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The Dunamis Screws are intended to be used as stand-alone bone screws indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bone appropriate for the size of the device.

When used in conjunction with Dunamis Force DFX Suture or Suture Tape, the Dunamis Screw and Suture Locking System is intended to be used for fixation of bone-to-bone or soft tissue-to-bone. The components are intended to serve as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair.

Specifically, Dunamis will be offering these devices for use in orthopedic procedures, such as ACL/PCL repair and reconstruction for the adult and pediatric patient population when the device does not bridge, disrupt, or interfere with the growth plate; MCL, POL, LCL repair and reconstruction; IBT and PRT repair; and MPFL, ALL, Quadriceps Tendon, PLC repair and reconstruction. When used in conjunction with the Dunamis Screws, the Suture Locking System can be used as a cerclage to treat bone fractures, such as patella, greater tuberosity, or olecranon fractures.

The Dunamis Screw and Suture Locking System is to be used for fixation of bone-to-bone or soft tissue-to-bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. The devices are intended to be used in the adult or pediatric patient population, when the device does not bridge, disrupt, or interfere with the growth plate.

The Dunamis Screw and Suture Locking System consists of standalone bone screws, and various components which are compatible with previously cleared Dunamis Fixation Button System, Force DFX sutures and suture tapes, including: screws with suture locking features and suture wheel with various adapter options. The standalone screws are provided in various diameters, lengths, and configurations including headed and headless styles with various overall and threaded lengths. Screws with suture locking features are available in various diameters, lengths, and configurations. The suture wheel is available for standalone use with sutures or for use with compatible orthopedic plates with two adapter options (threaded or non-threaded post). The new components are manufactured from stainless steel and titanium alloy.

This document is an FDA 510(k) clearance letter for a medical device called the "Dunamis Screw and Suture Locking System." It focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving a specific novel clinical performance or effectiveness through a clinical trial with acceptance criteria for an AI or software-based medical device.

Therefore, the requested information about acceptance criteria, AI performance metrics, sample sizes for test/training sets, expert adjudication, MRMC studies, standalone performance, and ground truth establishment for AI/software would not be applicable to this type of traditional medical device clearance.

The clearance letter primarily discusses:

• Intended Use and Indications: For bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation.
• Device Description: Consists of standalone bone screws and components compatible with previously cleared Dunamis systems, manufactured from stainless steel and titanium alloy.
• Predicate Devices: Several predicate devices are listed, including screws and suture systems.
• Performance Testing Summary: "Non-clinical performance data included ASTM F543 screw testing, static and dynamic construct testing, and engineering worst-case rationales." This indicates bench testing to demonstrate mechanical performance comparable to the predicates.
• Substantial Equivalence Conclusion: The device has the same intended use, similar technological characteristics, and similar materials to the predicate devices. Mechanical testing demonstrated substantially equivalent performance.

In summary, this 510(k) clearance is for a physical orthopedic implant system, not a software or AI-based medical device. The "acceptance criteria" here are met through demonstrating mechanical properties and performance that are substantially equivalent to already cleared devices, primarily via non-clinical bench testing.

Thus, a table of acceptance criteria for AI performance, details on test/training sets, expert adjudication, MRMC studies, or specific AI ground truth establishment methods are not present and not relevant to this 510(k) submission as described.

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The Riverpoint Medical HS Fiber® sutures are indicated for injury and/or reconstruction of soft tissue, excluding the ones listed in contraindications, where soft tissue ligation or approximation is required. The Riverpoint Medical HS Fiber® sutures are also indicated for conditions where allograft tissues are required to be fixated, such as ACL tears.

The Riverpoint Medical HS Fiber® sutures are non-absorbable, sterile, surgical sutures composed of multiple single strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HS Fiber sutures are available in common sizes and lengths with or without pre-attached needles.

This FDA 510(k) clearance letter pertains to a surgical suture, the HS Fiber® Suture, and not an AI/ML powered device. Therefore, the request to describe acceptance criteria and a study proving device performance in the context of AI/ML (e.g., test set, ground truth, expert consensus, MRMC study, training set) cannot be fulfilled based on the provided document.

The document states: "The updates being proposed are limited to the labeling, no additional performance testing or biological evaluation was required." This indicates that no new performance studies (of any kind, let alone AI/ML specific ones) were conducted for this particular 510(k) submission (K252201). The device is deemed substantially equivalent to a previously cleared predicate device (K231163) based on the technological identity and minor labeling changes.

Therefore, I cannot provide the requested information for an AI/ML device from this document.

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HyperSuture™ White/Green Extension Line sutures are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and the use of allograft tissues for orthopedic procedures.

HyperSuture™ White/Green Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture™ White/Green Extension Line cables are available in USP #2-0. USP #2. and USP #5 and tapes are available in 0.8mm (USP 2-0 equivalent), 1.5mm (USP 2 equivalent) and 2.0mm (USP 5 equivalent). Both HyperSuture™ White/Green Extension Line cables and tapes are available in white/green, 36 inches or 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture™ White/Green Extension Line." This document is a clearance letter from the FDA, indicating that the device is substantially equivalent to a previously cleared predicate device.

The information given is typical for a 510(k) submission for a physical medical device (suture) and does not contain the details typically found in a study proving an AI/software as a medical device (SaMD) meets acceptance criteria. Therefore, I am unable to construct the requested table and provide information on many of the points (sample size, expert ground truth, MRMC study, etc.) because the provided document is not about an AI/SaMD.

This document focuses on the physical and material properties of the suture (e.g., tensile strength, diameter, needle attachment, material composition, biocompatibility) and its substantial equivalence to a predicate suture. It does not mention any AI or algorithm component.

Therefore, I cannot fulfill the request as it pertains to an AI/SaMD and the provided text describes a traditional medical device.

If you have a document describing the study and acceptance criteria for an AI/Software as a Medical Device (SaMD), please provide that text for analysis.

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Arthrex FiberTape and Tiger Tape Cerclage sutures and Arthrex Radiopaque FiberTape Cerclage sutures are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

When used as bone fixation cerclage the sutures are intended for:

• · Trochanteric reattachment after trochanteric osteotomy following total hip arthroplasty)
• · Sternotomy indications including the "rewiring" of osteomized sternums
• · Trauma surgery indications including olecranon, ankle, patella and some shoulder fracture rewiring
• · Treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft)
• · Repair of long bone fractures due to trauma or reconstruction
• · Provide fixation during the healing process following syndesmotic trauma. such as fixation of acromioclavicular separation due to coracoclavicular ligament
• · Spinal applications including sublaminar and intrafacet wiring of the spinal column

The Arthrex Radiopaque FiberTape Cerclage sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene (UHMWPE) which incorporates Bismuth Trioxide (Bi2O3), and Polyester yarns over a core of suture also made with Ultra High Molecular Weight Polyethylene (UHMWPE) with Bismuth Trioxide (Bi2O3), and Polyester. Dyes include D&C Blue No. 6. The UHMWPE is naturally yellow due to the addition of Bismuth Trioxide (Bi2O3). The sutures are assembled on an ABS loader. The sutures may also contain a FiberLink shuttling suture that is used for passing only.

The Arthrex FiberTape and TigerTape Cerclage Sutures are non-absorbable braided sutures composed of Ultra High Molecular Weight Polyethylene, polyester, and possibly nylon yarns over a core of FiberWire or TigerWire Suture (each made of UHMWPE and polyester). FiberTape differs from TigerTape in color and materials. FiberTape is blue/white suture consisting of UHMWPE and polyester. TigerTape suture is white/black consisting of UHMWPE, polyester, and nylon. Additional materials include cyanoacrylate at the suture ends which are cut off during the procedure. Dyes include D&C Blue No. 6 and Logwood Black. For the loop assembly the looped end of the suture is tied as a hitch over a sheath that secures a double loop or tied over the post of an ABS loader.

Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the Arthrex FiberTape and TigerTape Cerclage Sutures and Arthrex Radiopaque FiberTape Cerclage Sutures:

Device: Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape Cerclage Sutures

The provided document is a 510(k) Premarket Notification summary, indicating a submission to expand and align the indications for the Arthrex Radiopaque FiberTape Cerclage Sutures and Arthrex FiberTape & TigerTape Cerclage Sutures. The primary purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices.

Based on the available text, the study presented focuses on demonstrating mechanical equivalence and biocompatibility, not clinical performance with human-in-the-loop for diagnostic accuracy. Therefore, several of the requested sections (e.g., MRMC studies, expert qualifications, adjudication methods, training set details) are not applicable or cannot be extracted from this document, as they pertain to AI/diagnostic device performance studies.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes mechanical testing and biocompatibility testing, not a clinical study on patient data.

• Mechanical Testing: The sample size for dynamic tensile fatigue testing is not explicitly stated in terms of the number of sutures tested, only the duration/cycles (5 million cycles). The provenance of the "test set" (i.e., the sutures themselves) would be from the manufacturer (Arthrex Inc.).
• Biocompatibility (Bacterial Endotoxin): The sample size for this testing is also not explicitly stated (e.g., how many units were tested), only the method.

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

Not applicable. This device is a surgical suture, not a diagnostic device requiring expert interpretation of results to establish ground truth from a test set. The validation relies on engineering and biological testing standards.

4. Adjudication Method for the Test Set

Not applicable. There is no "test set" in the context of diagnostic interpretation requiring adjudication.

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 suture, not an AI-assisted diagnostic tool.

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

Not applicable. This device is a surgical suture, not an algorithm.

7. The Type of Ground Truth Used

• Mechanical Performance: The "ground truth" is defined by established engineering standards for suture performance (e.g., ability to withstand 5 million fatigue cycles) and substantial equivalence to predicate devices with a known safety and effectiveness profile. This is typically determined by physical measurements and adherence to pre-defined mechanical property specifications.
• Biocompatibility/Pyrogenicity: The ground truth is defined by established biological safety standards (e.g., EP 2.6.14/USP pyrogen limits) to ensure the device does not cause adverse biological reactions.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no AI model or training set is applicable here.

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The OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct are intended for use in soft tissue to bone fixation for the following indications: Shoulder Rotator Cuff Repair

The Riverpoint Medical Interfacing Anchor is comprised of a pre-deployed all-suture anchor with attached repair sutures and 302 stainless steel needles. The Interfacing Anchor is inserted into either the humerus or into passing slots available in devices intended for total shoulder arthroplasty. The Riverpoint Medical Bone Tunnel Construct is comprised of a double armed Ultra-High Molecular Weight Polyethylene (UHMWPE) suture with a preassembled polypropylene passing loop and 302 stainless steel needles. Suture supplied meet United States Pharmacopeia (USP) requirements for nonabsorbable suture except for diameter. Suture dyes are FDA authorized. The device is sterilized by ethylene oxide gas and is provided sterile for single use. Interfacing Anchor and Bone Tunnel Construct are available in common sizes and lengths with preattached 302 stainless steel needles and will be sold sterile for single use. The device is intended for use in a hospital/clinic/surgical setting.

The provided text is a 510(k) summary for the OsseoFit Interfacing Anchor and OsseoFit Bone Tunnel Construct. This document details the regulatory review process for a medical device and its substantial equivalence to a predicate device.

It does NOT describe an AI/ML-driven medical device, nor does it contain information about diagnostic performance metrics (e.g., sensitivity, specificity, AUC), test set characteristics, expert adjudication processes, or MRMC studies.

The "Performance Data" section of the document refers to non-clinical performance testing for a surgical device (an anchor and tunnel construct), not a diagnostic AI. The tests mentioned are:

• Usability engineering validation with simulated use in cadaveric models (EN62366:2015)
• Endotoxin/pyrogenicity testing (ANSI/AAMI ST72:2019, USP , USP , USP )
• Mechanical testing to verify fixation strength (cyclic and pullout testing)

Therefore, I cannot provide the requested information regarding acceptance criteria and study details for an AI/ML device's performance, as the provided text pertains to a physical surgical device.

To directly answer your prompt based on the provided text, the following cannot be extracted:

• A table of acceptance criteria and reported device performance related to diagnostic accuracy (as it's not a diagnostic device). The acceptance criteria mentioned are for mechanical and usability performance of a surgical implant.
• Sample sizes used for a "test set" in the context of image analysis or diagnostic performance. The "test set" here refers to cadaveric models and mechanical testing samples.
• Data provenance (country of origin, retrospective/prospective) for a diagnostic dataset.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• MRMC comparative effectiveness study, including effect size.
• Standalone (algorithm only) performance.
• Type of ground truth (expert consensus, pathology, outcomes data).
• Sample size for a training set.
• How ground truth for the training set was established.

However, based on the provided text, here's what can be inferred or directly stated about the "acceptance criteria" and "study" for this specific device (a surgical implant):

Acceptance Criteria and Device Performance (for a surgical implant):

Study Details (for this surgical implant):

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

   • The "test set" refers to samples for mechanical testing and cadaveric models for usability. Specific numerical sample sizes are not provided in this summary.
   • Data provenance is not described (e.g., where the cadavers came from, or if the mechanical tests were done by a specific lab).
   • The studies were non-clinical ("bench testing" and "simulated use").

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable in the context of diagnostic "ground truth." The "ground truth" for a surgical implant's mechanical performance is defined by engineering standards and comparative testing to predicates. Usability testing would involve typical users (surgeons, OR staff), but the number or qualifications are not specified.

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

   • Not applicable as this is not a diagnostic study requiring human expert consensus/adjudication of results. Performance is measured against physical test standards and engineering specifications.

4. 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, a MRMC comparative effectiveness study was not done. This is a physical surgical device, not an AI/ML diagnostic tool.

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

   • Not applicable as this is a physical surgical device, not an algorithm.

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

   • For mechanical testing: Engineering specifications and comparative performance to a legally marketed predicate device.
   • For usability testing: Performance in simulated use conditions in cadaveric models against predefined usability objectives (derived from EN62366:2015).

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device with a "training set."

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

   • Not applicable.

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HyperSuture All Blue Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture All Blue Extension Line cables are non-absorbable, sterile, surgical sutures, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture All Blue Extension Line cables are available in USP 2 and USP 5 and meet all surgical suture requirements established by the USP for class II non-absorbable surgical sutures.

HyperSuture All Blue Extension Line tapes are non-absorbable, sterile, surgical braids, composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. HyperSuture tape sizes do not conform to USP diameter requirements; however, HyperSuture tapes meet USP tensile strength and needle attachment strength requirements for equivalent USP size sutures. HyperSuture tape sizes are available in 1.5mm tape (USP 2 equivalent) and 2.0mm tape (USP 5 equivalent).

Both HyperSuture All Blue Extension Line cables and tapes are available in blue, 36 inches in length, and with or without pre-attached needles.

The provided text is a 510(k) summary for the HyperSuture All Blue Extension Line. This document is a regulatory submission to the FDA for a medical device and describes its equivalence to a predicate device. It does not contain information related to software performance, clinical studies, or AI algorithm validation. The device in question is a surgical suture, not a software or AI-powered diagnostic tool.

Therefore, I cannot extract the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details) because these are concepts applicable to software or AI device validation, which is not what this document addresses.

The document focuses on establishing substantial equivalence to a predicate device based on material, manufacturing, and physical performance characteristics, primarily adhering to USP (United States Pharmacopeia) standards for surgical sutures.

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The AMT Suture Passer is indicated to pass suture through soft tissues of the body during endoscopic/laparoscopic surgery and interventional radiology procedures in child, adolescent and adult populations.

The AMT Suture Passer is a sterile, single-case use, hand-held suture grasping device. The device features a hypodermic needle through which a suture can be passed and retrieved through another. The retrieval component may be offered in two configurations: a non-magnetic version, and a magnetically assisted version, using a grasper with a magnetized arm. Using either configuration, the AMT Suture Passer provides more flexibility in stitch geometry and approach than traditional U-stitches. The preferred method to introduce the suture is through a separate introducer needle; the AMT Suture Passer Kit with Magnet Assist instrument set bundles the magnetically assisted configuration of the AMT Suture Passer with an introducer needle and two magnetic sutures to create a non-procedure-specific kit. For the magnetically assisted configuration, the magnetized arm of the grasper works in conjunction with a magnetic suture to reduce the technical difficulty of intracorporeal suture retrieval under laparoscopic, endoscopic, radiologic, or ultrasound guidance. This magnet-assist technology is derived from the ATLAS Suture Delivery System (K193612), also manufactured by Applied Medical Technology, which performs the same clinical function and is used in similar clinical applications. Both configurations of the AMT Suture Passer feature identical components, except for the end-effectors, and make use of Luer-lock compatible hubs that allow a syringe to be attached for the purpose of administering contrast through the device. The contrast enters through the Luer hub and exits from the distal end of the needle, which allows the needle position to be verified prior to passing the suture during interventional radiology procedures.

This document is an FDA 510(k) clearance letter for a medical device called the "AMT Suture Passer." It outlines the regulatory review process and the basis for the FDA's determination of substantial equivalence to previously cleared devices.

The request asks for details on acceptance criteria and a study proving the device meets these criteria. However, the provided document does not describe a study involving an AI/Machine Learning algorithm, human readers, or a test set with ground truth established by experts.

Instead, the document details the performance data for a physical medical device (AMT Suture Passer) through bench testing, biocompatibility testing, sterilization validation, and shelf-life testing. It explicitly states:

• "B. Software: There are no software components related in any way to this device. Therefore, Software Validation is not applicable to this device."
• "E. Animal Study: Animal testing was NOT performed."
• "F. Clinical Study: Clinical testing was NOT performed."

Therefore, I cannot provide the requested information regarding an AI study, test sets, expert ground truth, adjudication methods, MRMC studies, standalone algorithm performance, or training set details from this document. The information requested aligns with studies typically performed for AI/ML-driven medical devices, which the AMT Suture Passer is not.

However, I can extract the acceptance criteria and performance data for the physical device as presented in the document:

Acceptance Criteria and Device Performance (Based on the Provided Document for a Physical Device)

The "AMT Suture Passer" is a physical medical device, not an AI/ML diagnostic tool. Therefore, the acceptance criteria and performance data relate to its physical properties, sterility, biocompatibility, and functionality as a surgical instrument. There is no mention of AI performance metrics like sensitivity, specificity, AUC, or reader improvement.

Here's a summary of the performance data and acceptance criteria as described:

1. Table of Acceptance Criteria and Reported Device Performance

Since the device is a physical instrument without AI components, the following points as requested in the prompt are not applicable or detailed in the provided document:

2. Sample size used for the test set and the data provenance: Not applicable for a physical device's bench/biocompatibility testing in this context. These tests are typically performed on a statistically relevant sample size of manufactured devices/materials, but specific numbers are not provided. Data provenance would be from manufacturing and testing labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's performance is established by direct measurement and compliance with engineering/material standards, not by expert interpretation of data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 (no AI component).
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable (no AI algorithm).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For a physical device, the "ground truth" for acceptance is determined by adherence to established material specifications, manufacturing tolerances, mechanical performance criteria, and sterility/biocompatibility standards as measured through laboratory testing.
8. The sample size for the training set: Not applicable (no AI component).
9. How the ground truth for the training set was established: Not applicable (no AI component).

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HyperSuture Extension Line (both tape and cable) are indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular procedures, and the use of allograft tissue for orthopedic procedures.

HyperSuture Extension Line cables are non-absorbable, sterile, surgical sutures composed of multiple multifilament strands of ultra-high molecular weight polyethylene (UHMWPE) braided together to form the implant. The sutures are intended to be used for general soft tissue approximation and/or ligation, including use in cardiovascular surgery, and allograft tissues for orthopedic procedures. HyperSuture Extension Line cables are available in USP 2 and USP 5 and tapes are available in 1.5 (USP 2 equivalent) and 2.5 (USP 5 equivalent). Both HyperSuture Extension Line cables and tapes are available in white/blue, 40 inches in length, and with or without pre-attached AISI 302 stainless steel needles.

The provided text describes a 510(k) premarket notification for a medical device called "HyperSuture Extension Line". This process is for claiming substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria based on a clinical study of its performance in a clinical setting (such as for an AI/ML device where performance metrics like sensitivity/specificity are evaluated).

The documentation does cover acceptance criteria for physical and material characteristics of the suture, and outlines how the device meets these in comparison to a predicate device. So, while it doesn't involve an AI/ML style study, I can extract information related to acceptance criteria for the suture itself and the testing performed.

Here's a breakdown of the requested information based on the provided text, focusing on the available information regarding the device's characteristics and acceptance, rather than an AI/ML performance study:

Acceptance Criteria and Study for the HyperSuture Extension Line (K234079)

This submission is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a predicate device, not necessarily to prove clinical efficacy through a multi-reader, multi-case study, or standalone algorithm performance. The "acceptance criteria" here refer to the physical and material performance specifications of the suture itself, as well as biocompatibility, to ensure it is as safe and effective as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify exact sample sizes for each physical test (e.g., how many sutures were measured for diameter or tensile strength). However, it states that "The HyperSuture Extension Line sutures were tested per USP performance requirements for diameter, length, needle attachment and tensile strength." This implies adherence to the sample size and testing methodology defined by the USP standards for those specific tests.

• Data Provenance: The document does not explicitly state the country of origin of the data. The testing appears to be non-clinical (mechanical and biocompatibility testing) and not based on prospective or retrospective patient data.

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

This type of information (number and qualifications of experts for ground truth) is typically relevant for studies validating AI/ML algorithms, especially in diagnostic imaging, where human expert consensus is used to establish "true" disease presence. For this device, the "ground truth" for the physical characteristics and biocompatibility is established by adherence to recognized international and national standards (USP, ISO, ASTM).

The biocompatibility evaluation of the blue dye was conducted "by trained, board certified veterinary pathologists." The number of such pathologists is not specified.

4. Adjudication Method for the Test Set

Not applicable in the context of physical property testing or substantial equivalence claims for a medical device like a suture. Adjudication methods (e.g., 2+1, 3+1) are primarily used in clinical studies where human readers provide interpretations (e.g., radiology reads) and their disagreements need to be resolved to establish ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC study is relevant for evaluating the performance of AI-assisted systems in diagnostic scenarios (e.g., whether AI improves a radiologist's accuracy). This submission is for a surgical suture, which is a physical medical device, not an AI/ML algorithm.

6. Standalone (Algorithm Only Without Human-in-the Loop Performance) Study

No. This concept is applicable to AI/ML algorithms. The HyperSuture Extension Line is a physical surgical suture. The "performance" assessment refers to its physical and material properties, not an algorithmic output.

7. The Type of Ground Truth Used

The "ground truth" for the device's characteristics (diameter, tensile strength, biocompatibility, etc.) is established by:

• Established Standards: Compliance with United States Pharmacopeia (USP) standards (USP 43 <861> for Diameter, <881> for Tensile Strength, <871> for Needle Attachment).
• International Standards: Compliance with ISO 10993-1:2009 for Biological Evaluation of Medical Devices.
• Material Specifications: Adherence to material specifications (e.g., AISI 302 Medical Grade Stainless Steel per ASTM F899 for needles).
• Expert Evaluation: Biocompatibility evaluation of the blue dye was assessed by trained, board-certified veterinary pathologists.

8. The Sample Size for the Training Set

Not applicable. This device is a physical product and does not involve a "training set" in the context of machine learning or AI.

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

Not applicable, as there is no "training set" for this type of medical device submission.

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Megaloop Button System - Megaloop Button with Megaloop Adjustable Loop
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop AD Device
The device is intended to be used for fixation of bone or soft tissue to bone, and is intended as fixation posts, a distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. For example, ACL/PCL repair and reconstruction.

Megaloop Button System - Megaloop FLB Device, Megaloop FLW Device, Megaloop XL Button
Megaloop FLB Device and Megaloop FLW Device are used for fixation of soft tissue to bone in orthopedic procedures such as ACL repair.

When used in conjunction with the Megaloop FLB Device or Megaloop FLW Device, the Megaloop XL Button is intended for fixation of soft tissue to bone in orthopedic procedures such as ACL repairs.

Megaloop Button System - Megaloop DB Device, Megaloop AC Button with Megaloop Adjustable Loop
The Megaloop DB Device and Megaloop AC Button are intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically:

• The Megaloop DB Device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

• The Megaloop AC Button is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The Megaloop Button System is a family of titanium buttons for the fixation of bone to bone or soft tissue to bone. The system includes a variety of buttons made of Ti-6AI-4V ELI titanium alloy, with or without pre-assembled nonabsorbable loops, sutures and needles. The loops and sutures are offered in non-absorbable Ultra High Molecular Weight Polyethylene (UHMWPE) material. The long straight needles are offered in XM-16 stainless steel material. The sutures and needles are not implantable and are discarded after assisting with button placement.

The Megaloop Button System is provided sterile, non-absorbable, for single use only.

The provided text describes a 510(k) premarket notification for the "Megaloop Button System," which is a family of titanium buttons used for fixation of bone or soft tissue to bone. The submission asserts that the device is substantially equivalent to several predicate devices.

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for substantial equivalence are primarily based on comparing the subject device's characteristics and performance to legally marketed predicate devices. The document does not explicitly state quantitative acceptance criteria in terms of performance metrics (e.g., minimum pullout strength in Newtons, minimum cycles for fatigue life). Instead, it relies on demonstrating that the subject device's non-clinical test results are comparable to or perform as well as the predicate devices.

Therefore, the table below outlines the general performance aspects evaluated and the reported outcomes:

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

The document explicitly states: "Non-clinical bench tests were conducted in support of the substantial equivalence determination."

• Sample Size: The document does not specify the sample size used for the pullout or fatigue tests, or any other non-clinical bench tests.
• Data Provenance: The nature of "non-clinical bench tests" implies that the data was generated in a controlled laboratory environment, likely by the manufacturer (Suzhou Endophix Co., Ltd.) or a contracted testing facility. There is no information regarding the country of origin of the data beyond the manufacturer's location (China), nor any mention of retrospective or prospective human data. This entire submission relies on bench testing, not human or clinical data.

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

This information is not applicable to this submission. The "ground truth" for the non-clinical bench tests would be the measured physical properties of the materials and devices under specific testing conditions, as determined by laboratory instruments and protocols. There is no mention of human experts establishing a "ground truth" for the test set, as these are mechanical and material property tests.

4. Adjudication Method for the Test Set

This is not applicable. Since the evaluation is based on non-clinical bench tests measuring objective physical properties, there is no need for an adjudication method by human reviewers. The test results are quantitative measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic medical devices where expert readers evaluate cases. The Megaloop Button System is a surgical implantable device, and its evaluation is based on non-clinical bench testing.

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

This question is not applicable. The Megaloop Button System is a physical surgical implant, not a software algorithm or an AI-powered device. Therefore, the concept of "standalone performance" in the context of an algorithm does not apply.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical bench tests consists of:

• Material Specifications: Compliance with established international standards (ISO, ASTM) for the chemical composition and mechanical properties of the materials (titanium alloy, UHMWPE).
• Biocompatibility Standards: Compliance with ISO 10993-1.
• Mechanical Test Results: Measured load-to-failure (pullout) and cycles-to-failure (fatigue) data, which are compared against general performance expectations for such devices and, implicitly, against the predicate device's performance. The "ground truth" here is the objectively measured physical behavior of the device under stress.
• Sterilization Validation: Demonstrated SAL of 10^-8.
• Shelf-life Data: Results from accelerated aging tests.

No pathology, expert consensus, or outcomes data were used for establishing ground truth in this non-clinical submission.

8. The Sample Size for the Training Set

This is not applicable. The Megaloop Button System is a physical medical device, not an AI or machine learning model. Therefore, there is no "training set" in the context of algorithm development. The design and manufacturing process would involve internal testing and iteration, but not "training data" in the AI sense.

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

This is not applicable for the same reason as point 8.

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The SF Push-in Anchor is intended to be used for suture or tissue fixation in the foot, ankle, hand, wrist, elbow, knee, hip and shoulder. The SF Push-in Anchor is designed only to be inserted with the SupraFuser Generator.

SF Push-in Anchor 1.6mm:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Elbow: Ulnar or Radial Collateral Ligament Reconstruction
Shoulder: Bankart Repair, SLAP Lesion Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair

SF Push-in Anchor 2.3mm:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, Lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Metatarsal Ligament Repair, Hallux Valgus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Achilles Tendon Repair, Bunionectomy
Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis
Hip: Acetabular labral repair, capsular repair

SF Push-in Anchor 3.0mm and 3.6mm:
Hand/Wrist: Scapholunate Ligament Reconstruction, Carpal Ligament Reconstruction, Repair/ Reconstruction of collateral ligaments, Repair of Flexor and Extensor Tendons at the PIP, DIP and MCP joints for all digits, digital tendon transfers
Elbow: Biceps Tendon Reattachment, Ulnar or Radial Collateral Ligament Reconstruction, lateral epicondylitis repair
Shoulder: Rotator Cuff Repairs, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clavicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction
Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus and Varus reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction, Metatarsal tendon repair, Bunionectorny
Knee: Medial collateral ligament repair, lateral ligament repair, patellar tendon repair, posterior oblique ligament repair, and iliotibial band tenodesis
Hip: Acetabular labral repair, capsular repair

The SF Push-in Anchor system consists of implantable anchors with 1.6, 2.3, 3.0, and 3.6mm diameter, an ultrasonic system, a sonotrode, dedicated anchor size specific drills and stoppers, a handpiece front cover, and a guide with integrated wrench.

The SF Push-in Anchors are made of biocompatible and fully bioresorbable Poly-L-lactide-co-D,L-lactide. The SF Push-in Anchors are fully bioresorbable implants designed for soft tissue reattachment to bone by means of suture materials. The implantation process employs ultrasonic energy to liquefy the polymeric components of the Push-in Anchors at the interface with bone tissue. The liquid polymer flows into the marrow space of the surrounding cancellous bone, where it is immediately quenched and provides anchorage of the implant.

The ultrasonic energy for the implantation of the Push-in Anchors is produced by the SupraFuser® ultrasonic generator and applied via the attached handpiece. The sonotrode is mounted on the handpiece. It transmits the ultrasonic vibrations to the Push-in Anchor. The drills and the stoppers are dedicated to be used with the Push-in Anchor of the respective size.

The provided document is a 510(k) premarket notification for a medical device (SF Push-in Anchor) and does not contain information about the acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device.

The document details the device's indications for use, technological characteristics, and performance data from various physical tests (e.g., static pullout, dynamic pullout, creep, degradation, biocompatibility) to demonstrate its substantial equivalence to predicate devices. It also mentions "Software documentation and validation per FDA guidance" and "IEC 60601-1 and 60601-1-2 testing," which typically pertain to the electrical safety and electromagnetic compatibility of the control system (SupraFuser Generator) for the ultrasonic insertion mechanism, not for AI/ML performance.

Therefore, I cannot extract the requested information about acceptance criteria and study proving device meets acceptance criteria for an AI/ML powered device from the provided text.

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