The mi-eye 3 needlescope™ with cannula, mi-eye tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination of an interior cavity of the body through either a natural or surgical opening.

Device Description

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is a portable visualization device that uses a probe with integrated camera and separate LCD monitor attached via a cable. The sterile, single-use needlescope probe includes the camera and image capture features with LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.

The mi-eye 3 needlescope™ with cannula is available in 75 and 95mm lengths with 0 and 25 degree viewing angles, relative to the axis of the probe is packaged with a scalpel, cannula, obturator and switching stick for use in creating and maintaining the channel for the probe. The monitor has a 12" (diagonal) screen. The probe weight is under 300 grams.

AI/ML Overview

This document is a 510(k) summary for a medical device (mi-eye 3 needlescope™ with cannula, mi-tablet 3™). It asserts substantial equivalence to a predicate device and provides a table of performance data showing various tests passed. However, it does not contain the specific information required to answer your detailed questions about acceptance criteria for AI/ML device performance, the study design for proving it meets those criteria, sample sizes, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

The provided text describes a traditional medical device (an arthroscope and its associated monitor) and focuses on engineering and safety performance testing (e.g., biocompatibility, electrical safety, sterilization, mechanical strength). It is not an AI/ML powered device submission.

Therefore, based solely on the provided text, I cannot answer the questions about acceptance criteria and studies proving the device meets those criteria, as these pertain to AI/ML device performance, which is not discussed in this document.

The document details performance data related to manufacturing, safety, and physical properties (as seen in the "Performance Data" table), but these are not the type of performance criteria (e.g., sensitivity, specificity, AUC) you would expect for an AI/ML-powered diagnostic device.

If you have a different document or there's a misunderstanding of what "acceptance criteria" you are referring to based on the provided text, please clarify.

Summary

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September 15, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Trice Medical, Inc. David Vancelette Vice President of Ouality Assurance & Regulatory Affairs 40 General Warren Blvd, Suite 100 Malvern, Pennsylvania 19355

Re: K212556

Trade/Device Name: mi-eye 3 needlescope™ with cannula, mi-tablet 3TM Regulation Number: 21 CFR 888.1100 Regulation Name: Arthroscope Regulatory Class: Class II Product Code: HRX Dated: August 12, 2021 Received: August 13, 2021

Dear David Vancelette:

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 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

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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,

Laura C. Rose, Ph.D. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

510(k) Number (if known) K212556

Device Name

mi-eye 3 needlescope™ with cannula, mi-tablet 3TM

Indications for Use (Describe)

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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1. 510(K) SUMMARY

DATE	September 14, 2021
APPLICANT	Trice Medical, Inc.40 General Warren BlvdSuite 100Malvern, PA 19355Tel: (610) 989-8080Fax: (610) 706-5063
OFFICIALCORRESPONDENT	David VanceletteTrice Medical, Inc.40 General Warren BlvdSuite 100Malvern, PA 19355dvancelette@tenexhealth.comTel: (949) 238-8220Fax: (949) 580-1270
TRADE NAME	mi-eye 3 needlescope™ with cannula, mi-tablet 3™
COMMON NAME	Arthroscope
DEVICECLASSIFICATION	Class II, 21 CFR §888.1100
PRODUCT CODE	HRX: Arthroscope
PREDICATE DEVICE	mi-eye 2, mi-eye 2 monitor (K162475), now rebrandedas mi-eye 3, mi-tablet 3
SUBMISSION TYPE	Special 510(k). The subject device is a modification tothe previously cleared mi-eye 2, mi-eye 2 monitor(K162475).

SUBSTANTIALLY EQUIVALENT TO:

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is substantially equivalent to the previously cleared mi-eye 2, mi-eye 2 monitor (K162475).

DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:

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LED light source. The mi-eye 3 probe connects to, and is powered by, the reusable mi-tablet 3. The mi-tablet 3 includes an internal battery and power supply, along with a cable for external charging. The mi-tablet 3 LCD Monitor displays a real-time image from the probe. The Monitor is also capable of connecting to separate ultrasound transducer, linear and convex, imaging probes and displaying their visual output. The mi-eye 3 needlescope™ with cannula has a rigid shaft that extends from the handle. The distal tip of the probe contains the camera, illumination, and imaging optics. Irrigation may be provided through the distal end of the probe from user supplied solution attached to the handle.

INDICATIONS FOR USE:

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of an interior cavity of the body through either a natural or surgical opening.

Property	Subject Devicemi-eye 3 needlescope™ with cannula, mi-tablet 3™	Predicate Devicemi-eye 2, mi-eye 2 monitor
510(k) Number	N/A	K162475
Indications for Use	The mi-eye 3 with cannula is indicated for usein diagnostic and operative arthroscopic andendoscopic procedures to provide illuminationand visualization of an interior cavity of thebody through either a natural or surgicalopening.	Same
Operating Principles	Transmission of light to illuminateand image an arthroscopic joint, thenrelaying the image out of the surgicalsite for processing and display.	Same
Property	Subject Devicemi-eye 3 needlescope™ with cannula, mi-tablet 3™	Predicate Devicemi-eye 2, mi-eye 2 monitor
Principle Components	• Imaging Probe with camera, rigid shaft, handle and output cable.• LCD Display Monitor• Irrigation channel for user supplied solution• Scalpel, Cannula, Obturator and Switching Stick (for establishing arthroscope channel)	SameSameSameN/A
Materials
Probe & Patientcontacting features	304 Stainless Steel	Same
Battery	Lithium Ion	Same
Technological Characteristics
Probe Handle Size	35 - 55mm diameter	Same
Probe Needle OuterDiameter	2.3mm	Same
Probe Cannula OuterDiameter	2.9mm	None
Working ProbeLengths	75 and 95mm	50, 95, 120 and 160mm
Camera Angle	0 and 25 degrees	0 and 15 degrees
Camera + DisplayResolution	400 x 400	Same
Image leveling	Image stabilized for probe's position (displaydoes not rotate). Arrow indicating the top sideof probe handle rotates in the image.	Top of probe alwaysoriented at top of display(display rotates as proberotates)
Tablet OperatingSystem	MS Windows 10 Pro	Same
Display output	HDMI and SDI	Same
Media capture	USB, DB9 and TRS	Same
Irrigation with AngledView Probe	User attached solution is channeled throughthe annulus between the two tubes to the distalend of the probe	None
Packaging for SingleUse Probe	Sealed Tyvek lid and thermal formed tray	Same
Sterilization Method	Ethylene Oxide	Same
Sterility AssuranceLevel	10-6	Same

COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE:

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Image /page/5/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon on the left and the words "Trice Medical" in black on the right. The icon is a stylized design with three curved shapes converging in the center, resembling a three-leaf clover or a stylized medical symbol.

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Image /page/6/Picture/0 description: The image shows the logo for Trice Medical. The logo consists of a blue circular icon with three curved shapes inside, resembling a stylized flower or a three-way intersection. To the right of the icon, the words "Trice Medical" are written in a simple, sans-serif font, with the first letter of each word capitalized.

PERFORMANCE DATA:

The following performance data were provided in support of the substantial equivalence determination.

Test	Method	Result
Biocompatibility	ISO 10993-1ISO 10993-5	Pass
Electrical Safety & EMC	IEC 60601-1IEC 60601-1-2IEC 60601-2-18IEC 60529	Pass
Packaging	ASTM D4169, ASTM F2096, ASTMF88/F88M, ISO 11607-1, ISO 11607-2	Pass
Performance - BenchIrrigation FlowTube strength	ISO 9626	Pass
Shelf Life	ASTM F1980, ASTM F88/F88M, ISO 11607-1,ISO 11607-2	Pass
Software V&V	IEC 62304	Pass
Specification &Dimensional Analysis	ISO 594-1, ISO 594-2, ISO 7864, ISO 80369-7,ISO 9626	Pass
Sterilization	ISO 11135, ISO 11737-1, ISO 10993-7	Pass
Usability Validation	IEC 60601-1-6, IEC 62366-1	Pass

CONCLUSION:

The mi-eye 3 needlescope™ with cannula, mi-tablet 3™ Arthroscope is substantially equivalent in design, intended use, principles of operation, technological characteristics and safety features to the predicate device. There are no new issues of safety and/or effectiveness introduced by the mi-eye 3 needlescope™ with cannula, mi-tablet 3™ Arthroscope when used as instructed.

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.