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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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The Arthrex Double Loaded Knotless FiberTak® Suture Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
· Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure (Except Canada)
· Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair (Except Canada)

The Arthrex Double Loaded Knotless FiberTak Suture Anchor is an all-suture knotless anchor intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow and hip. The Arthrex Double Loaded Knotless FiberTak Suture Anchor is a sterile, single use implant device constructed from a hollow braid of polyester (sheath) preloaded on an inserter with a double loaded suture component composed of UHMWPE and polyester.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device: the "Arthrex Double Loaded Knotless FiberTak® Suture Anchor." This document describes a surgical implant and its intended uses, asserting its substantial equivalence to a previously cleared device. It does not describe an AI/machine learning device, nor does it contain information about acceptance criteria or a study that proves an AI device meets acceptance criteria.

The information you are requesting, such as ground truth, sample sizes for training/test sets, expert adjudication methods, or MRMC studies, are concepts applicable to AI/ML device evaluations, particularly for diagnostic imaging or assistive technologies. Since this document describes a physical surgical implant (a suture anchor), these concepts are not relevant to its regulatory submission.

Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The document explicitly states the "Performance Data" is "Cyclic pull-out testing was conducted on the proposed devices submitted in this Special 510(k). The test data demonstrates that the proposed devices perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This type of testing is standard for mechanical implants, not AI.

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The Arthrex BioSuture is intended for 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.

The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.

The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).

This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:

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

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: Not specified. The document only states "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
• Data Provenance: Not specified.

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 is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.

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

• Not applicable. This is not an AI/ML study involving human expert ground truth 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

• No, an MRMC comparative effectiveness study was not done. This document describes a submission for a surgical suture, not an AI/ML device that assists human readers.

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

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

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

• The "ground truth" or reference for comparison described in this document is based on:
  • Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
  • Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.
  • Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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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 VersaLoop™ Anchor System is intended for use in soft tissue to bone fixation in the repair of the natural ligament or tendon disruption or to assist in reconstruction surgeries.
Specific indications are: foot, ankle, knee, hip, hand, wrist, elbow and shoulder.

The VersaLoop™ Anchor System consists of an inserter and Ultra High Molecular Weight Polyethylene (UHMWPE) non-absorbable loop suture anchor and threaded sutures.
The inserter shaft ends with a "fork" tip which holds the suture anchor. There are 3 narrow slots on the handle which holds the suture, which can be press-locked and released. The handle is designed for hammering the inserter into the pilot hole to deploy the anchor.
When the suture anchor is inserted into bone and the inserter is removed, the main sutures are pulled, and the all-suture anchor (loop) creates a "bunching" effect using targeted compression zones within the implant sheath for optimal fixation.

This is a 510(k) premarket notification for a medical device called the VersaLoop™ Anchor System. The document does not describe a study involving an AI/ML device. Therefore, it is unable to provide information on acceptance criteria and a study proving the device meets them in the context of an AI/ML model.

This document describes a medical device, specifically a suture anchor system used for soft tissue to bone fixation. The provided text is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and nonclinical testing, rather than reporting on a clinical effectiveness study or AI/ML performance.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, adjudication methods, or MRMC studies is not applicable or present in this document. The document confirms that nonclinical testing was performed to demonstrate that the VersaLoop™ Anchor System meets established performance characteristics and design requirements.

Summary of available information related to performance:

• Nonclinical test discussion: Nonclinical testing was completed to demonstrate that the VersaLoop™ Anchor System devices meet the established performance characteristics and to verify that design requirements are satisfied.
• Types of testing: Biocompatibility evaluation (per ISO 10993-1), ethylene oxide sterilization validation, Bacterial Endotoxin (BET), dimensional, mechanical (fatigue testing, pullout testing, torque testing, applied forces testing), and functional testing.
• Conclusion from nonclinical tests: "It was concluded from the nonclinical tests that the device is as safe, as effective, and performs as well as or better than the legally marketed device predicate (21 CFR 807.92(b)(3))."
• FDA Guidance used: "Bone Anchors - Premarket Notification (510(k)) Submissions Guidance for Industry and Food and Drug Administration Staff."

The acceptance criteria and device performance would be specific to each of these nonclinical tests (e.g., specific tensile strength limits for pullout testing, sterility assurance levels for sterilization validation) but are not explicitly detailed in this summary.

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