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The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

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

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

Foot/Ankle: Lateral Stabilization (Brostrom, Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

The Grappler Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.

This document is a 510(k) premarket notification for a medical device called the Grappler Suture Anchor R3FLEX IOL System. It is a submission to the FDA (Food and Drug Administration) for clearance to market the device. The document states that the device is substantially equivalent to previously cleared predicate devices.

Here's an analysis of the provided text in relation to your request about acceptance criteria and supporting studies:

This document does not contain the detailed information you are requesting about acceptance criteria and study particulars for an AI/software-based medical device. This submission is for a physical medical device (suture anchors) and not an AI or software product.

The relevant section in the document for performance testing is:

Performance Testing:

"Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Specifically, an analysis was presented for Suture Abrasion and Dynamic Axial Dissociation Testing. The results of this testing demonstrate the subject device is substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria of FDA recognized standards."

Given the nature of the device (suture anchors), the "acceptance criteria" and "study" mentioned refer to engineering and biocompatibility tests for the physical product, not clinical performance studies or AI algorithm validation studies.

Therefore, I cannot populate the table or answer most of your detailed questions regarding AI/software performance acceptance criteria and studies because this information is not present in the provided text, as it's not applicable to this type of device submission.

However, I can extract what is mentioned about the performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the other questions, the document does not provide the requested information because it pertains to a physical medical device, not an AI/software product.

Here's why the specific questions cannot be answered from the provided text:

• 2. Sample size used for the test set and data provenance: This is relevant for AI model testing with patient data. For a physical device, 'test set' usually refers to samples tested in an engineering lab. The document does not specify sample sizes for the Suture Abrasion, Dynamic Axial Dissociation, or Bacterial Endotoxin tests. Data provenance (country, retrospective/prospective) is not applicable or specified for these types of engineering tests.
• 3. Number of experts used to establish the ground truth... and qualifications: Not applicable. Ground truth for a physical device's mechanical or biocompatibility performance is established by engineering standards and laboratory measurements, not expert consensus on interpretations of data.
• 4. Adjudication method: Not applicable for engineering tests.
• 5. Multi-reader multi-case (MRMC) comparative effectiveness study... human readers improve with AI vs without AI assistance: Not applicable. This is for AI-assisted diagnostic or interpretive devices.
• 6. Standalone (algorithm only without human-in-the-loop performance): Not applicable, as there is no algorithm, only a physical device.
• 7. Type of ground truth used (expert consensus, pathology, outcomes data, etc.): For this physical device, the "ground truth" would be the established engineering specifications and biological safety standards that the device must meet, verified through laboratory testing.
• 8. Sample size for the training set: Not applicable, as there is no AI model or training set.
• 9. How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

In summary, the provided FDA 510(k) clearance letter and summary are for a physical medical device (suture anchors) and thus the content focuses on manufacturing, materials, and mechanical performance testing to demonstrate substantial equivalence, not on AI/software performance criteria or studies.

Ask a specific question about this device

The Grappler Suture Anchor R3FLEX IOL System is intended for the fixation of soft tissue to bone including:

Elbow: Biceps Tendon Reattachment, Lateral Epicondylitis Repair, Tennis Elbow Repair

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

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

Foot/Ankle: Lateral Stabilization (Brostrom-Gould, Christman-Snook Repair), Ankle Ligament Repair, Medial Stabilization (Deltoid, Spring Ligament Repair), Achilles Tendon Repair, Metatarsal Ligament Repair, Syndesmosis Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, LisFranc Repair

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis, Extra Capsular Reconstruction, Patellar Ligament and Tendon Avulsion Repair

Hip: Capsular Repair, Acetabular Labral Repair

The plate interacting anchors are only indicated for the above Hand/Wrist and Foot/Ankle indications.

The Grappler Suture Anchor R3FLEX IOL System consists of suture anchors, suture, and the accompanying instrumentation for the intended use of soft tissue damage repair. The anchors are provided in titanium and all-suture and are connected by suture composed of UHMWPE.

This document is an FDA 510(k) clearance letter and summary for a medical device, the Grappler Suture Anchor R3FLEX IOL System. It does not describe an AI/ML powered device, nor does it detail a clinical study with human readers or AI algorithms. The information requested in the prompt (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, training set details) is typically found in documentation for AI/ML devices or clinical trials, not in a 510(k) summary for a mechanical medical device like a suture anchor system.

Therefore, I cannot provide the requested information from the provided text. The document focuses on demonstrating substantial equivalence to a predicate device through engineering analysis and performance testing of the physical device components, rather than clinical efficacy or diagnostic accuracy assessments using AI.

Specifically, the "Performance Testing" section states:

"Engineering analysis is presented to provide evidence that the original testing and subsequent performance is not adversely affected by the modifications to the subject devices. Specifically, an analysis was presented for Suture Abrasion, Dynamic Axial Dissociation Testing and a USP Monograph. The results of this testing demonstrate the subject device is substantially equivalent to the predicate devices. Bacterial endotoxin testing was conducted and the test results meet acceptance criteria of FDA recognized standards."

This indicates physical and material property testing, not a study evaluating human or AI performance.

Ask a specific question about this device