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The TriMed Bearing Plate is intended for use as an aid the fracture healing. The implants are applied to a to fracture hound secured with bone screws and threaded or unthreaded locking fixation pegs.

The TriMed Bearing Plate is indicated for:

1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion

The TriMed Bearing Plate is a bone fixation plates are inc frined bound to fracture fixation. The plates are is ased as an an an either medical grade 316 stainless manalabourea (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136). freamfamilian which workeristics of the devices are provided in enclosures 8 and 9.

The provided text is a 510(k) summary for the TriMed Bearing Plate. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance acceptance criteria through a study in the same way clinical trials for new drugs or software algorithms are conducted.

Therefore, the information requested in your prompt regarding acceptance criteria, study details, sample sizes, expert involvement, and ground truth is not present in this document.

This document specifically states: "report an intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976."

Here's why the requested information is absent and what can be inferred from the document:

• Acceptance Criteria & Reported Device Performance: This device, being a bone fixation plate, is evaluated based on its material properties (e.g., medical grade stainless steel or Titanium alloy) and its functional equivalence to existing plates. The document states, "The TriMed Bearing Plate has identical technical characteristics to existing bone plates in common use." There are no explicit performance metrics like sensitivity, specificity, or accuracy mentioned as there would be for a diagnostic or AI device.
• Study Details (Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone): A 510(k) for a physical medical device like this typically relies on bench testing for material and mechanical properties, and comparison to predicate devices, rather than clinical studies with human participants that would involve test sets, ground truth, or experts in the way your prompt describes for AI/diagnostic devices. The regulatory process for this type of device focuses on demonstrating that the new device is as safe and effective as a legally marketed device.
• Ground Truth: For a bone fixation plate, "ground truth" would be related to mechanical integrity and biocompatibility, typically established through material testing standards and established clinical use of similar materials and designs. It's not about an "expert consensus" on an image or pathology.
• Training Set (for AI/Algorithms): The concept of a "training set" is irrelevant for this type of physical medical device, as it does not involve any algorithms or machine learning.

What the document does provide:

• Predicate Devices: The document lists several predicate devices (e.g., Zimmer Forte plate, Synthes bone fixation plates, Smith-Nephews bone fixation plates and screws). The "substantial equivalence" is established by comparing the TriMed Bearing Plate to these existing devices.
• Material Specifications: The device is made of "medical grade 316 stainless steel (ASTM F139) or medical grade wrought Titanium-6Aluminum-4Vanadium alloy (ASTM F136)." These are standard materials used in similar devices, implying they meet established performance and safety requirements.
• Intended Use/Indications for Use: Fixation of fractures or non-unions of the distal radius, and osteotomies of the distal radius to correct malunion. These are typical indications for bone fixation plates.

In summary, the provided text is a regulatory submission demonstrating substantial equivalence for a physical medical device, not a performance study for an AI-powered diagnostic tool. Therefore, the specific criteria and study details requested are not applicable or found within this document.

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The TriMed Radial Bullet is intended for use as an aid to fracture healing. The implants are inserted across a fracture site and aid in stabilization of the bone fragments until bone healing occurs. The implant design includes a tip that is placed up against the subchondral bone of the tip of the radial styloid to prevent loss of radial length during fracture healing. The TriMed Radial Bullet may be used with bone screws, washers, locking bone screws and/or locking fixation pegs of the same material. The principal site of application is along the radial column in the context of distal radius fixation for treatment of fractures or osteotomies. Other sites of application may be reserved for future use.

The TriMed Radial Bullet is indicated for:

1. Fixation of fractures or non-unions of the distal radius
2. Osteotomies of the distal radius to correct malunion

The TriMed Radial Bullet is a bone fixation implant that is used as an aid to fracture fixation. All components of the implant are manufactured either from medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy.

The provided text is a 510(k) summary for the TriMed Radial Bullet, a bone fixation implant. It primarily focuses on demonstrating substantial equivalence to predicate devices for regulatory clearance, rather than presenting a study to prove the device meets specific acceptance criteria through performance metrics.

Therefore, many of the requested sections about study design, sample sizes for test and training sets, expert qualifications, and ground truth establishment are not present in this type of regulatory document.

However, I can extract information related to the device's intended use, technological characteristics, and how its equivalence is established.

Here's an attempt to structure the available information, noting the absence of details requested that are typically found in a clinical or performance study report:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify "acceptance criteria" in terms of performance metrics (e.g., accuracy, sensitivity, specificity) as one would find for a diagnostic or AI device. Instead, the "acceptance criteria" for a 510(k) submission for a bone fixation plate generally revolve around demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing:

• Similar intended use: The device is intended for the same uses as the predicate.
• Similar technological characteristics: The device operates and is constructed similarly to the predicate.
• Safety and efficacy: The differences (if any) do not raise new questions of safety or effectiveness.

Therefore, the "reported device performance" in this context is the assertion that it meets these substantial equivalence criteria due to its identical technical characteristics and intended use compared to existing devices.

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

Not applicable. This is a 510(k) submission for a medical device (bone fixation plate), not a study involving a "test set" of data or patient images for an AI algorithm. The evaluation is based on comparison to existing predicate devices and material specifications.

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

Not applicable. No "test set" or "ground truth" establishment in this context. The "expert" involved in the submission is Robert J. Medoff, MD, who prepared the 510(k) and is likely the device inventor/developer or a clinical consultant. His qualifications aren't explicitly detailed beyond being a Medical Doctor, but his role suggests expertise in orthopedics, given the device's application.

4. Adjudication Method for the Test Set

Not applicable. No "test set" to adjudicate.

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 bone fixation plate, not an AI-assisted diagnostic tool.

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

Not applicable. This is a bone fixation plate, not an algorithm.

7. The Type of Ground Truth Used

Not applicable for a typical "ground truth" definition for an AI or diagnostic study. For a medical device 510(k), the "ground truth" in a broader sense is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. This "ground truth" is established through years of clinical use, regulatory history, and potentially prior clinical studies for the predicate devices.

8. The Sample Size for the Training Set

Not applicable. No "training set" for an algorithm.

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

Not applicable. No "training set" for an algorithm.

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Skeletal fractures that are amenable to the principle of tension band wiring. Typical sites of application may include but are not limited to fractures of the olecranon, patella, of application malleolus, distal ulna, distal ulna, distal humerus, and proximal humerus. The decision to use a specific implant as well as the size and shape of the implant used I he uccision to use a specific xxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxxx the circumstances and configuration of the injury.

The TriMed tension band sleds are double 'U' shaped wire implants that are used as an aid to fracture fixation. They are manufactured from either medical grade 316 stainless steel or medical grade titanium-vanadium-aluminum alloy and vary in diameter from .028" to .250".

The provided text is a 510(k) submission for a medical device called "TriMed tension band sleds" (also referred to as "Tension Band Wire"). This document outlines the device's description, intended use, and technological characteristics, and includes the FDA's letter of substantial equivalence.

However, a 510(k) submission for this type of device (a bone fixation fastener) does not typically include detailed studies proving performance against specific acceptance criteria in the way that, for instance, an AI/ML software device would. The FDA's substantial equivalence determination for such a device is primarily based on showing that it is as safe and effective as a legally marketed predicate device, rather than on extensive clinical trials with specific performance metrics.

Therefore, the requested information regarding acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in the provided document because they are generally not required or part of a 510(k) submission for this class of device. The primary "study" is the comparison to predicate devices, which the document implicitly covers by stating the device has "identical characteristics to existing pins and wires commonly in use."

Here's a breakdown based on the information available and not available in the provided text:

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

• Not Applicable/Not Provided. The document is a 510(k) submission for a mechanical implant (tension band wire). The acceptance criteria for such a device are primarily related to material specifications, dimensional characteristics, and an overall demonstration of substantial equivalence to existing predicate devices in terms of safety and efficacy for its intended use. There are no specific numerical performance metrics (like sensitivity, specificity, or accuracy) reported that would typically be found for a diagnostic or AI/ML device.

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

• Not Applicable/Not Provided. This information pertains to studies typically conducted for AI/ML or diagnostic devices. For a mechanical implant, testing might include mechanical strength tests or biocompatibility tests, but these are not described in the terms of a "test set" as requested here. The "data provenance" for a material or mechanical device usually refers to where the materials were sourced or manufactured, not clinical data sets.

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. This is relevant for diagnostic performance studies. The "ground truth" for a bone fixation device is its ability to physically hold bone fragments.

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

• Not Applicable/Not Provided. This applies to methods for resolving discrepancies in expert interpretations, common in diagnostic imaging studies.

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/Not Provided. MRMC studies are associated with evaluating the performance of diagnostic imaging devices or AI-assisted diagnostic tools. This device is a surgical implant.

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

• Not Applicable/Not Provided. This concept is only applicable to AI/ML algorithms. The device is a physical implant.

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

• Not Applicable. The "ground truth" for this device's performance would be clinical outcomes related to fracture healing and stability, as well as mechanical testing results to ensure its structural integrity. These are not detailed in the provided 510(k) summary. The summary itself relies on the "substantially equivalent" principle to predicate devices, implying similar safety and efficacy without explicitly detailing new "ground truth" studies.

8. The sample size for the training set:

• Not Applicable/Not Provided. This is relevant for AI/ML model development.

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

• Not Applicable/Not Provided. This is relevant for AI/ML model development.

Summary of Device and Basis for Marketing:

• Device: TriMed tension band sleds (tension band wire forms)
• Intended Use: Aid to fracture healing by stabilizing bone fragments until healing occurs, used in conjunction with screws, washers, and/or plates of the same material. Applicable to fractures amenable to tension band wiring.
• Technological Characteristics: Described as having "identical characteristics to existing pins and wires commonly in use."
• Basis for Acceptance: Substantial equivalence to predicate devices (TriMed small fragment clamp and buttress pin, Smith and Nephew Kirschner wires and Steinman pins, Zimmer Kirschner wires and Steinman pins). The FDA granted 510(k) clearance based on this demonstration of substantial equivalence, as stated in the letter dated June 6, 2001. This means the FDA determined the device is as safe and effective as devices already on the market without requiring new clinical trials that would generate performance metrics or refer to "test sets" or "ground truth" in the manner requested.

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