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ECHELON ENDOPATH™ Staple Line Reinforcement is indicated for use in surgical procedures in which soft tissue transection or resection with staple line reinforcement is needed. ECHELON ENDOPATH™ Staple Line Reinforcement can be used for reinforcement of staple lines during lung resection and bariatric surgical procedures. The device can also be used for reinforcement of staple lines during gastric, small bowel, and colorectal procedures.

Echelon Endopath™ Staple Line Reinforcement is a staple line reinforcement, also known as a buttress, for use in the surgical environment for the purpose of reinforcing a staple line.

This submission is to increase the maximum sterilization dose from 25-30 kGy to 25-40 kGy and device Shelf-Life from 2 years to 3 years. There are no changes to the device itself associated with this submission.

Echelon Endopath™ Staple Line Reinforcement is to be used with surgical stapling devices. Surgical stapling devices place staggered rows of staples with a reinforcement material and simultaneously divide the tissue and the reinforcement material between the stapled rows.

The Subject Device is an absorbable staple line reinforcement material which is secured to both the stapler anvil and reload with a synthetic attachment material. The product consists of an applicator which includes the implantable device, one for each of the upper and lower stapler jaws. The implantable material consists of 3 materials: the Vicryl material, the Polydioxanone film and the attachment adhesive material.

Echelon Endopath™ Staple Line Reinforcement is an implanted material which works as an adjunct to surgical staples after transection, to provide support to soft tissue during the healing process. There are no modifications to the design of the Predicate device; and the materials of the Subject Device and Predicate Device are the same. Each unit is packaged sterile in separate pouch.

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The FiberLocker® System is a single-use device intended to be used for reinforcement of the rotator cuff, following or during repair by suture or suture anchors, where weakness exists in the soft tissue.

The FiberLocker® System is not intended to replace normal body structures or provide the full mechanical strength to support the rotator cuff. Sutures, used to repair the tear, and sutures or bone anchors, used to attach the tissue to the bone, provide mechanical strength for the repair.

The FiberLocker System is comprised of two components: (1) the FiberLocker Implant (SpeedPatch PET) and (2) an instrument (FiberLocker Instrument) for fixation of said implant. The implant, a needled textile felt is made out of polyester staple fibers and is non-degradable. The FiberLocker Instrument, a surgical micro-stapling or felting device, is a sterile, single use device designed for the fixation of medical felt patches in soft tissue. The instrument can be powered by either the FiberLocker PowerUnit or the Powermax Elite Shaver.

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Parietene™ flat Sheet Mesh is intended for the reinforcement of abdominal wall soft tissue where a weakness exists, in procedures involving abdominal wall hernias repair.

Parietene™ Flat Sheet Mesh is a Monofilament polypropylene mesh.

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The BioBrace® Extra-Articular Ligament Augmentation Kit is intended to reattach soft tissue to bone and reinforce soft tissue where weakness exists in extra-articular knee ligament surgical procedures.

The Argo Knotless® GENESYS™ Anchor 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 system thereby stabilizes the damaged soft tissue, in conjunction with appropriate postoperative immobilization, throughout the healing period.

The BioBrace® Reinforced BioInductive Implant is intended for reinforcement of soft tissues that are repaired by suture or suture anchors during knee repair surgery including reinforcement of patellar ligament, medial collateral ligament, lateral collateral ligament or other knee extra-articular ligaments. It is not intended to replace normal body structures or provide the full mechanical strength to the repair. 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 BioBrace® Extra-Articular Ligament Augmentation Kit is a single-use augmentation procedure kit for use in general surgical procedures for BioBrace® Reinforced BioInductive Implant ("BioBrace® implant") reinforcement of soft tissue where weakness exists, specifically in the extra-articular knee ligaments.

The kit is comprised of bioabsorbable implants and instrumentation. The kit includes one (1) tapered BioBrace Implant 5x250mm, which is threaded through the anchor eyelet.

Kit components are assembled in a single PETG tray and retainer then sealed in a Tyvek pouch. The BioBrace® Extra-Articular Ligament Augmentation Kit is supplied sterile (ETO).

Identical to K240090
Argo Knotless® GENESYS™ Anchor: The Non-Self-Punching Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The anchor configuration requires a pre-prepared bone hole. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK material. Each size features a single use driver, a threaded anchor, a PEEK suture eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Identical to K244025
Argo Knotless® GENESYS™ Anchor: The Argo Knotless® GENESYS™ Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor is manufactured of bioabsorbable material, and the suture eyelet is manufactured of PEEK Optima material. The device features a single use driver, a threaded anchor, a PEEK-Optima eyelet, a #2 UHMWPE, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. The suture eyelet can hold up to six (6) sutures or one (1) bioresorbable reinforced implant. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Identical to K242187
BioBrace® is intended for use in surgical procedures for reinforcement of soft tissue where weakness exists.

BioBrace® is also intended for reinforcement of soft tissues that are repaired by suture or other fixation devices during tendon and ligament repair surgery including reinforcement of rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. BioBrace® is not intended to replace normal body structure or provide the full mechanical strength to support the rotator cuff, patellar, Achilles, biceps, quadriceps tendon, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other tendons or extra-articular ligaments. Sutures, used to repair the tear, and sutures or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the repair.

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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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The OnFlex™ Mesh is indicated for use in the reinforcement of soft tissue where weakness exists, such as in the repair of inguinal hernias.

The OnFlex™ Mesh is a self-expanding, non-absorbable, sterile device made from monofilament polypropylene mesh and has a lightweight large pore design. This construction allows a prompt fibroblastic response through the interstices of the mesh as observed in a preclinical model, which may not correlate to performance in humans. The OnFlex™ Mesh has an anatomical shape design to cover potential defect areas. The OnFlex™ Mesh also contains a pocket on the larger medial apex of the mesh to facilitate insertion and positioning of the device.

The OnFlex™ Mesh contains SorbaFlex™ Memory Technology comprised of an absorbable PDO monofilament which forms an interrupted ring. SorbaFlex™ Memory Technology provides memory and stability to the device, facilitating ease of initial insertion and proper placement of the device. The PDO monofilament is folded and welded onto itself at the ends. The PDO monofilament fully degrades by means of hydrolysis in vivo in 6 – 8 months. The PDO monofilament is dyed violet by adding D & C Violet No. 2. The interrupted ring is placed within a mesh tube constructed from a knitted polypropylene monofilament. The purpose of the mesh tube is to contain the interrupted recoil ring during the degradation process. The interrupted ring, contained in the mesh tube, is sewn between two layers of mesh with polytetrafluoroethylene (PTFE) monofilament.

The OnFlex™ Mesh has a blue limit line at the lateral portion of the mesh, composed of polypropylene monofilament dyed with Phthalocyaninato(2-) copper colorant, to provide visual feedback for where the device can be tailored. The OnFlex™ Mesh can be tailored at the opening of the interrupted ring or outside of the blue limit line.

The OnFlex™ Mesh is offered in two sizes: medium (0115410) and large (0115411). The OnFlex™ Mesh is considered a tissue contacting permanent implant.

The provided FDA 510(k) clearance letter for the OnFlex™ Mesh (K251955) indicates that this is a Special 510(k) submitted to notify the FDA of changes to the device labeling only. The device itself remains identical to its predicate, OnFlex™ Mesh (K142711), cleared in 2015.

Therefore, the submission explicitly states: "No non-clinical or clinical testing was provided in support of this Special 510(k)."

This means that the document does not contain any information regarding acceptance criteria or a study proving that the device meets those criteria, as no new testing was performed for this specific submission. The substantial equivalence is based on the device's identity to its predicate and the conclusion that the labeling changes do not affect safety or effectiveness.

Because no new studies were conducted or presented in this document for the K251955 submission, I cannot provide the requested information. The document focuses solely on demonstrating that the labeling updates do not alter the substantial equivalence to the original predicate device (K142711).

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VersaCoat Tendon Protector 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 to manage and protect surrounding tissues such as ligament and skeletal muscle. In these procedures, the device may encounter implanted structures such as anchors, grafts, staples, or sutures.

VersaCoat Tendon Protector is an absorbable implant (device) designed to function as a gelatinous interface between an injured tendon and surrounding tissues, providing a non-constricting, protective encasement for injured tendons. VersaCoat Tendon Protector consists of a Hydrogel Pellet and Wetting Solution. The Pellet is a hollow, cylindrical hydrogel of alginate and hyaluronic acid. The Pellet is easy to handle and is designed for quick hydration with the Wetting Solution. The Pellet is supplied sterile, non-pyrogenic, for single use, in double peel pouches. The Wetting Solution hydrates the Pellet, rendering a viscous, flowable, tissue-adherent gel. The Wetting Solution is aqueous citrate and is provided in a dropper packaged in a double peel pouch. The Wetting Solution is sterile, non-pyrogenic, and is intended for single use only. A sterile container (dual syringe system) is offered and may be used to facilitate hydration of the Pellet with Wetting Solution.

The provided FDA 510(k) Clearance Letter for the VersaCoat Tendon Protector (K251655) does not describe a study involving an AI/Machine Learning device. Instead, it concerns a physical medical device (surgical mesh) and its performance, safety, and equivalence to a predicate device.

Therefore, I cannot provide information on acceptance criteria and study details related to an AI/Machine Learning device based on this document. The document details non-clinical laboratory tests for the physical properties and biocompatibility of the surgical mesh.

Specifically, the document implies that "studies" refer to bench testing and biocompatibility assessments of the physical device, not an AI model.

Summary of Information that CANNOT be Extracted for an AI/ML Device:

• A table of acceptance criteria and the reported device performance for an AI/ML model: The document outlines functional and safety testing for a surgical mesh, including visual inspection, dimensional/weight measurements, gel integrity, handling, tissue adherence, conformance, and biocompatibility. These are not performance metrics for an AI/ML algorithm.
• Sample sizes used for the test set and data provenance: Not applicable to a physical device.
• Number of experts used to establish ground truth & qualifications: Not applicable to a physical device.
• Adjudication method: Not applicable to a physical device.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not applicable. The device is a surgical mesh, not an AI tool assisting human readers.
• Standalone (algorithm only) performance: Not applicable.
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth, in the context of an AI model, refers to the definitive correct answer against which the AI's predictions are compared. For a physical device like surgical mesh, "ground truth" relates to measurable physical and biological properties.
• Sample size for the training set: Not applicable to a physical device.
• How ground truth for the training set was established: Not applicable to a physical device.

The document focuses on demonstrating substantial equivalence based on:

• Intended Use/Indications for Use: Managing and protecting tendon injuries.
• Materials of Construction: Alginate and hyaluronic acid hydrogel.
• Operating Principle: Providing a gliding surface and physical separation of damaged tissues.
• Fundamental Scientific Technology: Bioabsorbable hydrogel.
• Performance: Assessed through bench testing (visual inspection, dimensions, gel integrity, handling, tissue adherence/conformance) and biocompatibility testing (cytotoxicity, sensitization, irritation, systemic toxicity, pyrogenicity, genotoxicity, subchronic toxicity, muscle implantation toxicity).

In conclusion, this FDA clearance letter is for a physical medical device (surgical mesh) and does not contain the information requested about an AI/Machine Learning device's acceptance criteria or study methodologies.

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The Jewel Soft Tissue Reinforcement Device is a single-use device intended for reinforcement of soft tissues that are undergoing reconstruction surgery, utilizing autograft or allograft soft tissue grafts, or are to be repaired by suture or other fixation devices during ligament repair surgery. This includes reinforcement of extra-articular ligaments such as, but not limited to, medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, and ulnar collateral ligament.

The Jewel Soft Tissue Reinforcement Device is not intended to replace normal body structure or provide the full mechanical strength to support the medial collateral ligament, lateral collateral ligament, spring ligament, deltoid ligament, ulnar collateral ligament or other extra-articular ligaments. Sutures, or other fixation devices, used to attach the tissue to the bone, provide mechanical strength for the reconstruction or repair.

The Jewel Soft Tissue Reinforcement Device is a woven tubular implantable device intended to provide support for soft tissues where weakness exists including soft tissues that have been repaired using suture or other fixation devices during ligament repair surgery. The tubular structure of the implant is designed to allow insertion of an allograft or autograft inside the mesh structure; or alternately for reinforcement of the native tissue. The Jewel Soft Tissue Reinforcement Device is a gamma sterilized, single use, permanent implant manufactured from Polyester (Polyethylene Terephthalate; PET) a nonabsorbable material that has a long history of use in the orthopedic market. The Jewel Soft Tissue Reinforcement Device is treated with an atmospheric gas plasma process to improve surface wettability of the mesh structure. The Jewel Soft Tissue Reinforcement Device is MRI safe.

This document is a 510(k) clearance letter for a medical device called the "Jewel Soft Tissue Reinforcement Device" (K242237). It is not a study proving the device meets acceptance criteria related to an AI algorithm. Instead, it describes a medical device for use in surgery and provides information about its mechanical and biocompatibility testing to demonstrate substantial equivalence to a predicate device.

Therefore, many of the requested elements for describing an AI study's acceptance criteria and performance (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to this document. This document pertains to a physical surgical mesh device, not an AI software device.

However, I can extract the information that is present about the device's performance testing and acceptance criteria as described in the provided text.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that the series of tests were "successfully completed" and "The results demonstrate that the Jewel Soft Tissue Reinforcement Device... provides adequate mechanical properties for its intended use." The specific numerical acceptance criteria (e.g., minimum tensile strength in Newtons) are not provided in this summary, nor are the specific numerical results. The fundamental acceptance criterion for 510(k) clearance is "substantial equivalence" to a legally marketed predicate device, implying that the performance must be no worse than the predicate device for safety and effectiveness.

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

• Sample Size: Not specified in the provided text.
• Data Provenance: Not specified in the provided text. The testing was conducted by the manufacturer, Xiros Limited.

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

• Not Applicable. This is not an AI device clearance based on clinical image interpretation or diagnosis. The "ground truth" here refers to the physical properties of the device measured in performance tests rather than expert interpretation of data.

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

• Not Applicable. See point 3.

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

• No, Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• The "ground truth" for this device's evaluation is based on engineering and material science measurement standards and biocompatibility standards. For example, "Ultimate Tensile Strength" would be measured according to an established test method (e.g., ASTM standards) to determine its actual value, which is then compared to an acceptable range or the predicate device's performance.

8. The sample size for the training set

• Not Applicable. This is not an AI device with a training set.

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

• Not Applicable. This is not an AI device with a training set.

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For implantation to reinforce soft tissue where weakness exists in patients requiring soft tissue repair, or reinforcement in plastic or reconstructive surgery.

Kerecis SurgiBind (50241) is a part of a family of devices manufactured by Kerecis® Limited. The device is lyophilized, terminally sterilized, fish skin medical device comprised of biocompatible, resorbable fish skin (Wild North Atlantic Cod). The device is intended for single use only.

Analysis of Kerecis SurgiBind (K251844) Acceptance Criteria and Study

This FDA 510(k) clearance letter details the Kerecis SurgiBind device, which is essentially a re-submission of the Kerecis Reconstruct (K202430) with an updated label to include additional rehydration fluid options. Due to this, the performance testing for this submission primarily focuses on demonstrating that the change (new rehydration fluids) does not negatively impact the device's performance.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state formal "acceptance criteria" in a quantitative sense for this 510(k) submission, as it largely leverages prior testing of the predicate device. Instead, the focus is on demonstrating that the new rehydration fluids do not compromise the device's existing performance characteristics. The implicit acceptance criterion is that performance using the expanded rehydration fluids (including autologous body fluids) is comparable to performance using the previously cleared rehydration fluids (saline and Ringer's solution).

2. Sample Size Used for the Test Set and Data Provenance

The document states: "Performance testing... was largely leveraged from the Kerecis predicate device... As a result, performance testing is not required, except for rehydration and suture retention tests using autologous body fluid."

• Sample Size for this submission's additional tests: Not explicitly stated. The nature of these tests (bench testing) suggests a relatively small, controlled sample size, but the exact number is not provided.
• Data Provenance: The new tests (rehydration and suture retention with autologous body fluids) are presumed to be prospective bench testing conducted specifically for this submission. The origin of the "autologous body fluids (such as blood)" used for testing is not detailed (e.g., human, animal, synthetic proxy).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Experts: Not applicable for this type of bench testing. The "ground truth" for these tests would be the established scientific and engineering principles for material properties and device function.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable. Performance testing for this submission involves objective physical measurements (e.g., rehydration rate, suture pull-out force) rather than subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

• MRMC Study: No. This device is a biological surgical mesh (fish skin), not an AI/software device. Therefore, MRMC studies are not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Standalone Performance: Not applicable. This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Type of Ground Truth: For the specific tests conducted for this submission (rehydration and suture retention with autologous body fluids), the ground truth is based on bench testing measurements against established parameters or comparison to the predicate device's performance. For the broader substantial equivalence claim, the ground truth is the performance and safety profile of the legally marketed predicate device (K202430).

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. This is a medical device, not an AI/machine learning model that requires a "training set." The manufacturing process for the fish skin material itself has an inherent "training" through its development and validation, but this is not typically referred to as a "training set" in this context.

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set: Not applicable. See point 8.

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