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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

No MRMC study was done. This is a physical medical device (bone plating system), not an AI-driven diagnostic or image analysis tool.

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

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

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

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

8. The sample size for the training set

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

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

Not applicable.

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

The Tyber Medical Distal Radius System is not for Spinal Use.

The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments.

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

The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.

All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L).

A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system.

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

This FDA 510(k) summary describes a new medical device, the Tyber Medical Distal Radius Plating System, and its claim of substantial equivalence to predicate devices. The information provided heavily emphasizes mechanical and materials testing, typical for orthopedic implants, and explicitly states that no clinical testing was performed.

Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding human-in-the-loop performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, is not applicable in the context of this submission. The device is a physical implant, not an AI or software-based diagnostic tool that would typically involve such studies.

Here's a breakdown of the relevant information provided:

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

The document does not present a formal table of acceptance criteria with reported device performance in the way one might expect for a software or AI device. Instead, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section serves this purpose for a mechanical device.

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

• Not Applicable. This device is a physical implant. The "testing" referred to is mechanical and engineering analysis, not data analysis on a test set of patient cases.

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 establishment by experts is relevant for diagnostic or AI devices evaluating patient data, not for the mechanical properties of an implant.

4. Adjudication method (e.g. 2+1, 3+1, none) 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 hardware device (bone plating system), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of submission.

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

• Not Applicable. This is a hardware device. No algorithm exists for standalone performance evaluation in this context.

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

• For the mechanical aspects, the "ground truth" would be the material specifications (ASTM F 136, 316L Stainless Steel) and the established performance standards outlined in ASTM F382 and ASTM F543 for metallic bone plates and screws, respectively. The engineering analysis provided serves as evidence against these established standards.

8. The sample size for the training set

• Not Applicable. No training set is relevant for this type of mechanical device submission.

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

• Not Applicable. See point 8.

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The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

This special 510(k) submission is intended to add new plate designs, screw diameter options and lengths, pegs, and accompanying instrumentation to the Miami Device Solutions Distal Radius Plating System cleared through K161292/K162635.

The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, pegs, and locking caps. The Distal Radius Plates are available in bilateral and side-specific designs to accommodate different anatomies and fracture patterns. The addition of new devices through this special 510(k) provides the user with more options for fixation.

Materials: Ti-6Al-4V ELI alloy conforming to ASTM F136.

The provided text is an FDA 510(k) clearance letter and summary for a medical device: the Distal Radius Plating System. This document is related to orthopedic surgical implants, not to an AI/ML-driven diagnostic device.

Therefore, the document does not contain any information about:

• Acceptance criteria for an AI/ML model's performance.
• A study proving a device meets acceptance criteria for an AI/ML model.
• Sample sizes for test sets or data provenance for an AI/ML model.
• Number of experts or their qualifications for establishing ground truth for an AI/ML model.
• Adjudication methods for an AI/ML model.
• Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
• Stand-alone (algorithm-only) performance of an AI.
• Type of ground truth used for AI/ML.
• Sample size for training sets for AI/ML.
• How ground truth for training sets was established for AI/ML.

The "Performance Data" section explicitly states:

• Non-Clinical Performance and Conclusions: "The results of non-clinical (laboratory/performance) testing as well as engineering analysis for subject devices demonstrate that the device is as safe and as effective as the predicates. Substantial equivalence is demonstrated in the performance testing section of the submission by comparing subject and predicate designs, as well as testing according to ASTM F543-07, Standard Specification and Test Method for Metallic Bone Screws."
• Clinical Performance and Conclusions: "Clinical data and conclusions were not needed for this device."

This indicates that the clearance was based on bench testing (mechanical properties, material specification, comparison to predicates), not on the performance of a diagnostic algorithm or AI.

In summary, none of the requested information regarding acceptance criteria and performance studies for an AI/ML device can be extracted from this document, as it pertains to a different type of medical device.

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The VariAx Distal Radius Plating System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures. Indications include: compression fractures, intra-articular and extra-articular fractures, displaced fractures. Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

The Stryker VariAx 2 System screws, when used in conjunction with VariAx Plating Systems; or used independently in a lag screw technique, are indicated for: Internal fracture fixation; Osteotomies; Revision procedures such as non-unions or mal-unions;

In addition, the following indications are specific to the devices listed below: T8 2.4mm Screws & T8 2.0mm Locking Peg: For use in small bones, primarily including the Distal Radius, in the treatment of: Compression fractures; Intra-articular and extra-articular fractures; Displaced fractures; Reconstruction procedures; T8 2.7mm Screws: For use in small bones, including the Distal Radius as well as the fore, mid- and hind Foot and Ankle, in the treatment of: Intra-articular and extra-articular fractures of the Distal Radius, Displaced and compression fractures of the Distal Radius; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Reconstruction procedures in the Foot & Ankle and Distal Radius; T10 3.5mm and T10 2.7mm Screws: For use in the Radius, Ulna, Clavicle, Humerus, Foot and Ankle, Distal Tibia and Fibula, in the treatment of: Intra-articular and extra-articular fractures of the Distal Humerus and Proximal Ulna; Single, segmental and comminuted fractures; Replantation, joint fusions or arthrodesis and corrective osteotomies in the Foot & Ankle; Normal bone density or osteopenic bone.

This Traditional 510(k) submission is intended to provide information on a new packaging configuration of the VariAx Distal Radius Plates. The components of the VariAx Distal Radius System remain identical to those in the most recently cleared in K141430. No new components have been added to the system.

Briefly, the VariAx Distal Radius Plating System consists of several different plates and screws manufactured from Commercially Pure Titanium Grade 2 (ASTM F67) and Titanium Alloy (ASTM F136), respectively. The VariAx 2 System (screws) (cleared under K140769) include a series of Titanium Alloy (ASTM F136) screws intended to be used across the entire VariAx line. The VariAx 2 T8 2.0 mm peg, T8 2.4 mm and T8 2.7 mm screws, and washer are specifically indicated for use with VariAx Distal Radius Plating System. All implants are provided sterile and non-sterile.

The new packaging configuration, called the VariAx 2 Xpress Distal Radius Kit, includes already cleared sterile packed VariAx Distal Radius Plates and VariAx 2 T8 2.7 mm screws along with single use class I exempt instrumentation.

This document is a 510(k) summary for a medical device submission, specifically for the VariAx Distal Radius Plate System and VariAx 2 System.

The FDA 510(k) clearance process is for demonstrating substantial equivalence to a predicate device, not for proving a device "meets acceptance criteria" in the way one might prove performance of a new diagnostic algorithm. This specific document states that no clinical or non-clinical testing beyond LAL testing was required for this submission because the changes are primarily related to packaging configuration and no new components have been added. The products themselves remain identical to previously cleared predicate devices (K141430 and K140769).

Therefore, the information you've requested regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details do not apply to this specific 510(k) submission. This document explicitly states:

• "No additional non-clinical laboratory testing was required for this submission as there are no new components being added to the system." (Page 8)
• "Clinical testing was not required for this submission because there are no new components being added to the system." (Page 8)

The "acceptance criteria" for this submission are simply that the new packaging configuration does not alter the fundamental safety or effectiveness of the previously cleared components.

Given the nature of this 510(k), I cannot generate the requested table or answer the specific questions about performance studies, as such studies were not part of this particular submission. The device's "performance" was established by the original predicates it references, not by new studies for this packaging change.

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The MDS Distal Radius Plating System is intended for internal fixation of fractures of the distal radius.

This special 510(k) submission is intended to add the following device instruments and caddy as accessories to the Miami Device Solutions Distal Radius Plating System which was cleared in K161292:

1. Polyaxial Drill Guide
2. Polyaxial Drill Guide Sleeve for K-Wire
3. Polyaxial Drill Guide Caddy

The polyaxial drill guide caddy holds polyaxial drill guides and polyaxial drill guide sleeves for Kwires. The polyaxial drill guide and the polyaxial drill guide sleeve for K-wire helps the user during drill and K-wire insertion. The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.

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

Based on the provided document, the device in question (Distal Radius Plating System with added polyaxial drill guides and associated accessories) did not undergo a clinical study to establish acceptance criteria or performance relevant to clinical outcomes such as diagnostic accuracy or treatment effectiveness.

Instead, this submission (K162635) is a Special 510(k) application to add accessories to an already cleared device (K161292). The focus of this specific submission is on non-clinical performance and substantial equivalence to the predicate device.

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

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)

• Sample Size: Not specified. The document only mentions "Verification testing," which typically involves bench testing of samples but does not provide specific numbers for components tested.
• Data Provenance: Not specified, but given it's non-clinical testing, it would be laboratory-based rather than patient-derived.

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. Since no clinical study or diagnostic/treatment outcome assessment was performed, there was no need for experts to establish ground truth in this context. The "ground truth" for non-clinical tests is typically defined by engineering standards or material science principles.

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

• N/A. No clinical study involving expert interpretation or adjudication was conducted.

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. No MRMC study was conducted. This device is not an AI-assisted diagnostic tool.

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

• N/A. This device is a mechanical surgical system, not an algorithm or software. "Standalone" performance testing would refer to the mechanical properties and function of the components, which falls under "Non-Clinical Performance."

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

• For the non-clinical performance (compatibility, biocompatibility, cleaning/sterilization), the "ground truth" would be established by engineering specifications, recognized standards (e.g., ASTM F136 for materials, sterilization validation standards), and laboratory test results demonstrating compliance with these standards.

8. The sample size for the training set

• N/A. No training set was used as this device is not a learning algorithm or AI system.

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

• N/A. No training set was used.

Summary of Clinical Data (from the document):

"Clinical Performance and Conclusions: Clinical data and conclusions were not needed for this device."

This explicitly states that no clinical studies were performed, and thus no clinical acceptance criteria or human-performance metrics (like those for AI/diagnostic devices) were established or reported for this specific submission. The approval is based on substantial equivalence and non-clinical performance testing of the added accessories.

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The MDS Distal Radius Plating System is internal fixation of fractures of the distal radius.

The Distal Radius Plating System is an internal fixation system to be used for the treatment of distal radius fractures. The system consists of plates, screws, and locking caps. The Distal Radius Plates are bilateral and available in two different models; standard or with a multi-directional oblong hole (MDOH) feature. Each model comes in two sizes, 5 hole and 6 hole. The Distal Radius Plating System Screws are 2.7mm in diameter and available in various lengths.

The MDS device is single-use ONLY.

Materials: Ti-6A1-4V ELI alloy conforming to ASTM F136.

This document is a 510(k) premarket notification for a medical device called the "Distal Radius Plating System." As such, it focuses on demonstrating substantial equivalence to previously marketed devices rather than establishing novel safety and effectiveness through clinical trials with acceptance criteria for device performance.

Therefore, the typical metrics and study designs used to demonstrate performance of an AI/ML device (like sensitivity, specificity, MRMC studies, standalone performance with ground truth based on pathology or outcomes) are not applicable here. This document describes a traditional hardware medical device.

Here's an analysis based on the provided document, addressing the closest applicable sections:

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

   • Acceptance Criteria (Implied): The device must perform as well as the predicate devices in terms of mechanical properties and material composition. This is assessed by demonstrating compliance with recognized ASTM standards for metallic bone plates and screws.
   • Reported Device Performance:
     • Mechanical Testing (via ASTM standards):
       • ASTM F382-99: Standard Test Metallic Medical Bone Plates
       • ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws
     • Material Composition: Ti-6Al-4V ELI alloy conforming to ASTM F136.
     • Conclusion: The results of non-clinical testing demonstrate that the subject device (Distal Radius Plating System) and predicate devices have similar performance properties and perform "as well as" the predicate devices. This implies the device met the performance expectations defined by these standards when compared to the predicates.

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

   • This being a hardware device submission, the "test set" would refer to mechanical testing samples. The document does not specify the exact number of plates or screws tested.
   • Data provenance is not applicable in the context of device performance of this type, as it relates to internal lab testing for mechanical properties and material verification.

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

   • Not applicable. "Ground truth" in this context would be physical measurements and material analyses. The "experts" would be engineers and laboratory technicians responsible for conducting the ASTM standard tests and material verification.

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

   • Not applicable. Mechanical and material testing of hardware devices typically involves direct measurement and comparison to standard specifications, not expert adjudication in the clinical sense.

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 not an AI/ML device, nor is it a device that is 'read' by humans in a diagnostic capacity.

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 (expert consensus, pathology, outcomes data, etc)

   • The "ground truth" for this device's performance assessment involves established engineering standards and material specifications. This includes:
     • ASTM F382-99: Standard Test for Metallic Medical Bone Plates (e.g., fatigue life, bending strength)
     • ASTM F543-07: Standard Specification and Test Method for Metallic Bone Screws (e.g., torsional strength, pull-out strength)
     • ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (material composition and properties).

8. The sample size for the training set

   • Not applicable. This is not an AI/ML device, so there is no training set.

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

   • Not applicable. No training set for an AI/ML model, hence no ground truth establishment for it.

Summary specific to this device and its 510(k) submission:

The "Distal Radius Plating System" is a Class II medical device. Its acceptance criteria for regulatory clearance are based on demonstrating "substantial equivalence" to legally marketed predicate devices. This is achieved primarily through non-clinical performance testing that shows comparable mechanical properties and material composition. The study involves laboratory testing according to recognized ASTM standards (F382-99 for plates, F543-07 for screws, and F136 for material). No clinical performance data or studies involving human subjects were deemed necessary for this 510(k) submission.

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The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.

Indications include:

• compression fractures .
• intra-articular and extra-articular fractures ●
• . displaced fractures

Following additional indications apply only for the XXL Volar Distal Radius Plates: Osteotomies, non-unions, and malunions.

This Traditional 510(k) submission is being supplied to the U.S. Food and Drug Administration to provide authorization to market a line extension to the VariAx Distal Radius Plating, which was cleared in K04022, as the Universal Distal Radius System. The subject plate consists of distal radius fragment specific plates (lateral and dorsal medial). The subject components will be available sterile and non-sterile. The VariAx Distal Radius Plating System consists of multiple internal fixation plates in varying lengths and widths. The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, K132502 and K140769.

The provided document describes a 510(k) submission for a line extension to a bone plating system, specifically the VariAx Distal Radius Plating System. This type of submission is for medical devices that are "substantially equivalent" to predicate devices already on the market. Therefore, the "acceptance criteria" and "study" are focused on demonstrating this substantial equivalence through non-clinical testing, rather than a clinical study establishing efficacy or diagnostic performance as would be expected for an AI/ML device.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: The document mentions "worst case subject plates" were tested. It does not specify the exact number of plates or samples tested, but implies that representative samples deemed "worst case" were selected for mechanical testing.
• Data Provenance: The testing was "non-clinical laboratory testing." The document does not specify the country of origin of the data beyond implying it was conducted to ASTM standards, which are international standards. The testing was retrospective in the sense that it evaluates the manufactured product against established standards and a predicate device, not in the context of a prospective patient study.

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

This type of information is not applicable to this submission. The "ground truth" for this device's acceptance is based on engineering standards (ASTM F382-99:2008) and comparison to a legally marketed predicate device, not on expert medical consensus on diagnostic outcomes or interpretations.

4. Adjudication Method for the Test Set

This is not applicable. There was no expert-based ground truth to adjudicate for this type of submission. The performance was assessed against engineering 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 is not applicable. This submission is for a physical medical device (bone plating system), not an AI/ML diagnostic or assistive tool. Therefore, no MRMC study or AI assistance evaluation was performed or required.

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

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

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is:

• Engineering Standards: Compliance with "Standard Specification and Test Method for Metallic Bone Plates as per ASTM F382 - 99: 2008."
• Predicate Device Performance: Demonstrating substantial equivalence to the mechanical, intended use, and operational principles of the TriMed Wrist Plates (K060041).

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this 510(k) submission for a physical medical device. Manufacturing processes are validated, but this isn't referred to as a "training set" in the context of AI/ML.

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

This is not applicable for the same reason as point 8. There is no training set mentioned in the context of an AI/ML algorithm.

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The system is intended for fixation of fractures, malunions and osteotomies involving the distal radius.

The Modified Distal Radius Plating System consists of Titanium alloy Extra Narrow and Extra Long family of plates utilizing non-locking, locking and variable angle screws manufactured from Titanium alloy and CoCr for bone fixation and the management of fractures and reconstructive surgeries.

The provided text describes a 510(k) submission for a Modified Distal Radius Plating System and focuses on demonstrating substantial equivalence to predicate devices, rather than a study demonstrating the device meets specific acceptance criteria based on performance metrics such as sensitivity, specificity, or reader improvement.

Therefore, many of the requested elements for describing an AI/CAD-based study are not applicable to this document. The document primarily outlines pre-clinical mechanical testing to ensure the new device is comparable to existing ones.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document states that "pre-clinical data including axial load construct testing, 4-point bending testing, evaluation of galvanic corrosion potential and multidirectional screw capability" demonstrated substantial equivalence. Specific quantitative acceptance criteria (e.g., minimum load bearing, maximum corrosion rate) and the exact quantitative results are not provided in this summary.

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

• Sample Size: Not applicable. The "test set" here refers to the physical devices undergoing mechanical and material testing, not a dataset of medical images or patient records. The number of physical implants/constructs tested is not specified in the provided summary.
• Data Provenance: Not applicable in the context of clinical/imaging data. The data provenance relates to laboratory testing of device components.

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

• Not applicable. Ground truth in this context would be defined by engineering specifications and physical measurements, not expert consensus on medical images.

4. Adjudication method for the test set

• Not applicable. This concept is relevant for expert review of clinical data, not for material and mechanical testing.

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

• No, an MRMC comparative effectiveness study was not done. This document pertains to a medical device's physical and material properties, not an AI/CAD system for image interpretation.

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

• Not applicable. This is not an AI algorithm.

7. The type of ground truth used

• The "ground truth" for this device's performance would be derived from engineering specifications, material science standards, and mechanical testing protocols. For example, the load at which a construct fails in axial loading would be the measurable "truth" compared against a specified acceptance load.

8. The sample size for the training set

• Not applicable. This product is a physical implant, not an AI model requiring a training set.

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

• Not applicable. No training set for an AI model.

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The VariAx Distal Radius Locking System including the XXL Volar Distal Radius Plates is intended for internal fixation of small bone fractures, primarily including distal radius fractures.

Indications include:

• compression fractures .
• intra-articular and extra-articular fractures .
• displaced fractures .

Following additional indications apply only for the XXL Volar Distal Radius Plates:
Osteotomies, non-unions, and malunions.

This Traditional 510(k) submission is being supplied to the U.S. FDA to obtain authorization to market a line extension to the VariAx Distal Radius Plating System, which was cleared in K040022, as the Universal Distal Radius System. The VariAx Distal Radius Plating System Line Extension consists of multiple internal fixation plates in varying lengths and widths. The portfolio of plates is being extended to include new plate width (intermediate) and new plate length (extrashort). The plates will be used with the VariAx locking screws, non-locking screws, locking pegs, and partially threaded screws previously cleared in K040022, K080667, and K132502. The subject components will be available sterile and non-sterile.

The provided text is for a 510(k) submission for a medical device (VariAx Distal Radius Plating System Line Extension). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy or safety through clinical trials in the same way a new drug or novel medical device might.

Therefore, the document does not contain the specific information requested in the prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, or MRMC studies. This is because these are more typical requirements for AI/ML-driven devices or those requiring extensive clinical evidence.

The relevant sections are "Non-Clinical Test" and "Clinical Testing".

Here's a breakdown of what is available:

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

• Acceptance Criteria: The implicit acceptance criterion is "substantial equivalence" to the predicate devices (VariAx Distal Radius Plating System (K040022) and the VariAx Distal Radius Line Extension of XXL Plates (K100271)) in terms of intended use, design, materials, and operational principles. Specifically for mechanical performance, the standard "ASTM F382 - 99: 2008" serves as the benchmark.
• Reported Device Performance: "Testing demonstrated that the subject plates being added to the VariAx Distal Radius Plating System are substantially equivalent to the currently marketed predicate devices."

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: This device is a mechanical implant. The "test set" refers to physical samples of the device undergoing non-clinical mechanical testing. The document states "worst case subject plates" were tested but does not specify the exact number of plates or samples.
• Data Provenance: The testing was "Non-clinical laboratory testing," implying in-vitro or bench testing, not human patient data. Therefore, country of origin or retrospective/prospective does not apply in the typical sense.

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

• Not Applicable. Ground truth, in the context of expert consensus, is not relevant for this type of mechanical device submission. The "ground truth" here is compliance with an engineering standard (ASTM F382).

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

• Not Applicable. This pertains to expert review of medical images or data. For mechanical testing, the "adjudication" is the pass/fail result according to the specified ASTM standard.

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

• No. This is not an AI/ML device. MRMC studies are not applicable.

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

• No. This is a mechanical implant, not an algorithm.

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

• The "ground truth" for this device's performance is adherence to established engineering and material standards for metallic bone plates (ASTM F382 - 99: 2008). The comparison is against predicate devices that also met these standards.

8. The sample size for the training set

• Not Applicable. This is a mechanical device, not an AI/ML system. There is no concept of a "training set" in this context.

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

• Not Applicable. As there is no training set, this question is not relevant.

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The Zimmer Distal Radius Plating System is intended for use in surgical reduction, internal fixation, and stabilization of fractures and osteotomies of the distal radius. Examples of distal radius fractures include but are not limited to compression fractures, intra-articular and extra-articular fractures, displaced fractures, fractures in osteopenic bone, non-unions, and mal-unions.

The Zimmer Distal Radius Plating System is a plate and screw system intended for internal fixation and stabilization of fractures and osteotomies of the distal radius. The Zimmer Distal Radius Plating System consists of Volar, Medial and Dorsal locking plates. All the plates have screw holes which can accept either locking or non-locking screws and slots which can accept only non-locking screws. Locking screws and pegs may be inserted at 15° in any direction (30° cone) from the nominal screw hole trajectory. Thus, anatomically contoured plate design combined with locking screw technology creates fixed or variable angled constructs for use in simple or multi-fragment fractures. All the plates and screws are made from Ti-6AI-4V ELI alloy. All the plates and screws are Type II anodized except the nonlocking screws which are color anodized.

The provided text K133246 is a 510(k) Summary for the Zimmer Distal Radius Plating System. This document describes a medical device and its predicate devices, but does not contain information about acceptance criteria or a study proving that the device meets those criteria, nor does it describe a study involving an algorithm or artificial intelligence (AI).

The document explicitly states: "Clinical data and conclusions were not needed to show substantial equivalence." This means that the device was approved based on non-clinical performance and similarity to existing predicate devices, rather than a clinical study evaluating its effectiveness against specific performance criteria.

Therefore, I cannot provide the requested information from the given text as it is not present in the document.

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