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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 Arthrex AlloSync™ PushLock® suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder in the following procedures:

Shoulder: Rotator Cuff Repair, Bankart Repair, Superior Labrum from Anterior (SLAP) Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

The Arthrex AlloSync™ PushLock® Suture Anchor is a two-component suture anchor comprised of a hollow anchor body manufactured from human cortical bone, a Polyetheretherketone (PEEK) eyelet, and a disposable driver inserter. The anchor will be offered in a 2.9mm diameter and 12.5mm in total length (anchor + eyelet). The anchor is sold sterile, single-use.

The provided text is a 510(k) summary for the Arthrex AlloSync™ PushLock® Suture Anchor, a medical device used for soft tissue fixation to bone. It describes the device, its intended use, and its substantial equivalence to a predicate device.

However, the document does not contain information related to a study involving artificial intelligence (AI) or machine learning (ML) models. Specifically, it does not discuss the following:

• Acceptance criteria for an AI/ML model's performance.
• A test set for an AI/ML model.
• Ground truth establishment by experts for an AI/ML model.
• Adjudication methods for an AI/ML model's test set.
• Multi-Reader Multi-Case (MRMC) studies for AI assistance.
• Standalone performance of an AI algorithm.
• Training set for an AI/ML model or how its ground truth was established.

Instead, the performance data discussed in this document relates to the mechanical and biological testing of the physical suture anchor device, comparing its strength, biocompatibility, and pyrogenicity to existing predicate devices.

Therefore, I cannot provide the requested table and study details as the input document does not contain information about an AI/ML device or its performance evaluation.

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The Arthrex self-punching PushLock suture anchors are intended to be used for suture (soft tissue) fixation to bone in the shoulder: Shoulder: Rotator Cuff Repair

The Arthrex Self-Punching PushLock Anchor is a push-in, fully threaded barbed suture anchor comprised of a PEEK Optima eyelet and a hollow anchor body pre-assembled on a disposable inserter. The anchor body is made of either PLLA/βTCP or PEEK Optima. The Arthrex Self-Punching PushLock Anchor is intended to be used for suture (soft tissue) fixation to bone in the shoulder.

The provided FDA 510(k) summary is for a medical device called the "Arthrex Self-Punching PushLock Suture Anchor". This document does not include information about AI/ML device performance or clinical studies in the context of diagnostic accuracy, which is what your questions are geared towards.

The performance data summarized in this document relates to the mechanical properties, shelf-life, MR safety, and pyrogenicity of a physical medical device (suture anchor), not the performance of an AI model. Therefore, I cannot extract the information required for your questions (acceptance criteria, study design for AI models, expert ground truth, etc.) from this document.

The document states:

• Performance Data: "Ultimate load testing and insertion testing was performed on the subject device and compared to the predicate device cleared under K101679 to demonstrate that the modifications do not negatively impact mechanical strength." It also mentions shelf-life and MR safety.

This means the acceptance criteria and study proving it, in this context, would be based on engineering and biocompatibility standards, not on diagnostic accuracy metrics like sensitivity, specificity, or AUC as evaluated for AI models.

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The Arthrex Mini Hip PushLock is intended to be used for suture (soft tissue) to bone in the hip. Specifically, Acetabular Labral Repair.

The Arthrex Mini Hip PushLock is a barbed push-in suture anchor pre-loaded on a disposable inserter. The anchor is manufactured from PLLA/ $\u03b2$ TCP and is offered sterile, single use.

The provided document is an FDA 510(k) Premarket Notification for a medical device called the "Arthrex Mini Hip PushLock." This type of submission is for non-AI/software medical devices, specifically a suture anchor.

Therefore, the requested information about acceptance criteria, study design for AI devices (sample size, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, training data, etc.) is not applicable to this document. The document describes a traditional medical device, not an AI/ML-driven device.

The "Performance Data" section in the document details mechanical testing (pull-out testing) and biocompatibility, which are standard for physical medical devices.

Here's a breakdown of what is in the document regarding "acceptance criteria" and "study":

1. Acceptance Criteria and Device Performance (for a physical device):

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

• Sample Size: Not explicitly stated for pull-out testing, but mechanical testing typically involves a statistically relevant number of samples.
• Data Provenance: The testing was conducted by or for Arthrex Inc. as part of their 510(k) submission. The document doesn't specify if it was external lab testing or internal, but it's part of the regulatory submission process.

3. Number of Experts Used to Establish Ground Truth / Qualifications of Experts:

• Not applicable for this type of mechanical and biocompatibility testing. The "ground truth" is based on established engineering and materials science principles and validated testing methods.

4. Adjudication Method for the Test Set:

• Not applicable. Mechanical and biological tests are typically objective and follow standardized protocols, rather than requiring human adjudication of subjective assessments.

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

• No. This is a physical device, not an AI system. MRMC studies are for evaluating diagnostic performance of imaging interpretation, often with AI assistance.

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

• No. This is a physical device, not an AI system. "Standalone performance" refers to the accuracy of an algorithm.

7. The Type of Ground Truth Used:

• For pull-out strength: Engineering specifications (20 lbf) established for acetabular labral repair.
• For pyrogenicity: Regulatory standards (EP 2.6.14/USP ) for bacterial endotoxin limits.
• For biocompatibility: Equivalence to a previously cleared device (referencing its known biocompatibility).

8. The Sample Size for the Training Set:

• Not applicable. There is no "training set" as this is not an AI/ML device.

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

• Not applicable. There is no "training set."

In summary, the document describes the regulatory clearance of a physical medical device based on mechanical and material performance attributes, not an AI-driven diagnostic or therapeutic system.

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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.

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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.

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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.

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The Arthrex Bio-Composite Suture Anchor Family is intended to be used for Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and pelvis. For suture or tissue fixation in the foot, ankle, hip, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate. See the Indications for Use statements for specific indications.

The Arthrex Bio-Composite Suture Anchors Family is identical to the predicate devices.

This document is a 510(k) summary for the Arthrex Bio-Composite Suture Anchors, specifically for the expansion of indications to include the hip. It does not describe a study involving performance criteria for a device that relies on data analysis or AI/ML.

Instead, it is a submission to the FDA demonstrating substantial equivalence of a medical device (suture anchors) to a previously cleared predicate device. Substantial equivalence means the new device is as safe and effective as a legally marketed device. This is typically based on comparing the design, materials, manufacturing, and intended use, rather than a clinical study with acceptance criteria and performance metrics in the way one might expect for a diagnostic or AI-driven device.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving device performance in the context of data analysis or AI/ML, as that kind of information is not present in the provided text.

Here's a breakdown of what is in the document, relating to your request where possible, and highlighting what is absent:

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

• Not Applicable. This document does not describe performance metrics in terms of sensitivity, specificity, accuracy, or similar measures that would be used for a diagnostic device or AI/ML system. The basis for clearance is "substantial equivalence" to a predicate device. This typically involves comparison of materials, design specifications, and intended use rather than numerical performance criteria against a specific benchmark.

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

• Not Applicable. No test set or data provenance in the context of clinical performance evaluation (like for an imaging AI) is mentioned. The submission is based on engineering and material comparisons to a predicate device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Applicable. No ground truth establishment for a test set is discussed. The FDA's review for substantial equivalence primarily relies on the manufacturer's documentation and comparison to the predicate device, not on expert consensus for clinical interpretations.

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

• Not Applicable. There is no test set or adjudication method 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

• No. This type of study is completely irrelevant to the clearance of a suture anchor. The device is a surgical implant, not a diagnostic tool or an AI-assisted system.

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

• No. The device is a physical suture anchor, not an algorithm.

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

• Not Applicable. No quantifiable ground truth is mentioned in this type of submission for a physical implant. The "ground truth" for substantial equivalence would broadly be a demonstration that the new device shares the same fundamental scientific technology, materials, and intended use as the predicate device, and any differences do not raise new questions of safety or effectiveness.

8. The sample size for the training set

• Not Applicable. No training set for an algorithm is involved.

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

• Not Applicable. No training set is involved.

Summary of the provided document:

The document is a 510(k) Premarket Notification from Arthrex, Inc. for their Bio-Composite Suture Anchors. The purpose of this submission (K082810) is to expand the indications for use of these anchors to include the hip, in addition to previously cleared indications.

The key information provided is:

• Manufacturer: Arthrex, Inc.
• Trade Name: Arthrex Bio-Composite Suture Anchors (including PushLock, Tak, and Corkscrew)
• Common Name: Suture Anchor
• Predicate Device: Arthrex Bio-Composite Suture Anchors (K071177)
• Basis for Clearance: Substantial Equivalence to the predicate device. The document explicitly states: "The Arthrex Bio-Composite Suture Anchor Family is substantially equivalent to the predicate Arthrex Bio-Composite Suture Anchor Family in which the basic features and intended uses are the same. Any differences between the Bio-Composite Suture Anchor Family and the predicate K071177 are considered minor and do not raise questions concerning safety and effectiveness."
• New Indications for Use (Hip): Capsular Repair, acetabular labral repair.

The FDA's letter confirms that the device is substantially equivalent and can be marketed for the stated indications.

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The Arthrex Bio-Composite Suture Anchor Family is intended to be used for:
Fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis.
For suture or tissue fixation in the foot, ankle, hand, wrist, elbow, shoulder, and in select maxillofacial applications where size is appropriate.
Please see indications for use statements for specific indications.

The Arthrex Bio-Composite Corkscrew is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and pelvis in, but not limited to, the following procedures:
Shoulder: Rotator Cuff Repairs, 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: Anterior Cruciate Ligament Repair, 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, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

The Arthrex Bio-Composite PushLock™ is intended for fixation of suture (soft tissue) to bone in the shoulder, footlankle, knee, hand/wrist, elbow, and pelvis in the following procedures:
Shoulder: Rotator Cuff Repairs, 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, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collateral Ligament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

The Arthrex Bio-Composite Tak™ is intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, shoulder, elbow, and in select maxillofacial applications. Specific indications are listed below and are size appropriate per patient needs:
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. Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Shoulder: Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction. Scapholunate Ligament Reconstruction, Carpal Ligament Hand/Wrist: 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.
Pelvis: Bladder Neck Suspension for female urinary incontinence due to urethral hypermobility or intrinsic sphincter deficiency.

The Arthrex Bio-Composite Suture Anchors Family is very similar to the predicate devices in diameter, length, and eyelet design. The difference lies in the bio-degradable material used to construct the new model. The implants will use PLLA or PLDLA combined with TCP.

The provided text describes a 510(k) submission for the Arthrex Bio-Composite Suture Anchors. This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K061863), rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the typical sense.

Here's an analysis based on the information provided, addressing your requested sections where applicable:

Acceptance Criteria and Device Performance (as interpreted from a 510(k) context)

For a 510(k) submission, "acceptance criteria" are generally met by demonstrating substantial equivalence to a predicate device. This means showing that the new device is as safe and effective as a legally marketed device. The "device performance" is therefore described in terms of its similarities and any minor differences to the predicate, and how those differences do not raise new questions of safety or effectiveness.

• Diameter: New device: "3-5.5 mm". Predicate: "2.4 - 6.5 mm". The new device falls within the predicate's range, albeit with a narrower overall range.
• Length: New device: "14-14.7 mm". Predicate: "5-18.5 mm". The new device also falls within the predicate's range, with a narrower specific range.

These differences are not presented as raising safety/effectiveness concerns. |
| Similar Performance Characteristics (e.g., Strength, Biocompatibility) | Implied to be met through materials and design comparison: The document states "Any differences between the Bio-Composite Suture Anchor Family and the predicate K061863 are considered minor and do not raise questions concerning safety and effectiveness." This implies that the performance (e.g., mechanical strength, degradation profile, biocompatibility) is considered equivalent despite the material change, likely supported by non-clinical testing or existing data for the composite materials, though specific test results are not detailed in this summary. The mention that the biodegradable materials have a "long history of implantable use" supports the biocompatibility aspect. |
| Similar Sterile, Single Use, Packaging, Shelf Life | Met: All are listed as "Identical" for Packaging, Sterile, and Single Use. Shelf life for PLLA/PLDLA is 2 years for both new and predicate, ensuring equivalence for relevant material types. |

Study Information

The provided document describes a 510(k) Premarket Notification which primarily relies on demonstrating substantial equivalence to a predicate device. It does not present a study (e.g., clinical trial) in the traditional sense with acceptance criteria, sample sizes, experts, or ground truth as would be the case for a novel device or a device requiring a PMA.

Therefore, for most of the requested points, the answer is "Not Applicable" or "Not provided in this 510(k) summary."

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
   • Not Applicable. This is a 510(k) substantial equivalence submission, not a study with a test set of patient data. The "test set" here refers to a comparison of the new device's specifications against the predicate device's specifications and existing knowledge/data about the materials.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
   • Not Applicable. There is no "ground truth" established by experts for a test set in this context. The determination of substantial equivalence is made by the FDA reviewer based on the information provided by the manufacturer.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set
   • Not Applicable. No test set requiring adjudication in this format.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
   • Not Applicable. This is a physical medical device (suture anchors), not an AI/software device.
5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
   • Not Applicable. This is a physical medical device, not an algorithm.
6. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   • Not Applicable. The "ground truth" for a 510(k) substantial equivalence is the safety and effectiveness profile of the predicate device, as established by its clearance and general market use, and the scientific/clinical knowledge underpinning the materials and design. The new device is evaluated against this established standard.
7. The sample size for the training set
   • Not Applicable. There is no "training set" in the context of this 510(k) submission for a physical device.
8. How the ground truth for the training set was established
   • Not Applicable. No training set.

Summary of the 510(k) Process:

The key to this submission is demonstrating that the Arthrex Bio-Composite Suture Anchors are substantially equivalent to the predicate Arthrex PushLock, Tak, and Corkscrew Suture Anchors (K061863). The manufacturer achieves this by:

• Highlighting identical intended uses.
• Acknowledging minor differences in indications for use (exclusion of hip).
• Acknowledging differences in materials (new bio-composite), but justifying their safety and effectiveness due to their history of use in medical implants and other Arthrex devices.
• Showing similar design and dimensions that fall within the predicate's range or are presented as minor and not impacting safety/effectiveness.

The FDA's letter (Section 4, 5) confirms that based on the submitted information, the device is found substantially equivalent to legally marketed predicate devices. This means the device meets the "acceptance criteria" for demonstrating substantial equivalence for the purpose of market clearance via the 510(k) pathway.

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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.

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