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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.

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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.

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