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510(k) Data Aggregation
(22 days)
The Arthrex FiberTak Suture Anchor is intended for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip in the following procedures:
· Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction
· Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
• Hand/Wrist: Scapholunate Ligament Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers, Carpal Ligament Reconstruction and Carpometacarpal joint arthroplasty (basal thumb joint arthroplasty)
• Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus reconstruction, digital tendon transfers, Mid-foot reconstruction
• Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior
Oblique Ligament Repair, Iliotibial Band Tenodesis, Joint Capsule Closure · Hip: Capsular repair, Acetabular labral repair, Gluteal Tendon Repair.
The Arthrex FiberTak suture anchor is an 'all-suture' soft-tissue device intended to be used for fixation of suture (soft tissue) to bone in the shoulder, foot/ankle, knee, hand/wrist, elbow, and hip.
The anchor is constructed from a hollow braid of polyester with a single loaded suture component composed of UHWMPE or a polyblend of UHMWPE and polyester.
The anchor is preloaded on a disposable inserter and will be sold sterile for single use.
This document is a 510(k) premarket notification for the Arthrex FiberTak Suture Anchor. It details the device's indications for use, its comparison to predicate devices, and the performance testing conducted to demonstrate substantial equivalence.
Here's an analysis based on your request:
No AI/ML device is described in this document. This 510(k) submission is for a physical medical device: a suture anchor. Therefore, the questions related to AI/ML device acceptance criteria, study design, ground truth, and reader studies are not applicable.
The document primarily focuses on demonstrating that the Arthrex FiberTak Suture Anchor is substantially equivalent to existing predicate devices (K200341: Arthrex Self-punching FiberTak Suture Anchor and K171020: Arthrex SutureTak Suture Anchor), and that new indications (Gluteal Tendon Repair, Capsular Repair (Hip), and Joint Capsule Closure (Knee)) are supported by performance data and similarity to reference devices.
However, I can extract information relevant to performance acceptance criteria and the study that proves the device meets them for this physical medical device, framed within what's typically expected for a 510(k) for a non-AI/ML device.
Acceptance Criteria and Device Performance (for a physical medical device)
For a physical medical device like the Arthrex FiberTak Suture Anchor, acceptance criteria are typically related to mechanical performance, biocompatibility, and sterility, often demonstrating equivalence or non-inferiority to predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Inferred from text) | Reported Device Performance and Study Findings |
|---|---|---|
| Mechanical Performance | Cyclic pull-out strength/durability: Demonstrates mechanical stability and strength for intended surgical applications. (Implicit: must be equivalent or superior to predicate devices). | "Cyclic pull-out testing was performed on the subject device and compared to the Arthrex FiberTak predicate device. Results demonstrate that the Arthrex FiberTak Anchor performs statistically equivalent to the predicate device. Results were compared to K133671: Stryker Iconix All Suture Anchor System and K171020: Arthrex SutureTak Suture Anchor to show suitability for the gluteal tendon repair and joint capsule closure (knee) indications, respectively." |
| Biocompatibility | Pyrogenicity: Device must meet pyrogen limit specifications to ensure patient safety. | "Bacterial endotoxin per EP 2.6.14/USP was conducted on a representative device to demonstrate that the device meets pyrogen limit specifications." |
| Sterility | Device must be sterile for single use. | "The anchor... will be sold sterile for single use." (Implicit: sterility validation would have been performed and is a general control for medical devices). |
| Functional Equivalence | Basic design, intended use, packaging, and shelf life must be substantially equivalent to predicate. | "The proposed and predicate device (K200341) have the same basic design, intended use, packaging, shelf life, biocompatibility profile and sterilization method." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify the exact sample sizes (e.g., number of anchors tested, number of cycles) for the cyclic pull-out testing or bacterial endotoxin testing. This level of detail is typically found in the full test reports referenced in the 510(k), but not always explicitly stated in the summary.
- Data Provenance: Not specified, but generally, such testing for FDA submissions would be conducted in controlled laboratory environments, likely in the US or by labs with recognized accreditations. The data is prospective, generated specifically for this submission.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This is not applicable as the document describes a physical medical device, not an AI/ML diagnostic or prognostic tool. Ground truth in this context is established through quantitative mechanical testing and laboratory assays (e.g., bacterial endotoxin test), rather than expert interpretation of images or patient outcomes for diagnostic purposes.
4. Adjudication Method for the Test Set
- Not applicable for this type of device. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in human-AI interaction or diagnostic image interpretation studies, not for physical device performance testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size
- Not applicable. MRMC studies are specific to evaluating diagnostic performance, often comparing human readers with and without AI assistance for tasks like image interpretation. This document is about a mechanical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is not an AI/ML algorithm.
7. The Type of Ground Truth Used
- For the mechanical performance (cyclic pull-out): The "ground truth" is defined by the quantitative mechanical properties measured (e.g., force, displacement, cycles to failure) as per established test standards and protocols. The "truth" is that the device performs equivalently to previously cleared products based on these objective measurements.
- For biocompatibility: The "ground truth" is adherence to pre-defined pyrogen limits as per recognized standards (EP 2.6.14/USP ).
8. The Sample Size for the Training Set
- Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
- Not applicable.
Summary for this specific device:
The Arthrex FiberTak Suture Anchor is a physical medical device. Its acceptance criteria are based on demonstrating substantial equivalence to already marketed predicate devices, primarily through:
- Mechanical performance: Cyclic pull-out testing showing statistical equivalence to the predicate device and suitability for new indications compared to reference devices.
- Biocompatibility: Bacterial endotoxin testing confirming it meets pyrogen specifications.
- Design and manufacturing equivalence: Showing similar basic design, intended use, materials, manufacturing processes, and sterilization to predicate devices.
The "study" in this context refers to the engineering and laboratory testing (cyclic pull-out tests, bacterial endotoxin tests) rather than clinical trials or AI performance evaluations. The goal is to prove that the device is as safe and effective as its predicates.
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(56 days)
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Testing: Pull-out (tensile) strength of the proposed Arthrex SwiveLock Anchor for MPFL repair/reconstruction should meet criteria established by published literature. | Met the criteria established by published literature for MPFL repair/reconstruction. |
| Bacterial Endotoxin Testing: Device must meet pyrogen limit specifications as per USP , USP , FDA Guidance for Industry Pyrogen & Endotoxin Testing, and EP 2.6.14. | Met pyrogen limit specifications. |
| Substantial Equivalence: The device should have the same technological characteristics (device design, sterilization, biocompatibility) and substantially equivalent intended uses as the predicate device (K192532). Differences should be minor and not raise questions concerning safety or effectiveness. (This is a regulatory rather than a performance criterion, but it's central to the submission.) | The proposed and predicate devices have the same technological characteristics. Differences are minor and do not raise questions concerning safety or effectiveness. |
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.
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