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The REGENETEN™ Bioinductive* Implant is indicated for the management and protection of tendon or extra-articular ligament injuries in which there has been no substantial loss of tendon or ligament tissue. * Bioinductivity has been demonstrated for tendon only.

The REGENETEN Bioinductive Implant Delivery System is indicated for the arthroscopic delivery of the REGENETEN Bioinductive Implant.

The REGENETEN™ Bioinductive Implant is a bioabsorbable implant device that provides a layer of collagen over injured tendons or ligaments. The implant is designed to provide a layer of collagen between a tendon or ligament and the surrounding tissue. After hydration, the implant is an easy-tohandle, pliable, nonfriable, porous collagen sheet. The REGENETEN Bioinductive Implant is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, in a dual sterile seal.

The provided text is a 510(k) summary for the REGENETEN™ Bioinductive Implant, focusing on demonstrating substantial equivalence to a predicate device for an expanded indication for use (inclusion of extra-articular ligament injuries). It does not describe an AI/ML device or its performance against acceptance criteria in the manner requested (e.g., sensitivity, specificity, MRMC study, expert ground truth adjudication).

Therefore, it is not possible to extract the requested information regarding acceptance criteria, device performance metrics (like sensitivity, specificity), sample sizes for test/training sets, expert qualifications, or details of MRMC studies and ground truth establishment, as this documentation pertains to a medical device (bioinductive implant) rather than a software-as-a-medical-device (SaMD) or AI-powered diagnostic tool. The document details the device's physical characteristics, intended use, and the rationale for expanding its indications based on an animal study, not an AI model's performance.

To answer your request, I would need a 510(k) summary or similar regulatory document describing the validation of an AI/ML-powered medical device.

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Regeneten Bioinductive Implant is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Regeneten Bioinductive Implant is a resorbable type I bovine Achilles-derived collagen implant that provides a layer of collagen over injured tendons. The device is designed to provide a layer between the tendon and the surrounding tissue during healing. The device features a large porosity design with a low tensile modulus to allow for recipient tissue ingrowth into the implant at the repair site for natural remodeling and the passive formation of collagen over injured tendons. The physical structure and placement of Regeneten Bioinductive Implant provides and supports an environment for healing. When hydrated, Regeneten Bioinductive Implant is an easy-to-use, soft, pliable, nonfriable, porous implant. Regeneten Bioinductive Implant is provided as a sterile, single-use device in a variety of sizes. The arthroscopic configuration of the Bioinductive implant is preloaded in a cartridge and packaged in a sterile, dual seal tray-in-tray configuration.

The provided text does not describe a study involving an AI/ML powered medical device, an imaging device, or any study that would require acceptance criteria as typically understood for such devices (e.g., accuracy, sensitivity, specificity).

The document is an FDA 510(k) premarket notification for a medical device called the "Regeneten Bioinductive Implant," which is a surgical mesh for managing and protecting tendon injuries. The core of the submission argues for substantial equivalence to a predicate device (Rotation Medical Collagen Tendon Sheet-DDI).

Therefore, I cannot extract the requested information regarding acceptance criteria, study design, expert involvement, ground truth establishment, or sample sizes related to an AI/ML or imaging study from this document. The document explicitly states:

• "No clinical study was conducted for the predicate device and a clinical study was not required to substantiate new performance claims for the subject device."
• "Published clinical literature from investigator-initiated post-market clinical studies was reviewed in this submission in support of new performance claims for the subject device."
• "This submission does not include any performance or preclinical testing and therefore, is not claiming compliance to any new FDA recognized consensus standards."

The additional performance claims for the Regeneten Bioinductive Implant (bioinduction, formation of tendon-like tissue, and change the course of tear progression) are supported by:

• Review of an animal study (from section 19, not provided here).
• Review of published clinical literature from investigator-initiated post-market clinical studies (from section 20, not provided here).

Since the original request specifically asks for details related to acceptance criteria and a study proving a device meets these criteria in the context of AI/ML or imaging, and this document pertains to a resorbable collagen implant and lacks the mentioned study types, I must state that the information requested is not present in the provided text.

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