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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.

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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.

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).

Ask a specific question about this device