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TriMed RipCord devices are intended for use to supplement repair or reconstruction during healing of ligament injuries or deficiencies of the extremities.

The TriMed RipCord device is indicated to be used as an adjunct in combination with compatible TriMed fixation implants to provide fixation during the healing process in syndesmotic trauma, such as fixation of syndesmosis disruptions in connection with Weber B and C ankle fractures.

The TriMed RipCord Screw is a single-use, sterile, non-absorbable implantable device designed to aid in the treatment of syndesmotic injuries of the lower extremities. The device consists of a far button, an ultra-high molecular weight polyethylene (UHMWPE) suture, and a cannulated screw.

The provided document K251134 is an FDA 510(k) Clearance Letter for a medical device called "RipCord." This document focuses on demonstrating substantial equivalence to existing legally marketed devices, primarily through non-clinical testing. It does not contain information related to software, imaging, or AI-assisted diagnostic tools. Therefore, many of the requested elements, such as those pertaining to AI model performance, human reader studies, and AI-specific ground truth establishment, are not applicable to this documentation.

However, I can extract the information relevant to the device's acceptance criteria and the study that proves it meets them, based on the provided text, while acknowledging the limitations for an AI-centric request.

Acceptance Criteria and Study Proving Device Meets Criteria

The device in question, the TriMed RipCord Screw, is a mechanical implant for bone fixation. The study proving its performance is based on non-clinical bench testing, demonstrating mechanical properties, rather than clinical efficacy or diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the acceptance criteria were established to demonstrate performance equivalence to the predicate device cleared under K220650. However, the specific numerical acceptance criteria values are not detailed in this public FDA clearance letter. Similarly, the exact numerical reported performance values are not provided; only a qualitative statement that the device "successfully met the established acceptance criteria" is present.

Here's a generalized table based on the information provided:

Note: The document explicitly states: "Clinical studies were not conducted for the subject devices." This means the "acceptance criteria" and "device performance" relate solely to the mechanical properties as demonstrated through bench testing, not clinical outcomes or diagnostic accuracy.

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

• Sample Size: The specific sample sizes for the non-clinical tests (static loading, cyclic endurance, torsional strength, driving torque, axial pullout) are not specified in the provided document. The document simply states "TriMed RipCord Screw devices were subjected to static loading and cyclic endurance testing" and "TriMed Cannulated Hex 3.2mm screws were subjected to torsional strength, driving torque and axial pullout tests."
• Data Provenance: The data provenance for this in-vitro, non-clinical bench testing does not involve patient data or geographical origin in the context of clinical studies. It is based on laboratory testing performed by the manufacturer (TriMed, Inc.). The testing is by its nature prospective in the sense that the tests were designed and executed to evaluate the new device.

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

This question is not applicable as the document describes a mechanical device cleared based on non-clinical bench testing. There is no "ground truth" derived from expert interpretation of medical images or patient data. The "ground truth" for these tests would be the measured physical properties of the materials and device, compared against pre-defined engineering and performance specifications.

4. Adjudication Method for the Test Set

This question is not applicable as the document describes non-clinical mechanical testing, not a study involving human interpretation or adjudication of medical data. The results of mechanical tests are objective measurements, not subjective interpretations 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

This question is not applicable. The device is a bone fixation implant, not an AI-assisted diagnostic tool. No MRMC study was conducted, as confirmed by the statement "Clinical studies were not conducted for the subject devices."

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

This question is not applicable. The device is a bone fixation implant, not an algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance is based on engineering specifications and mechanical property measurements. The device's performance was compared to that of a predicate device (K220650) to demonstrate "performance equivalence." This is an in-vitro, physical/mechanical ground truth, not a clinical, pathological, or outcomes-based ground truth.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as the device is a mechanical implant, not an AI model or software algorithm that undergoes machine learning training.

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

This question is not applicable for the reasons stated in point 8.

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Acu-Sinch Knotless Mini, when used for fixation of bone-to-bone or soft-tissue to bone, is intended as a fixation post, distribution bridge, or for distributing suture tension over areas of ligament or tendon repair. Specifically, Acu-Sinch Knotless Mini is indicated for Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process of hematoma distraction arthroplasty by providing stablization at the base of the first and second metacarpal when the trapezium has been excised due to osteoarthritis.

The Acu-Sinch Knotless Mini is intended to provide fixation during the healing process of a trapeziectomy. Acu-Sinch Knotless Mini consists of two buttons, a suture strand, and instruments to aid in insertion. The buttons are manufactured from titanium alloy conforming to ASTM FI 36 (Ti-6AL-4V ELI). The suture is manufactured from Ultra High Molecular Weight Polyethylene (UHMWPE). The devices are sterile and for single use.

The provided document is a 510(k) premarket notification for a medical device called Acu-Sinch Knotless Mini. It describes the device's indications for use, technological characteristics, and a summary of non-clinical tests conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical values for metrics like sensitivity, specificity, or accuracy, as would be common for diagnostic AI/ML devices. Instead, the acceptance criteria are framed in terms of substantial equivalence to a predicate device (Arthrex CMC Mini Tightrope). The key performance criteria evaluated through non-clinical testing are static and dynamic fatigue, and MRI compatibility.

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The Bolo Button System is intended to provide fixation as an adjunct to fracture repair hardware during the healing period following an ankle syndesmotic trauma with fracture.

The Bolo Button System consists of two syndesmosis buttons made of titanium alloy (Ti6AI4V ELI (ASTM F136)) and suture tape (Ultra High Molecular Weight Polyethylene Suture (UHMWPE) (ASTM F2848)). It is intended for fixation of syndesmotic injuries in an ankle fracture. The system offers two lateral button sizes. One fits 1.5mm suture tape and the other fits 2.0mm suture tape. Both share the same medial button. System instrumentation includes: drill bits, K-wires, tissue protector, and an inserter which deploys the implants. The implants and associated instrumentation are supplied sterile. This is a single use system.

This document is a 510(k) premarket notification for a medical device called the Bolo Button System. It is not for an AI/ML device. Therefore, the questions regarding acceptance criteria and studies for an AI/ML device are not applicable to the provided document.

The document states:

• "No clinical studies were performed"
• "Non-clinical Test Summary: Validations were performed on the cleaning, packaging and sterilization of the implants and associated surgical instruments. Engineering rational along with static and dynamic testing was performed to show substantial performance equivalence. The results of the testing demonstrate that the device is substantially equivalent to the predicate device identified above."

The criteria and study described are for demonstrating substantial equivalence of a physical medical device (Bolo Button System) to its predicate devices based on design, materials, and mechanical performance, not for the performance of an AI/ML algorithm.

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The EXPERT - Flexible Joint Fixation System is intended as an adjunct in fracture repair involving metaphyseal and periarticular bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and nails, with fracture braces and casting. The EXPERT - Flexible Joint Fixation System are intended to provide fixation during the healing process following:

EXPERT FAST - SYNDESMOSIS and EXPERT FAST DUAL:

Syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

EXPERT ACL and EXPERT ACL II:

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. Specifically, these models are offered for Anterior Cruciate Ligament (ACL) Repair.

EXPERT FAST - CORACOID PLATE and EXPERT FAST- AC:

Specifically, these models are intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

The EXPERT - Flexible Joint Fixation System was designed for fixation, being used as a biomechanical structure to simulate a support pillar distributing the tensions in the suture wire or tape. The plates are manufactured in titanium alloy conforming to ASTM F136. The sutures are manufactured from UHMWPE. The devices are sold sterile and are single use. The EXPERT - Flexible Joint Fixation System is a line extension to the EXPERT - Joint Fixation System consisting of new models.

The provided text describes a medical device, the "EXPERT - Flexible Joint Fixation System," and its 510(k) summary for FDA clearance. However, the document does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the way a clinical or algorithmic performance study would.

The document discusses equivalence to predicate devices based on "submitted testing data" but does not detail the nature of these tests, specific acceptance criteria, or the results. It mentions:

• Performance Data: "Based on submitted testing data, the proposed EXPERT - Flexible Joint Fixation System is equivalent to the Arthrex ACL TightRope (K100652) and TightRopeTM Acromioclavicular (K052776) predicate devices." (Page 6)
• Conclusion: "Any differences between the proposed device and the predicate device are considered minor and do not raise new or different questions concerning safety or effectiveness." (Page 6)

This refers to engineering testing or benchtop studies to demonstrate the mechanical equivalence or biocompatibility of the device's components to previously cleared predicate devices, rather than a study evaluating diagnostic or prognostic capabilities of an AI/ML algorithm.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance related to a study proving the device meets these criteria in the context of AI/ML or clinical performance, nor can I provide information on sample sizes, ground truth establishment, expert qualifications, or MRMC studies for this particular device based on the provided text.

The information requested, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, training set size, and how training set ground truth was established, is not present in the provided FDA 510(k) summary for the EXPERT - Flexible Joint Fixation System. This is typical for a 510(k) for a physical medical device like a fixation system, which focuses on substantial equivalence to predicate devices through technical, material, and mechanical comparisons, rather than AI/ML algorithm performance.

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The TACTIX Vector Syndesmosis System is 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 TACTIC Vector Syndesmosis System 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 TACTIX Vector Syndesmosis System is intended to provide fixation during the healing process following a syndesmotic trauma using a TACTIX Vector suture loop and buttons.

The TACTIX Vector System features the following advantageous characteristics: a tensioner to apply suture tension for surgical repair, line lock suture technology without the need to tie a knot, removal of periosteum through a minimal medial button, and a small thru hole in the bone, only large enough to pass a 2.0 mm suture loop. The TACTIX Vector Syndesmosis System can be used in conjunction with Vilex fibular bone plates and screws, as deemed necessary by the surgeon.

The TACTIX Vector Syndesmosis System is composed of two titanium alloy buttons and one UHMWPE suture.

The instruments of TACTIX System are composed of stainless steel, UHMWPE, and nylon material.

The TACTIX Vector Syndesmosis System is intended for single use and provided sterile to the end user via ethylene oxide sterilization.

This document is for a medical device called the "TACTIX Vector Syndesmosis System," which is a metallic bone fixation appliance. It is a 510(k) premarket notification to the FDA. The document focuses on establishing substantial equivalence to previously cleared predicate devices.

The information provided does not describe a study that proves the device meets acceptance criteria in the context of clinical performance or diagnostic accuracy, as would be relevant for an AI/ML-driven medical device. Instead, the document describes non-clinical (bench) testing to demonstrate the device's mechanical performance and safety characteristics.

Therefore, for aspects related to "acceptance criteria" for performance metrics like sensitivity, specificity, AUC, human reader improvement with AI, or ground truth establishment relevant to AI/ML, there is no information provided in this document.

However, I can extract the information relevant to the non-clinical testing performed:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Test Set Sample Size: Not explicitly stated for each non-clinical test (e.g., number of devices tested for fatigue, pullout).
• Data Provenance: The tests are non-clinical (bench testing) performed by the manufacturer (Vilex LLC). The document does not specify the country of origin for these tests. The tests are "retrospective" in the sense that they are done in a lab setting to assess the final device design.

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

• Not applicable. This document describes non-clinical engineering bench testing, not clinical studies or AI/ML performance evaluations requiring expert ground truth for interpretation.

4. Adjudication method for the test set:

• Not applicable. This document describes non-clinical engineering bench testing.

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 document describes a medical device (physical implant), not an AI/ML diagnostic or assistive tool. No MRMC study was mentioned or performed.

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

• No, not applicable. This document is for a physical medical device.

7. The type of ground truth used:

• Not applicable in the AI/ML context. For the non-clinical tests, the "ground truth" is established by standard engineering test methods and their defined pass/fail criteria (e.g., meeting a certain force threshold, cycles to failure, absence of toxins). Comparison to a predicate device serves as the benchmark for "truth."

8. The sample size for the training set:

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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

• Not applicable. This document does not describe an AI/ML device that requires a training set.

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The TENSOR® Suture Button System is intended to be used 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 TENSOR® implants are intended to provide fixation during the healing process for the following indications:

Syndesmotic trauma, such as ankle syndesmosis fixation (syndesmosis disruptions), and as an adjunct in connection with trauma hardware for Weber B and C ankle fractures; fixation of dorsal distal radioulnar ligament (DRUL) disruptions; Acromioclavicular separations due to coracoclavicular ligament disruptions; Tarsometatarsal (TMT) injury, such as fixation of foot soft tissue separations due to a Lisfranc injury (Midfoot Reconstruction); Hallux Valgus reconstruction (correction) by providing for the reduction of 1st metatarsal intermetatarsal angle; and, Carpal Metacarpal (CMC) joint arthroplasty as an adjunct in the healing process.

The TENSOR® Suture Button System consists of metal buttons, a polymer suture, an optional washer, and instruments. The buttons are available in various sizes to accommodate varying patient anatomy and surgical needs. The buttons and washer are manufactured from titanium alloy or stainless steel, and the suture is manufactured from ultra high molecular weight polyethylene (UHMWPE) and polyethylene terephthalate (PET). The implants are sterile packaged with various instruments to aid in insertion.

The provided text is a 510(k) Premarket Notification from the FDA for a medical device called the TENSOR® Suture Button System. It outlines the device's classification, indications for use, and the basis for its substantial equivalence to previously cleared predicate devices.

However, the document does not contain any information about a study proving the device meets acceptance criteria related to AI/Machine Learning performance. The "Performance Data" section specifically mentions "Mechanical testing (static and dynamic tension)" and "Bacterial endotoxin testing (BET)," which are standard tests for evaluating the mechanical properties and biocompatibility of implantable devices. There is no mention of clinical trials, AI/ML algorithm development, or human-in-the-loop performance studies.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria in the context of AI/ML performance, as the provided document does not pertain to an AI/ML device.

To directly answer your questions based only on the provided text, a significant portion of the requested information is absent because the device is a mechanical implant, not an AI/ML-driven diagnostic or assistive system.

Here's what can be extracted and what cannot:

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

• Acceptance Criteria Mentioned (Implicit/Explicit):
  • Mechanical Performance: Static and dynamic tension (implied to meet relevant standards for load-bearing and fatigue).
  • Biocompatibility/Sterility: Bacterial endotoxin testing (BET) in accordance with ANSI/AAMI ST72:2011 (acceptance criteria would be below a certain endotoxin limit).
  • Substantial Equivalence: To predicate devices in terms of design, intended use, material composition, and range of sizes, and that differences "do not raise any different questions of safety or effectiveness."
• Reported Device Performance:
  • "Performance data demonstrates substantial equivalence to the predicate devices." (This is a summary statement, specific numerical results are not provided).

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

• Not applicable/Not provided. The testing mentioned (mechanical, endotoxin) uses material samples, not a "test set" in the sense of patient data for AI.

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

• Not applicable/Not provided. Ground truth, in the context of the requested AI/ML study, is not relevant for this device.

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

• Not applicable/Not provided.

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/Not provided. This is a mechanical implant, not an AI-assisted diagnostic tool.

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

• No, not applicable/Not provided.

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

• Not applicable. For mechanical testing, the "ground truth" would be engineering specifications and validated test methods.

8. The sample size for the training set

• Not applicable/Not provided. No AI/ML training set is mentioned.

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

• Not applicable.

In summary: The provided document is a regulatory clearance for a traditional medical implant, not an AI/ML device. Therefore, the requested information pertaining to AI/ML development, testing, and clinical validation is not present.

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The OIC FLEX-FIX™ System is intended to provide fixation during the healing process following trauma to the Ankle Syndesmosis (Syndesmosis disruption) and as an adjunct in connection with trauma hardware for ankle fractures such as Weber B and C. The device is intended for use in adults.

The OIC FLEX-FIX™ System consists of a medial toggle body, UHMWPE suture tape and a lateral button assembled on a deployment handle, a 3.7mm drill bit, and a 3.5mm washer. The device is provided sterile. EO gas is used to sterilize the device.

The medial toggle body, lateral button and washer are manufactured from material that conforms to: ASTM F136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Ally for Surgical Implant Applications (UNS R56401)

This document, K233531, is an FDA 510(k) clearance letter for a medical device called the OIC FLEX-FIX™ System, which is an orthopaedic implant for ankle fixation. The provided information focuses on the device's substantial equivalence to predicate devices and does NOT contain any data related to AI/ML software performance or an AI study. Therefore, I cannot extract the requested information regarding acceptance criteria and a study proving a device meets these criteria in the context of AI/ML, as no such study is described in this document.

The document discusses:

• The device's intended use for ankle syndesmosis and fractures.
• The device's components and materials.
• A comparison to predicate devices, noting similarities in intended use, operating principle, and design, and differences in material and toggle body dimensions.
• Performance testing: "Dynamic tensile testing and Static testing to failure was performed on the device and a predicate. The device was found to have acceptable mechanical characteristics for the intended uses." This refers to biomechanical testing of the physical implant, not a study of AI/ML software performance.

Therefore, I cannot fulfill your request for the following information based on the provided document:

1. A table of acceptance criteria and the reported device performance (in the context of AI/ML).
2. Sample size used for the test set and data provenance (for AI/ML).
3. Number of experts used to establish ground truth and their qualifications (for AI/ML).
4. Adjudication method (for AI/ML).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done (for AI/ML).
6. If a standalone (algorithm only) performance study was done (for AI/ML).
7. The type of ground truth used (for AI/ML).
8. The sample size for the training set (for AI/ML).
9. How the ground truth for the training set was established (for AI/ML).

The document is solely about the clearance of a mechanical orthopaedic implant based on substantial equivalence to existing devices and standard mechanical testing.

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The CC-Clip® device is intended as an adjunct in coracoclavicular ligament disruption repair.

Specifically, the CC-Clip® device is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of acromioclavicular separations due to coracoclavicular ligament disruptions.

CC-Clip® is an implantable device for an arthroscopic coracoclavicular (CC) ligament reconstruction and acromioclavicular (AC) ligament reconstruction technique. The original ligaments fail due to an AC joint separation and cause superior and posterior translation of the clavicle.

CC-Clip® device consists of a titanium implant on the clavicle, a titanium counterpart under the coracoid, and non-resorbable suture between the implants. A USP size 5 suture is not provided with CC-Clip®, but the Arthrex #5 FiberWire is recommended with the CC-Clip® device.

Instrumentation included with the CC-Clip® system includes two instruments: the CC-Clip® Straight Lasso guide and CC-Clip® Curved Lasso guide. Additional general-use, readily available instrumentation required for the CC-Clip® procedure includes lasso wire, guide pins, and drill bits which are to be supplied by the end user per the surgical technique. Both CC-Clip® guides are re-usable surgical instruments provided non-sterile to the user. The CC-Clip® implants are supplied sterile to the user and are single use.

This is an orthopedic device, not an AI/ML device. Therefore, the request for information on "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML performance metrics (such as effect size of human readers improving with AI, standalone performance, ground truth establishment for training, etc.) is not applicable.

The provided document describes the CC-Clip® Implant System, a medical device intended for coracoclavicular ligament disruption repair and acromioclavicular separations. The regulatory submission (K232780) establishes its substantial equivalence to a predicate device (Arthrex TightRope® Acromioclavicular (AC) device, K052776) based on mechanical testing and comparison of technological characteristics.

Here's the relevant information based on the provided text, adapted for a non-AI/ML medical device:

Acceptance Criteria and Study Proving Device Meets Criteria

The acceptance criteria for this non-AI/ML device are primarily demonstrated through mechanical testing to ensure safety and effectiveness, and by showing substantial equivalence to a legally marketed predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

• Study: Mechanical Testing Program for CC-Clip® Implant System (Table 6.1)

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

• Sample Size: Not explicitly stated for each mechanical test. The nature of mechanical testing usually involves multiple samples per test condition to achieve statistical significance.
• Data Provenance: The tests are non-clinical (laboratory-based mechanical testing), not derived from patient data.

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

• Not applicable as this is a mechanical device without "ground truth" established by human experts in the context of AI. The "ground truth" for mechanical testing is defined by engineering specifications, material properties, and regulatory standards for device performance.

4. Adjudication Method for the Test Set

• Not applicable, as this refers to expert review in AI/ML performance evaluation. Mechanical tests are governed by standardized protocols and objective measurements.

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 is a surgical implant, not an AI/ML diagnostic or assistive device.

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

• Not applicable. This is a surgical implant.

7. The Type of Ground Truth Used

• Ground Truth (for mechanical testing): Established through engineering specifications, material standards (e.g., ASTM F136 for titanium alloy), and performance requirements derived from the intended use and comparison to the predicate device. These are objective, measurable physical properties and forces.

8. The Sample Size for the Training Set

• Not applicable. This device does not involve a "training set" in the AI/ML sense. Design and manufacturing processes are iterative and based on engineering principles and material science.

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

• Not applicable for the same reason as above. The "ground truth" for the development of such a device stems from established biomechanical principles, material science, and the performance characteristics of predicate devices.

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Arthrex FiberTape and TigerTape 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
• · To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption.

The proposed Arthrex FiberTape and TigerTape Cerclage Sutures are available as flat braided sutures assembled in a loop configuration. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE), polyester, and nylon materials. These materials are identical to those cleared in K221485 and K170206. 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. The proposed Arthrex FiberTape and TigerTape Cerclage Sutures may be used with or without the cleared Arthrex Dog Bone Button (K220947).

The provided document describes a 510(k) Premarket Notification for a medical device (Arthrex FiberTape and TigerTape Cerclage Sutures). It is a regulatory submission to demonstrate substantial equivalence to a previously cleared predicate device, not a study proving the device meets specific acceptance criteria in the manner of an AI/software device.

Therefore, most of the requested information regarding acceptance criteria, test sets, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of document because the submission focuses on mechanical and biological equivalency for a physical suture device.

However, I can extract information related to the performance data and the comparison made for substantial equivalence:

Information Extracted from the Document:

• Device Name: Arthrex FiberTape and TigerTape Cerclage Sutures
• Predicate Device: K220947 Arthrex Knotless AC Repair Devices
• Reference Devices: K221485 Arthrex FiberTape and TigerTape Cerclage Sutures, K170206 Arthrex FiberTape Cerclage
• Purpose of Submission: To obtain an additional indication: "To provide fixation during the healing process following syndesmotic trauma, such as fixation of acromioclavicular separation due to coracoclavicular ligament disruption."

Given that this document is for a physical medical device (sutures) and a 510(k) submission, the traditional "acceptance criteria" and "study" framework for AI/software-based medical devices (which would involve test sets, expert ground truth, MRMC studies, etc.) does not apply directly.

Instead, the "study" proving the device meets the criteria of substantial equivalence involves performance testing to demonstrate that the new device is as safe and effective as the predicate device.

Here's how to frame the information from the document in relation to your request, highlighting what is and isn't present:

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

• Acceptance Criteria (for substantial equivalence): The new device must demonstrate similar mechanical properties and biocompatibility to the predicate device, especially for the new indication. The implied acceptance criteria are that the new device's performance in specified mechanical tests is comparable to or better than the predicate.
• Reported Device Performance:

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

• The document does not specify the sample size for the mechanical tests (ultimate load, cyclic displacement, bacterial endotoxin). This information would typically be found in the full testing report, which is not part of this summary.
• Data Provenance: Not specified in terms of country of origin. The tests were likely conducted internally by Arthrex Inc. or by a contract lab. These are performance tests on the device materials/constructs, not clinical trial data.

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

• Not Applicable. This is a physical device with objective mechanical and biological testing. There is no human "ground truth" to establish for these tests (e.g., no interpretation of images or clinical outcomes by experts to be used as ground truth).

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

• Not Applicable. As above, this is objective mechanical and biological testing, not 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 is for a physical surgical suture, not an AI/software device used by human readers for diagnosis or interpretation.

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

• Not Applicable. This is not an algorithm.

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

• Mechanical and Biological Properties: The "ground truth" for demonstrating substantial equivalence relies on standard, recognized testing methodologies for medical devices (ISO, ASTM standards, or equivalent) for properties like tensile strength, fatigue, and biocompatibility (e.g., endotoxin limits). There is no "expert consensus" or "pathology" in the typical sense for these types of tests.

8. The sample size for the training set:

• Not Applicable. This is not an AI/machine learning device.

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

• Not Applicable. This is not an AI/machine learning device.

In summary, this document is a regulatory submission for a physical medical device (suture) seeking expanded indications based on demonstrated substantial equivalence through objective mechanical and biological performance testing, rather than a study for an AI/software device that would involve the complex aspects of expert-annotated test and training datasets.

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Arthrex FiberTape and TigerTape 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

The proposed Arthrex FiberTape and TigerTape Cerclage devices are available as a flat braided suture assembled in a loop configuration. Cerclage is assembled on an HDPE card or on an ABS loader. The devices are manufactured from a polyblend of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester materials. These materials are identical to those cleared in K170206. For the loop assembly, the looped end of the suture is tied as a hitch over a sheath that secures a double loop.

This document is a 510(k) summary for the Arthrex FiberTape and TigerTape Cerclage Sutures. It describes the device, its intended use, and the data submitted to demonstrate substantial equivalence to a predicate device. This is a medical device submission, not a study of an AI/ML powered device. Therefore, it does not contain the information required to answer the questions about acceptance criteria for an AI/ML powered device.

The document discusses mechanical testing and bacterial endotoxin testing to demonstrate that modifications do not negatively impact mechanical strength or pyrogen limits, which are typical for physical medical devices. It also mentions "clinical literature was provided to justify the testing conditions and acceptance criteria of the subject Arthrex Cerclage Sutures," but it does not detail these criteria or the results of a clinical study, particularly not one involving AI/ML.

Therefore, I cannot provide the requested information. The prompt asks for details about an AI/ML powered device study, but the provided text describes a submission for a physical medical device (sutures).

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