The Upsylon Y mesh is intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

Device Description

Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Upsylon Y mesh. This is a traditional medical device submission seeking substantial equivalence to existing devices, primarily relying on bench testing and qualitative assessments rather than clinical studies with explicit acceptance criteria related to device performance in a living system.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes for test/training sets, expert involvement, and multi-reader multi-case studies, which are typical for AI/CADe submissions, is not applicable to this 510(k) submission for a surgical mesh.

However, I can extract information related to the performance testing conducted to demonstrate substantial equivalence to the predicate devices.

Here's a breakdown of the available information:

1. A table of acceptance criteria and the reported device performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format for specific performance metrics the way a diagnostic device might. Instead, it states that the performance testing "demonstrate equivalence of the Upsylon Y mesh to the predicate meshes." This implies the performance fell within a range considered acceptable for substantial equivalence to the predicate.

Acceptance Criteria Category	Reported Device Performance
Overall Performance	"demonstrate equivalence of the Upsylon Y mesh to the predicate meshes." Implies performance comparable to predicate devices for safe and effective use.
Y mesh leg tensile	Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence.
Y mesh leg elongation	Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence.
Y mesh attachment strength	Performance completed with samples aged at T=0 and T=7 months accelerated aging. Results supported the Upsylon Y mesh configuration and demonstrated equivalence.
Biocompatibility	Performance data provided in K103426 for LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh.
Mesh Characterization	Performance data provided in K103426 for LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh.
User Evaluation	"conducted a user evaluation in cadavers which evaluated placement of the mesh." (This is a qualitative user evaluation, not a quantitative performance acceptance criterion).

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

Sample Size for Test Set: Not explicitly stated as a number of devices or cases in the provided text. The performance testing was carried out on "samples" of the Upsylon Y mesh, aged at T=0 and T=7 months accelerated aging.
Data Provenance: The testing was "bench and user evaluation" conducted by Boston Scientific. This indicates in-house testing. The "user evaluation in cadavers" is a laboratory-based assessment, not a clinical trial on human subjects.

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

Not applicable. This submission focuses on material and mechanical properties, as well as a cadaver-based user usability assessment, not diagnostic accuracy or expert consensus on clinical findings. Therefore, "ground truth" in the diagnostic sense is not relevant.

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

Not applicable. Adjudication methods are typically used in clinical trials or studies where expert disagreement on a finding needs to be resolved for ground truth establishment. This was a bench and cadaver-based study.

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 device is a surgical mesh, not an AI/CADe system. Therefore, an MRMC study and AI assistance evaluation are not relevant.

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

Not applicable. This device is hardware; it does not involve algorithms or AI.

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

Not applicable in the traditional sense of diagnostic ground truth. For the mechanical and material testing, the "ground truth" would be established by validated test methods and engineering standards, comparing the results statistically or comparatively to the predicate devices. For the user evaluation, the "ground truth" would be the successful placement and evaluation of the mesh by the users in a cadaver model.

8. The sample size for the training set:

Not applicable. There is no "training set" for this type of medical device submission.

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

Not applicable. There is no "training set" for this type of medical device submission.

In summary: K122794 for the Upsylon Y mesh is a 510(k) submission based on substantial equivalence, primarily supported by bench performance testing (mechanical properties) and a user evaluation in cadavers. It is not a submission for a diagnostic AI/CADe device, and therefore, many of the requested criteria related to clinical studies, human readers, and AI performance are not relevant or present in the provided document. The "acceptance criteria" were qualitative, focused on demonstrating equivalence to predicate devices through engineering and simulated-use testing.

Summary

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K122794

Upsylon Y mcsh Traditional 510(k)

SECTION 5

Page 1 of 2

DEC 1 8 2012

Boston Scientific

510K SUMMARY

510(k) Summary for Upsylon Y mesh

A. Sponsor

Boston Scientific Corporation Urology and Women's Health Division 100 Boston Scientific Way Marlborough, MA 01756

B. Contact

Lauren Anderson Senior Specialist, Regulatory Affairs 508-683-4707 lauren.anderson@bsci.com

Donna Gardner Director, Regulatory Affairs 508-683-4398 gardnerd@bsci.com

C. Device Name

Upsylon Y mesh Trade name: Common/usual name: Surgical Mesh Classification Name: OTO- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapsc, Transabdominally Placed 21 CFR 878.3300, Class II

D. Predicate Device

LITE Pelvic Floor Repair Kits Trade name: Common/usual name: Surgical Mesh Classification Name: OTP- Mesh, Surgical, Synthetic, Urogynecologic, For Pelvic Organ Prolapse, Transvaginally Placed 21 CFR 878.3300, Class II

Premarket Notification: Boston Scientific, K103426

Restorelle Y Trade namc: Common/usual náme: Surgical mesh Classification Name: OTO- Mesh, Surgical, Synthetic, Urogynecologic, For Apical Vaginal and Uterine Prolapse, Transabdominally Placed 21 CFR 878.3300, Class II

Premarket Notification: Coloplast, K112322

Proprietary and Confidential Information of Boston Scientific Corporation

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Upsylon Y mesh Traditional 510(k)

SECTION 5

Boston Scientific

510K SUMMARY

E. Device Description

Upsylon Mesh is a preformed Y shaped lightweight polypropylene mesh consisting of two vaginal mesh arms and one sacral mesh arm. The Upsylon mesh is blue in color with a non-colored centering line.

F. Intended Use

Intended for use as a bridging material for sacrocolposuspension / sacrocolpopexy (laparotomy, laparoscopic or robotic approach) where surgical treatment for vaginal vault prolapse is warranted.

G. Technological Characteristics

The Upsylon Y mesh is a preconfigured, lightweight polypropylene mcsh and has the same technological characteristics and fundamental Y mesh design as the predicate Restorelle Y.

H. Substantial Equivalence

A direct comparison of key characteristics demonstrates that the proposed Y mesh is substantially equivalent to the predicate device in terms of intended use, technological characteristics, and performance characteristics. The Upsylon Y mesh is as safe, as effective, and performs as well as the predicate devices.

I. Performance Testing (Bench and User Evaluation)

Boston Scientific has conducted a user evaluation in cadavers which evaluated placement of the mesh. Performance testing was completed with samples aged at T=0 and T=7 months accelerated aging in support of the Upsylon Y mesh configuration. The following testing was completed:

Y mesh leg tensile .
Y mosh leg elongation t
. Y mesh attachment strength

Performance data for biocompatibility and mesh characterization provided in K 103426 for the LITE Pelvic Floor Repair Kits supports the Upsylon Y mesh. The results of the performance testing demonstrate equivalence of the Upsylon Y mesh to the predicate meshes.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 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" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized, curved lines. The logo is presented in black and white.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

December 18, 2012

Boston Scientific Corporation Urology/Women's Health % Ms. Lauren B. Anderson, RAC Senior Specialist, Regulatory Affairs 100 Boston Scientific Way MARLBOROUGH MA 01752

Re: K122794

Trade/Device Name: Upsylon Y mesh Regulation Number: 21 CFR§ 878.3300 Regulation Name: Surgical mesh Regulatory Class: II Product Code: OTO Dated: November 28, 2012 Received: November 29, 2012

Dear Ms. Anderson:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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Page 2 - Ms. Lauren B. Anderson, RAC

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Benjamin R. Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K122794

Upsylon Y mesh Traditional 510(k) Boston Scientific

INDICATIONS FOR USE SECTION 4

Indications for Use Statement

510(k) -Fo-be-determined: K122794 Number

Device Name Upsylon Y mesh

Indications For Use

Prescription Use X (21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Benjamin R. Fisher -S 2012.12.19 14:38:38 -05'00'

(Division Sign-Off) Division of Reproductive, Gastro-Renal, and Urological Devices 510(k) Number _ K122794

Proprietary and Confidential Information of Boston Scientific Corporation

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.