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The Proximal Humerus Fixtion System is indicated for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus.

The Skeletal Dynamics Proximal Humerus Fixation System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

This document is a 510(k) K242436 FDA clearance letter for the Skeletal Dynamics Proximal Humerus Fixation System. It primarily focuses on demonstrating substantial equivalence to existing devices through performance testing, rather than reporting on a study with acceptance criteria and device performance as typically seen for AI/ML-based devices. Therefore, a direct response to some of the requested categories (like number of experts, adjudication method, MRMC study, training set details) will not be available in this document.

Here's the information extracted from the provided text, structured according to your request:

1. Table of Acceptance Criteria and Reported Device Performance

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

Not applicable. This device is a mechanical fixation system, not a software or AI/ML device that uses a "test set" of data in the common sense. The "testing" refers to mechanical performance testing of the hardware components.

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

Not applicable. Ground truth, in the context of expert consensus, is not relevant for the mechanical testing of this hardware device.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods are typically used for evaluating human or AI interpretations of medical images or data, not for the mechanical testing of orthopedic implants.

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

No. This document does not mention any MRMC study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This is a medical device (orthopedic implant), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for the performance of this mechanical device is based on established engineering standards and measurements as defined by ASTM F382-17 for plates and ASTM F543-23 for screws. The comparison is made against the performance of legally marketed predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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

Not applicable. This is a medical device (orthopedic implant), not an AI/ML algorithm that requires a training set.

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The Skeletal Dynamics Total Wrist Arthroplasty System is intended for replacement of the painful wrist joint due to rheumatoid arthritis, osteo-arthritis, or post-traumatic arthritis.

The subject Total Wrist Arthroplasty System is a total joint replacement of the wrist. The system has four major components: a radial component, a carpal component, a poly "lunate" component, and screws which fix the carpal component to the carpus.

This document is a 510(k) premarket notification for a medical device called the "Total Wrist Arthroplasty System (TWA)." It is a submission to the FDA seeking clearance to market this device, demonstrating its substantial equivalence to a previously cleared predicate device.

The provided text does not describe:

• Acceptance criteria for an AI/software device.
• A study proving a device meets acceptance criteria related to AI performance metrics (like sensitivity, specificity, AUC).
• Any details about sample sizes for test sets, data provenance, expert adjudication, MRMC studies, standalone performance, or ground truth establishment for AI.

Instead, this document is a regulatory submission for a physical medical implant (a wrist joint replacement system). The "Performance Testing" section refers to sterilization validation and material testing (CoCr, CPTi, UHMWPE, Ti 6AL-4V ELI) as per ISO standards (ANSI/AAMI/ISO 11135 and ISO10993-7), not AI/algorithm performance.

Therefore, I cannot fulfill your request using the provided input as it pertains to an AI/software device's acceptance criteria and study data. The document describes a traditional medical device (implant) and its manufacturing/sterilization validation.

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The Skeletal Dynamics Protean Fragment Plating System is intended for stabilization and fixation in fresh fractures, revision procedures, joint fusion, and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, clavicle, scapula, finger, toe, and pelvis, particularly in osteopenic bone with the appropriate configuration of the device. The system is intended for use in adult and pediatric populations (children and adolescents).

The Skeletal Dynamics Protean Fragment Plating System is a set of medical-grade Titanium Alloy (Ti-6Al-4V ELI) bone plates and Titanium and Cobalt Chrome (CoCr) screws and pegs designed for the stabilization and repair of small bone fragments in conjunction with general and specialized instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

This is a 510(k) premarket notification for a medical device called the Protean Fragment Plating System. This document does not describe a study involving AI or human readers for device performance evaluation. The "Performance Testing" section states that engineering analysis and mechanical testing were performed, but these are bench tests for the physical properties of the plates and screws (e.g., strength, torque), not a study comparing the diagnostic performance of the device or human readers with and without AI.

Therefore, I cannot provide information on acceptance criteria and study details related to AI performance or human reader studies.

Here's a summary of what is provided regarding performance testing, although it does not directly answer the questions about AI/human reader studies:

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

The document mentions that bench testing was performed according to ASTM standards to establish equivalency with predicate devices regarding mechanical properties. It does not provide specific acceptance criteria values or a direct side-by-side comparison table of "reported device performance" in the way one might expect for a diagnostic AI study. Instead, it makes a general statement of equivalency.

Regarding the other points in your request, the document does not contain the following information as it pertains to AI/human reader studies:

2. Sample size used for the test set and the data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications.
4. Adjudication method for the test set.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs. without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
8. The sample size for the training set.
9. How the ground truth for the training set was established.

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The FreeFix Forearm Plating System is indicated for the treatment of fractures, fusions, and osteotomies of the radius and ulna.

The FreeFix Forearm Plating System is comprised of plates, screws and specific instrumentation. The implants and instruments are provided non-sterile and shall be sterilized at the health care facility.

The provided document is a 510(k) premarket notification letter and summary for the Skeletal Dynamics FreeFix Forearm Plating System. This document DOES NOT contain information about acceptance criteria and study that proves the device meets the acceptance criteria in the format requested.

The document states:

• "Mechanical testing, which established equivalency, includes ASTM F543-23, Standard Specifications and Test Methods for Metallic Bone Screws. All acceptance criteria were met, and the FreeFix Forearm Plating System performed better than its predicate device."

However, it does not provide:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used or their qualifications.
• Adjudication method.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study.
• Information on standalone algorithm performance.
• The type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

This document focuses on establishing substantial equivalence to a predicate device based on mechanical testing (ASTM F543-23) for bone screws and does not describe clinical performance studies with human readers or AI.

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The Suture Button Repair System is intended for fixation of bone and soft tissue in upper extremity orthopedic procedures requiring ligament or tendon reconstruction in the hand, wrist, forearm, elbow and shoulder.

The Suture Button Repair System is comprised of the following Suture Button configurations in conjunction with accessories: (1) Distal Bicep Suture Button Repair configuration, (2) IOL Suture Button-Repair configuration and (3) CMC Suture Button Repair configuration. The implants are provided sterile for single use. The instruments are provided non-sterile and shall be sterilized by the end user.

The provided FDA 510(k) summary for the "Suture Button Repair System" does not describe a study involving an AI/Machine Learning device or a diagnostic device that requires establishment of ground truth by experts or a multi-reader multi-case (MRMC) comparative effectiveness study.

Instead, this document is a 510(k) submission for a surgical implant (Suture Button Repair System) and focuses on demonstrating substantial equivalence to a predicate device. The performance testing described is primarily bench-top mechanical testing and standard regulatory tests for medical devices (sterilization, biocompatibility, stability).

Therefore, I cannot extract the information requested in your prompt (acceptance criteria, details of a study proving device meets criteria, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) because these concepts are not applicable to the type of device and submission described in the input document.

The document states:

• "Non-clinical performance testing for the Suture Button Repair System included sterilization validation... biocompatibility testing... stability testing... The Suture Button Repair System was also evaluated for strength and elongation during cyclic loading and ultimate load to failure conditions." (Page 4)
• "Bench top performance testing demonstrated substantially equivalent mechanical performance as the predicate device." (Page 5)

This indicates that the "study" proving the device meets acceptance criteria was a series of engineering/mechanical tests, not a clinical study involving interpretation of images or data by human readers or AI.

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The Double Internal Joint Stabilizer - Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Predicate Internal Joint Stabilizer - Elbow (IJS-E) System consists of a titanium base plate, with the following components: A Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using a cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments.

The subject Double Internal Joint Stabilizer - Elbow (IJS-E) System is modifying the predicate IJS-E Base Plate to add an additional set of components to the other side of the IJS-E Base plate. The Proximal Connecting Rods from each side of the Double IJS-E base plate are secured to the distal humerus at the axis of rotation using the predicate male axis pin from one side and the new female axis pin from the other side. The male axis pin telescopes within the female axis pin within the distal humerus.

The subject Double Internal Joint Stabilizer - Elbow Base Plate is attached to the Ulna by the same 3.5mm compression screws as the predicate IJS-E system (K153208). The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer - Elbow. The system includes specialized instrumentation.

The system is provided non-sterile and is sterilized in the user facility.

The provided text does not contain information about an AI/ML medical device, its acceptance criteria, or a study that proves the device meets those criteria. The document is a 510(k) clearance letter from the FDA for a non-AI medical device, the "Double Internal Joint Stabilizer- Elbow."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as the provided text lacks the necessary information.

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The Align Radial Head System and accessories are designed specifically for:

• Replacement of the radial head for degenerative or post-traumatic disabilities presenting pain, crepitation, and decreased motion at the radio-humeral and/or proximal radio-ulnar joint with:
  • o Joint destruction and/or subluxation.
  • o Resistance to conservative treatment.
• Primary replacement after fracture of the radial head.
• Symptomatic sequelae after radial head resection.
• Revision following failed radial head arthroplasty.

The system is intended for press fit use.

The subject Align Radial Head System and the predicate Align Radial Head System (K172688) are a radial head prosthesis and instrumentation platform that is designed to orient the radial head perpendicular to the axis of forearm rotation. It consists of cobalt chrome modular heads in different sizes with cobalt chrome locking screws, titanium alloy stems, necks, and specialized instrumentation.

The provided text is a 510(k) summary for the ALIGN Radial Head System, which is a medical device for radial head replacement. This document primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, many of the requested sections related to AI/ML study components (such as sample sizes for test and training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance) are not applicable to this type of regulatory submission and are not present in the provided text.

The "acceptance criteria" discussed in this document refer to the criteria for demonstrating substantial equivalence to a predicate device, primarily through mechanical testing to ensure safety and effectiveness.

Here’s the information based on the provided text, with "N/A" for sections not covered by this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

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

N/A. This document describes mechanical testing of a physical medical device, not a study involving a "test set" of data or patient provenance in the context of an AI/ML device. The testing would involve physical samples of the device components. The document does not specify the number of samples used for static and fatigue compression 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)

N/A. Not applicable to mechanical testing of a physical implant.

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

N/A. Not applicable to mechanical testing of a physical implant.

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

N/A. Not applicable as this is not an AI/ML device.

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

N/A. Not applicable as this is not an AI/ML device.

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

For the mechanical testing, the "ground truth" would be established engineering standards and specifications for material strength, fatigue life, and structural integrity under simulated physiological loads, which are used to determine if the device performs equivalently to the predicate. This document does not elaborate on specific standards or the methodology of establishing "ground truth" beyond stating "mechanical testing" was performed.

8. The sample size for the training set

N/A. Not applicable as this is not an AI/ML device.

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

N/A. Not applicable as this is not an AI/ML device.

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The Skeletal Dynamics Distal Elbow Plating System is indicated for fixation of fractures, osteotomies and nonunions of the radius and ulna, particularly in osteopenic bone.

The predicate Skeletal Dynamics Distal Elbow Plating System (K171590) consists of medical grade titanium alloy radial head plates, proximal ulna plates, double hockey stick, Y and coronoid plates designed for fracture fixation, fusions, osteotomies and non-unions of the proximal radius and ulna. Included in the system are titanium bone screws and pegs, cobalt chrome cannulated polyaxial screws, k-wires, and specialized instrumentation.

The system is provided non-sterile and is sterilized in the user facility.

The modifications to the currently marketed Distal Elbow Plating System include the following.

• . Two new Proximal Ulna Plate extension options
• New 3.5mm FreeFix™ screw options .
• Addition of Protean Radial Head Plate configurations. .
• Addition of Modified Proximal Ulna Plate configurations. .

The provided text is a 510(k) premarket notification for a medical device called the "Distal Elbow Plating Sytem." This document primarily focuses on demonstrating substantial equivalence to a predicate device based on design, materials, and performance testing for mechanical properties.

Crucially, this document does NOT describe an AI/ML-driven device or study involving acceptance criteria for device performance in terms of diagnostic accuracy, sensitivity, specificity, or human-in-the-loop studies.

Therefore, I cannot extract the information required by your prompt, such as:

• A table of acceptance criteria and reported device performance (in the context of AI/ML diagnostic performance)
• Sample size for test set and data provenance
• Number of experts used to establish ground truth
• Adjudication method
• MRMC comparative effectiveness study results
• Standalone algorithm performance
• Type of ground truth used
• Sample size for training set
• How ground truth for training set was established

The "Performance Testing" section in the document refers to mechanical testing (e.g., ASTM standards for metallic bone plates and screws) to ensure the physical integrity and strength of the implant device, not its performance as a diagnostic or AI-assisted tool.

In summary, this document is entirely unrelated to the type of AI/ML device performance study details requested in your prompt.

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The Internal Joint Stabilizer- Elbow is intended to provide temporary stabilization of the elbow joint after trauma or chronic elbow dislocation.

The Skeletal Dynamic's Internal Joint Stabilizer Elbow System (K153208) consists of a titanium base plate, with a Distal Connecting Rod and Proximal Connecting Rod, held together by adjustable locking joints and locking screws which allow for multiple degrees of freedom. The system is being modified to include an Internal Joint Stabilizer - Elbow titanium base plate applied to the Company's cleared Proximal Ulna Plates of the Distal Elbow Plating System (K171590), instead of directly to the ulna as does the base plate of the cleared Internal Joint Stabilizer Elbow System.

The subject Internal Joint Stabilizer- Elbow is attached to the cleared Proximal Ulna Plates by means of two #4-40 cobalt chrome screws of 5.5mm in length and the Proximal Connecting Rod is secured to the distal humerus at the axis of rotation using the cleared cobalt chrome axis pin provided in multiple lengths from 30mm to 70mm in 5mm increments. The modified system provides internal stabilization to the elbow joint in the same manner, function, and technology as the Company's cleared Internal Joint Stabilizer Elbow. The system includes specialized instrumentation.

When attached to the cleared Skeletal Dynamics proximal ulna plate, the Internal Joint Stabilizer Elbow sits on the same anatomical location over the ulna and under the musculature and soft tissue, as does the cleared Internal Joint Stabilizer - Elbow.

The system is provided non-sterile and is sterilized in the user facility.

The provided document is a 510(k) Premarket Notification from the FDA for a medical device called the "Internal Joint Stabilizer - Elbow." It describes the device, its intended use, and the basis for its substantial equivalence to a predicate device.

However, this document does not contain information on acceptance criteria for a study demonstrating device performance of a new or modified device against specific performance metrics for clinical or AI-based devices. Instead, it focuses on demonstrating substantial equivalence through mechanical testing and engineering analysis compared to a predicate device.

Therefore, I cannot provide a table of acceptance criteria and reported device performance related to clinical outcomes, nor can I describe study details like sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or training set details. This type of information is typically associated with studies demonstrating clinical efficacy or the performance of AI/ML-based diagnostic devices, which is not the subject of this 510(k) notification.

The document states:

• Performance Testing: "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamic's Internal Joint Stabilizer Elbow is equivalent to its predicate device currently marketed. Mechanical testing which established equivalency included static and fatigue testing of the construct applied to Skeletal Dynamic's cleared Proximal Ulna Plate."
• Conclusions: "The Skeletal Dynamic's Internal Joint Stabilizer - Elbow is substantially equivalent to the Internal Joint Stabilizer Elbow predicate device identified in this premarket notification."

The "study" in this context refers to the mechanical and engineering tests to show the modified device performs similarly to the predicate device in terms of structural integrity and function, not clinical or diagnostic accuracy. There is no mention of an algorithm or AI component in this device.

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The Hand Trauma Threaded Nail System is indicated for the fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized threaded nail.

The Skeletal Dynamic's Hand Trauma Threaded Nail System consists of cannulated and noncannulated threaded nails, with distal and proximal threads with a pitch differential between the threads which creates compression during threaded nail insertion. The threaded nails are selftapping, available in multiple diameters and various lengths and made of titanium alloy.

• 2.0mm non-cannulated Hand Trauma Threaded nail:12mm-28mm in 2mm increments
• 2.0mm non-cannulated Hand Trauma Threaded Nails: 28mm 48mm in 4mm increments.
• · 3.0mm cannulated Hand Trauma Threaded Nails: 20mm 70mm in 5mm increments.
• · 3.5mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.
• · 4.0mm cannulated Hand Trauma Threaded Nails: 25mm 70mm in 5mm increments.

The system is provided non-sterile and is sterilized in the user facility.

I am sorry, but the provided text does not contain information about acceptance criteria and a study proving the device meets those criteria. The document is an FDA 510(k) clearance letter and summary for a medical device (Hand Trauma Threaded Nail System), which primarily addresses substantial equivalence to a predicate device based on similar indications for use, design, materials, and performance.

The "Performance Testing" section mentions that "Axial Pullout Strength" testing was performed to verify the addition of smaller sizes, and that this testing followed FDA guidance. It concludes that the new sizes are "as safe and effective as the predicate device." However, specific acceptance criteria for this test and detailed results are not provided in the given text.

Therefore, I cannot fulfill your request for the detailed information regarding acceptance criteria and a study to prove they are met, including sample sizes, ground truth establishment, or expert involvement, as this information is not present in the input.

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