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The ZIPE® Knotless Tissue Repair and Attachment Devices are intended for fixation of tissue to bone and tissue to tissue.

This product is intended for the following indications:

• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-● Clavicular Separation Repair, Deltoid Repair, Capsulolabral Reconstruction
• . Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valqus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair
• . Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair
• . Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar and Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction

The ZipE® Knotless Tissue Repair and Attachment Devices are implantable soft tissue fixation and suture retention devices comprising of a resorbable pledge('button disc ("suture capture"), a titanium screw or biocomposite bone anchor ("plug"), an ultra-high polyethylene (UHMWPE) braided #2 suture having pre-tied half hitched protuberances along its length, a nitinol wire capture holder and a nitinol wire suture shuttle. All components are preloaded onto a stainless steel insertion driver having a TPE tip protector and a silicone O-ring encircling the diameter of the handle to hold the system in place. The implantable elements of the system are the bone anchor, suture and capture; the other components are part of the driver insertion system.

The capture is designed to interact with the knotted suture by locking with the protuberances on the suture so that once advanced across the protuberance, it cannot move backward. Once the anchor is inserted into the bone, the pushed down with the stainless steel driver, traveling forward over the knotted suture, preventing movement in the reverse direction, and thereby locking the repair tissue to the underlying tissue.

The ZipE® Knotless Tissue Repair and Attachment Devices come with all components pre-assembled into the insertion driver and ready to be operated by the user. Products may be sold separately.

I am sorry, but based on the provided text, there is no information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the typical format of a medical device submission beyond the non-clinical testing listed. The document is an FDA 510(k) clearance letter and a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and performance data for a clinical study with an AI component.

Here's a breakdown of what can be extracted and what is missing:

Information that can be extracted from the provided text:

• Device Name: ZipE® Knotless Tissue Repair and Attachment Devices
• Non-clinical Testing Performed:
  • Bench testing (Static pullout testing, Cyclic pullout testing, Degradation testing, Insert Torque testing)
  • Biocompatibility testing (Systemic toxicity, Reverse mutation, Intracutaneous injection, Kligman maximization, Micronucleus assay, Lymphoma mutagenesis, Intramuscular implantation, Pyrogen test, Systemic injection test, MEM elution test, Neutral red uptake test)
  • Sterilization validation (Bioburden, EO residual testing, Endotoxin (LAL) Validation)
  • Package and transportation testing (Transportation validation, Packaging testing, Accelerated aging)

Information that is not available in the provided text, as it pertains to AI-enabled device studies and clinical performance:

• A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria (e.g., sensitivity, specificity, AUC thresholds) or report device performance against such criteria. The reported performance is only a list of non-clinical tests.
• Sample sized used for the test set and the data provenance: Not applicable as no clinical study or AI performance evaluation is described.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: "Clinical Testing: None provided as a basis for substantial equivalence."
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an AI algorithm.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

This document describes a traditional 510(k) clearance for a physical medical device (tissue repair and attachment devices), not an AI-enabled medical device. Therefore, the questions related to AI-specific performance criteria, ground truth, expert review, and clinical study designs (like MRMC) are not addressed by this submission. The "acceptance criteria" for this device were likely based on the successful completion of the listed non-clinical tests, demonstrating that the device meets safety and performance standards equivalent to predicate devices within an engineering context (e.g., pullout strength exceeding a certain threshold), rather than statistical performance metrics for diagnostic or prognostic accuracy.

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The TranSet™ Fracture Fixation System is indicated as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated. It may also be used as an adjunct to external and intramedullary fixation systems involving fixation plates and rods, with fracture braces and casting, and with bone graft substitutes. The system is also indicated in ligament and tendon repair and reconstruction associated with fractures and soft tissue reattachment including ligament/tendon avulsions and meniscal repairs. The system consists of both absorbable and titanium fixation buttons used with up to USP Size No. 5-braided suture and are not intended for reuse. The system may also be used with the Unity Ultrasonic Fixation seat for tissue approximation and ligation when using USP Size No. 2-0 through 2-braided suture. Custom manual surgical instrumentation for button insertion and a sterilization tray complete the TranSet™ Fracture Fixation System.

The TranSet™ Fracture Fixation System is not indicated for use in intra-articular sites.

The TranSet™ Fracture Fixation System intended use is in the stabilization and linear fixation of bone or tissue fragments in orthopedic fractures and in ligament and tendon repair and reconstruction. The system consists of both absorbable and titanium cylindrical buttons manufactured from poly-L-lactic acid or titanium alloy. The buttons are provided sterile packaged with or without braided suture and are intended for single-patient use. Buttons are applied to the outer bone cortex and with suture running across the fracture site allows for stabilization and linear fixation of the bone or tissue fragments. This allows the bone or tissue fragments to be compressed and held together to promote healing. The cylindrical design of the buttons also allows them to be used as fixation devices in orthopedic ligament and tendon repair and reconstruction. The buttons are placed outside the cortical bone or though a soft tissue repair site and act as fixation posts by distributing suture tension over larger areas to promote healing and eliminate any suture tearing or pulling through the tissue. The absorbable buttons degrade over time and eliminate the need for any surgical removal. Removal of the titanium buttons is based upon surgeon preference. Reusable manual surgical instrumentation for insertion of the buttons and a sterilization tray for autoclaving complete the system.

This document, a 510(k) summary for the TranSet™ Fracture Fixation System, focuses on demonstrating substantial equivalence to predicate devices based on intended use and material similarity, as well as mechanical strength testing. It does not contain information typically found in a study proving a device meets specific acceptance criteria related to clinical performance or algorithm-driven accuracy.

Therefore, many of the requested categories cannot be filled from the provided text.

Here is the information that can be extracted or reasonably inferred, along with notations for what is not present:

Acceptance Criteria and Reported Device Performance

Study Details

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

   • Sample Size: Not specified for the mechanical performance testing.
   • Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). It is physical performance testing, not clinical data from patients.

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

   • Not Applicable. This was mechanical performance testing, not a clinical study involving expert assessment of patient outcomes or images. The "ground truth" would be the measured physical properties of the materials.

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

   • Not Applicable. This was mechanical performance testing, not a clinical study requiring human adjudication of results.

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 document describes a medical device (fracture fixation system), not an AI or imaging diagnostic device. Therefore, an MRMC study is not relevant.

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

   • No. This is not an algorithm or AI device.

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

   • Laboratory Measured Physical Properties: The "ground truth" for the performance testing would be the objectively measured mechanical properties (e.g., tensile strength, bending strength, failure load) of the devices under controlled laboratory conditions.

7. The sample size for the training set:

   • Not Applicable. This is not an AI or machine learning study, so there is no "training set."

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

   • Not Applicable. No training set was used.

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The Soft Tissue Anchoring Washers [washers], [washer, bolt nut] Indications For Use: are to be used for anchoring soft tissue to bone.

Soft Tissue Anchoring Washers [washers], [washer, bolt nut]

This document is a 510(k) premarket notification from the FDA for a device called "Soft Tissue Anchoring Washers." It is a regulatory letter determining substantial equivalence to a predicate device.

The provided text does not contain any information regarding clinical studies, acceptance criteria, or performance data of the device. It is a regulatory approval letter, not a device study report. Therefore, I cannot extract the requested information.

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For use in procedures requiring fixation of suspending sutures and/or surgical mesh to soft tissue. This includes but is not limited to pubourethral support and bladder neck support procedures for the treatment of female stress urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency

The system includes a surgical stainless stcel retention anchor with attached polypropylene suture, and a delivery device for placement of the implant. The system may be supplied with legally marketed surgical mesh marketed for use in treating female stress urinary incontinence.

This document is a 510(k) Premarket Notification for a Suture/Mesh Fixation System (K021384/K021834). It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The 510(k) process for this type of device (Class II surgical suture) typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a performance study with acceptance criteria in the same way a novel high-risk device or an AI/ML powered device might.

Therefore, I cannot extract the requested information from the provided text. The document focuses on regulatory classification, intended use, and the claim of substantial equivalence.

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The AMS soft tissue approximation system ("ASTA") is intended for use as a general use suture retention device. The ASTA system provides a method to deploy and anchor suture internally from a single access point, which may be used to grasp, manipulate, or affix the attached tissue.

The AMS soft tissue approximation system has two components: a clip and an applicator. The clip is shaped as a rod and is available in two different sizes. Each clip has a central hole through which non-absorbable suture up to and including size No. I may be threaded. The applicator is composed of a straight or curved stainless steel tube in which the tip of the clip is positioned and has a handle with a release button for clip deployment. The choice of shaft configuration and clip size depends upon the desired application.

The provided text focuses on regulatory approval (510(k) submission) for the "AMS Soft Tissue Approximation System" and does not contain detailed information about specific acceptance criteria or a dedicated study proving performance against those criteria. The submission is primarily concerned with establishing substantial equivalence to predicate devices rather than presenting a performance study with detailed metrics against defined acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not available in the provided document.

Here's a summary of what can be extracted and what is not available from the text:

1. Table of Acceptance Criteria and Reported Device Performance
This information is not provided in the document. The submission states: "Bench testing has demonstrated that the device is safe and effective and that its performance is substantially equivalent to a 510(k)-cleared device." However, it does not specify what acceptance criteria were used for "safe and effective," nor does it present quantitative performance data against such criteria.

2. Sample size used for the test set and the data provenance
This information is not provided. The text mentions "bench testing," which implies that a test set was used, but details on its size, composition, and provenance are absent.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. As no specific performance study with a test set is detailed, there's no mention of experts or their qualifications for establishing ground truth.

4. Adjudication method for the test set
This information is not provided.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
This information is not provided. The focus is on demonstrating substantial equivalence through bench testing, not a comparative effectiveness study with human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device described is a physical medical device (implantable clip and applicator), not an algorithm or AI system.

7. The type of ground truth used
This information is not provided. Given the nature of the device (implantable clip), "ground truth" would likely relate to material properties, mechanical performance (e.g., tensile strength, deployment success), and biocompatibility, but the specific methods for establishing ground truth for any bench testing are not detailed.

8. The sample size for the training set
This information is not applicable/not provided. The device is a physical product, not a machine learning algorithm.

9. How the ground truth for the training set was established
This information is not applicable/not provided.

In summary: The provided document is a 510(k) summary focused on regulatory clearance by demonstrating substantial equivalence to predicate devices. It references "bench testing" that showed the device is "safe and effective," but it does not provide the detailed study design, specific acceptance criteria, quantitative performance metrics, or information regarding sample sizes, ground truth establishment, or expert involvement that would be present in a comprehensive performance study.

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RCI Fixation Screws are used for interference fixation of Bone-Tunnel-Bone or Hamstring grafts in anterior or posterior cruciate ligament reconstruction.

RCI Fixation Screws are rounded head interference screws which include diameters from 7 to 9 mm and a range of lengths from 25 mm to 50 mm. To allow for maximum amount of thread engagement, the thread profile is constant throughout the entire length of the screw. Except for direction of the threads, the Reverse Thread RCI screw is identical to the current RCI screw.

The provided text describes a 510(k) submission for the "RCI Fixation Screws." This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study for an AI/ML device.

Therefore, many of the requested items (e.g., sample size for test set, number of experts for ground truth, MRMC study, training set details) are not applicable or cannot be extracted from this type of regulatory submission. The document details bench testing, which is a different type of performance evaluation.

Here's the information that can be extracted or inferred:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Test Set Sample Size: Not applicable. This document describes bench testing, not a clinical study with a "test set" in the context of an AI/ML device evaluation.
• Data Provenance: The RCI Fixation screws were "tested in the laboratory," indicating internal bench testing. No country of origin for clinical data is relevant here. The data is prospective for this specific bench test.

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

• Not applicable. Ground truth as typically defined for AI/ML devices (e.g., expert consensus on images or pathology) is not relevant for this type of mechanical device bench testing.

4. Adjudication method for the test set

• Not applicable. This concept is for clinical studies with expert reviewers, not mechanical bench testing.

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/ML diagnostic device.

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

• Not applicable. This is not an AI/ML diagnostic device.

7. The type of ground truth used

• The "ground truth" for the bench testing would be the measured mechanical properties (e.g., pull-out strength, insertion torque) compared against pre-defined engineering specifications for "suitable fixation strength."

8. The sample size for the training set

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

Study Description:

The safety and effectiveness of the RCI Fixation Screws were demonstrated through bench testing. The document states, "RCI Fixation screws have been tested in the laboratory and found to have suitable fixation strength for use as interference screws." This implies that the device underwent mechanical tests to assess its ability to provide stable fixation for bone-tunnel-bone or hamstring grafts, as required for ACL/PCL reconstruction. While specific quantitative results are not provided in this summary, the conclusion is that the device met the internal specifications for fixation strength. The 510(k) summary primarily relies on demonstrating substantial equivalence to existing legally marketed devices (Arthrex Extra Long Screw K915424 and RCI Screw K945687) by comparing indications, dimensions, material, and sterilization methods. The bench testing further supported the performance claim for the new device.

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