The Endoview™ Sapphire Contact Lens Set consists of one sterilization container, one lens ring (either infusion or non-infusion), and one each of the following lenses: Plano Concave, Symmetric Concave-Concave, Asymmetric Concave, Prism 15° - Concave, Prism 30° Concave, and a Prism Concave-Concave Lens. The lenses, rings and sterilization container may be sold separately or as a set. During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required.

AI/ML Overview

The provided text is a Premarket Notification [510(k)] Summary for the "Endoview™ Sapphire Lens Set" by American Medical Devices, Inc. This document focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study with acceptance criteria for device performance in the way a clinical trial or AI/software validation would.

Therefore, the document does not contain the specific information requested in your prompt regarding acceptance criteria, device performance metrics, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies for an AI/software device.

The study presented here is a comparison to predicate devices to demonstrate that the Endoview™ Sapphire Lens Set is as safe and effective as existing products.

Here's a breakdown of why many of your categories cannot be filled from this document:

Acceptance Criteria and Reported Device Performance: Not applicable in the context of this 510(k) submission. The "performance" being assessed is substantial equivalence to predicate devices, not meeting specific quantitative clinical performance metrics.
Sample size for the test set and data provenance: No test set in the sense of clinical data is described. The comparison is feature-based against existing devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would refer to the characteristics and performance of the predicate devices, which are established by their prior marketing clearance.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This is not an AI-assisted device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a surgical contact lens, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for substantial equivalence is the established safety and effectiveness of the identified predicate devices.
The sample size for the training set: Not applicable. There is no "training set" for a physical medical device in this context.
How the ground truth for the training set was established: Not applicable.

However, I can extract the substantial equivalence comparison, which serves as the "study" for this type of submission:

1. Table of Acceptance Criteria and the Reported Device Performance

In a 510(k) submission, "acceptance criteria" relate to demonstrating that the new device shares characteristics with legally marketed predicate devices, thereby establishing "substantial equivalence." The "performance" is the new device's features matching or being comparable to the predicate devices.

Feature / Criteria (for Substantial Equivalence)	Predicate Devices (DORC, Grieshaber, Ocular Instruments)	Endoview™ Sapphire Lens Set (Reported Performance)
Flat Lens for Central viewing	X	X
15 degree lens for mid-Peripheral viewing	X	X
30 degree lens for wide field viewing	X	X
Bi-concave lens For air filled phakik Patients	X	X
Shipped Non Sterile	X	X
Sterilize with either ETO Or steam	X	X
Sterilization Container	X	X
Infusion Lens Ring	X	X (Also explicitly mentions Ocular Instruments has this)
Lens Ring	X	X
Materials: Lenses	Quartz, high refractive index plastic (for comparison)	Single Crystal Sapphire (stated as ideal and previously approved for ophthalmic use via 510(k)s K853129, K860852, K861744)
Materials: Sterilization Container	High temperature plastic	High temperature plastic
Materials: Lens Ring	Aluminum	Aluminum
Sterility Status	N/A (Predicates are assumed to be similar)	Shipped Non-Sterile
Sterilization Instructions	N/A (Predicates are assumed to be similar)	ETO or steam sterilize according to AAMI or USP Standards
Indications for Use	For magnification during vitreoretinal surgery	For magnification during vitreoretinal surgery

2. Sample sized used for the test set and the data provenance:

Sample Size: Not applicable. This is a comparison of design features and materials, not a clinical data set. The "sample" can be considered the set of predicate devices identified by the manufacturer (DORC, Grieshaber, Ocular Instruments).
Data Provenance: The "data" pertains to the specifications and characteristics of the Endoview™ Sapphire Lens Set and those of the predicate devices. This information is derived from the manufacturer's design specifications and existing market information for predicate devices.

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 is established by the known characteristics and approved status of the predicate devices as legally marketed medical devices. The FDA regulatory staff (like the Director of the Division of Ophthalmic Devices) assess the submission.

4. Adjudication method for the test set:

Not applicable. The assessment is a regulatory review for substantial equivalence, not a clinical adjudication.

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:

Not applicable. This is a physical surgical device, not an AI/software diagnostic tool.

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

Not applicable. This is a physical surgical device.

7. The type of ground truth used:

Substantial Equivalence: The "ground truth" is the established safety, effectiveness, and intended use of the legally marketed predicate devices (DORC, Grieshaber, Ocular Instruments). The new device is compared feature-by-feature to these predicates to demonstrate that it raises no new questions of safety or effectiveness. Additionally, the use of Sapphire as a material had prior FDA clearance in other ophthalmic devices (K853129, K860852, K861744).

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical device's 510(k) submission.

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

Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo consists of the letters "A MDI" in a bold, sans-serif font. The "A" is in a white box, while the "MDI" is in a black box. To the right of the logo, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked vertically.

AUG - 6 1997

K971853

May 16, 1997

Premarket Notification [510(k)] Summary

Submitter: American Medical Devices, Inc 1100 Northside Drive Atlanta, GA 30318 Phone: (404) 815-5233 (404) 815-5235 Fax:

Official Correspondent: Frank J. Tighe

Trade Name: Endoview™ Sapphire Lens Set

Common Name: Surgical Contact Lens Set

Registration Number: We have registered but have not received our application back as of this date.

Class: Class II

Class Name: Unknown

Panel: Ophthalmic

Product Code: 86HDQ

Device Description

Page 1 Summary

Toll-Free	Direct	Facsimile	Internet
800-793-1473	404-815-5233	404-815-5235	ftighe@americanmedicaldevices.com

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The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. This type of ring device is currently available from Ocular Instruments (510(k) 902496. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required. Most lenses on the market have been manufactured from quartz and high refractive index plastic because of their low cost and good refractive properties. However, these materials can be easily scratched, chipped and damaged during normal cleaning, handling and sterilization. Single Crystal Sapphire, on the other hand, is an ideal material for ophthalmic surgery because of its wide transmission band, extreme hardness and excellent chemical resistance.

Substantial Equivalence Comparison
American MedicalDevices, Inc.	DORC	Grieshaber	OcularInstruments
Flat Lens forCentral viewing	X	X	X	X
15 degree lens for mid-Peripheral viewing	X	X	X	X
30 degree lens for widefield viewing	X	X	X	X
Bi-concave lensFor air filled phakikPatients	X	X	X	X
Shipped Non Sterile	X	X	X	X
Sterilize with either ETOOr steam	X	X	X	X
Sterilization Container	X	X	X	X
Infusion Lens Ring	X	X	X	X
Lens Ring**	X	X	X	X

Statement of indications for use. For magnification during vitreoretinal surgery.

** All lens sets have lens rings. American Medical Devices, Inc and Ocular Instruments offer a lens ring with an infusion port.

Page 2 Summary

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Image /page/2/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo is divided into two sections. The left section has a white background with the letter "A" in black, and a black background with the letters "MDI" in white. The right section has the words "AMERICAN MEDICAL DEVICES, Inc." stacked on top of each other in black.

Sterility

The Device is shipped non-sterile to the user. The user may either ETO or steam sterilize the lenses according AAMI or USP Standards. ETO and Steam Sterilization of Sapphire in Ophthalmic Devices has been performed since the mid 1980's A user instruction sheet is included with each lens set (See Page 4 of this summary), which instructs the user to clean the lenses immediately after used with warm soapy water. In addition, the instructions clearly state to only sterilize thoroughly cleaned instruments and to Steam or ETO sterilize the lenses prior to use according to AAMI or USP standards.

Packaging

The device is shipped in a high temperature plastic sterilization container, which contains a custom-molded cavity to secure the lenses and ring during sterilization.

Materials Used in Manufacture

Lenses - The lenses are manufactured from sapphire. Sapphire has been approved for use in ophthalmic devices since the mid-1980s with product code 86HNN and with the following 510(k)s: K853129 Rudolph Beaver Inc. Beaver Multipurpose Sapphire Knife. K860852 Med-Tech Development Corp. Sapphire Blade Surgical Knife. K861744 Keeler Instruments. Inc., Sapphire Knife Blade. These lenses are non-invasive and only contact the cornea during the surgical procedure whereas the sapphire knives are invasive and are used to make an entry into the cornea and actually enter the anterior chamber of the eve.

Sterilzation Container: Manufactured from high temperature plastic. The Ocular Instruments and DORC sterilization containers are also manufactured from high temperature plastic.

Lens Ring: Aluminum. Ocular Instruments, Grieshaber, and DORC all use aluminum for their lens rings

			Page 3 Summary
Toll-Free	Direct	Facsimile	Internet
800-793-1473	404-815-5233	404-815-5235	ftighe@americanmedicaldevices.com

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Image /page/3/Picture/0 description: The image shows the logo for American Medical Devices, Inc. The logo consists of two parts: a square divided into two halves, with the left half being white and the right half being black, and the letters "AMDI" in bold black font on the square. To the right of the square is the text "AMERICAN MEDICAL DEVICES, Inc." in a bold, sans-serif font.

ENDOVIEW™ SAPPHIRE CONTACT LENS SET

USER, CLEANING AND STERILIZATION INSTRUCTIONS

THIS DEVICE IS NON STERILE

Device Description

During vitreoretinal surgery, the surgeon requires the aid of a contact lens in order to visualize the posterior segment of the eye. First, the ring is sewn onto the sclera to hold the lens in place on the cornea. The customer has the option of choosing a ring with an infusion port, which eliminates the need for the surgeon to constantly place irrigant on the corneal. Once the ring is in place, the surgeon places one of the lenses in the ring in order to visualize the posterior segment of the eye. The surgeon changes the lenses during the case depending on where visualization is required. Most lenses on the market have been manufactured from quartz and high refractive index plastic because of their low cost and good refractive properties. However, these materials can be easily scratched, chipped and damaged during normal cleaning, handling and sterilization. Single Crystal Sapphire, on the other hand, is an ideal material for ophthalmic surgery because of its wide transmission band, extreme hardness and excellent chemical resistance.

Statement of indications for use. For magnification during vitreoretinal surgery.

CLEANING

Clean the lenses immediately after use with warm soapy water.

STERILIZATION THIS DEVICE IS NON STERILE.

Only sterilize the product after it has been thoroughly cleaned. ETO or steam sterilize the product prior to use according AAMI or USP Standards.

		Summary Page 4
Toll-Free	Direct	Facsimile	Internet
800-793-1473	404-815-5233	404-815-5235	ftighe@americanmedicaldevices.com

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Image /page/4/Picture/0 description: The image shows the logo for American Medical Devices, Inc. On the left side of the logo, the letter "A" is in white on a black square, and the letters "MDI" are in black on a white square. To the right of the square logo, the words "AMERICAN MEDICAL DEVICES, Inc." are stacked on top of each other.

ENDOVIEW™ SAPPHIRE LENS SET CONTENTS

Trade or proprietary or model name

ﺴ

Model Number

1.	EndoviewTM Sapphire Lens Set (Consisting of 1 each of the following)**	600.00
2.	EndoviewTM Flat Sapphire Lens (Machemer)	600.01
3.	EndoviewTM 15° Prism Sapphire Lens (Tolentino)	600.02
4.	EndoviewTM 30° Prism Sapphire Lens (Tolentino)	600.03
5.	EndoviewTM Biconcave Sapphire Lens (Landers)	600.04
6.	EndoviewTM Asymmetric Biconcave Sapphire Lens (de Juan)	600.05
7.	EndoviewTM 30° Biconcave Sapphire Lens (Woldoff,Tano)	600.06
8.	EndoviewTM Sapphire Lens Set Sterilization Container	600.07
9.	EndoviewTM Infusion Lens Ring**	600.08
10.	EndoviewTM Lens Ring**	600.09

**The customer has the option of choosing the lens ring with or without infusion.

Summary Page 5
Toll-Free	Direct	Facsimile	Internet
800-793-1473	404-815-5233	404-815-5235	ftighe@americanmedicaldevices.com

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG - 6 1997

American Medical Devices, Inc. c/o Mr. Frank |. Tighe 1100 Northside Drive Atlanta, GA 30318

Re: K971853 Trade Name: Endoview™ Sapphire Lens Set Regulatory Class: II Product Code: 86 HJK Dated: May 16, 1997 Received: May 20, 1997

Dear Mr. Tighe:

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 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 Flectronic 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 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 Rosyl Rosenthal

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

Enclosure

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Image /page/7/Picture/0 description: The image shows a logo for American Medical Devices, Inc. The logo is divided into three sections. The first section is a white square with a large black letter A. The second section is a black square with the letters MDI in white. The third section has the words AMERICAN MEDICAL DEVICES, Inc. in black.

(510(k) Number (if known):

Device Name: Endoview™ Sapphire Lens Set

Indications for Use:

For magnification during vitreoretinal surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel W. C. Brown, Ph.D.

Prescription Use ズ (Per 21 CFR 801.109) (Division Sign-Off) Division Ophthalmic Devices 510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

1 011-1 recSTATIS AND AND PERSONAL PROPERTY OF CHARACT PUBLICATION OF CHEARTH
800-793-1473

Direct 404-815-5233

Regulation Number and Section

§ 886.1385 Polymethylmethacrylate (PMMA) diagnostic contact lens.

(a)
Identification. A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.(b)
Classification. Class II.