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Intended Use:
The Tyber Medical Anatomical Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing.

Indications for Use:

Mini-Frag System

The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, non-unions, malunions, replantations, and fusion of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The Mini-Frag System is also intended for reduction and stabilization of non-load bearing long bone fragments.

The Tyber Medical Mini-Frag System is not for spinal use.

Ankle Fracture/Fusion System

The Tyber Medical Ankle Fracture/Fusion System is indicated for use in:

• · Fixation of fractures of the distal tibia including, but not limited to, ankle fractures, periarticular
  fractures, corrective osteotomies, non-unions, intra- and extra-articular and distal tibia fractures with a shaft extension, and malleolar fractures;

· In intra- and extra-articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;

• In distal tibia/fibula long bones which include the metaphyseal region of the tibia and fibula in the ankle.
  The Tyber Medical Ankle Fracture/Fusion System is not for spinal use.

The Tyber Medical Anatomical Plating System consists of this submission, with a brief description of each system below:

1. Tyber Medical Mini-Frag System

2. Tyber Medical Ankle Fracture/Fusion System

Mini-Frag System

The Tyber Medical Mini-Frag System offers a variety of plating options for the fixation of bone fragments. The system incorporates plates of various lengths, thicknesses, and configurations. The system also incorporates standard (non-locking) and locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized trays are available specific to the Tyber Medical Mini-Frag System. Other ancillary instrumentation is available that is not specific to the Tyber Medical Mini-Frag System.

The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing.

The subject devices are offered non-sterile.

Ankle Fracture/Fusion System

The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system incorporates plates of varying lengths, thicknesses, and configurations. The system also incorporates standard (non-locking screws of varying lengths and diameters. The system incorporates optional bone screw washers for non-locking screws at a range of sizes. Additionally, specialized drill guides and trays are available specific to the Tyber Medical Ankle Fracture/Fusion System. Other ancillary instrumentation is not specific to the Tyber Medical Ankle Fracture/Fusion System.

The plates subject to this submission are composed of Ti-6Al-4V ELI (ASTM F136) with an anodized Type Il surface treatment. The screws and bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) with color anodizing for sizing. The subject devices are offered non-sterile.

This FDA 510(k) summary describes a submission for the Tyber Medical Anatomical Plating System, which is a line extension to a previously cleared device. As such, the focus of the submission is to demonstrate substantial equivalence to the predicate devices rather than proving the device meets novel acceptance criteria through a new clinical study.

Therefore, the information typically found in a study proving acceptance criteria (like sample size, ground truth establishment, MRMC studies, etc.) is not applicable in this case. The submission relies on non-clinical testing and comparison to predicate devices.

Here's the breakdown based on your request, highlighting what is and isn't applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a 510(k) for a line extension of an existing device, the "acceptance criteria" are primarily related to demonstrating equivalence to the predicate devices for the specified indications for use and technological characteristics. The performance is assessed through non-clinical testing.

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

• Not Applicable. This submission relies on non-clinical testing and comparison to predicate devices. There is no "test set" of patient data in the context of a clinical study for this 510(k) line extension. The "test set" would refer to the components (plates, screws) that underwent mechanical and MR testing.

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

• Not Applicable. There is no "ground truth" establishment by experts in the context of a clinical study for this 510(k) line extension. The ground truth for mechanical behavior comes from engineering principles, ASTM standards, and the performance characteristics of the legally marketed predicate devices.

4. Adjudication method for the test set

• Not Applicable. As there is no clinical "test set" involving human interpretation or subjective assessment, no adjudication method was used.

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 metallic bone fixation system (plates and screws), not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI assistance are not relevant.

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

• Not Applicable. This device is a metallic bone fixation system, not an algorithm or AI.

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

• Engineering Standards and Predicate Device Performance: The "ground truth" for this device's performance is established by reference to recognized ASTM International standards for mechanical testing and MR compatibility (e.g., ASTM F136 for material, ASTM F2052, F2213, F2182, F2119 for MR safety) and the established safety and effectiveness of the legally marketed predicate devices. The comprehensive evaluation showed "no new worst case is being introduced."

8. The sample size for the training set

• Not Applicable. This submission is for a medical device (bone plates and screws), not an AI algorithm. There is no "training set."

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

• Not Applicable. As there is no AI algorithm or training set, this question is not relevant.

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Intended Use:

The intended use of the Tyber Medical Anatomical Plating System is to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the Mini-Fraq System and Ankle Fracture/ Fusion System with the following indications:

Indications for Use:

Mini-fraq System

The Tyber Medical Mini-Fraq System is indicated for fixation of fractures, osteotomies, nonunions, malunions, replantations, and fusions of short bones and small fragments of bone including, but not limited to, the hand, wrist, foot, and ankle. The mini-frag system is also intended for reduction and stabilization of non-load bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

Ankle Fracture/Fusion System

Tyber Medical Ankle Fracture/Fusion System is indicated for Use in:

Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, periarticular fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;

• In intra- and extra articular fractures, osteotomies, medial malleolar fractures and nonunions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
• In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.

The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.

The systems presented in this Special 510(k) submission consist of various bone plates, locking screws, washers, and instruments. The Tyber Medical Anatomical Plating System consists of the following categories:

1.Mini-frag System

2.Ankle Fracture/Fusion System

A description of each system is provided below:

Mini-frag/Small Bone System

The Tyber Medical Mini-frag System is designed to address a variety of indications for short bones and sincluding, but not limited to, the hand, wrist, foot and ankle.

The System will incorporate both Locking Screws and standard non-locking Screws in 2.0, 2.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.0mm sizes. All locking screws can be placed on-axis with the internal plate threads or up to 15 degrees off axis in any direction.

All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional bone screw washers are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The instruments are not specific to the system. The Tyber Medical Mini-frag/Small Bone System is offered both sterile and non-sterile.

Ankle Fracture/Fusion System

The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery.

The System will incorporate both locking Screws and standard non-locking screws in 2.7, 3.0, 3.5, and 4.0mm sizes in various lengths. Optional bone screw Washers are available for the non-locking Screws in 2.7, 3.5, and 4.0mm sizes. All locking screws can be placed onaxis with the internal plate threads or up to 15 degrees off axis in any direction.

All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws and optional screw washers are composed of Ti-6AI-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary Instrumentation) is available with the system. The instruments are not specific to the system.

The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile.

The provided text is a 510(k) Summary for the Tyber Medical Anatomical Plating System and does not contain the detailed information required for the questions regarding acceptance criteria and study particulars for a software-based medical device.

The document describes a medical device, which appears to be metallic bone fixation appliances and accessories (plates, screws, and washers). The submission is a Special 510(k), indicating a change to an existing cleared device, specifically the addition of optional bone screw washers to be used with non-locking screws in the Mini-fraq and Ankle Fracture/Fusion Systems.

Since this is a hardware device (bone fixation system) and the submission focuses on the addition of a physical component (washers), the request for details typically associated with software device evaluations (like test set sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable to the information provided in this document.

The document does mention "All design control activities, including verification, and other testing, demonstrates that adding optional screw Washers to the Tyber Medical Anatomical Plating System does not raise any questions of safety or performance and is substantially equivalent to the predicate device(s)." However, it does not elaborate on the specific acceptance criteria or the studies performed. The "Non-Clinical and/or Clinical Tests Summary & Conclusions" section is a general statement about design control activities.

Therefore, I cannot provide the requested information based on the given text.

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The Tyber Medical Mini-Frag System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone including the hand, wrist, foot, and ankle. The minifrag system is also intended for reduction and stabilization of non-load bearing long bone fragments.

The Tyber Medical Mini-frag System is not for Spinal Use.

The Tyber Medical Anatomical Plating System – Line extension to the Mini-Frag System consists of titanium plates (straight and T-plate) and locking /non-lockingscrews (1.3mm) and are offered in a range of configurations to accommodate patient anatomy. The plates and screws are non-sterile.

This document describes the FDA's decision regarding Tyber Medical, LLC.'s Tyber Medical Anatomical Plating System and does not contain information about the acceptance criteria or study details for a software device. The information provided is for a traditional metallic bone fixation appliance and accessories, which typically involve mechanical testing rather than AI/software performance studies.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study that proves a device meets the acceptance criteria based on the provided text, as the text describes a physical medical device and not a software device with associated AI/ML performance metrics.

The provided text only mentions:

• Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
  • "The mechanical testing for the subject devices were performed in conformance with the FDA currently-recognized version of ASTM F382 for metallic bone plates and ASTM F543 for bone screws."
  • "No clinical testing was performed."

This indicates that the evaluation was based on mechanical engineering standards for physical components, not on a study with AI performance metrics, ground truth, expert readers, or sample sizes related to an AI model's output.

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Mini-frag System
The Tyber Medical Mini-frag System is intended for fixation of fractures, nonunions, replantations, and fusions of short bones and short bone fragments including, but are not limited to, the hand, wrist, foot and ankle. The Tyber Medical Mini-frag System is not for Spinal Use.

Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of short bones and short bone fragments in the foot (Phalanges and Metatasals), and long bones and long bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures. joint fusions, osteotomies, nonunions, reconstruction of short and long bones, revision surgeries and replantations in an adult patient. The Tyber Medical Foot System is not for Spinal Use.

Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula.

The Tyber Medical Long Bone Fracture System is not for Spinal Use.

Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:

1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;

2). In intra- and extra articular fractures, medial malleolar fractures and non-unions of the metaphyseal region of the distal fibula, and calcaneus;

3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.

The Tyber Medical Ankle Fracture/Fusion System is not for Spinal Use.

The Tyber Medical Anatomical Plating System consists of the following categories:

1. Mini-frag System

2. Foot System

3. Long Bone Fracture System

4. Ankle Fracture/Fusion System

A brief and concise description of each system is as follows:

Mini-fraq System
The Tyber Medical Mini-frag System offers a variety of bone fragments. The system incorporates a series of standard and locking compression plates and screws of varying lengths, thicknesses, and configurations including 1). Straight Fracture Plates, 2). T-shape Fracture Plates, 3). Y-shape Fracture Plates, 4). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8), Oblique Fracture Compression Plates, 9), Double Y-Shape Plates, 11. Partial Zig-Zag Plates, 12. Mesh Plates

The System will incorporate both Locking Screws and Non-Locking Screws in 2.0mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary instrumentation is available with the system. The Tyber Medical Mini-frag System is offered both sterile and nonsterile for single-use.

Foot System
The Tyber Medical Foot System consists of a variety of plates with shapes and sizes designed for internal fixation of short bone fragments of the foot. The implants are designed to provide highly anatomic and versatile options and stabilizations of short bones in the feet. The plates are available in various lengths, with straight, right and left configurations. Plate types consist of 1). TMT-1 Fusion Plates, 2). Open Wedge Plates, 3). Cuboid Plates, 5). Lateral Talar Neck Plates, 6). Akin Plates, 7). 5th Metatarsal Jones Fracture Plates, 8). 5th Metatarsal Fracture Compression Plates, 9). 5th Metatarsal Avulsion Fracture Plates, 10). Medial Talar Neck Plates, 11). Distal Medial Column Plates, 13). ORIF Standard Calcaneal Plates, 14). Rectangular Plates, 15). X -Plates, 16). Cotton Plates, 17). Dwyer Plates, 19). MTP Fusion Revision Plates, 20). Stepped Lapidus Plates, 21). Plantar TMT Plates, 22). Medial Column Plates, 24). TMT-I Medial Fusion Plates, 25). Sinus Tarsi Plates, 26). 1st 2nd Ray Lisfranc Joint Plates, 27). 2nd and 3rd Ray Lisfranc Joint Plates, 28). Navicular Cuneiform Plates, 30). Talonavicular Plates.

The system will incorporate both locking and Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Foot System is offerile and non-sterile for single-use.

Long Bone Fracture System
The Tyber Medical Long Bone Fracture System consists of a straight low contact locking plate and a 1/3 locking tubular plate. The system will incorporate both Cortical locking and standard Cortical Non-locking screws. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELL (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Long Bone Fracture System is offered both sterile and non-sterile for single-use.

Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of various locking plate types which include 1). Posterior Tibia Plate, 2). Fibula Plate, 3). Medial Tibia Plate, 5). Anterolateral Tibia Plate, 7). Medial Malleolus Plate, 7). Medial Malleolus Plate, 8). Fibula Hook Plate, Straight, 9). Fibula Hook Plate, Anatomic, 10). Anterior TT Plate, 12). Anterolateral TT Plate, 13). Lateral TT Plate, 14). Lateral TTC Plate, 15). Posterior TTC Plate, 17). Posteromedial Tibia Plate, 17). Posteromedial Tibia Plate, 19). Posterior Fibular Plate.

The System will incorporate both Locking Screws and Non-locking Screws in various lengths. All plates are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L) with color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture/Fusion System is offered both sterile and non-sterile for single-use.

This document is a 510(k) premarket notification for the Tyber Medical Anatomical Plating System. It's important to note that this document is for a medical device (bone fixation appliance), not a software or AI-driven diagnostic device. Therefore, the questions related to AI/algorithm performance metrics (such as sensitivity, specificity, MRMC studies, ground truth establishment for training data, etc.) are not applicable to this type of submission.

The acceptance criteria for a device like this primarily revolve around mechanical performance, material compatibility, and safety, demonstrated through non-clinical testing, and substantial equivalence to a legally marketed predicate device.

Here's an attempt to answer the questions based on the provided text, while explicitly stating when a question is not applicable:

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

Since this is a mechanical medical device and not a diagnostic algorithm, the "acceptance criteria" are not reported in terms of diagnostic performance metrics like accuracy, sensitivity, or specificity. Instead, they relate to mechanical integrity and safety. The document states a comprehensive evaluation of all plates and screws was performed to ensure no "worse case" was introduced, and MR Conditional testing was conducted.

• Magnetically induced displacement force (ASTM F2052) - Passed
• Magnetically induced torque (ASTM F2213) - Passed
• MR image artifact (ASTM F2119) - Passed
• Radio frequency induced heating (ASTM F2182) - Passed |
  | Sterilization | Offered both sterile and non-sterile for single-use. (Implies meeting sterilization validation standards, though not explicitly detailed here). |

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

This question is not applicable. This submission concerns a physical medical device (bone fixation system), not a data-driven diagnostic tool or AI algorithm. There is no "test set" of data in the sense of medical images or patient records. The testing performed is non-clinical (engineering analysis, material testing, MR testing).

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 question is not applicable. "Ground truth" in the context of diagnostic algorithms refers to definitively proven disease states or findings. For this device, "ground truth" relates to the physical and mechanical properties of the implants, which are established through engineering standards and testing, not expert consensus on medical images.

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

This question is not applicable. There is no "adjudication method" involved as there is no diagnostic or interpretive element requiring human readers/experts to resolve discrepancies in a dataset.

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 question is not applicable. MRMC studies are used for evaluating diagnostic imaging systems and AI algorithms. This device is a surgical implant, not a diagnostic tool, and there is no AI component.

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

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

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

The "ground truth" for this device's performance is established by engineering standards, material specifications (e.g., ASTM F136 for Ti-6Al-4V ELI), and validated test methodologies for mechanical properties, material properties, and MR compatibility (e.g., ASTM F2052, F2213, F2119, F2182).

8. The sample size for the training set

This question is not applicable. There is no "training set" as this is not an AI/machine learning device.

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

This question is not applicable. As there is no training set, there is no ground truth established for one.

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The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing and is composed of the following bone plate categories:

Mini-frag/Small Bone System
The Tyber Medical Mini-Frag/Small Bone System is intended for fixation of fractures, osteotomies, nonunions, replantations, and fusions of small bone fragments including, but are not limited to, the hand, wrist, foot and ankle.
The Tyber Medical Mini-frag/Small Bone System is not for Spinal Use.

Foot System
The Tyber Medical Foot System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals), and medium/ large bones and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, osteotomies, nonunions, malunions, reconstruction of small, medium and large bones, revision surgeries and replantations in an adult patient.
The Tyber Medical Foot System is not for Spinal Use.

Long Bone Fracture System
The Tyber Medical Long Bone Fracture System is intended for osteotomies and non-unions, fixation of fractures of the clavicle, scapula, olecranon, humerus, radius, ulna, fibula.
The Tyber Medical Long Bone Fracture System is not for Spinal Use.

Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion System is Indicated for Use in:
1). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula, and calcaneus;
3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.
The Tyber Medical Ankle Fracture/Fusion Plating System is not for Spinal Use.

The Tyber Medical Anatomical Plating System consists of the following categories:

1. Mini-frag/Small Bone System
2. Foot System
3. Long Bone Fracture System
4. Ankle Fracture/Fusion System

Mini-frag/Small Bone System: Offers a variety of plates for fixation of bone fragments, including standard and locking compression plates and screws of varying lengths, thicknesses, and configurations. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary instrumentation is available. Offered sterile and non-sterile.

Foot System: Consists of a variety of plates with shapes and sizes designed for internal fixation of small bone fragments of the implants are designed to provide highly anatomic and versatile options for an array of fusions and stabilizations of small bones in the feet. Plates are available in various lengths, with straight, right and left configurations and numerous plate types. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.

Long Bone Fracture System: Consists of a straight low contact locking plate and a 1/3 locking tubular plate. Incorporates both Cortical locking and standard Cortical Non-locking screws. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.

Ankle Fracture/Fusion System: Designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. Composed of various locking plate types. Incorporates both Cortical Locking Screws and standard Cortical Non-locking Screws in various lengths. Plates and screws are composed of Ti-6Al-4V ELI (ASTM F136) or Stainless Steel (316L). Ancillary Instrumentation is available. Offered sterile and non-sterile.

The provided text is a 510(k) Pre-market Notification for the Tyber Medical Anatomical Plating System. This document focuses on demonstrating substantial equivalence to predicate devices based on design, materials, technological characteristics, and indications for use, rather than presenting clinical study results for specific performance metrics of an AI/ML powered device.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: This document does not specify performance criteria in the context of an AI/ML study, nor does it report specific device performance metrics in comparison to such criteria.
• Sample size used for the test set and the data provenance: There is no mention of a test set for an AI/ML model.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is irrelevant as no AI/ML test set is described.
• Adjudication method for the test set: Not applicable.
• 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 is not an AI-powered device, so such a study would not be presented here.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

However, I can extract information related to non-clinical testing and the basis for proving substantial equivalence to acceptance criteria, which, in this context, are represented by the performance of predicate devices.

Acceptance Criteria and Study for the Tyber Medical Anatomical Plating System:

1. Table of Acceptance Criteria and the Reported Device Performance:

The "acceptance criteria" for this type of device (metallic bone fixation appliances) are primarily demonstrated through substantial equivalence to legally marketed predicate devices, meaning the new device performs similarly and is as safe and effective. The performance is assessed through non-clinical testing.

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

• Test Set Sample Size: Not explicitly stated as a numerical count of plates or screws tested. The testing involved "identified worst-case plates" and screws. This implies a representative selection, but not a large "sample size" in the context of a clinical study or AI/ML performance evaluation.
• Data Provenance: The "study" is nonclinical (laboratory bench testing) conducted according to established ASTM standards. The provenance is internal testing performed by or for Tyber Medical LLC.

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

This information is not applicable as this is a nonclinical bench testing submission for a physical medical device, not an AI/ML product requiring expert ground truth for image interpretation or diagnosis.

4. Adjudication method for the test set:

This information is not applicable as this is a nonclinical bench testing submission.

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 section clearly states "Clinical Test Summary: n/a". The device is a bone plating system, not an AI-assisted diagnostic or treatment planning tool.

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

No – This is not an AI/ML device.

7. The type of ground truth used:

For mechanical testing, the "ground truth" is established by the specified parameters and methodologies within the ASTM F382-17 standard and the physical properties of the materials and designs under test. The comparison is against the performance of predicate devices as a benchmark for substantial equivalence.

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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The intended use of the Tyber Medical Anatomical Plating System is to draw two or more aligned bone fragments together to facilitate healing in an adult patient and is composed of the following bone plate categories:

I. Forefoot System:
The Tyber Medical Forefoot Plating System is Indicated for Use in fixation of small bone fragments in the foot (Phalanges and Metatarsals) for stabilization of fractures, joint fusions, osteotomies, malunions, reconstruction of small bones, revision surgeries and replantations in an adult patient. The Tyber Medical Forefoot System is not for Spinal Use.

II. Mid & Hindfoot System:
The Tyber Medical Mid & Hindfoot Plating System is Indicated for Use in fixation of medium/large bones and medium/ large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) for stabilization of fractures, joint fusions, osteotomies, nonunions, reconstruction of medium/large bones, revision surgeries and replantations in an adult patient.

The Tyber Medical Mid & Hindfoot System is not for Spinal Use.

III. Ankle Fracture System:
The Tyber Medical Ankle Fracture System is Indicated for Use in:

I). Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, non-unions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures; 2). In intra- and extra articular fractures, osteotomies, medial malleolar fractures and non-unions of the metaphyseal and diaphyseal region of the distal fibula;

3). In distal tibia/fibula long bones which include the metaphyseal regions of the tibia and fibula in the ankle.

The Tyber Medical Ankle Fracture System is not for Spinal Use.

The Tyber Medical Anatomical Plating System consists of the following categories:

1. Forefoot System
2. Mid & Hindfoot System
3. Ankle Fracture System

A brief and concise description of each system is as follows:

Forefoot System
The Tyber Medical Forefoot System is designed to address a variety of indications in forefoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include: 1). Straight Fracture Plates, 2). T-Shaped Fracture Plates, 3). Y-Shape Fracture Plates, 4). L-Shaped Fracture Plates, 5). Cloverleaf Fracture Plates, 6). TMT 1 Medial Fusion Plates, 7). Open Wedge Fusion Plates, 8). MTP Fusion Plates, 9). MTP Fusion Revision Plates, and 10). Dorsal TMT 1 Step Fusion Plates, - in various plate lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.0mm, 2.5mm, 3.0mm and 3.5mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Forefoot System is offered both sterile and non-sterile for single-use.

Mid and Hindfoot System
The Tyber Medical Mid & Hindfoot System is designed to address a variety of indications in midfoot & hindfoot reconstruction fixation/osteotomy surgery. The system is composed of many locking plate types which include:

1). Straight Fracture/Fusion Plates, 2). T-Shaped Fracture/Fusion Plates, 3). L-Shaped Fracture/Fusion Plates, 4). Cloverleaf Fracture/Fusion Plates, 5). X-Shaped Fracture/Fusion Plates, 6). Retangular Fracture/Fusion Plates, 7). Cotton Osteotomy Plates, 8). Dwyer Step Plates, 9). Evans Osteotomy Plates, 10.) Plantar TMT Plates, 11). Distal Medial & 3 - 4 Column Plates and 11). ORIF & Standard Calcaneal Plates - in various plate lengths, Right & Left versions.

The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of Medical Grade CP Titanium material (to ASTM F67) with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Mid and Hindfoot System is offered both sterile and non- sterile for single-use.

Ankle Fracture System
The Tyber Medical Ankle Fracture System is designed to address a variety of indications in ankle reconstruction mid-shaft and distal tibia/fibula fixation surgery. The system is composed of many locking plate types which include:
1). Distal Fibula Plates, 2). Medial Distal Tibia Plates, 3). AnteroLateral Distal Tibia Plates, 4). Posterior Distal Tibia T-Plates, 5). Straight Low Contact Plates, and 6). Straight 1/3 Tubular Plates – in various plate shapes, lengths, Right & Left versions. The System will incorporate both Cortical Locking Screws and standard Cortical Screws in 2.8mm, 3.0mm, 3.5mm and 4.0mm sizes in various lengths. All plates are composed of either Medical Grade CP Titanium (to ASTM F67) or 6-4 Alloyed Titanium (to ASTM F136) materials with an Anodized Type II surface treatment. All screws are composed of Medical Grade 6-4 Alloyed Titanium material (to ASTM F136) color anodized for sizing.

A full set of Ancillary Instrumentation is available with the system. The Tyber Medical Ankle Fracture System is offered both sterile and non- sterile for single-use.

The provided document is a 510(k) Premarket Notification from the FDA for the Tyber Medical Anatomical Plating System. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving efficacy through clinical trials as would be the case for a novel drug or high-risk medical device.

Therefore, the document does not contain acceptance criteria related to device performance in a clinical study, nor does it describe a study proving the device meets such criteria.

Instead, the submission asserts that the Tyber Medical Anatomical Plating System is "substantially equivalent" to a predicate device, the BioPro Foot Plating Systems (K162674). This substantial equivalence is based on similarities in design, material, technological characteristics, and indications for use.

Here's a breakdown of why the requested information cannot be fully provided from this document:

• Acceptance Criteria & Reported Device Performance: This document does not describe specific performance metrics (e.g., sensitivity, specificity, accuracy, etc.) for the device that would be typically established in a study. The acceptance criteria for a 510(k) submission revolve around demonstrating equivalence to a predicate, not absolute clinical performance.

• Study That Proves Device Meets Acceptance Criteria: No clinical study is described that tests the Tyber Medical Anatomical Plating System against specific performance criteria. The submission explicitly states: "Nonclinical Testing Summary: There have been no changes to the design, material, technological characteristics or indications of the plating systems since receiving clearance in K162674. Therefore, nonclinical testing is not provided in this submission. Clinical Test Summary: n/a". This indicates that no new nonclinical or clinical testing was performed for this specific 510(k) submission to demonstrate performance.

Given this context, I cannot fill out the detailed table and answer the questions pertaining to clinical study design, sample sizes, expert involvement, and ground truth establishment, as the information is not present in the provided text.

The closest information related to "acceptance criteria" is that the device is considered substantially equivalent if it has the "same in design, material, technological characteristics and indications" as the predicate device. The "study" for this type of submission is primarily the comparison analysis and documentation provided to the FDA to support the claim of substantial equivalence.

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