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The Tyber Medical Distal Radius Plating System includes Distal Radius, Forearm, and Fragment-Specific Plates, which are indicated for fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The Tyber Medical Distal Radius Plating System is not for spinal use.

This traditional 510K is a line extension to the Tyber Medical Distal Radius Plating System, previously cleared under K232693. The extension includes additional plates, screws, pegs, cases and trays, and instrumentation.

The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The implants – delivered sterile or non-sterile – are:

• Various bone plates of different shapes and hole configurations.
• Variable angle locking and non-locking screws in various lengths and diameters.

The implants are manufactured from Stainless Steel per ASTM F138, from Titanium alloy per ASTM F136, or Commercially Pure Titanium grade 4 per ASTM F67.

The instruments – delivered sterile and non-sterile – are intended to support the implantation of the Tyber Medical Distal Radius Plating System implants. Specialized cases/trays are available specific to the Tyber Medical Distal Radius Plating System. Other ancillary instrumentation is available but not specific to the Tyber Medical Distal Radius Plating System.

The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.

The provided document is an FDA 510(k) clearance letter for the "Tyber Medical Distal Radius Plating System." This type of document is a regulatory approval, not a scientific study report. Therefore, it does not contain the detailed acceptance criteria or a study proving the device meets said criteria in the way one would expect for a diagnostic or AI-driven medical device.

The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving efficacy through clinical trials as is the case for premarket approval (PMA).

However, I can extract the information that is present concerning device performance and testing.

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 does not explicitly state acceptance criteria in an "acceptance criteria" column and then "reported performance" against it for parameters like sensitivity, specificity, AUC, etc., as would be expected for a diagnostic device. Instead, it describes what mechanical tests were performed and what was concluded.

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

• Test Set Sample Size: Not specified. The testing mentioned is mechanical and engineering analysis, not clinical testing with human subjects. The phrase "subject plate designs" and "subject devices" refers to the new devices being submitted for clearance.
• Data Provenance: Not applicable for mechanical and engineering analysis. These are laboratory tests and simulations. No country of origin for patient data is mentioned as no patient data was used.
• Retrospective or Prospective: Not applicable as no clinical data was used.

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. This device is a bone fixation system (hardware), not a diagnostic tool requiring expert interpretation of medical images or patient data to establish ground truth. The "ground truth" for mechanical properties is established by engineering standards and measurements.

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

Not applicable. No human adjudication was involved in the mechanical testing or engineering analysis 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 MRMC study was done. This is a physical medical device (bone plating system), not an AI-driven diagnostic or image analysis tool.

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

This refers to AI or software performance. Not applicable to this physical device.

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

The "ground truth" for the mechanical testing would be defined by the specifications and tolerances established by the relevant ASTM standards (ASTM F543) and engineering principles for material strength and bending resistance.

8. The sample size for the training set

Not applicable. This is a physical medical device and does not involve machine learning or data training sets.

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

Not applicable.

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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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The TM Plating System is intended to bridge or otherwise stabilize bone fragments to facilitate healing. It is composed of the following indication categories:

I. TM Plating System - Complete Articular
The TM Plating system is indicated for the treatment of nonunions, osteotomies, and fractures of the femur and tibia. This includes simple, comminuted, lateral wedge, bicondylar combination of lateral wedge and depression, diaphyseal, epiphyseal, extra- and intra-articular fractures, periprosthetic, and fractures with associated shaft fractures.

II. TM Plating System - Partial Articular
The partial articular (also called buttress or anti-glide) proximal tibia plates are indication and reduction of proximal tibia fragments and treatment of partial articular fractures of the proximal tibia (AO/OTA Fracture Classifications Type B). The partial articular straight plates are indication and reduction of long bone fragments and partial articular fractures of the distal and proximal tibia (AO/OTA Fracture Classifications Type B), and for fracture fixation of the fibula.

The system presented in this 510(k) submission consists of various bone plates, locking screws, and instruments. The TM Plating System consists of the following indication categories:

Tyber Medical Anatomical Plating System

1. Complete Articular (All OA/OTA fracture classification types)
2. Partial Articular (OA/OTA fracture classification type B)

A description of each category is provided below:

Tm Plating System – Complete Articular
The TM System is designed to address a variety of indications for long bones of the tibia and femur. The system is composed of a Straight Plate and a Lateral Proximal Tibia Plate.

TM Plating System - Partial Articular
The Partial Articular plates of TM Plating System are designed to address specific indications for long bones of the tibia and fibula. These buttress (anti-glide) plates are designed for stabilization of bone fragments, and are intended to treat OA/OTA fracture classification type B fractures only.

The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.

All plates and screws are composed of Ti-6Al-4V ELI (ASTM F136).

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

The TM Plating System plates are offered nnly. The screws offered in this system have already been cleared in K222465 and are offered in both sterile and non-sterile.

The provided document is a 510(k) premarket notification letter from the FDA for the "TM Plating System." This type of submission is for medical devices that are substantially equivalent to a legally marketed predicate device. The document describes the device, its intended use, and its technological comparison to predicate devices, focusing on mechanical testing. Crucially, this document states: "No clinical testing was performed." This means that the device was not evaluated through a study involving human subjects or real-world clinical data to prove its performance in meeting specific acceptance criteria.

Therefore, many of the requested details about acceptance criteria, study findings, sample sizes, ground truth establishment, expert involvement, and MRMC studies are not applicable or cannot be extracted from this document, as they were not part of the substantial equivalence determination process for this device.

Here's a breakdown of the information that can be extracted, and what cannot:

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

• Acceptance Criteria: Not explicitly stated in terms of clinical performance or diagnostic accuracy, as no clinical testing was performed. The device's "performance" was assessed through mechanical testing.
• Reported Device Performance: The document states: "The mechanical testing for the subject devices were performance with the FDA currently-recognized version of ASTM F382 for metallic bone plates." This implies that the device met the requirements of ASTM F382 for metallic bone plates, but specific numerical results or acceptance thresholds for this standard are not provided. The conclusion is that "The TM Plating System is substantially equivalent to the predicate devices in material, basic design features, intended use, operation and performance."

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

• Sample Size for Test Set: Not applicable. No clinical test set. Mechanical testing would involve a sample of the physical devices, not a test set of data.
• Data Provenance: Not applicable. No clinical data was used.

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. No clinical test set requiring expert-established ground truth.

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

• Not applicable. No clinical test set requiring adjudication.

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. The document explicitly states "No clinical testing was performed." This device is a bone plating system, not an AI-assisted diagnostic tool, so an MRMC study is not relevant to its type.

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

• No. This device is a physical bone plating system, not an algorithm.

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

• Not applicable. No clinical ground truth was established as no clinical testing was performed. For mechanical testing, the "ground truth" would be the specifications and requirements of ASTM F382.

8. The sample size for the training set

• Not applicable. No training set as no clinical algorithm or AI was developed.

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

• Not applicable. No training set and therefore no ground truth for it.

In summary: The K233017 submission for the "TM Plating System" relies on demonstrating substantial equivalence to predicate devices through mechanical testing according to ASTM F382, rather than through clinical studies involving human subjects or AI performance evaluations. Therefore, the requested information pertaining to clinical studies, acceptance criteria for such studies, and ground truth establishment is not available in this document.

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

Mini-frag System:
The Tyber Medical Mini-Frag is indicated tor 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 infended for reduction and stabilization of non-bad bearing long bone fragments. The Tyber Medical Mini-frag System is not for Spinal Use.

Foot System
The Tyber Medical Foot System is indicated for fixation of fractures, osteotomies, malunions, replantations, and fusions of short bones and small fragments of bone in the foot (Phalanges and Metatarsals), and medium/large bone multi-fragments in the foot (Cuneiform, Cuboid, Navicular, Talus and Calcaneus) 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 indicated for fixation of fractures, ostectomies, nonunions, replantations, and fusions of the clavicle, scapula, olecranon, huma, 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:
· Fixation of fractures of the distal tibia included, but not limited to, ankle fractures, corrective osteotomies, nonunions, intra- and extra- articular and distal tibia fractures with a shaft extension, and malleolar fractures;
• In intra- and extra articular fractures, 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 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-frag 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, 5). Cloverleaf plates, 6). Straight Fusion Plates, 7). Oblique Fracture Plates, 8). Oblique Fracture Compression Plates, 10). Zig-Zag Plates, 10). 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/Small Bone sterile and non-sterile 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 small 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). Navicular 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 Nor-locking screws. All plates are composed of T-6A-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-4VELL (ASTM F136) or Stainless Steel (316L) with an Anodized Type II surface treatment. All screws are composed of T-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 Long Bone Fracture System is offered both sterile and non-sterile for single-use.

Ankle Fracture/Fusion System
The Tyber Medical Ankle Fracture/Fusion 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 Malleous 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, 18). Trimalleolar Plate, 19). Trimalleolar 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.

The provided document is a 510(k) summary for the Tyber Medical Anatomical Plating System, which is a medical device for bone fixation. However, it does not describe any acceptance criteria or a study proving the device meets those criteria.

Instead, the document states:

• "This traditional 510(k) is being completed to update the indications for use of the Tyber Medical Anatomical Plating System." (Page 4)
• "There are no new implants or instruments being added to the system and no changes to the design, functionality, and application of the devices that make up the system cleared under K222465." (Page 4)
• "There are no design, functionality, performance or technological changes to the devices that make up the Tyber Medical Anatomical Plating System." (Page 6)
• "This submission is for an indication change only to the Tyber Medical Anatomical Plating System. There are no changes to the devices, and therefore, there is no change in performance of the device. No new implants are being introduced in this submission. These devices remain the same as the devices cleared from K222465." (Page 6)
• "No clinical testing was performed." (Page 6)

Therefore, based on the provided text, there is no information available regarding:

• A table of acceptance criteria and reported device performance.
• Sample size or data provenance for a test set.
• Number or qualifications of experts used for ground truth.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study.
• Standalone (algorithm only) performance study.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The submission is for an expanded indication for use of an existing device, asserting substantial equivalence to previously cleared predicates without new performance testing, as no design, functionality, or performance changes were made to the device itself.

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The Tyber Medical Distal Radius Plating System includes the Tyber Medical Distal Radius, Forearm, and Fragment-Specific plates, which are indicated for fixation for fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The Tyber Medical Distal Radius System is not for Spinal Use.

The Tyber Medical Distal Radius Plating System presented in this 510(k) submission consist of various bone plates, screws, and instruments.

Distal Radius Plating System
The Tyber Medical Distal Radius System provides fixation of fractures, fusions, non-unions and malunions, or osteotomies of the radius, ulna, and hand.

The system will incorporate variable angle locking and non-locking screws in various lengths and diameters.

All plates and screws are composed of Ti-6Al-4V ELI (ASTM F 136) or Stainless Steel (316L).

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

The Tyber Medical Distal Radius Plating System is offered both sterile and non-sterile.

This FDA 510(k) summary describes a new medical device, the Tyber Medical Distal Radius Plating System, and its claim of substantial equivalence to predicate devices. The information provided heavily emphasizes mechanical and materials testing, typical for orthopedic implants, and explicitly states that no clinical testing was performed.

Therefore, the requested information about acceptance criteria and studies proving the device meets them, particularly regarding human-in-the-loop performance, expert ground truth, sample sizes for test/training sets, and MRMC studies, is not applicable in the context of this submission. The device is a physical implant, not an AI or software-based diagnostic tool that would typically involve such studies.

Here's a breakdown of the relevant information provided:

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

The document does not present a formal table of acceptance criteria with reported device performance in the way one might expect for a software or AI device. Instead, the "Non-Clinical and/or Clinical Tests Summary & Conclusions" section serves this purpose for a mechanical device.

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

• Not Applicable. This device is a physical implant. The "testing" referred to is mechanical and engineering analysis, not data analysis on a test set of patient cases.

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

• Not Applicable. See point 2. Ground truth establishment by experts is relevant for diagnostic or AI devices evaluating patient data, not for the mechanical properties of an implant.

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

• Not Applicable. See point 2.

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 hardware device (bone plating system), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant for this type of submission.

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

• Not Applicable. This is a hardware device. No algorithm exists for standalone performance evaluation in this context.

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

• For the mechanical aspects, the "ground truth" would be the material specifications (ASTM F 136, 316L Stainless Steel) and the established performance standards outlined in ASTM F382 and ASTM F543 for metallic bone plates and screws, respectively. The engineering analysis provided serves as evidence against these established standards.

8. The sample size for the training set

• Not Applicable. No training set is relevant for this type of mechanical device submission.

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

• Not Applicable. See point 8.

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The Tyber Medical Pin and Wire System is indicated for use in fixation of small bone fragment(s) of hand or foot), bone reconstructions, and as guide pins for inplants or implantation through the skin so that traction may be applied to the skeletal system.

The Tyber Medical Pin and Wire System is designed for hand, foot, and small bone fragment repairs or fusions. Uses include fixation of bone fractures, for bone reconstruction, and as guide pins for insertion of other implants. It is manufactured from stainless steel, and Titanium Alloy. They are available in a variety of lengths, and tips to accommodate different anatomic sizes of patients. The devices are provided non-sterile, single use. Non-sterile devices are intended to be sterilized at the point of use. The pins and wires are made from stainless steel (316L per ASTM F-138) and titanium alloy (Ti-Al-4V ELI per ASTM F136).

This FDA 510(k) summary provides limited information regarding formal acceptance criteria or a detailed study proving the device meets specific performance criteria. The document primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a standalone performance study with predefined acceptance criteria.

However, based on the provided text, here's an analysis of what can be inferred and what is not available:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific acceptance criteria or quantitative performance metrics are listed in the document. The submission is based on substantial equivalence, implying that the device's performance is considered acceptable if it is comparable to the predicate devices.

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

• Sample Size for Test Set: Not applicable. No "test set" in the context of an AI/algorithm performance study is mentioned as no clinical or performance study was conducted.
• Data Provenance: Not applicable. No data or test sets were used for a performance study.

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

Not applicable. No ground truth establishment by experts is mentioned as no performance study was conducted requiring such a process.

4. Adjudication Method:

Not applicable. No adjudication method is mentioned as no performance study was conducted.

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

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical testing was preformed."

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The document explicitly states: "No clinical testing was preformed." The device described is a physical medical device (Pin and Wire System), not an algorithm or AI.

7. Type of Ground Truth Used:

Not applicable. As no performance study was conducted, no ground truth was established for the purpose of validating the device's performance in a study setting. The "ground truth" in this context is the performance and safety profile of the predicate devices against which the new device is compared for substantial equivalence.

8. Sample Size for the Training Set:

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

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

Not applicable. This device is a physical medical device, not an AI/algorithm that requires a training set and corresponding ground truth.

Summary of the Study (or lack thereof) to Prove Acceptance Criteria:

The provided document describes a 510(k) Premarket Notification for the Tyber Medical Pin and Wire System. The "study" proving the device meets "acceptance criteria" is based on the principle of Substantial Equivalence (SE) to legally marketed predicate devices (K083490 - BioPro K-Wire and K100736 - SMT Schilling Metalltechnik GmbH).

The core of the submission's argument is:

• Indications for Use: The new device has similar indications for use as the predicate devices.
• Technological Characteristics: The new device shares similar design, material (stainless steel, titanium alloy), chemical composition, and principle of operation with the predicate devices.
• Manufacturing and Sterilization: The new device is manufactured and intended to be sterilized using the same materials and processes as the predicate devices (though the devices are provided non-sterile for point-of-use sterilization).

Based on these similarities, the FDA has determined that the Tyber Medical Pin and Wire System is substantially equivalent to the predicate devices. This determination implies that the new device is considered "safe and effective" without the need for new clinical or non-clinical performance studies, as no new or different questions regarding safety and effectiveness were raised compared to the predicate devices.

Key takeaway: This document is not about a performance study of an AI/algorithm. It's a regulatory submission for a physical medical device, demonstrating substantial equivalence to pre-existing, legally marketed devices. Therefore, many of the requested categories (like sample sizes, expert qualifications, and ground truth for AI performance) are not applicable to this type of submission.

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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 Tyber Medical Staple System is indicated for:

• Fracture and osteotomy fixation, joint arthrodesis hand and foot.
• Fixation of proximal tibial metaphysis osteotomy.
• Hand and foot bone fragment and osteotomy fixation and joint arthrodesis.
• Fixation of small bone fragments (i.e., small fragments of bone which are not comminuted to the extend to preclude staple placement). These fragments may be located in long bones such as the femur, fibula and tibia in the lower extremities; the humerus, ulna or radius in the upper extremities; the clavicle and in flat bone such as the pelvis and scapula.

The Tyber Medical Staple Fixation System consists of sterile, single use orthopedic implants and instruments. The single use bone fixation compression staples are intended to be permanently implanted. The staples are made out of Nickel Titanium (Nitino) available in two or four legged designs with multiple combinations of bridge width, leg lengths, and cross sections to accommodate various anatomies. The staple implant applies compression across the bone segments when the staple implant legs are released from an insertion system that applies opposing forces to the staple legs to keep them parallel during implantation. The staple is provided preloaded on a disposable inserter.

The sterile staple kit contains all the instruments necessary for a single-staple-implantation procedure. These instruments include an inserter with a preloaded staple implant, locating pin, a drill guide for creating appropriately spaced holes and drill bits to create appropriately sized holes in the bone for staple implantation. These components will be provided in a sterilized package to accommodate a range of anatomical sites and are discarded after the procedure is complete, removing the need for any facility reprocessing.

The provided document is a 510(k) Pre-market Notification for a medical device called the "Tyber Medical Staple Fixation System." This type of document focuses on establishing substantial equivalence to a legally marketed predicate device rather than providing detailed acceptance criteria and a comprehensive study report with specific performance metrics against those criteria.

Therefore, the requested information regarding "acceptance criteria" and "device performance" in a table, sample sizes for test and training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and detailed ground truth establishment is not available in this document.

However, based on the non-clinical tests summary, we can infer the types of tests performed to demonstrate performance and substantial equivalence.

Here's a breakdown of what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria (Inferred from tests performed): The document doesn't explicitly state numerical acceptance criteria. Instead, it states that test results "demonstrated good corrosion resistance," "demonstrated substantially equivalent results to predicates," and "showed equivalent bend stiffness to the predicate." This implies the acceptance criteria were likely based on meeting or exceeding the performance of the predicate devices or relevant ASTM standards.
• Reported Device Performance:
  • Corrosion Resistance: "good corrosion resistance" (per ASTM F2129)
  • Pull-out Strength: "substantially equivalent results to predicates" (per ASTM F564)
  • Bend Stiffness (Static and Dynamic): "equivalent bend stiffness to the predicate" (per ASTM F564)
  • MRI Compatibility: Results from MRI testing (magnetically induced displacement force, torque, image artifact, and radio frequency induced heating) are included in the Instructions for Use, indicating the device meets compatibility requirements. No specific numerical performance is provided in this summary.

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

• Sample Size: Not specified.
• Data Provenance: Not applicable. These are mechanical/material tests on the device itself, not clinical data involving human subjects or biological samples from a population.

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

• Not applicable. These tests involve laboratory measurements and engineering assessments, not expert interpretation of clinical ground truth.

4. Adjudication Method for the Test Set:

• Not applicable. This pertains to clinical data interpretation, not mechanical testing.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done:

• No. This is a mechanical/material device, not an AI/imaging device requiring MRMC studies.

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

• No. This is a mechanical/material device, not an AI algorithm.

7. The Type of Ground Truth Used:

• Not applicable. For mechanical/material tests, the "ground truth" is established by the standardized test methods (e.g., ASTM F2129, ASTM F564) and the scientific principles governing those measurements. The device's physical properties and performance under specific conditions are directly measured.

8. The Sample Size for the Training Set:

• Not applicable. This device is not an AI/machine learning model that requires a training set. The "training" for such a device involves design iterations, manufacturing process validation, and quality control.

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

• Not applicable. As above, no training set or associated ground truth in the AI/ML context is relevant here.

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