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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 MDS Plating System is internal fixation of fractures of various bones such as the clavicle, olecranon. humerus, radius, ulna, distal tibia, and for use in fixation of periprosthetic fractures. The system can be used with commercially available cerclage of material compatible with system implants including titanium alloy and cobalt chromium.

The Low Profile Head Screw is used independently and is internal fixation of fractures of the clavicle, olecranon, humerus, radius, ulna, distal tibia, fibula as well as foot and ankle.

The MDS Plating System is an internal fixation system intenal fixation of fractures of various bones. The system consists of the following single-use implants:

• Straight (broad and narrow) and pre-contoured plates available in a variety of sizes -
• -Screws of various lengths and diameters, some of which are identified in previously cleared premarket notifications (K141493, K161292/K162635, and K162898).
• Locking Caps of various diameters identified in previously cleared premarket notifications -(K141493, K161292/K162635, and K162898).
• Low Profile Head Screws -
• -Threaded cerclage buttons of various diameters used in conjunction with MDS plates to augment fracture stabilization.

Additionally, the system includes single use and reusable instruments.

Materials: Titanium alloy and Stainless Steel.

This document describes a 510(k) premarket notification for the "MDS Plating System," a medical device for internal fixation of bone fractures. As such, the FDA's review for substantial equivalence primarily relies on non-clinical performance data and comparison to predicate devices, rather than clinical studies with acceptance criteria in the typical sense of AI/Dx devices.

Therefore, the requested information elements related to clinical studies, ground truth establishment, expert adjudication, and specialized sample sizes (training/test sets for algorithms) are not applicable in this context. The data provided focuses on mechanical and material performance testing.

Here's an interpretation of the available information in the context of the device and regulatory submission:

1. Table of Acceptance Criteria and Reported Device Performance

For devices like the MDS Plating System, acceptance criteria are generally established based on recognized industry standards for mechanical performance and material properties. The "reported device performance" refers to the results of tests demonstrating compliance with these standards and comparability to predicate devices.

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

This is not applicable as there isn't a "test set" in the sense of an AI algorithm or diagnostic device. The performance testing involves mechanical and material tests performed in a laboratory setting. There are no "patients" or "data provenance" (country of origin, retrospective/prospective) in this context. The "samples" would be the manufactured device components (plates, screws, etc.) subjected to mechanical testing. The sample size for such tests is typically determined by relevant ASTM standards to achieve statistical significance for the mechanical properties measured.

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

This is not applicable. For mechanical performance testing of orthopedic implants, "ground truth" is defined by established engineering principles and measurements against recognized standards (e.g., ASTM). No human "experts" are establishing diagnostic ground truth for a test set.

4. Adjudication Method for the Test Set

This is not applicable. There is no human adjudication process involved in assessing the mechanical performance against engineering standards.

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

No, an MRMC study was not done. This type of study is relevant for diagnostic devices where human readers interpret medical images or data. The MDS Plating System is a surgical implant, not a diagnostic tool or an AI-assisted diagnostic system.

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

No, a standalone performance test in the context of an algorithm was not done. Again, this device is a surgical implant, not a software algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is based on engineering standards and physical measurements. This includes:

• Mechanical Test Results: Direct measurements of tensile strength, torsional strength, bending strength, fatigue life, etc., obtained through laboratory testing.
• Material Specifications: Compliance with established properties for titanium alloy and stainless steel as per international standards.
• Design Specifications: Conformance to detailed engineering drawings and specifications.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" for an AI algorithm in this context.

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

This is not applicable for the same reasons as point 8.

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The MDS Olecranon Plating System is intended for internal fixation of fractures of the Olecranon.

The Olecranon Plating System is an internal fixation system to be used for the treatment of Olecranon fractures. The system consists of plates, screws, and locking caps, as well as single use and reusable instruments. The Olecranon plates are pre-contoured and side-specific, available in two different sizes; 2 hole and 4 hole. The Olecranon Plating System Screws are 2.7mm in diameter and available in various lengths.

The MDS implants are single-use ONLY.

Materials: Titanium alloy and stainless steel

Here's an analysis of the provided text regarding the acceptance criteria and study for the Olecranon Plating System:

It's important to note that the provided document is a 510(k) summary for a medical device, specifically an Olecranon Plating System. This type of document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This is not a study of an AI-powered device or a comparative effectiveness study in the typical sense of measuring algorithm performance. Instead, it focuses on the engineering and material characteristics of a physical implant.

Therefore, many of the requested categories related to AI performance, ground truth, expert adjudication, and MRMC studies will not be applicable to this document.

1. Table of acceptance criteria and reported device performance:

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

• Sample Size: Not applicable in the context of a clinical test set. The performance data is based on non-clinical (laboratory/performance) testing and engineering analysis of the device itself (plates, screws). The sample size would relate to the number of physical components tested in the lab. The document does not specify the exact number of plates or screws physically tested.
• Data Provenance: Not applicable in terms of country of origin for a data set. The testing was non-clinical (laboratory) rather than using patient data. It involved materials and mechanical testing.
• Retrospective/Prospective: Not applicable.

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

• Not Applicable. This document describes the mechanical and material equivalence of a physical implant, not an AI or diagnostic device that requires expert-established ground truth from medical images or patient data. The "ground truth" here is the established mechanical performance standards (ASTM standards) and the characteristics of the predicate devices.

4. Adjudication method for the test set:

• Not Applicable. There was no human adjudication of results in the context of a diagnostic test set. The "adjudication" was through engineering analysis and comparison against established industry standards (ASTM) and predicate device specifications.

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 was not an MRMC study. This device is a physical bone implant, not an AI software or diagnostic tool that assists human readers.

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

• No. This is not an algorithm. It's a physical medical device.

7. The type of ground truth used:

• For mechanical properties: Established industry standards (ASTM F382-99 for bone plates, ASTM F543-07 for bone screws) and the specifications/performance of the predicate devices.
• For material composition: Accepted medical-grade titanium alloy and stainless steel (as verified against predicate devices).

8. The sample size for the training set:

• Not Applicable. There is no "training set" in the context of a physical medical device like this, which relies on engineering design, material science, and mechanical testing, not machine learning.

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 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 Cannulated Screw for the Proximal Humerus Plating System is indicated for internal fixation of fractures of the proximal humerus.

The Miami Device Solutions (MDS) Cannulated Screw is a cannulated bone screw intended for use with the MDS Proximal Humerus Plating System cleared in K141493. The MDS cannulated bone screw is 3.5 mm in diameter, 30 to 60 mm in length in 3 mm increments, fully cannulated and threaded, and can interface with MDS Proximal Humerus Plates and Locking Caps cleared in K141493. The MDS device is supplied not sterile and is single-use only.

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

The provided document describes a 510(k) premarket notification for a medical device called the "Cannulated Screw." This document focuses on demonstrating the substantial equivalence of the new device to legally marketed predicate devices, primarily through performance testing. However, it does not describe a study that involves an AI algorithm, human readers, or image analysis for diagnosis.

Therefore, I cannot fill in any details for the following requested information, as the document does not contain them:

• Acceptance Criteria and Reported Device Performance (as typically defined for AI/diagnostic devices)
• Sample size used for the test set and data provenance
• Number of experts used to establish ground truth and qualifications
• Adjudication method for the test set
• Multi-reader multi-case (MRMC) comparative effectiveness study
• Standalone (algorithm-only) performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How the ground truth for the training set was established

However, I can extract information related to the device's performance testing for its substantial equivalence claim:

Device: Cannulated Screw (intended for internal fixation of fractures of the proximal humerus)

Type of Study Conducted: Performance testing against consensus standard ASTM F543 to demonstrate substantial equivalence to predicate devices (Zimmer cannulated screw and Arthrex screw). This testing is for the physical and mechanical properties of the screw, not for diagnostic performance.

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

The document states that the acceptance criterion was that the MDS device possess "similar strength and performance characteristics" as the predicate devices. The reported performance was that "the results of these tests showed the MDS device to possess similar performance properties as the Zimmer predicate device, and the Arthrex predicate device (K041965), and therefore do not raise new questions of safety when used per the products labeling."

Note: The document only provides a qualitative statement of "similar performance properties" and does not list specific numerical thresholds or results for these tests.

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

• Sample Size: Not explicitly stated for the performance tests. The testing was done on the physical devices themselves (MDS Cannulated Screw and predicate Zimmer Cannulated Screw).
• Data Provenance: Not applicable in the traditional sense of human patient data. This refers to in-vitro mechanical testing of manufactured medical devices.

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

• Not applicable. Ground truth for mechanical performance testing is established by the specifications defined in the ASTM F543 consensus standard, not by human experts interpreting clinical data.

4. Adjudication method for the test set

• Not applicable.

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 a medical device (screw) clearance, not an AI diagnostic software.

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

• No. This is a medical device (screw) clearance.

7. The type of ground truth used

• The "ground truth" for the performance testing was the established performance characteristics and specifications outlined in the ASTM F543 consensus standard for bone screws, and the performance observed from the legally marketed predicate devices (Zimmer and Arthrex cannulated screws). This is a technical performance ground truth, not a clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

• Not applicable. This is a device clearance for a physical medical implant, not an AI algorithm.

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

• Not applicable.

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