Search Results

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.

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.

Ask a specific question about this device

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

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

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair, Flexor Hallucis Longus for Achilles Tendon reconstruction, tendon transfers in the foot and ankle

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

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

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

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

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

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

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

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

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

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

Ask a specific question about this device

SECULOK™ Suture Anchor is for fixation or reattachment of soft tissue including ligament and tendon to bone especially with below indications.

• Shoulder:
  Bankart repair, SLAP lesion repair, Acromio-Clavicular separation repair, Rotator Cuff repair, Capsular shift or Capsulolabral reconstruction, Biceps tenodesis, Deltoid repair.

• Foot/Ankle:
  Medial or lateral stabilization, Achilles tendon repair.

• Elbow/Wrist/Hand:
  Ulnar or Radial collateral ligament reconstruction, Lateral epicondylitis repair, Biceps tendon reattachment.

• Knee:
  Extra-capsular repairs: Medial/lateral ligament repair, posterior oblique ligament repair, Iliotibial band tenodesis Patellar realignment and tendon repairs : Vastus medialis obliquous advancement

The SECULOK™ Suture Anchor consists of two types, Suture Anchor and Knotless Anchor.

The Suture Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (ASTM F2026) and works with preloaded 1 ~ 3 USP#2 size sutures (Ultra High Molecular Weight Polyethylene(UHMWPE, ASTM F2848)). The Suture Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The Knotless Anchor is an implant used for fixation of sutures into bone. The implant is made of PEEK (implant body) and Titanium alloy (tip, ASTM F136) and fixate the USP #2 sutures without knotting. The Knotless Anchor is provided sterile as single package including the implant and inserter for users to use without additional process of sterilization in hospitals.

The SECULOK™ Suture Anchor comes preloaded on a disposable inserter made from surgical grade stainless steel and ABS plastic. The entire product is packaged in a box with a Tyvek® lid, and blister the finished product is sterilized by ethylene oxide. Both the implant, suture and inserter are designed for single use only and supplied non-pyrogenic.

Based on the provided text, the document describes a 510(k) premarket notification for the SECULOK™ Suture Anchor, demonstrating its substantial equivalence to predicate devices through performance testing.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document indicates that the acceptance criteria for performance testing were developed using data from the primary predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The reported device performance is that "The all tests met all acceptance criteria and that verifies performance of the SECULOK™ Suture Anchor is substantially equivalent to predicate devices."

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

The document refers to "non clinical setting (bench testing)" for performance testing. It does not explicitly state the sample size used for each specific test or the "test set" in terms of data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full test reports that support the 510(k) submission, but it's not present in this summary.

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

This section is not applicable to this type of submission. The performance testing described is bench testing of the physical device's mechanical properties, not a clinical study involving human or animal subjects where expert ground truth would be established for diagnoses or assessments. The "ground truth" for these tests is based on established engineering standards (ASTM, USP) and mechanical properties of predicate devices.

4. Adjudication Method for the Test Set:

This section is not applicable. Since the testing is bench testing of mechanical properties, no adjudication by human experts is involved. The results are quantitative measurements against defined criteria.

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 section is not applicable. The SECULOK™ Suture Anchor is a physical medical device (suture anchor), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to AI assistance for human readers would not be relevant.

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

This section is not applicable. As explained above, the SECULOK™ Suture Anchor is a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used:

For the performance testing, the "ground truth" is established by:

• Established engineering standards: ASTM F543-17 for torsional properties and driving torque, USP 29 for suture tensile strength.
• FDA guidance documents: Premarket Notification (510(k)) Submissions for Bone Anchors Draft Guidance (January 3, 2017) for axial pullout strength and fatigue tests.
• Mechanical performance data of legally marketed predicate devices: CrossFT BC Suture Anchor (K101100) and PushLock™ (K101679). The acceptance criteria were specifically "developed using the data of the primary predicate."

8. The Sample Size for the Training Set:

This section is not applicable. There is no "training set" in the context of this device and the described performance testing. Training sets are typically associated with machine learning or AI algorithm development, which is not relevant here.

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

This section is not applicable for the same reasons as point 8.

Ask a specific question about this device

The Knotless SutureTak Anchors are 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, Lateral Epicondylitis Repair Shoulder: Rotator Cuff Repairs, 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 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 Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure Hip: Capsular Repair, Acetabular Labral repair

The Knotless SutureTak Anchors are "tap-in" suture anchors with a ribbed profile and a proximally placed external suture eyelet. The anchors are preloaded with Arthrex Suture and are offered preassembled on a driver/inserter, for single use. The Knotless SutureTak Anchors are manufactured from either PEEK or bioabsorbable materials. The PEEK anchor was originally cleared under K120155 for indications in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. The indication for the PEEK anchor was expanded to include Joint Capsule Closure under K171020. The bioabsorbable version of the cleared Arthrex Knotless SutureTak Anchor is made of the same material as the Arthrex PushLock cleared under K101679.

This document is a 510(k) Pre-market Notification for a medical device, not a study report for an AI/ML device. Therefore, it does not contain the information required to answer your prompt. The questions you posed—regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device—are not applicable to this submission, which is for physical surgical anchors.

Specifically, the document pertains to:

• Device Name: Knotless SutureTak Anchors
• Device Type: Surgical anchors for suture or tissue fixation in orthopedic applications.
• Purpose of Submission: To obtain additional indications for use (Lateral Epicondylitis Repair) and introduce a bioabsorbable version of an already cleared device, demonstrating substantial equivalence to predicate devices.

There is no mention of any AI or machine learning component, diagnostic capabilities, or a study involving human readers or algorithm-only performance. The "Performance Data" section explicitly states that "Pull-out and degradation testing was conducted to demonstrate that the Knotless SutureTak Anchors perform statistically equivalent to the predicate device. Bacterial endotoxin per EP 2.6.14/USP was conducted to demonstrate that the device meets pyrogen limit specifications." This confirms that the performance evaluation was mechanical and material-based, not AI/ML model validation.

Therefore, I cannot provide the requested information about acceptance criteria for an AI/ML device, study design, sample sizes for AI/ML validation, expert adjudication, or MRMC studies based on the provided text.

Ask a specific question about this device

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

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

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

Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstructions, Repair/Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP, and MCP joints for all digits, Digital Tendon Transfers

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

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

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

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

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

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

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

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

Hip: Capsular Repair, Acetabular Labral repair

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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

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

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

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

4. Adjudication Method for the Test Set

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

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

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

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

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

7. The Type of Ground Truth Used

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

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

8. The Sample Size for the Training Set

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

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

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

Ask a specific question about this device