The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

Device Description

The OASIS Disposable M2-PE Microkeratome Blades are replacement stainless steel blades for the Moria M2 Microkeratome Blade. The Disposable M2-PE Microkeratome Blades are made of 400 Series Stainless Steel, packaged and sterilized using the same methods. The OASIS Disposable M2-PE Microkeratome Blades are single-use, disposable blades.

AI/ML Overview

The provided document is a 510(k) Premarket Notification Summary for the OASIS Medical, Inc. Disposable M2-PE Microkeratome Blades. It focuses on demonstrating substantial equivalence to a predicate device rather than comprehensive de novo clinical studies with acceptance criteria in the typical sense of AI/ML device evaluations. Therefore, the information requested might not be fully present or will be interpreted based on the available data.

Here's an analysis based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Strict "acceptance criteria" as would be defined for an AI/ML device comparing performance metrics (e.g., sensitivity, specificity thresholds) are not explicitly stated. Instead, the demonstration of substantial equivalence is based on the device having "the same" or "substantially equivalent" characteristics and performance compared to the predicate device.

Characteristic / Test	Acceptance Criteria (Implied from Substantial Equivalence Claim)	Reported Device Performance (OASIS M2-PE Microkeratome Blades)
Intended Use	Same as predicate (Moria M2 Microkeratome Blade)	Same
Target Population	Same as predicate	Same
Performance (Compatibility)	Compatible with Moria M2 Microkeratome (as predicate)	Same (Tested and shown to be acceptable)
Blade Material	Same as predicate (low carbon stainless steel)	Same
Biocompatibility	Same as predicate (for Stainless Steel Blades)	Same
Mechanical Safety	Assured, same as predicate	Assured, same as predicate
Dimensional Equivalency	Substantially equivalent to predicate in physical measurements	Substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc.
Sharpness	Perform as well as the predicate device	Perform as well as the predicate device
Fit into Moria M2 Microkeratome	Acceptable fit	Tested and shown to be acceptable
Non-clinical Testing (Corneal Lamellar Sections)	Equivalent to the predicate devices	Resulted in corneal lamellar sections equivalent to the predicate devices (on porcine eyes)

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

Sample Size for Test Set:
- For Dimensional Equivalency, Sharpness, and Fit tests: The document does not specify the exact number of blades tested. It only states "physical measurements of the predicate device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc." and "sharpness tests show that the OASIS M2-PE blades (0415) perform as well as the predicate device."
- For Non-clinical testing on porcine eyes: The document does not specify the number of porcine eyes used.
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given the nature of a 510(k) submission for a physical device like a blade, the testing would typically be prospective laboratory and possibly animal testing conducted by the manufacturer, or a contract lab on their behalf.

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

There is no mention of "experts" in the context of establishing ground truth for a test set, as this is not a study evaluating human-interpretable output where expert consensus would be required (e.g., image reading). The "ground truth" for these performance tests would be objective measurements (dimensions, sharpness metrics) or outcomes from the animal model (quality of lamellar sections).

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements in expert readings, which is not relevant for the types of tests (dimensional, sharpness, fit, animal model) conducted for this mechanical device.

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 is relevant for diagnostic devices that involve human interpretation of results, often with AI assistance, to measure the impact of AI on human reader performance. This document pertains to a surgical blade, not a diagnostic imaging or AI-assisted diagnostic device.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Yes, in a sense, the performance tests described (Dimensional Equivalency, Sharpness, Fit, Non-clinical testing on porcine eyes) can be considered "standalone" in that they assess the intrinsic characteristics and performance of the blade itself, without direct human-in-the-loop interpretation being the primary focus of the performance evaluation. However, this is not an "algorithm-only" study as described for AI/ML devices.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed was based on:

Objective Measurements: For dimensional equivalency, sharpness, and fit.
Observed Outcomes: For non-clinical testing on porcine eyes, the "equivalence" of corneal lamellar sections to those produced by the predicate device would be the observed outcome. While not explicitly stated, this observation would likely be qualitative or semi-quantitative, assessed by experienced personnel.

8. The Sample Size for the Training Set

Not applicable. The concept of a "training set" is relevant for AI/ML models that learn from data. This document describes the evaluation of a physical medical device (a microkeratome blade), not an AI algorithm.

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

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

Summary

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KO30401

JUN 1 9 2003

Image /page/0/Picture/2 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letter "A". The letters are thick and bold, with the "O" being a complete circle and the "S" letters being incomplete circles. The palm tree is black and has several fronds extending from the top of the trunk.

510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 914 . 285

510(k) Premarket Notification Summary Ref:

To: Document Control Clerk:

This is to notify you of the intention of OASIS Medical, Inc. to manufacture and market the following device:

Disposable M2-PE Microkeratome Blades

Establishment Registration Number: 2083373

This 510(k) summary of safety and effectiveness for the OASIS Microkeratome Blades is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92, and follows the Office of Device Evaluation quidance concerning the presentation and content of a 510(k) summary.

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

a.	Applicant:	OASIS Medical, Inc.512 South Vermont AvenueGlendora, CA 91741
b.	Telephone Number:	(626) 852-5170
	Facsimile Number:	(626) 914-9372
c.	Contact Person:	Yvonne Fernandez- RA/QA Director

Date Summary Prepared: d. 01/27/03
1. Name of the Device, including trade name, the common or usual name, and the classification:
- Trade/Proprietary Name: Disposable M2-PE Microkeratome Blades a.
- b. Common/Usual Name: Keratome Blade
- Classification Name: C. Keratome (Blade Only) - 21CFR §886.4370
- ರ. Classification: Class I
- Product Code: e. 86 HNO
- f. Classification Panel: Ophthalmic

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Image /page/1/Picture/1 description: The image shows the word "OASIS" in a stylized font. A palm tree is above the letters. The letters are bold and black. The background is white.

510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAX (626) 01:12285

Identification of legally marketed devices to which equivalence is being 3. claimed:

The OASIS Medical, Inc. Disposable M2-PE Microkeratome Blades are substantially equivalent in design, material and function to the devices as marketed by:

Company	Device	510(k) Number
Moria	Moria M2 Microkeratome	K002191

4. Description of the Device:

Certification of Safety and Effectiveness:

When used according to the keratome manufacturer's instructions, there are no adverse safety indications the 0415 blade.

Sterilization Methodology:

All blades are sterilized by exposure to ethylene oxide to a Sterilization Assurance Level (SAL) of 108 according a validated process in compliance with EN 550.

Labeling:

The pouch will indicate OASIS name, address, product identification, lot number, sterilization notes, single use, and federal law statements.

5. Intended Use for the Device:

The OASIS M2-PE Microkeratome Blades (Catalog #0415) are designed as replacement blades for the Moria M2 Microkeratome for lamellar resection of the cornea.

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Image /page/2/Picture/0 description: The image shows the word "OASIS" in a stylized font, with a palm tree above the letters "AS". The letters are thick and bold, with the "O" being a large circle and the "S" having a curved shape. The palm tree is black and has several fronds extending from the top of the trunk. The overall design is simple and eye-catching.

510-528 S. Vermont Avenue Glendora (A4174) (626) 914-289 i FAX (620) 11:2285

Summary of the technological characteristics of the submitted device 6. compared to predicate devices:

M2-PE Blade - Summary of Technological Characteristics of Device Compared to Predicate Device' [Section 807.92(a)(6)] - K002191

Characteristics	PD* - Moria M2 Blade	OASIS 0415 M2-PE Blade
Intended Use	As indicated	Same
Target population	As indicated	Same
Performance	Compatibility with Moria M2 Microkeratome	Same
Blade Material	Low carbon stainless steel	Same
Biocompatibility	For Stainless Steel Blades	Same
Mechanical Safety	Assured	Same

Performance Tests and Conclusions:

Dimensional Equivalency Test Physical measurements of the predicate 1. device are substantially equivalent to the measurements of blades manufactured by OASIS Medical, Inc.
1. Sharpness Tests - Sharpness tests show that the OASIS M2-PE blades (0415) perform as well as the predicate device.
1. Fit into the Moria M2 Microkeratome has been tested and shown to be acceptable.
র . Non-clinical testing on porcine eyes resulted in corneal lamellar sections equivalent to the predicate devices.

YO30401

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 9 2003

Oasis Medical, Inc. c/o Yvonne Fernandez RA/OA Director 512 S. Vermont Avenue Glendora, CA 91740

Re: K030401

Trade/Device Name: Disposable M2-PE (Precision Edge) Microkeratome Blade Regulation Number: 21 CFR 886.4370 Regulation Name: Keratome Regulatory Class: Class I Product Code: HNO Dated: February 05, 2003 Received: February 06, 2003

Dear Ms. Yvonne Fernandez:

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 – Ms. Yvonne Fernandez

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 (301) 594-4613. 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,

A Kalpi 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

Enclosure

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510-528 S. Vermont Avenue Glendora, CA 91741 (626) 914-2891 FAx : : : : : : : ) 914-2285

OASIS Medical, Inc. Disposable M2-PE (Precision Edge) Microkeratome Blades Indications For Use

510(k) Number (if known):

K030401

Device Name:

Disposable M2-PE Microkeratome Blades

The OASIS Disposable M2-PE (Precision Edge) Microkeratome Blade (Catalog #0415) is designed as a replacement blade for the Moria M2 Microkeratome for lamellar resection of the cornea.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Division Sign-Off Division of Ophthalmic Ear, Nose and Throat Devises

KO 30401 510(k) Number_

OR Over The Counter Use: Prescription Use: × (Per 21 CFR 801.109) (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.