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The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in skeletally mature pediatric and adult patients for the following procedures:

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

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

Knee: Anterior Cruciate Ligament Repair (4.75- 5.5 SwiveLock Only), Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair (4.75 SwiveLock C Only), Meniscal Root Repair (4.75 SwiveLock C Only), Secondary or adjunct fixation for ACL/PCL reconstruction or repair (4.75-5.5 SwiveLock only), MPFL Repair/Reconstruction(3.9 SwiveLock Only)

Hand/Wrist: Scapholunate Ligament Reconstruction and Ulnar/Radial Collateral Ligament Reconstruction

Elbow: Biceps Tendon Reattachment, Unar/Radial Collateral Ligament Reconstruction, and Lateral Epicondylitis repair

Hip: Capsular Repair, Acetabular labral repair, Gluteus Medius Repair (4.75 – 5.5 mm PEEK SwiveLock suture anchors only), and Proximal Hamstring Repair (4.75 - 5.5 mm PEEK SwiveLock suture anchors only).

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with an anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor, which seeks to obtain pediatric indications and an extended shelf life for an existing device. It largely focuses on mechanical testing, a review of clinical literature, and real-world data to demonstrate substantial equivalence to predicate devices, rather than an AI-powered device's performance study.

Therefore, many of the requested details regarding acceptance criteria for an AI device, specific study methodologies (like MRMC, standalone AI performance), ground truth establishment for AI training/testing, expert qualifications, and adjudication methods are not present in the provided document. The document details testing for a physical medical device (suture anchor).

However, I can extract information related to the performance data and the "study" (testing) that was done to support the submission for the physical device.

Acceptance Criteria and Device Performance (Based on Provided Text)

The "acceptance criteria" here refer to the standards the physical device needed to meet to demonstrate substantial equivalence, particularly concerning the proposed modifications (pediatric indication, extended shelf life).

Study Details (Based on Provided Text)

1. Sample sized used for the test set and the data provenance:

• Mechanical Testing: Not explicitly stated (e.g., number of anchors tested), but it was performed on the "subject device" and "predicate device." No geographical provenance is specified.
• Clinical Literature: The text states "Clinical literature was provided on the subject devices involving the proposed patient population of skeletally mature pediatric patients." The number of studies or patients is not specified. It's a retrospective review of existing data.
• Real World Data/Evidence: "Real World Data/Evidence is provided from the Surgical Outcomes System registry." The sample size (number of patients) is not specified, but it compares "patients less than 22 years of age versus patients greater than 22 years of age." The provenance of this registry data (e.g., country of origin) is not specified. This is retrospective data.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This concept is not applicable here as the "ground truth" for a physical medical device's performance primarily comes from engineering and clinical outcome data, not expert consensus on image interpretation. For the clinical literature review and RWD, the "truth" is established by the clinical outcomes themselves, as documented in studies and registries.

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

• This concept applies to interpreting complex data, typically images or clinical scenarios, often for AI or diagnostic devices. It is not relevant to the mechanical/biological testing or the clinical literature/RWD review described for this physical medical device.

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:

• No. This study type is for evaluating reader performance with and without AI assistance for diagnostic or prognostic devices. It is not relevant for a physical medical device like a suture anchor.

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

• No. This applies to AI algorithms. Not relevant for this physical medical device.

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

• Mechanical Testing: Ground truth established through direct physical measurement and engineering standards (e.g., force applied, displacement measured).
• Pyrogenicity Testing: Ground truth established by laboratory assay results meeting specified pyrogen limits.
• Clinical Literature/Real World Data: Ground truth is clinical outcomes data (e.g., success of repair, complications, patient outcomes), as documented in published literature and registries.

7. The sample size for the training set:

• Not applicable in the context of this device. This pertains to machine learning models. This submission is for a physical medical device.

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

• Not applicable. This pertains to machine learning models. This submission is for a physical medical device.

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

· Shoulder: Rotator Cuff Repair, 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 Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis and MPFL Repair/Reconstruction

• · Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction
  · Elbow: Biceps Tendon Reattachment, Unar or Radial Collateral Ligament Reconstruction, Lateral Epicondylitis Repair (Tennis Elbow)

· Hip: Capsular Repair, Acetabular labral repair

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided text describes a 510(k) premarket notification for the Arthrex SwiveLock Anchor. It aims to expand the indications for use of the 3.9mm BioComposite SwiveLock suture anchor to include MPFL Repair/Reconstruction. The submission focuses on demonstrating substantial equivalence to a predicate device (K192532).

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

No clinical studies involving human readers or AI performance are mentioned in this document. This 510(k) pertains to a physical medical device and its mechanical/biocompatibility performance, not a software device that interprets images or data. Therefore, many of the requested sections below are not applicable.

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

• Mechanical Testing: The document does not specify the sample size for the mechanical testing (pull-out strength).
• Bacterial Endotoxin Testing: The document does not specify the sample size for the bacterial endotoxin testing.
• Data Provenance: Not applicable as this is laboratory testing of a device, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for mechanical and endotoxin testing is established by standard laboratory methods and specifications, not by expert consensus on clinical data.

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

Not applicable. Adjudication methods are relevant for expert consensus on clinical data, not for laboratory testing.

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 MRMC comparative effectiveness study was done or is referenced in this document. This filing is for a physical medical device (suture anchor), not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is not an algorithm or AI device.

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

• Mechanical Testing: Ground truth is defined by established "published literature" regarding the required pull-out strength for MPFL repair/reconstruction.
• Bacterial Endotoxin Testing: Ground truth is defined by established regulatory and quality standards (USP , USP , FDA Guidance, EP 2.6.14) for pyrogen limits.

8. The sample size for the training set

Not applicable. This is a physical device and does not involve a "training set" in the context of machine learning.

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

Not applicable. This is a physical device and does not involve a "training set" or "ground truth" establishment in the context of machine learning.

Ask a specific question about this device

The Arthrex SwiveLock Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
• Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
· Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, 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
• · Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral Epicondy.itis Repair
  · Hip: Capsular Repair, Acetabular labral repair

The Arthrex SwiveLock Anchor is a sterile two-component suture anchor comprised of an eyelet and a hollow anchor body. The Arthrex SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

This document describes the FDA clearance for the Arthrex SwiveLock Anchor. As such, the information provided focuses on the regulatory review process and the basis for substantial equivalence to predicate devices, rather than a clinical study evaluating the performance of a medical device against specific acceptance criteria.

Therefore, the specific information requested in your prompt regarding acceptance criteria and a study to prove the device meets these criteria (including sample sizes, expert involvement for ground truth, adjudication methods, MRMC studies, standalone performance, training sets, etc.) is not present in the provided text.

The document primarily states:

• Performance Data: "Mechanical testing demonstrated that the pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor met the criteria established by the predicate device and that the anchor was successfully inserted into the bone substitute. Geometric analysis and Load vs Degradation Time comparison was conducted to demonstrate that the expected degradation and pull out strength of the proposed anchor is not a new worst case over the predicate and referenced predicate devices. Bacterial endotoxin per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing and EP 2.6.14 was conducted to demonstrate that the device meets pyrogen limit specifications."

This indicates that mechanical and biocompatibility tests were performed, and the results were compared against established criteria or predicate device performance. However, it does not provide the quantitative acceptance criteria, the specific methodology of these tests (e.g., number of samples tested, blinding, etc.), or details of a study meeting the criteria you've outlined for clinical performance or an AI/human-in-the-loop system.

In summary, the provided text from the FDA 510(k) clearance letter and summary does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria in the context of an AI-driven or diagnostic device. This document pertains to a mechanical surgical implant, and the assessment for such a device is typically based on mechanical properties, biocompatibility, and substantial equivalence to existing devices, rather than the types of performance metrics and study designs common for AI/human reader studies.

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The Arthrex SwiveLock Suture Anchors are intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, hip, knee, hand/wrist, elbow, and hip in the following procedures:
Shoulder: Rotator Cuff 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, Midfoot 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, Quadriceps Tendon Repair and Meniscal root repair (4.75 SwiveLock C only). Secondary fixation for ACL/PCL reconstruction or repair (4.75 - 5.5. SwiveLock only).
Hand/Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction, Radial Collament Reconstruction.
Elbow: Biceps Tendon Reattachment, Tennis Elbow Repair, Unar or Radial collateral Ligament Reconstruction, Lateral Epicondylitis Repair.
Hip: Capsular Repair, acetabular labral repair

The Arthrex SwiveLock Anchor is a BioComposite two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex cleared suture may also be provided with the device.

This document is a 510(k) premarket notification for the Arthrex SwiveLock Anchors, specifically for the addition of a meniscal root repair indication. It's a regulatory submission, not a study report per se, and it pertains to a physical medical device (suture anchors), not a software or AI-driven device.

Therefore, many of the requested fields are not applicable to this type of document or device. For example, there's no "device performance" in terms of accuracy metrics, no "test set" in the computational sense, no "ground truth" derived from expert consensus on images, no "training set," and no "AI assistance."

However, I can extract information related to the performance data provided to support the new indication.

Here's the breakdown of what can be extracted from the provided text, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated numerically (e.g., how many anchors were tested, how many repetitions). The document refers to "testing" performed.
• Data Provenance: The testing was conducted to demonstrate the mechanical properties and biocompatibility of the device for the new indication. It would be considered prospective testing for the purpose of this submission, performed by the manufacturer (Arthrex Inc.). Country of origin is not specified, but the manufacturer is based in Naples, Florida, USA.

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

• Not Applicable: This relates to a physical device, not an image-based diagnostic or AI system. The "ground truth" here is objective physical and chemical testing results, not expert interpretation.

4. Adjudication Method for the Test Set

• Not Applicable: As above, this is for physical/chemical testing, not expert adjudication of diagnostic outputs. The assessment of whether the ultimate load and displacement are "within the acceptable range" would be based on predefined engineering specifications, not human adjudication.

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

• No: This is not relevant for a physical medical device like a suture anchor. MRMC studies are typically for diagnostic imaging systems or AI products.

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

• Not Applicable: This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

• Engineering/Mechanical Specifications and Biocompatibility Standards: The "ground truth" for the performance data involves established mechanical thresholds for ultimate load and displacement in meniscal root repair applications, as well as pyrogen limit specifications defined by standards like EP 2.6.14/USP . It's based on objective physical and chemical measurements rather than expert consensus on interpretation.

8. The Sample Size for the Training Set

• Not Applicable: This is a physical device, and the concept of a "training set" for an algorithm does not apply.

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

• Not Applicable: As above, no training set for an algorithm exists here.

Ask a specific question about this device

The Arthrex SwiveLock Anchors 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, Siceps 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 and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

Hand Wrist: Scapholunate Ligament Reconstruction, Ulnar or Radial Collateral Ligament Reconstruction.

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

Hip: Capsular repair, acetabular labral repair. Proximal Hamstring Repair (4/75-5.5 PEEK SwiveLock only).

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

This provides an analysis of the provided text regarding the Arthrex SwiveLock Anchors.

1. Table of Acceptance Criteria and Reported Device Performance

The submission for the Arthrex SwiveLock Anchors (K190728) describes a comparison to predicate devices, focusing on mechanical performance. The "acceptance criteria" can be inferred from the statement that the device performs "statistically equivalent" to the predicate.

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

• Sample Size for Test Set: The document does not explicitly state the numerical sample size (n) used for the cyclic pull-out testing. It only mentions that "Cyclic pull-out testing was performed."
• Data Provenance: Not explicitly stated, but given it's a 510(k) submission from a U.S. company (Arthrex Inc., Naples, FL), the testing would typically be conducted in a controlled lab environment, likely in the US or by a recognized testing facility. It would be considered prospective testing for the purpose of this submission.

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

This information is not applicable to this type of device and study. The "ground truth" for mechanical testing of a medical device like a suture anchor is based on objective, quantifiable physical measurements (e.g., force, displacement, material properties) rather than expert opinion or diagnostic interpretation.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation (e.g., image reading) where there might be disagreement among experts. For mechanical testing, the results are typically derived from instrumentation, and judgment or adjudication in that sense is not usually employed.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. This submission is for a surgical implant (suture anchor), where performance is assessed through biomechanical testing, not reader interpretation.

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

Yes, a standalone performance assessment was done. The "Performance Data" section describes "Cyclic pull-out testing" and "Bacterial endotoxin testing." These are laboratory-based, objective tests conducted on the device itself without human intervention in the performance measurement process.

7. Type of Ground Truth Used

The ground truth used for the performance data is based on objective, quantitative physical and biological measurements:

• Biomechanical Metrics: For cyclic pull-out testing, the "ground truth" is the measured force-displacement characteristics and failure modes, compared against established performance benchmarks of the predicate devices.
• Physicochemical Analysis: For bacterial endotoxin testing, the "ground truth" is the measured endotoxin level compared against predefined pyrogen limit specifications.

8. Sample Size for the Training Set

This information is not applicable as this device does not involve an AI algorithm that requires a "training set." The device is a physical medical implant whose performance is evaluated through mechanical and biological testing, not by learned patterns from data.

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

This information is not applicable, as there is no AI algorithm or training set involved with this device.

Ask a specific question about this device

The Arthrex SwiveLock Anchors 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, 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 and Bunionectomy.

Knee: Medial Collateral Ligament Repair, Lateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis and Quadriceps Tendon Repair. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).

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: Capsular repair, acetabular labral repair.

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is premounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex 510(k) cleared suture may also be provided with the device.

The provided document is a 510(k) premarket notification for a medical device: Arthrex SwiveLock Anchors. It is primarily focused on demonstrating substantial equivalence to predicate devices for the purpose of a regulatory clearance for an expanded indication (quadriceps tendon repair).

Crucially, this document does not contain information about an AI/ML-driven device or study that would involve acceptance criteria for algorithms, human-in-the-loop performance, or the other specific details requested in your prompt (e.g., sample size for test/training sets, expert consensus, MRMC studies, ground truth establishment methods for AI).

The "Performance Data" section of this 510(k) summary refers to:

• Static pull-out testing of the Arthrex SwiveLock Anchor and a predicate device.
• Cyclic pull-out testing of the subject device after degradation, compared to a non-resorbable predicate.
• Bacterial endotoxin testing (pyrogen limit specifications).

These are biomechanical and biocompatibility tests for a physical implantable device, not performance metrics for an AI algorithm.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves an AI device meets acceptance criteria based on this document. The document describes the regulatory submission for a physical medical device (suture anchors) and its associated mechanical and biological performance, not an AI product.

Ask a specific question about this device

The Arthrex SwiveLock Anchors 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 and Bunionectomy.
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation of ACL/PCL reconstruction or repair (4.75 - 5.5 SwiveLock only).
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: Capsular repair, acetabular labral repair.

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor composed of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. Arthrex suture may also be provided with the device.

This document is a 510(k) premarket notification for a medical device, the Arthrex SwiveLock Anchors. It focuses on demonstrating substantial equivalence to a predicate device rather than undergoing a new, comprehensive clinical trial for a novel AI device. Therefore, the questions related to AI-specific study design (such as human reader improvement with AI assistance, ground truth for training sets, etc.) are not directly applicable to this document's content.

However, I can extract the information relevant to the device's performance testing and how it meets acceptance criteria for substantial equivalence to its predicate.

Here's the relevant information based on the provided text, framed as closely as possible to your request for acceptance criteria and study details:

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

For a 510(k) submission for a modification, the "acceptance criteria" are typically defined by demonstrating that the modified device performs equivalently to the predicate device in relevant performance tests, or that the modifications do not introduce new safety or effectiveness concerns. The "reported device performance" is then the outcome of these tests.

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

• Sample Size: The document does not specify the exact number of units or samples used for the pull-out, compressive load, and mode of failure testing, nor for the bacterial endotoxin testing. This level of detail is typically found in the full test reports, which are not part of this summary.
• Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) for a manufacturing modification, the testing would generally be prospective laboratory testing conducted by the manufacturer (Arthrex Inc., located in Naples, Florida, USA).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is not a study involving human interpretation of medical images or data requiring expert consensus for ground truth. The "ground truth" for mechanical testing is established by the physical testing equipment and methods themselves (e.g., measuring force, observing failure points).

4. Adjudication method for the test set

Not applicable. This is not a study involving human-based data interpretation or classification where adjudication would be necessary.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is not an AI device or a study involving human readers.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

For the mechanical tests (pull-out, compressive load, mode of failure), the ground truth is established through physical measurement and observation during standardized laboratory testing. For the bacterial endotoxin test, the ground truth is established by laboratory assay results against a pyrogen limit specification.

8. The sample size for the training set

Not applicable. This is not an AI device that requires a training set. The device is a modification of an existing mechanical anchor.

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

Not applicable. As above, there is no AI training set.

Ask a specific question about this device

The Arthrex SwiveLock anchors 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 and Bunionectomy.Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, and Illiotibial Band Tenodesis. Secondary fixation for ACL/PCL reconstruction or repair (4.75 – 5.5 SwiveLock only).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: Capsular repair, acetabular labral repair.

The Arthrex SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.

The provided document is a 510(k) summary for the Arthrex SwiveLock Anchors, specifically an amendment to include a new indication for secondary fixation in ACL/PCL reconstruction or repair. This document does not describe a study involving an AI device or a comparative effectiveness study with human readers.

Instead, it focuses on demonstrating substantial equivalence of a medical device (surgical anchors) to previously cleared predicate devices through specific technical and biomechanical testing, rather than clinical performance based on diagnostic accuracy or AI-assisted interpretation.

Therefore, many of the requested fields related to AI performance, human reader studies, and ground truth establishment for a diagnostic algorithm cannot be answered from this document.

However, I can extract information related to the acceptance criteria and the study that demonstrates the device meets these criteria in the context of this 510(k) submission for the Arthrex SwiveLock Anchors.

Here's a breakdown of the information that can be extracted or inferred from the document:

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

The document states: "Biomechanical testing (ultimate load) was conducted to demonstrate that the use of the SwiveLock as a secondary fixation in ACL reconstruction is greater than a construct without it."

While specific numerical acceptance criteria (e.g., "ultimate load must be > X Newtons") are not explicitly stated as a table in this summary, the acceptance criterion is implicitly "greater than a construct without it". The reported performance is that the SwiveLock did meet this criterion.

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

• Sample Size: Not explicitly stated in this 510(k) summary. Biomechanical testing usually involves a defined number of samples, but the exact count is not provided.
• Data Provenance: The study is described as "biomechanical testing," implying laboratory-based testing rather than clinical data from a specific country. It's a study conducted specifically to support this regulatory submission, not a retrospective or prospective clinical data collection.

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 question is not applicable. For a biomechanical test of a surgical anchor, there isn't "ground truth" derived from expert consensus on diagnostic images. The "truth" is established by the physical testing methods themselves, performed according to established engineering and mechanical testing standards.

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

Not applicable, as this refers to adjudication of expert opinions for ground truth establishment in studies involving human interpretation or subjective assessment, which is not the case here.

5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable. This is not an AI device, and no MRMC study was conducted.

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

Not applicable. This is not an algorithm or AI device.

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

The "ground truth" for this type of device and study is the direct measurement of physical properties (ultimate load) under controlled laboratory conditions, following validated biomechanical testing protocols. It's not based on expert consensus, pathology, or outcomes data in the traditional medical sense, but rather on direct empirical evidence from engineering tests.

8. The sample size for the training set:

Not applicable. This is not an AI device requiring a training set.

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

Not applicable. This is not an AI device.

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The Arthrex SwiveLock Anchors 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 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.
Hip: Capsular Repair, acetabular labral repair

The SwiveLock Anchor is a two-component, knotless suture anchor comprised of an eyelet and a hollow anchor body. The SwiveLock Anchor is pre-mounted on a driver with the anchor body and eyelet physically separated on the driver shaft. FiberWire suture may also be provided with the device.

The provided 510(k) summary (K101823) describes the Arthrex SwiveLock Anchors, a medical device intended for fixing suture (soft tissue) to bone in various anatomical regions. The device is seeking substantial equivalence to previously marketed predicate devices.

1. Acceptance Criteria and Reported Device Performance:

The primary acceptance criteria for the Arthrex SwiveLock Anchors are based on demonstrating substantial equivalence to existing predicate devices. Since this is an equivalence submission, specific quantitative acceptance criteria for absolute performance metrics are not explicitly stated in the summary. Instead, the performance is compared against the known performance of the predicate devices.

The study aimed to demonstrate that the SwiveLock Anchors perform comparably to the predicate devices in terms of:

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

The document does not explicitly state the specific sample sizes for each test mentioned (degradation, mechanical pull-out, insertion, animal testing). It only refers to "data" for each category.

The data provenance is not specified. It is an industry standard to conduct these tests in a controlled laboratory environment or animal models. Neither the country of origin nor whether the data is retrospective or prospective is mentioned.

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

This information is not applicable to this type of 510(k) submission. Establishing "ground truth" by experts is typically relevant for diagnostic or AI-driven devices where human interpretation is involved. For a mechanical device like a suture anchor, the "truth" is established through physical and biological testing against established standards or predicate device performance.

4. Adjudication Method:

This information is not applicable. Adjudication methods (like 2+1, 3+1) are used to resolve disagreements among human readers/experts in diagnostic studies, which is not relevant for the mechanical and biological testing of a suture anchor.

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

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices where human readers interpret medical images or data, and the effect of AI assistance on their performance is evaluated.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not done. This device is a physical medical implant, not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. Type of Ground Truth Used:

The "ground truth" in this context is established through physical and biological testing methodologies. This includes:

• Degradation data: Measuring the breakdown of biomaterials over time.
• Mechanical pull-out (tensile) testing data: Quantifying the force required to pull the anchor out of bone, adhering to engineering standards.
• Insertion testing data: Assessing the ease and characteristics of device insertion.
• Animal testing data: Observing the biological response (histology), in-vivo pull-out strength, and imaging of the device in a living system.

The "truth" is rooted in the physical and biological properties and performance of the device as measured by these tests, compared against the known performance of predicate devices.

8. Sample Size for the Training Set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. The Arthrex SwiveLock Anchor is a mechanical device, not an AI or algorithm-driven system.

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

This information is not applicable for the reasons stated above.

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