Search Results

The Arthrex FiberWire® suture configurations are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Arthrex FiberWire® configurations consist of single strand suture with or without needles, suture with stiffened ends, suture chains, and FiberTape®.

The provided text is a 510(k) summary for the Arthrex FiberWire® suture. It does not contain information about acceptance criteria, detailed device performance studies, sample sizes, expert involvement, or adjudication methods for an AI/ML powered device.

The document states that the Arthrex FiberWire® is "substantially equivalent to the predicate Arthrex FiberWire®" and that "Any differences between the FiberWire and the predicate K041589/K041553 are considered minor and do not raise questions concerning safety and effectiveness."

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number of experts or their qualifications for establishing ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study information.
• Standalone performance details.
• Type of ground truth used.
• Training set sample size or how its ground truth was established.

This document is focused on regulatory clearance for a medical suture based on substantial equivalence to existing predicate devices, not on the performance characteristics of an AI/ML system.

Ask a specific question about this device

The Arthrex Fiberwire® Family is intended for use in soft tissue approximation and or ligation including allograft tissue.
The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and/or ligation including allograft tissue.

Arthrex Fiberwire® and FiberTape™ sutures of varying lengths, diameters, and needle types are made of long chain polyesters, braided with nylon or silk, and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

It appears there might be a misunderstanding of the provided document. The text is a 510(k) summary for a medical device (Arthrex FiberWire® Family sutures) submitted to the FDA.

This type of document primarily focuses on establishing "substantial equivalence" to existing legally marketed devices, rather than presenting a study with acceptance criteria and device performance results in the way a diagnostic or AI-driven device might.

Therefore, most of the information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth, and expert adjudication is not applicable to this 510(k) summary for a surgical suture.

Here's why and what information can be extracted:

• Substantial Equivalence: For devices like sutures, the FDA's 510(k) process typically relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar materials, design, intended use, and performance characteristics, rather than extensive clinical studies with specific performance metrics and acceptance criteria as one might see for an AI algorithm or a diagnostic test.

Let's address the points of your prompt based on the provided text, indicating where information is not available or not applicable:

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

   • Not Applicable. The document does not present quantitative acceptance criteria or detailed performance results for the suture in the way a diagnostic device would. The core claim is "substantial equivalence" to predicate devices. There are no reported numerical performance metrics like sensitivity, specificity, or accuracy that would require acceptance criteria.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):

   • Not Applicable. There is no "test set" in the context of an AI or diagnostic study described here. The evaluation is based on comparing the new suture's characteristics to those of predicate sutures.

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. No "ground truth" establishment by experts in this manner is described. The assessment is a regulatory review by the FDA based on the information provided by the manufacturer.

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

   • Not Applicable. No adjudication method for a test set 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:

   • Not Applicable. This is a surgical suture, not an AI-assisted diagnostic or imaging device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or would be relevant.

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

   • Not Applicable. This is a physical medical device (suture), not an algorithm.

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

   • Not Applicable. The "ground truth" for a suture's safety and effectiveness is primarily established through its materials, manufacturing processes, and comparison to devices with a known safe and effective history (predicate devices) as determined by regulatory bodies. There isn't a specific "ground truth" derived from clinical outcomes or expert consensus described as part of a formal study in this document.

8. The sample size for the training set:

   • Not Applicable. There is no "training set" as this is not an AI or machine learning device.

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

   • Not Applicable. As there's no training set, there's no ground truth for it.

In summary, the provided 510(k) summary is for a physical medical product (surgical suture) and therefore does not contain the types of information requested that are typically associated with performance studies for diagnostic devices or AI algorithms. The primary "study" implicitly referenced is the comparison to predicate devices to establish substantial equivalence.

Ask a specific question about this device

The Arthrex ACL RetroConstruction™ Button Kit for fixation of bone to bone or soft tissue to bone is intended as a fixation post, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair utilizing titanium buttons and recommending use of size 2 or size 5 FiberWire™ or equivalent. Specifically, Arthrex will be offering this for ACL repair.

Arthrex, Inc. ACL RetroConstruction™ Button Kit consists of metal buttons. These buttons are Titanium 6AL4V ELI and have either 2 or 4 holes for inclusion of suture. The suture recommended for use with this kit is FiberWire™, an Arthrex product, which is offered in various sizes and configurations.

The provided text is a 510(k) summary for the Arthrex ACL RetroConstruction™ Button Kit. This type of regulatory submission focuses on demonstrating substantial equivalence to pre-existing devices rather than independent performance studies with detailed acceptance criteria for a new medical device technology like an AI-powered diagnostic tool.

Therefore, the document does not contain the information requested in the prompt. It primarily discusses:

• Intended Use of the device.
• Description of the components.
• Substantial Equivalence to legally marketed predicate devices, meaning it has the same basic features and intended uses, and any minor differences do not raise questions of safety or effectiveness.

There are no details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number or qualifications of experts for ground truth.
4. Adjudication methods.
5. MRMC comparative effectiveness studies.
6. Standalone algorithm performance.
7. Type of ground truth used (pathology, expert consensus, etc.).
8. Sample size for the training set.
9. How ground truth for the training set was established.

Ask a specific question about this device

Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Arthrex, Inc. Fiberwire™ suture consists of a family of varying length, needle type, and standard USP diameter sutures. They are made of long chain polyesters which are braided and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

The provided text is a 510(k) summary for a medical device called "Arthrex Fiberwire™ USP suture family." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance as typically understood for AI/algorithm-based devices.

Therefore, the requested information elements related to AI algorithm performance (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's why and what information is available:

This 510(k) submission is for a physical medical device (sutures), not an AI/software as a medical device (SaMD). The regulatory pathway for this device, at the time of submission (2002), primarily involved demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing device characteristics, materials, intended use, and performance claims to those already approved.

Summary of available information based on the prompt's request:

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

   • Not Applicable. The document does not describe a study with specific acceptance criteria and a reported performance for an AI/algorithm. Instead, it asserts "substantial equivalence" based on similar features and intended use to predicate devices. The "performance" for a suture would typically relate to mechanical properties, biocompatibility, and sterility, which are not detailed in this summary but would have been part of the full 510(k) submission.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not Applicable. No test set or data provenance related to an AI/algorithm's performance is mentioned.

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. No ground truth establishment for an algorithm is described.

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

   • Not Applicable. No adjudication method for an algorithm's test set 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:

   • Not Applicable. This type of study is relevant to AI/diagnostic imaging devices, not physical sutures.

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

   • Not Applicable. This device is not an algorithm.

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

   • Not Applicable. Ground truth in the context of AI is not relevant here. The "truth" for this device's safety and effectiveness is established by its similarity to already approved devices and its compliance with relevant standards (though not explicitly stated in this summary).

8. The sample size for the training set:

   • Not Applicable. No training set for an algorithm is mentioned.

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

   • Not Applicable. No ground truth establishment method for a training set is described.

Key takeaway for this document:
The purpose of this 510(k) summary is to assert substantial equivalence of the "Arthrex Fiberwire™ USP suture family" to predicate devices based on common features and intended use in soft tissue approximation and ligation for orthopedic surgeries. It does not contain information about studies for an AI/algorithm-based device as requested.

Ask a specific question about this device

The Arthrex Fiberwire™USP size 5 suture is intended for use in soft tissue approximation and or ligation.

Arthrex, Inc. Fiberwire™ suture is 38 " in length and has a diameter of 0.700 to 0.799 mm. It is made of long chain polyesters which are braided and sterilized and for surqical use. It is available in dyed and non-dyed varieties, with or without needles.

The provided document is a 510(k) summary for a surgical suture (Arthrex Fiberwire™ USP size 5 suture). It does NOT contain information about acceptance criteria, device performance studies, or AI/software validation.

Therefore, I cannot provide the requested information. The document focuses on establishing substantial equivalence to predicate devices based on basic features and intended use, rather than detailed performance studies with acceptance criteria commonly found for AI/imaging devices.

Ask a specific question about this device

Ask a specific question about this device