MicroOptical's Critical Data Viewers are intended to display video images or patient data while mounted in front of the user's eye(s) anytime a video display is used. Typical applications include display of images from endoscopic cameras, ultrasound imaging systems, magnetic resonance imaging systems, or display of data from any type of patient monitor.

Device Description

MicroOptical's Critical Data Viewers contain an LCD display unit, nonprescription safety glasses, a control box with signal converter and battery mount, cables from viewer to control box and from control box to signal source, a lithium-ion rechargeable battery and a battery charger. The LCD display unit is mounted on a pair of non-prescription safety glasses and is connected via a fourfoot cable to a small battery-powered control box that can be clipped onto a belt. A cable from the control box connects the control box to the video source. The battery is recharged using a separate battery charger. MicroOptical's Critical Data Viewers operate using a standard VGA signal and displaying it onto a small LCD.

AI/ML Overview

The provided text describes MicroOptical's Critical Data Viewers and their 510(k) submission, listing predicate devices and intended use, but it does not contain information about specific acceptance criteria, device performance metrics, or a detailed study proving the device meets acceptance criteria in the way typically found for AI/ML-based medical devices.

The "PERFORMANCE TESTING" section states generally: "MicroOptical's Critical Data Viewers have been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device." This is a very high-level statement and does not provide the granular information requested about acceptance criteria, study design, or specific results.

Therefore, many of the requested fields cannot be populated from the provided document.

Here's a breakdown of what can and cannot be answered based on the text:

1. Table of acceptance criteria and the reported device performance:

Cannot be provided. The document states "standard optical, electrical, firmware, and mechanical tests" were performed, but no specific acceptance criteria or their corresponding performance results are detailed.

2. Sample sized used for the test set and the data provenance:

Cannot be provided. No information on specific test sets, sample sizes, or data provenance (country of origin, retrospective/prospective) is given for the "standard tests."

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

Cannot be provided. This is not relevant for the type of device (a head-mounted display) or the type of performance testing mentioned (optical, electrical, mechanical). Ground truth establishment by experts is typically for diagnostic/interpretive devices assessing images or data.

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

Cannot be provided. See point 3.

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:

Cannot be provided. This device is a display system, not an AI/ML diagnostic or assistive tool. There is no mention of such a study.

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

Cannot be provided. This is not an algorithmic device. Performance would relate to display quality, robustness, etc., not algorithmic output.

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

Cannot be provided. For "standard optical, electrical, firmware, and mechanical tests," ground truth typically refers to engineering specifications, calibrated measurements, and adherence to established industry standards, not medical ground truth from patient data or expert consensus.

8. The sample size for the training set:

Cannot be provided. This device does not have a training set in the context of AI/ML.

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

Cannot be provided. See point 8.

In summary: The provided document is a 510(k) summary for a head-mounted display system. Its performance evaluation focuses on engineering and functional capabilities (optical, electrical, mechanical) rather than an AI/ML algorithm's diagnostic accuracy or clinical effectiveness, which would typically involve expert-adjudicated ground truth and specific performance metrics. Therefore, most of the detailed questions regarding study design and AI/ML specific criteria cannot be answered.

Summary

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

K040244 1 of 2

MAR 2 4 2004

510(k) Summary for MicroOptical's Critical Data Viewers

1. SPONSOR

The MicroOptical Corporation Westwood, MA

Contact Person: Mark Spitzer, Ph.D., Chief Executive Officer 781-326-8111

2. Device Name

Proprietary Name:	Models MD-3 and MD-6
Common/Usual Name:	Head-mounted display system
Classification Information:

Head-mounted display systems have been classified as Class II devices under the following classification name:

Name	Product Code	21 CFR Ref.	Panel
Laparoscope and accessories	GCJ	876.1500	General Surgery

3. PREDICATE DEVICES

MicroOptical's Critical Data Viewers are substantially equivalent to the Nomad ND1000M Augmented Vision System, 510(k) No. K030940 and the Vista Head Mounted Display System (510(k) No. K961800).

4. DEVICE DESCRIPTION

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

KD40244 2 of 2

INTENDED USE 5.

TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

MicroOptical's Critical Data Viewers are similar to the predicate devices in terms of indication, display format, field of view and focal range.

7 PERFORMANCE TESTING

MicroOptical's Critical Data Viewers have been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

MAR 2 4 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

The MicroOptical Corporation c/o Mr. Daniel J. Dillon, RAC. CQA-Biomedical Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K040244

Trade/Device Name: MD-3 and MD-6 Critical Data Viewers Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: February 2, 2004 Received: February 3, 2004

Dear Mr. Dillion:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth 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 1000-1050.

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

Page 2 - Mr. Daniel J. Dillon, RAC, CQA-Biomedical

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

44 Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known): K040244

MD-3 and MD-6 Critical Data Viewers Device Name:

Indications for Use:

MicroOptical's Critical Data Viewers are intended to display video images or patient data while mounted in front of the user's eye(s) anytime a video display is used. Typical witho mount include display of images from endoscopic cameras, ultrasound imaging apprivations magnetic resonance imaging systems, or display of data from any type of patient monitor.

Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative. and Neurological Devices

510(k) Number_________________________________________________________________________________________________________________________________________________________________

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.