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

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
• · 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

· 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 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

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.

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.

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Milagro Interference Screw (5x12, 6x12, 7x15, 8x15)

The MILAGRO BR Interference Screws are 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)

Milagro Advance Interference Screw (7x23, 8x23, 9x23)

The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9mm x 23mm screws are indicated for: medial and lateral ligament repart, medial patellofemoral ligament reconstruction (femur fixation) of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The proposed devices are interference screws used for attachment of soft tissue to bone in Orthopedic surgeries. The proposed devices are cannulated, threaded interference screws, made of absorbable Biocryl® Rapide™ (composite of β-TCP and PLGA copolymer). The devices are provided as sterile (EtO), and are for single patient use only.

There is no accessory accompanied with the devices. Manual Orthopedic instruments such as tap and driver are used for screw insertion. Instruments are classified as LXH: Orthopedic Manual Surgical Instruments, Class I Exempt device, regulated per 21 CFR 888.4540. No new instrumentation is developed for the purpose of this submission.

This document is a 510(k) Premarket Notification from the FDA regarding the Milagro / Milagro Advance Interference Screw. It focuses on establishing substantial equivalence to a predicate device rather than presenting a novel device requiring extensive clinical trials with specific acceptance criteria related to accuracy or performance metrics.

Therefore, the requested information components related to acceptance criteria, ground truth, expert adjudication, and comparative effectiveness studies typical for AI/CAD devices are not applicable in this context. The device is a bone fixation appliance, not an AI or diagnostic device.

Here's a breakdown of the available information based on your request, highlighting why certain sections are not applicable:

1. Table of acceptance criteria and reported device performance:

   • Acceptance Criteria: Not explicitly defined in terms of numerical performance thresholds as this is a medical implant seeking substantial equivalence, not a diagnostic or AI device with performance metrics like sensitivity/specificity. The implicit "acceptance criterion" is demonstrating substantial equivalence to the predicate device in terms of safety and effectiveness for the stated indications for use.
   • Reported Device Performance:
     | Performance Metric | Reported Performance |
     | :----------------- | :------------------- |
     | Fixation Strength | Demonstrated substantial equivalence to the predicate device. |

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: Not specified in the provided document. The study was "bench-top mechanical testing," implying lab-based material or device samples, not patient data.
   • Data Provenance: Not applicable. This was a physical bench-top test, not a study involving human data.

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. The ground truth for mechanical testing is typically established by engineering standards and measurement accuracy, not expert consensus as in diagnostic imaging.

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

   • Not applicable. This is not a human-readable diagnostic test; it's mechanical performance assessment.

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 a medical implant, not an AI or diagnostic tool that would involve human readers.

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

   • Not applicable. This is a medical implant, not an algorithm.

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

   • The "ground truth" for the mechanical testing would be defined by engineering standards and measured physical properties (e.g., force required for failure, displacement under load) obtained through controlled laboratory experiments. It's not clinical data like pathology or outcomes.

8. The sample size for the training set:

   • Not applicable. This is not a machine learning or AI device that requires a training set.

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

   • Not applicable. As above, this is not an AI device.

Summary of the Study:

The study conducted was bench-top mechanical testing to assess the fixation strength of the Milagro / Milagro Advance Interference Screw. The primary goal was to demonstrate that its fixation performance was substantially equivalent to that of the predicate device (Bioraptor Knotless Anchor and BioTenodesis Interference Screw). The document explicitly states: "The data demonstrated substantial equivalence of fixation performance." There were no changes to the material, packaging system, or sterilization, further supporting the substantial equivalence claim.

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The MILAGRO ADVANCE Interference Screw is intended for attachment of soft tissue grafts or bone-tendon-bone grafts to the tibia and/or femur during cruciate ligament reconstruction procedures.

Additionally, the 7, 8 and 9 mm x 23 mm screws will be indicated for: medial and lateral collateral ligament repair of the knee, proximal bicep tenodesis in the shoulder and distal bicep tenodesis in the elbow.

The MILAGRO ADVANCE Interference Screw is an absorbable, tapered, cannulated, threaded fastener for use in interference fixation of soft tissue grafts or bone-tendon grafts. The Interference Screw is made from a composite made of absorbable Poly (lactide-co-glycolide) polymer and Tricalcium Phosphate (TCP). The MILAGRO ADVANCE Interference Screw is provided sterile and is for single patient use only.

Here's an analysis of the provided text regarding the MILAGRO ADVANCE Interference Screw, focusing on acceptance criteria and the study conducted.

It's important to note that the provided documents are a 510(k) summary and FDA clearance letter, which typically focus on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria in the way one might see for a novel drug or a high-risk device. Therefore, some of the requested information, particularly regarding detailed statistical analysis, specific sample sizes for clinical trials, and multi-reader studies, might not be explicitly present or applicable to this type of submission.

Acceptance Criteria and Reported Device Performance

Study Details

Due to the nature of a 510(k) summary for a device demonstrating substantial equivalence, the "study" described is primarily non-clinical performance testing rather than a full-scale clinical trial.

1. Sample size used for the test set and the data provenance:

   • Test set sample size: Not explicitly stated. The document mentions "screw fixation strength testing" and "screw torque testing," which are typically benchtop mechanical tests performed on a specific number of devices. The exact number of screws or test conditions used is not detailed in this summary.
   • Data provenance: Non-clinical (benchtop/laboratory) testing. No information on country of origin for this specific testing is provided, but it would typically be conducted by the manufacturer or a contract research organization. The study is described as "non-clinical testing," which implies it is prospective in nature for the purpose of this submission. There is no mention of human clinical data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • This question is not applicable in the context of this 510(k) submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or those involving image interpretation. For a mechanical orthopedic implant, "ground truth" is established by engineering specifications, material properties, and mechanical testing standards. The "experts" involved would be engineers, material scientists, and quality assurance personnel.

3. Adjudication method for the test set:

   • Not applicable. Adjudication methods like "2+1" or "3+1" are used when interpreting subjective data (e.g., radiology scans) where multiple readers disagree. For objective mechanical tests like strength and torque, data is quantitative and ideally directly measurable against a defined specification.

4. 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 type of study (MRMC, AI assistance) is for diagnostic or AI-enabled devices, which the MILAGRO ADVANCE Interference Screw is not. This device is a mechanical implant.

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

   • No. This question pertains to AI algorithms. The device is a mechanical implant, not an algorithm.

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

   • For the non-clinical testing described, the "ground truth" would be based on engineering specifications, established biomechanical performance standards, and comparison to the predicate device's known performance characteristics. This is primarily mechanical property data and performance specifications.

7. The sample size for the training set:

   • Not applicable. This question typically refers to machine learning algorithms. For mechanical devices, there isn't a "training set" in the computational sense. Development might involve iterative design and testing, but it's not analogous to an AI training set.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no "training set" in the AI sense for this device. The design and validation are based on engineering principles, material science, and established biomechanical testing methods.

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