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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 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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