The Bausch & Lomb Hansatome Excellus Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea.

Device Description

The Hansatome® Excellus™ Microkeratome is a precision-manufactured instrument indicated for use in patients undergoing LASIK surgery or other treatment requiring initial lamellar resection of the cornea. It functions identically to the existing Hansatome Microkeratome in that the cutting head rotates about a piyot pin. Propulsion is via a rolling gear within the head which engages with an arcuate gear rack affixed to the suction ring. In addition, the Hasatome Excellus Power/Suction Supply Unit includes 1) a vacuum regulator to allow the physician to set vacuum prior to surgery, 2) a vacuum tank that provides reserve vacuum in the event the vacuum pump fails or power is interrupted during the course of surgery, and 3) a battery pack back-up power supply to the microkeratome motor in the event power is interrupted during the course of surgery. The microkeratome's LCD also contains a back-lit display so the User can read the LCD display in low/no light conditions.

AI/ML Overview

The provided text describes a 510(k) submission for the Hansatome Excellus Microkeratome, seeking to establish substantial equivalence to a predicate device. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than requiring extensive new clinical studies with detailed acceptance criteria and performance metrics against such criteria.

Therefore, the document does not contain the kind of detailed acceptance criteria and a study design with performance metrics that would be typical for a new device requiring efficacy or diagnostic accuracy studies. Instead, the "study" is a comparison to a predicate device, focusing on similarities and differences in design and function.

I will, however, extract what can be inferred about "acceptance criteria" and "device performance" in the context of a 510(k) for a device like a microkeratome, and explain why other details (like sample sizes for test/training sets, expert qualifications, MRMC studies, etc.) are not present.

1. A table of acceptance criteria and the reported device performance

In a 510(k) for a microkeratome, "acceptance criteria" primarily relate to demonstrating that the new device performs its intended function similarly to the predicate device and meets relevant safety standards. The "reported device performance" is essentially the detailed description of the new device's features and how they align with or improve upon the predicate, without introducing new questions of safety or effectiveness.

Acceptance Criteria (Inferred from 510(k) submission type)	Reported Device Performance (Hansatome Excellus)
Intended Use: Device performs lamellar resection of the cornea preceding LASIK surgery or other treatment requiring initial lamellar resection of the cornea, identically to the predicate device.	Performs "Lamellar resection of the cornea preceding LASIK surgery or other treatment requiring initial lamellar resection of the cornea" – Identical to Current Hansatome.
Operating Principle: Device uses an electrically driven oscillating blade housed in a head which guides the blade across the cornea within controlled parameters, identically to the predicate device.	Uses "Electrically driven oscillating blade housed in a head which guides the blade across the cornea within controlled parameters" – Identical to Current Hansatome.
Patient Contact Portions: Device's patient contact portions (Suction Ring, Microkeratome Head, Blade) are made of materials identical to the predicate device.	Patient contact portions (Suction Ring, Microkeratome Head, Blade) are made of "Stainless Steel, Stainless Steel, Low Carbon Stainless Steel" respectively – Identical to Current Hansatome.
Keratome Mechanism: Device's mechanism (single arcuate gear rack, temporal pivot, interchangeable heads, DC power, footswitch blade oscillation) is identical to the predicate device's mechanism.	Mechanism is "Single arcuate gear rack with temporal pivot pin, 3 interchangeable heads with fixed thickness, DC powered 6-9 volts, Footswitch Blade oscillation" – Identical to Current Hansatome.
Safety and Functionality Features (Improvements): The new device incorporates enhancements (vacuum regulator, vacuum tank, battery pack, backlit LCD) that improve safety and user experience without altering the fundamental cutting mechanism or therapeutic effect, or that meet recognized safety standards (e.g., UL Listing).	- Vacuum Regulator: Allows physician to set vacuum prior to surgery. - Vacuum Tank: Provides reserve vacuum if pump fails or power is interrupted. - Battery Pack: Back-up power for microkeratome motor if power is interrupted. - Back-lit LCD: User can read display in low/no light conditions.- More efficient vacuum pump: Can operate at elevations up to 7000 feet (vs. 6500 for predicate).- Power/Suction Supply Unit: UL Listed (vs. Not UL Listed for predicate).

2. Sample size used for the test set and the data provenance

Sample Size for Test Set: Not applicable. This 510(k) submission is for a medical device (microkeratome) and relies on demonstrating substantial equivalence to a predicate device through engineering and design comparisons, and potentially bench testing, rather than a clinical "test set" for performance evaluation in a diagnostic or efficacy study. No human or animal subject data from a "test set" is described for the purpose of validating performance against specific clinical acceptance criteria.
Data Provenance: Not applicable. The "data" are primarily engineering specifications, design comparisons, and functional descriptions of the device and its predicate.

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

Number of Experts & Qualifications: Not applicable. Ground truth, in the sense of expert consensus on diagnostic outcomes or pathology, is not relevant for this type of device submission. The "ground truth" here is the established safety and effectiveness of the predicate device, as demonstrated through its prior marketing and regulatory clearance, and the assumption that the new device, being substantially equivalent, shares that history.

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

Adjudication Method: Not applicable. As there is no clinical "test set" requiring adjudication of outcomes, this information is not relevant to this submission.

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

MRMC Study: Not applicable. This device is a surgical instrument, not an AI-assisted diagnostic tool or an imaging device requiring interpretation by human readers. Therefore, an MRMC study is not relevant.

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

Standalone Performance: Not applicable. This device is a mechanical surgical instrument; it does not involve algorithms or AI operating in a standalone capacity. Its performance is intrinsically tied to its mechanical function and human use in surgery.

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

Type of Ground Truth: The "ground truth" for this 510(k) submission is the established safety and effectiveness of the legally marketed predicate device (Hansatome® Microkeratome). The argument for the new device's safety and effectiveness relies on its substantial equivalence in intended use, operating principle, materials, and fundamental mechanism, with noted improvements in safety and user convenience features (e.g., UL listing, vacuum tank, battery backup) that do not alter the core function in a way that would introduce new risks or questions of effectiveness.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is a medical device clearance based on substantial equivalence, not a machine learning model requiring a training set.

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

Ground Truth for Training Set: Not applicable, as there is no training set for a machine learning model.

Summary

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K021640

JUN 1 9 2002

Hnasatome Excellus Microkeratome

510(k) SUMMARY (per 21 CFR §807.92)

Submitter's Name:Address:	Bausch & Lomb3365 Tree Court Industrial Blvd.St. Louis, MO 63122
Telephone #:Fax #:	(636) 226-3183(636) 226-3245
Official Correspondent:	Dennis PozZORegulatory Affairs Specialist
Date Summary Prepared:	May 15, 2002
Device Name/Proprietary name:	Hansatome® Excellus™ Microkeratome
Classification/Common Name	Keratome
Class:	I
Panel:	Ophthalmic
Product Code:	ΗΝΟ

The marketed device(s) to which substantial equivalence is claimed: Hansatome® Microkeratome

PRODUCT DESCRIPTION:

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Substantial Equivalent Basis

The Hansatome® Excellus™ Microkeratome is substantially equivalent to the Hansatome® Microkeratome (K972808 and K010260), see Comparison Martix below.

COMPARISON MATRIX
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SIMILARITIES

CHARACTERISTICS	Current HansatomeMicrokeratome	PROPOSED Hansatome ExcellusMicrokeratome
Intended use	Lamellar resection of the corneapreceding LASIK surgery or othertreatment requiring initial lamellarresection of the cornea	Lamellar resection of the corneapreceding LASIK surgery or othertreatment requiring initial lamellarresection of the cornea
Operating Principle	Electrically driven oscillating bladehoused in a head which guides theblade ascross the cornea withincontrolled parameters.	Electrically driven oscillating bladehoused in a head which guides theblade ascross the cornea withincontrolled parameters.
Patient contact portion	Suction Ring Microkeratome Head Blade	Suction Ring Microkeratome Head Blade
Materials	Stainless Steel Stainless Steel Low Carbon Stainless Steel	Stainless Steel Stainless Steel Low Carbon Stainless Steel
Keratome Mechanism	Single arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation	Single arcuate gear rack with temporal pivot pin 3 interchangable heads with fixed thickness DC powered 6-9 volts Footswitch Blade oscillation

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COMPARISON MATRIX

DIFFERENCES

CHARACTERISTICS	Current HansatomeMicrokeratome	PROPOSED Hansatome ExcellusMicrokeratome
Power Switch	Power Switch is on front of powersupply	Power Switch is on back of powersupply
Front Panel Labeling	Symbology and verbiage on frontpanel.	Symbology only on front panel.
Vacuum Pump	Less efficient pump, can onlyoperate at elevations up to 6500 feetabove sea level.	More efficient pump, can operate atelevations up to 7000 feet above sealevel.
	The vacuum pump is listed withsafety agencies.	The vacuum pump is not listed withsafety agencies.
Power/Suction Supply Unit	Not UL Listed	UL Listed

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2002

Bausch & Lomb, Inc. c/o Mr. Dennis Pozzo Regulatory Affairs Specialist 3655 Tree Court Industrial Blvd. St. Louis. MO 63122-6694

Re: K021640

Trade/Device Name: BAUSCH & LOMB Hansatome® Excellus™ Microkeratome Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: 86 HNO Dated: May 17, 2002 Received: May 20, 2002

Dear Mr. Pozzo:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895, A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Ouality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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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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510(K) Number

510(K) Number -

Device Name: Hansatome® Excellus™ Microkeratome

Indications for Use:

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ V ____ OR Over-the-Counter Use __________________________________________________________________________________________________________________________ R. Binfa hickotons

(Division Sign-Off)

510(k) Number KOR 1640

Bausch & Lomb Surgical

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.