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The Dunamis PunchTac Suture Anchors are intended to be used for reattachment of soft tissue to bone for the following indications:

• Shoulder Capsular stabilization Bankart repair Anterior shoulder instability repair SLAP lesion repairs Capsular shift or capsulolabral reconstructions Acromioclavicular separation repairs Deltoid repairs Rotator cuff tear repairs Biceps tenodesis
  Elbow Ulnar or radial collateral ligament reconstructions Lateral epicondylitis repair Biceps tendon reattachment

Foot and Ankle Hallux valgus repairs Medial or lateral instability repairs/ reconstructions Achilles tendon repairs/ reconstructions Midfoot reconstructions Metatarsal ligament/ tendon repairs/ reconstructions Bunionectomy

Knee

Extra-capsular repairs: medial collateral ligament, lateral ligament, posterior oblique ligament

Patellar realignment and tendon repairs: vastus medialis obliquous advancement, Iliotibial band tenodesis

Hip

Hip capsule repair Acetabular labrum reattachment Abductor tendon repair (in anchors 4.5mm - 6.5mm)

The Dunamis PunchTac Suture Anchors is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components:

• Suture Anchor (threaded, push-in and knotless designs)
• . USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene Suture(s) or Suture Tape (provided in configurations with suture only)
• . Inserter Tool

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Dunamis LLC for their PunchTac Suture Anchors.

It primarily details:

• The FDA's determination of substantial equivalence for the Dunamis PunchTac Suture Anchors to legally marketed predicate devices.
• The regulatory classification and product codes for the device.
• The intended indications for use of the suture anchors.
• A brief description of the device components.
• The predicate devices used for comparison.
• Statements indicating that testing was performed (pull-out strength and insertion testing) and that the device met "pre-determined acceptance criteria identified in the Design Control Activities" and LAL testing requirements. However, it does not specify what those acceptance criteria were, what the reported performance was, or provide details about the study itself.

Therefore, I cannot provide the requested information from this document.

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The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone. The components are intended to serve as fixation posts, a distributing suture tension over areas of ligament or tendon repair.

Specifically, the Dunamis Fixation Button System is intended for use in the fixation of bone and soft tissue in orthopedic procedures requiring ligament or tendon repair/ reconstruction fixation during the healing process following acromioclavicular separations, as an adjunct to fracture repair in syndesmotic trauma, and ACL and PCL repair.

The Dunamis Fixation Button System is to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The Dunamis Fixation System consists of titanium fixation buttons, non-absorbable suture loops, optional passing sutures, and optional button supports.

The provided text describes a FDA 510(k) premarket notification for the "Dunamis Fixation Button System." The document extensively details the device's administrative information, indications for use, device description, predicate devices, and the claim of substantial equivalence based on non-clinical testing.

However, the document does not contain information about a study involving human-in-the-loop performance, AI assistance, multi-reader multi-case (MRMC) studies, or the establishment of ground truth by multiple experts. It also does not mention any training or test sets for an AI/algorithm.

The "study" mentioned in the document refers to non-clinical performance testing to demonstrate substantial equivalence to predicate devices, not clinical studies involving human readers or AI performance.

Therefore, I cannot provide the requested information regarding acceptance criteria and performance data for an AI/algorithm as it is not present in the provided text.

Specifically, the document states:
"Non-clinical testing performed included static testing, dynamic testing, sterilization, sterile barrier packaging performance and aging of sterile medical device. The non-clinical performance testing conducted demonstrates that the insertion and fixation properties of the Dunamis Fixation Button System (with Continuous Loop or Adjustable Loop) are substantially equivalent to the predicate device, Arthrex TightRope (K112990)."

This indicates that the "study" was focused on the physical and mechanical properties of the device, not on diagnostic performance or AI-assisted interpretation.

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The Dunamis Suture Anchor suture anchors are intended for use for the reattachment of soft tissue to bone for the following indications: Shoulder (Capsular Stabilization - Bankart Repair, - Anterior Shoulder Instability, - SLAP lesion repairs, - Capsular Shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid Repairs, Rotator Cuff tear repairs, Biceps tenodesis), Elbow, Wrist, and Hand (Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Biceps tendon reattachment), Knee (Extra-capsular repairs: - medial collateral ligament, - lateral collateral ligament, - posterior oblique ligament, Patellar realignment and tendon repairs: - vastus medialis obliquous advancement, Iliotibial band tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instablility repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy).

The Dunamis Suture Anchor is a sterile single use implantable suture anchor system designed to provide fixation and reattachment of soft tissue to bone. The system consists of the following components: Suture Anchor, Teleflex Force Fiber Suture(s), USP Size 2, White & Blue, CoBraid Ultra High Molecular Weight Polyethylene, Inserter tool. The Dunamis Suture Anchor is packaged ready to use condition and provides aseptic O.R delivery. The system is provided complete and is not intended to be used or integrated with other bone anchor fixation implantable devices.

The provided text describes information about the Dunamis Suture Anchor PEEK device, but it does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

The document is a 510(k) premarket notification acceptance letter and summary for a physical medical device (suture anchor). The performance data mentioned (Axial Pull-Out Strength, Biocompatibility, Sterilization Validation, Ethylene Oxide Residuals, Sterile Barrier Packaging performance, Aging of Sterile Medical Device) are for mechanical and material properties of the suture anchor, not for a software algorithm's performance.

Therefore, I cannot provide the requested information for acceptance criteria and study details for an AI/ML device from the given text.

If you have a document about an AI/ML device, please provide that text, and I will do my best to extract the relevant information.

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The Dunamis Force DFX Tensile Tape Sutures are indicated for use in approximation and/or ligation of soft tissues including use of allograft tissue for orthopaedic surgeries".

The Dunamis Force DFX Tensile Tape Sutures are sterile single use sutures used in approximation and/or ligation of soft tissues, including use in allograft tissue for orthopaedic surgeries. Force DFX Tensile Tape suture is an uncoated braid offered in a variety of cut lengths, with or without needles, and provided sterile for single use only. Force DFX Tensile Tape suture is flat in shape and differs from USP requirements (not USP). It is available in 1.5mm, 2mm, tape width sizes and composed of undyed or blue Ultra High Molecular Weight Polyethylene (UHMWPE). Force DFX Tensile Tape suture sizes meet USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture.

This document describes a 510(k) premarket notification for the "Dunamis Force DFX Tensile Tape Sutures". It compares the new device to a legally marketed predicate device, the "Teleflex Force Fiber OrthoTape Polyethylene Non-Absorbable Surgical Sutures (K150438)".

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated with numerical targets in this document. Instead, the document claims that the Dunamis device's performance is "identical to the Teleflex device characteristics" and meets "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture." The reported performance for the Dunamis device is that it meets these requirements.

2. Sample Sizes Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions that "Dunamis LLc. has established a contract manufactured product specifications that has been accepted by Teleflex Medical which documents and secures the product configuration and required test methods to assure the device is equivalent in performance and to all the elements of Teleflex 510k K150438." This suggests that the testing likely followed the same or similar protocols as the predicate device, but specific details are absent.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This is a medical device submission focused on physical and mechanical properties, not diagnostic accuracy requiring expert interpretation of results.

4. Adjudication Method for the Test Set

Not applicable. This is a medical device submission focused on physical and mechanical properties.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically associated with diagnostic imaging or clinical decision support systems where human interpretation is a key factor. This submission concerns the physical properties and performance of a surgical suture.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a medical device submission for a physical surgical suture, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance criteria appears to be established by:

• USP (United States Pharmacopeia) standards: Specifically, "USP tensile strength requirements and USP needle attachment requirements for USP size #2 suture."
• Predicate device characteristics: The Dunamis device claims to have "identical" characteristics and "risk profile identical" to the Teleflex Force Fiber OrthoTape (K150438). This implies that the performance established for the predicate device serves as the benchmark.

8. The Sample Size for the Training Set

Not applicable. This is a medical device submission for a physical surgical suture, not a machine learning algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device.

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The Dunamis Interference Screw are indicated for the reattachment of ligament, tendon, soft tissue, or bone to bone during cruciate ligament reconstruction surgeries of the knee. All screws with a diameters of 9mm or less and a length of 25mm or less are also intended for use in the following procedures: Knee (ACL Repairs, PCL Repairs, Extra-capsular repairs - Medial collateral ligament, Lateral collateral ligament, Posterior oblique ligament, Patellar realignment and tendon repairs - Vastus medialis obliquous advancement, Iliotibial band tenodesis), Shoulder (Capsular stabilization - Bankart repair, Anterior shoulder instability, SLAP lesion repairs, Capsular shift or capsulolabral reconstructions, Acromioclavicular separation repairs, Deltoid repairs, Rotator cuff tear repairs, Biceps tenodesis), Foot and Ankle (Hallux valgus repairs, Medial or lateral instability repairs/reconstructions, Achilles tendon repairs/reconstructions, Midfoot reconstructions, Metatarsal ligament/tendon repairs/reconstructions, Bunionectomy, Flexor Hullucis Longus (FLH), Tendon Transfers), Elbow, Wrist, and Hand (Biceps tendon reattachment, Ulnar or radial collateral ligament reconstructions, Lateral epicondylitis repair, Scapholunate ligament reconstruction, Tendon Transfers, Carpometacarpal Joint Arthroplasty, Carpal Ligament Reconstruction).

Reattachment of ligament, tendon, soft tissue, or bone, shoulder, foot, ankle, knee, elbow and hand/wrist.

The provided text describes a 510(k) premarket notification for a medical device (Dunamis Interference Screw), indicating its substantial equivalence to a predicate device. However, it does not contain the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, or any data related to AI/human performance evaluation.

The document primarily focuses on:

• The FDA's decision regarding the 510(k) submission.
• The legal and regulatory framework for medical devices.
• The intended use and indications for the Dunamis Interference Screw.
• A comparison of the Dunamis Interference Screw to a predicate device (Smith & Nephew Biosure PK Interference Screw K083635).
• A summary of performance tests conducted (Torsional Yield Strength, Insertion and Removal Torque, Axial Push-Out Strength, Self-Tapping force, Biocompatibility, Sterilization Validation, Ethylene Oxide Residuals, Sterile Barrier Packaging performance, Aging of Sterile Medical Device), but not the specific acceptance criteria or reported performance values for these tests.

Therefore, I cannot fulfill your request for the detailed information about acceptance criteria and study proving device meets them, as that information is not present in the provided text.

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The Dunamis Force DFX Sutures, Polyethylene Non-Absorbable Surgical Sutures are indicated for use in approximation and or ligation of soft tissues including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries

The Dunamis Force DFX Sutures are sterile single use sutures are used in approximation and/or ligation of soft tissues, including use in cardiovascular surgeries and the use of allograft tissue for orthopaedic surgeries. The technical design configuration for both USP Size 2 and Size 5 are as follows:

USP Size 2 (metric 5)

White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 2 (oversized) x 36" length, single armed HC-5 needle.

Packaged 1(one) strand per pouch, 12 pouches per box, sterile.

USP Size 5 (metric 7)

White/Blue Co-braid - Ultra High Molecular Weight Polyethylene (UHMWPE) Suture USP Size 5 (oversized) x 36" length, single armed HS48 needle.

Packaged 1(one) strand per pouch, 12 pouches per box, sterile

Materials:

Co-Braid of UHMWPE and Blue Monofilament Polypropylene Non-absorbable Surgical Sutures meets USP requirements except for diameter.

Polymer/Colorant: Ultra High Molecular Weight Polyethylene (white): None

Polypropylene (blue): [bhthalocyaninato (2-)] copper with a concentration not to exceed 0.5% by weight.

The provided text is a 510(k) summary for the Dunamis Force DFX Suture. It states that the device is identical to a legally marketed predicate device (Teleflex Force Fiber Polyethylene Non-Absorbable Surgical Sutures, K063778) except for brand name, part number, and "manufactured for" indication on the labeling. As such, the Dunamis Force DFX Suture leverages the testing and established performance of the predicate device.

Given this context, the request for acceptance criteria and a study proving the device meets those criteria, along with details like sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information is not directly applicable to this specific submission. This is because the device's substantial equivalence is established by its identical specifications to a previously cleared product, rather than new, independent performance testing for the Dunamis device itself.

Therefore, the following information is derived from the context of substantial equivalence to the predicate device:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance
The document states, "Because the sutures are manufactured to the same specifications as those cleared in K063778, data provided in K063778 may be leveraged to support equivalence, including testing in accordance to the USP for non-absorbable sutures, biocompatibility testing performed in accordance with ISO 10993-1, and stability testing. No additional testing was performed on the contract-manufactured product."

Therefore, specific sample sizes and data provenance for the Dunamis device are not provided as its performance is inferred from the predicate device (K063778). The provenance of the predicate device's data would be from its original submission. This would be retrospective for the Dunamis submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as no new performance testing with a 'test set' was conducted for the Dunamis Force DFX Suture to establish a new ground truth. The device demonstrates equivalence to a predicate.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as no new performance testing with a 'test set' requiring adjudication was conducted for the Dunamis Force DFX Suture.

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
This information is not applicable. This device is a surgical suture, not an AI-assisted diagnostic or imaging tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable. This device is a surgical suture, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the predicate device (K063778) on which the Dunamis device's performance is based, the "ground truth" would be established by standardized laboratory testing methods as specified in the USP for non-absorbable sutures and ISO 10993-1 for biocompatibility. These are objective engineering and biological measurements, not expert consensus or pathology in the typical sense.

8. The sample size for the training set
This information is not applicable. This is not an AI/ML device requiring a training set.

9. How the ground truth for the training set was established
This information is not applicable. This is not an AI/ML device requiring a training set.

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