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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 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 Distal Radius Plating System is indicated for use in open reduction and internal fixation of Frykman type I-IV dorsally displaced Colles fractures, intomies, and carpal fusions of the distal radius in the presence of appropriate immobilization.

The Distal Radius Plating System consists of resorbable dorsal and volates. The plates are used in conjunction with 2.5mm resorbable screws. The plates and screws are made of a L-lactide/glycolide co-polymer.

This document is a 510(k) premarket notification for a medical device called the "Distal Radius Plating System." It outlines the device's description, intended use, and a comparison to substantially equivalent devices. However, it explicitly states that no clinical data was completed. Therefore, the request for acceptance criteria and a study proving the device meets those criteria cannot be fully answered as these were not provided or conducted for this specific submission.

Given the information provided, here's what can be extracted and what cannot:

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

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

• Mechanical and biocompatibility testing: The document does not specify the sample sizes used for the in-vitro mechanical testing or the biocompatibility testing.
• Clinical test set: There was no clinical test set.

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

• This information is not applicable as no clinical testing was performed for this 510(k) submission. For the non-clinical testing (mechanical and biocompatibility), the "ground truth" would be established by the testing methodology itself, rather than expert consensus on retrospective data.

4. Adjudication method for the test set

• This information is not applicable as no clinical testing was performed.

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. The device is a physical orthopedic implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and AI-related metrics are irrelevant.

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

• This information is not applicable. The device is a physical orthopedic implant, not an algorithm.

7. The type of ground truth used

• For mechanical properties, the "ground truth" was established by recognized testing standards and comparison to the mechanical integrity of legally marketed predicate devices.
• For biocompatibility, the "ground truth" was established by standardized laboratory tests to assess toxicity, mutagenicity, and pyrogenicity.
• For clinical outcomes, there was no ground truth established as no clinical data was collected.

8. The sample size for the training set

• This information is not applicable as the device is not an AI algorithm requiring a training set. The "training" for this type of device development involves materials science, engineering design, and testing, not machine learning.

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

• This information is not applicable as the device is not an AI algorithm.

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