. The thermal effect of the X series of products was found to be substantially equivalent to that of the predicate devices.
Summary of Clinical Tests: Conclusion:	Clinical Testing was not required for these products. The indications for use, technology and performance characteristics of the PlasmaBlade X devices are equivalent to the predicate devices, as such, Medtronic Advanced Energy claims substantial equivalence 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.