The MB 102 Millennium Blade is a replacement blade designed to be used with the Hansatome™ Microkeratome. The MB 102 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 MB 102 Millennium Blades

The provided document describes the premarket notification for the Millennium Biomedical Inc. MB 102 Millennium Blades, which are intended as replacement blades for the Hansatome™ Microkeratome. The primary method of demonstrating safety and effectiveness is through substantial equivalence to a predicate device, the B&L Accuglide™ Blade.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated in a quantitative manner but are implied through the comparison of technological characteristics to the predicate device and the successful functional performance testing. The "reported device performance" is essentially the determination of substantial equivalence based on these comparisons and tests.

Characteristic	Acceptance Criteria (Implied: Substantially equivalent to predicate)	Reported Device Performance (MB 102 Millennium Blade)
Intended Use	Indicated for use with the Hansatome™ Microkeratome by surgeons to cut cornea in the form of a hinged flap in LASIK refractive surgery procedures.	Intended to be used as a replacement blade for the Hansatome™ Microkeratome.
Operating Principle	Blade held in keratome head, oscillates via turbine, adapts to turbine via threaded part, gas-powered turbine motor.	Blade held in keratome head, oscillates via turbine, adapts to turbine via threaded part, gas-powered turbine motor.
Blade Design	Single edge blade with plastic blade holder.	Single edge blade with plastic blade 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	Blade cutting edge.	Blade cutting edge.
Functional Performance	Acceptable functional performance.	Functional performance was found to be acceptable and substantially equivalent to the predicate blade.

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

Sample Size: The document does not specify a numerical sample size for the functional performance testing. It refers to "test results of the functional performance testing" but provides no quantitative details on how many blades were tested or under what conditions.
Data Provenance: The document does not specify the country of origin of the data. The data appears to be retrospective in the sense that it relies on a comparison to an already marketed predicate device and likely internal testing to confirm equivalence. There is no mention of a prospective clinical trial.

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

The document does not mention the use of experts to establish a "ground truth" in the traditional sense for the functional performance testing. The comparison is made against the established characteristics and performance of the predicate device, which is already FDA-cleared.

4. Adjudication Method for the Test Set

No adjudication method is described. The assessment appears to be based on direct comparison of technological characteristics and internal functional performance testing.

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

No MRMC study was done. The device is a surgical blade, and the evaluation relies on its physical and functional equivalence to a predicate device, not on comparative effectiveness with human readers or AI assistance.

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

This concept is not applicable to the device, which is a physical surgical blade. Therefore, no standalone study in this context was performed.

7. Type of Ground Truth Used

The "ground truth" for the MB 102 Millennium Blade's performance is implicitly the established performance and characteristics of the predicate device (B&L Accuglide™ Blade). The study's goal was to demonstrate that the MB 102 Millennium Blades are "substantially equivalent" to this predicate.

8. Sample Size for the Training Set

This concept is not applicable to this device. As a physical medical device, there is no "training set" in the context of an algorithm or AI.

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

Not applicable, as there is no training set for this device.

Summary

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

Millennium Biomedical Inc. MB 102 Millennium Blades

: 201

December 26, 2001 Premarket Notification

K020122

FEB 1 5 2002

Section 16

Summary of Safety and Effectiveness

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

K020122

Millennium Biomedical Inc. MB 102 Millennium Blades

December 26, 2001 Premarket Notification

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: Fax: (909)-621-7556

Contact Person: b.

Jerry Kaeni President

Date Summary Prepared: C.

December 26, 2001

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

a. Trade/Proprietary Name:	MB 102 Millennium Blades
----------------------------	--------------------------

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

Company	Device	510(k) No.	Date Cleared
Chiron Vision(Bausch & Lomb)	Hansatome™Microkeratomewhich uses Bausch& Lomb Accuglide™blades	K972808	11-5-91

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

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):

5. A statement of intended use:

The MB 102 Millennium blade is intended to be used as a replacement blade for the Hansatome™ Microkeratome.

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

Millennium Biomedical Inc.

December 26, 2001
emarket Notificatio

A statement of how the technological characteristics of the device compare to those of the predicate or legally

marketed devices: 9

MMARY OF TECHNOLOGICAL CHARACTERISTICS OF DEVI

CHARACTERISTICS
	B&L Accuglide™ Blade(PREDICATE DEVICE)	MBI MB 102MILLENNIUM BLADE
Intended Use	Indicated for use with theHansatome™ Microkeratome bysurgeons to cut cornea in the formof a hinged flap in LASIKrefractive surgery procedures.	Indicated for use as a replacementblade for the Hansatome™Microkeratome.
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

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

7. Brief summary of clinical tests and results

The performance of the MB 102 Millennium Blades was found to be acceptable the test results of the functional performance testing. The results showed that the functional performance of the MB 102 Millennium Blades was substantially equivalent to that of the predicate blade.

{5}------------------------------------------------

Image /page/5/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem consisting of three abstract human figures or profiles facing to the right, with flowing lines suggesting movement or connection.

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: K020122

Trade/Device Name: MB 102 Millennium Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: I Product Code: HNO Dated: December 26, 2001 Received: January 14, 2001

Dear Mr. Kaeni:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(x) personalially equivalent (for the indications ferenced above and nave welling a would marketed predicate devices marketed in interstate for use stated in the encrosule) to regars) actual to the Medical Device Amendments, or to commence prior to May 20, 1978, are excerdance with the provisions of the Federal Food, DNAA devices that have been recuire approval of a premarket approval application (PMA). alla Cosmetic Act (11ct) that to november to the general controls provisions of the Act. The You may, merciole, market the act include requirements for annual registration, listing of gencial controls provisions of are tice, 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 If your device is classified too a croy of als. Existing major regulations affecting your device can may be subject to subli additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood on enents concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Toast of advised that I DT is issuation that your device complies with other requirements of the Act that I Drinas made a and regulations administered by other Federal agencies. You must of any I each statutes and regainents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CITY art 6077, adoning (21 CFR 22000), 3
forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic forth in the quality by stems (Sections 531-542 of the Act); 21 CFR 1000-1050.

{6}------------------------------------------------

Page 2 -- Mr. Jerry Kaeni, President

This letter will allow you to begin marketing your device as described in your Section 510(k) This leter will anow you to begin maing of substantial equivalence of your device to a legally promatics notification: "The starsification 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 additionally 21 CFTC Far 0077. Additionally, for questions on the promotion and advertising of Complance at (301) 59 to 1010 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 Other general informational 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

{7}------------------------------------------------

Millennium Biomedical Inc. MB 102 Millennium Blade

December 26, 2001 Premarket Notification

1020122 510(k) Number (if known):

Device Name: _________________________________________________________________________________________________________________________________________________________________

MB 102 Millennium Blade

Indications for Use:

The MB 102 Millennium blade is intended to be used as a replacement blade for the Chiron Hansatome™ Microkeratome.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Toris L. McCarthy

a and Throat Devisas

510(k) Number K020122

Prescription Use ____x

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR

(Per 21 CFR 801.109)

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.