The subject device combines two cleared devices (i.e., EndoButton CL Ultra and GTS Tapered Screw) into disposable kits along with the necessary disposable instruments to perform cruciate ligament reconstruction procedures. Both the EndoButton CL Ultra and GTS Tapered Screw provided in the ACL SMART System are identical in design to the previously cleared predicate devices. However, the GTS Tapered Screw was originally cleared for use with the GTS Sleeve and the GTS Tapered Screw in the ACL SMART System is intended to be used independent of the sleeve.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "ACL SMART System" by Smith & Nephew, Inc. However, it does not include detailed acceptance criteria and a study proving the device meets those criteria in the format requested.

The document primarily focuses on demonstrating substantial equivalence to predicate devices based on indications for use and performance characteristics, supported by non-clinical bench (mechanical) testing. It explicitly states: "non-clinical bench (mechanical) testing was conducted on the GTS Tapered Screw without the GTS sleeve. Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device."

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text, as the information is not present. Here's what I can extract and what is missing:

Summary of Acceptance Criteria and Device Performance (Based on Provided Text)

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (From Preclinical Testing Summary)
Functionality and safety comparable to predicate devices.	Substantially equivalent to previously cleared BioRCI Screw.
Fixation strength comparable to predicate devices.	Met fixation strength requirements in bench testing.
Insertion characteristics comparable to predicate devices.	Met insertion requirements in bench testing.

Detailed Information on the Study (Missing for most points)

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria: Not explicitly stated in quantitative terms within this document. The document relies on substantial equivalence to predicate devices rather than specific performance thresholds.
- Reported Device Performance: The document states that "Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device" for "Fixation strength" and "Insertion". No specific numerical performance values or comparative metrics are provided.
Sample size used for the test set and the data provenance:
- Sample Size: Not specified. The document only mentions "non-clinical bench (mechanical) testing."
- Data Provenance: The tests were "non-clinical bench" conducted by the manufacturer, Smith & Nephew, Inc. The country of origin of the data is not specified, but the company is based in Andover, Massachusetts.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical bench study, not involving human experts for ground truth establishment in a diagnostic context. The "ground truth" would be the mechanical properties being measured (e.g., actual fixation strength, insertion force).
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. As a mechanical bench test, there would be no adjudication method involving human interpretation.
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:
- No. This device is a surgical fixation system, not an AI-powered diagnostic tool. Therefore, an MRMC study related to AI assistance for human readers is not relevant and was not performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical surgical implant system, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" for this mechanical bench testing would be the actual physical/mechanical properties measured according to engineering standards (e.g., tensile strength, displacement under load, torque for insertion). It's based on objective physical measurements rather than clinical interpretations like pathology or expert consensus.
The sample size for the training set:
- Not applicable. As a physical device undergoing mechanical testing, there is no "training set" in the context of machine learning or AI.
How the ground truth for the training set was established:
- Not applicable. (See point 8).

Summary

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

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 4, 2015

Smith & Nephew, Inc. Mr. Samir Ibrahim Senior Regulatory Affairs Specialist 150 Minuteman Rd. Andover, Massachusetts 01810

Re: K143172 Trade/Device Name: ACL Smart System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: MAI, MBI Dated: November 3, 2014 Received: November 4, 2014

Dear Mr. Ibrahim,

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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

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

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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.

Sincerely yours,

Mark N. Melkerson -S

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

Enclosure

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

Premarket Notification Indications for Use Statement

510(k) Number (if known): __K143172 __________________________________________________________________________________________________________________________________________

Device Name: ACL SMART System

Indications for Use:

The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

Prescription Use X__ AND/OR (Part 21 CFR 801.109)

Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________ (Optional Format 1-2-96)

(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 Orthopedic Devices 510(k) Number: K142933

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

510(k) Summary Smith & Nephew, Inc. ACL SMART System

Submitted by:	Smith & Nephew, Inc.150 Minuteman RoadAndover, MA 01810
Date of Summary:	January 23, 2015
Contact Person and Address:	Samir Ibrahim, PhD, MBA, RACSenior Regulatory Affairs SpecialistT (901) 399-6139F (901) 721-2421
Name of Device(s):	Smith & Nephew, Inc. ACL SMART System
Common Names:	Fastener, Fixation, Biodegradable, Soft TissueFastener, Fixation, Nondegradable, Soft Tissue
Device Classification Names
and References:	21 CFR 888.3030 Single/multiple component metallic bone fixationand accessories.
Device Class:	Class II
Panel Code:	Orthopedics
Product Codes:	MAI (primary)MBI (secondary)

Device Description

Indications for Use

The Smith & Nephew ACL SMART System is indicated for fixation of soft tissue grafts during cruciate ligament reconstruction.

{4}------------------------------------------------

The indications for the subject device are identical to the GTS Tapered Screw and similar to the EndoButton CL Ultra and BioRCI Screw. The indications of the EndoButton CL Ultra and BioRCI Screw also include fixation of soft tissue grafts during cruciate ligament reconstruction, therefore the indications of the subject device are equivalent to the predicate devices.

Technological Characteristics

Device comparisons described in this premarket notification demonstrate that the proposed implants in the ACL SMART System are substantially equivalent to the legally marketed predicate devices (listed below in Table 1) with regard to indications for use and performance characteristics. The primary technological differences that exist between the subject and predicate implant devices are the following:

Use of the GTS Tapered Screw without the GTS Sleeve.

Manufacturer	Description	Submission Number	Clearance Date
Smith & Nephew, Inc.	EndoButton CL Ultra	K980155, K081098	04/01/1998
Smith & Nephew, Inc.	GTS Sleeve and GTS Tapered Screw	K040542	03/25/2011
Smith & Nephew, Inc.	BioRCI Screw	K992396, K032224	10/07/2004

Table 1: Substantially Equivalent Predicates to the implants in the ACL SMART System

Summary of Preclinical Testing

To further support a determination of substantial equivalence, non-clinical bench (mechanical) testing was conducted on the GTS Tapered Screw without the GTS sleeve. Test results demonstrated that the proposed device is substantially equivalent to the previously cleared BioRCl Screw predicate device listed in Table 1. The specific types of non-clinical testing conducted are listed below:

Fixation strength
Insertion

Conclusion

Based on the similarities to the predicate devices and a review of the mechanical testing performed, the subject device is substantially equivalent to the predicate devices listed in Table 1.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.