The MB 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

AI/ML Overview

Acceptance Criteria and Study for Millennium Biomedical Inc. MB 103 Millennium Blades

Based on the provided document, the MB 103 Millennium Blade is a replacement blade for a microkeratome, not a diagnostic AI device requiring complex performance assessments. The acceptance criteria and supporting "study" are therefore focused on physical and functional equivalence to predicate devices, rather than typical AI performance metrics like sensitivity or specificity.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the device, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to predicate devices in terms of physical characteristics and performance, as presented in the "How the technological characteristics of the device compare to those of the predicate or legally marketed devices" section. The "reported device performance" refers to the results of the field study.

Acceptance Criteria (Technological Characteristics)	MB 103 Millennium Blade Performance (Reported)
Intended Use	As a replacement blade for the Moria CB Microkeratome.
Operating Principle	Blade held in keratome head, oscillates by turbine; keratome head adapts to turbine via threaded part; gas-powered turbine motor.
Blade Design	Single edge blade with plastic blade holder.
Blade Hardness	52 Rockwell C
Sterilization Method	Cobalt 60 radiation
Blade Material	Stainless steel
Blade Holder Material	Delrin
Patient Contact Portion of Device	Blade cutting edge
Dimensional Equivalency	Match to predicate (specific measurements not explicitly stated as criteria, but shown to be equivalent).
Sharpness Verification	Clinically tested and verified.
Overall Performance	Acceptable for intended use; no adverse events reported.

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

Sample Size: Not explicitly stated as a number of devices or procedures. The study is referred to as a "market field study," implying real-world usage.
Data Provenance: The study was "conducted in Korea and China." It is a prospective observational study, as it's a "market field study" assessing performance and adverse events during use.

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

This type of information is not applicable and not provided for this device. The "ground truth" here is successful performance in clinical use as a surgical blade, which would be assessed by the performing surgeons during the "market field study." No formal "experts" establishing "ground truth" on individual cases are mentioned in the context of an AI study.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically relevant for AI studies involving subjective human assessment for ground truth determination. This is not applicable here as the "ground truth" is direct device performance in a surgical context, rather than interpretive diagnostic outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study assesses how AI assistance impacts human reader performance, which is not relevant for a surgical blade.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (in the context of an AI algorithm) was not performed. The device is a physical surgical blade, not an algorithm. Its performance is inherently "standalone" in its mechanical function, but evaluated in the context of human surgical use.

7. The Type of Ground Truth Used

The ground truth used was outcomes data and expert observation. The "market field study" essentially assessed the blade's performance in its intended use, with the primary outcome being "acceptable performance" and the absence of "adverse events" as reported by the users (surgeons) in the target markets. "Clinically tested and verified" for sharpness also implies a form of ground truth established by clinical observation of performance.

8. The Sample Size for the Training Set

This concept is not applicable. The device is a physical product, not an AI algorithm that requires a "training set." The design and manufacturing process would involve internal testing and validation, but this is distinct from "training data" for an algorithm.

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

Not applicable, as there is no "training set" in the AI sense for this device. The design and engineering process established the specifications based on predicate devices and presumably internal quality standards for surgical blades.

Summary

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Millennium Biomedical Inc. MB 103 Millennium Blades

FEB 1 5 2002

May 22, 2001 Premarket Notification K011833

Section 16 Summary of Safety and Effectiveness

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Millennium Biomedical Inc. MB 103 Millennium Blades

K011833

Summary of Safety and Effectiveness

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

Submitter's name, address, telephone number, contact person, and data 1. summary prepared:

Millennium Biomedical Inc. a. 360 East Bonita Avenue Pomona, California 91767 (909)-621-7646 Phone: 909)-621-7556 Fax:
Contact Person: b.

Jerry Kaeni President

May 22, 2001

Date Summary Prepared: C.

Name of device, including trade name and classification name: 2.

a.	Trade/Proprietary Name:	MB 103 Millennium Blades
----	-------------------------	--------------------------

Keratome, AC-Powered, and/or Blades Classification Name: b.
Identification of the predicate device or legally marketed device or devices to 3. which substantial equivalence is being claimed:

Company	Device	510(k) No.	Date Cleared
Moria(PlanconInstruments)	Moria CB Blade	K980924	04-15-1998
Surgical SpecialtiesCorp.	Precision EdgeMicrokeratomeBlade	K002849	10-18-2000

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A description of the device that is the subject of the 510(k), including 4. explanation of how device function, basic scientific concepts, significant physical and performance characteristics (design, material, physical properties):
The MB 103 Millennium Blade is a replacement blade designed to be used with the Moria CB Microkeratome. The MB 103 Millennium Blade is a single-use only, disposable device. The Blade material is similar to that used in predicate devices (stainless steel).

A statement of intended use: 5.

The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.

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Millennium Biomedical Inc
MB 103 Millennium Blades

May 22, 2001
Premarket Notification

A statement of how the technological characteristics of the device compare to those of the predicate or legally
marketed devices: 9

CHARACTERISTICS	MORIA CB BLADE(PREDICATE DEVICE)	MBI MB 103MILLENNIUM BLADE
Intended Use	Indicated for use with the MoriaCB Microkeratome by surgeons tocut cornea in the form of a hingedflap in LASIK refractive surgeryprocedures.	Indicated for use as a replacementblade for the Moria CBMicrokeratome.
Operating Principle	The blade is held in the keratomehead and oscillates by means ofthe turbine. The keratome headadapts to the turbine by means of athreaded part. The turbine motoris gas powered.	The blade is held in the keratomehead and oscillates by means ofthe turbine. The keratome headadapts to the turbine by means of athreaded part. The turbine motoris gas powered.
Blade Design	Single edge blade with the plasticblade holder	Single edge blade with the plasticblade holder
Blade Hardness	52 Rockwell C	52 Rockwell C
Sterilization Method	Cobalt 60 radiation	Cobalt 60 radiation
Blade Material	Stainless steel	Stainless steel
Blade Holder Material	Delrin	Delrin
Patient Contact Portion of Device	Blade cutting edge	Blade cutting edge

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illennium Biomedical I

May 22, 2001
Premarket Notification

MENSIONAL EQUIVALENCY CHA

IILLENNIUM BLAMB 103	0.4600" ±0.002"	0.316" ± 0.001"1	.010" ± 0.0003"	130	2800" ± 0.0010"	0.0860" ± 0.0010"	Clinically tested and verific
REDICATE DEVICE) MEASUR	0.45975	0.31570	0.1015:	이 대한민국 대학교 대학교 대학교 대학교10000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000000013°:	0.2810	10.0861	:1-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------	: 上一篇:and the comments of the comments of:
TRIBUT	Length	Width	ﺍﻟﻤﺮﺍﺟﻊ ﺍﻟﻤﺴﺘﻘﻠﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﺘﻲ ﺗﻘﺮﻳﺒﺎ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟﻤﺘﻮﻗﻊ ﺍﻟThicknes	ar of the pand and the comments of the countBevel	Mounting hole length	产品 2017Aounting hole width	arpness verification	and the production of the count

・・・・・・・・・・・

: 上一篇:

서로 이용된 사람들이 보

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7. Brief summary of clinical tests and results

The performance of the MB 103 Millennium Blades was found to be acceptable by rne perfermanate from the market field study conducted in Korea and China. The positive roombile intended use and there were no adverse events reported when used according to the Moria CB microkeratome manufacturers' instructions.

. RET 2016 01/05/2000 09/04/2008 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three stripes representing the agency's mission to protect the health of all Americans and provide essential human services.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 5 2002

Mr. Jerry Kaeni President Millennium Biomedical Inc. 360 East Bonita Avenue Pomona, CA 91767

Re: K011833

Trade/Device Name: MB 103 Millennium Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: December 1, 2001 Received: December 7, 2001

Dear Mr. Kaeni:

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. Jerry Kaeni, President

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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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Millennium Biomedical Inc. MB 103 Millennium Blade

May 22, 2001 Premarket Notification

510(k) Number (if known):	K011833
Device Name:	MB 103 Millennium Blade
Indications for Use:

The MB 103 Millennium blade is intended to be used as a replacement blade for the Moria CB Microkeratome.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Denise L. McCarthy

(Division Sign-Up)
Division of Ophthalmic Ear,
Nose and Throat Devices

510(k) Number K011833

Prescription Use _

(Per 21 CFR 801.109)

Over-The-Counter Use _ OR

Regulation Number and Section

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.