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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K153575. The intended use and technological characteristics of the device remain unchanged.

This document describes the 510(k) premarket notification for the Tyber Medical Trauma Screw (K192975). This submission's primary purpose is to add MR Conditional information to the device labeling for a previously cleared device (K153575). Therefore, the study described focuses on demonstrating the device's safety in an MRI environment, rather than its general clinical effectiveness.

Here's a breakdown of the requested 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

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical evaluation. It generally refers to "the Tyber Medical Trauma Screw" being exposed to the MR environment.
• Data Provenance: The data provenance is from non-clinical testing (bench testing) performed to evaluate the MRI safety of the device. There is no information about the country of origin, but it can be assumed to be conducted by or for Tyber Medical LLC, based in Bethlehem, Pennsylvania, USA. The study is prospective in nature, as it involves active testing to generate new safety data for the device in the MR environment.

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

• This information is not applicable as the evaluations were non-clinical (bench testing) focusing on physical properties and interactions with an MRI scanner. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on adherence to the specified ASTM testing standards and objective measurements.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluations were non-clinical (bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and 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 submission is for a physical medical device (trauma screw) and its MRI compatibility, not an AI-powered diagnostic tool. The document states "Clinical Test Summary: n/a".

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, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this study was established by objective measurements and adherence to international recognized ASTM standards for MRI safety testing. These standards define the parameters and methods for evaluating magnetic field interactions, torque, heating, and artifact generation.

8. The Sample Size for the Training Set

• This information is not applicable. There was no "training set" as this was non-clinical bench testing of a physical device, not an AI model requiring training data.

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

• This information is not applicable as there was no training set.

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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K133842. The intended use and technological characteristics of the device remain unchanged.

The provided text describes a 510(k) premarket notification for the "Tyber Medical Trauma Screw." This document focuses on demonstrating substantial equivalence to a predicate device, specifically to add MR Conditional information to the device labeling.

Based on the information provided, this submission does not involve an AI/ML medical device, and therefore, it does not contain the information requested regarding acceptance criteria and studies for device performance in the context of AI/ML.

The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" sections, along with all the detailed points you requested (sample sizes, ground truth establishment, expert adjudication, MRMC studies, etc.), are relevant to AI/ML device submissions, particularly those involving diagnostic or prognostic algorithms that analyze medical images or data.

The provided document is for a traditional medical device (a trauma screw) and outlines non-clinical testing for MR safety and mechanical properties.

Here's why the requested information isn't present in this document:

• Type of Device: The device is a "Tyber Medical Trauma Screw," a physical bone fixation fastener. It's not an AI/ML algorithm.
• Purpose of Submission: The primary purpose of this 510(k) is to add "MR Conditional" information to the device labeling and to compare its mechanical performance (driving torque) to a predicate device.
• Testing Described: The document details non-clinical testing such as:
  • MR Safety Testing (in accordance with ASTM 2503-13): Magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating.
  • Mechanical Testing: Driving Torque per ASTM F543-17 Annex A2.
• Clinical Test Summary: Explicitly states "n/a" (not applicable), confirming no clinical studies were performed or required for this submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance, ground truth, expert opinions, or MRMC studies from the provided text.

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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. This submission adds a headed screw and snap off option as well as an optional washer to the previously cleared headless trauma screw with and without previously cleared modified surface treatment. The screws will be provided sterile and non-sterile in both solid and cannulated form, made of from titanium (with and without Modified Surface treatment) and

The provided document is a 510(k) summary for the Tyber Medical Trauma Screw. It describes the device's characteristics, intended use, and substantial equivalence to a predicate device, but it does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

The document pertains to a physical medical device (trauma screw) and primarily focuses on demonstrating substantial equivalence through non-clinical testing of mechanical properties, specifically static torsion. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving an AI/ML device meets them based on the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are highly specific to AI/ML device evaluations and are not applicable to the content of this 510(k) summary for a trauma screw.

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A trauma screw designed to apply compression and fixation between two adjacent segments of cortical and/or calcaneus bone.
The Tyber Medical Trauma Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The sterile and non-sterile implants come solid and cannulated, titanium and stainless steel.

This document describes K133842 for the Tyber Medical Trauma Screw.

1. Table of Acceptance Criteria and Reported Device Performance:

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

The document does not specify a distinct "test set" and instead refers to non-clinical mechanical testing. The sample size for this mechanical testing is not explicitly stated. The data provenance is non-clinical, meaning it originates from laboratory testing. No information is provided regarding country of origin or whether it's retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. This device is a mechanical implant, and its performance is evaluated through objective mechanical tests (Pullout and Torsional Yield) rather than relying on expert-established ground truth like in image-based diagnostic devices.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods are typically used when subjective assessments or multiple reader interpretations are involved, which is not the case for mechanical testing of a bone screw.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Not applicable. This is a medical device (bone screw), not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

6. Standalone Performance Study:

Yes, a standalone performance study was done in the form of non-clinical mechanical testing. The study evaluated the Tyber Medical Trauma Screw's Pullout and Torsional Yield strength. The results indicated substantial equivalence to predicate devices.

7. Type of Ground Truth Used:

The "ground truth" for this device's performance is established by the standardized requirements and testing methods defined in ASTM F544 for pullout and torsional yield strength. The performance is assessed against these established mechanical properties.

8. Sample Size for the Training Set:

Not applicable. This device does not involve a "training set" in the context of machine learning or AI algorithms. It's a physical medical device.

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

Not applicable, as there is no "training set" for this device.

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