Search Results

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."

Ask a specific question about this device

The Arthrex Tenodesis PushLock Anchor is intended to provide soft tissue reattachment, i.e. fixation of ligament and tendon graft tissue in surgeries of the shoulder, elbow, knee, foot/ankle, and hand/wrist. Specifically;

Shoulder: Rotator Cuff Repairs, Bankart 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, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Illiotibial Band Tenodesis

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction, Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty), Carpal Ligament Reconstructions and repairs, tendon transfer in the hand/wrist

The Arthrex PushLock Tenodesis Anchor is a push-in anchor made of Polyetherether-ketone. This is the same material of the predicate device. The proposed anchor is designed with either a forked or closed eyelet and comes preloaded on a disposable inserter. These are similar features to the cleared Arthrex PushLock (K101679) and Arthrex SwiveLock (K101823) suture anchors. The proposed anchor is offered sterile.

The provided text describes a medical device, the Arthrex PushLock Tenodesis Anchor, and its substantial equivalence to a predicate device. However, it does not contain information regarding a study with acceptance criteria and device performance as typically understood for AI/software devices, nor does it provide details about sample sizes, ground truth establishment, expert qualifications, or MRMC studies.

The "Performance Data" section solely refers to tensile testing and bacterial endotoxin testing, which are standard engineering and biocompatibility tests for physical medical implants, not performance metrics for an AI or digital health device.

Therefore, I cannot fulfill the request as the necessary information is not present in the provided document.

Here's a breakdown of why I cannot generate the requested table and study description based on the input:

• No AI/Software Device: The document describes a physical medical implant (a tenodesis anchor), not an AI/software device. Acceptance criteria and performance metrics for a physical implant are typically mechanical strength, biocompatibility, and sterility, not diagnostic accuracy, sensitivity, or specificity.
• No Clinical Study for Performance (as requested): The "Performance Data" section details physical and chemical tests (tensile testing and bacterial endotoxin testing), not a clinical study involving human subjects or data analysis for diagnostic or prognostic performance.
• Missing Information: All specific points requested (sample size for test set, data provenance, number of experts, adjudication, MRMC, standalone performance, type of ground truth, training set size, training set ground truth) are absent because they are relevant to AI/software validation, which is not what this document addresses.

In summary, the provided document is a 510(k) summary for a physical medical implant, not a study report for an AI-powered device. Therefore, the information requested in the prompt is not available in the given text.

Ask a specific question about this device

The 2.5mm Arthrex Mini Bio-PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

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

Shoulder: Rotator Cuff Repairs, Bankart Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

The 2.9mm BioComposite PushLock is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Elbow: Bicens Tendon Reattachment, Tennis Elbow Repair.Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair

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, Ulnar or Radial Collateral Ligament Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Bunionectomy

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

Hip: Capsular Repair, Acetabular Labral repair

The Arthrex PushLock is a two piece "push-in" suture anchor device comprising a biodegradable anchor body manufactured from either PLLA or PLDLA/betaTCP with a polyetheretherketone (PEEK) eyelet pre-loaded on a disposable inserter. The anchor body ranges in diameter from 2.5mm to 2.9mm and 8mm to 15.5mm in length.

Here's a breakdown of the acceptance criteria and study information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state a sample size for a "test set" in the context of validating a device for its intended use or performance against a specific clinical outcome. The testing mentioned (inherent viscosity, peak load, bacterial endotoxin) is related to material properties and safety rather than a clinical performance test.

• Sample Size: Not explicitly stated for a "test set" in the traditional sense of clinical or performance validation. It refers to the number of units tested for material properties and shelf-life.
• Data Provenance: The testing was performed after four years on the shelf, indicating a controlled laboratory environment. No country of origin for the data is specified, but the submission is from Arthrex Inc. in Naples, Florida, USA, implying U.S. based testing or standards. The testing is retrospective in the sense that it evaluates the effects of storage over time.

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

Not applicable. This device is a surgical implant (suture anchor), and the submitted data pertains to material properties, shelf-life, and biocompatibility, not a diagnostic or AI-driven device requiring expert-established ground truth from images or clinical assessments.

4. Adjudication Method for the Test Set

Not applicable. There was no "test set" in the context of diagnostic performance requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is a surgical implant, not a diagnostic device that would typically undergo an MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests performed relates to:

• Material Specifications: Established limits for inherent viscosity and minimum peak load for the biodegradable materials (PLLA, PLDLA/βTCP) to ensure structural integrity and proper degradation over time.
• Regulatory Standards: Pyrogen limit specifications as defined by EP 2.6.14/USP for bacterial endotoxin.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning model, so there is no "training set."

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

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

Ask a specific question about this device

The Arthrex PushLock™ Anchors are intended to be used for suture (soft tissue) to bone in the shoulder, foot, ankle, knee, hand, wrist, elbow, hip, and pelvis 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, Metatarsal Ligament Repair, Hallux Valgus Repair/Tendon Reconstruction, Mid-foot Reconstruction, 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, Ulnar or Radial Collateral Ligament Reconstruction
• Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair
• Hip: Acetabular Labral Repair.

The Arthrex PushLock Anchors family is similar to the predicate devices in materials and overall design. The Arthrex PushLock Anchors family is intended to be used for sutures or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, hip.

Here's a breakdown of the acceptance criteria and the study information based on the provided text for the Arthrex PushLock Anchors:

1. Table of Acceptance Criteria and Reported Device Performance

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

The provided text does not specify sample sizes for a 'test set' in the traditional sense of a clinical trial or AI model validation. The study described is focused on demonstrating substantial equivalence through mechanical and biomechanical testing. Therefore, the "test set" here refers to the samples of Arthrex PushLock Anchors and predicate devices used in the mechanical and biomechanical testing.

• Sample Size: Not explicitly stated for specific tests, but implies multiple samples were tested for each device type (proposed and predicate) to generate the "mechanical testing data."
• Data Provenance: Not explicitly stated, but as this is a 510(k) submission from a US manufacturer (Arthrex, Inc. in Naples, FL), it can be inferred that the testing was conducted either internally by the manufacturer or by a contracted laboratory, likely within the US. The nature of the testing (mechanical/biomechanical) would make it similar to a prospective study aimed at generating specific data points for regulatory submission.

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

This information is not applicable to this submission. The "ground truth" for this type of device (suture anchor) in a 510(k) submission is established through:

• Engineering specifications and material science: For material equivalence.
• Mechanical and biomechanical testing standards: For performance equivalence (e.g., pull-out strength, insertion strength).
• Comparison to legally marketed predicate devices: For intended use and technological characteristics.

There's no mention of human experts interpreting data to establish a 'ground truth' in a clinical or diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable to this submission. Adjudication methods (like 2+1, 3+1 consensus) are typically used in clinical studies or imaging-based AI assessments where multiple human readers interpret data that is inherently subjective or requires expert consensus. The assessment here is based on objective mechanical measurements and comparison to established predicate properties.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices or AI algorithms that assist human readers in tasks like image interpretation. The Arthrex PushLock Anchors are a physical medical device (suture anchors), not a diagnostic tool or an AI algorithm, so an MRMC study would be irrelevant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an algorithm. The "standalone" performance here would refer to the device's inherent mechanical properties, which are evaluated through the biomechanical and mechanical testing.

7. Type of Ground Truth Used

The ground truth used here is primarily:

• Predicate Device Data: The mechanical and material properties of the legally marketed predicate devices (Arthrex Bio-Composite Suture Tak Anchors, Arthrex BioComposite Suture Anchors, Arthrex PushLock, Tak and Corkscrew Suture Anchors) served as the benchmark or "ground truth" for comparison.
• Biomechanical and Mechanical Measurement Data: Objective, quantifiable results from laboratory testing regarding insertion and pull-out strength.
• Material Composition Standards: Specifications for the Bio, BioComposite, and Peek materials.

8. Sample Size for the Training Set

This information is not applicable. The concept of a "training set" is relevant for machine learning or AI algorithms. This submission pertains to a physical medical device. The "design iterations" and "testing" involved in its development might be analogous to a training phase, but there isn't a quantifiable "training set" in the AI sense.

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

This information is not applicable as there is no "training set" in the AI context. The development process would have involved engineering design principles, material science, and iterative testing where the "ground truth" for design decisions was based on desired mechanical performance, biocompatibility, and manufacturing feasibility, guided by existing knowledge of successful predicate devices.

Ask a specific question about this device

The Arthrex PushLock™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and in select maxillofacial applications. Specific indications are listed below:

Stabilization and fixation of oral cranio-maxillofacial skeletal bone, Skull: mandible and maxillofacial bones, Lateral Canthoplasty, Repair of Nasal Vestibular Stenosis, Brow Lift, Temporomandibular Joint (TMJ) reconstruction, soft tissue attachment to the parietal temporal ridge, frontal, zygoma, and perioorbital bones of the skull

Biceps Tendon Reattachment. Ulnar or Radial Collateral Ligament Elbow: 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 PushLock™ (suture anchor) is a 2 piece "push-in" anchor. The suture anchor is designed to use the principles of compression to force the eyelet, threaded with appropriate suture, into a predrilled hole.

The provided text does not contain information about acceptance criteria, device performance, or any studies with specific details like sample sizes, expert qualifications, or ground truth establishment. The document is primarily a 510(k) summary for the Arthrex 2.5 mm PushLock™, focusing on its substantial equivalence to a predicate device and its intended uses.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based only on the provided input.

The document states:

• Substantial Equivalence Summary: "The Arthrex PushLock™ (suture anchor) is substantially equivalent to the predicate Arthrex Tak Family in which the basic features and intended uses are the same. Any differences between the PushLock™ (suture anchor) and the predicate Tak Family are considered minor and do not raise questions concerning safety and effectiveness. Based on the information submitted, Arthrex, Inc. has determined that the new PushLock™ (suture anchor) is substantially equivalent to the currently marketed predicate device."

This indicates that the primary "proof" for market clearance in this 510(k) was based on demonstrating substantial equivalence to a legally marketed predicate device, rather than through a de novo study with explicit acceptance criteria and performance metrics. The FDA has made a substantial equivalence determination.

To answer your questions, I would need additional documentation, such as performance testing reports, clinical data summaries, or detailed bench testing results, which are not present in this 510(k) summary.

Ask a specific question about this device