The Straight-In Bone Screw System is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed (e.g., bladder neck suspension and urethral sling procedures for female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency).

Device Description

The Straight-In Bone Screw System consists of a motorized inserter and bone screws with attached suture. It is intended for soft tissue fixation to bones in the pelvic region (e.g., pubic, sacral, etc.) by means of bone screws threaded with suture. It is indicated for use during open or laparoscopic surgical procedures where soft tissue fixation to bones in the pelvic region is needed.

AI/ML Overview

The provided K020446 document describes a 510(k) premarket notification for a medical device called the "Straight-In Bone Screw Fixation System." This submission is for a modification to an existing device, where the only change is the addition of braided suture. The document is a 510(k) summary and the FDA's clearance letter.

Based on the provided text, this document does not describe a software-based medical device that would have acceptance criteria, a study with a test set, ground truth, or training data in the typical sense associated with AI/ML or complex diagnostic algorithms.

Here's why and what information can be extracted:

Device Type: This is a physical, implantable medical device (bone screws with suture and an inserter) used for fixation, not a diagnostic or AI/ML-driven device.
"Study" Description: The "Supporting Information" section states: "The mechanical properties of the braided suture have been tested on the bench for compatibility with the Straight-In system. The suture complies with the USP Monograph for Non-Absorbable Sutures." This indicates bench testing of mechanical properties, not a clinical study to evaluate diagnostic performance against acceptance criteria using patient data.

Therefore, most of the requested information regarding acceptance criteria for device performance in the context of a diagnostic algorithm or AI/ML study, sample sizes, experts, ground truth, MRMC studies, or training sets is not applicable to this 510(k) submission.

However, I can populate the table with the closest interpretation of "acceptance criteria" and "reported device performance" based on the provided text for a physical device, and explain why other fields are not relevant.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (for the modification)	Reported Device Performance (for the modification)
Suture Compatibility: The braided suture must be compatible with the Straight-In system.	The mechanical properties of the braided suture have been tested on the bench for compatibility with the Straight-In system.
Suture Standard Compliance: The braided suture must comply with the USP Monograph for Non-Absorbable Sutures.	The suture complies with the USP Monograph for Non-Absorbable Sutures.

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

Sample Size: Not specified in terms of number of samples, but implied to be sufficient for mechanical bench testing.
Data Provenance: Bench test data; not from human subjects, countries, or retrospective/prospective studies.

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

Not applicable. This device does not involve expert readers establishing ground truth for a diagnostic test. Performance was evaluated against a standard (USP Monograph) and mechanical properties.

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

Not applicable. There was no clinical test set requiring adjudication.

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 not an AI-assisted diagnostic device.

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):

Ground Truth: USP Monograph for Non-Absorbable Sutures (a recognized industry standard for suture properties) and established mechanical properties for compatibility.

8. The sample size for the training set:

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable. There is no "training set" or corresponding ground truth.

In summary, this 510(k) submission is for a modification to a physical medical device, and the "study" described is limited to bench testing of the mechanical properties of a new suture material against established standards and compatibility requirements. The concepts of acceptance criteria for diagnostic performance, human readers, ground truth from experts, and training/test sets for algorithms do not apply in this context.

Summary

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K020446

510(k) SUMMARY

Submitter's Name:	American Medical Systems, Inc.	MAR 1 3 2002
Address:	10700 Bren Road WestMinnetonka, MN 55343
Tel:	952-933-4666
Fax:	952-930-6157
Contact Person:	Elsa A. Linke
Date of Summary Preparation:	February 8, 2002
Device Common Name:	Bone Screw Inserter & Bone Screws
Device Trade Name:	Straight-In Bone Screw Fixation System
Device Classification Name:	Fastener, Fixation, Nondegradable, Soft TissueClassification: Class IIProduct Code: MBI
Predicate Device:	Straight-In Bone Screw Fixation SystemK972622

Device Description

Indications for Use

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.

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020446
[510(k) Summary continued]

Supporting Information

The mechanical properties of the braided suture have been tested on the bench for The monatibility with the Straight-In 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 is a black and white logo for the U.S. Department of Health & Human Services. The logo features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings. The design is simple and conveys a sense of official government affiliation.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 3 2002

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

Re: K020446

Trade/Device Name: Straight-In Bone Screw Fixation System Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, MBI, GAT Dated: February 8, 2002 Received: February 11, 2002

Dear Ms. Linke:

We have reviewed your Section 510(k) premarket notification of intent to market the device w oneve lowe 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 for associated in the 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 I ou may) annovisions 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. Page 2 - Ms. Elsa Linke

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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) 594-4659. 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 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.

Mark McMillan

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:	K020446
Device Name:	Straight-In Bone Screw Fixation System
Indications for Use:	The Straight-In Bone Screw System is intended for soft tissuefixation to bones in the pelvic region (e.g., pubic, sacral, etc.)by means of bone screws threaded with suture. It is indicatedfor use during open or laparoscopic surgical procedures wheresoft tissue fixation to bones in the pelvic region is needed(e.g., bladder neck suspension and urethral sling proceduresfor female stress urinary incontinence resulting from urethralhypermobility and/or intrinsic sphincter deficiency).

510(k) Number:

K020446

Device Name:

Straight-In Bone Screw Fixation System

Indications for Use:

The Straight-In Bone Screw System is intended for soft tissuefixation to bones in the pelvic region (e.g., pubic, sacral, etc.)by means of bone screws threaded with suture. It is indicatedfor use during open or laparoscopic surgical procedures wheresoft tissue fixation to bones in the pelvic region is needed(e.g., bladder neck suspension and urethral sling proceduresfor female stress urinary incontinence resulting from urethralhypermobility 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
(Per 21 CFR801.109)

OR
Over the Counter Use
for
(Division Sign-Off)

Division of General, Restorative and Neurological Devices

510(k) Number_

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.