The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws threaded with suture. It consists of a transvaginal inserter and bone screws with attached suture.

AI/ML Overview

The provided text describes a 510(k) summary for the In-Fast Bone Screw System, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving the safety and effectiveness through extensive clinical trials with the kind of detailed acceptance criteria and study designs that would be typical for a novel device or drug.

Therefore, many of the requested elements (sample sizes for test and training sets, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types beyond basic compliance) are not applicable to this document as it pertains to a 510(k) submission for a device modification.

Here's an analysis based on the information provided:

Description of Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The In-Fast Bone Screw System's acceptance criteria and proof of performance are primarily based on achieving "substantial equivalence" to a legally marketed predicate device (K970292), specifically regarding the addition of braided suture. The study conducted was a bench test of mechanical properties to ensure compatibility and compliance with established standards.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Compliance with USP Monograph for Non-Absorbable Sutures	The suture "complies with the USP Monograph for Non-Absorbable Sutures."
Mechanical properties compatible with the In-Fast system	"The mechanical properties of the braided suture have been tested on the bench for compatibility with the In-Fast system."
Substantial equivalence to predicate device in terms of:	"The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics."
- Intended Use	(Implicitly met by not changing the intended use)
- Technological Characteristics	(Implicitly met by not fundamentally changing technology, only adding suture)
- Performance Characteristics	(Implicitly met through bench testing and USP compliance)

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: Not specified. This type of engineering bench test would typically use a sufficient number of samples to ensure statistical validity for mechanical properties, but the exact number is not provided in a 510(k) summary.
Data Provenance: The study was a "bench test," meaning it was conducted in a laboratory setting. No country of origin is specified for the data itself, but the submitting company is American Medical Systems, Inc. (Minnetonka, MN, USA). The study is prospective in the sense that the testing was performed specifically to support this 510(k) submission.

3. 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. For mechanical bench testing and compliance with a USP Monograph, the "ground truth" is established by adherence to standardized testing protocols and the specifications within the USP Monograph, not by expert consensus in the typical sense of clinical expert review. The experts involved would be engineers or quality control personnel familiar with testing methodologies and material science, but their number and specific qualifications are not detailed.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of data (e.g., medical images) by multiple experts. This submission involves mechanical bench testing against a standard.

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 medical device for soft tissue fixation, not an image analysis or AI-driven diagnostic tool. Therefore, MRMC studies are not relevant nor mentioned.

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

Not Applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for the performance evaluation was primarily compliance with the USP Monograph for Non-Absorbable Sutures and the mechanical specifications for compatibility with the In-Fast system. This relies on established material science standards and engineering principles.

8. The sample size for the training set:

Not Applicable. This type of device submission (510(k) for a modification) does not involve a "training set" in the context of machine learning or complex statistical modeling from a large dataset. The testing performed was for product validation, not model training.

9. How the ground truth for the training set was established:
* Not Applicable. As there is no "training set" in this context, this question is not relevant.

Summary

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JUL 1 3 2001

510(k) SUMMARY

Submitter's Name: American Medical Systems, Inc. Address: 10700 Bren Road West Minnetonka, MN 55343 Tel: 952-933-4666 Fax: 952-930-6157 Contact Person: Elsa A. Linke June 18, 2001 Date of Summary Preparation: Device Common Name: Bone Screw Inserter & Bone Screws Device Trade Name: In-Fast Bone Screw System Device Classification Name: Fastener, Fixation, Nondegradable, Soft Tissue Classification: Class II Product Code: MBI

Predicate Device:

In-Fast Bone Screw System K970292

Device Description

Indications for Use

The In-Fast Bone Screw System is intended for soft tissue fixation to the public bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Comparison to Predicate Device

The fundamental scientific technology of the device does not change with this modification. The only material change is the addition of braided suture to the device system.

[510(k) Summary continued]

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Supporting Information

The mechanical properties of the braided suture have been tested on the bench for compatibility with the In-Fast system. The suture complies with the USP Monograph for Non-Absorbable Sutures.

Conclusion

The proposed modification is equivalent to the predicate with respect to intended use, technological characteristics, and performance characteristics.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 3 2001

Ms. Elsa A. Linke Regulatory Affairs Specialist American Medical Systems, Inc. 10700 Bren Road West Minnetonka, Minnesota 55343

Re: K011910

Device Name: In-Fast Bone Screw System Regulation Number: 21 CFR 888.3040 Regulatory Class: II Product Codes: HWC, MBI, GAS Dated: June 18, 2001 Received: June 19, 2001

Dear Ms. Linke:

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 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). 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 OS 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 Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Elsa A. Linke

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 nredicate 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" (21CFR 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/dsma/dsmamain.html".

Sincerely yours,

Mark N Milken

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

Enclosure

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INDICATIONS FOR USE ENCLOSURE

510(k) Number:

Koi 1916

Device Name:

In-Fast Bone Screw System

Indications for Use:

The In-Fast Bone Screw System is intended for soft tissue fixation to the publo bone by means of bone screws with attached suture. The In-Fast System is indicated for cystourethropexy and vaginal sling procedures for the cystouremropexy and vaginary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) (Division Sign-off) Division of General and Restorative Devices

510(k) Number __

Prescription Use X (Per 21 CFR801:109)

Over the Counter Use_

Mark N. Mulburn

Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K011916

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.