Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate. Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.

AI/ML Overview

The provided text is a Premarket Notification (510(k)) for the "Surgisorb" absorbable suture, indicating it is substantially equivalent to a predicate device. This type of document does not typically contain acceptance criteria or detailed study results in the manner requested for AI/device performance.

The document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Dexon® II polyglycolic acid, synthetic absorbable surgical sutures) based on material, packaging, sterilization, sizes, and functional characteristics (absorption rate, strength, etc.), as well as meeting or exceeding USP 23 performance requirements.

Therefore, I cannot provide the specific information requested in the format of a table of acceptance criteria, reported device performance, sample sizes, expert qualifications, or details of standalone or MRMC comparative effectiveness studies, as these types of studies and their detailed results are not typically included in a 510(k) submission summary for this class of medical device.

Here's what can be extracted and inferred from the document:

Acceptance Criteria & Reported Device Performance:
- Acceptance Criteria (Implied): The device must meet or exceed the performance requirements of USP 23 (United States Pharmacopeia) for absorbable surgical sutures. It also must be substantially equivalent to the Dexon® II polyglycolic acid suture in terms of materials, packaging, sterilization method, sizes, multi and monofilament types, dyed and undyed states, and functional characteristics (absorption rate, strength).
- Reported Device Performance: The document explicitly states: "Surgisorb and Dexon® II both meet or exceed the performance requirements of USP 23." This implicitly states that Surgisorb also meets these criteria. The "Summary Comparison Table" (page 2) lists features where Surgisorb is "SAME" as the predicate device, implying comparable performance.
Sample Size and Data Provenance: Not specified in this 510(k) summary. These details would be in the underlying testing documentation, not the public summary.
Number of Experts and Qualifications: Not specified. The determination of "substantial equivalence" is made by the FDA based on the manufacturer's submission. The performance testing against USP standards would be conducted in laboratories, but the specific expert involvement for establishing "ground truth" as might be relevant for AI models is not applicable here.
Adjudication Method: Not applicable for this type of device submission.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. This device is not an AI-assisted diagnostic tool.
Stand-alone Performance (Algorithm Only): Not applicable, as this is a physical medical device (suture), not an algorithm.
Type of Ground Truth Used: The "ground truth" here is compliance with established industry standards (USP 23) and demonstrated equivalence to a predicate device through material and functional characteristic comparisons. This is based on USP standards and direct material/performance testing, not expert consensus, pathology, or outcomes data in the AI sense.
Sample Size for Training Set: Not applicable. This is not an AI/machine learning device.
How Ground Truth for Training Set was Established: Not applicable. This is not an AI/machine learning device.

In summary, the provided document is a 510(k) Pre-market Notification for a surgical suture and does not contain the detailed study information (especially related to AI/algorithm performance) that your template requests.

Summary

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Image /page/0/Picture/5 description: The image shows a sequence of handwritten characters. The characters are 'K984374'. The characters are written in a bold, sans-serif font and are black in color. The background of the image is white.

Summary of Safety and Effectiveness Information

Premarket Notification, Section 510(k) SANITARY CORPORATION
K963999

Registiation Authority: Safe Madical Devices Act of 1930, 21 CFR 807,92

1. Device Name:
  Trace Name: S. Agisorb

Containon Alisorbable suture, synthetic absorbable suture, PGA suture Nonex(s):

Clarido and Nન્દાાા(s): Sulture, Absorbable, Synthelic, Polyglycolic Acid

Establishment Nome & Registration Number: 2.
SAMYANG CCRPORATION N:#:#:3: Num! XIII Pending

3. Classification:

PGA based suture is not specifically categorized or defined in 21CFR, Parts 800-1299. The responsible device provided the following cless, classification panel and product corte for this product.

Device Class: Class II

Class : Micalion Pa. .el: General & Plestic Surgery Devices Panel

Product Co-It(s): 79GAM

1. E quivalent Predicate Device:
  SAMTANG CORPORATION believes that Surgisorb PGA Absorbable Sulure is substantially equivalent to the following absorbable suture marketed by Davis & Geck:
Dexon® II polyglycolic acid, synthetic atsorbable surgical sutures with polyceprolute axating ー system.
With respect to substantial equivalison the comparison a virtually identical Malurials, packaging, storilization method, sizes, multi and monofiliment, dyed and device. undyod as well as functional characteristics (absorption rate, strangth, etc.) Equivalericy can also be diawn with respect to the design, material composition, performance and intended use. Surg: sou and Dex: on® II both meet or exceed the performance requirements of USP 23.

5. Device Description:

Survisorb brand absorbable suture is provided both dyed (D&C Viclet #2) and undyed (milk white), braided and monofiliment types and coated with polyceprolate and calcium sterate.

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K984374

Sizes offered are U.S.P. 8.0 through 2 (mstric equivalcht 0.4 through 5). The brief table below illustrates the sizes offered.

USP Size
(Metric Size)
8.0(0.4)
7.0(0.55)
6.0(0.7)
5.0 (1)
4.0(1.5)
3.0 (2)
2.0 (3)
0 (3.5)
1 (4)
2 (5)

Michaels. Polyglycolic acid. U.S.P. & polycaprolate and calcium sterate.

Indications for Use. "General soft tissue approximation; including use in ophthalmic surgery, but not for use in cardiovascular and neurological tissue."

6. Applicant Name & Address:

SANTANG COLPORATIC N 263 Yeonii-dung, Chongno-gu Seoul 110-725, Korea

7. Compsity Contact:

Mr. Dong-Kee Yoo SASIYANIS COLLIFORATION 263 Yeonji-dung, Chongrio-gu Seoul 110-725, Korea Tel. 011.82.2.740.7296 Fax 011.82.2.743.5626

Submission Contespondent: 8.

Mr. David W. Schlorf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356 2640 - 925.356.2654 - fax

ਰੇ. Farformance Standards:

United States Food and Drug Administration mandated performance standards for this device do not exist. Vanous voluntary performance standards are utilized. Voluntary standards uffilized include U.S.P., ASTM, Standard Operating Procedures, veridor & process certification and qualification procedures, Quality Systems Regulations, ISO materials standards and ISO 9000 series quality regulations.

SANTANG CORPORATION also mests appropriate general controls authurized under Sections 501, 502, 510, 516, 518, 519, and 520 of the Food, Drug, and Cosmetic Act.

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10. Special Conticts:

The following spe .ial controls apply to the marketing of this device when used as PGA based absolbable suture

Cony.Cance with specifical laboling requirements. As outlined in the guidance "Altomate ﻬﺎ Suture Labeling Resulting from the January 11, 1993 Mosting with HIMA".

Storage, Packaging & Sterilization Information: 11.

Packaying should be inspected on arrival for evidence of shipping damage. Packaging. Dameged packaging may indicate the presence of unsalle product and it should not be used until cansfully inspected. If the parkage or product is damaged, the product should not be used and should be returned. Once of ened, the product should never be resterilized or reused.

Storinge. Product must be handled, stored and opened in such a way that it is protected from inadvartent damage or contamination. Rotate stock and observe shelf life dates. Discard when outdated or damaged. When used, the product must be placed into use following accapted surgical sterile technique.

Sistilization. The suture is torminally EtO ges sterilized.

12. Summary Comperison Table:

FEATURE	Surgisorb	Davis & Geck	SE?
Indications for Use:	GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE INOPHTHALMIC SURGERY, BUT NOT FOR USE INCARDIOVASCULAR AND NEUROLOGICAL TISSUE.	SAME	YES
Design:	BRAIDED AND MONOFILIMENT	SAME	YES
Sterile:	YES - EtO	SAME	YES
Sizes:	USP - 8.0 THROUGH 2	SAME	YES
Material:	PGA	SAME	YES
Origin:	KOREA	USA	YES
Manufacturer:	SAM YANG	DAVIS GECK	YES
Product Code:	79GAM	SAME	YES
K - Number:	PENDING	PREAMENDMENT DEVICE	YES

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and 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 a stylized image of an eagle with three wing-like shapes, representing health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 4 1999

SAMYANG Corporation c/o Mr. David W. Schlerf Buckman Company, Incorporated 200 Gregory Lane, Suite C-100 Pleasant Hill, California 94523

Re: K984374 Trade Name: Surgisorb Absorbable Suture Regulatory Class: II Product Code(s): GAM Suture, Absorbable, Synthetic, PolyGlycolic Acid (PGA) Dated: March 20, 1999 Received: April 13, 1999

Dear Mr. Schlerf:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosures) to devices that were regulated as transitional devices and that have been reclassified into class II. Notice of this reclassification was published in the Federal Register on Monday, December 11, 1989 (Vol. 54, No. 236, Pages 50737 and 50738). A copy of this Federal Register can be obtained by calling the Division of Small Manufacturers Assistance (DSMA) at (800) 638-2041 or (301) 443-6597. You may, therefore, market the devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

The Polygolycolic acid (PGA) Surgical Sutures are indicated for use in general soft 1. tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
1. The Polygolycolic acid (PGA) Surgical Sutures may not be manufactured from any material other than homopolymers and copolymers made from glycolide and/or Llactide. Any deviation of the polymer composition or processing as described in this 510(k) notification must be sumitted to FDA in a new premarket notification at least 90 days prior to implementation of the proposed changes. In addition, you must maintain documentation at your premises regarding vendor certification for raw or semiprocessed source material, all manufacturing and quality control release procedures, and validation of sterilization procedures used in the manufacturing of the PGA surgical suture. Any deviation of the source material or processing as described in this 510(k) notification requires submission of a new premarket notification and FDA clearance prior to commercial distribution of the modified device.

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Page 2 -- Mr. David W. Schlerf

The sale, distribution and use of these devices are restricted to prescription use in accordance with 21 CFR 801.109.

The general controls provisions of the Act include requirements for registration, listing of devices, good manufacturing practice, and labeling, and prohibition against misbranding and adulteration.

Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under the Radiation Control for Health and Safety Act of 1968, or other Federal Laws or Regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices 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) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4595. 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,

C. S. M. Witte, Ph.D., M.D.

Cella M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page_1 of

510(k) Number : K984374

Device Name(s): SurgiSorb® Absorbable PGA Suture

Intended Use(s) of the Device:

GENERAL SOFT TISSUE APPROXIMATION; INCLUDING USE IN OPHTHALMIC SURGERY, BUT NOT FOR USE IN CARDIOVASCULAR AND NEUROLOGICAL TISSUE.

Fresse DO MOT MBITE BETOM THIS LINE - COMITING ON AMOLITIERS BROETE VECESSERY Concurrence of CDRH, Office of Device Evaluation (ODE)

DC Olles

(Division Sign-Off) Division of General Restorative Devices 1942 510(k) Number

Prescription Use
(Per 21 CFR 801.109) X

ાર

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional format 1-2-96)

Regulation Number and Section

§ 878.4493 Absorbable poly(glycolide/l-lactide) surgical suture.

(a)
Identification. An absorbable poly(glycolide/l-lactide) surgical suture (PGL suture) is an absorbable sterile, flexible strand as prepared and synthesized from homopolymers of glycolide and copolymers made from 90 percent glycolide and 10 percent l-lactide, and is indicated for use in soft tissue approximation. A PGL suture meets United States Pharmacopeia (U.S.P.) requirements as described in the U.S.P. “Monograph for Absorbable Surgical Sutures;” it may be monofilament or multifilament (braided) in form; it may be uncoated or coated; and it may be undyed or dyed with an FDA-approved color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.