STAPLETAC BONE ANCHOR SYSTEM by INFLUENCE, INC.

The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Device Description

The StapleTac Bone Anchor System is substantially equivalent to Influence, Inc.'s MicroTac Bone Anchor System cleared under K990160 with respect to intended use, materials and performance of the bone anchors. The major difference between the two systems is that the anchor of the StapleTac Bone Anchor System is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate device is designed for use with sutures in both sling procedures and cystourethropexy.

AI/ML Overview

The provided document is a 510(k) summary for the Influence, Inc.'s StapleTac Bone Anchor System. This type of regulatory submission establishes substantial equivalence to a predicate device and typically does not include detailed clinical study data with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader, multi-case studies as you might find for software-as-a-medical-device (SaMD) or diagnostic devices.

The information provided focuses on the device's intended use, materials, and performance testing for demonstrating equivalence to a predicate device (Influence, Inc.'s MicroTac Bone Anchor System, cleared under K990160), rather than establishing novel safety and effectiveness against specific performance metrics for an AI/algorithm-based device.

Therefore, most of the requested information cannot be extracted from this document, as it outlines a device clearance based on substantial equivalence for a physical surgical implant system, not a study proving an algorithm's performance against specific acceptance criteria.

However, I can extract the following based on the prompt's categories:

1. Table of Acceptance Criteria and Reported Device Performance:

Based on the document, the "acceptance criteria" is essentially substantial equivalence to the predicate device, the MicroTac Bone Anchor System (K990160). The "reported device performance" is that the StapleTac Bone Anchor System meets this equivalence.

Acceptance Criteria Category	Acceptance Criteria (from predicate device)	Reported Device Performance (StapleTac)
Intended Use	Soft tissue fixation to the pubic bone for vaginal sling procedures to treat stress urinary incontinence.	Substantially equivalent to predicate. Indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.
Materials	Equivalent materials to MicroTac Bone Anchor System.	Substantially equivalent to predicate.
Performance	Safe and effective performance as demonstrated by the predicate device for soft tissue fixation to the pubic bone. Risk analysis and testing for modifications.	Substantially equivalent to predicate. "Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance. The device modifications do not raise any new questions of safety or effectiveness."
Technological Characteristics	Similar design with a difference in sling fixation method (staple without sutures vs. sutures).	Substantially equivalent to predicate with the major difference being the anchor is designed for sling fixation with a staple and without sutures in sling procedures only, while the predicate uses sutures in both sling procedures and cystourethropexy.

The following information cannot be extracted from the provided 510(k) summary because it is not relevant to a substantial equivalence determination for a physical surgical device, and implies a clinical/AI performance study which is not described here:

Sample size used for the test set and the data provenance: Not applicable. No "test set" for an algorithm is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No "ground truth" for an algorithmic output is described.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. No "test set" for an algorithm is described.
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 physical device, not an AI or imaging diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable. No "ground truth" for an algorithmic output is described.
The sample size for the training set: Not applicable. No "training set" for an algorithm is described.
How the ground truth for the training set was established: Not applicable. No "training set" for an algorithm is described.

Summary

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510(k) Summary of Safety and Effectiveness Influence, Inc.'s StapleTac Bone Anchor System 510(k) Number ﷼92277

This 510(k) notification is submitted by Influence, Inc., 900 Kearny Street, 5th floor, San Francisco, California 94133. The contact person is Peter Bick, M.D., President and CEO.

This 510(k) notification describes a device intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.

Information on risk analysis of the modifications and performance testing provided in the application demonstrates equivalence to the predicate device with respect to performance.

Based on the performance data gathered, the device modifications do not raise any new questions of safety or effectiveness.

Based on the information provided the StapleTac Bone Anchor System is substantially equivalent to the MicroTac Bone Anchor System with respect to intended use, technological characteristics, and performance.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 30 1999

Mr. Jonathan S. Kahan, Esq. Representing Influence, Incorporated c/o Hogan & Hartson, LLP Columbia Square 555 Thirteenth Street, N.W. Washington, D.C. 20004

Re: K992277

Trade Name: StapleTac Bone Anchor System Regulatory Class: II Product Code: MBI and HWC Dated: June 14, 1999 Received: July 7, 1999

Dear Mr. Kahan:

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 control provisions of the Act. The general control 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 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 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 - Mr. Jonathan S. Kahan, Esq.

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 at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.

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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INDICATIONS FOR USE ENCLOSURE

510(k) Number (if known):	K992277
Device Name:	StapleTac Bone Anchor System.
Indications for Use:	The StapleTac Bone Anchor System is intended for soft tissue fixation to the pubic bone by means of bone anchors. It is indicated for vaginal sling procedures for the treatment of stress type (female) urinary 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 K992277

Prescription Use OR Over the Counter (Per 21 CFR 801.109) Use (Division Division of General Restorativ 9922

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.