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The OsteoCentric Cannulated Fasteners and Nuts is indicated for use in bone reconstruction, osteotomy, arthrodesis (joint fusion), and fixation of fractures and ligaments:

The OsteoCentric 2.4mm and 3.0mm Cannulated Screw are intended for fixation of fractures and non-unions of small bones and small bone arthrodesis. Examples include scaphoid and other carpal fractures, metacarpal and phalangeal fusions, osteotomies, and bunionectomies.

The OsteoCentric 3.5mm Cannulated Screws are intended for the arthrodesis or fixation of fractures and fragments of hand, midfoot, and forefoot bones, extremity osteochondritis dissecans lesions, and for extremity ligament fixation.

The OsteoCentric 4.5mm to 8.0mm Cannulated Screws are intended for fixation of long bone fractures and fragments. Iong bone osteotomies, femoral neck fractures, slipped capital femoral epiphyses, as an adjunct to treatment with a dynamic hip screw (DHS) in basilar neck fractures, tibial plateau fractures, pediatric femoral neck fractures, intercondylar femur fractures, fixation of the pelvis and pelvic joints, and arthrodesis (e.g., ankle, subtalar).

The OsteoCentric 7.0mm and 8.0mm Cannulated Nut is indicated for reduction and stabilization of fractures or inter-osseous distances (e.g. syndesmosis injuries).

The OsteoCentric Technologies Cannulated Fasteners and Nuts come in a variety of lengths and diameters to accommodate different anatomic sizes of patients. The fasteners are provided non- sterile and are manufactured from Stainless Steel per ASTM F138 or from Titanium per ASTM F136 or F1295. Instrumentation is also provided non-sterile to properly insert the OsteoCentric Technologies Cannulated Fasteners and Nuts. All instrumentation is intended to be reusable, with the exception of the guidewires are provided non-sterile and are intended for single-use only.

The provided text is a 510(k) summary from the FDA for a medical device (cannulated fasteners and nuts). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain any information about acceptance criteria or a study proving that a device meets acceptance criteria related to a software or AI based medical device.

The document primarily focuses on the physical characteristics, materials, and mechanical applications of bone fixation fasteners and nuts, asserting that the new device is "physically and technologically identical" to a previously cleared predicate device. There is no mention of an algorithm, AI, or any data-driven performance study typically associated with the type of questions asked (e.g., sample size, expert ground truth, MRMC studies, standalone performance).

Therefore, I cannot fulfill your request to describe acceptance criteria and associated study details for an AI/software device based on the provided text. The document is for a hardware medical device, not a software one.

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The Monster® Screw System is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, ligament fixation, fracture repair and fracture fixation, appropriate for the device. Specific examples include:

Fractures and Osteotomies

• · Fractures of the tarsals, metatarsals and other fractures of the foot (i.e. LisFranc)
• · Avulsion fractures and fractures of the 5th metatarsal (i.e. Jones Fracture)
• · Talar fractures
• · Ankle fractures
• Navicular fractures
• · Fractures of the fibula, malleolus, and calcaneus
• · Metatarsal and phalangeal osteotomies
• · Weil osteotomy
• · Calcaneal osteotomy

Hallux Valgus Correction

• · Fixation of osteotomies (i.e. Akin, Scarf, Chevron)
• Interphalangeal (IP) arthrodesis
• · Proximal, midshaft, or distal osteotomy
• Lapidus arthrodesis

Arthrodesis/Deformity Correction

• 1st MTP arthrodesis
• Metatarsal deformity correction
• · Tarsometatarsal joint arthrodesis
• · Naviculocuneiform joint arthrodesis
• · Talonavicular arthrodesis
• Subtalar joint arthrodesis
• · Triple arthrodesis
• Medial column arthrodesis
• Subtalar joint distraction arthrodesis
• · Ankle arthrodesis
• · Lateralizing calcaneal osteotomy
• Lateral column lengthening
• · Hammertoe

Fusion resulting from neuropathic osteoarthropathy (Charcot) such as:

• Medial and lateral column
• · Subtalar, talonavicular, and calcaneocuboid

The Monster Screw System is comprised of threaded bone screws (Ti Alloy or Stainless Steel) offered in 2.0mm to 9.5mm diameters (in 0.5mm increments). In addition, a 2.7mm diameter is also part of the system. The overall screw length ranges from 8mm (for smaller diameters) thru 200mm (for larger diameters). The screws are available in a variety of designs including: fully or partially threaded, self-drilling or blunt, cannulated or solid, and headed or headless. Sizedmatched washers are also available.

The provided document is a 510(k) summary for the Paragon 28 Monster® Screw System. This document DOES NOT contain information regarding acceptance criteria or a study that proves a device meets acceptance criteria related to AI/ML device performance.

Instead, it's a regulatory submission for a medical device (bone fixation screws) demonstrating substantial equivalence to previously marketed predicate devices. The "studies" mentioned are preclinical tests (engineering analysis, torsional, pullout, insertion/removal evaluations, sterilization validations) to show that modifications to the screws do not adversely affect performance compared to the predicate devices.

Therefore, I cannot fulfill your request as the information requested is not present in the provided text.

Here's a breakdown of why this document doesn't fit your request:

• Acceptance Criteria for AI/ML Performance: Not applicable. This is a traditional medical device (hardware).
• Study Proving Device Meets Acceptance Criteria (AI/ML): Not applicable. The "studies" are mechanical and material tests for screws, not AI/ML performance evaluations.
• Table of Acceptance Criteria and Reported Device Performance: Not applicable for AI/ML.
• Sample Size for Test Set and Data Provenance: Not applicable for AI/ML.
• Number of Experts for Ground Truth and Qualifications: Not applicable for AI/ML.
• Adjudication Method: Not applicable for AI/ML.
• Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not applicable. There are no human readers or AI assistance.
• Standalone (algorithm only) Performance: Not applicable.
• Type of Ground Truth Used: Not applicable for AI/ML. (For the screws, the "ground truth" would be the established mechanical properties and safety profiles of predicate devices).
• Sample Size for Training Set & How Ground Truth Established for Training Set: Not applicable. This device does not use a training set in the AI/ML sense.

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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 Medline Unite® Mini Plates and Screws are in stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system can be used in both adult and pediatric patients.

Examples include:

• · Metatarsal or metacarpal fractures and osteotomies
• · Cuboid fractures
• Navicular fractures
• Talar neck fractures
• · Jones and avulsion fractures of the 5th metatarsal
• · Lesser metatarsal shortening osteotomies (i.e. Weil Osteotomies)
• ·Phalanges fractures and osteotomies

The Medline Unite® Mini Locking and Non-Locking Screws are indicated for use with the Medline Unite® Plates of the same base material. The Non-Locking Cortical Screws are also indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation, appropriate for the size of the device.

The Medline Unite® Mini Plates and Screws are manufactured from Titanium Alloy. The System includes plates offered in various styles, sizes and options; each contoured for specific anatomy and designed for specific procedures, and 2.0mm, 2.4mm and 2.7mm diameter locking and non-locking screws to be used with the polyaxial locking holes and compression slots included in the plates as well as 4.0mm cannulated screws to be used with the hook plate. The system also includes reusable instrumentation necessary to implant the plates and screws, e.g. drill guides, tissue protectors, and drill bits.

This document is a 510(k) premarket notification for a medical device, specifically bone fixation plates and screws. It details an equivalency comparison to a predicate device. As such, it does not contain information about AI models, algorithms, or typical machine learning study designs.

Therefore, most of the requested information (sample sizes for training/test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this document.

Here's what can be extracted based on the document's content:

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

The document describes non-clinical testing to demonstrate substantial equivalence to a predicate device, rather than setting specific acceptance criteria for a new, AI-driven performance metric. The acceptance criteria implicitly involve demonstrating equivalent mechanical properties to the predicate device. The reported device performance refers to the results of these equivalency tests.

Since this 510(k) is for a traditional medical device (metallic bone fixation appliances) and not an AI/ML powered device, the following points are not applicable to the provided text.

2. Sample size used for the test set and the data provenance: Not applicable - this is a mechanical testing report, not a study of an AI algorithm on a data set.

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 is based on mechanical engineering standards and measurements, not expert human interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable - no human interpretation or adjudication is involved in these mechanical tests.

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-powered device or a study involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable - this is a traditional medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For mechanical testing, the "ground truth" is typically the measured physical properties of the materials and devices, determined by standardized laboratory methods (ASTM standards in this case).

8. The sample size for the training set: Not applicable - no AI training set is involved.

9. How the ground truth for the training set was established: Not applicable - no AI training set is involved.

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The MDS Injection Screw is intended for the fixation of bone fractures and bone reconstructions of the humerus. The MDS Injection Screws can be used to deliver injectable bone void fillers to a surgical site and are compatible with applicable MDS plating systems.

Miami Device Solutions (MDS) Injection Screws enable fixation of simple and complex fractures of the humerus. The MDS Injection Screws are only to be used in combination with compatible MDS 3.5T plating systems in the humerus (Proximal Humerus Plating System, K141493/K161058; MDS Plating System, K172786). When inserted through a 3.5T plate screw hole, injection screw placement is possible at any angle within a 40° cone. MDS Injection Screws can be used with or without bone void fillers. Fenestrations along the screw length allow bone void filler delivery directly into the surgical site.

This document (K173556) is a 510(k) premarket notification for a medical device called the "Injection Screw." It does not contain information about acceptance criteria or a study proving the device meets them in the context of an AI/ML software. Instead, it demonstrates substantial equivalence to predicate devices through non-clinical performance testing.

Therefore, I cannot answer the questions as they relate to AI/ML device acceptance criteria and studies. The device in this document is a physical medical implant (a bone screw), and the "performance data" refers to mechanical testing.

However, I can provide the information available in the document regarding the device's technical validation:

1. Table of Acceptance Criteria and Reported Device Performance
This document does not specify "acceptance criteria" in the typical sense of a target metric for an AI/ML system (e.g., accuracy, sensitivity, specificity).
Instead, it references industry standards and internal testing to demonstrate the physical device's mechanical properties and functionality.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/provided for an AI/ML context. The document refers to "non-clinical (laboratory/performance) testing" and "Cadaver Lab" for functional testing of the physical screw. Specific sample sizes for mechanical tests would relate to the number of screws tested, and "cadaver lab" would refer to the number of cadaveric specimens used. These details are not elaborated in the 510(k) summary.

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 is a physical device, and its ground truth is established through engineering and materials science principles and testing, not expert consensus on interpretations.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept is relevant for expert review in diagnostic studies, not for the mechanical testing of a bone screw.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a physical device, not an AI/ML diagnostic system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, 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 based on established engineering principles, material science data, and mechanical testing results compliant with industry standards like ASTM F543. For the BVF delivery aspect, it refers to "cadaver lab" testing, which implies direct observation and measurement of the physical phenomenon.

8. The sample size for the training set
Not applicable. This is a physical device, and the concept of "training set" is for AI/ML models.

9. How the ground truth for the training set was established
Not applicable.

In summary: The provided document is for a traditional physical medical device (bone screw) and addresses its substantial equivalence through non-clinical performance and engineering analysis, not through the evaluation of an AI/ML algorithm. Therefore, many of the requested details pertaining to AI/ML device validation are not present or applicable.

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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 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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