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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 TMC Implant Fixation System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. The system can be used in both pediatric (aged > 12-21) and adult (aged 22 and over) patients. In the foot, the system can be used for the following specific examples:

• Osteotomy of the 1st metatarsal for the treatment of deformity (e.g., hallux valgus) such as:

• Opening base wedge osteotomy
• Closing base wedge osteotomy
• Crescentic osteotomy
• Proximal Chevron osteotomy
• Distal Chevron osteotomy (Austin)
• Transverse osteotomy

• Arthrodesis of the tarsometatarsal (TMT) joints or the 1st metatarsophalangeal (MTP) joint for the treatment of deformity (e.g., hallux valgus, hallux rigidus, metatarsus adductus) and/or arthritis

• First metatarsal fracture fixation

• Flatfoot Osteotomies

• Lateral Column Lengthening (Evans Osteotomy)
• Plantar Flexion Opening Wedge Osteotomy of the Medial Cuneiform (Cotton Osteotomy)

• Mid / Flatfoot Fusions

• LisFranc Arthrodesis and/or Stabilization
• Intercuneiform Fusions
• Navicular-Cuneiform (NC) Fusion
• Talo-Navicular (TN) Fusion
• Calcaneo-Cuboid (CC) Fusion

• Medial Column Fusion

The TMC Implant Fixation System is comprised of straight, L-shaped, H-shaped, anatomically curved plates, intramedullary plates, cannulated and non-cannulated compression implants, and associated instruments. It includes 2.5 mm, 2.7 mm, 3.0 mm, and 3.3 mm diameter cannulated and non-cannulated, locking, and non-locking screws in lengths ranging from 10-36 mm. The plates, screws, and compression implants are intended for use in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of the feet. All implantable components are manufactured from implant grade titanium alloy (Ti-6Al-4V-ELI) per ASTM F136 and are provided sterile by gamma irradiation.

This document describes the regulatory clearance of a medical device, the "TMC Implant Fixation System," not an AI diagnostic device. Therefore, many of the requested categories for AI-specific studies are not applicable. I will extract the information that is relevant to the provided text.

Here's an analysis of the provided FDA 510(k) clearance letter:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size (Test Set): Not explicitly stated. The document refers to "testing and analysis" between the subject and predicate devices for mechanical properties. This typically involves a defined number of test specimens (e.g., plates, screws) for each test type, but the exact quantity is not detailed in this summary.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The testing described is mechanical, performed on physical device samples.

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

• Not applicable. This device is a metallic bone fixation system, and the "ground truth" for mechanical testing is established by recognized engineering standards (like ASTM F382) and FDA guidance, not by expert interpretation of images or clinical outcomes in the same way an AI diagnostic device would.

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

• Not applicable. Mechanical testing results are objective measurements (e.g., force, displacement, cycles to failure) against predefined pass/fail criteria, not subjective human assessments 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:

• No. This is a medical device for bone fixation, not an AI diagnostic tool. MRMC studies are used for evaluating diagnostic performance with and without AI assistance.

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

• No. This is a physical implant system, not a software algorithm.

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

• For mechanical performance: The ground truth refers to established engineering standards (ASTM F382) and FDA guidance for orthopedic implants. Performance is measured against physical properties like strength, fatigue resistance, and screw pullout force.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable.

Summary of the Study Proving Device Meets Acceptance Criteria:

The study proving the TMC Implant Fixation System meets acceptance criteria was a series of mechanical performance tests. The primary testing included:

• Static 4-point bend testing
• Dynamic 4-point bend testing
• Axial pullout testing

These tests were conducted in accordance with established standards:

• ASTM F382 Standard Specification and Test Method for Metallic Bone Plates was used for the 4-point bend testing.
• Modified acceptance criteria derived from the FDA Guidance for Orthopedic Non-Spinal Metallic Bone Screws and Washers – Performance Criteria for Safety and Performance Based Pathway (issued November 22, 2024) were used for the axial pullout testing.

The document states that "The testing and analysis demonstrated that the subject devices met all acceptance criteria and therefore are substantially equivalent to the predicate devices." This substantial equivalence determination suggests that the new device's mechanical performance is comparable to or better than that of the legally marketed predicate devices, thereby assuring its safety and effectiveness for its intended use.

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The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System.

The 2.4mm Non-Locking (NL) Hexalobe Screws are intended to be used in conjunction with The Acumed Wrist Fixation System, which consists of plates, screws, and instruments designed to aid in implantation. The intended use of the 2.4mm NL Hexalobe Screw is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna when used in conjunction with The Acumed Wrist Fixation System. The implant is manufactured from Titanium Alloy per ASTM F136-13(2021)e1. The implant is provided sterile and non-sterile and is for single use only.

The provided FDA 510(k) clearance letter and summary for "The Acumed Wrist Fixation System - 2.4mm Screws" (K252356) describe a medical device (bone screws), not an AI/software device. Therefore, the information requested regarding acceptance criteria and studies specifically for AI/software performance metrics (such as "sample size used for the test set," "data provenance," "number of experts," "MRMC comparative effectiveness study," "standalone performance," and "training set") is not applicable or cannot be extracted from this document.

The document discusses substantial equivalence based on non-clinical performance testing for a physical medical implant.

However, I can extract the acceptance criteria and the summary of the study results that demonstrate the device meets these criteria, as described in the provided text.

Acceptance Criteria and Study for The Acumed Wrist Fixation System - 2.4mm Screws (K252356)

The device, "The Acumed Wrist Fixation System - 2.4mm Screws," is a physical medical implant, not an AI/software device. Its acceptance criteria and performance evaluation are based on non-clinical engineering and materials testing, adhering to recognized consensus standards and FDA guidance documents for medical devices of this type.

1. Table of Acceptance Criteria and Reported Device Performance

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

• The document does not explicitly state the sample sizes (number of screws) used for each specific non-clinical test (e.g., torsional strength, driving torque, pullout calculations, or MR compatibility evaluations). These tests typically involve a predetermined number of test specimens according to the respective ASTM standards to ensure statistical validity.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The data provenance here refers to the source of the physical test specimens (manufactured according to specifications) and the laboratory where the tests were conducted (implied to be in-house or by a certified testing facility).

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

• This question is not applicable as the document describes non-clinical engineering tests for a physical device, not an AI/software device requiring expert ground truth for image or data interpretation. Performance is assessed against engineering standards.

4. Adjudication Method for the Test Set

• This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) refer to clinical expert consensus for ground truth establishment in studies involving human interpretation, which is not relevant to the non-clinical testing of this physical device. The "adjudication" in this context would be the interpretation and approval of test results against the specified ASTM standards by qualified engineers and regulatory specialists.

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 evaluating the impact of an AI system on human reader performance, which is not applicable to a physical bone screw. The submission states, "Clinical Testing was not required to support substantial equivalence (Not Applicable)."

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

• This question is not applicable as the device is a physical bone screw and not an algorithm or software. Its performance is inherent to its physical properties and design, tested independently of human intervention during the test itself (though human engineers conduct the tests).

7. The Type of Ground Truth Used

• The "ground truth" for the non-clinical tests described is defined by the specific requirements and methodologies outlined in the referenced ASTM consensus standards (e.g., ASTM F543-23 for mechanical properties, ASTM F2052, F2213, F2182, F2119 for MR compatibility). These standards provide quantifiable thresholds and test procedures that determine if a device performs as expected for its intended use. In essence, the "ground truth" is compliance with these established engineering and material science specifications.

8. The Sample Size for the Training Set

• This question is not applicable. The concept of a "training set" refers to data used to train an AI model. This device is a physical product and does not involve AI.

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

• This question is not applicable as there is no AI training set for this physical device.

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The T2 Alpha Humerus Nailing System is indicated for the treatment of humerus fractures. Fractures can include, but are not limited to, non-unions, malunions, malalignments, pathological fractures, and impending pathological fractures.

The IMN Screws System is intended to stabilize the intramedullary nail-bone construct for temporary stabilization.

The T2 Humeral Nail is intended to provide temporary stabilization of various types of fractures, malunions, and non-unions of the humerus. The nails are inserted using an open or closed technique and can be static, dynamic, or compression locked. The subject and predicate devices are indicated for use in the humerus. Types of fractures include, but are not limited to, fractures of the humeral shaft, non-unions, malalignments, pathological humeral fractures, and impending pathological fractures.

The T2 Alpha Humerus Nailing System is an intramedullary humerus fracture nailing system consisting of sterile implants (Nails, End Caps, Compression Screw, and Washer) and non-sterile indication-specific instrumentation. The Nails, End Caps, Compression Screw, and Washer are made of titanium alloy as per ASTM F136. The T2 Alpha Humerus Nailing System will be used with the existing Locking Screws and Advanced Locking Screws of the IMN Screws System.

The IMN Screws System includes bone screws (Locking Screws and Advanced Locking Screws) that are inserted through the intramedullary nail to stabilize the nail-bone construct. All screws are sterile and made of titanium alloy (Ti6Al4V ELI) per ASTM F136.

The T2 Humeral Nail System is an intramedullary nailing system that allows antegrade and retrograde humeral nailing. The nails, end caps, compression screw, and washer are provided sterile and made of titanium alloy as per ASTM F136.

The provided FDA 510(k) clearance letter (K251400) does not concern an AI/software device. Instead, it pertains to a physical medical device: the Stryker T2 Alpha Humerus Nailing System, IMN Screws System, and T2 Nailing System, which are intramedullary fixation rods and bone screws used for treating humerus fractures.

Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/software performance metrics (e.g., accuracy, sensitivity, specificity, F1-score, expert consensus, MRMC studies) are not applicable to this submission.

The document discusses non-clinical performance testing for the physical device, focusing on mechanical properties, sterilization, packaging, and biocompatibility, to demonstrate substantial equivalence to previously cleared predicate devices.

Key points from the document regarding "performance":

• Non-Clinical Performance: This section details various engineering and material tests performed on the physical implants, such as dynamic and static bending, torsional stiffness, targeting accuracy, insertion torque, pull-out force, MRI assessment (magnetically induced displacement/torque, RF-induced heating, image artifacts), packaging tests, and biocompatibility evaluation. All these tests are standard for orthopedic implants.
• Clinical Performance: The document explicitly states: "Clinical data were not needed for the subject devices to demonstrate substantial equivalence to the predicate devices." This is a common situation for 510(k) submissions of physical devices where substantial equivalence can be demonstrated through non-clinical testing and comparison to predicates.

Since the request asks for information relevant to AI/software device performance, and this document is for a physical orthopedic device, I cannot extract the requested information (e.g., sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance) because it is not present and not relevant to this specific biological device 510(k) submission.

In summary, there is no AI/software component in this device clearance that would require the types of performance statistics and study methodologies described in the prompt.

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The ANTHEM® Fracture System is indicated for fixation of fractures, osteotomies, arthrodesis and reconstruction of bones for the appropriate size of the device to be used in adult patients, including the clavicle, scapula, humerus, radius, ulna, small bones (metacarpals, metatarsals, phalanges), wrist, pelvis, femur, tibia, fibula, ankle, and foot. The clavicle hook plate may be used for dislocations of the acromioclavicular joint. Distal femur, distal humerus, proximal ulna, and proximal radius plates are indicated for diaphyseal, metaphyseal, epiphyseal, supracondylar, intra-articular, extra-articular, condylar, periprosthetic, and comminuted fractures, and for non-unions and malunions. Mini fragment plates are also indicated for fixation of fractures of the acetabulum, patella, and bone fragments, replantation, malunions and nonunion, and for non-load bearing stabilization and reduction of long bone fragments. Metaphyseal plates are indicated for non-load bearing stabilization and reduction of long bone fragments, and for fixation of bones including the radius and ulna.

In addition to adult patients, small fragment, mini fragment, proximal tibia, clavicle, metaphyseal, distal humerus, proximal ulna, proximal radius, and distal fibula plates are indicated for use in infant, child, and adolescent pediatric subgroups and small stature adults. Distal femur plates are indicated for use in the diaphyseal and metaphyseal areas of long bones in adolescent pediatric patients. Distal radius, distal tibia, metaphyseal, and mini fragment plates are indicated for use in adolescents (12-21 years of age). Plating can be used in patients with osteopenic bone.

The ANTHEM® Fracture System is a family of plates, screws, and washers designed to be used for internal bone fixation. The implants are available in various sizes and shapes, and may be contoured or straight, with various lengths to accommodate patient anatomy. The subject ANTHEM® plates are manufactured from titanium alloy per ASTM F136 or stainless steel as specified in ASTM F138 and F139. Plates are also available additively manufactured from titanium alloy powder per ASTM F3001.

I am sorry, but based on the provided FDA clearance letter for the ANTHEM® Fracture System, I cannot extract the information you requested regarding acceptance criteria and the study that proves the device meets those criteria, specifically concerning human-in-the-loop performance, ground truth establishment, or training set details.

This document is a 510(k) clearance letter for a physical medical device (bone fixation system) and focuses on demonstrating substantial equivalence to predicate devices, primarily through engineering analysis and mechanical testing of the physical components. It does not appear to involve any AI/software component that would require the kind of performance study details you are asking for (e.g., sample size for test/training sets, expert adjudication, MRMC studies, standalone algorithm performance, or different types of ground truth like pathology or outcomes data).

Therefore, I cannot populate the table or answer the specific questions about AI/software performance studies. The "Performance Data" section solely refers to mechanical testing according to ASTM F382 and biocompatibility, which are standard for physical implants.

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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 indications for use of these internal fixation devices include:

• Open and closed femoral fractures
• Pseudoarthrosis and correction osteotomy
• Pathologic fractures, impending pathologic fractures and tumor resections
• Supracondylar fractures, including those with intraarticular extension
• Fractures involving osteopenic and osteoporotic bone
• Fractures distal to a total hip prosthesis
• Periprosthetic fractures
• Nonunions and malunions

The struts of the T2 Alpha Femur Retrograde Nailing System are intended to be used only with the nails of this system; they are not to be used as stand-alone devices.

T2 Alpha Femur Retrograde Nailing System, previously cleared in K203819, consists of sterile implants (intramedullary nails in various diameter and sizes, compression screw and end caps), as well as nonsterile instruments (targeting devices).

The subject of this 510(k) submission is to introduce new devices of the T2 Alpha Femur Retrograde Nailing System. This line extension consists of anatomically pre-contoured struts and interlinking dowels designed to be used in combination with the existing nails of the T2 Alpha Femur Retrograde System for the treatment of complex fractures of the distal femur.

All struts are manufactured from Ti6Al4V ELI (Type II anodization) and are available in different sizes and left/right versions; these will be provided both non-sterile and sterile packaged. Interlinking dowels to the femoral nail are manufactured from CoCr and will be provided sterile packaged.

This appears to be a 510(k) clearance letter for an orthopedic implant, not an AI/Software as a Medical Device (SaMD). The document describes the "T2 Alpha Femur Retrograde Nailing System," which is a physical device used for internal fixation of femoral fractures.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, expert ground truth, MRMC studies, standalone performance, and training/test set provenance does not apply to this clearance document. These criteria are typically evaluated for AI/SaMD products, where algorithmic performance and human-AI interaction are critical.

The provided document details:

• Device Type: Intramedullary fixation rod (physical implant).
• Performance Data: Non-clinical bench testing (fatigue strength, cut-out performance, stiffness, shear-off, pull-out, insertion, static bending, fretting corrosion, targeting accuracy, MR assessment, packaging) and references to clinical evidence from peer-reviewed scientific literature.
• Comparison to Predicate Devices: Focuses on material, manufacturing, intended use, and mechanical performance equivalence.

No mention of AI, algorithms, or software performance evaluation is present.

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The Aevumed PHANTOM™ Suture Anchors are intended to be used for suture or tissue fixation in the foot, ankle, knee, hand, wrist, elbow, shoulder, and hip. Specific indications are listed below:

Shoulder: Rotator Cuff Repair, Bankart Repair, SLAP Lesion Repair, Biceps Tenodesis, Acromio-Clabicular Separation Repair, Deltoid Repair, Capsular Shift or Capsulolabral Reconstruction

Foot/Ankle: Lateral Stabilization, Medial Stabilization, Achilles Tendon Repair, Metatarsal Ligament Repair, Hallux Valgus Reconstruction, Digital Tendon Transfers, Mid-foot Reconstruction

Knee: Medial Collateral Ligament Repair, Lateral Collateral Ligament Repair, Patellar Tendon Repair, Posterior Oblique Ligament Repair, Iliotibial Band Tenodesis

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

Hip: Capsular repair, Acetabular Labral Repair

The Aevumed PHANTOM™ Sutures Anchor with HS Fiber™ suture is a suture anchor manufactured from polyetheretherketone (PEEK) material and are preloaded on a disposable inserter assembly intended for fixation of soft tissue to bone. The Aevumed PHANTOM™ Suture Anchors are available in diameter sizes: 3.5mm and 4.5mm. They are offered sterile and are for single use only.

The document provided is an FDA 510(k) clearance letter for the Aevumed PHANTOM Suture Anchors. This type of device (a bone fixation fastener) is a physical implant and not an AI/ML-driven diagnostic or assistive technology. Therefore, the questions related to AI/ML device performance (such as acceptance criteria for AI performance, sample size for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, ground truth establishment for training and test sets, and training set size) are not applicable to this submission.

The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (Aevumed RAPID Suture Anchors, K223878) based on non-clinical performance and material characteristics, rather than diagnostic accuracy or AI effectiveness.

Here's an analysis based on the information provided, tailored to a medical device clearance:

1. Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study conducted was a non-clinical mechanical testing study. This involved direct comparative testing of the Aevumed PHANTOM™ Suture Anchor against its primary predicate device, the Aevumed RAPID™ Suture Anchor (K223878).

• Tests performed: Insertion testing, cyclic tensile testing, and static tensile testing.
• Key finding: The Aevumed PHANTOM™ Suture Anchor demonstrated "significantly higher pullout strength" in comparison to the predicate RAPID™ Anchor.
• Conclusion drawn: The data supports the relative safety of the device and demonstrates that it performs as intended and comparably (or superiorly in key mechanical aspects) to the predicate device.

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

• Sample Size: The document does not specify the exact number of devices (suture anchors) used in the non-clinical mechanical tests. These tests typically involve a statistically significant number of samples to ensure repeatability and reliability of the results.
• Data Provenance: The data is generated from laboratory-based non-clinical mechanical testing. This means the "data provenance" isn't in terms of patient population (e.g., country of origin, retrospective/prospective) but rather controlled experimental conditions.

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

• Not Applicable. For a physical medical device like a suture anchor, "ground truth" for non-clinical mechanical testing is established by engineering standards and validated testing methodologies, not by expert interpretation of patient data or images. The "ground truth" would be the measured physical properties (e.g., pullout strength).

4. Adjudication Method for the Test Set:

• Not Applicable. As mentioned above, this device does not involve human interpretation of data for its primary evaluation for 510(k) clearance. Mechanical tests have quantitative outputs, not subjective interpretations requiring adjudication.

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

• No. An MRMC effectiveness study is relevant for diagnostic imaging or AI-assisted diagnostic devices where human readers interpret cases. This is not applicable to a physical implantable device like a suture anchor.

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

• Not Applicable. This is not an algorithm-based device.

7. The Type of Ground Truth Used:

• The "ground truth" for demonstrating substantial equivalence for this device is based on objective engineering and mechanical performance data (e.g., measured pullout strength, tensile strength, and material properties) obtained from non-clinical laboratory testing, alongside adherence to established standards for biocompatibility and sterilization.

8. The Sample Size for the Training Set:

• Not Applicable. This device is not an AI/ML model, so 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 type of device.

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The RONAVIS-FX is intended to be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system and for temporary bone stabilization (

The RONAVIS-FX is an external fixation device configured as a pin, which is inserted into the bone unicortically during orthopedic procedures. It consists of three components: a sleeve, an inner pin, and an anchor head. It is made of SUS316L and is provided non-sterilized. It should be sterilized by the user before use and is prohibited from being reused.

The provided document is an FDA 510(k) clearance letter for a medical device called RONAVIS-FX. This letter does not contain any information regarding clinical studies, acceptance criteria for an AI/algorithm, or the performance of such an AI/algorithm. It pertains to a physical medical device (an anchor pin) for bone fixation, not a digital health product or an AI-based diagnostic tool.

Therefore, I cannot fulfill the request for information regarding a study that proves the device meets acceptance criteria for an AI/algorithm, as the provided input does not describe such a device or study.

The document discusses:

• Device Type: Smooth or Threaded Metallic Bone Fixation Fastener (an anchor pin).
• Indications for Use: Applied to the skeletal system for pulling force (traction) and temporary bone stabilization (

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