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The Arthrex SpeedFLEX™ Implant is intended for use in general surgical procedures for reinforcement of soft tissue where weakness exists. The Arthrex SpeedFLEX™ Implant is also intended for reinforcement of soft tissues that are repaired by suture or suture anchors, during tendon repair surgery including but not limited to reinforcement of rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. The Arthrex SpeedFLEX™ Implant is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, or quadriceps tendons. Sutures used to repair the tear, and sutures or bone anchors used to attach the tissue to bone, provide mechanical strength for the tendon repair.

The Arthrex SpeedFLEX™ Implant consists of a decellularized human allograft dermis that is pre-sutured with FiberWire® suture (passing suture) and TigerLink™ SutureTape (implanted). The allograft implant will be offered in four (4) sizes. The Arthrex SpeedFLEX™ Implant is sold sterile, single use.

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TYBR Collagen Gel is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue. The device may also be used in the management and protection of surrounding tissues such as skeletal muscle and ligament.

TYBR Collagen Gel is a naturally-derived collagenous semi-permeable barrier device that conforms to the application site and degrades within 30 days. The TYBR Collagen Gel includes a blue color additive to aid with visualization. The applicator provides controlled delivery of the collagen gel to support uniform coverage at the desired location.

I'm sorry, but the provided FDA 510(k) Clearance Letter for TYBR Collagen Gel does not contain the information required to answer your request regarding acceptance criteria and a study proving the device meets those criteria, particularly for an AI/software-based medical device.

The document describes a physical medical device (collagen gel) and its performance testing, which includes:

• Cadaveric simulated use testing: To assess biomechanical effects and risk of improper gel application (loading for tendon sliding and gliding).
• Animal performance studies (chicken flexor tendon repair model): To evaluate tendon rupture strength, histopathology, gross pathology (adhesion scoring), and range of motion compared to a predicate device.

This type of testing is relevant for a biomedical material, not for an AI device. The questions you've asked (about sample size for test/training sets, data provenance, expert ground truth, MRMC studies, standalone algorithm performance, etc.) are specific to the validation of AI/machine learning algorithms in medical imaging or diagnostics, which are not present in this document.

Therefore, I cannot extract the requested information from the provided text.

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Kerecis® Tendon Protect is indicated for the management and protection of tendon injuries in which there has been no substantial loss of tendon tissue.

Kerecis® Tendon Protect is a medical device made from solid fish skin (North Atlantic Cod) sheets of thickness no less than 0.4 mm. The product is intended to provide a covering around the newly repaired tendon for the management and protection of tendon injuries in which there has been no substantial loss of tissue. The device with natural structure and proteins from fish skin is applied around the newly repaired tendon. The structure of the fish skin provides a supportive environment for new host tissue deposition as part of wound healing while still providing an initial barrier facilitating the sliding of the repaired tendon within the surrounding tissue during tendon use. The biomechanical strength for the tendon itself is provided separately by sutures used to repair the tendon tear and/or by sutures or bone anchors used to attach the tendon tissue to the bone.

The fish skin is fully integrated into the surrounding tissue over time, with corresponding new host tissue deposition. The device is biocompatible, non-crosslinked, bioresorbable, strong, and pliable. Its tensile strength supports fixation by sutures customary for tendon protection surgical procedures. The device is intended for one-time use and supplied sterile in labelled Tyvek® pouch packaging.

The subject device is available in following sizes:

• 3x5 cm size
• 6x9 cm size

Kerecis® Tendon Protect is a standalone, single use medical device made from fish skin that is technologically similar to the predicate device Tendon Wrap Tendon Protector (K053655) (Substantial Equivalence) and identical to the Kerecis® Reconstruct™ (K202430).

The provided text is a 510(k) clearance letter and summary for a medical device called "Tendon Protect." It details the device's characteristics, indications for use, and a summary of the non-clinical performance testing conducted to demonstrate its safety and effectiveness and substantial equivalence to predicate devices. However, it does not contain the specific detailed information typically found in acceptance criteria tables or a comprehensive study report, particularly regarding a multi-reader multi-case (MRMC) study, standalone algorithm performance, or the detailed methodology for ground truth establishment that would be associated with AI/ML-based medical devices.

The document describes a physical medical device (surgical mesh made from fish skin) rather than an AI/ML-based diagnostic or assistive software. Therefore, many of the questions related to AI/ML specific criteria (such as sample size for training set, number of experts for ground truth, adjudication methods, MRMC studies, and standalone algorithm performance) are not applicable to this particular device submission.

Here's a breakdown of the applicable information found in the document:

1. A table of acceptance criteria and the reported device performance:

The document mentions that the device "met all the pre-defined acceptance criteria" for various tests, but it does not provide a table detailing the specific numerical or quantitative acceptance criteria and the corresponding reported performance values. It only states that the tests were "conducted and passed successfully according to the test specifications."

2. Sample sizes used for the test set and the data provenance:

• Test Set Sample Size: Not explicitly stated for most tests (e.g., biocompatibility bench tests). For the Tendon GLP Chicken Study, it is a chronic model evaluating early, mid-term, and late time points, comparing the subject device to a control and a negative control. The specific number of animals or tendons tested is not provided.
• Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be pre-clinical (bench and animal testing), not human clinical data, and are likely prospective given they are part of a regulatory submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the device is a physical surgical mesh, not a diagnostic or AI-based device requiring expert interpretation of images or signals for ground truth. Ground truth for the animal study would be based on objective scientific measurements and observations (e.g., histology, biomechanics).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This is not applicable for the reasons stated above.

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:

This is not applicable as the device is a physical surgical mesh, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable as the device is a physical surgical mesh, not an AI algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the animal study:

• Histopathology evaluation
• Macroscopic evaluations
• Tendon biomechanical function assessment
• Overall animal health

For bench testing, ground truth would be established by the physical and mechanical properties of the material itself, measured against predefined specifications.

8. The sample size for the training set:

This is not applicable as the device is a physical surgical mesh, not an AI/ML system requiring a training set.

9. How the ground truth for the training set was established:

This is not applicable for the reasons stated above.

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

The TAPESTRY® Biointegrative Implant is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. The implant is provided sterile for single use only. It is supplied as a standalone implant, in an insertion sleeve, or on an introducer assists in delivering the implant to the surgical site during arthroscopic procedures. The device is provided in a dual pouch configuration.

This document is an FDA 510(k) summary for the TAPESTRY® Biointegrative Implant. It outlines the device, its intended use, and compares it to a predicate device. However, it does not describe acceptance criteria, nor does it present a study that proves the device meets specific performance criteria related to AI/algorithm performance.

The performance data section explicitly states: "The testing in this submission was directly applicable to the new introducer and no additional performance testing was required for the implant based on the modification." This indicates that the reported performance data focuses on the mechanical aspects of the introducer instrument, rather than clinical efficacy or AI/algorithm performance.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance for an AI/algorithm, as the provided document does not contain such details. It pertains to a physical medical device (an implant and its introducer) and its regulatory clearance based on substantial equivalence to a predicate device.

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

The TAPESTRY® Biointegrative Implant (TAPESTRY) is composed of collagen and poly(D,Llactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY is designed for stand-alone use. At the discretion of the surgeon. TAPESTRY may be hydrated with sterile isotonic solution.

Preclinical studies of TAPESTRY showed dense collagenous fibrous connective tissue ingrowth into and around the scaffolding.

This document describes a 510(k) premarket notification for the Tapestry Biointegrative Implant. The notification, K212306, seeks to demonstrate substantial equivalence to its predicate device, Tapestry (K201572).

Crucially, the provided text states that the Tapestry Biointegrative Implant (the subject device) is "the same device as its TAPESTRY predicate" with "the same indications for use, design, materials, and technological characteristics." The primary change leading to this 510(k) submission is the addition of validation methods for establishing collagen stability throughout the device's shelf life, and the introduction of two new product sizes within the already cleared size range.

Given this context, the acceptance criteria and the study proving the device meets these criteria are not based on new clinical performance data for the device itself. Instead, the submission relies on the established performance of the predicate device and additional bench testing for the new shelf-life validation.

Therefore, many of the requested details regarding clinical studies (such as sample size for test sets, expert adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment for clinical data) are not applicable to this 510(k) submission for the Tapestry Biointegrative Implant, as no new clinical performance claims or studies are presented.

Here's a breakdown based on the provided text:

Acceptance Criteria and Device Performance for Tapestry Biointegrative Implant (K212306)

The acceptance criteria for this 510(k) submission are primarily focused on demonstrating that the subject device, despite minor changes (shelf-life validation and new sizes), maintains substantial equivalence to its predicate device. This means ensuring that the changes do not raise new questions of safety or effectiveness.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance:

• Sample Size: Not applicable for a clinical test set as no new clinical performance studies were conducted for this 510(k) submission.
• Data Provenance: The reliance is on existing data from the predicate device (K201572) and new bench test data for collagen stability. The document does not specify the country of origin for the predicate's data. The collagen stability testing would have been done in a laboratory, but specific details on its provenance (e.g., specific country, specific lab) are not provided. The study design is retrospective in the sense that it relies on performance data of the previously cleared predicate device, supplemented by prospective bench testing for the new shelf-life validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. There was no clinical test set requiring expert ground truth establishment for this 510(k). The evaluation of substantial equivalence is based on engineering, material, and bench test data, as well as the prior clearance of the predicate.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• Not applicable. No clinical test set requiring adjudication was used.

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:

• Not applicable. This device is a surgical implant, not an AI-assisted diagnostic or imaging device. Therefore, MRMC studies are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is not an algorithmic device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The "ground truth" for this 510(k) is the established safety and performance of the legally marketed predicate device (K201572) for its intended use, combined with analytical and material testing data (Hydroxyproline analysis, FTIR analysis) to confirm the new aspects (collagen stability) do not alter the inherent properties or introduce new risks. Preclinical animal studies of the predicate showed "dense collagenous fibrous connective tissue ingrowth into and around the scaffolding," which would likely have been part of the initial "ground truth" for the predicate's safety and effectiveness.

8. The sample size for the training set:

• Not applicable. No training set for an AI/algorithm was used. The device is a physical implant.

9. How the ground truth for the training set was established:

• Not applicable. No training set for an AI/algorithm was used.

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

The TAPESTRY® Biointegrative Implant device is composed of collagen and poly(D,L-lactide). It is designed to function as a non-constricting, protective layer between the tendon and surrounding tissues. TAPESTRY® is conformable and designed for easy placement between the tendon and surrounding tissue and may be secured in place using standard fixation techniques. TAPESTRY® is provided sterile, non-pyrogenic, for single-use only, in a variety of sizes, ranging from 20mm x 25mm to 70mm x 50mm. TAPESTRY® is available with or without a co-packaged polyethylene Insertion Sleeve, which is used to maintain the implant's orientation and to facilitate easy application onto the tendon. The Insertion Sleeve is discarded after use and not implanted. TAPESTRY® is designed for stand-alone use. At the discretion of the surgeon, TAPESTRY® may be hydrated with sterile isotonic solution.

The provided text describes a 510(k) premarket notification for the TAPESTRY® Biointegrative Implant, a Class II surgical mesh. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study for an AI-powered diagnostic device with specific acceptance criteria and performance metrics typically associated with AI.

Therefore, the document does not contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets these criteria for an AI/diagnostic device.

The text discusses:

• The device (TAPESTRY® Biointegrative Implant) and its intended use (management and protection of tendon injuries).
• Comparison of technological characteristics with a predicate device (Rotation Medical Inc. Collagen Tendon Sheet).
• Preclinical studies (in vivo animal study) to evaluate tissue response, systemic toxicity, and device resorption, not performance metrics of an AI diagnostic tool.
• Biocompatibility testing against ISO 10993-1 standards.

It is a submission for a surgical implant, not an AI-powered diagnostic tool. Hence, the concepts of "acceptance criteria" and "study proving the device meets the acceptance criteria" as they apply to diagnostic accuracy (e.g., sensitivity, specificity, AUC) for an AI model are not present in this document. There's no mention of:

• A table of acceptance criteria with reported device performance for an AI/diagnostic task.
• Sample sizes for test sets in an AI context.
• Number of experts or their qualifications for ground truth.
• Adjudication methods for test sets.
• MRMC studies or effect sizes for human reader improvement.
• Standalone AI performance.
• Type of ground truth (e.g., pathology, outcomes data in an AI context).
• Sample size for a training set or how its ground truth was established.

In summary, this document is entirely unrelated to the type of AI/diagnostic device evaluation you are asking about.

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The BioBridge™ Collagen Matrix is intended to reinforce soft tissue where weakness and deficiencies exist, specifically, for reinforcement of soft tissue repaired by suture anchors in tendon repair, including small tendons, ligaments, and general surgical procedures for tissue repair where weakness exists, including muscle flap reinforcement.

BioBridge is not intended to replace normal body structure or provide the full mechanical strength to support tendon repair.

BioBridge is a sterile implantable biocompatible and biodegradable surgical mesh ribbon comprised of highly purified porcine collagen that is designed to provide mechanical support for weaknesses and deficiencies in soft tissue. The collapsed ribbon structure contains multiple folds of a thin membrane with aligned collagen fibrils in the same lengthwise direction. This structure provides mechanical properties that contribute to strong tensile strength, that which provides support to weaknesses and deficiencies in soft tissue and aids in bridging a connection between two healthy soft tissues.

BioBridge is fabricated using a proprietary manufacturing process that produces a narrow and very thin ribbon-like membrane comprised of collagen fibrils, creating a multiluminal structure that provides mechanical properties for support of soft tissue repair. This approach presents the opportunity to enable the use of highly purified, pepsin treated collagen, in a defined structure that has mechanical properties similar to those of the predicates. The smaller ribbon-like form factor gives the surgeon greater flexibility to tailor their procedures compared to the predicates without changing the intended use. One or more BioBridge devices can be implanted depending on the surgeon's discretion, including arrangement of the individual devices in bundles or braided together by the physician, to better address a specific patient need. It is particularly well suited, for example, in supporting repair of small tendons and ligaments. Fibralign sources the highly purified porcine-derived Type I collagen from an FDA-registered and ISOqualified supplier. Fibralign employs a proprietary manufacturing process that takes highly purified porcine-derived Type I collagen and produces narrow, ribbon-like membranes comprised of highly aligned collagen fibrils that provides mechanical strength for use in supporting soft tissue. A chemical crosslinking agent is used during the manufacturing process to promote the crosslinking of the collagen but the crosslinker itself is not added to nor bound to the collagen matrix. The crosslinker residuals are water soluble and are removed by product rinsing at the end of the production process. The final product is packaged into individual storage containers and then sealed within an outer tray and terminally sterilized.

I am sorry, but I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria for the "BioBridge Collagen Matrix."

The provided text, which appears to be an FDA 510(k) summary, does not contain specific acceptance criteria, performance metrics with numerical values, or detailed study results in a format that would allow me to construct the requested table or answer the detailed questions about sample sizes, ground truth establishment, or expert qualifications.

While the document lists various nonclinical tests performed (e.g., Dry Tensile Pull Test, Wet Tensile Pull Test, Biocompatibility testing, in vivo studies), it does not provide the quantitative acceptance criteria for these tests nor the actual reported device performance values against those criteria. It also states that "This section is not applicable as the 510(k) clearance of this device was not supported by clinical testing," which means there would be no information on human reader studies (MRMC or standalone AI performance).

Therefore, with the information given, I cannot generate the specific details you've asked for.

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