FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Knee: Medial and lateral collateral ligament repair
· Knee: Medial patellofemoral ligament reconstruction (femur fixation)
· Shoulder: Proximal Biceps Tenodesis
· Elbow: Distal Biceps Tenodesis

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Reconstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE PEEK Interference Screws (7x30mm, 8x30mm):

The DePuy Mitek MILAGRO ADVANCE PEEK Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recorstruction, Flexor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO ADVANCE BR Interference Screws (7x23mm, 8x23mm, 9x23mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction
· Knee: Medial and lateral ligament repair, medial patellofemoral ligament reconstruction (femur fixation)
Shoulder: Proximal Biceps Tenodesis
· Elbow: Distal Biceps Tenodesis

MILAGRO ADVANCE BR Interference Screws (8x30mm, 7x30mm):

The DePuy Mitek MILAGRO ADVANCE BR Interference Screw is indicated as follows:

· Knee: Attachment of a bone-tendon-bone (BTB) graft to the tibia and/or femur during cruciate ligament reconstruction procedures.

· Knee: Attachment of a soft tissue (ST) graft to the tibia and/or femur during cruciate ligament reconstruction

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction, Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (7x15mm, 6x12mm, 5x12mm):

The DePuy Mitek MILAGRO BR Interference Screws designed to attach soft tissues to bone in orthopedic surgical procedures for the following indications:

· Shoulder: Proximal Biceps Tenodesis, Acromio-Clavicular Repair

· Elbow: Distal Biceps Tenodesis, Ulnar Collateral Ligament Repair

· Knee: Collateral Ligament Repair, Medial Patellofemoral Ligament Reconstruction (patella fixation)

· Foot and Ankle: Lateral Stabilization. Medial Stabilization. Mid-Foot Reconstruction. Tendon Transfer in the Foot and Ankle

MILAGRO BR Interference Screws (5x23mm, 6x23mm, 6x30mm, 6x30mm):

The DePuy Mitek MILAGRO Interference Screw is indicated as follows:

· Knee: (ST) graft to the tibia and/or femur during cruciate ligament reconstruction procedures
· Knee: Medial and lateral collateral ligament repair*
· Shoulder: Proximal bicep tenodesis *
Elbow: Distal bicep tenodesis*

· Foot and Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Mid-Foot Recor Hallucis Longus for Achilles Tendon Reconstruction. Tendon Transfer in the Foot and Ankle

These indications do not apply to 5x30mm Screws and 6x30mm Screws

Device Description

The subject devices of this Special 510(k) are the MILAGRO Interference Screws and the Milagro ADVANCE Interference Screws. These interference screws are cannulated, threaded, tapered fasteners for use in interference fixation of soft tissue grafts and/or bone-tendon-bone grafts.

The MILAGRO Interference Screws and MILAGRO ADVANCE Interference Screws are offered in varying sizing configurations. The devices are offered in absorbable Biocryl Rapide material which is a biocomposite material of 70% PLGA copolymer (85% PLLA/15% PGA) and 30% β-TCP or PEEK (Polyether ether ketone) material.

The devices are provided sterile via Ethylene Oxide (EO) sterilization and are for single use only.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the FDA for DePuy Mitek MILAGRO Interference Screws. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the safety and effectiveness of a novel device through clinical trials and detailed acceptance criteria for an AI/software as a medical device (SaMD).

Therefore, the document does not contain the information requested regarding acceptance criteria and studies for an AI/SaMD. Specifically:

No acceptance criteria table or device performance is reported in the context of an AI/SaMD. The document mentions "performance testing for insertion force" and "assessment of fixation strength" for the physical interference screws, which are not relevant to AI/SaMD performance.
No sample size information for a test set for AI/SaMD is present.
No data provenance for AI/SaMD is mentioned.
No information regarding experts for ground truth establishment, adjudication methods, MRMC studies, standalone AI performance, or types of ground truth is available.
No information about training set size or ground truth establishment for a training set for AI/SaMD is provided.

The document primarily focuses on:

Device Identification: MILAGRO Interference Screw; MILAGRO ADVANCE Interference Screw.
Regulatory Information: Class II medical device, product codes MAI, MBI, regulated under 21 CFR 888.3030.
Substantial Equivalence: Listing predicate devices (K103831, K143660, K123362, K161001). The primary reason for this 510(k) is a modification to the labeling to add additional foot and ankle indications, asserting that the "anchor design, materials, principal of operation, and intended use of the subject devices are identical to that of the predicate devices."
Indications for Use: Detailed list of applications in knee, shoulder, elbow, foot, and ankle for various screw types and sizes.
Non-clinical Testing: Briefly states "Verification activities were performed... included an assessment of fixation strength... as well as performance testing for insertion force," concluding that these tests demonstrated suitability for the additional indications.

In summary, the provided text does not describe an AI/software medical device or the specific types of studies (like MRMC or standalone performance evaluations) that would involve acceptance criteria for AI algorithms. It pertains to a physical orthopedic implant and its substantial equivalence to previously cleared devices.

Summary

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.