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

The Skeletal Dynamic's Hand Trauma Screw System consists of titanium screws and specialized instrumentation.

• 2.0mm non-cannulated Hand Trauma Screws: 24mm 48mm in 4mm increments. ●
• 3.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
• 3.5mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
• 4.0mm cannulated Hand Trauma Screws: 25mm - 70mm in 5mm increments.
  The system is provided non-sterile and is sterilized in the user facility.

This FDA 510(k) clearance document for the "Hand Trauma Screw System" does not describe an AI/ML device. It pertains to a physical medical device (bone screws) and therefore the requested information regarding acceptance criteria and study details for an AI/ML device is not applicable to this document.

The document discusses substantial equivalence based on:

• Engineering analysis
• Mechanical testing (ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws)

It concludes that the device is substantially equivalent to predicate devices based on similarities in intended use, indications for use, materials, design, performance, sterility, and packaging. There is no mention of an algorithm, AI, or specific performance metrics related to diagnostic or predictive capabilities.

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The Skeletal Dynamics Inc's Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Inc's Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium allov. The system also includes 2.7mm, 3.5mm and 4.5mm locking and compression titanium alloy screws and 3.0mm polyaxial Cobalt Chrome locking screws which are provided in various lengths. The System is being modified to include additional lengths of existing screw options and new 3.5mm and 4.5mm locking and compression Titanium Alloy Screws. Additionally, minor modifications have been made to the plates to accept the new screws above mentioned. Also included in the system is specialized instrumentation. The System is provided nonsterile for sterilization in the user facility.

The Distal Humerus Plating System is comprised of:

• · Titanium alloy plates, screws, and fasteners
• · CoCr Cannulated Polyaxial Locking Screws (PLS)
• · Stainless steel K-wires (for provisional fixation; not for implantation)
• · System specific instrumentation

This document describes a medical device, the "Distal Humerus Plating System," which is a metallic bone fixation appliance. The FDA clearance is based on substantial equivalence to a predicate device, not on extensive clinical outcome studies typically associated with AI/software devices.

Therefore, many of the requested points, particularly those related to AI algorithm performance (acceptance criteria, ground truth, expert consensus, MRMC studies, etc.), are not applicable to this type of device clearance. The clearance is based on engineering analysis and mechanical testing, ensuring the device's physical properties are safe and effective.

Here's an analysis of the provided text in relation to your questions, highlighting what is present and what is absent:

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

• Acceptance Criteria (for this type of device): The primary acceptance criterion for this type of medical device cleared through the 510(k) pathway is substantial equivalence to a predicate device. This means demonstrating that the new device is as safe and effective as a legally marketed device and does not raise new questions of safety or effectiveness. For metallic bone fixation, this typically involves material compatibility, mechanical strength, and design similarities.
• Reported Device Performance: The document states:
  • "Engineering analysis and mechanical testing demonstrated that the Skeletal Dynamics Inc's Distal Humerus Plating System is equivalent to predicate devices currently marketed."
  • "Static testing, which established equivalency included ASTM-F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws."
  • "The subject device is as safe and effective as the legally marketed predicate device."

Table of Acceptance Criteria and Performance (as applicable to this device type):

2. Sample sized used for the test set and the data provenance

• Not Applicable. This is a hardware device cleared through a 510(k) pathway, not an AI/software device requiring a test set of medical images or patient data in the sense of an algorithm. The "testing" refers to mechanical and engineering tests, not data sets.

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

• Not Applicable. See point 2. Ground truth in the context of AI relates to expert labels on data. For this device, "ground truth" relates to engineering standards and validated test methods.

4. Adjudication method for the test set

• Not Applicable. See point 2.

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

• Not Applicable. This is a physical implantable device, not an AI-assisted diagnostic tool. MRMC studies are used for evaluating the impact of AI on human interpretation of medical images.

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

• Ground Truth (for this device type): Engineering specifications, validated mechanical testing standards (e.g., ASTM-F543-17), and material properties are the "ground truth" against which the device's performance is measured for substantial equivalence. There isn't "expert consensus" or "pathology" in the sense of clinical image interpretation for this specific clearance.

8. The sample size for the training set

• Not Applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

• Not Applicable. See point 8.

In summary: The provided FDA clearance document for the "Distal Humerus Plating System" pertains to a physical medical device. The regulatory pathway (510(k)) relies on demonstrating substantial equivalence to a predicate device, primarily through engineering analysis and mechanical testing. The questions you posed are highly relevant to AI/machine learning medical devices, but not to this specific hardware device clearance.

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The Skeletal Dynamics Small Bone Nailing System is indicated for the fixation of extra-articular fractures of the long bones of the hand including the metacarpals and the proximal phalanges.

The Skeletal Dynamics Small Bone Nailing System consists of intramedullary nails and screws with diameters of 2.1mm, 3.0mm, and 4.0mm, and lengths from 25mm to 70mm to address proximal phalanx and metacarpal fractures. The intramedullary nails and screws are made of medical grade titanium allov. Cobalt Chrome 1.7mm transfixion screws are also provided in various lengths. Included in the system is specialized instrumentation. The System is provided non-sterile for sterilization in the user facility.

The Small Bone Nailing System is comprised of:

• Titanium alloy intramedullary nails and screws
• CoCr locking screws and transfixion screws
• Stainless steel K-wires (for provisional fixation: not for implantation)
• System specific instrumentation

This is not an AI/ML device. The document describes a Small Bone Nailing System used for fracture fixation, which is a physical medical device and not a software-based AI/ML device. Therefore, the requested information about acceptance criteria, study details, ground truth, and training sets for an AI/ML device is not applicable and cannot be extracted from this document.

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The Skeletal Dynamics Ulnar Shortening Plating System is indicated for fractures and osteotomies, in particular for the ulna.

The Skeletal Dynamics Ulnar Shortening Plating System consists of Distal Ulnar Shortening Plates with left and right configurations in two lengths and Proximal Ulnar Shortening Plates in two lengths. The Ulnar Shortening Plates are from medical grade Titanium Allov (ASTM F136). Included within the Ulnar Shortening Plating System Set are 3,5mm cortical locking and non-locking bone screws as well as 2.3mm and 2.7mm locking and non-locking pegs from medical grade Titanium Alloy (ASTM F136) for fixation and class 1 surgical instrumentation.

The FDA 510(k) summary for the Skeletal Dynamics Ulnar Shortening Plating System (K201962) indicates that the device's acceptance criteria are based on its substantial equivalence to predicate devices, particularly in terms of performance. The study proving the device meets these criteria is primarily through performance testing, specifically static and dynamic bend strength tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide specific numerical acceptance criteria (e.g., minimum bend strength in Newtons) or exact reported device performance values. Instead, it states a qualitative acceptance criterion and confirms it was met.

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

The document does not specify a sample size for the tests. It refers to "performance test data" and "engineering analysis" but doesn't mention how many plates were tested or how many repetitions were performed.

The provenance of the data is implied to be laboratory testing (in vitro) conducted by Skeletal Dynamics, Inc., based on the mention of ASTM standards. It is not patient or clinical data.

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

This information is not applicable to this type of submission. The "ground truth" for the performance testing of a metallic bone fixation appliance is typically defined by established engineering and biomechanical standards (e.g., ASTM standards) and the performance of known predicate devices, not by expert medical opinion on a test set of clinical cases.

4. Adjudication Method for the Test Set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving interpretation of medical images or outcomes, not for in vitro mechanical performance testing of orthopedic hardware.

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 would compare human readers' performance with and without AI assistance, which is not relevant for a metallic bone fixation appliance.

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

No, a standalone performance study in the context of an algorithm's performance was not done. This refers to algorithmic decision-making, which is not what this device is.

7. The Type of Ground Truth Used:

The ground truth for the performance study was based on established engineering standards (specifically ASTM F382, ASTM F2193, and ASTM F1541) and the performance characteristics of the identified predicate devices.

8. The Sample Size for the Training Set:

The concept of a "training set" is not applicable here. Training sets are used in machine learning and AI development. This submission is for a medical device (metal plate and screws) that does not involve machine learning.

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

This question is not applicable as there is no training set for this device submission.

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The Skeletal Dynamics REDUCT® Headless Compression Screw System is intended for fixation of osseous fragments or fractures, arthrodesis of small joints, and osteotomies, with the appropriately sized screw.

The REDUCT® Headless Compression Screw (HCS) System consists of the following screws from medical grade Titanium Alloy (ASTM F136).

• · 2.5mm cannulated HCS screws: 10mm 30mm
• 3.5mm cannulated HCS screws: 10mm 50mm
• 4.5mm cannulated HCS screws: 20mm 65mm
• · 2.0mm non-cannulated HCS Arthrodesis screws: 20mm 34mm
• 2.5mm cannulated HCS Arthrodesis screws: 26mm 40mm
• 3.5mm cannulated HCS Arthrodesis screws: 32mm 46mm
  The REDUCT® Headless Compression Screw includes appropriate instrumentation, as identified in the surgical technique.

The provided text describes the 510(k) premarket notification for the REDUCT® Headless Compression Screw System. This document details the device's technical specifications and claims of substantial equivalence to a predicate device, rather than providing a study on an AI/ML powered device. Therefore, most of the requested information regarding acceptance criteria, study design, and performance metrics related to AI/ML devices is not present in the provided text.

However, I can extract the relevant information concerning the device's performance testing and acceptance criteria as described for this non-AI medical device.

1. A table of acceptance criteria and the 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)

The document does not specify the exact sample sizes for each mechanical test (e.g., number of screws tested for each parameter). The tests were performance-based, carried out in accordance with established ASTM standards. This type of testing is generally performed in a laboratory setting, not with patient data. Therefore, the concepts of "data provenance," "country of origin," "retrospective," or "prospective" do not apply in the context of this mechanical 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. The "ground truth" for this device is based on objective mechanical properties measured by instruments and adherence to established ASTM standards, not on expert interpretations of data.

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

This question is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the case for the mechanical testing of a bone screw system.

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 AI/ML powered devices that interact with human interpretation of medical images or data. The REDUCT® Headless Compression Screw System is a physical medical device, not an AI/ML system.

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

This question is not applicable. The device is not an algorithm.

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

The ground truth for this device's performance testing is based on:

• Mechanical properties: Measured values (e.g., force, torque, strength) obtained through standardized laboratory testing.
• Adherence to standards: Compliance with the specifications and methodologies outlined in ASTM F543 and ASTM F2193.
• Substantial equivalence: Comparison of these mechanical properties and the device's design/materials to a legally marketed predicate device (K143624).

8. The sample size for the training set

This question is not applicable. There is no AI/ML model for which to define a training set.

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

This question is not applicable. There is no AI/ML model, and thus no training set or ground truth for a training set.

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

The Skeletal Dynamics Forearm Plating System include Midshaft Radius Plates and Midshaft Ulna Plates, manufactured from titanium alloy (ASTM F-136) and available in multiple lengths and hole configurations.

The provided text describes a 510(k) submission for the "Skeletal Dynamics Forearm Plating System." This type of submission is for medical devices, specifically bone fixation appliances, not AI or software medical devices. Therefore, the information requested regarding acceptance criteria and studies that prove device meets criteria for an AI/ML device (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance) is not applicable to this document.

The document focuses on demonstrating substantial equivalence to a predicate device, which is a common pathway for medical devices in the US.

Here's the relevant information that can be extracted from the provided text, modified to address the non-AI nature of the device:

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

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

This information is not applicable as this is a traditional medical device (bone plate system), not an AI/ML device that uses test sets or data provenance in the same way. The performance was demonstrated through mechanical 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 information is not applicable. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices. For a bone plate system, performance is assessed through standardized mechanical tests.

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

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical trials or for evaluating human expert performance, not for the mechanical testing of a bone plate.

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 information is not applicable. An MRMC study is relevant for diagnostic AI tools that assist human readers. This device is a surgical implant.

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

This information is not applicable. This is a physical medical device, not an algorithm.

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

The "ground truth" for this device's performance is established through standardized mechanical testing, specifically ASTM F382, which evaluates the physical properties and strength of the metallic bone plates. The goal is to demonstrate that the device performs equivalently to the predicate devices under these test conditions.

8. The sample size for the training set

This information is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This information is not applicable. This device is not an AI/ML algorithm.

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The Skeletal Dynamics Distal Humerus Plating System is indicated for intra-articular fractures of the distal humerus, comminuted supracondylar fractures, osteotomies, and non-unions of the distal humerus.

The Skeletal Dynamics Distal Humerus Plating System consists of five titanium bone plates in different shapes (medial direct, lateral direct, lateral capitellar, and supracondylar), in multiple lengths, and in left and right configurations to address distal humerus fractures. The plates are made of medical grade titanium alloy. Locking and compression screws in 2.7mm, 3.5mm and 4.5mm and 3.0mm polyaxial locking screws are provided in various lengths. Also included in the system is specialized instrumentation. The System is provided non-sterilization in the user facility.

The Distal Humerus Plating System is comprised of:

• . Titanium alloy plates, screws and fasteners
• CoCr Cannulated Polyaxial Locking Screws (PLS) .
• Stainless steel K-wires (for provisional fixation: not for implantation) ●
• System specific instrumentation ●

The provided text is a 510(k) summary for a medical device called the "Distal Humerus Plating System," which is a metallic bone fixation appliance. It describes the device, its indications for use, and how its substantial equivalence to predicate devices was demonstrated through mechanical testing.

However, the request asks for information related to "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/Software as a Medical Device (SaMD). The provided document does not describe an AI/SaMD device; instead, it describes a hardware device (bone plates and screws) and the performance testing (mechanical testing, specifically ASTM standards) done to demonstrate its equivalence to predicate devices.

Therefore, I cannot fulfill all aspects of your request because the document does not contain information about:

• A table of acceptance criteria and reported device performance related to AI metrics (e.g., sensitivity, specificity, AUC).
• Sample sizes for test sets in the context of AI (e.g., number of images).
• Data provenance for AI test sets.
• Number of experts and their qualifications for establishing ground truth for AI.
• Adjudication methods for AI test sets.
• MRMC studies for AI and human-in-the-loop performance.
• Standalone performance for an AI algorithm.
• Types of ground truth for AI (e.g., pathology, outcomes data).
• Sample size for AI training sets.
• How ground truth for AI training sets was established.

The document focuses on the mechanical and material equivalence of a physical implantable device.

Here's what can be extracted and inferred from the provided text, reinterpreted as much as possible for your request, but with the explicit understanding that it's not an AI/SaMD context:

Device Description:
The Skeletal Dynamics Distal Humerus Plating System is a physical medical device consisting of titanium bone plates, locking and compression screws, and specialized instrumentation, designed for fixing fractures of the distal humerus.

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

Since this is a physical device, the "acceptance criteria" and "performance" are based on mechanical equivalency to predicate devices.

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

• Test Set Sample Size: Not explicitly stated as "sample size" in the context of a discrete number of tests on identical units, but indicated to be sufficient to demonstrate equivalency according to ASTM standards. ASTM standards define the number of samples typically required for such tests.
• Data Provenance: The "study" is an engineering analysis and mechanical testing performed to demonstrate equivalency. The data provenance would be laboratory testing conducted by the manufacturer or a third-party lab. No information on country of origin of "data" in a clinical/retrospective sense, as this is pre-market mechanical testing.

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

• Not applicable in the context of mechanical testing. The "ground truth" for mechanical testing is established by the specified parameters and methodologies within the ASTM standards themselves, interpreted and executed by qualified engineers and technicians. This is not about human labelers/readers.

4. Adjudication method for the test set:

• Not applicable. This is mechanical testing against defined engineering standards, not human expert adjudication.

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

• Not applicable. This device is a physical implant, not an AI or imaging device that would involve human readers.

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

• Not applicable. No algorithm is involved.

7. The type of ground truth used:

• The "ground truth" for the performance testing of this physical device is the mechanical and material specifications and performance parameters outlined in the referenced ASTM standards (ASTM F382 for plates and ASTM F543 for screws) and the performance characteristics of the legally marketed predicate devices.

8. The sample size for the training set:

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

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

• Not applicable.

In summary, the provided document details the regulatory clearance of a physical orthopedic implant based on demonstrating mechanical equivalence to existing products, not an AI/SaMD product. Therefore, most of your specific questions related to AI/SaMD testing and ground truth cannot be answered from this text.

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