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The Arthrex SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissues are used for repair.

The Arthrex SutureTape is comprised of non-absorbable sutures made of a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester yarns but may also include nylon yarns.

The Arthrex 0.9 mm SutureTape is a 0.9 mm-wide tape suture with a round braided suture tail that is smaller than the tape portion. The tape and tail portion of the suture are implantable while the suture tail is not intended to be knotted. The flat tape portion of the Arthrex 0.9 mm SutureTape suture meets or exceeds USP performance standards for knot pull tensile strength for size 2 non-absorbable surgical sutures. The suture tail portions of the Arthrex 0.9 mm SutureTape suture meet the performance standards for USP 2-0 non-absorbable surgical suture, except for an oversize in diameter.

The Arthrex 0.9 mm SutureTape is supplied sterile, in pre-cut lengths, in various loop configurations, and in some cases, with various swaged needles and with stiffened ends. The Arthrex 0.9 mm SutureTape is available non-dyed, dyed, and fully or partially striped. Dyes may include D&C Blue No. 6 and Logwood Black. Suture strands that are dyed with Logwood black are made of nylon. Additional material for the Arthrex 0.9 mm SutureTape includes cyanoacrylate.

This document describes the 510(k) premarket notification for the Arthrex SutureTape, specifically the K221354 submission for the 0.9 mm SutureTape as a line extension. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving performance against acceptance criteria for a new type of AI/medical imaging device.

Therefore, many of the requested elements (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, ground truth for test and training sets) are not applicable to this type of regulatory submission because it's a materials science and mechanical performance comparison for a medical device (suture), not an AI/imaging diagnostic device.

However, I can extract the relevant "acceptance criteria" and "reported device performance" based on the provided text, focusing on the mechanical and performance standards for sutures.

Acceptance Criteria and Reported Device Performance for Arthrex SutureTape

This submission (K221354) is for a line extension of the Arthrex SutureTape device, specifically the 0.9 mm SutureTape. The "proof" of meeting acceptance criteria is demonstrated through mechanical performance testing against established USP (United States Pharmacopeia) standards for surgical sutures and comparison to a legally marketed predicate device (K171296: Arthrex SutureTape).

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the exact sample sizes (N numbers) for the mechanical performance tests (tensile strength, BET). It states that "representative samples" were used for the Bacterial Endotoxins Test. The data provenance is implied to be from internal testing conducted by Arthrex Inc., a U.S.-based company. The studies are prospective in the sense that they are conducted specifically for this regulatory submission to demonstrate compliance.

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

This is not applicable. Ground truth for mechanical devices like sutures is established through standardized laboratory testing (e.g., USP methods) rather than expert consensus on diagnostic images.

4. Adjudication Method for the Test Set

This is not applicable. No human adjudication is involved in evaluating the mechanical properties of a suture.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable. This submission is for a surgical suture, not an AI or imaging diagnostic device.

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

This is not applicable. This is not an algorithmic device.

7. The Type of Ground Truth Used

The ground truth used for performance evaluation is USP (United States Pharmacopeia) performance standards for surgical sutures and comparison to the mechanical and physical properties of a legally marketed predicate device. This is a form of objective, standardized laboratory measurement rather than clinical outcomes or expert consensus.

8. The Sample Size for the Training Set

This is not applicable. This is not an AI/machine learning device that requires a training set.

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

This is not applicable. This is not an AI/machine learning device that requires a training set.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the Arthrex 0.9 mm SutureTape meets acceptance criteria is primarily a series of bench tests and laboratory evaluations designed to demonstrate that the device's mechanical properties and safety aspects (like pyrogenicity) conform to well-established industry standards (USP) and are substantially equivalent to a pre-existing, legally marketed predicate device. The key performance indicators evaluated were:

• Knot pull tensile strength of the flat tape portion.
• Tensile strength of the braided suture tail portion.
• Needle pull tensile strength of any attached needles.
• Bacterial Endotoxins Test (BET) for pyrogenicity.

The conclusion is that "Any differences between the proposed and predicate devices are considered minor and do not raise questions concerning safety or effectiveness," and based on "technological characteristics, and the tensile test data submitted, Arthrex Inc. has determined that the proposed device is substantially equivalent to the currently marketed predicate device." This demonstrates that the new line extension performs as expected for its intended use as a surgical suture.

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The Arthrex SutureTape is 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 tissues are used for repair.

Arthrex SutureTape is a suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends, and is available in precut lengths in straight and loop configurations, and with or without needles. Arthrex SutureTape is packaged sterile for single use. New colorant additives meet the requirements of 21 CFR 73.1015 and 21 CFR 74.3054.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called "Arthrex SutureTape." This document details the regulatory clearance for a surgical suture and focuses on demonstrating substantial equivalence to previously cleared devices.

Crucially, this document does not describe acceptance criteria for an AI/ML-based device or a study proving that an AI/ML device meets such criteria. It pertains to a physical medical device (suture) and its mechanical and biocompatibility testing. Therefore, I cannot extract the information required to answer your prompt regarding acceptance criteria and study details for an AI/ML device.

The information you are asking for, such as sample size for a test set, number of experts for ground truth, adjudication methods, MRMC studies, standalone algorithm performance, types of ground truth, and training set details, are specific to the validation of AI/ML systems, particularly in medical imaging or diagnostic contexts. This document is about a surgical suture.

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SutureTape is intended for use in soft tissue approximation and/or ligation. The suture may be provided individually or be incorporated as a component, into surgeries where constructs including those with allograft tissue are used for repair.

SutureTape is a braided suture made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester, and may include nylon. The proposed suture is braided flat with round ends and has a width of 1.3 mm. SutureTape is available in precut lengths in straight and loop configurations, and with or without needles. SutureTape is packaged sterile for single use. SutureTape meets USP standards for size 2 suture, except for an oversize in diameter. The SutureTape modifications as compared to the predicate device(s) include smaller tape width (1.3mm vs. 1.5mm), lack of a suture core and different braiding pattern of colored yarns. Additionally, SutureTape is braided flat similar to the cleared LabralTape (K122374) but has round suture tails similar to the cleared FiberTape (K032245).

The provided text is a 510(k) summary for a medical device called "SutureTape." It describes the device, its intended use, and performance data from various tests. However, it does not contain information about a study involving AI or human readers, or any other details related to AI performance criteria.

Therefore, many of your requested points cannot be answered from the provided document.

Here's a breakdown of what can and cannot be answered:

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

2. Sample size used for the test set and the data provenance: Not mentioned in the document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this is not an AI-assisted diagnostic device. The "ground truth" here refers to established standards (USP requirements, EP/USP standards).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is not an AI device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.

7. The type of ground truth used: For mechanical properties, the ground truth is United States Pharmacopeia (USP) requirements for surgical sutures. For pyrogen testing, the ground truth is EP 2.6.14/USP standards. Biocompatibility and shelf-life are determined based on similarity to predicate devices.

8. The sample size for the training set: Not applicable, as this is not an AI device.

9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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HS Fiber® Suture is intended to be used in general soft tissue approximation and/or ligation, including use in cardiovascular, and the use of allograft tissue for orthopedic procedures.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles. HS SutureTape is a flat braid configuration of the HS Fiber suture.

The provided document is a 510(k) summary for a medical device called HS SutureTape. This type of document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device. As such, it primarily focuses on comparing the new device to the predicate device and establishing substantial equivalence rather than presenting an independent study to prove the device meets specific acceptance criteria in a clinical setting.

Therefore, the document does NOT contain the detailed information typically found in a clinical study report addressing acceptance criteria for device performance as a standalone product. It instead focuses on performance data that demonstrates compliance with recognized standards.

Here's an attempt to answer your questions based on the available information, with clear notes where the information is absent:

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

   Acceptance Criteria	Reported Device Performance
   Compliance with United States Pharmacopeia (USP) requirements for surgical sutures (general standards)	"The Riverpoint Medical HS Fiber Sutures meet requirements established by the United States Pharmacopeia." The HS SutureTape (the new device) is also "tested per USP performance requirements for tensile strength, needle and attachment." This implies the HS SutureTape also meets these requirements.
   USP performance requirements for needle attachment	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for needle attachment." This implies compliance, though specific quantitative results are not provided.
   USP performance requirements for tensile strength	The HS Fiber sutures and HS SutureTape are "tested per USP performance requirements for tensile strength." This implies compliance, though specific quantitative results are not provided.
   Biological Evaluation of Medical Devices (ISO 10993-1:2009)	"Materials used were evaluated per ISO 10993-1:2009 - Biological Evaluation of Medical Devices." This indicates that the materials (UHMWPE) used in the suture are biocompatible according to this standard.
   Endotoxin quantities (per FDA Guidance "Pryogens and Endotoxins Testing: Questions and Answers")	"Limulus Amebocyte Lysate (LAL) endotoxin quantification assessments, both process validation and routine testing, demonstrate endotoxin quantities below the recommended limits outlined in FDA Guidance 'Pryogens and Endotoxins Testing: Questions and Answers.'"
   Pyrogenicity (Rabbit pyrogenicity assessments)	"Rabbit pyrogenicity assessments were also performed on a manufacturing process-validation basis with periodic determinations." This implies the device meets pyrogenicity limits, though specific results or quantitative acceptance criteria are not detailed beyond "periodic determinations" and "process-validation basis."
   Substantial Equivalence to Predicate Device (K100006 – Riverpoint Medical HS Fiber)	"The HS SutureTape line extension is substantially equivalent to the previously cleared HS Fiber Sutures. The HS SutureTape has the same intended use and indications for use, the same principles of operation, and similar technical characteristics as the predicate device... These differences do not raise new questions of safety or effectiveness, therefore the HS SutureTape line extension is substantially equivalent to the currently marketed predicate device." This is the overarching "acceptance criteria" for a 510(k) submission. Specific performance data demonstrating this equivalence (e.g., side-by-side comparison of tensile strength values for both devices) are not provided in this summary, but would have been part of the full 510(k) submission.

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

   • Sample Size for Test Set: Not specified. The document only states that the sutures are "tested per USP performance requirements" and that "LAL endotoxin quantification assessments" and "Rabbit pyrogenicity assessments" were performed. The specific number of samples for these tests is not provided in this summary.
   • Data Provenance: Not specified. The tests are general performance tests and not clinical data. The location where these tests were conducted is not mentioned.
   • Retrospective or Prospective: Not applicable as these are laboratory and bench testing, not clinical studies in humans.

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. This document describes a medical device's technical and safety performance through laboratory and bench testing against recognized standards (USP, ISO, FDA guidance), not a diagnostic device requiring expert interpretation of results or establishing "ground truth" through expert consensus.

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

   • Not applicable. This pertains to expert review in diagnostic assessments, which is not relevant for the type of testing described here.

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

   • No. This is a surgical suture, not a diagnostic imaging device involving human readers or AI assistance.

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

   • Not applicable. This device does not involve algorithms or AI. It is a physical medical device.

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

   • Not applicable. For this type of device, "ground truth" is established by compliance with predefined, objective engineering and material science standards (e.g., a specific tensile strength value, a certain level of biocompatibility, endotoxin limits). The "ground truth" for showing safety and effectiveness is largely based on meeting these established performance criteria from USP, ISO, and FDA guidance documents.

8. The sample size for the training set

   • Not applicable. There is no "training set" as this is not an AI/machine learning device. The document describes the materials and performance characteristics of a physical suture.

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

   • Not applicable. See explanation for #8.

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