The Tenodesis Screw System is intended for soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue and tendon transfers in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically: Shoulder: Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction. Knee: Anterior Cruciate Ligament Repair Medial Collateral Ligament Repair Lateral Collateral Ligament Repair Patellar Tendon Repair Posterior Oblique Ligament Repair Illiotibial Band Tenodesis Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist: Scapholunate Ligament Reconstruction Ulnar Collateral Ligament Reconstruction Radial Collateral Ligament Reconstruction Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty) Carpal Ligament Reconstructions and repairs Ligament Reconstruction and Tendon Interposition.

Device Description

The Tenodesis Screw System is composed of a screw manufactured from polyetheretherketone (PEEK). They are fully threaded, cannulated anchors with a flat head. The screws are provided in multiple lengths and sizes to accommodate variations in patient anatomy.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "Tenodesis Screw System." It describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Based on the nature of this document (510(k) summary for a mechanical orthopedic implant), the information requested in your prompt regarding acceptance criteria and study design for an AI/Software as a Medical Device (SaMD) is largely not applicable. This document details the mechanical, material, and performance testing for a physical implant, not an AI-driven diagnostic or assistive tool.

Therefore, for aspects related to AI/SaMD studies (like sample size for test sets, expert consensus, MRMC studies, training set details, etc.), the answer will be that this information is not relevant or not present in the provided document, as it deals with a different type of medical device.

I will address each point of your query based on the information available in the provided text.

Acceptance Criteria and Study for the Tenodesis Screw System

The "Tenodesis Screw System" is a mechanical implant designed for soft tissue reattachment, primarily fixation of ligament and tendon graft tissue. Its performance is evaluated through mechanical testing, not clinical studies involving AI or human interpretation of images.

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

The document states:
"All necessary testing has been performed on representative Tenodesis Screw System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended. All testing was performed on finished Tenodesis Screw System implants. The device performance was characterized via Static Torsion, Static Insertion and Removal Torque, and Static Axial Pullout Testing per ASTM F543. Clinical data are not needed to support the safety and effectiveness of the subject devices."

The specifics of acceptance criteria (e.g., minimum torque values, maximum displacement) and reported device performance (e.g., actual measured values) are not explicitly provided in this 510(k) summary table. This summary states that the device meets the criteria (by demonstrating substantial equivalence) but does not list the numerical targets or results. The testing was conducted according to ASTM F543, which is a standard specification for metallic medical bone screws. Compliance with this standard implies that specific mechanical properties were tested and met, but the precise numbers are proprietary and typically found in the full submission, not the public summary.

Additionally, a "Bacterial Endotoxin Test has been conducted on the subject device and it meets the specified 20 EU/Device limit." This is an acceptance criterion for biocompatibility.

Acceptance Criterion Type	Specific Acceptance Criterion (from document)	Reported Device Performance (from document)
Mechanical Performance	Meet requirements of ASTM F543 for:	"All necessary testing has been performed on representative Tenodesis Screw System components to assure substantial equivalence to its predicate and demonstrate the subject device performs as intended." (Implies acceptance criteria were met, but specific values are not disclosed in this summary)
	- Static Torsion
	- Static Insertion and Removal Torque
	- Static Axial Pullout Testing
Biocompatibility	Bacterial Endotoxin Limit: <= 20 EU/Device	"it meets the specified 20 EU/Device limit."

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

Sample size: The document does not specify the number of screws or test specimens used for the mechanical testing (Static Torsion, Insertion/Removal Torque, Axial Pullout). It mentions "representative Tenodesis Screw System components."
Data Provenance: The data is generated from laboratory mechanical testing of the device components, not from patient studies. Therefore, concepts like "country of origin of the data," "retrospective," or "prospective" are not applicable in the context of this device's testing.

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. This is a mechanical implant, not an AI/SaMD requiring ground truth established by medical experts for diagnostic accuracy. The "ground truth" for mechanical testing is based on engineered specifications and material science, verified through standardized testing methods (e.g., ASTM F543) conducted by qualified engineers/technicians in a laboratory setting.

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

Not Applicable. Adjudication methods are relevant for clinical studies or studies involving human judgment (like image interpretation). This device's performance is verified through objective mechanical measurements, not subjective human assessment needing 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/SaMD device. No MRMC study was conducted or is relevant for this type of mechanical implant.

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

Not Applicable. This is not an AI/SaMD device. There is no algorithm to test for standalone performance.

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

The "ground truth" for this device's performance is established by engineering standards (e.g., ASTM F543) and material properties. The device is expected to meet specific quantifiable mechanical performance metrics (e.g., torque, pullout strength) as stipulated by these standards and comparison to the predicate device. It's based on objective physical measurements rather than clinical or pathological "ground truth."

8. The sample size for the training set

Not Applicable. This is not an AI/SaMD device. There is no "training set" as it does not involve machine learning.

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

Not Applicable. This is not an AI/SaMD device. There is no training set or associated ground truth establishment methods relevant to AI.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 1, 2019

Paragon 28, Inc. Eric Lintula Director of Regulatory Affairs 4B Inverness Court E. Suite 280 Englewood, Colorado 80112

Re: K183690

Trade/Device Name: Tenodesis Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: December 21, 2018 Received: December 31, 2018

Dear Mr. Lintula:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrl/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Laurence D. Coyne -S

For 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

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known) K183690

Device Name Tenodesis Screw System

Indications for Use (Describe)

· Rotator Cuff Repairs
· Bankart Repair
· SLAP Lesion Repair
· Biceps Tenodesis
· Acromio-Clavicular Separation Repair
· Deltoid Repair
· Capsular Shift or Capsulolabral Reconstruction.
Foot/Ankle:
· Lateral Stabilization
· Medial Stabilization
· Achilles Tendon Repair
Hallux Valgus Reconstruction
Midfoot Reconstruction
· Metatarsal Ligament Repair
· Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and
· Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction.

Knee:

· Anterior Cruciate Ligament Repair
· Medial Collateral Ligament Repair
· Lateral Collateral Ligament Repair
· Patellar Tendon Repair
· Posterior Oblique Ligament Repair
· Illiotibial Band Tenodesis

Elbow:

· Biceps Tendon Reattachment
· Ulnar or Radial Collateral Ligament Reconstruction Hand/Wrist:
Scapholunate Ligament Reconstruction
Ulnar Collateral Ligament Reconstruction
· Radial Collateral Ligament Reconstruction
· Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
· Carpal Ligament Reconstructions and repairs
· Ligament Reconstruction and Tendon Interposition.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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510(k) Summary

Date:	December 21st, 2018
510(k) Number:	K183690
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888Fax: (888) 728-1220
Sponsor contact:	Eric Lintula, Director of Regulatory Affairs
Trade Name:	Tenodesis Screw System
Regulatory Class:	Class II
Regulation,Product Code,Classification, andCommon Name:	888.3040, MBI, Fastener, Fixation, Nondegradable, Soft Tissue
DeviceDescriptions:	The Tenodesis Screw System is composed of a screwmanufactured from polyetheretherketone (PEEK). They are fullythreaded, cannulated anchors with a flat head. The screws areprovided in multiple lengths and sizes to accommodatevariations in patient anatomy.
Indications forUse:	The Tenodesis Screw System is intended for soft tissuereattachment, i.e. fixation of ligament and tendon graft tissueand tendon transfers in surgeries of the shoulder, elbow, knee,foot/ankle, and hand/wrist. Specifically:Shoulder:Rotator Cuff Repairs Bankart Repair SLAP Lesion Repair Biceps Tenodesis Acromio-Clavicular Separation Repair Deltoid Repair Capsular Shift or Capsulolabral Reconstruction. Foot/Ankle: Lateral Stabilization Medial Stabilization Achilles Tendon Repair Hallux Valgus Reconstruction Midfoot Reconstruction Metatarsal Ligament Repair Flexor Hallucis Longus Transfer for Achilles Tendon Reconstruction, and Flexor Digitorum Longus Transfer for Posterior Tibial Tendon Reconstruction.
	• Anterior Cruciate Ligament Repair• Medial Collateral Ligament Repair• Lateral Collateral Ligament Repair• Patellar Tendon Repair• Posterior Oblique Ligament Repair• Illiotibial Band TenodesisElbow:• Biceps Tendon Reattachment• Ulnar or Radial Collateral Ligament ReconstructionHand/Wrist:• Scapholunate Ligament Reconstruction• Ulnar Collateral Ligament Reconstruction• Radial Collateral Ligament Reconstruction• Carpometacarpal joint arthroplasty (basal thumb jointarthroplasty)• Carpal Ligament Reconstructions and repairs• Ligament Reconstruction and Tendon Interposition.
Materials:	The Tenodesis Screw System implants are made from PEEK perASTM F2026. The instrumentation is primarily manufacturedfrom medical grades of stainless steel.
PrimaryPredicate:	K051726, Arthrex Tenodesis Screw Family
Comparison toPredicateIndications:	The subject Tenodesis Screw System and Arthrex TenodesisScrew Family devices are intended to be used for soft tissuereattachment. All indications for the subject device are withinthe indications of the predicate devices.
Comparison toPredicateTechnologicalCharacteristics:	The subject Tenodesis Screw System components possess thesame technological characteristics as the respective predicatedevices. These include:• performance,• basic design,• material, manufacturing and• sizes (dimensions are comparable to those offered by thepredicate systems).Differences between the Tenodesis Screw System and ArthrexTenodesis Screw Family implants were shown not to raise newquestions of safety and effectiveness. Therefore, thefundamental scientific technology of the subject TenodesisScrew System components is similar to previously cleareddevices.
PerformanceData:	All necessary testing has been performed on representativeTenodesis Screw System components to assure substantialequivalence to its predicate and demonstrate the subject deviceperforms as intended. All testing was performed on finished
	The device performance was characterized via Static Torsion,
	Static Insertion and Removal Torque, and Static Axial Pullout
	Testing per ASTM F543. Clinical data are not needed to support
	the safety and effectiveness of the subject devices.
	A Bacterial Endotoxin Test has been conducted on the subject
	device and it meets the specified 20 EU/Device limit. This is the
	recommended limit for devices that do not contact the
	cerebrospinal fluid.
Conclusion:	Performance testing demonstrates the substantial equivalence of
	the Tenodesis Screw System to the Arthrex Tenodesis Screw
	Family. Therefore, the Tenodesis Screw System is substantially
	equivalent to the predicate devices with respect to their
	indications for use, technical characteristics, and function.

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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.