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The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Arthrex SpeedFLEX™ Implant consists of a decellularized human allograft dermis that is pre-sutured with FiberWire® suture (passing suture) and TigerLink™ SutureTape (implanted). The allograft implant will be offered in four (4) sizes. The Arthrex SpeedFLEX™ Implant is sold sterile, single use.

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The Arthrex PushLock Suture Anchors (2.9 - 4.5 mm) are 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, Hallux Valgus Reconstruction, Mid-foot Reconstruction, Metatarsal Ligament Repair/Tendon Repair, Bunionectomy

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

Hand/Wrist: Scapholunate Ligament Reconstruction, UInar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis repair.

Hip: Capsular repair (2.9 x 15.5 - 24 mm only), acetabular labral repair.

The Arthrex PushLock Suture Anchors (2.5 mm) are 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, Carpal 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

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 Short Suture Anchors (2.0 - 2.4 mm) are intended to be used for suture (soft tissue) fixation to bone in the hip. Specifically, acetabular labral repair.

The Arthrex Self-Punching PushLock Suture Anchors (3.5 mm) are intended to be used for suture (soft tissue) fixation to bone in the shoulder:

Shoulder: Rotator Cuff Repair

The Arthrex PushLock Suture Anchor is a two piece "push-in" suture anchor device comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchors are threaded and range from 2.0 mm to 4.5 mm in diameter and 8.6 mm to approximately 24 mm in length. The device is sold sterile and is single-use.

The Arthrex Self-Punching PushLock Suture Anchor is a "push-in" suture anchor comprised of a polyetheretherketone (PEEK) anchor body with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body is fully threaded and barbed. The anchor is 3.5 mm in diameter and 19.8 mm in length. The device is sold sterile and is single-use.

The provided FDA 510(k) clearance letter describes a medical device, the Arthrex PushLock Suture Anchors, and its substantial equivalence to predicate devices, rather than a study proving the device meets performance criteria for an AI/CADe device. Therefore, much of the requested information regarding acceptance criteria, study design, and ground truth for an AI/CADe system cannot be extracted directly from this document.

However, I can extract information related to the device itself and the types of performance testing conducted to demonstrate its safety and effectiveness relative to its predicates.

Here's a breakdown of the available information based on your request, with an emphasis on what can be extracted and what cannot from this specific document:

Device Name: Arthrex PushLock Suture Anchors
K Number: K251145

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

This document does not specify quantitative acceptance criteria or detailed reported performance values for an AI/CADe system. Instead, it focuses on demonstrating substantial equivalence to predicate devices for a physical orthopedic implant. The performance data mentioned are general categories of testing for such devices.

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

This information is not provided in the 510(k) clearance letter. The document mentions "product functionality... sterilization validation, biological safety evaluation and temperature study testing," but does not detail the sample sizes for these tests, nor their provenance in terms of patient data. These tests are typically conducted on the physical device itself or its materials, not on clinical datasets in the way an AI/CADe study would use.

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)

This information is not applicable and not provided. This clearance is for a physical medical device (suture anchor), not an AI/CADe system that requires expert interpretation for ground truth establishment.

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

This information is not applicable and not provided for the reasons stated above.

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 information is not applicable and not provided. An MRMC study is relevant to AI/CADe systems, not a physical implant like a suture anchor.

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

This information is not applicable and not provided.

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

This information is not applicable in the context of an AI/CADe device's ground truth. For the Arthrex PushLock Suture Anchors, "ground truth" would relate to its physical properties, biocompatibility, and mechanical performance, which are evaluated through standardized test methods (e.g., ASTM standards) rather than expert consensus on clinical data or pathology reports. The document mentions "product functionality," "biological safety evaluation," and "sterilization validation," implying the use of established scientific and engineering principles for evaluation.

8. The sample size for the training set

This information is not applicable and not provided. There is no AI/CADe system being trained with clinical data.

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

This information is not applicable and not provided.

Summary of what the document does convey about the study (testing) conducted:

The submission aimed to obtain FDA clearance for the Arthrex PushLock Suture Anchors, sterilized using the Arthrex X-ray radiation sterilization process. The core of the "study" for this type of device is demonstrating substantial equivalence to existing legally marketed predicate devices.

The performance data supplied consisted of:

• Product functionality (including accelerated aging)
• Product induced radiation
• Sterilization validation
• Biological safety evaluation
• Temperature study testing

These tests compared the subject device to several predicate and reference devices, confirming that the new device, particularly with its new sterilization process, performs equivalently in terms of safety and effectiveness. The conclusion states that "Any differences between the Arthrex PushLock Suture Anchors and the predicate devices are considered minor and do not raise different questions of safety or effectiveness."

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The iBalance UKA System is indicated for use in unicompartmental knee arthroplasty as a result of:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful unicompartmental knee replacement or other procedure;
• As an alternative to tibial osteotomy in patients with unicompartmental osteoarthritis.

These components are single use only and are intended for implantation with bone cement.

The iBalance PFJ System is indicated for use in patellofemoral joint, (PFJ) knee arthroplasty as a result of:

• Degenerative arthritis in the distal femur and patella;
• A history of patellar dislocation or fracture;
• Failed previous surgery (arthroscopy, tibial tubercle elevation, lateral release) where pain, deformity or dysfunction persists.

These components are single use only and are intended for implantation with bone cement.

When used concurrently, the Arthrex iBalance UKA and PFJ systems create the Arthrex iBalance BiCompartmental Arthroplasty System. The Arthrex iBalance BiCompartmental Arthroplasty System is intended to be used as a multicompartmental knee arthroplasty in patients with:

• Moderately disabling joint disease of the knee resulting from painful osteoarthritis or post traumatic arthritis;
• Correction of functional deformities;
• Revision of previous unsuccessful partial knee replacement or other procedure.

The iBalance BiCompartmental Arthroplasty System is not intended to be used as a dual-condyle or tri-compartmental knee.

These components are single use only and are intended for implantation with bone cement.

The Arthrex iBalance Partial Knee System encompass the following FDA cleared devices:

• Arthrex iBalance UKA System
• Arthrex iBalance PFJ System
• Arthrex iBalance BiCompartmental Arthroplasty System

These systems are comprised of femoral, tibia and patellar components for use in knee prosthesis.

The provided FDA 510(k) clearance letter for the Arthrex iBalance Partial Knee System does not contain the information requested regarding acceptance criteria and the study proving the device meets those criteria, particularly in the context of an AI/algorithm-based medical device.

This document is a clearance letter for a physical medical device (a knee replacement system), not an AI-powered diagnostic or treatment algorithm. The "performance data" mentioned refers to non-clinical and in-vivo electromagnetic simulation related to the device's "MR Conditional" status, which is about its safety in an MRI environment, not its diagnostic or therapeutic accuracy as an AI would have.

Therefore, I cannot extract the requested information (such as sample sizes for test/training sets, expert consensus, MRMC studies, etc.) from this document because it is not relevant to an AI/algorithm-based device study.

To provide the information you're looking for, I would need a 510(k) clearance letter or a clinical study report specifically detailing the performance evaluation of an AI/algorithm-based medical device.

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The SuturePatch Tissue Reinforcement is intended for the management and protection of soft tissue injuries. The SuturePatch Tissue Reinforcement is also intended for the reinforcement of soft tissues repaired by sutures or suture anchors during tendon repair surgery including reinforcement of the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures used to repair the tear and sutures, or bone anchors used to attach the tissue to the bone provide biomechanical strength for the tendon repair. The SuturePatch Tissue Reinforcement device reinforces and protects healing soft tissues.

The SuturePatch Tissue Reinforcement device is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, achilles, biceps, quadriceps, or other tendons. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to bone, provide mechanical strength for the repair.

The Arthrex SuturePatch Tissue Reinforcement device is a non-absorbable, permanent, implantable orthopedic surgical mesh intended for the reinforcement of soft tissue/tendon repair. It is manufactured from embroidered polyester yarns with integral reinforcements across its width and around its perimeter to provide improved stability and high suture retention strength. The SuturePatch is available in rectangular and trapezoidal patterns and configurable sizes. Sutures passed through soft tissue can also be passed throughout the SuturePatch with needles or suture passer.

This document is a 510(k) clearance letter for a medical device called "SuturePatch Tissue Reinforcement." It does NOT describe an AI/ML device or its acceptance criteria and a study proving it meets them. The text provided is wholly unrelated to AI/ML.

Therefore, I cannot extract the requested information as it is not present in the provided text. The document is for a physical surgical mesh and details its regulatory clearance, not the performance of an AI/ML algorithm.

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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 <85> 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.

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The Humeral Plating System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.

The Cerclage Button is intended for use with the humeral plating system and FiberTape® cerclage suture, to augment fracture stabilization with humeral plates in long bone fixation. The cerclage button is designed for use with the humeral plating system and may not be used alone.

The Arthrex Humeral Plating and Cerclage Button consist of straight humeral plates and a 3.5 threaded cerclage button for use in the repair of proximal humerus fractures. The devices are provided sterile (gamma) and non-sterile, for single use. The proposed plates range in length from 90.5 - 309 mm and include suture holes for soft tissue refixation. The proposed devices are manufactured from titanium alloy conforming to ASTM F136. The proposed devices are compatible with Arthrex 3.5 mm screws (K241592 and K203294) and Arthrex 4.0 mm screws (K150456, K143614, and K103705).

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving a device meets those criteria, as typically found in submissions for AI/ML-based medical devices. The document describes a traditional 510(k) premarket notification for a Class II metallic bone fixation appliance (Arthrex Humeral Plating System and Cerclage Button).

The "Performance Data" section mentions mechanical testing (4-point bend, MRI compatibility) and bacterial endotoxin testing, which are standard for orthopedic implants to demonstrate engineering performance and biocompatibility compared to predicate devices. However, this is not a study proving an AI/ML device meets clinical acceptance criteria.

Therefore, I cannot extract the information required to populate the fields you listed, such as sample size, expert ground truth establishment, MRMC studies, or standalone algorithm performance, as these concepts are not applicable to the type of device described in this document.

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The Arthrex Tightrope Soft Button, RT implant is intended to be used for fixation of bone or soft tissue to bone, and are intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Arthrex will be offering these for ACLI PCL repair and reconstruction MCL, POL, LCL repair and reconstruction; ITB and PTR repair; and MPFL, ALL, quadriceps tendon, PLC repair and reconstruction for the adult patient population.

The proposed Arthrex TightRope Soft Button, RT is comprised of a suture loop, suture button and passing sutures. The suture loop and passing sutures are braided nonabsorbable surgical sutures.

The provided text is a 510(k) summary for a medical device called the "Arthrex TightRope Soft Button, RT". This type of document is a premarket notification to the FDA to demonstrate that a device is substantially equivalent to a legally marketed predicate device.

The summary does not contain information about acceptance criteria or a detailed study report with the specific metrics requested. Instead, it states that the device is "equivalent to the primary Arthrex ACL Tightrope RC predicate device" based on "cyclic pull-out testing".

Therefore, I cannot provide the detailed tables and information requested, as it is not present in the provided text.

Based on the information available:

1. Table of acceptance criteria and reported device performance:
This information is not explicitly provided in the document. The document states: "Based on cyclic pull-out testing, the proposed Arthrex TightRope Soft Button, RT device is equivalent to the primary Arthrex ACL Tightrope RC predicate device." This implies that the performance of the new device met the performance of the predicate device in cyclic pull-out testing, but the specific acceptance criteria and the numerical results are not given.

2. Sample size used for the test set and the data provenance:
Not specified in the document. The document only mentions "cyclic pull-out testing."

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 a mechanical test, not an evaluation by human experts using a test set with ground truth.

4. Adjudication method for the test set:
Not applicable for a mechanical test.

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 medical device for bone/soft tissue fixation, not an AI-powered diagnostic tool requiring MRMC studies.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This is a medical device, not an algorithm. The "equivalence" is based on mechanical performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" here would be the validated performance of the predicate device in cyclic pull-out testing, which serves as the benchmark for equivalence. The specific details of that ground truth are not provided.

8. The sample size for the training set:
Not applicable. This is a mechanical device, not an AI or machine learning model that requires a training set.

9. How the ground truth for the training set was established:
Not applicable.

Summary of available details regarding the study:

• Study type: Cyclic pull-out testing (a type of mechanical bench testing).
• Purpose: To demonstrate substantial equivalence to a predicate device (Arthrex ACL TightRope RC, K112990).
• Outcome: The proposed device was found to be "equivalent" to the predicate.

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Arthrex FiberTape and Tiger Tape Cerclage sutures and 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
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation requiring adjudication.

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

Not applicable. This device is a surgical suture, 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 device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP <85> pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no AI model or training set is applicable here.

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The Arthrex DynaNite Nitinol Staple is intended to be used for fixation such as: LisFranc arthrodesis, mono or bi-cortical osteotomies in the forefoot, first metatarsophalangeal arthrodesis, Akin osteotomy, midfoot and hindfoot arthrodeses or osteotomies, fixation of osteotomies for hallux valgus treatment (Scarf and Chevron), and arthrodesis of the metatarsocuneiform joint to reposition and stabilize metatarsus primus varus.

The Arthrex DynaNite Nitinol Staples are indicated for:
• Fracture and osteotomy fixation and joint arthrodesis of the hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement). These fragments may be located in long bones such as femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and ribs; and in flat bone such as the pelvis, scapula and sternum.
• When used with Arthrex FiberTape Cerclage System, the Arthrex DynaNite Nitinol Staple (sizes 13x10 and 15x12 only) is intended for sternotomy indications including the "rewiring" of osteotomized sternums.

The Arthrex DynaNite Nitinol Staples are Nickel Titanium (Nitinol) bone fixation devices intended to be permanently implanted. The implant is formed with two legs connected by a bridge and is offered in multiple combinations of bridge widths, leg lengths, and cross sections to accommodate various anatomy.

This document is a 510(k) Summary for the Arthrex DynaNite Nitinol Staples, which is a medical device. It describes the device's indications for use and states that the submission is to expand these indications. The document mainly focuses on proving substantial equivalence to a predicate device rather than presenting a study to meet specific performance acceptance criteria for a new device.

Therefore, the information provided does not directly describe a study that sets acceptance criteria for device performance in the sense of accuracy or efficacy (as would be typical for an AI/CADe device). Instead, it describes performance testing conducted to demonstrate safety and substantial equivalence for an implantable medical device.

Based on the provided text, here’s an extraction of the requested information, adapted for a medical device rather than an AI/CADe system:

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

The document does not explicitly state numerical acceptance criteria in a table format for specific performance metrics in the way one would for an AI model (e.g., sensitivity, specificity thresholds). Instead, it describes types of performance tests and implies the acceptance criterion is "perform substantially equivalent" or "meets specifications" for safety parameters.

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 does not specify sample sizes or data provenance for the performance tests conducted. These tests are typically biomechanical or material tests performed in a lab setting, not clinical studies with human data.

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)

This is not applicable as the studies described are laboratory performance tests for a physical implant, not diagnostic assessments requiring expert interpretation or ground truth establishment in a clinical sense.

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

This is not applicable for the types of engineering and material performance tests described.

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, as the device is a physical bone fixation staple, not an AI/CADe system for diagnostic imaging.

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

This is not applicable, as the device is a physical bone fixation staple, not an algorithm. Performance tests are inherently "standalone" in this context, evaluating the physical properties of the device.

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

For the performance tests described:

• Cyclic/Fatigue Testing: The "ground truth" or reference is the performance of the predicate device/construct (Arthrex Cerclage Suture construct).
• MRI Compatibility: The "ground truth" is established by relevant national and international standards (FDA guidance, ASTM standards).
• Bacterial Endotoxin: The "ground truth" is established by pharmacopeial standards (EP 2.6.14/USP <85> pyrogen limit specifications).

8. The sample size for the training set

This is not applicable, as the device is a physical bone fixation staple and does not involve AI model training.

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

This is not applicable for the reasons mentioned above.

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The trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures. The long trochanteric nail is additionally indicated for subtrochanteric fractures, peritrochanteric fractures associated with shaft fractures, pathologic fractures (including prophylactic use) in osteoporotic bone of the trochanteric and diaphyseal areas, long subtrochanteric fracture, ipsilateral femoral fractures, proximal and distal non-unions and malunions and revisions procedures.

The ES trochanteric nail is intended to treat stable and unstable proximal fractures of the femur including peritrochanteric, intertrochanteric and high subtrochanteric fractures and combinations of these fractures.

The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is 5.0 mm in diameter and 15 mm in length. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is a line extension to the Anti-Rotation Screws cleared within Arthrex Intramedullary Nails (K230257). The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is manufactured from Titanium Alloy conforming to ASTM F136. The Arthrex Anti-Rotation Screw, 5.0 x 115 mm is sold sterile and is single-use.

The provided text is a 510(k) premarket notification for a medical device (Arthrex Intramedullary Nails, specifically an Anti-Rotation Screw line extension). This document describes the device, its indications for use, and a comparison to a predicate device to establish substantial equivalence.

Crucially, this document is not for a device that uses Artificial Intelligence (AI) or machine learning. Therefore, it does not contain the kind of information typically found in an AI/ML device submission regarding acceptance criteria, performance studies with test sets, expert ground truth, MRMC studies, or training set details.

The "Performance Data" section solely refers to mechanical testing (failure torque/insertion torque, torsional yield strength) and MR compatibility testing for a physical implantable screw. It does not involve any algorithm performance or diagnostic accuracy metrics that would require the elements you've asked for.

Therefore, I cannot provide the requested information from the given text.

To illustrate, if this were an AI/ML device, the sections you asked about would typically be found in a "Clinical Study" or "Performance Evaluation" section, detailing:

1. Acceptance Criteria Table: Would list quantitative thresholds for metrics like sensitivity, specificity, AUC, or F1-score.
2. Sample Size and Data Provenance: Would describe the number of images/cases in the test set, their origin (e.g., U.S. hospitals), and whether they were collected retrospectively or prospectively.
3. Experts for Ground Truth: Would specify the number of clinicians (e.g., 3 radiologists) and their qualifications (e.g., 5+ years of experience in musculoskeletal imaging).
4. Adjudication Method: Would explain how disagreements among experts were resolved (e.g., 2 out of 3 agreement, or a senior expert for tie-breaking).
5. MRMC Study: Would detail if human readers were evaluated with and without AI assistance, and quantify the improvement (e.g., increase in AUC, reduction in reading time).
6. Standalone Performance: Would present the algorithm's performance without any human intervention.
7. Type of Ground Truth: Would specify if ground truth was from expert consensus, pathology reports, surgical confirmation, or patient outcomes.
8. Training Set Sample Size: The number of images/cases used to train the AI model.
9. Training Set Ground Truth: How the labels for the training data were established.

Since the provided document is for a physical medical implant and not an AI/ML device, none of this information is present.

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