Search Results

The Knotless Suture Fixation System is intended to secure soft tissue to bone of: The Shoulder, Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Rotator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radia! Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Ankle/Foot Indications: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

Knotless Suture Fixation System includes threaded anchors used to facilitate fixation of soft tissue to bone. This is a knotless suture anchor for surgical treatment of ligament, tendon and soft tissue pathologies of the shoulder and other joints. The implant is constructed of Polyetheretherketone (PEEK) which is widely used for products in the product code.

The provided text describes a 510(k) summary for the "Knotless Suture Fixation System" by Core Essence Orthopaedics, Inc. This document focuses on demonstrating substantial equivalence to predicate devices for market clearance, rather than presenting a detailed study proving the device meets specific acceptance criteria in a clinical or analytical setting with defined endpoints like accuracy, sensitivity, or specificity.

Here's a breakdown of the information based on your request, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document mentions "The following tests were performed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to other predicate devices: Pullout force Suture retention".

• Sample Size for Test Set: Not specified. The document only states that tests were performed to demonstrate equivalence.
• Data Provenance: Not specified. It's implicitly laboratory testing, but details like country of origin or whether the data is retrospective/prospective are not relevant for these types of mechanical tests and are not provided.

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

Not applicable. The tests performed are mechanical (pullout force and suture retention), not diagnostic or clinical tests requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

Not applicable. Mechanical tests do not typically involve adjudication methods for ground truth, as the measurements are objective.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "No clinical tests were performed." Therefore, no MRMC study was conducted.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Not applicable. This device is a physical medical device (suture fixation system), not an algorithm or AI system.

7. Type of Ground Truth Used

The ground truth for the "pullout force" and "suture retention" mechanical tests would be the measured physical properties themselves, determined by standardized testing protocols (e.g., ASTM standards). The document indicates that the tests showed the device "met the acceptance criteria," implying there were objectively measurable thresholds.

8. Sample Size for the Training Set

Not applicable. This is a physical medical device, not an AI or machine learning model 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.

Summary of the Study and Acceptance Criteria:

The "study" described is a set of nonclinical mechanical tests (pullout force and suture retention) designed to demonstrate that the Knotless Suture Fixation System is substantially equivalent to existing predicate devices. The acceptance criteria for these tests were met, confirming the device's mechanical integrity for its intended use. However, the document does not provide the specific numerical values for these acceptance criteria nor the detailed results or sample sizes from these tests. It only states that the criteria were met. No clinical studies were conducted or presented as part of this 510(k) submission.

Ask a specific question about this device

PONTiSTM Sutures with Optional Crimps are indicated to secure soft tissue to soft tissue reattachment in the hand:

• Collateral Ligaments around the PIP, DIP and MCP Joints .
• Flexor and Extensor Tendons .

PONTiSTM Suture Anchors with Optional Crimps are indicated to secure soft tissue to bone reattachment in the hand:

• Collateral Ligaments around the PIP, DIP and MCP Joints .
• Flexor and Extensor Tendons .

This premarket notification covers line extensions for the PONTiS™ product line. The ferroFibre™ stainless steel (SS) sutures were cleared for marketing in 2008, and are marketed in the PONTiS ™ product group. The PONTiS™ product family has been expanded to include stainless steel suture anchors geometrically similar to the reNOVO™ titanium product family (cleared in 2007), in combination with ferroFibre™ SS Sutures and optional suture crimps.

The PONTiS [1] implants incorporate non-absorbable ferroFibre [1] 316 L Stainless Steel Surgical sutures and are available in United States Pharmacopoeia (USP) sizes 4-0 and 3-0 in various lengths.

316L Stainless steel is used in a wide variety of medical devices including previously approved implants of this type. The ferroFibre™ Stainless Steel Sutures may be secured by either knot tying or crimping with a collar.

The ferroFibre™ multifilament sutures are supplied sterile, armed with cutting needles.

The implant components also include stainless steel collars specific to each suture size. The collars are used to secure multiple suture strands together simultaneously by crimping. For example, crimps are sized to accept between four (4) and eight (8) strands of each specific size of ferroFibre™ suture for crimping. A crimping instrument is supplied to crimp the collars to the suture strands. An adjustable tendon holder with suture tensioning slots is provided to facilitate suture cable tightening and tensioning. Excess suture is cut and removed.

The stainless steel PONTiS™ Suture Anchors are 3.0mm in diameter, are selftapping, and fully threaded. The anchors are each available with 4-0 and 3-0 multistrand ferroFibre™ stainless steel sutures. A disposable anchor driver holds the excess suture and delivers the anchor directly into the bone. The strands are then used to secure the soft tissue to bone.

Prior to installation, a hole is created in the bone using k-wire, drill or punch. The anchor is threaded into this hole. The anchor has self-tapping flutes.

Unlike the previously cleared titanium reNOVO™ Suture Anchor, PONTiS™ Suture Anchors are fully threaded allowing thread fixation in both cancellous and cortical bone.

The shorter overall length of the 3.0mm anchors, when compared to the self-drilling titanium reNOVO™ anchors, allows use in smaller/thinner bones where a lower profile is needed to achieve results without subsequent tissue injury.

The PONTiS™ threaded suture anchors are stainless steel to assure compatibility with the stainless steel in the ferroFibre™ stainless steel multi-strand sutures and the stainless steel crimp collars.

The size of the nonabsorbable stainless steel ferroFibre™ sutures used in the PONTiS™ Anchors is USP 4-0 and 3-0.

A single use driver and hand piece holds the excess suture and delivers the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to bone.

The PONTiS™ Suture Anchors are provided sterile for single use applications.

The sizes and materials are designed to address the indications cited.

The provided text is a 510(k) summary for a medical device (PONTiS™ Sutures and Suture Anchors with Optional Crimps). This type of document is heavily focused on demonstrating substantial equivalence to previously approved devices rather than conducting novel clinical or performance studies with acceptance criteria in the way one might see for a new drug or a highly innovative device.

Therefore, the specific information requested in the prompt (acceptance criteria, details about a "study that proves the device meets the acceptance criteria," sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance, etc.) is not explicitly present in the level of detail typically associated with those terms in a rigorous scientific study. The document describes performance testing and biocompatibility reviews, but not in a format that lends itself to a direct mapping to the requested table and study details.

Here's an attempt to extract and interpret the information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Specified" in the context of a 510(k) for substantial equivalence:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence)

The PONTiS™ Sutures and Suture Anchors with Optional Crimps are not evaluated against specific quantitative acceptance criteria in this 510(k) summary in the same way a new, novel device might be. Instead, their performance is deemed acceptable if they are substantially equivalent in materials, operational principles, indications, and function to predicate devices already on the market.

The "studies" conducted primarily involve comparison to predicate devices and established standards, ensuring material safety and adequate mechanical properties for the stated indications.

Table 1: Acceptance Criteria and Reported Device Performance (Interpretation for Substantial Equivalence)

Study Details for Demonstrating Substantial Equivalence

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

• Suture Loop Pull-Strength Test: Not specified.
• Anchor Pull-Out Performance (foam bone, bovine cortical bone): Not specified.
• Biocompatibility Tests: Not specified for sample sizes of tested materials or specimens.
• Data Provenance: The mechanical testing appears to be lab-based developmental and comparative testing, not necessarily clinical patient data. The biocompatibility tests are lab-based.

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

• Not Applicable. This is not a study requiring human expert assessment for a "ground truth" in the diagnostic or clinical outcome sense.
• The document mentions "surgeons and engineers" functionally evaluating suture anchors in animal and human cadaver bone, but this is described as an "evaluation" rather than a formal "ground truth" establishment for a test set. No specific number or qualifications are given beyond "surgeons and engineers."

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

• Not Applicable. This concept is not relevant to the type of testing described (mechanical and biocompatibility).

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-assisted reading) is entirely irrelevant to this device (sutures and anchors) and the nature of the 510(k) submission.

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

• No. This is not an algorithm-based device.

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

• Not Applicable / Industry Standards and Predicate Device Performance. The "ground truth" here is compliance with established material standards (e.g., ISO, USP) and demonstrating equivalent mechanical properties and biocompatibility to predicate devices that are already deemed safe and effective. For mechanical tests, the "ground truth" is derived from physical measurements (e.g., tensile strength, pull-out force).

7. The sample size for the training set:

• Not Applicable. This is not a machine learning or algorithm-based device that requires a training set.

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

• Not Applicable. See above.

Ask a specific question about this device

TAC-tite™ Suture Anchors are intended to secure soft tissue to bone of: The Shoulder: Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair The Elbow: Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair The Hand and Wrist: Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

The TAC-tite™ Suture Anchors are available in 5.5mm and 7.0mm diameters. The TAC-tite™ Suture Anchors are available with a threaded titanium (ASTM F136/ ISO 5832-3) anchor body (that provides a self drilling and self tapping thread). The TAC-tite™ anchor eyelet is designed to accept size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece delivers the preloaded anchor into the bone. The TAC-tite " Suture Anchor will be provided sterile for single use application.

This 510(k) summary (K090128) for the TAC-tite™ Suture Anchor System does not contain details about specific acceptance criteria or a study that proves the device meets such criteria.

The document primarily focuses on establishing "substantial equivalence" of the TAC-tite™ Suture Anchors to a predicate device (reNOVO Suture Anchors, K071520). Substantial equivalence in the FDA 510(k) process means that a new device is as safe and effective as a legally marketed predicate device. This is often demonstrated by showing equivalent intended use, materials, operational principles, and indications for use, rather than through a new, comprehensive performance study with acceptance criteria.

Therefore, most of the information requested in your prompt cannot be extracted from this document, as it describes a different regulatory pathway.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of acceptance criteria and the reported device performance:

• Cannot be provided. The document does not define specific acceptance criteria (e.g., tensile strength, pull-out force thresholds) or present performance data against such criteria. The basis for clearance is "substantial equivalence" to a predicate, not direct performance testing against new acceptance criteria.

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

• Cannot be provided. No specific "test set" or associated data (country of origin, retrospective/prospective) for a performance study is mentioned.

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

• Cannot be provided. This type of information is relevant for studies relying on expert review (e.g., image-based diagnostic devices). This document does not
  describe such a study.

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

• Cannot be provided. Not applicable as no such study is described.

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:

• Cannot be provided. This is a surgical implant; MRMC studies are not relevant. This type of study is typically for diagnostic aids or AI-assisted interpretation of medical images.

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

• Cannot be provided. Not applicable. The device is a physical surgical implant, not an algorithm.

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

• Cannot be provided. There is no explicit "ground truth" discussed in the context of a performance study for this device within the document. The "truth" for substantial equivalence is implicitly the safety and effectiveness profile of the predicate device.

8. The sample size for the training set:

• Cannot be provided. No training set is mentioned as this is a physical device submission, not an AI or data-driven software submission.

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

• Cannot be provided. Not applicable as no training set is mentioned.

Summary regarding acceptance criteria and studies:

The provided 510(k) summary for the TAC-tite™ Suture Anchor System (K090128) asserts substantial equivalence to the reNOVO Suture Anchors (K071520) rather than demonstrating performance against specific, pre-defined acceptance criteria through a new clinical or performance study detailed in this document.

The basis for equivalence is stated as "equivalence in intended use, materials, operational principals, and indications." This is a common pathway for medical device clearance when a suitable predicate device exists. The FDA grants clearance when it determines that the new device is as safe and effective as the legally marketed predicate. The "study" mentioned here is essentially a comparative analysis against the predicate device, not a de novo performance study.

Ask a specific question about this device

ferroFibre 14 Stainless Steel Sutures are intended for use in soft tissue approximation and for use in abdominal wound closure, hernia repair, sternal closure and certain orthopaedic procedures including cerclage and tendon repair.

The ferroFibre™ Stainless Steel Suture is available in United States Pharmacopocia (USP) sizes 5-0 to #5 in various lengths. The ferroFibre multifilament stainless stecl sutures are supplied storile, armed with cutting needles. The sutures are fabricated from 316 stainless steel that meets ASTM F138-03.

The provided text describes a 510(k) submission for the ferroFibre™ Stainless Steel Suture. This document focuses on the regulatory clearance for a medical device and does not contain information about an AI/ML powered device, nor does it detail a clinical study with acceptance criteria and reported device performance in the way requested.

The document outlines performance testing conducted to characterize biocompatibility, diameter, and tensile strength according to ISO 10993 standards and USP Monographs. However, it does not provide specific acceptance criteria or reported performance values for these tests. It also does not include details on sample sizes for testing, ground truth establishment, expert involvement, or any multi-reader multi-case (MRMC) studies, as these types of studies are not relevant for the regulatory approval of a non-AI/ML surgical suture device.

Therefore, I cannot populate the requested table or answer the specific questions related to AI/ML device performance and clinical study design for this submission. The content is about a traditional medical device (surgical sutures) and its regulatory clearance based on substantial equivalence to existing products.

Ask a specific question about this device

reVERTO™ Shape Memory Staples are intended for use in:

Fixation of Osteotomies of the Hand, Foot and Tibia

Arthrodesis of the Joints of the Hand and Foot

Fixation of Soft Tissue to Bone, as in the case of the Anterior Cruciate Ligament

reVERTO™ Shape Memory Staples are also indicated for adjunctive fixation of Small Bone Fragments of:

The Upper Extremity, such as the Radius, Ulna, Humerus, Clavicle and Scapula

The Lower Extremity, such as the Tibia, Fibula and the Femur

The Upper Torso, such as the Sternum and the Ribs

reVERTO™ Shape Memory Staples are dynamic compression implants that use shape memory metal nickel-titanium alloy called NiTinol (see below for more information on NiTinol). The NiTinol construction causes the legs of the implant to deflect, thereby creating a compressive force across the site of fixation. reVERTO Shape Memory Staples are advantageous to screws and plates in that they require less disruption of the surrounding bone for implantation and provide a 'low-profile' fixation. The most important factor related to the use of NiTinol is its ability to maintain a compressive force across the site of fixation during the healing process.

This document is a 510(k) summary for the reVERTO™ Shape Memory Staples and does not include performance data from a specific study to demonstrate the device meets acceptance criteria. The submission focuses on establishing substantial equivalence to previously cleared predicate devices based on intended use, materials, and operational principles, rather than presenting a detailed clinical or performance study with acceptance criteria and results.

Therefore, I cannot provide the requested information about acceptance criteria and the study that proves the device meets those criteria from the provided text. The document does not describe such a study or present a table of acceptance criteria and reported device performance.

Here's a breakdown of why the requested information is not available in the provided text:

1. A table of acceptance criteria and the reported device performance: This information is not present. The 510(k) summary is for regulatory clearance based on substantial equivalence, not a detailed performance study report.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable, as no such test set or study data is described.
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, as no test set requiring ground truth establishment is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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. The device is a physical bone fixation staple, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. The device is a physical bone fixation staple, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The provided document is a regulatory submission demonstrating substantial equivalence, which is a different type of submission than one detailing a clinical or performance study with specific acceptance criteria and results for a novel device.

Ask a specific question about this device

reNOVO Suture Anchors are intended to secure soft tissue to bone of:

The Shoulder:

Bankart Repair SLAP Lesion Repair Acromio-Clavicular Separation Roatator Cuff Repair Capsule Repair Biceps Tenodesis Deltoid Repair

The Elbow:

Ulnar or Radial Collateral Ligament Reconstruction Bicep Tendon Reconstruction Tennis Elbow Repair

The Hand and Wrist:

Scapholunate Ligament Reconstruction Ulnar / Radial Collateral Ligament Reconstruction Collateral Ligaments around the PIP, DIP and MCP Joints Flexor and Extensor Tendons

The Ankle and Foot: Lateral Stabilization Medial Stabilization Achilles Tendon Repair / Reconstruction Hallux Valgus Reconstruction Mid and Rear Foot Reconstruction

The reNOVO™ Suture Anchors range in size from 2.0mm to 5.5mm in diameter. The anchor portion consists of a threaded titanium (ASTM F136/ ISO 5832-3) segment that provides a self drilling and self tapping thread. The anchor eyelet provides a means to attach the range of suture sizes utilized on the anchors. The size of sutures used in the reNOVO line range from size 3-0 thru size 2 (USP) nonabsorbable UHMW polyethylene UltraFibre™ sutures. A single use driver and handpiece hold the excess suture and deliver the preloaded anchor into the bone. The suture strands are used to reapproximate and secure the soft tissue to the bone.

The reNOVO™ Suture Anchor will be provided sterile for single use applications.

The sizes and materials are designed to address the indications cited.

This 510(k) submission for the reNOVO™ Suture Anchor System does not describe specific acceptance criteria and a study demonstrating the device meets those criteria in the way a performance study for, for example, an AI/ML device would. Instead, the submission relies on demonstrating substantial equivalence to predicate devices.

Here's an analysis based on the provided text:

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

No explicit table of acceptance criteria or reported device performance metrics (e.g., tensile strength thresholds, pull-out force requirements) is provided in the document. The claim is one of substantial equivalence, meaning the device is considered to perform similarly to already legally marketed devices.

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

No test set or associated sample size is mentioned in the document. The submission is based on a comparison to existing devices, not a new performance study with a test set.

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

Not applicable. There is no test set in the conventional sense, and thus no ground truth to be established by experts.

4. Adjudication method for the test set

Not applicable. There is no test set or adjudication process described.

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 device (suture anchor), not an AI/ML diagnostic or assistive tool.

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

Not applicable. This is a surgical implant, not an algorithm.

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

Not applicable. For this type of device submission, the "ground truth" for demonstrating safety and effectiveness is established by showing that its intended use, materials, operational principles, and indications are equivalent to those of predicate devices that have already been cleared by the FDA.

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI/ML device.

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

Not applicable. There is no training set.

Summary of the Study (Basis for Substantial Equivalence):

The "study" that proves the device meets the "acceptance criteria" (which, in this context, is substantial equivalence) is a comparison to predicate devices.

• Acceptance Criteria (Implicit for Substantial Equivalence): The reNOVO™ Suture Anchor System must be shown to be substantially equivalent in intended use, materials, operational principles, and indications for use to legally marketed predicate devices. This implicitly means that its performance characteristics (e.g., mechanical properties, biocompatibility) are expected to be similar or equal to those of the predicate devices.

• Reported Device Performance (Implicit): The submission claims that "Core Essence Orthopaedics reNOVO suture anchors are substantially equivalent to the currently marked devices and present no substantial differences in design, material, intended use and function to the products on the table above." This statement serves as the "reported device performance" in the context of a 510(k) for a device like this.

• Predicate Devices Used for Comparison:

  • Mitek: K962511, K962793, K982420
  • Zimmer: K962397, K926384
  • Arthrotek: K012503, K973775, K943806
  • Arthrex: K971723, K960516
  • Smith & Nephew: K053344, K972326
  • United States Surgical: K040594

In essence, for this 510(k), the "study" is the analytical comparison of the reNOVO™ Suture Anchor System's characteristics (design, materials, indications, operational principles) against those of multiple already-cleared predicate suture anchors, rather than a separate clinical or bench performance study with specific metrics. The FDA's clearance (K071520) indicates they found this comparison sufficient to establish substantial equivalence.

Ask a specific question about this device