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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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