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The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.

When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.

The Dunamis Screw and Suture Locking System is to be used for fixation of bone-to-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 devices are intended to be used in the adult or pediatric patient population, when the device does not bridge, disrupt, or interfere with the growth plate.

The Dunamis Screw and Suture Locking System consists of standalone bone screws, and various components which are compatible with previously cleared Dunamis Fixation Button System, Force DFX sutures and suture tapes, including: screws with suture locking features and suture wheel with various adapter options. The standalone screws are provided in various diameters, lengths, and configurations including headed and headless styles with various overall and threaded lengths. Screws with suture locking features are available in various diameters, lengths, and configurations. The suture wheel is available for standalone use with sutures or for use with compatible orthopedic plates with two adapter options (threaded or non-threaded post). The new components are manufactured from stainless steel and titanium alloy.

This document is an FDA 510(k) clearance letter for a medical device called the "Dunamis Screw and Suture Locking System." It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific novel clinical performance or effectiveness through a clinical trial with acceptance criteria for an AI or software-based medical device.

Therefore, the requested information about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software would not be applicable to this type of traditional medical device clearance.

The clearance letter primarily discusses:

• Intended Use and Indications: For bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
• Device Description: Consists of standalone bone screws and components compatible with previously cleared Dunamis systems, manufactured from stainless steel and titanium alloy.
• Predicate Devices: Several predicate devices are listed, including screws and suture systems.
• Performance Testing Summary: "Non-clinical performance data included ASTM F543 screw testing, static and dynamic construct testing, and engineering worst-case rationales." This indicates bench testing to demonstrate mechanical performance comparable to the predicates.
• Substantial Equivalence Conclusion: The device has the same intended use, similar technological characteristics, and similar materials to the predicate devices. Mechanical testing demonstrated substantially equivalent performance.

In summary, this 510(k) clearance is for a physical orthopedic implant system, not a software or AI-based medical device. The "acceptance criteria" here are met through demonstrating mechanical properties and performance that are substantially equivalent to already cleared devices, primarily via non-clinical bench testing.

Thus, a table of acceptance criteria for AI performance, details on test/training sets, expert adjudication, MRMC studies, or specific AI ground truth establishment methods are not present and not relevant to this 510(k) submission as described.

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This device is used during laparoscopy, creating a point of entry for laparoscopic instruments into the abdominal cavity.

The Auto Suture™ Locking Trocar is a sterile, single-use device designed for primary punctures during laparoscopy.

The provided document is a 510(k) summary for the Auto Suture™ Locking Trocar. It does not contain information about the acceptance criteria and study details as requested for a device involving AI or complex performance metrics. The device in question is a surgical trocar, which is a mechanical device, and the document focuses on demonstrating substantial equivalence to a predicate device through bench testing rather than detailed performance reporting against specific clinical acceptance criteria.

Therefore, many of the requested sections about AI-specific criteria, human reader studies, ground truth establishment, sample sizes for training/test sets, and expert qualifications are not applicable or cannot be extracted from this document.

Here's what can be extracted based on the information provided:

1. A table of acceptance criteria and the reported device performance

The document states: "Bench Performance testing was conducted to demonstrate that the Auto Suture™ Locking Trocar is substantially equivalent to the predicate device and performs as intended."

Specific quantitative acceptance criteria are not provided in this summary. The performance is described in terms of "substantial equivalence" to the predicate device and "performs as intended," without explicit metrics.

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 for Test Set: Not specified.
• Data Provenance: The testing appears to be "Bench Performance testing," implying laboratory-based testing rather than clinical data from human subjects. No information on country of origin or retrospective/prospective nature is provided, as it's not a clinical study.

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. Ground truth, in the context of expert review, is typically relevant for interpretative devices (like imaging AI). For a mechanical surgical trocar, performance is assessed through engineering and biocompatibility testing, not expert consensus on interpretations.

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

Not applicable, as it's not an interpretative study requiring adjudication.

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 device is a surgical trocar, not an AI-powered diagnostic or interpretive tool. No human reader studies or AI assistance are mentioned.

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

Not applicable. This device is a physical medical instrument, not an algorithm.

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

For this type of device, the "ground truth" would be established by engineering specifications, safety standards (e.g., ISO 10993-1 for materials), and functional requirements met through mechanical testing. The document states "All components of the Auto Suture™ Locking Trocar are comprised of materials which are in accordance with ISO 10993-1," which refers to biocompatibility standards. Specific functional "ground truth" for dimensions, strength, seal integrity, etc., would be defined by internal specifications and predicate device performance, but not explicitly detailed in this summary.

8. The sample size for the training set

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

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

Not applicable. This is not a machine learning device.

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The intended use of the KFx Suture Lock Tissue Fixation System is for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:
Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromio-clavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs.
Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.
Knee: Medial collateral ligament repairs, lateral ligament repairs, posterior oblique ligament repairs, lliotibial band tenodesis, patellar tendon repairs.
Hand, Wrist and Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System consists of a Nail Bone Anchor with two suture leads pre-loaded in a single use insertion handle and a Bone Screw Anchor (also pre-loaded in a single use delivery handle) used to capture the sutures, eliminating the need to tie suture knots. The KFx Tissue Fixation System also includes re-usable surgical instruments for the implantation of the Nail Bone and Bone Screw Anchors.
Devices are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas and provides a sterility assurance level of 10-6.

The provided text describes the KFx Suture Lock Nail Bone Anchor, a medical device for tissue fixation. It refers to "Bench test results" that "indicate that the device is safe and satisfies functional performance requirements" and concludes that the device is "substantially equivalent" to a previously cleared predicate device.

However, the document does not provide specific acceptance criteria or detailed results of a study in a tabular format as requested. It states that the device is substantially equivalent to a previously cleared device (K072063). The "Biocompatibility and Performance Data" section provides a high-level summary of the study findings, but lacks the granular details needed to fill out all the requested information about a specific study proving it meets acceptance criteria.

Therefore, much of the requested information cannot be extracted directly from the provided text.

Here is what can be inferred or stated based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details

1. 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.
   • Data provenance: Not specified (bench tests are typically conducted in a controlled lab environment, not on human data in the context of this device). The document refers to "bench test results."

2. 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 as this is a mechanical device evaluated through bench testing, not image analysis or clinical expert review.

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

   • Not applicable; this would typically be relevant for studies involving human interpretation or clinical endpoints.

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 MRMC study was done, as this is a mechanical bone anchor device, not an AI or imaging diagnostic tool.

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

   • Not applicable; this is a physical medical device, not a software algorithm.

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

   • The "ground truth" (or basis for evaluation) appears to be derived from established engineering and biocompatibility standards for medical devices and comparison to a predicate device. For mechanical performance, this would involve quantitative measurements against specified thresholds, but these thresholds are not provided.

7. The sample size for the training set:

   • Not applicable, as this is not a machine learning model.

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

   • Not applicable, as this is not a machine learning model.

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The KFx Tissue Fixation System (comprised of the KFx Suture Lock Bone Screw Anchor and KFx Suture Lock Nail Bone Anchor) and Accessories are intended for the fixation of soft tissue to bone in the shoulder, foot/ankle, knee, hand/wrist, and elbow. Specifically:

Shoulder: Bankart lesion repairs, SLAP lesion repairs, acromioclavicular separation repairs, rotator cuff repairs, capsular shift or capsulolabral reconstructions, biceps tenodesis, deltoid repairs

Foot and Ankle: Hallux valgus repairs, medial or lateral instability repairs/reconstructions, Achilles repairs/reconstructions, mid-foot reconstructions, metatarsal ligament repair.

Knee: Medial collateral ligament repair, lateral collateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis, patellar tendon repair.

Hand/Wrist/Elbow: Scapholunate ligament reconstructions, ulnar or radial collateral ligament reconstructions, tennis elbow repair, biceps tendon reattachment.

The KFx Tissue Fixation System is intended for the fixation of soft tissue to bone using Teleflex ForceFiber® #2 braided suture. The KFx 5.5mm Suture Lock Bone Screw Anchor component of the Tissue Fixation System is used to capture the Nail Bone Anchor sutures, eliminating the need to tie suture knots.

The KFx Nail Bone Anchor and the KFx Suture Lock Bone Screw Anchors are provided "STERILE"; sterilization is by Ethylene Oxide (EO) gas.

The provided text describes a medical device submission (K080229) for the KFx 5.5mm Suture Lock Bone Screw Anchor. This is a 510(k) Premarket Notification for a modified device, establishing substantial equivalence to a previously cleared predicate device (K072063).

It does not contain any information about a study involving AI or software, or acceptance criteria related to such a study. The document focuses on the mechanical performance and biocompatibility of a physical bone anchor in comparison to a predicate device.

Therefore, I cannot fulfill your request for the specific details regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance, as these items are not discussed in the provided text.

The closest relevant information is:

Acceptance Criteria and Device Performance (Bench Testing):

Remaining Requested Information (Not Available in the Text):

• Sample sized used for the test set and the data provenance: Not mentioned.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The "ground truth" here is likely mechanical testing standards and biocompatibility standards, not expert clinical interpretation.
• Adjudication method: Not applicable/mentioned for physical device bench testing.
• If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is for a physical medical device, not an AI/software.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: No, not applicable.
• The type of ground truth used: For biocompatibility, it's established standards and data on similar materials. For functional performance, it's likely engineering specifications and comparison to the predicate device's performance.
• The sample size for the training set: Not applicable; there is no "training set" in the context of this physical device submission.
• How the ground truth for the training set was established: Not applicable.

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The Suture Lock is intended to be use to secure soft tissue to bone, by securing the placement of sutures used in surgical procedures. The Suture Lock is indicated for use in Bankart and Rotator Cuff Repair procedures.

The Suture Lock is a sterile, single-use device manufactured from polyacetal.

This is a medical device 510(k) summary for a "Suture Retention Device" called Suture-Lock. It is a physical device, and therefore the request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/algorithm performance metrics is not applicable. The provided document does not contain information about an AI/algorithm-based device or its performance studies.

Therefore, I cannot answer the questions regarding acceptance criteria and performance studies in the requested format. This document describes a traditional medical device and its substantial equivalence to a predicate device based on characteristics like materials, intended use, and indications.

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