Search Results

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.

Ask a specific question about this device

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.

Ask a specific question about this device

CoNextions TR Tendon Repair System is indicated for the repair of severed Tendons in adults (22 years of age or older). The product is intended for the following indications:

• Digital Flexor Tendons
• Digital Extensor Tendons Proximal to the Metacarpophalangeal Joints (Zones 6-8)

The CoNextions TR Tendon Repair System consists of a single-use, sterile implant consisting of two identical stainless steel anchors implanted in either end of the injured tendon and connected by two loops of UHMWPE fiber. The implant is provided pre-loaded into an Implant Mechanism and with a Deployment Mechanism to facilitate placement.

The information regarding the acceptance criteria and study details for the CoNextions TR Tendon Repair System is extracted from the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Test Set Sample Size:

  • Initially, 90 participants were screened and randomized: 40 to the CoNextions TR group and 50 to the Suture group.
  • After exclusions (8 participants under 22, 1 participant with unrelated injury), 81 participants remained.
  • For the 12-week follow-up: 72 participants (88.9% of 81).
  • For the 24-week follow-up: 70 participants (86.4% of 81).
  • Specific numbers for CoNextions TR group and Suture group are:
    • Rupture (12 weeks): 33 CoNextions TR, 45 Suture (for specific analysis 1/34 CoNextions TR, 5/47 Suture)
    • Surgical site infection: 34 CoNextions TR, 47 Suture
    • Strickland Score (12 weeks): 27 CoNextions TR, 41 Suture
    • Strickland Score (24 weeks): 30 CoNextions TR, 42 Suture
    • Secondary Effectiveness (24 weeks): N=32-33 for CoNextions TR, N=40-42 for Suture.

• Data Provenance: Prospective, multi-site clinical evaluation. The country of origin is not explicitly stated, but the FDA submission implies a US-based study or one adhering to US regulatory standards.

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

• Number of Experts: 5
• Qualifications of Experts: Fellowship-trained hand surgeons.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for establishing ground truth, such as a 2+1 or 3+1 consensus. The study was a clinical evaluation conducted by the involved surgeons and clinical staff, with outcomes assessed and recorded per protocol. Participants and therapists performing the majority of outcome assessments were blinded for the first 12 weeks.

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

This was not an MRMC study and does not involve AI assistance. The study compares a novel medical device (CoNextions TR Tendon Repair System) to a standard-of-care suture repair method for tendon lacerations.

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

This was not a standalone (algorithm only) study. It was a clinical study comparing a medical device with a human-in-the-loop (surgical implantation) to another surgical method.

7. The Type of Ground Truth Used

The ground truth was established through direct clinical outcomes and measurements from human patients, including:

• Physical examinations for re-rupture and surgical site infection.
• Objective measurements like goniometry for Strickland's Scores (mobility).
• Patient-reported outcomes (VAS Pain Scores, DASH Questionnaire Scores).
• Strength measurements (Grip Strength, Tip Pinch Strength).

8. The Sample Size for the Training Set

The document describes a clinical evaluation for the device and provides a summary of benchtop and animal testing. It does not mention a "training set" in the context of an algorithm or AI. The term "training set" is not applicable here as this is a device performance study, not an AI/ML study.

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

Not applicable, as there is no training set for an AI/ML algorithm mentioned in the document.

Ask a specific question about this device

DYNATAPE suture is indicated for orthopedic procedural use in soft-tissue approximation, and or ligation, including use with allograft tissue.

DYNATAPE™ Suture is a sterile non-absorbable orthopedic suture. DYNATAPE™ Suture has a double sheath and core design, composed of Ultra High Molecular Weight Polyethylene and Polyester, with or without colorants, as well as a Silicone/NaCl core. DYNATAPE™ Suture's outer sheath is braided flat, with rounded tips.

The provided text does not describe acceptance criteria for a medical device's performance in the context of clinical or diagnostic accuracy studies. Instead, it refers to the DYNATAPETM Suture, a non-absorbable orthopedic suture, and its substantial equivalence to a predicate device.

The "acceptance criteria" mentioned relate to non-clinical testing for material properties and regulatory compliance, not performance in a diagnostic or clinical accuracy sense. Specifically, the text states:

• USP Knot Tensile Strength: The DYNATAPE™ Suture "meets USP knot tensile strength for size 2 non-absorbable sutures."
• In-vitro approximation force over time: This testing was conducted to demonstrate the laxity resistance of the suture.
• Sterility testing: Testing was conducted.
• Biocompatibility, stability, in-vivo testing of the predicate device: These were included by reference (K181182).
• Bacterial endotoxin testing: Completed as part of another submission (K200949), meeting endotoxin limits.

The study presented is a 510(k) Premarket Notification, which aims to demonstrate that a device is "substantially equivalent" to a legally marketed predicate device. This is a regulatory pathway, not a clinical trial to establish device performance in terms of diagnostic accuracy or comparative clinical effectiveness.

Therefore, most of your specific questions regarding sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set information are not applicable to the information provided in this document, as it focuses on non-clinical testing and substantial equivalence.

Here's a breakdown of what can be extracted and why other parts are not applicable:

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)

• The document describes non-clinical laboratory testing (e.g., mechanical property tests, sterility tests). It does not provide details on specific sample sizes for these tests, nor does it refer to a "test set" in the context of patient data or clinical studies. Data provenance (country, retrospective/prospective) is not applicable or provided for these types of non-clinical tests.

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. "Ground truth" in this context refers to clinical outcomes or expert diagnoses, which are not part of this 510(k) summary for a surgical suture based on non-clinical testing.

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

• Not applicable. This pertains to clinical studies involving multiple readers or evaluators, not non-clinical laboratory testing of a device's material properties.

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 document is about a surgical suture, not a diagnostic imaging device or an AI-assisted system.

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

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

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

• For the non-clinical tests described, the "ground truth" would be established by standardized testing methods and specifications (e.g., USP standards for tensile strength) rather than expert clinical consensus or pathology.

8. The sample size for the training set

• Not applicable. There is no mention of a "training set" as this document is not about an algorithm or machine learning model.

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

• Not applicable. See point 8.

Ask a specific question about this device

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.

Ask a specific question about this device

The HEALIX ADVANCE Anchor is indicated for use in soft-tissue-to-bone fixation in association with postoperative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromioclavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

The proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a line extension to the currently marketed HEALIX ADVANCE™ Anchor family. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is available in absorbable BR and non-absorbable PEEK materials. HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures is provided sterile and is for single use only.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures. This document primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than presenting a detailed study of acceptance criteria and performance for a novel AI/software device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, MRMC studies, standalone performance, and training set information is not present in the provided text. The document describes a traditional medical device (suture anchor) and its non-clinical testing for safety and effectiveness, not a computational device with performance metrics typically found in AI/software submissions.

Specifically, the document states:

• Non-clinical Testing: "Device safety and effectiveness is supported by non-clinical testing performed on the proposed device and / or its predicate. Performance testing included straight and knot tensile strength, suture approximation force, anchor fixation post cyclic loading and sterility."
• Safety and Performance: "Results of performance testing have demonstrated that the proposed devices are suitable for their intended use. Based on similarities in the indications for use, technological characteristics, and performance in comparison to the predicate devices, the proposed HEALIX ADVANCE™ Anchor with DYNATAPE™ Sutures has shown to be substantially equivalent to the predicate devices under the Federal Food, Drug and Cosmetic Act."

This indicates that the "acceptance criteria" were essentially demonstrating equivalence to existing predicate devices through mechanical performance testing relevant to a physical suture anchor, as opposed to accuracy, sensitivity, or specificity metrics for an AI system.

Ask a specific question about this device

The HEALIX TiTM Anchors with DYNACORD™ is intended for:

Shoulder: Rotator Cuff Repair, Bankart Repair, Biceps Tenodesis, Acromioclavicular; Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction:

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair;

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis. Patellar Tendon repair and secondary fixation in ACL/PCL reconstruction repair:

Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction;

Hip: Capsular repair, Acetabular Labral Repair.

The HEALIX TiTM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX TiTM Anchors with DYNACORDTM Suture is available in Titanium material, which is a common material used on existing Depuy Mitek devices. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX TiTM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

This document is a 510(k) premarket notification for a medical device called the HEALIX Ti™ ANCHOR with DYNACORD™. It establishes substantial equivalence to a predicate device, meaning it does not require a new study to prove its safety and effectiveness in the same way a novel device would. Therefore, the information typically found in an AI/Software as a Medical Device (SaMD) submission regarding acceptance criteria, training/test sets, expert adjudication, and MRMC studies is not applicable here.

The provided text focuses on the non-clinical testing performed to demonstrate the device's substantial equivalence to a predicate, rather than a clinical study evaluating the performance of an AI/SaMD.

Here's an analysis based on the provided document:

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

The document describes non-clinical testing, not performance against specific clinical acceptance criteria of an AI/SaMD. The "acceptance criteria" here relate to engineering and material performance for a physical implant.

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

• Sample Size: Not specified in terms of number of anchors tested, but general non-clinical testing was conducted.
• Data Provenance: Not applicable in the context of clinical data for AI/SaMD. This refers to lab-based testing of physical properties.

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/SaMD and does not involve human expert labeling of data. The "ground truth" for these tests would be the established engineering and materials science standards.

4. Adjudication method for the test set:

• Not applicable for non-clinical engineering tests.

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 a physical medical device, not an AI/SaMD.

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

• Not applicable. This is a physical medical device, not an AI/SaMD.

7. The type of ground truth used:

• For the non-clinical testing, the "ground truth" is defined by established engineering standards, USP specifications for suture materials, and biological safety standards (e.g., ISO standards for biocompatibility, endotoxin limits).

8. The sample size for the training set:

• Not applicable. This is not an AI/SaMD.

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

• Not applicable. This is not an AI/SaMD.

In summary, the provided document is a regulatory submission for a physical medical device (suture anchor) based on demonstrating substantial equivalence to an existing predicate device through non-clinical performance and safety testing, not through clinical trials or evaluations of an AI/SaMD.

Ask a specific question about this device

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text is a 510(k) summary for the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture. It describes the device, its intended use, and substantial equivalence to predicate devices, supported by non-clinical testing. However, it does not contain information related to a study proving a device meets acceptance criteria for an AI/algorithm-based medical device performance.

Specifically, the document discusses a suture anchor (a physical medical device used in orthopedic surgery), not an image-based AI or algorithm. Therefore, the requested information (acceptance criteria for an AI, sample sizes for AI test/training sets, expert ground truth establishment, MRMC studies, standalone AI performance) is not applicable to this document.

The "studies" mentioned in the document are non-clinical physical tests of the suture anchor and suture, such as:

• suture diameter
• knot tensile strength
• suture approximation force
• chemical characterization
• anchor fixation (in-vitro and in-vivo)
• torque testing
• biocompatibility
• sterility
• packaging
• shelf-life
• bacterial endotoxin testing

These tests are to demonstrate the physical properties and safety of the orthopedic implant and suture, not the performance of an AI algorithm.

Therefore, I cannot provide the requested table or details about an AI study based on the provided text.

Ask a specific question about this device

The HEALIX ADVANCE Anchor is indicated for use in soft tissue to bone fixation with post-operative immobilization as follows:
Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Elbow: Biceps Tendon Reattachment, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction
Hip: Capsular Repair, Acetabular Labral Repair

The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is a threaded suture anchor preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. HEALIX ADVANCETM Anchors with DYNACORDTM Suture are available in absorbable BR and non-absorbable PEEK materials. Devices with needles will be offered to facilitate suture passage through tissue. The HEALIX ADVANCETM Anchor with DYNACORDTM Suture is provided sterile and is for single use only.

The provided text describes the HEALIX ADVANCE™ Anchor with DYNACORD™ Suture, which is a medical device for soft tissue to bone fixation. However, the document does not contain information about specific acceptance criteria or a dedicated study providing quantitative performance metrics by which the device's performance can be explicitly measured against pre-defined criteria.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (K133794 HEALIX ADVANCE™ Anchor with PERMACORD™ Suture) through non-clinical testing. This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than conducting a de novo study against specific acceptance criteria.

Therefore, many of the requested details cannot be extracted from this document. Below is a summary of what is available and what is not:

HEALIX ADVANCE™ Anchor with DYNACORD™ Suture Device Performance Summary

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not specified in the document. The non-clinical testing refers to "anchor fixation testing," "in-vitro testing," "torque testing," "suture testing per USP," "suture approximation force testing," and "in-vivo testing," but the number of samples or specimens for each test is not provided.
• Data Provenance: The testing was "performed on the proposed device and/or its predicates." No information on country of origin or whether it was retrospective or prospective is given. Given the nature of mechanical/biocompatibility testing, it would generally be prospective laboratory testing.

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

• Not applicable for this type of submission. This device is a physical implant, and its performance is evaluated through mechanical, chemical, and biological testing, not by expert review of data like in an AI/imaging study. Ground truth is established by standardized testing methods and measurements.

4. Adjudication Method for the Test Set:

• Not applicable. As noted above, this device's performance is determined by objective physical and biological tests, not by human expert adjudication of interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a physical medical device, not an AI or imaging diagnostic tool. MRMC studies are not relevant for this product.

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

• Not applicable. This phrase typically refers to the performance of an AI algorithm in isolation. This is a physical device, and its performance is assessed directly through non-clinical testing.

7. The Type of Ground Truth Used:

• Objective Test Results / Standardized Measurements: Ground truth for this device's performance is established by the results of various non-clinical tests (e.g., tensile strength in Newtons, torque in Nm, presence/absence of bacterial endotoxins within specified limits, biocompatibility as determined by in-vivo models). These are direct measurements or observations against established material and biological standards (e.g., USP standards).

8. The Sample Size for the Training Set:

• Not applicable. This submission does not involve machine learning or AI, so there is no "training set."

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

• Not applicable. As there is no training set for this device.

Ask a specific question about this device

The Arthrex FiberTape Cerclage suture 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 or autograft tissues are used for repair. When used as a bone fixation cerclage the suture is intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty.
• · Sternotomy indications including the "rewiring" of osteotomized sternums.
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring.
• · Repair of long bone fractures due to trauma or reconstruction.

The Arthrex FiberTape Cerclage suture is available as a flat braided suture or assembled in a loop configuration. The Arthrex FiberTape Cerclage suture is braided from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials identical to those used in other cleared Arthrex sutures (K032245, K041553 and K122374). For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double looped suture.

The provided document is a 510(k) premarket notification for the Arthrex FiberTape Cerclage suture, seeking clearance for its use as a bone fixation cerclage. This document focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and performance data from various studies.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in a quantitative format with corresponding reported performance values for each criterion. Instead, it describes various tests performed to demonstrate substantial equivalence to predicate devices. The implicit acceptance criterion for each test is that the Arthrex FiberTape Cerclage performs equivalently or acceptably compared to the cleared predicate devices.

However, based on the Substantial Equivalence Summary, we can infer the types of performance aspects evaluated:

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

The document does not specify the exact sample sizes (e.g., number of units, number of tests) used for each of the performance tests (fatigue strength, tensile force, creep, knot strength, wear testing, bacterial endotoxins).

• Data Provenance: The studies appear to be pre-clinical, benchtop (in-vitro) studies conducted by the manufacturer (Arthrex Inc.) for the purpose of demonstrating substantial equivalence. There is no indication of country of origin for the data provided, nor whether it is retrospective or prospective, as these terms usually apply to clinical studies involving human or animal subjects. These are laboratory-based tests.

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

This type of information (number of experts, qualifications) is not applicable to the studies described. The tests performed are mechanical and chemical characterizations of the device, not diagnostic or clinical assessment studies that would require expert interpretation to establish a ground truth. The "ground truth" here is objective measurement against defined physical or chemical properties and standards (e.g., tensile strength, presence of endotoxins).

4. Adjudication Method for the Test Set

This is not applicable as there are no "readers" or subjective interpretations requiring adjudication for the benchtop tests described. The results are quantitative measurements.

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

This is not applicable. The device is the "Arthrex FiberTape Cerclage suture," which is a physical surgical suture, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies and AI-related effectiveness metrics are irrelevant to this submission.

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

This is not applicable. As stated in point 5, this is not an AI algorithm.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The "ground truth" for the tests performed is based on objective, quantifiable physical and chemical properties and established standards.

• For mechanical tests (fatigue, tensile, creep, knot strength, wear), the "ground truth" is the measured performance data compared against the performance of predicate devices and engineering specifications.
• For the Bacterial Endotoxins Test, the "ground truth" is compliance with the pyrogen limit specifications outlined in USP .

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is a physical product.

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

This is not applicable as there is no training set.

Ask a specific question about this device