The KVac Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Device Description

The KVac Wands are bipolar, sterile, high frequency electrosurgical devices designed for ablation, and resection of soft tissue and hemostasis of blood vessels during arthroscopic and orthopedic surgery. The KVac Wands will be offered in two versions: the KVac Wand with Integrated Cable (KVac ICW) and the Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS). The two wands are identical in all design and functional aspects, as well as principle of operation, with the exception of the Integrated Finger Switches on the Ambient KVac IFS and the Proprietary Ambient Technology on the Ambient KVac IFS. The shafts of the Wands feature a 50 degree bend in the distal end, which terminates in the electrode tip. The electrode tip consists of a flat, tungsten screen welded to Platinum/Iridium lead wires, which pass through an alumina ceramic spacer that serves as a ground. Openings in the electrode screen overlay a spacer suction lumen, which connects with internal suction tubing that runs through and exits the handle and is connected to OR wall suction. The handpiece is connected to the Quantum/Quantum 2 Controller via an integrated cable, which terminates in an 18-pin connector.

AI/ML Overview

Your request is for information on acceptance criteria and study details for the provided document. However, the document provided is a 510(k) premarket notification for a medical device (ArthroCare® KVac™ Wand) and does not contain detailed acceptance criteria tables or specific studies proving the device meets those criteria in the way you've outlined.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a different regulatory pathway than providing detailed performance studies with acceptance criteria as might be seen for novel devices requiring PMAs or more extensive clinical trials.

The document explicitly states that no animal or clinical data are included in the submission. The performance testing section specifically refers to "Performance Testing - Bench" for evaluating design specifications and comparing to the predicate.

Given these limitations, I cannot provide the exact information you requested in the format of a table with specific acceptance criteria and detailed study results, sample sizes, expert qualifications, etc., as that information is not present in the provided text.

However, I can extract what is available regarding performance testing and the comparison to an older device:

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

The document does not provide a formal table of acceptance criteria with numerical targets. Instead, it states that:

"The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device."
"All testing demonstrates that the KVac Wands perform as intended and have acceptable mechanical properties when used in accordance with its labeling."

The "reported device performance" is qualitative and comparative:

Performance bench testing was conducted to verify designs meet specifications and to evaluate performance compared to the predicate device.
Testing involved tissue models (muscle, cartilage, meniscus, tendon).
High, default, and low ablation and coagulation settings were used.
Compared the amount of tissue removed (ablation depth) and thermal effect depth created.

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

Sample Size: Not specified for the bench tests.
Data Provenance: Bench testing, likely conducted internally by ArthoCare Corporation (Austin, TX, USA). It is not clinical data (animal or human), so terms like retrospective/prospective don't apply in the same way.

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

This information is not provided. Since no clinical data was used, there would be no ground truth established by external clinical experts in the context of human or animal studies. The "ground truth" for bench testing would be the measured physical properties evaluated against internal design specifications.

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

This information is not provided and is not typically relevant for bench testing of medical devices where objective measurements are taken against specifications.

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

No MRMC or comparative effectiveness study involving human readers/AI was mentioned or conducted, as this device is an electrosurgical wand, not an AI-assisted diagnostic tool.

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

This is not applicable as the device is an electrosurgical wand, not an algorithm/AI system.

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

For the bench testing described, the "ground truth" would be objective measurements of physical parameters (e.g., ablation depth, thermal effect depth) against predefined engineering specifications. This is not derived from expert consensus, pathology, or outcomes data.

8. The sample size for the training set

Not applicable as this is not an AI/machine learning device. No "training set" was used.

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

Not applicable as this is not an AI/machine learning device.

Summary of Device Performance and Justification of Equivalence (from the document):

The submission demonstrates substantial equivalence primarily through non-clinical performance data (bench testing):

Performance Testing - Bench:
- Tests Performed: Functional testing, ablation life, coagulation, biocompatibility, and electrical safety testing.
- Purpose: Verify designs meet performance specifications and evaluate performance compared to the predicate device.
- Tissue Models: Muscle, cartilage, meniscus, and tendon.
- Settings: High, default, and low ablation and coagulation settings.
- Measurements: Amount of tissue removed (ablation depth) and thermal effect depth created.
- Conclusion: "The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device."
Technological Comparison to Predicate Device (Ambient Super MultiVac Wand, K083306):
- The document explicitly states: "The technological characteristics of the proposed subject devices are the same as the predicate device. No changes or modifications have been made to the intended use, fundamental scientific technology, or principle of operation previously cleared in 510(k) K083306."
- Several minor design differences (e.g., shaft length, outer diameter, number of internal suction ports, electrode screen attachment method, material for active wire connection point) are listed and justified as either improving performance (e.g., better access, improved visibility, better plasma resistance, improved fixation) or manufacturability without affecting safety or efficacy.
- Conclusion on Substantial Equivalence: "Non-clinical performance data such as design verification, tissue effect testing (histology, thermal margins) demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended." And "The differences between the KVac Wands and the predicate device do not raise any new concerns about the safety or effectiveness of the subject devices."

Summary

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

September 29, 2016

ArthoCare Corporation Ms. Ashley Johnston Regulatory Affairs Specialist 7000 West William Cannon Drive Austin, Texas 78735

Re: K162126

Trade/Device Name: Ambient® KVac™ Wand with Integrated Finger Switches (Ambient KVac IFS); KVac™ Integrated Cable Wand (KVac ICW) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: July 29, 2016 Received: August 1, 2016

Dear Ms. Johnston:

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 of medical devicerelated adverse events) (21 CFR Part 803); good manufacturing practice requirements as set forth

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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 Parts 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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 vours.

Christopher J. Ronk -S

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K162126

Device Name

ArthroCare® KVac® Integrated Cable Wand ArthroCare Ambient® KVac Wand with Integrated Finger Switches

Indications for Use (Describe) Please see attached.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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The KVac Wands (Ambient KVac IFS and KVac ICW) are indicated for resection, ablation, and coagulation of soft tissue, and hemostasis of blood vessels in arthroscopic and orthopedic procedures.

Joint	Ablation/Debridement	Excision/Resection	Coagulation
All Joints (Hip,Knee, Shoulder,Wrist, Ankle,Elbow)	■ Articular Cartilage■ Bursectomy■ Chondroplasty■ Fascia■ Ligament■ Scar Tissue■ Soft Tissue■ Synovectomy■ Tendon	■ Articular Labrum■ Capsule■ Cysts■ Ligament■ Loose Bodies■ Plica Removal■ Scar Tissue■ Soft Tissue■ Synovial Membrane■ Tendon	■ Articular Cartilage■ Ligament■ Tendon
Hip		■ Acetabular Labrum
Knee	■ ACL/PCL■ Notchplasty	■ Capsular Release■ Cartilage Flaps■ Discoid Meniscus■ Lateral Release■ Meniscal Cystectomy■ Meniscectomy■ Villusectomy	■ ACL/PCL■ Medial Retinaculum
Shoulder	■ Acromioplasty■ Subacromial Decompression	■ Frozen Shoulder Release■ Glenoidale Labrum	■ Glenohumeral Capsule■ Rotator Cuff
Wrist		■ Triangular Fibrocartilage(TECC)	■ Carpal Ligaments■ Wrist Tendons

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510(k) Summary

ArthroCare® Corporation

KVac™ Wands (Ambient® KVac™ Wand with Integrated Finger Switches and KVac™ Integrated Cable Wand)

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address	7000 West William Cannon DriveAustin, TX 78735
Contact Person:	Ashley JohnstonRegulatory Affairs SpecialistPhone: 512-358-5762Fax: 512-895-1489
Date Prepared:	September 27, 2016

Device Name

Proprietary Name:	Ambient® KVacTM Wand with Integrated Finger Switches (Ambient KVacIFS); KVacTM Integrated Cable Wand (KVac ICW)
Regulation Name:	Electrosurgical cutting and coagulation device and accessories
Regulatory Class:	II
Product Code:	GEI
Regulation Number:	21 CFR 878.4400

Predicate Device

Ambient Super MultiVac Wand with Integrated Finger Switches (IFS) of the K083306 ArthroCare ArthroWands Family, K083306 (cleared December 10, 2008)

Description

The KVac Wands will be offered in two versions: the KVac Wand with Integrated Cable (KVac ICW) and the Ambient KVac Wand with Integrated Finger Switches (Ambient KVac IFS). The two wands are identical in all design and functional aspects, as well as principle of operation, with the exception of the following:

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Integrated Finger Switches - The Ambient KVac IFS Wand will incorporate finger switches into the handle to activate the ablation and coagulation functions. The KVac ICW Wand is controlled via a foot pedal attached to the Controller (note: the foot pedal may also be used with the Ambient KVac IFS Wand to activate ablation and coagulation functions instead of the Integrated Finger Switches).
Proprietary Ambient Technology - The Ambient technology provides accurate (± 3 ℃) real time temperature monitoring of the circulating irrigation fluid in the joint space between 20 ℃ and 60 °C and includes a user adjustable alarm set-point. An alarm on the Quantum 2 Controller sounds if the temperature exceeds the pre-set range. Only the Ambient KVac IFS Wand will offer the Ambient® technology. This feature will not be available on the KVac ICW.

Aside from these features, the Wands are identical in all other aspects and are designed for the same intended use. The shafts of the Wands feature a 50 degree bend in the distal end, which terminates in the electrode tip. The electrode tip consists of a flat, tungsten screen welded to Platinum/Iridium lead wires, which pass through an alumina ceramic spacer that serves as a ground. Openings in the electrode screen overlay a spacer suction lumen, which connects with internal suction tubing that runs through and exits the handle and is connected to OR wall suction is used to draw the tissue closer to the active electrode for optimal ablation and also allows for increased user visibility by removing bubbles and floating tissue generated during tissue ablation. The handpiece is connected to the Quantum/Quantum 2 Controller via an integrated cable, which terminates in an 18-pin connector.

Intended Use/Indications for Use

Joint	Ablation/Debridement	Excision/Resection	Coagulation
All Joints (Hip,Knee, Shoulder,Wrist, Ankle,Elbow)	■ Articular Cartilage■ Bursectomy■ Chondroplasty■ Fascia■ Ligament■ Scar Tissue■ Soft Tissue■ Synovectomy■ Tendon	■ Articular Labrum■ Capsule■ Cysts■ Ligament■ Loose Bodies■ Plica Removal■ Scar Tissue■ Soft Tissue■ Synovial Membrane■ Tendon	■ Articular Cartilage■ Ligament■ Tendon
Hip		■ Acetabular Labrum
Knee	■ ACL/PCL■ Notchplasty	■ Capsular Release■ Cartilage Flaps■ Discoid Meniscus■ Lateral Release■ Meniscal Cystectomy■ Meniscectomy■ Villusectomy	■ ACL/PCL■ Medial Retinaculum
Shoulder	■ Acromioplasty■ Subacromial Decompression	■ Frozen Shoulder Release■ Glenoidale Labrum	■ Glenohumeral Capsule■ Rotator Cuff
Wrist		■ Triangular Fibrocartilage(TFCC)	■ Carpal Ligaments■ Wrist Tendons

Technological Comparison to Predicate

The technological characteristics of the proposed subject devices are the same as the predicate device. No changes or modifications have been made to the intended use, fundamental scientific technology,

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or principle of operation previously cleared in 510(k) K083306. The following table represents a summary of the technological characteristics:

Parameter	Predicate DevicesAmbient Super MultiVacWand (K083306)	Subject DevicesAmbient KVac IFS andKVac ICW Wands	Justification of Differences
Controllers	Quantum 2	Quantum/Quantum 2	Ambient KVac IFS Wand isused with Quantum 2 (for theAmbient technology);KVac ICW Wand is used withQuantum or Quantum 2
Wand Materials
Electrode Screen/Lead WireMaterial	Electrode screen attachedonly by epoxy with the legsof the screen bent into theholes of the spacer forconnection with lead wires	Electrode screen attachedto a ceramic spacer withepoxy and the legs of thescreen laser welded toPlatinum/ Iridium leadwires which pass throughholes in the spacer	Provides additional fixationof screen to wire leads
Active WireConnection Point	Tungsten	Platinum/Iridium	Platinum/Iridium is moreresistant to plasmadegradation. No effect onsafety or efficacy.
Wand Design
Shaft Length	137 mm	160 mm	Increased length improvesaccess to anatomical sites(e.g. hip)
Outer Diameterof Shaft	3.8 mm	3.4 mm	The smaller OD allows betteraccess to small jointanatomical spaces(e.g. knee)
Number ofInternal SuctionPorts	2	3	An increased number ofsuction ports improvevisibility by clearing bubbles.
Screen	Tungsten screen with legsbent into holes in spacer andbonded to spacer with epoxy.	Tungsten screen withwelded Pt/Ir leads that arebonded to holes in spacerwith epoxy.	Provides additional fixationof screen to wire leads.
Internal SuctionTubeConfiguration	Stainless steel tube betweensuction tube and ceramicspacer	Suction tube bondeddirectly to ceramic spacer	Improves manufacturabilityof the KVac wands. Noeffect on safety or efficacy.
ThermocoupleConnection	Autosplice	Autosplice and Solder	Improves stability ofconnection to thermocouple
Tyvek Packaging/Adhesive	Adhesive layer covers entireback of Tyvek lid	Adhesive is zone-coatedaround the edge of theTyvek	Packaging was validated toidentical parameters

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Performance Testing - Bench

Performance bench testing, inctional testing, ablation life, coagulation, biocompatibility, and electrical safety testing were performed on the KVac Wands, to verify the designs meet performance specifications and to evaluate the performance of the KVac Wands compared to the predicate device.

Performance testing was performed in tissue models representing muscle, cartilage, meniscus, and tendon. High, default and low ablation and coagulation settings were used to compare the amount of tissue removed (ablation depth) and thermal effect depth created. The test results demonstrate that the KVac Wands meet all design and performance specifications and are substantially equivalent to the predicate device.

Performance Testing - Animal

No animal data are included in this submission.

Performance Testing - Clinical

No clinical data are included in this submission.

Substantial Equivalence

Non-clinical performance data such as design verification, , tissue effect testing (histology, thermal margins) demonstrated that the subject devices are substantially equivalent to the predicate devices and are safe and effective when used as intended.

Summary

All testing demonstrates that the KVac Wands perform as intended and have acceptable mechanical properties when used in accordance with its labeling. The KVac Wands are substantially equivalent to the predicate Ambient Super Multi Vac Wand with IFS (K083306). The differences between the KVac Wands and the predicate device do not raise any new concerns about the safety or effectiveness of the subject devices.

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.