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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 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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