The AMS Mainstay™ Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

Device Description

The AMS Mainstay™ Urologic Bone Anchor for bladder neck suspension procedures are titanium alloy implants. They are used to anchor suture material within cortical or cancellous bone sites, thereby providing a means for firmly securing soft tissue to bone. Two (2) Mainstay™ anchors are packaged in one box.

The recommended nonabsorbable suture size for the 3.5 mm Mainstay™ anchor is up to a maximum size of #0 (USP) when using two (2) strands and up to a maximum size of #2 when using a single strand.

AI/ML Overview

The provided text describes the AMS Mainstay™ Urologic Bone Anchor, a medical device intended for bladder neck suspension. The document focuses on demonstrating substantial equivalence to a predicate device rather than outright acceptance criteria and a detailed study proving the device meets those criteria in a quantitative sense as might be seen for a new, novel device. However, based on the information provided, we can infer the acceptance criteria and the "study" (bench testing) performed.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly derived from the comparison to the predicate device and the specific bench testing performed. The "reported device performance" refers to the results of the bench testing.

Acceptance Criteria	Reported Device Performance
Functional Equivalence: Must have the same intended use as predicate device (fixation of surgical suture material to the pelvis for bladder neck suspension for female urinary incontinence).	The AMS Mainstay™ Urologic Bone Anchor has the same intended use as the predicate device (Howmedica® Mainstay™ Soft Tissue Anchor) for bladder neck suspension.
Material Equivalence: Must be made of Ti-6Al-4V.	The AMS Mainstay™ Urologic Bone Anchor is made of Ti-6Al-4V, equivalent to the predicate.
Design Equivalence: Must feature cancellous screw thread, be self-drilling/self-tapping, and have a proximal hole for suture attachment.	The AMS Mainstay™ Urologic Bone Anchor has a cancellous screw thread, is self-drilling/self-tapping, and has a proximal hole for suture attachment, equivalent to the predicate.
Operational Principle Equivalence: Must serve as an attachment site for suture, be anchored by screw threads, and be removable.	The AMS Mainstay™ Urologic Bone Anchor serves as an attachment site for suture, is anchored by screw threads, and is removable, equivalent to the predicate.
Suture-to-Bone Anchor Interface Strength: Maximum force required to break monofilament suture attached to the bone anchor must exceed the USP recommended minimum knot-pull strength for the respective class and size of suture (non-absorbable, Class I).	All sutures tested (#3-0 and #2 monofilament) exceeded the USP recommended minimum knot-pull strength by more than a factor of four (4).

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

Sample Size for Test Set: The document states that "Two (2) sizes of a nonabsorbable monofilament suture were evaluated in this test" for the Maximum Suture to Bone Anchor Interface Break Force. It does not explicitly state the number of anchors or individual tests performed for each suture size.
Data Provenance: The bench testing was performed by American Medical Systems. The country of origin of the data is not explicitly stated but is implied to be the USA given the company's address and submission to the FDA. The study was prospective in nature, as it was a specific performance test conducted for this 510(k) submission.

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

This type of information is not applicable for this submission. The "ground truth" for the bench testing was based on established engineering and material science principles, specifically the USP (United States Pharmacopeia) recommended minimum knot-pull strength for sutures. There were no human experts establishing a "ground truth" for the bench test results in the way one might for diagnostic imaging.

4. Adjudication Method for the Test Set

Not applicable. As the "test set" refers to the bench testing of suture strength, there was no subjective interpretation or adjudication needed. The results were quantitative measurements compared against a predefined standard (USP).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. A MRMC comparative effectiveness study was not performed. This type of study is typically used for diagnostic or screening devices where human readers interpret medical images or data, and their performance with and without AI assistance is compared. This device is a surgical implant, not a diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a physical implant, not an algorithm or AI system. There is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth for the bench testing (suture-to-bone anchor interface strength) was based on USP (United States Pharmacopeia) recommended minimum knot-pull strength standards for non-absorbable, Class I sutures. For the substantial equivalence claim, the ground truth was the performance and characteristics of the legally marketed predicate device (Howmedica® Mainstay™ Soft Tissue Anchor).

8. The Sample Size for the Training Set

Not applicable. This device is a physical implant, not an AI or machine learning model that requires a "training set."

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

Not applicable. As there is no training set, there is no ground truth to establish for it.

Summary

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American Medical Sys Pfizer Hospital Products C 700 Bren Road West linnetonka, MN 55343 Tel 612 933 4666 Fax 612 930 Toll Free 800 328 3881

JUL - 9 1997

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American Medical Systems

SUMMARY OF SAFETY AND EFFEC TIVENESS

SUBMITTER I.

American Medical Systems, Inc. Name and Address: 10700 Bren Road West Minnetonka, MN 55343 USA John M. Otto Contact Person: April 9, 1997 Date of Summary Preparation: June 9, 1997 Date Summary Amended: 2183959 Establishment Registration Number:

DEVICE NAME II.

Device Common or Usual Name:

Staple, Fixation, Bone Appliance for Reconstruction of Bone to Soft Tissue

Device Trade Name:

AMS Mainstay™ Urologic Bone Anchor

PREDICATE DEVICE III.

Howmedica® Mainstay™ Soft Tissue Anchor K953531

DEVICE DESCRIPTION IV.

The recommended nonabsorbable suture size for the 3.5 mm Mainstay™ anchor is up to a maximum size of #0 (USP) when using two (2) strands and up to a maximum size of #2 when using a single strand.

V. INDICATIONS FOR USE

The AMS Mainstay Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

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VI. COMPARISON TO PREDICATE DEVICE

The AMS Mainstay™ Urologic Bone Anchor with the proposed modifications is substantially equivalent to the currently marketed Howmedica® Mainstay™ Soft Tissue Anchor.

Intended Use a.

The AMS Mainstay™ Urologic Bone Anchor with the proposed modifications has the same intended use as one of the indications cleared for the currently marketed Howmedica® Mainstay™ Soft Tissue Anchor (Bladder Neck Suspension).

b. Device Performance

The AMS Mainstay™ Urologic Bone Anchor with the proposed modifications is comparable with respect to intended use and technological characteristics to the Howmedica® Mainstay™ Soft Tissue Anchor which is in commercial distribution in the United States. American Medical Systems has provided a table on the following page which compares the similarities and differences of the devices.

Bench Testing C.

The only new test performed for the AMS Mainstay™ Urologic Bone Anchor was for the Maximum Suture to Bone Anchor Interface Break Force for Monofilament Suture.

The objective of the test was to measure the maximum force required to break monofilament suture that has been attached to a bone anchor, and to compare these data to the minimum knot-pull strength requirements in the USP for the same size and class of suture. Two (2) sizes of a nonabsorbable monofilament suture were evaluated in this test.

All of the sutures tested exceeded the USP recommended minimum knot-pull strength for their respective class and size of suture (non-absorbable, Class I). The average suture break force for both the #3-0 and the #2 exceeded the USP minimum recommended knot-pull strength by more than a factor of four (4).

In summary, American Medical Systems has provided information within the 510(k) Premarket Notification to indicate that the AMS Mainstay™ Urologic Bone Anchor with the proposed modifications is safe and effective for its intended use (Bladder Neck Suspension) as one of the indications cleared for the currently marketed Howmedica® Mainstay™ Soft Tissue Anchor. Additionally, the modified AMS Mainstay™ Urologic Bone Anchor has been shown to be comparable in terms of intended use and technological characteristics to the Howmedica® Mainstay™ Soft Tissue Anchor currently in

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commercial distribution. The data and information provided within this 510(k) Premarket Notification adequately support that the AMS Mainstay™ Urologic Bone Anchor with the proposed modifications is substantially equivalent to the Howmedica® Mainstay™ Soft Tissue Anchor that is currently in commercial distribution.

EQUIVALENCY TABLE

American Medical SystemsMainstay Urologic BoneAnchor	Howmedica Mainstay SoftTissue Anchor (K953531)	Zimmer Statak Anchors(K926384)
INTENDED USE
a. Soft Tissue Attachment toBone	X	X
b. Bladder Neck Suspension	X	X
MATERIAL
Ti-6Al-4V	X	X
DESIGN
a. Cancellous Screw Thread	X	X
b. Self-drilling, Self-tapping	X	X
c. Proximal Hole for SutureAttachment	X	X
OPERATIONALPRINCIPLES
a. Attachment Site for Suture	X	X
b. Anchored by Screw Threads	X	X
c. Removable	X	X

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SERVICES • USA

DEPARTMENT OF HEALTH & HUMAN

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. John M. Otto Senior Requlatory Affairs Associate American Medical Systems, Inc. 10700 Bren Road West 55343 Minnetonka, Minnesota

Re : K971332 AMS Mainstay™ Urologic Bone Anchor Regulatory Class: II Product Codes: MBI and HWC Dated: June 9, 1997 Received: June 10, 1997

JUL - 9 1997

Dear Mr. Otto:

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 (for the indications for use stated in the enclosure) 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 The general controls provisions of the Act 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 Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, 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 In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. 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 Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Mr. John M. Otto

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) 594-4659. 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.qov/cdrh/dsmamain.html".

Sincerely yours,

Celia 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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510(k) Number (if Known): K971332

Device Name: AMS Mainstay™ Urologic Bone Anchor

Indications For Use: The AMS Mainstay™ Urologic Bone Anchor is intended only for the fixation of surgical suture material to the pelvis for the purpose of bladder neck suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

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Concurrence of CDRH, Office of Device Evaluation (ODE)

Device Evaluation (ODE)

001 ULI 4343 . 4 0

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number K971332

Prescription Use X

Over-The Counter Use

(Per 21 CFR 801.109)

t:\510k\ifuform.doc

Regulation Number and Section

N/A