The TAS400 NeoTract Anchor System is used for the approximation of soft tissue in open surgical procedures. It consists of a single use delivery device that delivers the permanently implanted Suture Anchor. The delivery system is comprised of a polycarbonate handle and trigger assembly connected to a stainless steel shaft.

AI/ML Overview

Here's an analysis of the provided text regarding the NeoTract Anchor System's acceptance criteria and study information:

Based on the provided 510(k) summary, the device is a surgical suture system, and the focus of its submission is on substantial equivalence to existing predicate devices, rather than a de novo clinical study with specific acceptance criteria related to diagnostic performance. Therefore, the information you're looking for, especially concerning diagnostic performance metrics, reader studies, and ground truth establishment, is largely not applicable in this context.

The "acceptance criteria" for this type of submission are primarily about demonstrating that the new device is as safe and effective as a legally marketed predicate device, often through in-vitro testing and material comparisons.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for a surgical suture system seeking substantial equivalence to existing devices, specific "acceptance criteria" in terms of diagnostic performance (e.g., sensitivity, specificity, AUC) are not defined or reported. Instead, the acceptance criteria relate to the physical and functional properties of the device, which are evaluated through in-vitro testing.

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance
Materials suitable for intended use	"All materials used in the manufacture of the NeoTract Anchor System are suitable for this use and are comparable to the predicate products."
Components, subassemblies, and/or full devices met required specifications	"In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests."
Intended use is identical or substantially equivalent to predicate	"The TAS400 NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures." (Matches predicate's likely use)
Method of operation is identical or substantially equivalent to predicate	"method of operation... are either identical or substantially equivalent to existing legally marketed predicate products."
Methods of construction are identical or substantially equivalent to predicate	"methods of construction... are either identical or substantially equivalent to existing legally marketed predicate products."

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

Test Set Sample Size: Not specified. The document only mentions "In-vitro testing" without detailing the number of units tested.
Data Provenance: Not specified, but generally, in-vitro testing is performed by the manufacturer (NeoTract, Inc.) in a controlled laboratory setting. It is not patient or human data, so concepts like country of origin or retrospective/prospective do not apply.

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

Not Applicable. For a surgical suture system's in-vitro testing, the "ground truth" isn't established by medical experts in the diagnostic sense. It's established by engineering specifications and standards for material properties, tensile strength, securement, etc. The "experts" involved would be engineers and quality control personnel assessing compliance with these specifications.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving human interpretation or challenging diagnoses. In-vitro testing relies on objective measurements against predefined engineering standards.

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

No. An MRMC study is relevant for diagnostic imaging devices or algorithms that impact human reader performance. This device is a physical surgical implant, not a diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

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

7. The Type of Ground Truth Used

Engineering Specifications and Performance Standards. The "ground truth" for the in-vitro testing would be objective, measurable specifications for mechanical properties (e.g., strength, durability, securement), biocompatibility, and material integrity, defined by industry standards and the manufacturer's own design requirements.

8. The Sample Size for the Training Set

Not Applicable. "Training set" refers to data used to train an AI algorithm. This device is a physical product, not an AI system.

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

Not Applicable.

In Summary:

The provided 510(k) summary focuses on demonstrating the substantial equivalence of the NeoTract Anchor System to predicate devices for its intended use (approximation of tissue in open surgical procedures). The evaluation relies on in-vitro testing to confirm material suitability and performance against established specifications. The typical metrics and study designs associated with diagnostic AI or imaging devices (like acceptance criteria for sensitivity/specificity, reader studies, ground truth establishment by experts) are not relevant or present in this submission.

Summary

{0}------------------------------------------------

4. 510(k) Summary

K102028
Page 1 of 1

General Information

Date Compiled	July 16, 2010
Classification	21 CFR 878.5000, Nonabsorbable Polyethylene Terephthalate Surgical Suture21 CFR 878.4750, Staple, implantableProduct code GAT, GDW

Trade Name	NeoTract Anchor System
Common Name	Surgical Suture
Submitter	NeoTract, Inc.4473 Willow Rd., Suite 100Pleasanton, CA 94588Tel: 415 609 9875Fax: 925 401 0676
FDA Registration No.:	3005791775
Contact	Kevin MacDonaldVice President, Regulatory, Quality, Clinical Affairs

AUG 04 2010### Intended Use

The TAS400 NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

Predicate Devices

NeoTract Anchor System Manufactured by NeoTract, Inc.

K101252

Device Description

Materials

All materials used in the manufacture of the NeoTract Anchor System are suitable for this use and are comparable to the predicate products.

Testing

In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.

Summary of Substantial Equivalence

NeoTract, Inc. believes the TAS400 NeoTract Anchor System is substantially equivalent to the predicate device. The intended use, method of operation, methods of construction and materials used, are either identical or substantially equivalent to existing legally marketed predicate products.

{1}------------------------------------------------

Image /page/1/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" around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MI) 20993-0002

NeoTract, Inc. % Mr. Kevin F. MacDonald VP, Regulatory, Clinical and Quality 4473 Willow Road Pleasanton, California 94588

AUG 0 4 2010

Re: K102028

Trade/Device Name: NeoTract Anchor System Regulation Number: 21 CFR 878.5000 Regulation Name: Nonabsorbable poly(ethylene terephthalate) surgical suture Regulatory Class: II Product Code: GAT, GDW Dated: July 16, 2010 Received: July 20, 2010

Dear Mr. MacDoanld:

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. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21

{2}------------------------------------------------

Page 2 - Mr. Kevin F. MacDonald

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/CDRHOffices/ucm115809.htm far 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/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

ly yours,

Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

y ior↓

Special 510(k) Premarket Notification Modified NeoTract Anchor System

3. Indications for Use Statement

510(k) Number (if known):

This application

K102028

Device Name:

NeoTract Anchor System

Indications for Use:

The NeoTract Anchor System is intended for the approximation of tissue in open surgical procedures.

AUG 04 2010

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

Over-The-Counter Use (Per 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)

David Kunefer filx M

Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102028

Regulation Number and Section

§ 878.5000 Nonabsorbable poly(ethylene terephthalate) surgical suture.

(a)
Identification. Nonabsorbable poly(ethylene terephthalate) surgical suture is a multifilament, nonabsorbable, sterile, flexible thread prepared from fibers of high molecular weight, long-chain, linear polyesters having recurrent aromatic rings as an integral component and is indicated for use in soft tissue approximation. The poly(ethylene terephthalate) surgical suture meets U.S.P. requirements as described in the U.S.P. Monograph for Nonabsorbable Surgical Sutures; it may be provided uncoated or coated; and it may be undyed or dyed with an appropriate FDA listed color additive. Also, the suture may be provided with or without a standard needle attached.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: Surgical Sutures; Guidance for Industry and FDA.” See § 878.1(e) for the availability of this guidance document.