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The Syntec Dental Implant is intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as to restore the patient's chewing function, and artificial teeth. It is intended for delayed loading.

The Syntec Dental Implant provides Titanium Alloy (commercially followed by ASTM F136) intended to be surgically placed in the bone of the upper or lower jaw arches. To provide support for prosthetic devices, such as artificial teeth, and to restore the patient's chewing function. It consists of implant, cover screw, healing abutment screw and abutments. The Syntec Dental Implant is for one and two stage surgical procedures. Its materials, dimensions, and intended use are similar to devices currently marked worldwide. The range of implant in diameter is from 3.4mm to 4.8mm and in length from 8.0mm to 14.0mm. The range of abutment in diameter is from 4.5mm to 6.5mm, and in length from 5.5mm to 12.0mm.

The Syntec Dental Implant K111189 510(k) summary does not contain information on an AI/ML device.

Here's a breakdown of the provided information, specifically addressing the criteria you've outlined, even though it's for a traditional medical device (dental implant):

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

Since this is a submission for a traditional dental implant and not an AI/ML device, the acceptance criteria are based on mechanical properties, biocompatibility, and sterilization, rather than performance metrics like sensitivity, specificity, or AUC. The "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through various bench tests conforming to international standards.

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

This information is not provided in the 510(k) summary. For bench testing of physical devices, "sample size" typically refers to the number of units tested per experiment, which is not detailed here. The studies are bench tests, not clinical studies with human participants. Data provenance is implied to be from the internal testing of Syntec Scientific Corporation in Taiwan.

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)

This is not applicable to a traditional dental implant submission. "Ground truth" in this context would be defined by the physical characteristics and performance measured against the standards, not by expert interpretation of data.

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

Not applicable for a traditional dental implant submission based on bench testing.

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

Not applicable. This is not an AI/ML device, and no MRMC study was conducted.

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 is established by the international standards and regulations (e.g., ISO 14801, ISO-10993, ISO 11137, etc.) referenced in the bench testing section. The device's physical and mechanical properties are measured and compared directly to the requirements outlined in these standards.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

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Syntec OS Spinal Fixation System is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of the following:

• Degenerative disc disease .
• Spondylolisthesis .
• Trauma (i.e., fracture or dislocation) .
• Spinal stenosis .
• Deformities or curvatures (i.e., scoliosis, kyphosis, and/or lordosis) ●
• . Tumor
• . Pseudoarthrosis
• . Failed previous fusion

The Syntec OS Spinal Fixation System is manufactured from titanium alloy (as per ASTM F136) and is designed with various sizes to provide stabilization as an adjunct to spinal fusion surgery. Surgeons can use our top loading technique through the screws and rods to fix the components into a U-shaped opening

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not explicitly state the "sample size used for the test set" in terms of a number of physical devices. Instead, it refers to "the modified and predicate systems" being tested. There is no information regarding the data provenance (e.g., country of origin, retrospective or prospective) for these tests.

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

This information is not provided in the document. The study involved engineering analysis and performance testing of the device itself against established ASTM standards, not the interpretation of human physiological data. Therefore, the concept of "ground truth" established by experts in a clinical context (like radiologists) does not apply here.

4. Adjudication Method for the Test Set

This information is not provided in the document. As mentioned above, the testing involved physical device performance against standards, not expert adjudication of clinical outcomes.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The reported performance data relates to engineering tests of the device itself (mechanical properties) and not to human reader interpretation or clinical outcomes.

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

Yes, the testing described appears to be a standalone performance evaluation of the device itself, without human-in-the-loop interaction.

7. The Type of Ground Truth Used

The "ground truth" in this context is the performance standards defined by ASTM F1717 for static and dynamic axial compression and static torsion tests. The device's performance was compared against these established engineering standards and against the performance of a predicate device.

8. The Sample Size for the Training Set

This information is not applicable and is not provided. The study is a performance evaluation of a physical medical device, not a machine learning algorithm that requires a training set.

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

This information is not applicable and is not provided, as there is no training set for a machine learning algorithm.

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Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.

This document describes a 510(k) premarket notification for a medical device and is a submission for substantial equivalence to a predicate device, not a study proving the device meets acceptance criteria via clinical trials or AI performance metrics. Therefore, many of the requested fields regarding acceptance criteria, AI performance, ground truth, expert involvement, and sample sizes for training/test sets are not applicable in this context.

Here's the information extracted from the provided text, modified to acknowledge the nature of a 510(k) submission:

1. Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device through engineering performance tests, rather than clinical outcomes. The device performance is reported as meeting or being comparable to the predicate device in specific mechanical tests.

2. Sample Size for Test Set and Data Provenance

• Sample size used for the test set: Not explicitly stated. The document refers to "test results" from mechanical tests rather than human subject testing or specific data sets.
• Data provenance: The mechanical tests were performed on the "Syntec Osteo-plate and screw Fixation" device. The provenance of the data is internal testing conducted by Syntec Scientific Corporation in Taiwan. The tests compare the new device to the predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants). This would be considered internal, laboratory-based, prospective testing of the device prototypes.

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

Not applicable. This is a 510(k) submission for a physical medical device based on mechanical testing, not a study involving expert-established ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring human review or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This is a 510(k) submission for a physical medical device. MRMC studies are typically for diagnostic devices or AI systems.

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

Not applicable. This is a 510(k) submission for a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is the established mechanical performance of the legally marketed predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants) and compliance with recognized industry standards (ASTM F138, ASTM F136) for material properties. The claim is that the new device performs equivalently in these mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device. There is no "training set" in the context of AI or machine learning. The device design is based on engineering principles and existing designs.

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

Not applicable. As there is no training set, no ground truth was established for it in the context of this 510(k) submission.

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The screws are intended to provide fixed anchorage for attachment of orthodontic appliances intended to facilitate the orthodontic movement of teeth. They are used temporarily and are intended to be removed after orthodontic treatment has been completed. The screws are intended for single use only.

The screws are manufactured from commercially SUS316L ( stainless steel ) and Ti-6AL-4V ( titanium alloy ) . The screws are available with thread diameter are from 1.3mm to 2.0 mm, and total lengths from 5mm to 17mm. There is a pair of self-tapping flutes and self-drilling flutes for easy insertion and removal. The design of smooth curve surface of screw head is comfortable to patients, and the screws with or without a 0.65mm diameter hole can supply different orthodontic methods for orthodontists.

This document is a 510(k) premarket notification for the "Syntec orthodontic mini screws." It's a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, not a study reporting on the device's performance against specific acceptance criteria. Therefore, the information requested in your prompt regarding acceptance criteria, study details, and performance metrics is generally not present in this type of regulatory document.

However, I can extract the information that is available and explain why other details are missing:

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

• Not Applicable. This document does not describe acceptance criteria and reported device performance through a study. Instead, it asserts "substantial equivalence" to a predicate device. Substantial equivalence means the device has the same intended use and the same technological characteristics as the predicate device, or if it has different technological characteristics, the information submitted demonstrates that the device is as safe and effective as the predicate device and does not raise different questions of safety and effectiveness.

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. No test set or data provenance is detailed because this is not a clinical study report. The submission relies on demonstrating equivalence through comparison of materials, intended use, and general characteristics to a predicate device, rather than patient data.

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. No ground truth establishment by experts is mentioned as this is not a study assessing diagnostic accuracy or clinical outcomes requiring such a process.

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

• Not Applicable. No adjudication method is mentioned.

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 device is a physical orthodontic mini screw, not an AI software or diagnostic tool. Therefore, an MRMC study or AI assistance is not relevant.

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

• Not Applicable. This is a physical medical device, not an algorithm, so standalone performance in that context is not relevant.

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

• Not Applicable. Since no performance study against a ground truth is presented, this information is not included.

8. The sample size for the training set

• Not Applicable. This is not an AI/machine learning device, so there is no concept of a training set.

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

• Not Applicable. As above, there is no training set mentioned.

Summary of what is available in the document regarding the device and its regulatory clearance:

• Device Name: Syntec orthodontic mini screws
• Intended Use: To provide fixed anchorage for attachment of orthodontic appliances to facilitate orthodontic movement of teeth. They are temporary and removed after treatment. Single use only.
• Material: Surgical stainless steel (ISO 5832-1) and Surgical titanium alloy (ISO 5832-3).
• Sterility: Non-sterile. Steam sterilize before use.
• Predicate Device: Leone Orthodontic Mini Implant (cleared 510(k) no. K071490).
• Substantial Equivalence: The submission asserts that the Syntec orthodontic mini screws have the "same intended use" as the predicate and "equivalent performance characteristics," raising "no new issues of safety or effectiveness." The FDA concurred with this determination, clearing the device for market.

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The bone plates and screws are provided non-sterile. The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

The plate is manufactured from commercially 316LS Stainless Steel which in conformance with ASTM F138 and an alternative material which is Pure Titanium. The plates designed are from 1.5mm to 6.5mm thickness, from 6.5mm to 17.5mm width, and are available variously in length from 24.0mm (2 holes) to 394.0mm (22 holes). It should assembly with the same screw that was the predicate device in concurrence by FDA, (K983495).

This 510(k) summary (K090839) describes the Syntec-Taichung Bone Plates and Screw Implants. However, the provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) submission, and its purpose is to demonstrate substantial equivalence to a predicate device, not necessarily to present performance studies in the way a clinical trial or a detailed engineering test report would.

Here's why the requested information cannot be extracted from the provided text:

• No Acceptance Criteria: The text does not list any specific performance metrics (e.g., tensile strength, fatigue life, accuracy, sensitivity, specificity) with corresponding thresholds that the device needs to meet.
• No Study Details: There is no description of a study conducted to evaluate the device's performance against any criteria. The document focuses on material composition and intended use, comparing it to a predicate device.
• Focus on Substantial Equivalence: The primary objective of this 510(k) is to demonstrate "Substantially Equivalence" to an already cleared predicate device (K983495), implying that its performance is presumed to be similar to the predicate based on material, design, and intended use, rather than through new, explicit performance studies detailed in this summary.

Therefore, I cannot populate the requested table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details. This information is typically found in performance testing reports, clinical study summaries, or detailed engineering analyses, which are not present in this 510(k) summary.

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The Unreamed Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(femur, and tibia) for the fixation of fractures.

The interlocking system makes up of Femoral, Tibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nail. The interlocking nails have the same features such as: Dynamic locking: Using the proximal oval hole permits axial loading with A rotational stability. A Anatomical design: Femur: The 1.6m radius of the Unreamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 8° in the upper third of the Unreamed Tibial Nail allows for easy insertion and good anatomical fit. A Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the unreamed interlocking nail ranges in diameter from 8 to 12 mm and total length 255 to 480 mm. The locking bolt screws have high strength, self-tapping and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9, 4.9, and 5.0mm and total length 20 to 125 mm.

The provided text describes a 510(k) submission for a non-sterile unreamed interlocking nail system. This document focuses on establishing substantial equivalence to a predicate device already on the market, rather than a study proving the device meets specific acceptance criteria through performance testing with human subjects or a clinical study.

Therefore, many of the requested elements (acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth information) are not present in this type of submission.

Here's an output based on the information available in the provided text, while also explicitly stating what cannot be extracted due to the nature of the document:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the 510(k) summary. A 510(k) submission for this type of device typically demonstrates substantial equivalence through material properties, design features, and intended use compared to a predicate device, rather than performance against pre-defined clinical acceptance criteria.

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

This information is not applicable and not provided. This document relies on comparison to a predicate device, not a performance study with a test set of data.

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

This information is not applicable and not provided. Ground truth establishment for a test set is relevant for performance studies, which are not detailed in this 510(k) submission.

4. Adjudication Method for the Test Set

This information is not applicable and not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done or at least not described in this 510(k) submission. The submission focuses on substantial equivalence to a predicate device.

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

This information is not applicable and not provided. This device is a surgical implant, not an algorithm or AI system.

7. The Type of Ground Truth Used

This information is not applicable and not provided. The "ground truth" in the context of this 510(k) is the established safety and effectiveness of the predicate device (Synthes-Titanium Unreamed Femoral Nail) to which the Syntec-Taichung device is deemed substantially equivalent. The substantial equivalence is based on:

• Design: Shared features like dynamic locking, anatomical design (femur curvature and tibial curvature), and distal locking.
• Sizes: Similar overall dimensions (diameter, length of nails and screws).
• Material: Both devices use commercially 316LS stainless steel and titanium alloy (Ti-6Al-4V).
• Appliance (Intended Use): Both are for fixation of fractures in the medullary canal of long bones.

8. The Sample Size for the Training Set

This information is not applicable and not provided. This document does not describe a training set for an AI/algorithm driven device.

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

This information is not applicable and not provided.

Summary of the Study (as described in the 510(k) document):

The "study" presented in this 510(k) is a comparison to a predicate device to establish substantial equivalence.

• Predicate Device: Synthes-Titanium Unreamed Femoral Nail.
• Comparison Basis: Design, sizes, material, and intended use ("appliance").
• Conclusion: Syntec-Taichung (Taiwan) believes that its non-sterile Unreamed Interlocking Nail System is substantially equivalent to the Synthes-Titanium Unreamed Femoral Nail. The FDA concurred with this assessment, allowing the device to be marketed.

This approach is common for medical devices seeking 510(k) clearance, where a direct comparison to an already legally marketed device demonstrates safety and effectiveness without requiring extensive new clinical trials or performance studies that define specific acceptance criteria.

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The Small Orthopedic Fixation System is provided non-sterile. The implants by the External Fixation Instrument may be used for highly comminuted closed fracture of hand, wrist, foot and tarsus ; for severe open fractures; for complex soft-tissue damages; or for dislocated joint fractures.

The Small Orthopedic Fixation System makes up of instrument and implants. The instrument is utilized with the implants. The implants are divided two kinds of styles: Schanz Screw, and Kirschner Wire. The dimension of the Schanz Screw ranges in thread diameter from 1.6 to 3.0 mm, thread length 15 mm, and total length 150, 200 mm; The dimension of Kirschner Wire with Threaded Tip ranges in thread diameter from 3.0/4.0 mm, total length from 80 mm.

This 510(k) summary does not contain information on acceptance criteria, a study proving device performance against such criteria, or details regarding sample sizes, ground truth establishment, or expert involvement.

The document is a submission for a non-sterile Small Orthopedic Fixation System and focuses on demonstrating substantial equivalence to a predicate device (Electro-Biology -- EBI Small External Fixator (S/E/F/)) based on similar design, sizes, materials, and appliance, rather than presenting a performance study with acceptance criteria.

Therefore, I cannot provide the requested information from the given text. The document is primarily a regulatory submission demonstrating substantial equivalence to an existing device, which is a different type of evaluation than a performance study against predefined acceptance criteria.

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The Interlocking Nail System is provided non-sterile. The implants are inserted into the medullary(bone marrow) canal of long bones(humerus, femur, and tibia) for the fixation of fractures.

The interlocking system makes up of Humeral, Fibial Nail and bolt screws. The bolt screws are utilized with the different interlocking nails have the same features such as: Proximal locking: Choice of two oval holes for static locking(only three holes for humerus) secures the rotational and axial stability. Anatomical design: Humerus: The curvature of 5° in the upper third of the Reamed Humeral Nail allows for easy insertion and good anatomical fit. Femur: The 1.88m radius of the Reamed Femoral Nail corresponds closely with the average anatomical curvature of the femur. Tibia: The curvature of 15° in the upper third of the Reamed Tibial Nail allows for easy insertion and good anatomical fit. Distal locking: Through two medial holes, additional locking is also possible in the anatomical seat. Easy insertion: The curvature of the posterior aspect of the nail reduces damage to the interior posterior cortical surface during insertion. The dimension of the interlocking nail ranges in diameter from 7 to 16 mm and total length 200 to 480 mm. The locking bolt screws have high strength, no tapping necessary and easy locking technique. The dimension of the bolt screw ranges in thread diameter from 3.9 to 6.4 mm and total length 20 to 100 mm.

This document is a 510(k) summary for the Syntec-Taichung Non-sterile Interlocking Nail System. It describes the device and claims substantial equivalence to a predicate device. However, the document does not describe any specific acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) submission process for Class II devices like this one focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring new clinical trials to prove safety and effectiveness against predefined acceptance criteria.

Therefore, I cannot provide the requested information from the provided text for the following reasons:

1. A table of acceptance criteria and the reported device performance: This information is not present in the document. The document states a "Basis of Substantial Equivalence" where it compares the Syntec-Taichung device to the Richards - Trimax Nail System in terms of design, sizes, material, and appliance, but no specific performance metrics or acceptance criteria are listed.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set" or a study involving such a set. The substantial equivalence claim is based on comparison to a predicate device's existing market data and characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no such test set or ground truth establishment is described.
4. Adjudication method for the test set: Not applicable, as no such test set or adjudication process is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned. The document is about an orthopedic implant, not an AI or imaging device where MRMC studies are typically performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
7. The type of ground truth used: Not applicable, as no study requiring ground truth is described.
8. The sample size for the training set: Not applicable, as this is not an AI/machine learning device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI/machine learning device.

In summary, the provided document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device. It does not contain information about specific acceptance criteria, performance studies, or clinical trial data as would be found for novel devices or those undergoing a PMA (Premarket Approval) process. The FDA's letter confirms that the device is "substantially equivalent" to predicate devices, allowing it to be marketed under the general controls provisions, without requiring new clinical performance studies outlined by specific acceptance criteria.

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The titanium alloy Mini plate is provided non-sterile. The device is intended to treat fractures of various bones, including the clavicle, scapula, pelvis, calcaneus, long bone (humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and plialanges).

The Mini plate is device, which is fastened to bone for purpose of providing fixation. The device is principally differentiated by its function. Thus there is various types and sizes of bone fixation plates. The Mini plate is geometry shape as follows: Straight, L-shaped, T-shaped, H-shaped, Condylar, Cloverleaf, Calcaneal, and Straight Reconstruction. The plate must be used for various sizes of screw onto bone fixation. The device range in thickness from 0.9 to 2.8 mm, width from 3.8 to 15.2 mm, length from 17 to 262 mm, and hole number from 3 to 22 holes.

I am sorry, but the provided text only contains regulatory information and a description of the device (Syntec-Taichung Non-sterile Titanium Alloy Mini Plate). It does not include any information regarding acceptance criteria, study details, performance data, or ground truth establishment for the device.

Therefore, I cannot populate the table or answer the specific questions about the study that proves the device meets the acceptance criteria. The document is primarily a 510(k) clearance letter from the FDA, confirming substantial equivalence to a predicate device.

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The DHS/DCS Plate System is provided non-sterile. The device may be used for fixation of fractures of the proximal femur, such as femoral neck, trochanteric, pertrochanteric, or intertrochanteric zones.

The system makes up of DHS/DCS Plates, DHS/DCS Screw, DHS/DCS Compression Screw, and 4.5 mm Cortex Screw (self-tapping). The DHS Plates are available with barrel length 25 mm and 38 mm, and barrel angles 135°, 140°, 145°, and 150° . The standard barrel length is 38 mm. Otherwise, the self-tapping 4.5 mm Cortex Screw may be used to fix the DHS/DCS Plates to the femoral shaft.

The DHS/DCS Compression Screw can be used to achieve fracture compression. Its dimension is available with thread length 26 mm and outer diameter 4.0 mm.

The thread of DHS/DCS Screw has a buttress type. The DHS/DCS Screw is available with thread length 22 mm, total length from 50 to 145 mm, outer diameter 12.5 mm, and shaft diameter 8.0 mm.

The provided text describes a 510(k) summary for the Syntec-Taichung Non-sterile DHS/DCS Plate System, a medical device for fixing proximal femur fractures. The document indicates that the device has been found substantially equivalent to predicate devices, but does not contain information about acceptance criteria, device performance studies, sample sizes, expert involvement, or adjudication methods.

Therefore, I cannot fulfill your request for the specific details outlined in your prompt based on the provided text. The document is primarily a regulatory approval letter and a summary of the device's basic characteristics and intended use.

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