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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 FiberTape and TigerTape 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
• · To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

The proposed Arthrex FiberTape and TigerTape Cerclage Sutures are available as flat braided sutures assembled in a loop configuration. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, and nylon materials. These materials are identical to those cleared in K221485 and K170206. 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. The proposed Arthrex FiberTape and TigerTape Cerclage Sutures may be used with or without the cleared Arthrex Dog Bone Button (K220947).

The provided document describes a 510(k) Premarket Notification for a medical device (Arthrex FiberTape and TigerTape Cerclage Sutures). It is a regulatory submission to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, most of the requested information regarding acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of document because the submission focuses on mechanical and biological equivalency for a physical suture device.

However, I can extract information related to the performance data and the comparison made for substantial equivalence:

Information Extracted from the Document:

• Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures
• Predicate Device: K220947 Arthrex Knotless AC Repair Devices
• Reference Devices: K221485 Arthrex FiberTape and TigerTape Cerclage Sutures, K170206 Arthrex FiberTape Cerclage
• Purpose of Submission: To obtain an additional indication: "To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption."

Given that this document is for a physical medical device (sutures) and a 510(k) submission, the traditional "acceptance criteria" and "study" framework for AI/software-based medical devices (which would involve test sets, expert ground truth, MRMC studies, etc.) does not apply directly.

Instead, the "study" proving the device meets the criteria of substantial equivalence involves performance testing to demonstrate that the new device is as safe and effective as the predicate device.

Here's how to frame the information from the document in relation to your request, highlighting what is and isn't present:

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

• Acceptance Criteria (for substantial equivalence): The new device must demonstrate similar mechanical properties and biocompatibility to the predicate device, especially for the new indication. The implied acceptance criteria are that the new device's performance in specified mechanical tests is comparable to or better than the predicate.
• Reported Device Performance:

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

• The document does not specify the sample size for the mechanical tests (ultimate load, cyclic displacement, bacterial endotoxin). This information would typically be found in the full testing report, which is not part of this summary.
• Data Provenance: Not specified in terms of country of origin. The tests were likely conducted internally by Arthrex Inc. or by a contract lab. These are performance tests on the device materials/constructs, not clinical trial data.

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

• Not Applicable. This is a physical device with objective mechanical and biological testing. There is no human "ground truth" to establish for these tests (e.g., no interpretation of images or clinical outcomes by experts to be used as ground truth).

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

• Not Applicable. As above, this is objective mechanical and biological testing, not 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 is for a physical surgical suture, not an AI/software device used by human readers for diagnosis or interpretation.

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

• Not Applicable. This is not an algorithm.

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

• Mechanical and Biological Properties: The "ground truth" for demonstrating substantial equivalence relies on standard, recognized testing methodologies for medical devices (ISO, ASTM standards, or equivalent) for properties like tensile strength, fatigue, and biocompatibility (e.g., endotoxin limits). There is no "expert consensus" or "pathology" in the typical sense for these types of tests.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

In summary, this document is a regulatory submission for a physical medical device (suture) seeking expanded indications based on demonstrated substantial equivalence through objective mechanical and biological performance testing, rather than a study for an AI/software device that would involve the complex aspects of expert-annotated test and training datasets.

Ask a specific question about this device

Arthrex FiberTape and TigerTape 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 proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE card or on an ABS loader. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These materials are identical to those cleared in K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop.

This document is a 510(k) summary for the Arthrex FiberTape and TigerTape Cerclage Sutures. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI/ML powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML powered device.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate that modifications do not negatively impact mechanical strength or pyrogen limits, which are typical for physical medical devices. It also mentions "clinical literature was provided to justify the testing conditions and acceptance criteria of the subject Arthrex Cerclage Sutures," but it does not detail these criteria or the results of a clinical study, particularly not one involving AI/ML.

Therefore, I cannot provide the requested information. The prompt asks for details about an AI/ML powered device study, but the provided text describes a submission for a physical medical device (sutures).

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