MicroAire's SMARTRELEASE® Endoscopic Soft Tissue Release System is comprised of four (4) components: The SMARTRELEASE® Endoscope, the SMARTRELEASE® Handpiece, the SMARTRELEASE® Standard and Low Profile Blade Assemblies and the SMARTRELEASE® Sterilization Tray. In addition, the system includes a set of FDA Class 1 Manual Surgical Instruments. The SMARTRELEASE® Handpiece, the SMARTRELEASE® Endoscope, and the Manual Surgical Instruments are re-usable after cleaning and subsequent sterilization in the SMARTRELEASE® Sterilization Tray. The SMARTRELEASE® Blade Assemblies are gamma sterilized, single-use devices.

AI/ML Overview

The provided text describes the MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System and its 510(k) summary, which outlines the device's technical characteristics, intended use, and comparison to predicate devices, along with a summary of supporting data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state quantitative acceptance criteria in a tabular format with corresponding reported performance metrics. Instead, it generally states that the device "passed" various tests or "demonstrated" the intended use safely and effectively.

Based on the "Summary of Supporting Data," the following functional tests were performed. The acceptance criteria for these would implicitly be successful completion and performance as intended.

Acceptance Criteria (Implied)	Reported Device Performance
Blade Assembly Actuation (proper deployment/retraction)	All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Assembly Actuation.
Horizontal Deflection (within acceptable limits for stability)	All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Horizontal Deflection performance.
Vertical Deflection (within acceptable limits for stability)	All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Vertical Deflection performance.
Blade Sharpness (sufficient for cutting ligament/fascia)	All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Sharpness.
Blade Piercing (sufficient for initial penetration)	All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform its intended use safely and effectively, including Blade Piercing.
Performance in Cadaver Study (surgical efficacy and safety)	The system was evaluated by multiple surgeons per the instructions for use during a cadaver study. All test results demonstrated the system can perform its intended use safely and effectively.
Package and Distribution Testing (maintaining integrity)	The SMARTRELEASE® Endoscopic Soft Tissue Release System passed package and distribution testing.
Biocompatibility Testing (safety for human contact)	The SMARTRELEASE® Endoscopic Soft Tissue Release System passed applicable biocompatibility testing.
Sterilization Tray (meeting ANSI AAMI ST 77:2003 requirements)	The sterilization tray meets the requirements set forth in ANSI AAMI ST 77:2003.

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

Test Set Sample Size: The document mentions a "cadaver study" where the system was "evaluated by multiple surgeons." However, it does not specify the number of cadavers used or any other quantitative sample size for the functional tests.
Data Provenance: The document does not explicitly state the country of origin of the data. The study appears to be prospective in the sense that MicroAire conducted these tests specifically to support their 510(k) submission.

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

Number of Experts: The document states the cadaver study was evaluated by "multiple surgeons." A specific number is not provided.
Qualifications of Experts: The experts are identified as "surgeons," which implies they are medically qualified to assess surgical device performance. No specific details on their years of experience or sub-specialty (e.g., orthopedic surgeons, hand surgeons) are provided.

4. Adjudication Method for the Test Set:

The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the cadaver study or other functional tests. It simply states that "multiple surgeons" evaluated the system, implying a consensus or individual assessment against predetermined criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The study appears to be focused on demonstrating the safety and effectiveness of the device itself rather than comparing human reader performance with and without AI assistance. The device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

This question is not applicable to the device described. The MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System is a physical surgical instrument system, not an algorithm or software-only device. Therefore, a standalone performance study without human involvement is not relevant in this context. The functional tests and cadaver study describe the direct performance of the physical device components.

7. Type of Ground Truth Used:

For the cadaver study, the ground truth was established by expert assessment/consensus (the evaluation by "multiple surgeons") regarding the device's ability to perform its intended use safely and effectively in a simulated surgical environment (cadavers).
For the functional tests (Blade Assembly Actuation, Horizontal and Vertical Deflection, Blade Sharpness, Blade Piercing, etc.), the ground truth would have been based on engineering specifications and performance standards.

8. Sample Size for the Training Set:

This question is not applicable as the device is a physical surgical instrument and not an AI/machine learning algorithm that requires a training set.

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

This question is not applicable for the same reason as point 8.

Summary

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November 6, 2018

MicroAire Surgical Instruments LLC % Ms. Vikki O'Connor Regulatory Affairs Consultant Ambriel Associates, Inc. 411 Walnut St. Unit 9236 Green Cove Springs, Florida 32043

Re: K181819

Trade/Device Name: SMARTRELEASE Endoscopic Soft Tissue Release System Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX, KCT, EMF Dated: October 4, 2018 Received: October 5, 2018

Dear Ms. O'Connor:

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 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 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 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.

Long H. Chen - Digitally signed by Long H.
Chen - Chen - Chen -s Date: 2018.11.06 08:16:55 S -05'00'

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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K181819

Device Name

MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System

Indications for Use (Describe)

The MicroAire SMARTRELEASE® Endoscopic Soft Tissue Release System is indicated for use in minimally invasive ligament or fascia release:

· Carpal tunnel release in the wrist
Cubital tunnel release in the elbow

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: MicroAire SMARTRELEASE®

Endoscopic Soft Tissue Release System

In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular, 21 CFR Part 807.92, the following summary of information is provided:

Submitter:	MicroAire® Surgical Instruments Inc.
	3590 Grand Forks Blvd.
	Charlottesville, VA 22911 USA
Contact Person	Vikki M. O'Connor
	Regulatory Consultant
	Phone : 207-214-8535
	Email : vikki0730@yahoo.com
Correspondance	Mr. Glenn Gerstenfeld
	Vice President, QA/RA and Compliance Officer
	Phone: 434-975-8344
	FAX: 434-975-4144
	Email: glenn.gerstenfeld@microaire.com
Date Prepared	November 5, 2018
Trade Name	MicroAire SMARTRELEASE® Endoscopic Soft Tissue
	Release System
Proposed Class	Class II
Classification Name	Diagnostic Devices - Arthroscope, 21 CFR 888.1100,
and Number	Class II
	Sterilization Container, 21 CFR 880.6580, Class II
	Manual Surgical Instrument, 21 CFR 878.4800, Class I
Product Code	HRX, KCT, EMF
Predicate Devices	Deployment Handle and Blade Assembly Primary
	Predicate – A.M. Surgical Mountable Endoscopic Blade -
	K080133 (Class I), A.M. Surgical STRATOS® Endoscopic
	Release System – Carpal and Cubital Tunnel Release
	(Class I, no 510k). Reference: 3M Carpal Tunnel System -
	K881703 (Class II) Carpal Tunnel Release.
	Arthroscope Primary Predicate - Henke Sass Wolfe
	Arthroscope: K080560 (Class II);
	Sterilization Tray Primary Predicate - Paragon Medical
	Inc. Surgical Instrument Delivery System: K032119 (Class
	II);
Device Description	MicroAire's SMARTRELEASE® Endoscopic Soft TissueRelease System is comprised of four (4) components: TheSMARTRELEASE® Endoscope, the SMARTRELEASE®Handpiece, the SMARTRELEASE® Standard and LowProfile Blade Assemblies and the SMARTRELEASE®Sterilization Tray. In addition, the system includes a set ofFDA Class 1 Manual Surgical Instruments. TheSMARTRELEASE® Handpiece, the SMARTRELEASE®Endoscope, and the Manual Surgical Instruments are re-usable after cleaning and subsequent sterilization in theSMARTRELEASE® Sterilization Tray. TheSMARTRELEASE® Blade Assemblies are gammasterilized, single-use devices.
Intended Use	The MicroAire® SMARTRELEASE® Endoscopic SoftTissue Release System is indicated for use in minimallyinvasive ligament or fascia release:• Carpal tunnel release in the wrist• Cubital tunnel release in the elbow
Subject DeviceSummary of theTechnologicalCharacteristics	The SMARTRELEASE® Endoscope is a standardendoscope used in endoscopic / arthroscopic surgery. Itconnects to any standard C-mount video camera systemfor visualization and has a light post and two Light Post
	Adapters that attach to six of the most common lightsources. There is no electrical source and the endoscopeis re-usable after cleaning and heat sterilization.The SMARTRELEASE® Handpiece has a pistol grip andtrigger to facilitate raising and retracting the surgical blade.The SMARTRELEASE® Blade Assembly is designed tocut the carpal tunnel ligament or fascia release in thecubital tunnel with one retracting cut.The SMARTRELEASE® Sterilization Tray is large enough,and segmented, to hold and heat sterilize all devices andinstruments required to perform a carpal or cubital tunnelsurgery. The sterilization tray meets the requirements setforth in ANSI AAMI ST 77:2003.
Comparison toPredicate(s)	The SMARTRELEASE® Endoscope is made by contractmanufacturer Henke Sass Wolf and is identical to theHenke Sass Wolf Arthroscope (K080560). This is the samearthroscope used in the 3M Carpal Tunnel System.MicroAire's SMARTRELEASE® Handpiece and BladeAssembly is similar in technology, materials and design tothe predicates. The subject and predicate devices allprovide technology to access the wrist or elbow to releasethe ligament or fascia during carpal or cubital tunnelsurgery. The Handpieces are made of similar materials,hold the Blade Assembly and can deploy the blade tomake a cut and retract the blade for removal of the devicefrom the surgical area(s). The blades are made of 300/400series stainless steel and are sharp enough to cut fascia /
	ligament and are biocompatible.
	The subject and predicate tray are made from 300 SeriesStainless Steel and hold all devices that require re-sterilization. The subject sterilization tray includes a siliconmat.
Summary ofSupporting Data	The following functional testing was performed to verify thefollowing basic functions of the Handpiece and BladeAssembly: Blade Assembly Actuation, Horizontal andVertical Deflection, Blade Sharpness and Blade Piercing.The system was also evaluated by multiple surgeons perthe instructions for use during a cadaver study. All testresults demonstrated the MicroAire SMARTRELEASE SoftTissue Release System can perform it's intended usesafely and effectively.In addition, the SMARTRELEASE® Endoscopic SoftTissue Release System passed package and distributiontesting and applicable biocompatibility testing.

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Summary / Conclusion

MicroAire's SMARTRELEASE® Endoscopic Release System is comprised of the SMARTRELEASE® Handpiece and SMARTRELEASE® Blade Assembly(s) which are FDA Class I Manual Surgical Instruments. The addition of the dedicated SMARTRELEASE® Endoscope to the system and a Sterilization Tray for re-sterilizing the Endoscope, Handpiece and Class I instruments make the overall system a Class II device.

Basic device functional tests and a cadaveric study by multiple surgeons were performed to evaluate the system for the intended use. All test results demonstrated the MicroAire SMARTRELEASE Soft Tissue Release System can perform the intended use safely and effectively.

Regulation Number and Section

§ 888.1100 Arthroscope.

(a)
Identification. An arthroscope is an electrically powered endoscope intended to make visible the interior of a joint. The arthroscope and accessories also is intended to perform surgery within a joint.(b)
Classification. (1) Class II (performance standards).(2) Class I for the following manual arthroscopic instruments: cannulas, currettes, drill guides, forceps, gouges, graspers, knives, obturators, osteotomes, probes, punches, rasps, retractors, rongeurs, suture passers, suture knotpushers, suture punches, switching rods, and trocars. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 888.9.