The Aevumed PHANTOM™ suture anchors are intended to be used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures:
· Shoulder: Rotator Cuff 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.
· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.
• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

Device Description

The Aevumed PHANTOM ™ Anchor with HS Fiber ™ suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM ™ Anchor with HS Fiber ™ are pre-loaded with or without needles. The Aevumed PHANTOM ™ Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (AEVUMED PHANTOM Suture Anchors). This document describes the device, its intended use, and a comparison to a predicate device to demonstrate substantial equivalence.

However, the provided text DOES NOT contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML-based medical devices. The document is for a traditional mechanical medical device (suture anchors) and the "NON-CLINICAL TESTS" section only mentions mechanical testing (Torsional Strength, Driving Torque, Pullout Strength) as the basis for substantial equivalence.

Therefore, I cannot extract the information required by your request, as the request pertains to the evaluation of an AI/ML device, and the provided document describes a non-AI/ML device.

Here's what I can tell you from the document regarding the "study" that proves the device meets the acceptance criteria, even though it's not an AI/ML study:

Study Type: Non-clinical mechanical testing.
Tests Conducted: Torsional Strength, Driving Torque, and Pullout Strength.
Purpose: To demonstrate substantial equivalence to the predicate device (Arthrex Corkscrew FT) by showing comparable mechanical performance.
Ground Truth: The mechanical properties of the predicate device serve as the de facto "ground truth" for comparison.
Acceptance Criteria: While specific numerical acceptance criteria are not explicitly listed in this summary, the implication is that the Aevumed PHANTOM™ Suture Anchors must perform comparably to the predicate device in these mechanical tests to establish substantial equivalence.

To directly answer your numbered points based on the provided text, I must state that this information is not available for an AI/ML device study:

A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML study. The document mentions mechanical tests (Torsional Strength, Driving Torque, Pullout Strength), but doesn't provide a table of acceptance criteria or specific numerical performance results for these non-clinical tests. It only states they were tested.
Sample sized used for the test set and the data provenance: Not applicable for an AI/ML study. For the mechanical tests, the sample sizes and provenance of the test articles are not specified in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML study. Ground truth for mechanical testing is based on physical measurements, not expert consensus.
Adjudication method for the test set: Not applicable for an AI/ML study.
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 mechanical device, not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a mechanical device.
The type of ground truth used: For this mechanical device, the "ground truth" is likely defined by the established mechanical standards and performance of the predicate device.
The sample size for the training set: Not applicable. There is no AI/ML training set.
How the ground truth for the training set was established: Not applicable. There is no AI/ML training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is a symbol of a stylized human figure. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 31, 2018

Aevumed, Inc. % Carol Rutkowski Partner, Pyxa Solutions Pyxa Solutions LLC 1034 West Thomas Road Plymouth Meeting, Pennsylvania 19462

Re: K180464

Trade/Device Name: AEVUMED PHANTOM Suture Anchors Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: MBI Dated: April 30, 2018 Received: April 30, 2018

Dear Ms. Rutkowski:

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 quality systems (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-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,

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) K180464

Device Name AEVUMED PHANTOM Suture Anchors

Indications for Use (Describe)

· Shoulder: Rotator Cuff 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.

· Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis.

• Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction.

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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5. Premarket Notification 510(k) Summary

MANUFACTURER /SPONSOR:	Aevumed Inc.877 Richards Rd.Wayne, PA 19807
CONTACT:	Saif Khalil, Ph.D.Chief Operating OfficerPhone: (610) 745-7284Fax: (610) 783-0307
TRADE NAME :	Aevumed PHANTOM TM Suture Anchor
COMMON NAME:	Suture Anchor
DEVICECLASSIFICATION:	Smooth or threaded metallic bone fixation fasteners, classified asClass II, product code MBI, Regulation 21 CFR 888.3040
PREDICATE DEVICE:	Arthrex Corkscrew FT, 510(k) number K061665.
DEVICE DESCRIPTION:	The Aevumed PHANTOM TM Anchor with HS Fiber TM suture is a threaded suture anchor manufactured from polyetheretherketone (PEEK) material preloaded on a disposable driver assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM TM Anchor with HS Fiber TM are pre-loaded with or without needles. The Aevumed PHANTOM TM Suture Anchor are available in diameter sizes: 5.5mm and 6.5mm. They are offered sterile and are for single use only.

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TECHNOLOGICAL The proposed Aevumed PHANTOM™ Anchors with HS Fiber™ CHARACTERISTICS: suture are similar to the predicate Arthrex Corkscrew FT (K061665) in that they share the same intended use, have the same anchor materials and principal operation . The devices do not raise different questions of safety and effectiveness. The Aevumed PHANTOM™ suture anchors are intended to be INDICATIONS FOR USE: used for suture and/or soft tissue fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow in, but not limited to, the following procedures: Shoulder: Rotator Cuff Repair, 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, Mid-foot Reconstruction, Metatarsal Ligament Repair. ● Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair and Illiotibial Band Tenodesis. Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral ● Ligament Reconstruction. Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament . Reconstruction. INTENDED POPULATION: Patients age 18 and older. Contraindication: Not for use across growth plates in patients who are not skeletally mature. The Aevumed PHANTOM™ suture anchor is prescribed by the physician. The substantial equivalence is based on non-clinical data. Both the NON-CLINICAL TESTS: Aevumed PHANTOM™ suture anchor and predicate device were mechanically tested for the following: Torsional Strength ● ● Driving torque Pullout Strength. ●

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Version 1.0 FINAL

SAFETY& PERFORMANCE:

The Aevumed PHANTOM™ Anchor is substantially equivalent to the Arthrex Corkscrew FT Suture Anchor. The data support the safety of the device and demonstrate that the Aevumed PHANTOM™ device should perform as intended in the specified use conditions and performs comparably to the predicate device that is currently marketed for the same intended use. Any differences between the Aevumed PHANTOM™ suture anchor and the Arthrex Corkscrew FT are considered minor and do not raise questions concerning safety and efficacy.

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.