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Transon General Spinal System (GSS) is intended for posterior pedicle screw fixation (GSS-VII can be applied for anterior or anterolateral fixation) of the non-cervical posterior spine in skeletally mature patients. It provides stabilization and immobilization of spinal segments as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities.

When used as a posterior spine thoracic/lumbar system, Trauson General Spinal System (GSS) is indicated for one or more of the following: (1) trauma (i.e. fracture or dislocation), (2) curvatures (scoliosis, and/or lordosis), (3) spinal tumor, (4) failed previous fusion (5) pscudarthrosis, (6) spinal stenosis.

Trauson General Spinal System (GSS) is not intended for pedicle screw fixation above T8.

The applicant device of Trauson General Spinal System (GSS) made of Titaniuim Alloy (Ti-6AL-4V) that meet ASTM 136 is intended for posterior pedicle screw fixation of the non-cervical posterior spine in skeletally mature patients.

The applicant devices are not provided sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.

All variants use the same material, same design principle and are constant thickness.

No chemical for the enhancement of its clinical performance is applied on or incorporated into applicant device.

The provided text is a 510(k) summary for the Trauson General Spinal System (GSS), a medical device. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed acceptance criteria table and a study proving device performance against those criteria.

Therefore, the input does not contain the information requested in the prompt (acceptance criteria, device performance table, sample sizes, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, or training set details). The document states "Performance tests demonstrate that the specifications of the proposed device meet its design input," but it does not elaborate on what those specifications or performance tests were.

Without explicit information from the provided text, I cannot complete the requested tables and descriptions based on this submission. This is a common characteristic of 510(k) summaries, which aim to establish equivalence rather than present full validation study results.

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Trauson Intramedullary Nail is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease.

The Trauson Intramedullary Nail made of medic 11 grade 3 16L stainless steel that meet ASTM F138 - 08 Standard Specification for Wrought 18Chromium-14 Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants. It is intended to be implanted into the intramedullary canal of femur or humerus for alignment, stabilization, fixation of fractures caused by trauma or disease. The subject devices are not provided sterile. No new materials are used in the development of this device.

The provided document is a 510(k) summary for a medical device called "Trauson Intramedullary Nail". This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed clinical study data for acceptance criteria.

Therefore, the document does not contain the information requested regarding acceptance criteria, a study proving the device meets those criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or detailed descriptions of ground truth establishment for a diagnostic AI device.

This submission is for a medical implant, an intramedullary nail, and relies on bench testing of material properties and comparison to existing legally marketed devices to establish safety and effectiveness. It is not a diagnostic AI device requiring the kind of performance metrics and study design outlined in the request.

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Trauson Bone Plate is intended for the fixation of fractures of humerus.

The applicant device of Trauson Bone Plate made of medic 11 grade 3 16L stainless steel that meet ASTM F138 is intended for the fixation of fractures of humerus. The plates vary essentially through different lengths, number of plate holes. The applicant devices are not sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.

The provided text describes a submission for a medical device called "Trauson Bone Plate" and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device.

This document pertains to a Class II metallic bone fixation appliance, which is a physical implant, not an AI/ML system or a diagnostic device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of device and are not present in the provided text.

Based on the information given, here's what can be extracted and what cannot:

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

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

• Not applicable / Not provided. The tests mentioned are bench tests on the physical device components, not studies on 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 / Not provided. Ground truth, in the context of diagnostic performance or AI, is not relevant for a bone plate's mechanical and material properties.

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

• Not applicable / Not provided. Adjudication is not relevant for bench testing of material properties.

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 type of study is entirely irrelevant for a bone fixation plate.

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):

• Ground truth for mechanical/material properties: Adherence to established ASTM standards (F138 for material, F382 and F897 for mechanical tests). The "ground truth" here is the specified performance criteria defined by these standards.

8. The sample size for the training set:

• Not applicable / Not provided. There is no "training set" for a physical medical device in this context.

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

• Not applicable / Not provided. There is no "training set" or "ground truth" in the AI/ML sense. The ground truth for the device's properties is based on industry-standard material and mechanical testing protocols.

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Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head. The applicant devices are not sterile. No new materials are used in the development of this implant.

This document describes the 510(k) submission for the Trauson Bone Screw, indicating that it's a medical device (a bone screw) and that its approval is based on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, independently established acceptance criteria through a clinical or performance study that would generate the kind of data requested in the prompt.

Here's a breakdown based on the provided text, highlighting what can be answered and what cannot:

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

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

• Sample Size: Not applicable in the context of the provided information. This submission relies on "substantial equivalence" to a predicate device, which typically involves bench testing rather than clinical performance (patient) studies with sample sizes.
• Data Provenance: The bench tests were "conducted" as part of the submission process, but the country of origin of the testing data itself is not specified beyond the manufacturer being in China. The nature of these tests is prospective for this specific device.

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 and expert consensus are concepts typically associated with diagnostic AI or image analysis. This submission is for a physical orthopedic implant. The "ground truth" for the material and mechanical properties would be established by industry standards (ASTM, ISO) and laboratory testing protocols.

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

• Not applicable. Adjudication methods are usually relevant for expert review in clinical studies or assessment of diagnostic outcomes. Bench testing for mechanical properties would involve standardized measurement and verification against pre-defined 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

• Not applicable. This is not an AI/diagnostic device.

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

• Not applicable. This is not an AI/diagnostic 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 material standards (ASTM 138) for its composition and biological evaluation standards (ISO 10993) for biocompatibility. For mechanical properties, it would be the physical and mechanical specifications of the predicate device as the benchmark for substantial equivalence, determined through laboratory bench tests.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that uses a "training set."

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

• Not applicable. As above, there is no "training set" for this type of medical device submission.

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