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The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the elbow, shoulder, hand/wrist, foot/ankle, knee, and hip 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, Repair/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
• Hip: Acetabular Labral Repair and Reconstruction

The fundamental technology of the Arthrex FiberTak Suture Anchors is that the Arthrex FiberTak Anchors are "all-suture" soft-tissue fixation devices with a push-in design. The subject device is FiberTak Anchor with 1.3 mm SutureTape (White/Blue) and is a knotted FiberTak with a Polyester Sheath and a Polyester/UHMWPE repair suture.

The subject device is preloaded on a disposable inserter, which facilities deployment. The subject anchor and connected sutures are impacted into a pilot hole. The suture is then manually tensioned to set the anchor by "bulging/bunching" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and is fixated via its surgical technique. The device is provided sterile and is intended for single-use.

The provided FDA 510(k) Clearance Letter concerns a physical medical device (suture anchor) and not an AI/Software as a Medical Device (SaMD). Therefore, the questions related to AI acceptance criteria, training sets, ground truth establishment by experts, MRMC studies, and stand-alone algorithm performance are not applicable to this document.

The clearance for the Arthrex FiberTak Suture Anchor is based on substantial equivalence to existing predicate devices, primarily demonstrated through performance testing rather than clinical study data from image analysis or diagnostic tasks.

Here's an analysis of the provided text based on the nature of the device:

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 in the provided text. The document states "Straight Pull testing... was conducted." For mechanical testing, the "sample size" would refer to the number of anchors tested, which is typically outlined in the test report referenced (ASTM F3690).
• Data Provenance: Not specified. It's likely that the testing was performed in a lab setting (in vitro) to regulatory standards (ASTM F3690). This is not retrospective or prospective clinical 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 clearance based on mechanical testing and substantial equivalence, not on diagnostic accuracy established by expert consensus. There is no "ground truth" established by experts in the context of image interpretation or diagnosis.

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

• Not Applicable. As per point 3, there is no expert panel or image interpretation data that would require 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 not an AI-assisted diagnostic device.

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.):

• The "ground truth" in this context refers to the objective mechanical performance characteristics of the device (e.g., force at failure, displacement) as measured by standardized engineering tests (e.g., ASTM F3690). The "truth" is derived from these empirical measurements, not expert interpretation of clinical data.

8. The sample size for the training set:

• Not Applicable. There is no "training set" as this is not a machine learning model.

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

• Not Applicable. There is no "training set" or "ground truth" in the context of machine learning for this device.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, Repair/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
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex 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 anchor is constructed from a hollow braid sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The suture components include a repair suture and a passing suture which are braided polyester sutures made of ultra-high molecular weight polyethylene (UHMWPE) where the suture may also include nylon yarns. The anchor is preloaded on a disposable inserter and is provided sterile (Ethylene Oxide), single-use, and is packaged in a 5-pack.

The provided document is a 510(k) premarket notification for a medical device, the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving the device meets specific acceptance criteria in the context of an AI/algorithm-based diagnostic or prognostic tool.

Therefore, many of the requested elements regarding acceptance criteria, training/test sets, expert adjudication, MRMC studies, and standalone performance for an AI/algorithm are not applicable to this document. This document details the physical characteristics of a mechanical medical device and its performance through mechanical testing and biocompatibility assessment.

However, I can extract information related to the performance data and the comparison to the predicate device, which serves a similar function to demonstrating "acceptance criteria" in the context of a 510(k) submission for a physical device.

Here's the information that can be extracted from the provided text, and where gaps exist due to the nature of the document:

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

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

• Sample Size: The document does not explicitly state the sample size used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was conducted."
• Data Provenance: The data was generated by Arthrex Inc. in the context of demonstrating substantial equivalence for their new device. There is no mention of country of origin of the data or whether it was retrospective or prospective in the context of a clinical study, as this is a device performance test.

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 mechanical device, and "ground truth" is established through physical testing standards and specifications (e.g., measured pull-out strength, endotoxin levels), not expert interpretation of diagnostic images or data.

4. Adjudication method for the test set:

• Not Applicable. As above, mechanical tests do not involve adjudication by multiple human experts.

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 pertains to a physical medical device (suture anchor), not an AI-assisted diagnostic tool.

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

• Not Applicable. This is not an AI/algorithm device.

7. The type of ground truth used:

• The "ground truth" for this device's performance is established by engineering and material science standards and specifications. For example:
  • Mechanical strength: Measured values from cyclic pull-out tests that are compared against predefined performance benchmarks or the performance of a legally marketed predicate device.
  • Biocompatibility: Demonstrated through adherence to established biocompatibility testing standards (e.g., ISO 10993) and comparison to a predicate device with a known biocompatibility profile.
  • Sterility: Demonstrated through validated sterilization processes and testing to ensure compliance with sterility assurance levels.
  • Pyrogenicity: Demonstrated by a bacterial endotoxin test meeting specified limits.

8. The sample size for the training set:

• Not Applicable. This is not an AI/algorithm device that requires a training set.

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

• Not Applicable. This is not an AI/algorithm device.

Summary of the study proving the device meets the "acceptance criteria" (i.e., substantial equivalence):

The study described is a performance testing study primarily focused on cyclic pull-out testing and bacterial endotoxin testing.

• Purpose: To demonstrate that the new Arthrex FiberTak Suture Anchor performs equivalently to its primary predicate device (K221396) and meets safety specifications.
• Methodology:
  • Cyclic Pull-out Testing: Performed on the new device. The results were then compared statistically to the performance of the predicate device (K221396). The document states the new device "performs statistically equivalent to the primary predicate device."
  • Bacterial Endotoxin Testing: Conducted per EP 2.6.14/USP to ensure the device meets pyrogen limit specifications.
  • Technological Comparison: The submission also relies on a detailed technological comparison, stating that the subject device is a line extension with "identical basic design, indications for use, intended use, packaging, shelf-life, biocompatibility profile, overall manufacturing, and sterilization processes" to the predicate. The only stated modification is to the pre-loaded sutures, and this difference is considered minor, not raising new questions of safety or effectiveness.
• Conclusion: Based on the performance data and technological comparison, Arthrex determined that the subject device is substantially equivalent to the currently marketed primary predicate device, implying it meets the necessary performance and safety criteria for its intended use.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:

· Shoulder: Rotator cuff repair, Bankart repair, biceps tenodesis, acromio-clavicular separation repair, deltoid repair, capsular shift or capsulolabral reconstruction

· Foot/Ankle: Lateral stabilization, medial stabilization, achilles tendon repair, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers

· Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, and joint capsule closure, medial patellofemoral ligament repair/reconstruction, and anterolateral ligament repair/reconstruction

• Hand/Wrist: Scapholunate ligament reconstructions, repair/reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)

· Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondy.itis repair

· Hip: Acetabular labral repair and gluteal tendon repair

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use.

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone. The submission is to expand indications of the 2.6 mm FiberTak Suture Anchor to include Anterolateral Ligament Repair/Reconstruction.

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not explicitly state the sample size (number of anchors tested) for the mechanical testing. It also doesn't specify the country of origin of the data or whether the study was retrospective or prospective. It only mentions "mechanical testing."

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

This is not applicable as the study involved mechanical testing against established criteria from published literature, not expert human assessment to establish a "ground truth" for diagnostic or prognostic purposes.

4. Adjudication Method for the Test Set:

Not applicable, as this was mechanical testing.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. This type of study is not relevant for a mechanical device like a suture anchor. The assessment focuses on the physical properties of the device, not its performance in interpretation by human readers.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance):

Not applicable. This device is a physical medical implant, not an AI algorithm. Its performance is inherent in its mechanical properties.

7. Type of Ground Truth Used:

The ground truth for the acceptance criteria was "criteria established by published literature for anterolateral ligament repair/reconstruction." This implies a consensus or widely accepted standard derived from previous research on the biomechanical requirements for such repairs.

8. Sample Size for the Training Set:

Not applicable. As this is a mechanical medical device, there is no "training set" in the context of machine learning or AI models.

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

Not applicable. There is no training set for this type of medical device.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
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, mid-foot reconstruction, hallux valgus reconstruction, metatarsal ligament repair, and digital tendon transfers Knee: Medial collateral ligament repair, lateral collateral ligament repair, patellar tendon, posterior oblique ligament repair, iliotibial band tenodesis, joint capsule closure, and Medial Patellofemoral Ligament Repair/Reconstruction Hand/Wrist: Scapholunate ligament reconstruction, carpal ligament reconstructions, repair/reconstruction of collateral ligaments digital tendon transfers, and carpometacarpal joint arthroplasty (basal thumb joint arthroplasty Elbow: Biceps tendon reattachment, ulnar/radial collateral ligament reconstruction, and lateral epicondylitis repair

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip. The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is pre-loaded on a disposable inserter and will be sold sterile for single-use

This document is a 510(k) Premarket Notification for the Arthrex FiberTak Suture Anchor. It primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device (K203268) to expand its indications for use to include Medial Patellofemoral Ligament Repair/Reconstruction.

Therefore, the "study" described is mechanical testing rather than a typical clinical study involving human readers or AI algorithms as would be the case for medical imaging devices.

Here's the information based on the provided document:

Acceptance Criteria and Device Performance for Arthrex FiberTak Suture Anchor

Type of Device: Suture Anchor (Class II Medical Device)
Purpose of Submission: Expansion of Indications for Use to include Medial Patellofemoral Ligament Repair/Reconstruction.

This submission relies on mechanical performance testing to demonstrate substantial equivalence for the expanded indication, rather than a clinical study involving human readers or AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

• Sample Size for Test Set: Not explicitly stated as a number of "cases" or "patients" in this summary. The "test set" here refers to the samples used in the mechanical testing. The standard practice for such testing involves a sufficient number of devices/constructs to achieve statistical significance.
• Data Provenance: The study is reported as "Mechanical testing", implying it was conducted as laboratory-based testing. Country of origin and retrospective/prospective nature are not applicable in the typical sense for this type of testing (it's not patient data).

3. Number of Experts and Qualifications for Ground Truth

• Not Applicable (N/A): This submission pertains to a physical medical device (suture anchor) and its mechanical properties, not a diagnostic or AI-driven imaging device that would require expert-established ground truth from clinical data. The "acceptance criteria" here are based on established engineering and biomechanical literature for sufficient tensile strength in the context of ligament repair.

4. Adjudication Method for the Test Set

• N/A: As this is mechanical testing, there is no adjudication process involving multiple human reviewers. The results are quantitative measurements of physical properties.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No: An MRMC comparative effectiveness study was not performed as this is not an imaging or diagnostic device. The study is focused on the mechanical performance of the suture anchor.

6. Standalone Performance (Algorithm Only)

• N/A: This is not an algorithm or AI device.

7. Type of Ground Truth Used

• Literature-established Mechanical/Biomechanical Criteria: The "ground truth" for success in this context is the fulfillment of established criteria for pull-out (tensile) strength, derived from published literature relevant to Medial Patellofemoral Ligament Repair/Reconstruction.

8. Sample Size for Training Set

• N/A: No "training set" is applicable as this is not a machine learning model.

9. How Ground Truth for Training Set was Established

• N/A: No "training set" is applicable.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, 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
• Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair

The Arthrex 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 anchor is constructed from a hollow braided sheath made of polyester yarns with Arthrex suture components assembled to the sheath. The sutures components are made of ultra-high molecular weight polyethylene yarns or a polyblend of UHMWPE and polyester yarns. The anchor is preloaded on a disposable inserter and provided sterile for single use.

The provided text is a 510(k) summary for a medical device (Arthrex FiberTak Suture Anchor). It describes the device, its intended use, and a comparison to predicate devices, but does not contain information about an AI/ML-driven medical device or a study involving human readers, ground truth establishment by experts, or MRMC studies.

Therefore, I cannot extract the information required to answer your questions regarding acceptance criteria, study design for AI/ML performance, sample sizes for AI/ML test/training sets, expert consensus, or human reader performance.

The "Performance Data" section only mentions:

• "Cyclic pull-out testing was conducted on the proposed devices and submitted in this Traditional 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 refers to mechanical and biocompatibility testing of the suture anchor, not performance of an AI/ML system.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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 · Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester.

The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

This document is a 510(k) premarket notification for the Arthrex FiberTak Suture Anchor. It details the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.

Here's an analysis based on your request:

No AI/ML device is described in this document. This 510(k) submission is for a physical medical device: a suture anchor. Therefore, the questions related to AI/ML device acceptance criteria, study design, ground truth, and reader studies are not applicable.

The document primarily focuses on demonstrating that the Arthrex FiberTak Suture Anchor is substantially equivalent to existing predicate devices (K200341: Arthrex Self-punching FiberTak Suture Anchor and K171020: Arthrex SutureTak Suture Anchor), and that new indications (Gluteal Tendon Repair, Capsular Repair (Hip), and Joint Capsule Closure (Knee)) are supported by performance data and similarity to reference devices.

However, I can extract information relevant to performance acceptance criteria and the study that proves the device meets them for this physical medical device, framed within what's typically expected for a 510(k) for a non-AI/ML device.

Acceptance Criteria and Device Performance (for a physical medical device)

For a physical medical device like the Arthrex FiberTak Suture Anchor, acceptance criteria are typically related to mechanical performance, biocompatibility, and sterility, often demonstrating equivalence or non-inferiority to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact sample sizes (e.g., number of anchors tested, number of cycles) for the cyclic pull-out testing or bacterial endotoxin testing. This level of detail is typically found in the full test reports referenced in the 510(k), but not always explicitly stated in the summary.
• Data Provenance: Not specified, but generally, such testing for FDA submissions would be conducted in controlled laboratory environments, likely in the US or by labs with recognized accreditations. The data is prospective, generated specifically for this submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool. Ground truth in this context is established through quantitative mechanical testing and laboratory assays (e.g., bacterial endotoxin test), rather than expert interpretation of images or patient outcomes for diagnostic purposes.

4. Adjudication Method for the Test Set

• Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interaction or diagnostic image interpretation studies, not for physical device performance testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size

• Not applicable. MRMC studies are specific to evaluating diagnostic performance, often comparing human readers with and without AI assistance for tasks like image interpretation. This document is about a mechanical implant.

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

• Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

• For the mechanical performance (cyclic pull-out): The "ground truth" is defined by the quantitative mechanical properties measured (e.g., force, displacement, cycles to failure) as per established test standards and protocols. The "truth" is that the device performs equivalently to previously cleared products based on these objective measurements.
• For biocompatibility: The "ground truth" is adherence to pre-defined pyrogen limits as per recognized standards (EP 2.6.14/USP ).

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.

Summary for this specific device:

The Arthrex FiberTak Suture Anchor is a physical medical device. Its acceptance criteria are based on demonstrating substantial equivalence to already marketed predicate devices, primarily through:

• Mechanical performance: Cyclic pull-out testing showing statistical equivalence to the predicate device and suitability for new indications compared to reference devices.
• Biocompatibility: Bacterial endotoxin testing confirming it meets pyrogen specifications.
• Design and manufacturing equivalence: Showing similar basic design, intended use, materials, manufacturing processes, and sterilization to predicate devices.

The "study" in this context refers to the engineering and laboratory testing (cyclic pull-out tests, bacterial endotoxin tests) rather than clinical trials or AI performance evaluations. The goal is to prove that the device is as safe and effective as its predicates.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
• Hip: Acetabular labral repair.

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid of polyester with a single or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

The provided text is a 510(k) Summary for the Arthrex FiberTak Suture Anchor. It describes a medical device, not an AI/ML powered device, therefore, the information requested in the prompt is not available in the provided text. The submission is for a line extension of an existing predicate device and focuses on establishing substantial equivalence through mechanical testing, not through clinical or reader studies involving AI.

Specifically, the document states:

• Purpose of Submission: "This Special 510(k) premarket notification is submitted to obtain clearance for the self-punching Arthrex FiberTak Suture Anchor as a line extension to the Arthrex FiberTak Suture Anchor devices cleared under K181769."
• Performance Data: "Ultimate load and pyrogenicity testing was conducted on a representative device and compared to the predicate device to demonstrate that the proposed devices are substantially equivalent to the predicate."

Therefore, I cannot extract information related to acceptance criteria and studies proving the device meets those criteria from an AI/ML perspective because this is a mechanical device submission.

If you have a document describing an AI/ML powered medical device, I would be happy to provide the requested information.

Ask a specific question about this device

The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) 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, 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

· Hip: Acetabular labral repair.

The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.

The anchor is constructed from a hollow braid of polyester with a single or double loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester. The anchor is preloaded on a disposable inserter and will be sold sterile for single use.

The provided text is a 510(k) summary for the Arthrex FiberTak Suture Anchor. It details the device's purpose, description, and indications for use, and then discusses performance data.

However, the information provided does not contain details about a study evaluating an AI/Algorithmic device's performance against specific acceptance criteria, or an MRMC study. The "Performance Data" section solely refers to:

• Tensile testing to demonstrate the new FiberTak models perform statistically equivalent to the predicate and meet acceptance criteria for hip acetabular labral repair indications. This relates to the physical strength and function of the surgical anchor, not an AI or algorithmic medical device.
• Bacterial endotoxin testing to ensure the device meets pyrogen limit specifications. This relates to the sterility and safety of the physical device.

Therefore, I cannot fulfill your request for information regarding AI/algorithmic device acceptance criteria and study details based on the provided text. The document describes a traditional medical device (a suture anchor), not an AI-powered diagnostic or therapeutic tool.

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The Arthrex FiberTak Suture Anchor is intended to be used for suture or tissue fixation in the foot/ankle, knee, hand/wrist, elbow, and shoulder. Specific indications are listed below:
• 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, Repair/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

The Arthrex FiberTak Suture Anchor is an "all-suture" soft-tissue fixation device with an expandable push-in design. The anchor and connected sutures are impacted into a pilot hole. The sutures are then manually tensioned to set the anchor by "bulging" the suture sleeve within the pilot hole. Once the anchor is set, the suture is passed around the soft tissue and tied in a knot to complete the repair. The device is provided sterile intended for single use. The anchor is constructed from a hollow braid of polyester. A blue and white striped suture comprised of UHMWPE (white) and Polyester (blue) is assembled through the hollow braid. The striped suture component is designated as TigerWire CL. The device comes preloaded on a disposable inserter. The inserter is made from surgical grade nitinol and ABS plastic. The FiberTak Suture may be sold separately or in a kit with implantation instrumentation.

The provided text describes the Arthrex FiberTak Suture Anchor, a medical device intended for soft tissue fixation. It does not contain information about acceptance criteria for a study that proves the device meets specific performance metrics in the context of an AI/ML or diagnostic device. Instead, the document is a 510(k) premarket notification approval letter for a physical medical device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to an AI/ML study, nor any of the other requested information pertaining to studies for AI/ML performance, sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies.

The document primarily focuses on establishing substantial equivalence to a predicate device based on mechanical testing and similar indications for use.

Here's what can be extracted related to this device approval, but it doesn't align with your request for AI/ML study details:

Device: Arthrex FiberTak Suture Anchor
Purpose of Submission: To obtain clearance for the Arthrex FiberTak Suture Anchor by demonstrating substantial equivalence to a predicate device.
Predicate Device: K112237: Arthrex MicroSuture Anchor

Substantial Equivalence Summary (equivalent to showing device meets certain criteria):
The submission states:

• "The indications for use of the proposed Arthrex FiberTak Suture Anchor are identical to the predicate device."
• "The submitted mechanical testing demonstrates that the pull-out strength of the proposed devices meets or exceeds the pull-out strength of the predicate devices."

This indicates that the key acceptance criteria for this specific device clearance were:

1. Identical Indications for Use as the predicate device.
2. Equivalent or superior mechanical performance (specifically "pull-out strength") compared to the predicate device.

The document does not provide:

• A table of specific quantitative acceptance criteria or detailed mechanical test results.
• Sample sizes for mechanical testing.
• Information on "experts" or "ground truth" in the context of diagnostic/AI performance.
• Any details about AI/ML studies (MRMC, standalone, training sets, etc.).

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