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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 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 non-absorbable suture anchors are intended to reattach soft tissue to bone in orthopedic surgical procedures.

The CONMED Argo Knotless® Anchor may be used in either arthroscopic or open surgical procedures. After the suture is anchored to the bone, it may be used to reattach soft tissue, such as ligaments, tendons, or joint capsules to the bone. The suture anchor system thereby stabilizes the damaged tissue, in conjunction with appropriate postoperative immobilization throughout the healing period.

The CONMED Argo Knotless® Anchor is an implantable bone anchor, that is supplied single use, sterilized via ethylene oxide (ETO) to a SAL of 10-6. The threaded anchor and the suture eyelet are manufactured of PolyEtherEtherKetone (PEEK) material. Each size features a single use driver, a threaded anchor, suture eyelet, a 1.0mm UHMWPE Hi-FiTM, non-absorbable retention suture, and loader tab. The retention suture holds the PEEK eyelet in place on the driver and can be incorporated into the repair if desired. A maximum of six (6) Hi-Fi #2 suture, or 1.3mm Hi-Fi ribbon suture, or (2) two limbs of Hi-Fi tape, or one (1) bioresorbable reinforced implant can be threaded through the eyelet. The repair sutures are then tensioned and cleated on the driver cleat, if deemed necessary by the surgeon. These anchor configurations require a pre-prepared bone hole which can be created with Class I, Exempt instrumentation.

Analysis of the Provided Text for Device Acceptance Criteria and Study Details

The provided text from the FDA 510(k) clearance letters for "The Acumed Wrist Fixation System" (K251296) and "CONMED Argo Knotless® Anchor" (K251530) pertains to medical devices that are physical implants, not AI-powered or software-based devices requiring performance studies with human readers or AI algorithms.

Therefore, the information requested in your prompt (e.g., acceptance criteria for AI performance, sample sizes for AI test sets, number of experts for ground truth, MRMC studies, standalone AI performance, training set details) is not present in these documents.

These 510(k) summaries describe:

• The Acumed Wrist Fixation System: Metallic bone fixation appliances. Clearance is based on substantial equivalence to pre-1976 devices. Performance data is not detailed in this specific excerpt, as it's a general clearance letter.
• CONMED Argo Knotless® Anchor: An implantable bone anchor made of PEEK. Clearance is based on substantial equivalence to a predicate device (Argo Knotless™ SP Anchor, K220757). The performance testing listed (Insertion, Ultimate Pull Displacement Resistance, Cyclic, User Validation, Packaging, Sterilization, Pyrogen, Biocompatibility, Shelf-life) are all engineering and materials-based tests for a physical implant, not diagnostic accuracy or AI performance evaluations.

Conclusion:

Based on the provided FDA 510(k) clearance letters, it is not possible to answer the questions related to AI device acceptance criteria, study methodologies (like MRMC, human reader studies, or ground truth establishment for AI), or training data for AI models. The devices described are physical orthopedic implants, and their clearance is based on mechanical and material performance, as well as substantial equivalence to previously cleared devices.

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

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

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

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

1. Table of Acceptance Criteria and Reported Device Performance

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

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The Acumed Wrist Plating System provides fixation for fractures, fusions, or osteotomies of the distal radius and ulna.

Acumed Wrist Plating System is a set of plates, screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Congruent Bone Plate Systems, per K012655, K120903 and K102998.

Acumed Wrist Plating System plates and screws are designed to provide fixation for fractures of the distal radius and ulna. The system provides plates and screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the plates and screws are manufactured from titanium alloy per ASTM F136 and pure titanium per ASTM F67, are single use and are provided both sterile and non-sterile.

The Acumed Wrist Plating System plates and screws are an extension of the Congruent Bone Plate family with new lengths and the addition of new size plates and screws. Plates and screws are intended for single patient use only.

Instruments supplied with the Acumed Wrist Plating System are intended to aid removal. Instruments are supplied sterile and non-sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

The Acumed Wrist Plating System is a medical device designed to provide fixation for fractures, fusions, or osteotomies of the distal radius and ulna. The FDA determined that the device is substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly list quantitative acceptance criteria in a dedicated table with specific pass/fail values. Instead, it refers to FDA guidance documents and international standards, implying that the device's performance met the requirements outlined in these documents.

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

The document does not explicitly state the sample sizes used for each specific non-clinical test. The testing was non-clinical, indicating that it involved laboratory-based evaluations of the device's physical and mechanical properties, not human or animal subjects. Therefore, the concept of "country of origin of the data" or "retrospective or prospective" is not directly applicable in the same way it would be for a clinical study involving patients. The data provenance is from laboratory testing conducted by or for Acumed LLC.

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

This information is not applicable as the study was non-clinical testing of the device's physical and mechanical properties. "Ground truth" in the context of expert review typically refers to clinical diagnosis or evaluation, which was not the nature of these tests. Standards like ASTM and ISO set the "ground truth" or performance benchmarks through established methodologies and consensus from experts in materials science, engineering, and medical device safety.

4. Adjudication Method for the Test Set

This information is not applicable as the study was non-clinical testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies to resolve discrepancies in expert opinions, which is not relevant for objective laboratory measurements defined by standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. The FDA 510(k) summary explicitly states: "Clinical testing was not necessary." This indicates that the regulatory pathway for this device did not require human-in-the-loop performance studies or AI assistance.

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

A standalone performance study for an algorithm was not performed. This device is a physical implant (plates and screws), not a software or AI-driven diagnostic tool.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests was established by recognized industry standards (ASTM and ISO), along with internal engineering specifications. These standards define the methodologies for testing, acceptable limits, and performance requirements for medical devices like bone fixation systems. The device's performance was compared against the requirements and specifications outlined in these standards and FDA guidance for substantial equivalence.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI/ML algorithm. Therefore, there is no "training set" in the context of machine learning. The "training" for the device design would refer to engineering principles and prior device iterations, but not data sets used to train a model.

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

This information is not applicable as there is no "training set" in the context of machine learning for this physical device. The design and manufacturing processes are guided by established engineering principles, biocompatibility requirements, and material science, all based on widely accepted scientific and regulatory standards.

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Acutrak 3 Headless Compression Screw System screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. The screws are not intended for interference or soft tissue fixation.

Acutrak 3 Headless Compression Screw System is a set of screws and instruments that are provided in case and tray configurations when distributed non-sterile as well as sterile packaged product. The system is an extension of the core technology cleared for Acumed's Acutrak 2 Headless Compression Screw Systems, per K930834, K944330 and K221333.

Acutrak 3 Headless Compression Screw System screws are designed for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The system provides screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.

The AT3 System screws are an extension of the Acutrak family with new lengths and the addition of a new smaller screw size. AT3 System screws include 4 sizes, which are referred to as Nano, Micro, Mini and Standard. The screw naming scheme is not to imply the presence of any additional features in the screws. Screws are intended for single patient use only. The AT3 System introduces a modified variable pitch screw design designed to accommodate various fracture patterns for which the AT3 System can be used.

Instruments supplied with the AT3 System are intended to aid in the screw insertion and removal. Instruments are supplied sterile, to be sterilized by the end users. System cases consisting of screw trays, instrument trays, caddies and lids are also provided to house non-sterile implants and instruments.

The provided text is a 510(k) summary for a medical device (Acumed Acutrak 3 Headless Compression Screw System). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, primarily through non-clinical testing.

Crucially, this document does not describe a study involving an AI/Machine Learning (AI/ML) powered device that would have acceptance criteria related to accuracy, sensitivity, specificity, or human-in-the-loop performance improvement.

The "device" in this context is a physical medical implant (a bone screw system), not a software or AI-powered diagnostic/analytic tool. Therefore, the questions related to AI/ML device performance metrics (such as acceptance criteria for AI algorithms, sample sizes for test sets, expert ground truth establishment, MRMC studies, standalone performance, training sets, etc.) are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and material performance of the physical screw system, through non-clinical bench testing.

However, to directly answer your request based on the provided text, and to clarify that the nature of the device means many of your specific questions are not relevant, here's what can be extracted:

Device: Acumed Acutrak 3 Headless Compression Screw System

Type of Device: Physical medical implant (bone screw system)

Study Focus: Non-clinical (bench) testing to demonstrate substantial equivalence to predicate devices and ensure safety and performance of the physical screw system.

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

The document lists the non-clinical tests performed, implying that the device "passed" or "met" the performance requirements for these tests to be deemed substantially equivalent. The specific acceptance criteria values (e.g., minimum torsional yield strength in Nm) and reported performance values for each test are not explicitly provided in this summary. They would typically be in the full submission, but not in the public 510(k) summary.

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

• Sample Size for Test Set: Not specified in the summary. For mechanical tests like these, sample sizes are typically determined by the relevant ASTM standards or internal validation protocols.
• Data Provenance: Not explicitly stated, but assumed to be from laboratory testing related to the manufacturer (Acumed LLC, based in Hillsboro, Oregon, United States). These are laboratory bench tests, not clinical data from patients. The terms "retrospective" or "prospective" are not applicable to this type of device testing.

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):

This question is not applicable. Ground truth, in the sense of expert consensus on medical images or patient outcomes, is not established for this type of non-clinical, mechanical device testing. The "ground truth" for these tests are the objective measurements against
established engineering and material science standards (e.g., precise force measurements, torque values, etc.).

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

This question is not applicable. Adjudication methods are relevant for cases where human experts interpret data (e.g., medical images) to establish a ground truth. For mechanical testing of a medical implant, the results are measured directly against predefined engineering and material standards.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

This question is not applicable. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic aids where human readers are involved in interpreting medical cases. This device is a surgical implant, not an AI diagnostic tool. The document explicitly states: "Clinical testing was not necessary."

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

This question is not applicable. This device is a physical screw, not an algorithm.

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

The "ground truth" for this type of device testing relies on adherence to international and national engineering standards (e.g., ASTM, ISO) for material properties and mechanical performance. The device's performance is measured directly against the specifications and requirements outlined in these standards, and in comparison to predicate devices.

8. The sample size for the training set:

This question is not applicable. This device is a physical product, not an AI algorithm that requires a "training set."

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

This question is not applicable. As above, there is no "training set" for a physical medical implant.

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Acutrak Fusion, Standard and Mini, AcuTwist and Acutrak 2 Micro, Mini, Standard, 4.7, and 5.5 screws are Intended as a fixation device for small bones, bone fragments, and osteotomies. It is not intended for interference or soft tissue fixation.

Acutrak Plus and (4/5), (6/7) and Acutrak 2 (7.5) and Dual-Trak screws are intended for fusions, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, and calcaneous.

The Acutrak Screw Systems are intended for use by surgeons with orthopedic training and knowledge of the indications and techniques required for fracture fixation. The device is to be implanted by the surgeon in a sterile operating room setting.

The Acumed Acutrak and Acutrak 2 Screws are designed to provide fixation of various fractures and osteotomies while they heal. These systems offer screws in different diameters and lengths to suit different anatomical locations, patient size, and fracture patterns. All the screws are manufactured from Titanium alloy per ASTM F136, are single use and are provided both sterile and non-sterile.

Instruments supplied to aid in the screw insertion and are supplied sterile and/or non-sterile and most are reusable. Sterilization trays provided to house non-sterile implants and instruments.

This is a 510(k) premarket notification for a medical device, not an AI/ML device. Therefore, the questions related to AI/ML specific criteria (such as effect size of AI assistance, standalone algorithm performance, training set details, and expert ground truth establishment for AI) are not applicable.

The acceptance criteria and studies described in this document relate to the safety and performance of the Acumed Acutrak System and Acumed Acutrak 2 System, which are metallic bone fixation fasteners.

1. Table of Acceptance Criteria and Reported Device Performance

This 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, primarily by proving that the subject devices meet established mechanical and MR safety standards. The "acceptance criteria" are the thresholds or performance requirements defined by these standards, and "reported device performance" indicates that the devices met these criteria.

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

The document does not explicitly state the exact sample sizes used for each physical and mechanical test (e.g., number of screws tested for torsional yield strength). However, the testing was conducted on samples of the Acutrak and Acutrak 2 screws, comparing them to relevant predicate screws.

• Test Set: Acutrak and Acutrak 2 Screw Systems.
• Data Provenance: The tests are non-clinical, laboratory-based tests conducted in accordance with recognized industry standards (ASTM standards). The origin of individual samples is not specified beyond being manufacturing products of Acumed LLC. The data is prospective, generated specifically for this 510(k) submission.

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

Not applicable. This is a submission for a physical medical device, and its performance is evaluated against engineering and safety standards (e.g., MR safety, mechanical strength), not against expert interpretations of a test set in the way an AI/ML device would be evaluated (e.g., image interpretation).

4. Adjudication Method for the Test Set

Not applicable. The tests are objective, laboratory-based measurements against defined physical/engineering standards, not subjective assessments requiring adjudication.

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

No. This is not an AI/ML device, so an MRMC study comparing human readers with and without AI assistance is not relevant.

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

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

7. The Type of Ground Truth Used

For this device, "ground truth" is established by:

• Established Engineering Standards: Compliance with ASTM standards (e.g., F2052, F2213, F2182, F2119, F2503 for MR safety; F543-17 for mechanical performance). These standards define acceptable performance metrics based on engineering principles and industry consensus.
• Predicate Device Performance: The mechanical performance of the subject devices was compared to existing legally marketed predicate devices to demonstrate substantial equivalence, implying that the performance of the predicate devices serves as a benchmark for "ground truth" in terms of acceptable and safe mechanical characteristics.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set."

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The Acumed Ankle Syndesmosis Repair System is intended as an adjunct in fracture repair involving metaphyseal and periarticular small bone fragments where screws are not indicated, and as an adjunct in external and intramedullary fixation systems involving plates and rods, with fracture braces and casting.

Specifically, the Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma, such as fixation of syndesmosis disruptions) in connection with Weber B and C ankle fractures.

The Acumed Ankle Syndesmosis Repair System is intended to provide fixation during the healing process following a syndesmotic trauma.

The Acumed Ankle Syndesmosis Repair System contains a fibula button, a tibia button and a high strength fiber suture assembled onto a driver, and is provided in a sterile kit as two options, one with and one without a drill. The system also offers optional washers in a separate sterile kit. The driver and drill are part of the sterile kits and are not available individually.

The metal implants including the buttons and washers are manufactured from Titanium Alloy (Ti 6AL-4V ELI per ASTM F136) and the suture is manufactured from ultra-high-molecular-weight polyethylene (UHMWPE).

I am sorry, but the provided text does not contain the information required to describe the acceptance criteria and the study proving the device meets these criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for a medical device (Acumed Ankle Syndesmosis Repair System).

While it mentions that non-clinical bench testing was conducted to demonstrate substantial equivalence to a predicate device, it does not provide:

• A table of acceptance criteria and reported device performance. It only states that static and dynamic fatigue testing was conducted and that the system performs "statistically equivalent" to the predicate. No specific performance metrics or acceptance thresholds are given.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• If an MRMC comparative effectiveness study was done or its effect size.
• If a standalone performance (algorithm only) was done.
• The type of ground truth used. (This device is a hardware implant, not an AI/software device, so the concept of ground truth in the context of expert consensus or pathology is not applicable here).
• Sample size for the training set. (Again, not applicable for a hardware device unless referring to development iterations, which are not detailed).
• How ground truth for the training set was established. (Not applicable).

The document mentions that "Clinical testing was not required to support substantial equivalence," which further indicates that the detailed study information you are asking for, especially related to human readers or ground truth derived from clinical data, would not be present in this submission type.

In summary, the provided text details the regulatory clearance of a physical medical device based on substantial equivalence to a predicate device through non-clinical bench testing, not an AI/software-based diagnosis or image analysis system that would typically involve the detailed study characteristics you've requested.

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The Acumed Clavicle Hook Plating System is intended for fixation of lateral clavicle fractures, osteotomies, mal-unions, non-unions and dislocations of the acromioclavicular joint.

The Acumed Clavicle Hook Plating System contains pre-contoured hook plates, 3.5mm locking screws and other typical instrumentation for AC joint reduction or distal clavice fragments cases. All implants are manufactured from Titanium Alloy (Ti 6AL-4V) per ASTM F136 and are provided both sterile and non-sterile.

The provided document is a 510(k) Premarket Notification for the Acumed Clavicle Hook Plating System. It details the device's substantial equivalence to existing predicate devices based on technological characteristics and non-clinical testing. Crucially, this submission does NOT describe a study involving an AI/software device whose performance needs to be proven against acceptance criteria related to accuracy or diagnostic capabilities.

The 'acceptance criteria' and 'study' mentioned in the document relate to mechanical testing of the bone fixation device (plates and screws), not to the performance of a diagnostic or AI-driven system. Therefore, I cannot extract the information required in your prompt's format, as the prompt is designed for the evaluation of AI/software as a medical device (SaMD).

Here's why and what the document does discuss:

• Device Type: The Acumed Clavicle Hook Plating System is a physical medical device (metallic bone fixation appliances and accessories), not a software or AI product.
• Purpose of Study/Testing: The "studies" described are non-clinical bench tests (mechanical tests) to ensure the device meets required strength criteria and performance for its intended use, demonstrating its safety and effectiveness.
• Acceptance Criteria Mentioned: These refer to the mechanical performance of the plates (static and dynamic bending tests per ASTM F382-17) and screws (torsion torque, pullout strength per ASTM F543-17), compared against predicate devices and FDA guidance for orthopedic metallic bone screws.
• No AI/Software: There is no mention of any AI component, image analysis, diagnostic aid, or human-in-the-loop performance evaluation in the context of AI.

Therefore, I cannot populate the table or answer the specific questions about AI/software device performance, ground truth, expert adjudication, or MRMC studies, as these concepts are not relevant to the content of this 510(k) submission.

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The Acumed Ankle Plating System contains orthopedic plates and lag screws intended for fixation of fractures, osteotomies, and non-unions of the distal tibia and fibula, particularly in osteopenic bone.

The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula. Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.

The Acumed Ankle and Small Fragment Base Set Update introduces new 2.7mm and 3.5mm variable angle screws for use with previously cleared plates from the Acumed Ankle Plating System (K143385) and Acumed Small Fragment Base Set (K143394). Additionally, this submission expands the Ankle Plating System to include use of existing 2.7mm and 3.5mm non-locking screws in independent bone fixation, for the K143385 indications.

This is a 510(k) premarket notification for a medical device, not an AI/ML medical device. As such, the document does not contain information about acceptance criteria, study details, or other specifics related to AI/ML device performance or validation. The information provided is for metal bone fixation appliances and accessories.

Therefore, I cannot provide the requested information.

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