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The non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The device may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor systems thereby stabilize the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The CONMED Paradigm™ All-Suture Anchor manufactured from High Strength Flat Braided Suture, co-braided with a nylon monofilament, and threaded with one #2 (5 metric) Hi-Fi® suture strand. The ParadigmTM All-Suture Anchor is provided single-use, sterile, and preloaded on disposable driver. The anchor, suture, and disposable driver are EO Sterilized.

The provided text is a 510(k) summary for the CONMED Paradigm™ All-Suture Anchor. This document is a premarket notification to the FDA to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.

It does not contain information related to an AI/ML-based medical device or a study proving its performance against specific acceptance criteria for diagnostic/prognostic tasks. Instead, it describes a medical device (a surgical anchor) and its equivalence to existing predicate devices based on material, design, intended use, and performance data relevant to its mechanical and biological properties.

Therefore, I cannot extract the information required to answer your prompt, such as:

• Acceptance Criteria Table and Reported Performance: The document lists "Verification Testing" and "Validation Testing" categories for the physical device, such as Reliability, Ultimate Fixation Strength, Biocompatibility, and Shelf-life. It states "Testing has been completed to demonstrate that the Paradigm™ All-Suture Anchor performs as intended and is substantially equivalent to the predicate device" and that "Bacterial endotoxin testing was conducted and met the endotoxin limits." However, it does not provide specific numerical acceptance criteria or performance numbers (e.g., a required tensile strength in N and the achieved tensile strength for the device).
• Sample size for test set and data provenance: Not applicable to this type of device.
• Number of experts and qualifications for ground truth: Not applicable.
• Adjudication method for test set: Not applicable.
• Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used: Not applicable in the context of diagnostic performance. The "ground truth" for this device would relate to its structural integrity, biocompatibility, and similar physical/chemical properties, which are confirmed through engineering and biological testing.
• Sample size for training set: Not applicable.
• How ground truth for training set was established: Not applicable.

In summary, the document describes the substantial equivalence of a physical medical device (a surgical suture anchor) to a predicate device, focusing on material, mechanical, and biological properties, not on an AI/ML algorithm's diagnostic performance. Therefore, the requested information elements related to AI/ML study design are not present in this text.

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