Sharpoint® UltraPlug™ Extended Wear Plug may be used in the treatment of dry eve syndrome and the dry eye components of various ocular surface diseases. When indicated, UltraPlug™ Extended Wear Plugs may be used after ocular surgery to prevent complications due to dry eye and to enhance the retention of ocular medications. Patients experiencing dry eye related contact lens problems also may be aided by UltraPlug™ Extended Wear Plugs.

Device Description

The Sharpoint UltraPlug Extended Wear Plug is made from absorbable suture material. The plugs are available in two lengths 1.6mm and 2.0mm, and in three diameters: 0.2mm, 0.3mm and 0.4mm

AI/ML Overview

The provided text is a 510(k) summary for the Sharpoint® UltraPlug™ Extended Wear Punctum Plug. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, the document does not contain information about a study that proves the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, accuracy, or other quantitative measures typically associated with AI/ML device performance.

This is a medical device clearance for a physical product (a punctum plug), not a software or AI/ML-based device that would typically undergo performance testing and report on metrics like those listed in your prompt. The "acceptance criteria" for such a device primarily revolve around material properties, biocompatibility, and functional equivalence to similar already-marketed devices (predicates).

Therefore, I cannot fulfill most of your request directly from the provided text because it's not applicable to this type of medical device submission.

Here's what I can extract and extrapolate based on the document's content:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance (from text)
Material Composition and Safety	Made from PCL Absorbable Synthetic Suture material, ε-Caprolactone-L-Lactide Copolymer. This material has been approved for ophthalmic usage (SSC's 510(k) K003015) and well characterized through absorption and biocompatibility studies.
Absorption Profile (Duration of Occlusion)	"PCL Plugs are a synthetic absorbable suture material, which will dissolve in 180 days (reference 510(k) K003015 data)." This distinguishes it from Collagen Plugs (7-10 days) and Silicone Plugs (permanent).
Physical Dimensions and Availability	Available in two lengths: 1.6mm and 2.0mm; and three diameters: 0.2mm, 0.3mm, and 0.4mm.
Intended Use (Clinical Conditions it addresses)	Intended for temporary use with patients experiencing dry eye symptoms (redness, burning, reflex tearing, itching, foreign body sensations). Also used in treatment of dry eye syndrome and components of various ocular surface diseases (e.g., corneal ulcers, conjunctivitis, pterygium, blepharitis, keratitis, red lid erosion, filamentary keratitis). May be used post-surgery to prevent dry eye and enhance ocular medication retention. AIDS patients with dry eye related contact lens problems.
Substantial Equivalence to Predicate Devices	Determined substantially equivalent to legally marketed predicate devices for stated indications for use. Specifically compares material to Eagle Vision Temporary Intracanalicular Collagen Insert.
Biocompatibility	Material has been well characterized through biocompatibility studies (per reference to K003015).

The following items (2-9) are not applicable or cannot be answered from the provided text, as they pertain to performance studies of AI/ML algorithms, not a physical medical device like a punctum plug.

Sample size used for the test set and the data provenance: Not applicable. This document refers to the physical properties and intended use of a punctum plug, not a data-driven algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as typically defined for AI/ML performance studies is not relevant here. The "ground truth" for a physical device is its material composition, physical dimensions, and biocompatibility, which are verified through manufacturing and testing standards rather than expert consensus on a test set.
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.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" for its characteristics (e.g., dissolution time, material properties) would be based on validated material science testing, chemical analysis, and potentially in-vivo or in-vitro degradation studies referenced in the predicate device's data (K003015).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

In summary, the 510(k) submission for the Sharpoint® UltraPlug™ Extended Wear Punctum Plug focuses on demonstrating substantial equivalence to predicate devices based on material composition, absorption characteristics, physical dimensions, and intended use, rather than performance metrics derived from data analysis by an AI/ML algorithm.

Summary

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

JUL 2 6 2002

510 (k) SUMMARY OF SAFETY AND EFFECTIVENESS 5. SUBSTANTIAL EQUIVALENCY

SubmitterAddress:	Surgical Specialties Corporation100 Dennis DriveReading, PA 19606
Telephone:Contact Person:	610 404 1000, ext. 2231Elizabeth LazaroRegulatory Affairs Specialist
Date Prepared:	March 15, 2002
Name of Device:	Sharpoint® UltraPlug™ Extended Wear Plug
Common / UsualClassification Name:	Punctum Plug
Predicate Devices:	Indications for use Predicate Devices:Surgidev Silicone Punctum Plug,US IOL Inc, Occu-Flo Punctum Plug,Eagle Vision Temporary Intracanalicular CollagenInsertSurgical Specialties Corporations (formerly Look, Inc.) TemporaryIntracanalicular Collagen Implant.Material Predicate Device:Surgical Specialties Corporation's PCL Monofilament SyntheticAbsorbable Suture Material.
Device Description	UltraPlug Extended Wear Punctum Plug are intended fortemporary use with patients experiencing dry eye symptoms suchas redness, burning, reflex tearing, itching or foreign bodysensations which can be relieved by blockage of the canaliculus.The Sharpoint UltraPlug Extended Wear Plug is made fromabsorbable suture material. The plugs are available in two lengths1.6mm and 2.0mm, and in three diameters: 0.2mm, 0.3mm and0.4mm
Indications of Use:	UltraPlug™ Extended Wear Punctum Plugsmay be used in the treatment of dryeye syndrome and the dry eye components of variousocular surface diseases such as corneal ulcers,conjunctivitis, pterygium, blepharitis, keratitis, red liderosion, filamentary keratitis and other external eyediseases. When indicated, UltraPlug Extended WearPunctum Plug may be used after ocular surgery toprevent complications due to dry eye and to enhance theretention of ocular medications. Patients experiencingdry eye related contact lens problems also may be aidedby UltraPlug Extended Wear Punctum Plugs.
TechnologicalCharacteristics	UltraPlug™ Extended Wear Punctum Plugis made of PCL Absorbable Synthetic Suture material, ε-Caprolactone-L-Lactide Copolymer. This material hasbeen approved for ophthalmic usage in SSC's 510(k)K003015. The material has been well characterizedthrough absorption studies and biocompatibility studies.The product is similar to the predicate device, EagleVision Temporary Intracanalicular Collagen insert, inthat they are both made from absorbable materials.
Punctum Plugs:	PCL' Plugs are a synthetic absorbable suture material,which will dissolve in 180 days (reference 510(k)K003015 data).Collagen Plugs provide temporary lacrimal occlusion byreducing tears drainage through Partial blockage of thehorizontal canaliculus. Collagen Plugs dissolve in 7 to10 days.Silicone Plugs are permanent in that they do notdissolve.

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

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (continued)

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

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure, composed of three curved lines that suggest the head and body of the bird.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Surgical Specialties Corporation c/o Ms. Elizabeth Lazaro Regulatory Affairs Specialist 100 Dennis Drive Reading, PA 19606 3776

JUL 2 6 2002

K020882 Re:

Trade Name: Sharpoint® UltraPlug™ Extended Wear [Punctal] Plug Regulatory Class: Unclassified Product Code: LZU Dated: June 25, 2002 Received: June 26, 2002

Dear Ms. Lazaro:

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.

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

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

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

4. FDA INDICATIONS FOR USE FORM

510(k) Number (if known): _ KO20882

Sharpoint® UltraPlug™ Extended Wear Plug Device Name:

Indications for Use:

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

CONCURRENCE OF CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR § 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Duna R. Kirchner

(Division Sign-Off) Division of Ophthalmic Ea Nose and Throat Devises

510(k) Number KO

Regulation Number and Section

N/A