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The AlphaVent Suture Anchors are 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, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot and Ankle: Lateral Stabilization, Achilles Tendon Repair, Hallux Valgus Reconstruction, Midfoot Reconstruction, Metatarsal Ligament Repair and Bunionectomy

Knee: Anterior Cruciate Ligament Repair, Medial Collateral Ligament Repair, Lateral Cigament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Quadriceps Tendon Repair, Secondary or adjunct fixation for ACL/PCL Reconstruction or Repair

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

Elbow: Biceps Tendon Reattachment Ulnar or Radial Collateral Reconstruction, Lateral Epicondylitis Repair

Hip: Capsular Repair, Acetabular Labral Repair, Gluteal Tendon Repair, Proximal Hamstring Repair

The AlphaVent Suture Anchors are bone anchors with a screw-in design. Each anchor is vented and cannulated and is provided pre-loaded with one or more working sutures with or without needles. The working sutures run through the cannulated anchor body and are attached to the distal end of the anchor by an integrated suture loop, referred to as a "soft eyelet." The anchor with working sutures is provided pre-assembled on an inserter, which enables insertion of the anchor into bone after creation of a pilot hole. The devices are provided sterile and are packaged in sterile barrier systems (SBS) that include one anchor pre-loaded with suture on an inserter.

This document describes the 510(k) premarket notification for Stryker's AlphaVent Suture Anchors, focusing on the substantial equivalence to predicate devices rather than the performance of an AI application or the direct demonstration of meeting specific performance acceptance criteria through a clinical validation study with defined endpoints.

Therefore, the requested information regarding acceptance criteria, study design for device performance (especially for AI), sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment cannot be provided from the given text. The document describes a traditional 510(k) submission based on modifications to an existing device and equivalence to predicates, not the de novo clearance of a novel device or AI/ML product where such detailed performance studies with acceptance criteria are typically required and reported.

The document primarily focuses on:

• Device Description: AlphaVent Suture Anchors, screw-in design, vented, cannulated, pre-loaded with sutures.
• Modifications: Introduction of absorbable "AlphaVent Biocomposite Suture Anchors" and expanded indications for use to include skeletally mature pediatric patients and additional surgical procedures (gluteal tendon repair, proximal hamstring repair).
• Comparison to Predicates: Demonstrated substantial equivalence to AlphaVent PEEK Suture Anchors (K211502) and Arthrex SwiveLock Anchors (K203495) based on intended use, operational principle, design, materials, sterilization, packaging, and performance attributes.
• Performance Data (Non-Clinical): Benchtop testing for Ultimate Tensile Strength (UTS) and insertion testing. For biocomposite anchors, UTS was also performed after in vitro degradation. Biocompatibility testing per ISO 10993-1:2018 and pyrogenicity/bacterial endotoxin testing were also conducted.

Based on the provided text, none of the requested information regarding acceptance criteria and the study proving the device meets those criteria (in the context of an AI/ML device) is available. The submission describes a traditional 510(k) for a modified mechanical device, not an AI/ML-driven diagnostic or therapeutic device.

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The Paratrooper™ Plantar Plate Repair System is intended for fixation of tissue to tissue to tissue. Specific indications:

Foot/ankle:

• · Lateral Stabilization
• · Medial Stabilization
• · Achilles Tendon Repair
• Metatarsal Ligament and Tendon Repair
• · Hallux Valgus Reconstruction
• · Digital Tendon Transfers
• · Mid-foot Reconstruction
• · Plantar Plate Repair

The Paratrooper™ Plantar Plate Repair System includes an all-suture soft tissue fixation device. The suture implant comes in one size and is provided attached to a needle or preloaded on an inserter.

The provided text describes a medical device, the Paratrooper™ Plantar Plate Repair System, and its FDA 510(k) clearance. However, it does not include information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML powered device. This document is a regulatory submission for a physical medical device, specifically a soft tissue fixation device, and not an AI or imaging diagnostic tool.

Therefore, the requested information elements related to AI/ML device testing (such as "type of ground truth used," "sample size for the training set," "number of experts used to establish the ground truth," "adjudication method," "multi-reader multi-case study," and "standalone performance") are not applicable and cannot be extracted from this document.

The document discusses the substantial equivalence of the Paratrooper™ Plantar Plate Repair System to a predicate device, based on:

1. Indications for Use: The modified device has the same intended use.
2. Technological Characteristics: Similar performance, basic design, material, sterilization, and sizes.
3. Performance Testing: Mechanical performance testing and usability testing were conducted, along with bacterial endotoxin testing.

There is no information in the provided text to populate the requested table or answer the specific questions related to AI/ML device acceptance criteria and study design.

If you are looking for information about an AI/ML medical device, please provide a different document.

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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

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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Stryker Suture Tape is intended to approximate and/or ligate soft tissues, including the use of allograft tissue for orthopaedic surgeries.

Stryker Suture Tape (herein referred to as the proposed device(s)) is a non-absorbable suture composed 100% of ultra high molecular weight polyethylene (UHMWPE). These devices are braided to be flat in shape and offered in white/blue coloration patterns. Stryker Suture Tape complies with USP standards for #2 suture with the exception of size classifications. Each Suture Tape variation will be cut to length and provided to the end user in a single-use sterile barrier system (SBS).

The provided document is a 510(k) Premarket Notification from the FDA regarding the Stryker Suture Tape. It does not contain information about acceptance criteria and studies demonstrating device performance in the context of an AI/algorithm-driven medical device, as the request implies. Instead, it describes a traditional medical device (surgical suture) and its substantial equivalence to predicate devices based on non-clinical benchtop testing.

Therefore, I cannot fulfill the request as it asks for information (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance of an algorithm, training set details) that is not relevant to this type of device submission.

The document explicitly states: "Non-clinical benchtop testing was performed to verify that Stryker Suture Tapes exceed the minimum requirements of USP standards for knot pull tensile strength of nonabsorbable surgical sutures. Clinical testing was not required to demonstrate substantial equivalence for this submission."

It is important to note that this device is a physical surgical suture, not a software or AI-based device, hence the absence of the requested AI-specific information.

If you would like me to summarize the performance data and equivalence claims made for the Stryker Suture Tape based on the provided document, I can do so.

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