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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures 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.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• · Repair of long bone fractures due to trauma or reconstruction
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation 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 suture, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, no AI model or training set is applicable here.

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Arthrex Radiopaque FiberTape cerclage sutures 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.

When used as bone fixation cerclage the sutures are intended for:
• Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• Sternotomy indications including the “rewiring” of osteomized sternums
• Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring

• Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
  • Repair of long bone fractures due to trauma or reconstruction

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures assembled on an ABS loader. The Radiopaque FiberTape Cerclage implant is hitched around the post of the ABS loader which allows the nitinol wire to pass through the knot. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and polyester materials.

This document pertains to the 510(k) premarket notification for Arthrex Radiopaque FiberTape Cerclage sutures, a medical device. The information provided outlines the regulatory clearance and briefly mentions performance data, but it does not contain the detailed study information regarding acceptance criteria, sample sizes for test/training sets, expert qualifications, or the methodologies for ground truth establishment or MRMC studies that would be typically found in a clinical study report for an AI/ML-based device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance based on the provided text, nor can I answer questions about MRMC studies, standalone algorithm performance, or detailed ground truth establishment as these details are not present.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on material composition, intended use, and general performance testing (tensile strength, cyclic displacement, creep displacement, and bacterial endotoxin testing), rather than a clinical study demonstrating AI performance.

Here's what can be extracted and what cannot:

What can be extracted from the document:

• Device Name: Arthrex Radiopaque FiberTape Cerclage sutures
• Intended Use: Soft tissue approximation and/or ligation, and as bone fixation cerclage for specific indications (e.g., trochanteric reattachment, sternotomy, trauma, glenoid bone loss, long bone fractures).
• Basis for Clearance: Substantial Equivalence to predicate devices (K221485: Arthrex FiberTape and TigerTape Cerclage Sutures and K143716: DSM Biomedical DRP Cable).
• Performance Data Mentioned (not detailed acceptance criteria):
  • Tensile strength
  • Cyclic displacement
  • Creep displacement
  • Bacterial Endotoxins Test (BET) per EP 2.6.14/USP to meet pyrogen limit specifications. This is a sterility/biocompatibility test, not a performance metric for the device's functional use in approximating tissue or fixing bone in a clinical context.

What cannot be extracted from the document (as it's not present):

1. A table of acceptance criteria and the reported device performance (in the context of clinical or AI performance): The document mentions "performance data" but only lists types of mechanical/biocompatibility tests. It does not provide specific acceptance criteria values (e.g., "tensile strength > X N") or the measured performance values from these tests. Critically, there's no mention of performance criteria relevant to an AI/ML device (e.g., sensitivity, specificity, AUC).
2. Sample size used for the test set and the data provenance: Not mentioned. The performance data mentioned (tensile, cyclic, creep, BET) would have sample sizes, but these are for material properties, not for a clinical evaluation or an AI model's test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/not mentioned. This device is not an AI/ML imaging device that would require expert-established ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/not mentioned.
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/not mentioned. This is a physical medical device (suture), not an AI/ML system.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/not mentioned.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/not mentioned in the context of an AI/ML model.
8. The sample size for the training set: Not applicable/not mentioned. There is no AI model involved.
9. How the ground truth for the training set was established: Not applicable/not mentioned.

Conclusion:

The provided FDA letter and 510(k) summary are for a conventional medical device (sutures), not an AI/ML-driven device. Therefore, the detailed information typically associated with acceptance criteria and study designs for validating AI/ML performance (e.g., test/training set sizes, expert ground truth, MRMC studies) is not present in this document. The "performance data" mentioned refers to mechanical and biocompatibility testing of the suture materials, which are relevant for a physical device's safety and effectiveness compared to a predicate.

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