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The TriMed Distal Xtremities System is indicated for use in stabilization of fractures, malunions and non-unions of the small bones of the foot.

The TriMed Distal Xtremities System includes 2.0mm and 2.3mm locking screws and six new plate configurations designed for distal extremity fixation. The titanium plates vary in hole count and geometric profile (straight and T-shaped) to accommodate a range of anatomical and clinical needs. The Distal Xtremities plates represent variations in design to TriMed's current Xtremities plate, with additional sizes and removal of the PEEK inserts.

The provided FDA 510(k) Clearance Letter for the TriMed Distal Xtremities System does not contain any information about an acceptance criteria table, a study proving the device meets acceptance criteria, or any details related to AI/algorithm performance.

The document describes a medical device (bone fixation appliances) and its regulatory clearance process, which relies on demonstrating substantial equivalence to a predicate device based on material properties, design comparisons, and non-clinical engineering analyses (FEA analysis, theoretical calculations, and retrospective review of physical testing data for screws).

Therefore, I cannot provide the requested information for acceptance criteria and study proving meeting those criteria from the given text.

The following points are what the document does include regarding performance evaluation:

• Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b)):
  • Subject device screws were evaluated against TriMed predicate screws for performance and found to be substantially equivalent. Analysis included theoretical calculations along with retrospective review of physical testing data to show that the new 2.0 and 2.3mm screws did not create a new worst case within the TriMed screw families. Therefore physical testing of the new screws was not necessary.
  • FEA analysis was completed comparing material performance between the new Distal Xtremities plates and the current Easy Lock and Xtremities plates. The analysis showed that the dimensional differences and the change in plate materials does not impact performance.
  • Engineering analysis and physical test data show that the Distal Xtremities Screws are substantially equivalent to other TriMed screws used in the fixation of small bones of the foot. FEA analysis comparing the Distal Xtremities Plates to the predicates, showed that the dimensional and material changes did not impact mechanical performance.

This content indicates that the "study" proving the device meets the criteria was primarily non-clinical engineering analysis (FEA, theoretical calculations, and retrospective review of existing physical test data), not a clinical study involving human or AI performance. The criteria for acceptance were likely based on demonstrating comparable mechanical performance and material properties to the predicate devices.

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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 OsteoCentric® Unifi MI® TCS Plating System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, tibia, and fibula, including but not limited to periarticular and intraarticular fractures.

The OsteoCentric® UnifiMI® TCS Plating System consists of implants and instruments designed for fixation to treat fractures, deformations, revisions and replantations of bone and bone fragments. The purpose of the submission is for a line extension of the OsteoCentric Bone Plate and Screw System, which includes 2.7mm angle iron plates, additional screw sizes, and the inclusion of titanium as a material. The principal benefit of the proposed 2.7mm angle iron new plate geometry is that it allows for a stronger and more stable plate in a smaller form factor. Having a stronger and more stable plate in a smaller form factor has the potential clinical benefits of aiding the user in minimizing the incision required for the procedure and providing an option to the surgeon user that allows for the same strength and stability as a much larger plate, without having to disrupt as much soft tissue. This line extension has the same Indications for Use as the original system. This Line Extension will be known as the OsteoCentric® UnifiMI® TCS Plating System. The system features angle plates and bone screws for fixation that are locking or non-locking, and a set of instruments to facilitate installation and removal of the implants. The plates have screw holes, which allow for attachment to the bones or bone fragments. The plates are fabricated from medical grade stainless steel per ASTM F138 or Titanium per ASTM F136. Plates and screws are provided non-sterile. Instruments are provided non-sterile with instructions for sterilization.

This 510(k) clearance letter for the OsteoCentric® UnifiMI® TCS Plating System describes an orthopedic plating system, not an AI/software device. Therefore, the information typically found in a study proving acceptance criteria for an AI-based medical device (such as those involving performance metrics like sensitivity, specificity, or AUC, and details about training/test sets, expert ground truth, and reader studies) are not applicable to this document.

The document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (bone plates and screws) by assessing its mechanical performance.

Here's a breakdown based on the provided document, addressing the closest applicable points:

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

The document broadly states: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case. The data demonstrates that the subject device is substantially equivalent to the predicates."

While specific quantitative acceptance criteria and their corresponding reported performance values are not explicitly laid out in a table in this summary, the implicit acceptance criterion is:

• Acceptance Criterion: The mechanical strength and stability of the new 2.7mm angle iron plates and additional screw sizes must be equivalent to or better than the predicate devices, and not present a "new worst-case" scenario.
• Reported Device Performance: The data demonstrates substantial equivalence to the predicates in terms of mechanical strength and stability.

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

• Sample Size: Not explicitly stated in the public summary document. For mechanical testing of physical devices, this typically refers to the number of individual plates/screws tested.
• Data Provenance: Not applicable in the context of data acquisition for AI/software. The "data" here refers to the results of mechanical engineering tests (e.g., fatigue testing, static testing) performed on the physical devices. This testing would be done in a lab setting.

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

• Not applicable as this is a physical device clearance based on engineering testing, not clinical data requiring expert review for ground truth. The "ground truth" here is established by standardized mechanical testing methodologies (e.g., ASTM standards) and engineering principles.

4. Adjudication method for the test set:

• Not applicable. Mechanical test results are objective measurements (e.g., force, displacement), not subjective interpretations requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

• No. This is a physical device, and MRMC studies are relevant for software/AI devices where human readers' performance with and without AI assistance is evaluated.

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:

• The "ground truth" for demonstrating substantial equivalence for this physical device is based on engineering analysis and standardized mechanical testing results. The performance of the subject device (strength, stability) is compared against the known performance characteristics of the predicate devices, likely derived from similar benchtop testing or regulatory submissions.

8. The sample size for the training set:

• Not applicable. There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable. No training set is involved.

Summary specific to this device type (physical orthopedic implant):

The "acceptance criteria" for this type of device primarily revolve around mechanical performance and material biocompatibility to ensure it is as safe and effective as existing legally marketed predicate devices. The study proving this involves:

• Non-Clinical Testing: "Engineering analysis was performed to demonstrate that the new bone plates and screws did not present a new worst-case." This would typically include:
  • Mechanical Testing: Such as static compression/tension/torsion tests, fatigue testing, push-out/pull-out tests for screw fixation. These tests are often conducted according to relevant ASTM or ISO standards for bone plates and screws.
  • Material Characterization: Ensuring the Titanium and Stainless Steel meet medical-grade specifications (ASTM F136, ASTM F138).
• Comparison to Predicates: The test results are then compared to the performance envelopes of the predicate devices. The "acceptance" is achieved if the new device's performance falls within an acceptable range, demonstrating it is "substantially equivalent" and does not introduce new safety or effectiveness concerns due to its mechanical properties or new geometry.

The document implicitly states that the acceptance criterion was met as the data demonstrated substantial equivalence to the predicates, particularly in showing that the "new bone plates and screws did not present a new worst-case."

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The KLS Martin Ixos system is indicated for use in forearm fractures, osteotomies, and arthrodeses. This system is intended for adults, as well as adolescents (12-21 years) and children (2-12 years) in which growth plates have fused or in which growth plates will not be crossed by fixation.

The KLS Martin Ixos System consists of metallic plates used in conjunction with bone screws and locking pins intended for the internal fixation, alignment, stabilization, and reconstruction of the distal radius and/or ulna. Plates are manufactured from Ti-6Al-4V and are available in various shapes and dimensions. The system also includes the necessary instruments to facilitate placement of the implants. The manufacturing process, sterilization methods, materials and packaging are identical to those of the cleared predicate device, KLS Martin LINOS Wrist System (K222624).

The provided FDA 510(k) clearance letter for the KLS Martin Ixos System does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria for an AI/software device.

This document describes a metallic bone fixation appliance, not a software or AI medical device. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section explicitly states "Clinical Performance Data: Not Applicable" and details mechanical performance testing (in accordance with ASTM F382) and MR compatibility testing (per various ASTM standards). These are standard tests for orthopedic implants to demonstrate their static and dynamic strength, and safety in an MRI environment.

Therefore, I cannot extract the following information as it is not present in the provided text:

• A table of acceptance criteria and the reported device performance (for AI/software).
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth
• Adjudication method
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence to predicate orthopedic implants based on:

• Same intended use/indications for use.
• Similar technological characteristics: manufactured from the same materials (Ti-6Al-4V), using the same manufacturing methods, and having similar principles of operation.
• Performance data: Non-clinical comparative static and dynamic mechanical performance testing against a secondary predicate (Stryker VariAx 2 distal radius plates) and MR compatibility testing.

In summary, the provided document is a 510(k) clearance for a physical medical device (bone plate system), not an AI/software device, and thus does not include the type of performance evaluation details (e.g., ground truth, reader studies, training data) relevant to AI/software.

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The Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The Tyber Medical Distal Radius Plating System is not for spinal use.

This traditional 510K is a line extension to the Tyber Medical Distal Radius Plating System, previously cleared under K232693. The extension includes additional plates, screws, pegs, cases and trays, and instrumentation.

The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The implants – delivered sterile or non-sterile – are:

• Various bone plates of different shapes and hole configurations.
• Variable angle locking and non-locking screws in various lengths and diameters.

The implants are manufactured from Stainless Steel per ASTM F138, from Titanium alloy per ASTM F136, or Commercially Pure Titanium grade 4 per ASTM F67.

The instruments – delivered sterile and non-sterile – are intended to support the implantation of the Tyber Medical Distal Radius Plating System implants. Specialized cases/trays are available specific to the Tyber Medical Distal Radius Plating System. Other ancillary instrumentation is available but not specific to the Tyber Medical Distal Radius Plating System.

The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.

The provided document is an FDA 510(k) clearance letter for the "Tyber Medical Distal Radius Plating System." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets said criteria in the way one would expect for a diagnostic or AI-driven medical device.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials as is the case for premarket approval (PMA).

However, I can extract the information that is present concerning device performance and testing.

Here's an analysis of the provided text in relation to your request:

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

The document does not explicitly state acceptance criteria in an "acceptance criteria" column and then "reported performance" against it for parameters like sensitivity, specificity, AUC, etc., as would be expected for a diagnostic device. Instead, it describes what mechanical tests were performed and what was concluded.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Test Set Sample Size: Not specified. The testing mentioned is mechanical and engineering analysis, not clinical testing with human subjects. The phrase "subject plate designs" and "subject devices" refers to the new devices being submitted for clearance.
• Data Provenance: Not applicable for mechanical and engineering analysis. These are laboratory tests and simulations. No country of origin for patient data is mentioned as no patient data was used.
• Retrospective or Prospective: Not applicable as no clinical data was used.

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

Not applicable. This device is a bone fixation system (hardware), not a diagnostic tool requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for mechanical properties is established by engineering standards and measurements.

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

Not applicable. No human adjudication was involved in the mechanical testing or engineering analysis described.

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 MRMC study was done. This is a physical medical device (bone plating system), not an AI-driven diagnostic or image analysis tool.

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

This refers to AI or software performance. Not applicable to this physical device.

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

The "ground truth" for the mechanical testing would be defined by the specifications and tolerances established by the relevant ASTM standards (ASTM F543) and engineering principles for material strength and bending resistance.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or data training sets.

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

Not applicable.

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The A.L.P.S Proximal Humerus Plating System is indicated for fixation of fractures and fracture dislocations, fusions, osteotomies and non-unions of the humerus, particularly in osteopenic bone.

The A.L.P.S. Proximal Humeral Plating System is made from a titanium alloy and is available in configurations for both the left and right sides, as well as in various lengths. This system includes both locking and non-locking screws/pegs, along with multidirectional screws crafted from titanium alloy and cobalt chromium. It comes complete with general orthopedic instrumentation and system-specific instruments designed for use during implant installation.

Implants are available in both gamma-sterilized and non-sterile options. The disposable instruments are provided only in a sterile condition, while the reusable instruments are offered non-sterile, allowing users to perform steam sterilization before use.

This FDA 510(k) clearance letter is for a medical device called the "A.L.P.S. Proximal Humerus Plating System," which is a metallic bone fixation appliance. As such, it is not an AI/ML (Artificial Intelligence/Machine Learning) device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for an AI device is not applicable to this submission.

The FDA clearance for this device is based on comparing its technological characteristics and intended use to a legally marketed predicate device (K143697 - Biomet Proximal Humerus Plating System) and demonstrating substantial equivalence through non-clinical mechanical testing, rather than an AI performance study.

Summary of available information relevant to device performance and clearance (not AI-related):

• Acceptance Criteria & Reported Performance: The document states that the subject device's performance was evaluated through non-clinical testing. These tests include:

  • Implant Construct Axial Load Static Testing (for plates)
  • Implant Construct Axial Load Fatigue Testing (for plates)
  • Screw and Peg Performance Testing
  • The conclusion is that "any differences do not raise any different questions of safety and effectiveness; and the proposed device is at least as safe and effective as the legally marketed predicate devices." Specific numerical acceptance criteria and reported performance values from these mechanical tests are not provided in this clearance letter.

• Study Type: Non-clinical (mechanical) testing, not a clinical or AI performance study.

• Sample Size (Test Set): Not applicable in the context of an AI device's test set. For mechanical testing, the number of implants/constructs tested would be used, but this is not specified.

• Data Provenance (Test Set): Not applicable for an AI device. The "data" here refers to the results from mechanical testing of the device components.

• Number of Experts & Qualifications (Ground Truth for Test Set): Not applicable, as no expert-derived ground truth for an AI model's output is relevant here.

• Adjudication Method (Test Set): Not applicable.

• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted, as this is not an AI-assisted device.

• Standalone Performance (Algorithm Only): Not applicable, as there is no algorithm.

• Type of Ground Truth Used: Not applicable in the AI sense. The "ground truth" for this device would be established engineering standards and physical measurements from the mechanical tests.

• Sample Size for Training Set: Not applicable, as there is no AI model.

• How Ground Truth for Training Set was Established: Not applicable.

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The Indications for Use for The Acumed Wrist Fixation System / Plates, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

The Indications for Use for The Acumed Wrist Fixation System/ Screws, is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna.

The Acumed Wrist Fixation System is a new system designed for distal radius and ulna fracture fixation. The system is comprised of plates, screws, and instruments designed for aid in implantation of the distal. The intended use of The Acumed Wrist Fixation System is to provide fixation of fractures, fusions, osteotomies, and nonunions of the distal radius and ulna. The implants are manufactured from Titanium Alloy per ASTM F136-13(2021)e1 and Cobalt Chrome per ASTM F1537-20. The implants are provided sterile and non-sterile and are for single use.

This FDA 510(k) clearance letter is for a device, the Acumed Wrist Fixation System, which comprises plates and screws, not an AI/ML powered medical device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and AI-specific metrics (like MRMC studies, ground truth establishment for training sets, or expert qualifications for test sets) is not applicable to this document.

The document primarily focuses on demonstrating substantial equivalence to predicate devices through technological comparison, material safety, and mechanical performance testing, rather than studies involving human readers or AI algorithms.

Here's a breakdown of why this document does not contain the requested information:

• Device Type: This is a physical orthopedic implant (plates and screws), not a software or AI-driven diagnostic or therapeutic device.
• Acceptance Criteria/Performance: The "acceptance criteria" for such a device are typically defined by engineering standards (e.g., ASTM standards for mechanical properties, material biocompatibility), and the "performance" refers to how the device meets these physical and mechanical benchmarks. The document lists the specific ASTM standards used for testing (e.g., F382-24 for bone plates, F543-23 for bone screws) and states that "all generated passing results." However, it does not provide specific numerical criteria or reported values in a table as requested for AI performance metrics (e.g., sensitivity, specificity).
• Study Design (Test Set, Data Provenance, Experts, Adjudication, MRMC, Standalone): These concepts are fundamentally linked to evaluating AI algorithms for diagnostic or prognostic purposes, which involve processing data (images, signals) and making predictions that need to be compared against a human-established ground truth. Since this is a physical implant, these types of studies are not relevant.
• Ground Truth Type: For a physical implant, the "ground truth" relates to its material properties, biocompatibility, and mechanical integrity, which are assessed through engineering tests, not expert consensus on medical findings or pathology.
• Training Set Size/Ground Truth for Training: These are exclusively relevant to machine learning models, where a dataset is used to train the algorithm. A physical device does not have a "training set."

Summary of available information relevant to "studies" for this device:

1. Acceptance Criteria and Reported Device Performance:

   • Acceptance Criteria Basis: Compliance with various ASTM (American Society for Testing and Materials) standards and FDA Guidance Documents for orthopedic fracture fixation devices.
   • Specific Standards Mentioned:
     • ASTM F382-24: Standard Specification and Test Method for Metallic Bone Plates (for static and simulated dynamic 4-point bending testing of plates).
     • ASTM F543-23: Standard Specification and Test Methods for Metallic Medical Bone Screws (for torsional strength, driving torque, and theoretical axial pullout strength calculation of screws).
     • ASTM F384-17: Standard Specifications and Test Methods for Metallic Angled Orthopedic Fracture Fixation Devices (for single-cycle bend testing of pegs).
     • ASTM F3044-20: Standard Test Method for Evaluating the Potential for Galvanic Corrosion for Medical Implants (for corrosion testing).
     • ASTM F2052, F2213, F2182, F2119: Standards for MR safety evaluations (magnetically induced force, torque, radio frequency induced heating, and image artifact evaluations).
   • Reported Device Performance: The document states that evaluations "have all generated passing results," indicating conformity to the specified standards and guidance documents. Specific numerical performance data (e.g., exact bending strength values, torque values) are not provided in this summary but would be detailed in the full submission.

2. Sample Size/Data Provenance for Test Set:

   • Not applicable as this involves mechanical and material testing, not data analysis on a "test set" in the AI sense. The "samples" would be physical devices tested according to engineering protocols.

3. Number of Experts/Qualifications for Ground Truth:

   • Not applicable. Ground truth for mechanical testing is established by adherence to standardized testing protocols and measurement science, not expert clinical consensus.

4. Adjudication Method:

   • Not applicable.

5. MRMC Comparative Effectiveness Study:

   • Not applicable. This is not an AI-powered device.

6. Standalone Performance:

   • The "performance" described is inherently "standalone" in the sense that it refers to the physical device's characteristics under controlled laboratory conditions, without human interaction in a diagnostic loop.

7. Type of Ground Truth Used:

   • Engineering and material science standards (e.g., ASTM specifications for mechanical properties, material composition, and biocompatibility).

8. Sample Size for Training Set:

   • Not applicable. This is not an AI/ML device.

9. How Ground Truth for Training Set was Established:

   • Not applicable.

In conclusion, the provided FDA 510(k) clearance letter pertains to a non-AI medical device and therefore does not contain the specific information requested about acceptance criteria, study design, and performance metrics typically associated with AI/ML-powered medical devices. The "studies" for this device were non-clinical, mechanical, and material integrity tests to ensure safety and effectiveness in comparison to predicate devices.

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The TriMed Total Wrist fusion system is indicated for the following:

1. Wrist arthrodesis
2. Fractures of the wrist
3. Osteotomies of the wrist

The TriMed Total Wrist Fusion products are devices which are to be used as an aid to fixation of bone for treatment of certain fractures, osteotomies, or arthrodesis that lend themselves to the principle of plate and/or screw fixation.

The TriMed Total Wrist Fusion System implants are made from implant grade stainless steel.

The provided FDA 510(k) clearance letter is for a medical device (TriMed Total Wrist Fusion System) andではありません a software/AI product. Therefore, the questions related to acceptance criteria, study details, expert involvement, and ground truth establishment for AI performance are not directly applicable.

However, I can extract the information relevant to the device's testing and acceptance criteria as described in the document, which focuses on mechanical performance rather than AI performance.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The specific numerical or qualitative acceptance criteria from these guidance documents are not detailed in the provided FDA letter. The letter only states that the device met them.

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

• Sample Size: Not explicitly stated. The document refers to "All test samples," indicating that a set of samples were tested, but the exact number is not provided.
• Data Provenance: Not applicable in the context of clinical data for AI. For mechanical testing, the data would originate from laboratory testing of manufactured devices.

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

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

4. Adjudication Method for the Test Set

• Not applicable. This relates to AI model evaluation, not the mechanical testing of a physical medical device.

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

• No. The document explicitly states: "Clinical studies were not conducted for the subject devices." MRMC studies are typically for evaluating the clinical effectiveness of diagnostic tools, often involving AI.

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

• Not applicable. This refers to AI algorithm performance. The device is a physical fusion system.

7. The Type of Ground Truth Used

• For mechanical testing: The "ground truth" implicitly refers to the specified performance requirements and limits outlined in the FDA guidance documents (e.g., strength, fatigue life, stiffness). The device's performance is measured against these engineering standards.

8. The Sample Size for the Training Set

• Not applicable. This refers to AI model training data.

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

• Not applicable. This refers to AI model training data.

Summary specific to the provided document:

The TriMed Total Wrist Fusion System underwent non-clinical (mechanical) testing based on FDA guidance documents for orthopedic fracture fixation plates and metallic bone screws/washers. The key finding is that all tested samples of the device met the specified acceptance criteria outlined in these guidance documents. No clinical studies were performed. The "ground truth" in this context refers to the engineering performance standards set by the FDA for such devices.

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Intended Use: Plate and screw Implants are intended for temporary fixation, correction or stabilization of bones in various anatomical regions.

One-Quarter Tubular Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius). The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Straight Plates 2.4/2.7 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the foot, hand, wrist, and forearm (including radius) and arthrodesis of small bones of the foot and hand.

Reconstruction Plates 2.4/2.7 are indicated for fixation of fractures of the foot, hand, wrist, and forearm (including radius)

Radius Distal Styloid Plate 2.4/2.7 is indicated for the fixation for fractures of the radial styloid that have metaphyseal comminution or as an adjunct to either volar of dorsal plate fixation when additional support of the radial styloid is required.

The Radius Proximal head plates 2.4/2.7 are indicated for extra-articular and intra-articular fractures of the proximal radius and multifragmented radial neck fractures.

The Radius Distal Volar Plates 2.4/2.7 are indicated for the fixation for fractures, fusions, or osteotomies of the distal radius.

One-Third Tubular Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), and fibula. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Reconstruction Plates 3.5 are indicated for fixation of fractures of the elbow (distal humerus and ulna), wrist, and forearm (including radius), fibula, and calcaneus

Straight Plates 3.5 are indicated for fixation of fractures, osteotomies, malunions and nonunions of the elbow (distal humerus and ulna), wrist, forearm (including radius), and fibula.

Tibia T-Plates 3.5 are indicated for buttressing of partial articular fractures and bone fragments of the distal tibia.

The Clavicle Superior Plates 3.5 are indicated for:

• Fractures of the clavicle shaft
• Fractures of the lateral clavicle
• Malunions of the clavicle
• Non-unions of the clavicle

The Clavicle Hook Plate 3.5 is indicated for fixation of lateral clavicle fractures and dislocations of the acromioclavicular joint.

The Humerus Proximal Plates 3.5 are indicated for the fixation of fractures, fracture dislocations, non-unions and osteotomies of the proximal humerus.

The Tibia Proximal Lateral Plates 3.5 are indicated for:

• Split-type fractures of the lateral tibial plateau
• Lateral split fractures with associated depressions
• Pure central depression fractures
• Split or depression fractures of the medial plateau

The Tibia Distal Medial Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Tibia Distal Anterolateral Plates 3.5 are indicated for the fixation of fractures, osteotomies, and non-unions of the distal tibia.

The Humerus Distal Dorsolateral Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Humerus Distal Medial Plates 2.7/3.5 are indicated for

• Intraarticular fractures of the distal humerus
• Supracondylar fractures of the distal humerus
• Non-unions of the distal humerus

The Ulna Proximal Olecranon Plates 3.5 are indicated for

• Complex extra- and intra-articular olecranon fractures
• Non-unions of the proximal ulna
• Osteotomies
• Simple olecranon fractures

Broad Curved Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Broad Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, femur, and tibia.

Narrow Plates 4.5/5.0 are indicated for fixation of fractures, osteotomies, malunions and nonunions of humerus, and distal tibia.

T Plate 4.5/5.0 is intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load-sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

T-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

LL-Buttress Plates 4.5/5.0 are intended to buttress metaphyseal fractures of the proximal humerus, medial tibial plateau and distal tibia. The plates should only be used for load sharing purposes, e.g., buttressing, tension banding, neutralization, or compression.

Femur Distal Plates 4.5/5.0 are indicated for distal shaft fractures, supracondylar fractures, intraarticular fractures, and periprosthetic fractures of the distal femur

Tibia Proximal Lateral Plates 4.5/5.0 are indicated for proximal shaft fractures, metaphyseal fractures, intra-articular fractures and periprosthetic fractures of the proximal tibia.

The Genostis Osteosynthesis System comprises of fracture fixation plates, corresponding screws and required surgical instruments. Different shapes and sizes are available to accommodate for different anatomical regions and locations of fractures. The plate screw interface is either locking, non-locking or, for some plates, realized by a combination hole offering both options (locking and non-locking).

All plates and screws are made of titanium alloy (Ti 6Al 4V ELI) according to ASTM F136 and ISO 5832-3.

The implants of the Genostis Osteosynthesis System are sterilized by radiation and are delivered sterile.

The provided FDA 510(k) clearance letter for the Genostis Osteosynthesis System does not describe a study involving an AI/software device or human readers. Instead, it describes a traditional medical device (bone fixation plates and screws) and primarily references non-clinical (biomechanical and biocompatibility) testing to demonstrate substantial equivalence to predicate devices.

Therefore, many of the requested criteria related to AI/software performance, human reader studies, and ground truth establishment in a diagnostic context are not applicable to this document.

However, I can extract and structure the information that is relevant to the device's acceptance criteria based on the provided text, particularly concerning non-clinical testing.

Here's the breakdown based on the information available:

Acceptance Criteria and Study for Genostis Osteosynthesis System

The Genostis Osteosynthesis System is a traditional medical device (bone fixation plates and screws), not an AI/software diagnostic device. As such, the "acceptance criteria" and "study" proving it meets them are primarily based on non-clinical engineering and biological tests, not AI performance metrics or human-in-the-loop diagnostic studies.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states "All results were satisfactory" for all tests, indicating the device met the pre-defined acceptance criteria for each test.

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

• Sample Size: The document does not specify the exact number of units or samples used for each biomechanical or biocompatibility test. It generally states that testing was "performed" and "conducted on final sterile product."
• Data Provenance: Not explicitly stated as "country of origin," but testing would be performed in a controlled laboratory environment. The tests are non-clinical (biomechanical and biocompatibility), not data from patients. The study is by nature prospective in that new manufactured devices were tested to meet the standards, not a retrospective analysis of existing data.

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

• Not Applicable. This is a medical device (hardware) clearance, not an AI/software diagnostic device that requires expert ground truth for interpretation of medical images or other diagnostic data. The "ground truth" here is the adherence to established engineering and biocompatibility standards.

4. Adjudication Method for the Test Set

• Not Applicable. As this is non-clinical mechanical and biocompatibility testing, there is no "adjudication" in the sense of reconciling expert opinions on diagnostic findings. The results are quantitative and objective measurements against established standard thresholds.

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

• Not Applicable. MRMC studies are for evaluating clinical interpretation of diagnostic results, typically with AI assistance. This device is a physical implant, not a diagnostic tool or AI.

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

• Not Applicable. This pertains to AI algorithm performance. The device is a bone fixation system and does not rely on an algorithm for its primary function.

7. The Type of Ground Truth Used

• Pre-defined Standards and Controls: The "ground truth" for this device's performance is established by well-defined, internationally recognized (ISO) and American (ASTM) standards for material properties, mechanical strength, and biocompatibility. The device must perform within the specified parameters of these standards. For example, screws must meet certain torque resistance (ASTM F543), and plates must meet specific load-sharing characteristics (ASTM F382).

8. The Sample Size for the Training Set

• Not Applicable. This device does not involve a "training set" in the context of machine learning or AI.

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

• Not Applicable. There is no "training set" for this type of medical device clearance. The design and manufacturing processes are established based on engineering principles and existing predicate device designs, with performance validated against the standards mentioned above.

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