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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 Syntec Orthodontic Mini Screw Extended System is a modification of our own device Syntec Orthodontic Mini Screw (K090476). The screws are fabricated from stainless steel (SUS316L) per ISO 5832-1:2007/ASTM F138-13 and Titanium-6 Aluminum-4 Vanadium Eli (Extra Low Interstitial) Alloy per ISO 5832-3:1996/ASTM F136-13 as same as previous devices (K090476). The modifications included in the subject submission are a change to the screw hole type, from the previously cleared circular design, to a rectangular shape.

The provided text does not contain information about an AI/ML-based medical device. Instead, it describes a traditional medical device, the "Syntec Orthodontic Mini Screw Extended System," and its 510(k) premarket notification to the FDA.

Therefore, I cannot provide the requested information about acceptance criteria, study details, ground truth establishment, or human-in-the-loop performance studies, as these concepts are typically applied to AI/ML device evaluations and are not present in this document.

The document primarily focuses on demonstrating substantial equivalence of the new orthodontic mini screw system to a previously cleared predicate device, based on material composition, dimensions, and manufacturing processes, with a minor modification in screw hole shape. The performance data section refers to non-clinical tests (dimensional, material mechanical property standards, biocompatibility, fracture load, rotational fracture torque, and axial pull-out strength), stating these tests were leveraged from the predicate device and not repeated for the new submission.

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The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondy lar and ipsilateral fractures; Delayed union fractures: Open and closed femur shaft fractures: Combined inter and subrochanteric fractures: High subtrochanteric fractures . Pseudoarthrosis and correction osteotomy: Pathological fractures, impending pathologic and tumor resections: Pertrochanteric fractures: and Nonunions and malunions.

The Syntec Femoral Nail Extended System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail Extended System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

This document is a 510(k) submission for the Syntec Femoral Nail Extended System, a medical device used for long bone fracture fixation. The submission declares the device substantially equivalent to previously cleared predicate devices.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the acceptance criteria are generally implied rather than explicitly stated with numerical thresholds. The primary criterion is conformance to established material and mechanical property standards, and the reported performance is simply that the device meets these standards.

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

• Sample Size for Test Set: Not explicitly stated. The document refers to "those nails in the scope of this submission" and "mechanical strength comparison, analysis of results, engineering justifications, dimensional and material comparisons." This implies laboratory testing on representatives of the device variants, rather than a sample of patient data.
• Data Provenance: Not applicable in the context of clinical data. For the non-clinical testing, the testing was conducted for the specific submission as part of the regulatory process. The manufacturing location is Taiwan.

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

• This information is not provided in the document. The studies described are non-clinical, mechanical, and material characteristic comparisons, not studies requiring expert clinical assessment for ground truth.

4. Adjudication method for the test set

• This information is not provided and is not applicable given the nature of the non-clinical testing described.

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, an MRMC comparative effectiveness study was NOT done. This device is an intramedullary nail, which is a physical implant for fracture fixation, not an AI-powered diagnostic or assistive technology.

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

• No, a standalone algorithm performance study was NOT done. This device is a physical medical implant.

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

• For the non-clinical tests, the "ground truth" is established by engineering standards and specifications (e.g., ASTM F136-13, ASTM F138-13, ISO 5832-1:2007, ISO 5832-3:1996) and established mechanical testing methodologies.

8. The sample size for the training set

• This is not applicable. This device is a physical medical implant, not an AI/ML algorithm that requires a training set.

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

• This is not applicable. This device is a physical medical implant, not an AI/ML algorithm.

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The Steinmann pins are provided non-sterile. The devices are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, as guide pins for insertion of other implants.

The Syntec Non-Sterile Steinmann Pins System is modify from our own device from K983121-Non-Sterile Kirschner Wires and Steinmann Pins product systm. The modify Pins are fabricated from stainless steel (SUS316L) per ASTM F138-13.The design feature for the Non-Sterile Steinmann Pins System is similar to the predicate devices including dimensions, shape, style and sizes.

This document is a 510(k) premarket notification for the Syntec Non-Sterile Steinmann Pins System. It explicitly states that clinical data and conclusions were not needed for these devices and performance tests are not required to support substantial equivalence in special 510k.

Therefore, the provided text does not contain any information about:

• Acceptance criteria related to device performance in a clinical or non-clinical study.
• Reported device performance from such a study.
• Sample sizes used for test or training sets.
• Data provenance.
• Number of experts, their qualifications, or adjudication methods for establishing ground truth.
• MRMC studies, effect sizes, or standalone algorithm performance.
• Type of ground truth used.
• How ground truth for a training set was established.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K983121 - Non-Sterile Kirschner Wires and Steinmann Pins product system) based on:

1. Identical Intended Use and Indications for Use: The Steinmann pins are indicated for use in fracture fixation, for healing of facile bone fragments, for osteotomies in the presence of adequate immobilization, and as guide pins for insertion of other implants.
2. Technological Characteristics: The modified pins are fabricated from stainless steel (SUS316L) per ASTM F138-13, and their design features (dimensions, shape, style, and sizes) are similar to the predicate devices.
3. Conformance to Standards: The device was considered in conformance with dimensional and material mechanical property standards ASTM F138-13, ASTM F366-10, and ISO 5838-1.

In summary, the provided text does not describe a study involving performance testing against acceptance criteria. It's a regulatory submission demonstrating equivalence for a medical device that, due to its nature as a "Special 510(k)," did not require extensive clinical or non-clinical performance data for clearance.

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The Syntec Tibial Nail System is intended to stabilize fractures of the proximal and the tibial shaft; certain pre-and post-isthmic fractures; open and closed tibial shaft fractures; and tibial malunions and non-unions

The Syntec Tibial Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 12° in the upper third of the reamed Tibial Nail. These nails will use ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8.4 in 15mm lengths is available for proximal closing of the nail. The Syntec Tibial Nail System (nail, screw and end cap) are provided non-sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

I am sorry, but the provided text does not contain the information required to answer your request. The document describes a medical device, the Syntec Tibial Nail System, and its clearance as substantially equivalent to predicate devices by the FDA. However, it does not include details about acceptance criteria, device performance metrics, sample sizes for testing, expert qualifications, ground truth establishment, or clinical study results with effect sizes against human readers. The document explicitly states that "Clinical studies are not required to support substantially equivalent" and only mentions "Biomechanical Test: The biomechanical tests ASTM F1264-16e1 were performed to determine substantial equivalence for the Syntec Tibial Nail System".

Therefore, I cannot provide a table of acceptance criteria and reported device performance or information regarding multi-reader multi-case studies, standalone performance, or sample sizes/ground truth details for training and test sets.

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The Syntec Femoral Nail System is indicated for long bone fracture fixation which may include the following: Fractures, and tumor resections; Fractures proximal to a total knee arthroplasty; Supracondylar and ipsilateral fractures; Delayed union fractures; Open and closed femur shaft fractures; Combined inter and subrochanteric fractures; High subtrochanteric fractures; Pseudoarthrosis and correction osteotomy; Pathological fractures, impending pathologic and tumor resections; Pertrochanteric fractures; and Nonunions and malunions.

The Syntec Femoral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) nail with a 5° proximal bend allows the nail to be inserted through the tip of the greater trochanter for an easier surgical approach. These nails have a 135° recon screw angle for easier placement of two 6.3 mm Recon Screws into the femoral neck and ø5mm internal hex captured screws in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø13 in 3, 5, 10, 15mm lengths is available for proximal closing of the nail. The Syntec Femoral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

This document describes the Syntec Femoral Nail System, an intramedullary fixation rod. The information provided outlines the system's design, intended use, and a comparison to predicate devices, but it contains limited details regarding specific acceptance criteria and study outcomes.

Here's an analysis of the provided text in relation to your request:

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

The document mentions that "The procedure of evaluating the device tests was according to the standard of ASTM-F1264-16." It also states, "According device test report of performance data demonstrate that the Syntec Femoral Nail is as safe and effective as K040462, K984543 and K161327."

However, the document does not provide a table of specific acceptance criteria (e.g., minimum bending strength, torsional stiffness, fatigue life) or the actual reported device performance values against those criteria. It only states that the testing was performed and demonstrated substantial equivalence to the predicate devices. To fulfill this request, concrete numerical values for both acceptance criteria and the device's performance would be needed.

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

The document states, "The testing was done to our Syntec Femoral Nail System device to demonstrate substantial equivalence."

The document does not specify the sample size used for the test set, nor does it provide information on the data provenance (e.g., country of origin, retrospective or prospective study design). Given that the testing was "to our Syntec Femoral Nail System device," it's likely referring to a bench testing study on the device itself, rather than a clinical study with human patients.

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 information is not applicable to the type of study described. The document refers to "device tests" according to a standard like ASTM-F1264-16, which are typically mechanical or material property tests performed in a lab setting, not evaluations requiring expert interpretation of medical images or clinical outcomes.

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

This information is not applicable for the same reasons as point 3. Adjudication methods are relevant for studies involving human interpretation or clinical endpoint assessments, which are not detailed here.

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 described is an intramedullary fixation rod, a physical implant for fracture fixation. It is not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not applicable as the device is a physical medical implant, not an algorithm or software.

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

For the "device tests" mentioned (which are presumed to be mechanical testing), the "ground truth" would be established by the specific test methods and measurement standards outlined in ASTM-F1264-16. For example, force exerted, displacement measured, or cycles to failure. These are objective, measurable physical properties, not ground truth established by expert consensus, pathology, or outcomes data.

8. The sample size for the training set:

This information is not applicable as the device is a physical product and does not involve machine learning or AI that would require a training set.

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

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

In summary, the provided text describes the regulatory clearance of a physical medical device (Syntec Femoral Nail System) based on substantial equivalence and performance testing to an industry standard (ASTM-F1264-16). It lacks the detailed information typically found in documentation for AI/software medical devices regarding acceptance criteria, study design, expert involvement, and ground truth establishment. The context of your questions seems to overlap with requirements for AI/ML-based medical devices, which the Syntec Femoral Nail System is not.

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THE SYNTEC HUMERAL NAIL SYSTEM IS INDICATED FOR FRACTURES OF THE PROXIMAL HUMERUS. INCLUDING 2-PART SURGICAL NECK FRACTURES, 3-PART FRACTURES, AND 4-PART FRACTURES, PROXIMAL HUMERAL FRACTURES WITH DIAPHYSEAL EXTENSION INTO THE SHAFT, AND IMPENDING PATHOLOGIC HUMERAL FRACTURES.

The Syntec Humeral Nail System are manufactured from commercially SUS316L (stainless steel) and Ti-6AL-4V (Titanium alloy). It is an intramedullary (IM) straight nail with a 5° proximal bend configuration to fit the anatomy of the humerus and is inserted proximally over ø2.0 calibrated guide wires. Those nail accepts only an ø3.8mm Cortical Screw in various lengths for cross-screw fixation in both the proximal and distal portion of the nail. Also, an End Cap ø8 ~ ø 9 in 9mm lengths is available for proximal closing of the nail. The Syntec Humeral Nail System (nail, screw and end cap) are provided Non-Sterile and single use only. Also, it is not for spinal use. Associated instrumentation such as aiming device for proximal and distal, insertion guide wire, drill accessories, system and removal instruments are available with the system.

Here's an analysis of the provided text regarding acceptance criteria and device performance:

The provided document is a 510(k) Summary for a medical device (Syntec Humeral Nail System), which primarily focuses on demonstrating substantial equivalence to a predicate device. It does not contain the detailed information typically found in a study report that rigorously tests a device against pre-defined acceptance criteria using clinical or algorithmic performance metrics.

Therefore, I cannot extract the information required to populate all sections of your request. Specifically, the document does not contain information on:

• Acceptance criteria and reported device performance related to specific clinical or diagnostic outcomes.
• Sample size for a test set (clinical or imaging data).
• Data provenance for a test set.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study or effect size.
• Standalone (algorithm-only) performance.
• Sample size for a training set.
• How ground truth for a training set was established.

The document only refers to "Performance Data" in the context of mechanical testing according to a standard, and then makes a general statement about substantial equivalence based on that.

Here's what can be extracted and inferred from the provided text according to your request:

1. Table of Acceptance Criteria and the Reported Device Performance

Based on the document, the "acceptance criteria" appear to be related to demonstrating mechanical equivalence to a predicate device based on a recognized standard. The reported performance is a general statement of equivalency.

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

The document mentions "device test report of performance data" and testing according to ASTM-F1264-14, which refers to mechanical testing. It does not specify sample sizes of devices tested, nor does it refer to patient data or its provenance for any clinical or diagnostic performance assessment.

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

Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert interpretation of clinical data or images.

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

Not applicable. The document describes mechanical testing of the device itself, not an assessment requiring expert consensus.

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. The Syntec Humeral Nail System is an intramedullary fixation rod, a physical implant. It is not an AI-powered diagnostic device or an AI-assisted tool for human readers.

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

Not applicable. This device is a physical implant, not an algorithm.

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

For the mechanical testing, the "ground truth" would be established by the physical and mechanical properties and behaviors of the device as measured against the specifications outlined in the ASTM standard. There is no clinical or diagnostic "ground truth" as described (expert consensus, pathology, outcomes data) relevant to the performance data cited here.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, this is not an AI model.

Summary of what the document does convey regarding "acceptance criteria" and "study":

The "study" described, albeit briefly, is primarily focused on mechanical performance testing against the ASTM-F1264-14 standard to demonstrate that the Syntec Humeral Nail System performs similarly to its predicate device (I.T.S. IM Nail Systems CFN-CTN-CHN). The "acceptance criteria" appear to be met when the device's mechanical test results support a conclusion of substantial equivalence regarding safety and effectiveness compared to the predicate, particularly in its intended uses and technological characteristics. There is no mention of clinical trials or studies assessing patient outcomes or diagnostic accuracy in the context of what you've asked.

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THE SCREWS ARE INDICATED FOR USE AS A FIXED ANCHORAGE FOR ATTACHMENT OF ORTHODONTIC APPLIANCES TO FACILITATE THE ORTHODONTIC MOVEMENT OF TEETH. THEY ARE USED TEMPORARILY AND ARE REMOVED AFTER ORTHODONTIC TREATMENT HAS BEEN COMPLETED. THEY ARE INTENDED FOR SINGLE USE ONLY.

The screws are manufactured from commercially SUS316L (stainless steel) and Ti6AL-4V (Titanium alloy). The screws are available with thread diameter are from 1.4mm to 2.0 mm, and total thread lengths from 6.0mm to 12.0mm. The minor technological modification for Syntec Wetali Orthodontic Mini Screws is re-designed self-drilling angle for more easily insertion and removal. The design of smooth curve surface of screw head is comfortable to patient and the screws with or without a 0.7mm diameter hole can supply different orthodontic methods for orthodontists.

This document describes a 510(k) premarket notification for the "Syntec Wetali Orthodontic Mini Screws." The core of the submission is to demonstrate substantial equivalence to a legally marketed predicate device, the "Syntec Orthodontic Mini Screws (K090476)."

Here's an analysis of the acceptance criteria and the study that proves the device meets them, 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 states that "Both of comparative testing was done to our own predicate device," referring to the pull-out strength and insertion torque tests. However, it does not specify the sample size used for these tests.

Regarding data provenance:

• Country of Origin: The company is Syntec Scientific Corporation, located in Taiwan (R.O.C.). It can be inferred that the testing was conducted by or on behalf of Syntec Scientific, likely in Taiwan or a region accessible to them.
• Retrospective or Prospective: The text does not explicitly state whether the data was retrospective or prospective. Given that this is a premarket notification for a new version of a device, it is highly likely that the testing (e.g., mechanical tests like pull-out strength and insertion torque) was prospectively generated for the purpose of this submission. It's not clinical data, but rather mechanical testing data.

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

This information is not applicable in this context. The "test set" for this submission consists of physical mechanical tests (pull-out strength and insertion torque) on the device, not clinical data requiring expert interpretation. The ground truth is established by the physical properties of the materials and the mechanical measurements, not by expert consensus in a medical diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable. The "test set" involves objective mechanical measurements (pull-out strength and insertion torque) against a recognized standard (ASTM-F543), not subjective human assessment requiring adjudication.

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. This type of study is typically performed for diagnostic medical devices where expert readers evaluate images or data. The "Syntec Wetali Orthodontic Mini Screws" is a physical medical device (orthodontic mini screw) and its performance is evaluated through mechanical bench testing, not clinical imaging or diagnostic interpretation.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This question is not applicable as the device is not an algorithm or software requiring performance evaluation in a "standalone" or "human-in-the-loop" context. It is a physical medical device.

7. The Type of Ground Truth Used

The ground truth used here is based on objective mechanical measurements against a recognized industry standard. Specifically:

• ASTM-F543 standard: This standard defines the methodologies and acceptable parameters for evaluating the mechanical properties of bone screws, including pull-out strength and insertion torque. The "ground truth" is that the device's performance metrics (e.g., the measured pull-out strength and insertion torque values) must conform to or be comparable to acceptable values defined by this standard and/or to the predicate device.

8. The Sample Size for the Training Set

This information is not applicable. There is no "training set" in the context of this device and the presented evaluation. Training sets are typically used for machine learning algorithms or AI models. This submission focuses on physical device characteristics demonstrated through mechanical testing.

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

This information is not applicable as there is no "training set."

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