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Phoenix Sinus Tarsi Stent is an implant stabilization device used in the treatment of talotarsal joint instability in adult and pediatric patients four years of age and older. The stent is designed to stabilize the talus to prevent excessive anterior, and/or medial, and/or plantarflexion of the talus, while allowing normal talotarsal joint motion.

The Phoenix Sinus Tarsi Stent is a non-pyrogenic type IIB extra-osseous talotarsal stabilization (EOTTS) device used in the treatment of talotarsal joint instability per Graham Et al. EOTTS classification system. The stent system consists of an implant designed to be inserted into the sinus tarsi and has corresponding instrumentation to facilitate the insertion. All stents are manufactured from Ti6Al-4V ELI per ASTM F136 and have 5 sizes with varying diameter.

The Phoenix Sinus Tarsi Stent System is a medical device, and the provided FDA 510(k) clearance letter focuses on its substantial equivalence to predicate devices based on non-clinical performance testing. This type of submission does not typically involve the kind of AI/ML performance evaluation criteria and studies that would address human-in-the-loop performance, multi-reader multi-case studies, or detailed ground truth establishment as requested.

The provided document describes non-clinical performance testing to demonstrate the device's physical and biological properties. It does not involve AI or algorithms, nor does it refer to human interpretation of medical images or data. Therefore, many of the requested categories (such as human readers, AI assistance, ground truth for AI, etc.) are not applicable to this specific device and its regulatory submission.

However, I can extract the acceptance criteria and study information that is present in the document regarding the device's physical and material performance.

Acceptance Criteria and Study for the Phoenix Sinus Tarsi Stent System (Non-Clinical Performance)

The Phoenix Sinus Tarsi Stent System's acceptance criteria and performance are established through a series of non-clinical tests designed to demonstrate its safety and functionality as a physical implant. These tests do not involve AI/ML components or human interpretation studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document explicitly states: "All testing showed the subject device performed as intended. All testing met applicable predetermined acceptance criteria."

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

• Sample Size: Not explicitly stated for each test (e.g., number of stents tested for pullout, bending, etc.). For physical and material tests, sample sizes are typically determined by relevant ISO/ASTM standards.
• Data Provenance: The tests are non-clinical, implying laboratory-based testing of the device itself (e.g., physical specimens of the stent and its materials), not patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" studies are not applicable in this context.

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

• Not Applicable. For non-clinical performance testing of a physical implant, "ground truth" is established by adherence to recognized international standards (e.g., ASTM, ISO, AAMI, USP) and predefined pass/fail criteria for material and mechanical properties. There are no human "experts" establishing ground truth in the sense of medical diagnosis or interpretation for this type of testing.

4. Adjudication Method for the Test Set:

• Not Applicable. Adjudication methods like 2+1 or 3+1 are used in studies involving human interpretation of data where consensus on ground truth is required. For the non-clinical tests described, outcomes are typically objectively measured against predefined criteria specified in the test standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study is designed to evaluate the performance of diagnostic devices, especially those involving human interpretation (e.g., radiologists reading images), often with and without AI assistance. The Phoenix Sinus Tarsi Stent System is a physical implant, not a diagnostic device involving human interpretation; thus, MRMC studies are not applicable.

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

• No. This device does not incorporate any AI or algorithm component. Its performance is purely based on its physical and material properties.

7. The Type of Ground Truth Used:

• Scientific Standards and Predetermined Criteria: For mechanical tests (e.g., screw pullout, cantilever bending), ground truth is defined by the requirements and methodologies outlined in the applicable ASTM standards (e.g., ASTM F543, ASTM 2193), with specific performance thresholds (e.g., minimum pullout strength, maximum deflection).
• Biological/Material Standards: For biocompatibility (Endotoxin, Cytotoxicity) and sterilization, ground truth is based on meeting the specifications and acceptable limits defined by international standards (e.g., AAMI ST72, USP , ISO 10993-5, ISO 11137-1/2).
• Packaging Integrity: For shelf-life, ground truth is meeting parameters defined by ISO 11607-1 and relevant ASTM standards regarding package integrity.

8. The Sample Size for the Training Set:

• Not Applicable. This device does not use AI/ML, therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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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 Eleganz™ Fusion Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, and bunionectomies.

The screws are not intended for interference or soft tissue fixation.

The EleganzTM Fusion Screw System includes screws for bone fixation and a set of instruments used for screw site preparation and delivery. The device is offered in two non-sterile trays that contain the screw, Kirschner wire, bone preparation instrumentation and a driver.

The screws and Kirschner wires are used to stabilize a fracture, osteotomy site, or joint so that healing and fusion may occur which achieves its intended function.

The screws are available in solid and cannulated versions and are made from Ti6Al4V alloy. They range from 8-50 mm in length. The outer diameter is tapered, varying from 2.5 mm at the tail to 2.0 mm (solid) or 2.25 mm (cannulated) at the tip. The Kirschner wires are 316 stainless steel.

The instrumentation includes a drill, driver handle, driver bit, depth gauge / countersink, Kirschner wire, and ball and socket reamers. The drills and driver components are cannulated. The drills are offered in two lengths. The driver handle is used with the driver bit to insert the screw as well as with the drill for hand drilling. The depth gauge measures the Kirschner wire to determine its depth in the bone. The countersink has cutting flutes for easier entry into the intramedullary canal. The ball and socket reamers create a spherical radius on joint surfaces for better bony fusion.

The provided text is an FDA 510(k) clearance letter for the "Eleganz Fusion Screw System." This document primarily focuses on the regulatory clearance process for a bone fixation device, asserting its substantial equivalence to previously cleared predicate devices based on design, materials, and intended use.

Crucially, the document explicitly states under "Non-Clinical and/or Clinical Tests Summary & Conclusions":

"No clinical tests were submitted, referenced or relied for the 510(k)."

This means that the clearance was not based on studies demonstrating the device meets acceptance criteria related to its performance in a clinical setting, such as the accuracy of an AI algorithm or the improvement of human readers with AI assistance. Instead, it relies on non-clinical testing (e.g., mechanical properties) and comparison to predicate devices.

Therefore, I cannot provide the detailed information requested in your prompt regarding acceptance criteria, study findings, sample sizes, expert ground truth establishment, or MRMC studies, as this information is not present in the provided FDA 510(k) clearance letter. The questions you've asked are typically relevant to the clearance of AI/ML-enabled medical devices, where performance metrics and human-in-the-loop studies are often critical for demonstrating safety and effectiveness. The Eleganz Fusion Screw System is a physical orthopedic implant, and its clearance pathway did not necessitate the types of studies you are inquiring about.

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The TriMed® Small Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot.

The TriMed® Large Compression Screws are indicated for fracture fixations, non-unions, and osteotomies of large bones and large bone fragments in the hand, wrist, elbow, ankle, and foot.

TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium. The small screws are indicated to be used as an aid in fracture fixations, non-unions and osteotomies of small bones and small bone fragments; the large screws are indicated to be used in fracture fixations, non-unions and osteotomies of large bones and large bone fragments. The TriMed Compression Screws are designed to provide additional constraint of movement of a fractured/osteotomized bone and non-unions and are intended only as an aid to fix the fracture/osteotomy in place during the healing process.

Based on the provided FDA 510(k) Clearance Letter for TriMed® Compression Screws (K243943), here's an analysis of the acceptance criteria and the study proving the device meets them.

It's important to note that this document is for a physical medical device (compression screws), not an AI/software-as-a-medical-device (SaMD). Therefore, many of the typical criteria for AI/ML-based devices (such as ground truth establishment by experts, adjudication, MRMC studies, standalone algorithm performance, training/test set sample sizes for AI, etc.) are not applicable here.

The "study" in this context refers to mechanical testing to demonstrate the device's performance and substantial equivalence to predicate devices, rather than clinical studies with human subjects or AI model validation.

Acceptance Criteria and Reported Device Performance

The acceptance criteria for bone fixation fasteners like the TriMed® Compression Screws are primarily related to their mechanical properties, material biocompatibility, and intended use as compared to "predicate" devices already on the market. The core concept for a 510(k) clearance is "substantial equivalence."

Table of Acceptance Criteria and Reported Device Performance

The submission implies successful completion of these tests, leading to the substantial equivalence determination. |
| Material Compatibility | The materials used (medical grade stainless steel and titanium) must be biocompatible and suitable for long-term implantation in the human body. | "TriMed Compression Screws consists of small and large cannulated compression screws made of medical grade stainless steel and titanium."

The use of "medical grade" materials and comparison to predicate devices (some using stainless steel and titanium, others titanium only) implies conformance to established material safety standards. |
| Design and Principles of Operation | The device's design features, principles of operation, and manufacturing processes should be substantially equivalent to legally marketed predicate devices, ensuring similar safety and effectiveness profiles. | "TriMed Compression Screws are substantially equivalent to the predicate devices in terms of design features, principles of operation, manufacturing, packaging, and labeling."

The document specifically discusses the introduction of additional materials (stainless steel) and new screw diameters/lengths, asserting that these differences are "minor and do not raise different questions concerning safety or effectiveness." |
| Intended Use / Indications for Use | The stated indications for use for the device must align with historical use of similar devices and be supported by the device's design and performance. | TriMed® Compression Screws are indicated for "fracture fixations, non-unions, and osteotomies of small bones and small bone fragments in the hand, wrist, elbow, ankle, and foot" (Small Screws) and "large bones and large bone fragments" (Large Screws). This aligns with the use of predicate bone fixation fasteners. |
| Predetermined Change Control Plan (PCCP) | The PCCP outlines pre-approved modifications and the testing required to ensure continued safety and effectiveness without requiring new 510(k)s. This demonstrates a proactive approach to managing changes. | The PCCP details planned modifications (new materials, screw head designs, headed screw line extension) and specifies the test methods and validation activities (e.g., ASTM F543-17, FDA guidance, IEC 62366-1) that will be performed for each change. |

Study Details (as applicable to a physical medical device)

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

• Test Set Sample Size: Not explicitly stated as a "sample size" in the context of human data. For mechanical testing, this refers to the number of components or devices tested. ASTM F543-17 would specify the required number of samples for each mechanical test (e.g., torsional strength, bending strength, fatigue).
• Data Provenance: The document focuses on performance testing (mechanical studies) rather than clinical data from patients. The testing was conducted "in accordance with ASTM F543-17, FDA Guidance Orthopedic Non-Spinal Metallic Bone Screws and Washers - Performance Criteria for Safety and Performance Based Pathway, and/or in comparison to compression screws cleared under predicates K050681 and K093676." This implies the data is generated from laboratory testing of the manufactured devices. No country of origin for data (like patient data) is relevant here, as it's product engineering test data. It's prospective data generation from in vitro testing.

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

• Not Applicable (N/A). This is a physical medical device, not an AI/SaMD. "Ground truth" is established by engineering standards (e.g., ASTM F543-17) and direct comparison to the physical properties of predicate devices. The "experts" would be the engineers and scientists conducting the mechanical tests and comparing the results to the specified performance criteria, but their number and specific qualifications for "ground truth" establishment are not detailed in the context of expert consensus on an image or clinical finding.

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

• Not Applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical/imaging studies, typically for AI models. For mechanical testing, the results are quantitative and objective, measured against predefined standards.

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:

• Not Applicable (N/A). MRMC studies are specific to evaluating the clinical performance of diagnostic or AI-assisted devices with human readers interpreting cases. This device is a surgical implant.

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

• Not Applicable (N/A). This criterion is for AI algorithms. The "standalone performance" of these screws refers to their mechanical integrity without human interaction, which is assessed through the mechanical testing mentioned.

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

• Engineering Standards and Predicate Device Performance Data. For a physical implant, "ground truth" for clearance is based on adherence to recognized mechanical engineering standards (e.g., ASTM F543-17) and demonstrating that the device performs equivalently or better than, and poses no new safety concerns compared to, the already cleared predicate devices.

7. The sample size for the training set:

• Not Applicable (N/A). This question is for AI/ML models. There is no "training set" in the context of clearing a physical medical device. The "training" for the device would be its design and manufacturing process, optimized through engineering principles.

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

• Not Applicable (N/A). As there's no training set for an AI model, this question is irrelevant here. The design and manufacturing of the screws are based on established biomechanical principles and material science.

In summary, the 510(k) clearance for the TriMed® Compression Screws relies on demonstrating substantial equivalence to predicate devices through a combination of engineering design comparisons, material characterization, and rigorous mechanical performance testing according to well-established standards. The typical criteria for AI/ML devices do not apply to this type of traditional medical device.

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The SnapHammer Hammertoe Correction System is indicated for the fixation of osteotomies and reconstruction of the lesser toes following correction procedures for hammertoe, claw toe, and mallet toe. Cannulated implants in the SnapHammer Hammertoe Correction System can be used with K-wires for the delivery of implants or the temporary stabilization of outlying joints (e.g. MTP Joint).

The SnapHammer Hammertoe Correction System is comprised of an additively manufactured titanium fixation device attached to a snap-off post. The snap-off post aids in a quick insertion and snaps off after implant has been threaded in. The implants are offered in Ø3.0mm and Ø3.50mm diameters and in lengths ranging from 12mm to 15mm. The system includes drills, implant inserters, and sizers manufactured from medical grade stainless steel.

The provided FDA 510(k) Clearance Letter for the "SnapHammer Hammertoe Correction System" describes a medical device, specifically a metallic bone fixation fastener. This document is a regulatory clearance for a physical medical device, not a software or AI-based medical device.

Therefore, the information requested in your prompt regarding acceptance criteria and studies for an AI/software medical device (e.g., sample size for test set, data provenance, number of experts, adjudication methods, MRMC study, standalone performance, ground truth, training set information) is not applicable to the provided document.

The document states:

• "No FDA performance standards have been established for the SnapHammer Hammertoe Correction System."
• The non-clinical testing performed focused on:
  • "Engineering analysis comparing device characteristics including materials, intended use and processes (cleaning and sterilization methods)"
  • "The steam sterilization process has been validated per ISO 17665-1 & 17665-2 to a sterility assurance level of 10⁻⁶"
• The basis for equivalence is that the device "maintain[s] the same features as the previously cleared devices, but steam sterilization is being added as an alternative sterilization method."
• "This modification does not change the intended use or performance of the device and does not raise additional questions of substantial equivalence."

In summary, this clearance is for a physical orthopedic implant and is based on demonstrating substantial equivalence to a predicate device, primarily by showing that a new sterilization method does not alter its safety or efficacy, rather than AI/software performance metrics.

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The TITANEX® Screw Systems are indicated for fracture fixation, osteotomies, reconstruction procedures and arthrodesis of bones in the foot and ankle.

The TITANEX® Screw Systems contain cannulated bone screws and general instrumentation as a reconstruction solution for foot and ankle applications. The screws are provided in various diameters and lengths with headed, headless, partially, and fully threaded configurations. The implants are composed of titanium alloy. The instrumentation are composed of stainless steels. The devices are provided non-sterile and are intended to be steam sterilized prior to use.

I am sorry, but the provided text from the FDA 510(k) Premarket Notification does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria for an AI/ML-based medical device.

The document pertains to the "TITANEX® Screw Systems," which are metallic bone fixation fasteners, and focuses on demonstrating substantial equivalence to already marketed predicate devices. The non-clinical tests performed (e.g., torsional properties, driving torque, axial pullout strength, sterilization, biological evaluation) are typical for mechanical orthopedic implants.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualification of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone AI performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Training set sample size.
9. Ground truth establishment method for the training set.

This information is not present in the provided document because the device in question is a physical orthopedic implant, not an AI/ML-based diagnostic or therapeutic device.

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The Caliber Intramedullary Fixation System is indicated to repair an acute fracture, mal-union or non-union of the clavicle.

The Caliber Intramedullary Fixation System is an intramedullary bone fixation screw system used to repair an acute fracture, mal-union or non-union of the clavicle. The intramedullary implant consists of a cannulated screw with distal and proximal threads, a cross-screw receiving hole and a screw head. The diameter ranges from 4.5mm in lengths from 50mm to 120mm. Additionally, the subject device is self-tapping and self-tapping and is made from Titanium Alloy.

The provided text is a 510(k) premarket notification document for a medical device called the "Caliber Intramedullary Fixation System." This document aims to demonstrate the substantial equivalence of the new device to legally marketed predicate devices.

The information provided does not contain any data related to the acceptance criteria and study proving device performance for an AI/ML-driven medical device. Instead, it focuses on the physical and mechanical properties of an orthopedic implant.

Therefore, many of the requested items (e.g., sample size for test set, data provenance, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable (N/A) to the information presented in this document.

For the items that are relevant to this type of medical device 510(k) submission, here is the information:

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

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

• Sample Size: Not explicitly stated as a number of devices. The document refers to standard testing protocols (ASTM F543, ASTM F1264) which would define sample sizes for mechanical testing.
• Data Provenance: Not specified (e.g., country of origin). The testing was "performed to demonstrate safety based on recognized consensus standards and current industry practice."

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

• N/A. This device is a mechanical implant, not an AI/ML diagnostic tool requiring expert interpretation for ground truth.

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

• N/A. Not relevant for mechanical device 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:

• N/A. This is a mechanical orthopedic implant, not an AI-assisted diagnostic device.

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

• N/A. This is a mechanical orthopedic implant, not an AI algorithm.

7. The type of ground truth used:

• For mechanical properties, the "ground truth" is established by adherence to recognized consensus standards (ASTM F543, ASTM F1264) and direct measurement of physical performance within specified acceptance limits. The conclusion is based on the device meeting the performance criteria of these standards.

8. The sample size for the training set:

• N/A. This is a mechanical device, not an AI/ML model that requires a training set.

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

• N/A. Not applicable, as there is no training set for this type of device.

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Quick-Start Screws are indicated for interference fixation of grafts for ligament reconstruction such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions.

The Innovate Orthopaedics Quick-Start Orthopaedic Fixation Screw family of products are interference screws indicated for the fixation of grafts in ligament reconstruction procedures such as anterior/posterior cruciate ligament (ACL/PCL), medial collateral (MCL), lateral collateral (LCL), posterolateral corner (PLC) and medial patellofemoral (MPFL) reconstructions. The screw is composed of medical grade titanium alloy and is supplied sterile for single use in both standard thread and reverse thread designs.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "Quick-Start Orthopaedic Fixation Screw and Reverse Thread Screw." This type of document primarily confirms substantial equivalence to a predicate device and does not contain the detailed study information typically found in a clinical trial report or a comprehensive premarket submission that would elaborate on acceptance criteria and performance data for AI/ML-based devices.

The document discusses the physical characteristics and intended use of the orthopedic screws, with a focus on demonstrating equivalence to an already cleared predicate device (K231819). It mentions "bench testing" to support the use of the screws with synthetic grafts but does not provide specific performance metrics, sample sizes, or details about the methodology (e.g., ground truth establishment, expert adjudication) that would be relevant to an AI/ML-based device's validation.

Therefore, the information required to answer your request about acceptance criteria and study details for an AI/ML device is not present in the provided text. The document describes a traditional medical device (orthopedic screws) and its regulatory clearance process, not an AI/ML-driven diagnostic or therapeutic system.

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The Arthrex VAL KreuLock™ Compression Screws (2.7 mm solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7) and Distal Radius Plates.

The Arthrex VAL KreuLock™ Compression Screws (3.5 mm and larger, solid) are intended to be used in a plate-screw system for internal bone fixation for bone fractures, fusions, Osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneus, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex VAL Screws (2.7 mm solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions, in the ankle, foot, hand, wrist, tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, radius, ulna, calcaneus, and clavicle. When used with a plate, the screw may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Distal Extremity Plates, Mesh Plates (2.7-3.0) and Distal Radius Plates.

The Arthrex VAL Screws (3.5 mm and larger, solid) are intended to be used as stand-alone bone screws, or in a plate-screw system for internal bone fixation for bone fractures, fusions, osteotomies and non-unions in the ankle, foot, hand, wrist, clavicle, scapula, olecranon, humerus, radius, ulna, tibia, calcaneous, pelvis, acetabulum, metacarpals, metatarsals, femur and fibula. When used with a plate, the screws may be used with the Arthrex Low Profile Plate, Small Fragment Plates, Fracture Plates, Distal Extremity Plates, Distal Radius Plates, Humeral Fracture Plates, Osteotomy Plates, and Ankle Fusion Plates.

The Arthrex SS VAL KreuLock™ Compression Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 10 mm to 110 mm. The screws are sold single-use and non-sterile.

The Arthrex SS VAL Screws are fracture fixation devices comprised of stainless steel (316L Stainless Steel per ASTM F138) self-tapping, solid, fully threaded, variable angle locking (VAL) screws. They are offered with a 2.7 mm or 3.5 mm diameter and range in lengths from 8 mm to 110 mm. The screws are sold single-use and non-sterile.

The provided text describes mechanical performance testing for a medical device and not an AI/ML powered device, therefore the information required to answer the questions for an AI/ML powered device is not available.

The device in question, the "Arthrex SS VAL and VAL KreuLock™ Compression Screw System," is a physical medical device (fracture fixation screws) and the performance data described relates to mechanical properties (pull-out, compression, torque, etc.) and MRI compatibility. There is no mention of any AI/ML components, software algorithms, or clinical performance metrics typically associated with AI/ML device evaluations (e.g., sensitivity, specificity, AUC).

Therefore, I cannot provide a table of acceptance criteria and reported device performance in the context of AI/ML, nor can I answer questions regarding sample size for test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth for a training set was established. These categories are specifically designed for the evaluation of AI/ML-powered devices.

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