The MD-6W Wireless Critical Data Viewer is intended to display patient vital signs in such a way that the data is continuously in a medical specialist's field of view. A typical application would be to view the vital signs of a patient undergoing surgery.

Device Description

The MD-6W Wireless Critical Data Viewer contains a mobile viewer (consisting of an LCD display unit, non-prescription safety glasses, and a control box with signal converter and lithium-ion rechargeable battery) and a base station that connects via cable to a patient monitor. The LCD display unit is mounted on the non-prescription safety glasses and is connected via a four-foot cable to the control box. The control box receives signal via wireless telemetry from the base station. The battery is recharged using a separate battery charger.

AI/ML Overview

Acceptance Criteria and Device Performance Study for MD-6W Wireless Critical Data Viewer

This document describes the acceptance criteria and the study that proves the MD-6W Wireless Critical Data Viewer meets these criteria, based on the provided 510(k) summary.

Note: The provided document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than presenting extensive de novo performance studies with detailed statistical analyses for novel devices.

1. Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Technological Characteristics	Indication, display format, field of view, focal range similar to predicate device (MD-6 Critical Data Viewer).	The MD-6W Wireless Critical Data Viewer is similar to the predicate device in terms of indication, display format, field of view, and focal range.
Performance Testing	Acceptability demonstrated through standard optical, electrical, firmware, and mechanical tests.	The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device.

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

The provided 510(k) summary does not explicitly detail a specific "test set" or its sample size in the way one might expect for a de novo performance study involving human subjects or image analysis. The performance testing appears to be centered on engineering and technical validation rather than clinical efficacy measured in a patient cohort.

Sample Size for Test Set: Not specified. The testing described (optical, electrical, firmware, mechanical) would typically involve testing of device units/components rather than a patient or clinical data set.
Data Provenance: Not applicable in the context of a clinical test set. The tests are likely internal engineering and quality assurance tests.

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

This information is not applicable or provided in the context of the described performance testing. The "ground truth" for optical, electrical, firmware, and mechanical tests would be defined by engineering specifications and industry standards, not expert consensus from medical professionals.

4. Adjudication Method for the Test Set

This information is not applicable or provided. Since the testing focuses on technical performance (optical, electrical, mechanical), there would not be an adjudication method like 2+1 or 3+1 used for expert consensus in a clinical evaluation.

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

No MRMC comparative effectiveness study was mentioned or performed. The 510(k) summary focuses on substantial equivalence to a predicate device and technical performance testing, not on the impact of the device on human reader performance (e.g., medical specialists). Therefore, no effect size of human readers improving with AI vs. without AI assistance can be determined from this document. The device is a display tool, not an AI-powered diagnostic aid.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted, but it was purely technical. The summary states, "The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device." This implies an evaluation of the device's technical specifications and functionality independent of human interaction beyond basic usability. It's not a standalone clinical performance study, but a standalone engineering performance evaluation.

7. Type of Ground Truth Used

The "ground truth" for the performance testing cited (optical, electrical, firmware, and mechanical) would be based on:

Engineering Specifications: The design and performance parameters defined by MicroOptical Corporation.
Industry Standards: Relevant electrical safety, optical performance, and mechanical durability standards.
Predicate Device Performance: Implicitly, the performance of the predicate device (MD-6 Critical Data Viewer) sets a benchmark for substantial equivalence.

It does not involve expert consensus, pathology, or outcomes data in the context of clinical "ground truth."

8. Sample Size for the Training Set

Not applicable. This device is a display system, not a machine learning or AI-driven diagnostic tool that requires a "training set" of data. Its function is to display vital signs, and its performance is evaluated based on its ability to do so reliably and according to its specifications.

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

Not applicable. As there is no training set for this device, a method for establishing its ground truth is not relevant.

Summary

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KD42923

DEC 17 2004

510(k) Summary for MD-6W Wireless Critical Data Viewer

1. SPONSOR

The MicroOptical Corporation 33 Southwest Park Westwood, MA

Contact Person:	Paul Zavracky, Ph.D., President
Telephone:	781-326-8111

Date Prepared: October 20, 2004

2. DEVICE NAME

Proprietary Name:	MD-6W Wireless Critical Data Viewer
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

The MD-6W Wireless Critical Data Viewer is substantially equivalent to MicroOptical's MD-6 Critical Data Viewer, 510(k) No. K040244.

4. DEVICE DESCRIPTION

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ഗ് INTENDED USE

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The MD-6W Wireless Critical Data Viewer is similar to the predicate device in terms of indication, display format, field of view, and focal range.

7 PERFORMANCE TESTING

The MD-6W Wireless Critical Data Viewer has been subjected to standard optical, electrical, firmware, and mechanical tests to demonstrate the acceptability of the device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 17 2004

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

Re: K042923

Trade/Device Name: MD-6W Wireless Critical Data Viewer Regulation Number: 21 CFR 876.1500 Regulation Name: Laparoscope and accessories Regulatory Class: II Product Code: GCJ Dated: October 20, 2004 Received: October 20, 2004

Dear Mr. Dillon:

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.

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Page 2 - Mr. Daniel J. Dillon

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 (240) 276-0115. 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

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

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Indications for Use

510(k) Number (if known):

MD-6W Wireless Critical Data Viewer Device Name:

Indications for Use:

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)

Muriam C. Provost

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

510(k) Number K042723

October 20, 2004

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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.