The Adjustable Fixation Device consists of a graft suspension loop and a titanium cortical button. The suspension loop is threaded through the titanium cortical button to form a graft suspension construction. The device facilitates repair through placement and retention of the soft tissue graft within bone.

AI/ML Overview

The provided text is a 510(k) Summary for the ArthroCare Adjustable Fixation Device. It describes the device, its intended use, and non-clinical data establishing substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets those criteria in the context of AI/algorithm performance.

Instead, it refers to:

Bench testing: "Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading."
Design Verification testing: "to demonstrate conformance to design and performance specifications."

The document explicitly states: "No clinical or animal data are included in this submission." This indicates that the regulatory submission primarily relies on non-clinical (bench) testing and comparison to predicate devices, rather than a study with human subjects, AI standalone performance, or MRMC studies.

Therefore, many of the requested categories for AI/algorithm-related studies cannot be filled from this document.

Here's a breakdown of what can be inferred or directly stated from the provided text, and what cannot:

1. A table of acceptance criteria and the reported device performance

The document mentions "conformance to design and performance specifications" and that "All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices" and "meet their design, performance, and safety specifications." However, no specific quantitative acceptance criteria (e.g., minimum tensile strength, fatigue life cycles) or the exact reported performance values are provided in this summary. It only states that the device passes these unspecified criteria.

Acceptance Criteria	Reported Device Performance
Not specified in this document (e.g., specific thresholds for cyclic and static loading, design specifications)	Not specified quantitatively in this document (e.g., actual load values sustained, specific metrics from design verification tests). The document only states that the device "meets their design, performance, and safety specifications" and is "substantially equivalent" to predicates.

Regarding the study that proves the device meets the acceptance criteria:

Since this is a physical medical device (Adjustable Fixation Device for soft tissue to bone fixation), the "study" referred to is a series of non-clinical, bench-top tests, not a study of an AI algorithm's performance.

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

Test Set Sample Size: Not specified for the bench testing.
Data Provenance: The document only mentions "simulated human bone substrate" for comparative testing, indicating laboratory-based, non-clinical data. No country of origin for data is relevant or mentioned as it's not a human study.
Retrospective or Prospective: Not applicable as this is bench testing on simulated materials.

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. Ground truth for mechanical bench testing is typically based on engineering standards, material properties, and standardized testing protocols, not expert human interpretation.

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

Not applicable, as this refers to adjudication for human-interpreted data (like radiology reads) which is not part of this submission. The "ground truth" for bench tests is determined by physical measurements and engineering analyses.

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

No. An MRMC study is for evaluating diagnostic image interpretation by humans, often with and without AI assistance. This submission is for a physical orthopedic fixation device and does not involve AI or human readers for diagnostic tasks.

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

No. This device is not an algorithm. Therefore, "standalone" algorithm performance is not relevant.

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

The "ground truth" for the non-clinical bench testing would be engineering specifications, material science properties, and adherence to established biomechanical testing standards. For instance, a certain load (in Newtons) or number of cycles might be the "ground truth" performance requirement that the device must meet or exceed.

8. The sample size for the training set

Not applicable. There is no AI algorithm being trained for this device.

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

Not applicable, as there is no AI algorithm being trained.

Summary

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

January 28, 2016

ArthroCare Corporation Ms. Katherine Marcaccio Regulatory Affairs Specialist II 15285 Alton Parkway, Number 200 Irvine, California 92618

Re: K153186

Trade/Device Name: Adjustable Fixation Device Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: November 2, 2015 Received: November 3, 2015

Dear Ms. Marcaccio:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the

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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

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Indications for Use

510(k) Number (if known)

K153186

Device Name Adjustable Fixation Device

Indications for Use (Describe)

The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

· ACL/PCL repair / reconstruction
· ACL/PCL patellar bone-tendon-bone grafts
· Double-Tunnel ACL reconstruction
· Extracapsular repair: MCL, LCL, and posterior oblique ligament
· Illiotibial band tenodesis
· Patellar tendon repair
VMO advancement
· Joint capsule closure

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

ArthroCare® Corporation

Adjustable Fixation Device

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

General Information

Submitter Name:	ArthroCare Corporation
Address	15285 Alton Parkway, Suite 200Irvine, CA 92618
Contact Person:	Katherine MarcaccioRegulatory Affairs Specialist IIPhone: 508-261-3602Fax: 978-749-1443
Date Prepared:	2 November 2015

Device Name

Proprietary Name:	Adjustable Fixation Device
Common Name:	Fastener, Fixation, Nondegradable, Soft Tissue
Classification Name:	Smooth or threaded metallic bone fixation fastener
Device Class:	II
Product Code:	MBI
CFR Section:	888.3040

Predicate Devices

The predicate devices for the Adjustable Fixation Device are:

Biomet ToggleLoc cleared via 510(k) K083070 and subsequently K130033.
N8TIVE ACL Reconstruction System cleared via 510(k) K133606. ●

Description

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Characteristics	Biomet ToggleLocK083070, K130033	N8TIVE ACLReconstruction SystemK133606	AdjustableFixation DeviceProposedDevice
Intended Use	Fixation of soft tissue to bone	Same	Same
How Supplied	Sterile	Same	Same
Sterilization Method	Ethylene Oxide	Same	Same
Implant Materials
• Cortical Button	Titanium (Ti-6AL-4V Alloy)	Same	Same
• Suspension Loop	UHMWPE/Polypropylene/Polyester	UHMWPE/Polyester	Same asN8TIVE
• Suture/Suture Tape	Not Applicable	UHMWPE	Not Applicable
• Graft Spacer	Not Applicable	PEEK Optima®	Not Applicable
• Screw	Not Applicable	Same	Not Applicable
• Sheath	Not Applicable	PEEK Optima	Not Applicable
• Tether Sutures	Not Applicable	UHMWPE	Not Applicable
Method of Insertion	Inserted into drilledhole/tunnel	Same	Same
Design Technology	Graft suspension loop withcortical button	Graft Spacer andSuspension Loop withCortical Button	Same as BiometToggleLoc
ImplantSize/Dimensions
• Cortical Button	13.2mm x 2.0mm x 1.8mm	12.1mm x 3.9mm x1.8mm (FemoralImplant)18mm x 11.5mm 6.1mm(Tibial Implant)	Same asN8TIVEFemoralImplant
• Suspension Loop	Adjustable	Same	Same
• Graft Spacer	Not Applicable	23mm x 6mm x 6mm	Not applicable
• Screw	Not Applicable	Range of 29 to 36mmlength, 8mm diameter	Not Applicable
• Sheath	Not Applicable	Range of 33 to 40mmlength	Not Applicable

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Intended Use

The Adjustable Fixation Device is indicated for soft tissue to bone fixation for:

ACL/PCL repair / reconstruction ●
ACL/PCL patellar bone-tendon-bone grafts
Double-Tunnel ACL reconstruction
Extracapsular repair: MCL, LCL, and posterior oblique ligament ●
Illiotibial band tenodesis
Patellar tendon repair ●
VMO advancement
. Joint capsule closure

Non-Clinical Data

Bench testing was conducted as follows:

l Comparative testing of the proposed and predicate devices in which the proposed and predicate devices were inserted into a simulated human bone substrate and subjected to cyclic and static loading.
I Design Verification testing to demonstrate conformance to design and performance specifications.

All test results confirm that Adjustable Fixation Device is substantially equivalent to the predicate devices. Additionally, the test results confirm that the devices meet their design, performance, and safety specifications.

Clinical Data

No clinical or animal data are included in this submission.

Summary

All testing demonstrates that the Adjustable Fixation Device performs as intended and has acceptable mechanical properties when used in accordance with the device labeling.

As the intended use, operating principle, materials, and technological characteristics are comparable to the predicate devices, ArthroCare believes the Adjustable Fixation Device is substantially equivalent to the predicate devices. The minor differences between the ArthroCare devices and their predicate devices do not raise any new questions of safety or effectiveness.

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.