The Surgistar Microkeratome is indicated for use as a replacement blade in the Chiron Vision Automatic Corneal Shaper Surgical Instrument (ACS). The surgical indication for use is in patients undergoing surgery requiring initial lamellar resection of the cornea.

Device Description

Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade

AI/ML Overview

The Surgistar Inc. Microkeratome Blade (K992978) does not describe a study to prove the device meets acceptance criteria in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting results from a comprehensive performance study with acceptance criteria.

However, the document does list dimensional and sharpness equivalency criteria which can be interpreted as acceptance criteria for manufacturing and functional attributes. The "reported device performance" would then be the measured characteristics of the Surgistar blade, demonstrating its equivalence to the predicate device.

Here's an analysis based on the information provided, framed around "acceptance criteria" where applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Attribute	Acceptance Criteria (Surgistar Micro Keratome Blade Specification)	Reported Device Performance (Chiron ACS Blade as Measured - Predicate)
Length	0.445" +/- .005	0.448"
Width	0.313" +/- .003	0.313"
Thickness	0.010" +/- .0003	0.0102"
Bevel	11.5 Deg +/- 1 Deg	11 to 12.5 Deg
Mounting Hole Length	0.2805 +/-.0005	0.2805
Mounting Hole Width	0.0866 +/-.0005	0.0866
Mounting Hole Radius	0.0433 +/-.0005	0.0433
Sharpness*	5.5 OZ +/- 1.5 OZ	4 to 7 OZ

Note: The "Reported Device Performance" for the Surgistar blade is implicitly stated as meeting these specifications since the document is asserting equivalence based on these criteria. The table shows the predicate device's measurements for comparison against the Surgistar specifications.

Details of the study that proves the device meets the acceptance criteria (based only on the provided text):

The provided text does not describe a formal study to prove the device meets acceptance criteria in the sense of a clinical trial or performance study. Instead, it presents a comparison of technological characteristics and dimensional/sharpness equivalency between the Surgistar Microkeratome Blade and a legally marketed predicate device (Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument blade).

The "proof" stems from the assertion that the Surgistar blade's specifications fall within or are equivalent to the measured characteristics of the predicate device, implying that if the predicate device is safe and effective, then the Surgistar device, with similar characteristics, should also be.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample size for the test set: Not explicitly stated. The data presented "CHIRON ACS BLADE AS MEASURED" likely refers to measurements taken on a sample of the predicate device. The size of this sample is not specified.
Data provenance: Not explicitly stated. Given the context, it is presumed to be retrospective measurements of the predicate device. Country of origin is not mentioned.

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

Not applicable. The "ground truth" here is the measurement of physical attributes of the predicate device, not an expert assessment of medical images or outcomes. These measurements would typically be performed by trained technicians or engineers using calibrated equipment.

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

Not applicable. Adjudication methods are relevant for qualitative assessments or interpretations, not for direct physical measurements.

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

No MRMC comparative effectiveness study was done. This device is a surgical blade, not an AI-assisted diagnostic tool.

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

No standalone algorithm performance study was done. This device is a physical surgical blade.

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

The "ground truth" for the comparison is based on physical measurements of the predicate device's dimensions and sharpness.

8. The sample size for the training set

Not applicable. This is not an AI/algorithm-based device requiring a training set. The Surgistar blade's "design" or "specifications" (which could be analogously considered as its "training") are based on engineering design and the characteristics of the predicate device.

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

Not applicable. As above, there is no training set in the context of this device. The specifications for the Surgistar blade were established to be equivalent to the predicate device, with manufacturing tolerances.

Summary

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

NOV I 6 1999

Surgistar Inc. Microkeratome Blade

K992978

November 1, 1999 510k No. K992978

510(K) Summary (As required by 21 CFR 807.92)

Page 1 of 3

Submitter:

Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA. 92009

Contact person:

Jonathan Woodward

Telephone:

(760) 431-7400 Fax: (760) 431 6768

Trade name:	Surgistar Microkeratome Blade
Common name:	Microkeratome Blade
Classification name:	Microkeratome Blade

Legally marketed device to which we are claiming equivalence:

Chiron Vision Corp Automatic Corneal Shaper Surgical Instrument (BLADE ONLY) 510(k) Number - K941550

Description of the Device:

Replacement Stainless Steel Blade for Chiron Automatic Corneal Shaper Blade

Intended use of the device:

Replacement Blade for Chiron Automatic Corneal Shaper Blade

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

Surgistar Inc. Microkeratome Blade

November 1, 1999 510k No. K992978

Page 2 of 3 Summary

Summary of Technological characteristics of device compared to predicate device.(Section 807.92(a)(6)

CHARACTERISTICS	AUTOMATIC CORNEAL SHAPER BLADEONLY(PREDICATE-)	SurgistarMICROKERATOMEProd No. 2200
INTENDED USE	FOR PERFORMING LAMELLAR RESECTIONS OFTHE CORNEA	SAME
OPERATIONPRINCIPLE	BLADE IS HELD IN ELECTRICALLY DRIVENOCILLATING HEAD (PROVIDED BY ORIGINALEQUIPMENT MANUFACTURER Eg CHIRON)WHICH GUIDES BLADE ACROSS CORNEA	SAME
PATIENT CONTACTPORTION OF DEVICE	BLADE	SAME
MATERIALS	LOW CARBON STAINLESS STEEL	SAME
STERILIZATIONMETHOD (BLADE)	EO	RADIATION-GAMMA

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

Page 3 of 3 Summary

DIMENSIONAL & SHARPNESS EQUIVALENCY CHART

ATTRIBUTE	CHIRON ACSBLADEAS MEASURED	SURGISTARMICRO KERATOME BLADESPECIFICATION
LENGTH	0.448"	0.445" +/- .005
WIDTH	0.313"	0.313" +/- .003
THICKNESS	0.0102"	0.010" +/- .0003
BEVEL	11 TO 12.5 DEG	11.5 Deg +/- 1 Deg
MOUNTINGHOLE LENGTH	0.2805	0.2805 +/-.0005
MOUNTINGHOLE WIDTH	0.0866	0.0866 +/-.0005
MOUNTINGHOLE RADIUS	0.0433	0.0433 +/-.0005
SHARPNESS*	4 to 7 OZ	5.5 OZ +/- 1.5 OZ

As measured in ounces of force.

At Will

(Signature)

Jonathan Woodward

(Typed Name)

November 1,.1999

K 992978 (Premarket Notification [510(k)] Number)

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

Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV I 6 1999

Mr. Jonathan Woodward President Surgistar, Inc. 6068 Corte Del Cedro Carlsbad, CA 92009

Re: K992978 Trade Name: Microkeratome Blade Regulatory Class: I Product Code: 86 HNO Dated: October 13, 1999 Received: October 14, 1999

Dear Mr. Woodward:

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 Quality System Regulation (QS) 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 .

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

Page 2 - Mr. Jonathan Woodward

This letter will allow you to begin marketing your device as described in your 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 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" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

A. Ralph Rosenthal

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

Enclosure

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

Page 2 of 5

510(k) Number (if known):__K 992978

SURGISTAR MicroKeRTome BLADE Device Name:_

Indications For Use:

Statement of indication for use

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Jas Calloway
(Division Sign-Off)

Division of Ophthalmic Devices

510(k) Number K992978

Prescription Use_v (Per 21 CFR 801.109)

Over-The-Counter Use_

(Optional Format 1-2-96)

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.