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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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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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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K153575. The intended use and technological characteristics of the device remain unchanged.

This document describes the 510(k) premarket notification for the Tyber Medical Trauma Screw (K192975). This submission's primary purpose is to add MR Conditional information to the device labeling for a previously cleared device (K153575). Therefore, the study described focuses on demonstrating the device's safety in an MRI environment, rather than its general clinical effectiveness.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: The document does not specify the exact number of devices tested for each non-clinical evaluation. It generally refers to "the Tyber Medical Trauma Screw" being exposed to the MR environment.
• Data Provenance: The data provenance is from non-clinical testing (bench testing) performed to evaluate the MRI safety of the device. There is no information about the country of origin, but it can be assumed to be conducted by or for Tyber Medical LLC, based in Bethlehem, Pennsylvania, USA. The study is prospective in nature, as it involves active testing to generate new safety data for the device in the MR environment.

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

• This information is not applicable as the evaluations were non-clinical (bench testing) focusing on physical properties and interactions with an MRI scanner. There was no "ground truth" derived from expert interpretation of medical images or patient outcomes. The ground truth was based on adherence to the specified ASTM testing standards and objective measurements.

4. Adjudication Method for the Test Set

• This information is not applicable as the evaluations were non-clinical (bench testing). Adjudication methods are typically relevant for studies involving human interpretation or clinical endpoints.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

• No, an MRMC comparative effectiveness study was not done. This submission is for a physical medical device (trauma screw) and its MRI compatibility, not an AI-powered diagnostic tool. The document states "Clinical Test Summary: n/a".

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

• No, a standalone algorithm performance study was not done. This device is a physical medical implant, not a software algorithm.

7. The Type of Ground Truth Used

• The "ground truth" for this study was established by objective measurements and adherence to international recognized ASTM standards for MRI safety testing. These standards define the parameters and methods for evaluating magnetic field interactions, torque, heating, and artifact generation.

8. The Sample Size for the Training Set

• This information is not applicable. There was no "training set" as this was non-clinical bench testing of a physical device, not an AI model requiring training data.

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

• This information is not applicable as there was no training set.

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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. The purpose of this submission is to add MR Conditional information to the device labeling for K133842. The intended use and technological characteristics of the device remain unchanged.

The provided text describes a 510(k) premarket notification for the "Tyber Medical Trauma Screw." This document focuses on demonstrating substantial equivalence to a predicate device, specifically to add MR Conditional information to the device labeling.

Based on the information provided, this submission does not involve an AI/ML medical device, and therefore, it does not contain the information requested regarding acceptance criteria and studies for device performance in the context of AI/ML.

The "Acceptance Criteria" and "Study that proves the device meets the acceptance criteria" sections, along with all the detailed points you requested (sample sizes, ground truth establishment, expert adjudication, MRMC studies, etc.), are relevant to AI/ML device submissions, particularly those involving diagnostic or prognostic algorithms that analyze medical images or data.

The provided document is for a traditional medical device (a trauma screw) and outlines non-clinical testing for MR safety and mechanical properties.

Here's why the requested information isn't present in this document:

• Type of Device: The device is a "Tyber Medical Trauma Screw," a physical bone fixation fastener. It's not an AI/ML algorithm.
• Purpose of Submission: The primary purpose of this 510(k) is to add "MR Conditional" information to the device labeling and to compare its mechanical performance (driving torque) to a predicate device.
• Testing Described: The document details non-clinical testing such as:
  • MR Safety Testing (in accordance with ASTM 2503-13): Magnetically induced displacement force, magnetically induced torque, MR image artifact, and RF-induced heating.
  • Mechanical Testing: Driving Torque per ASTM F543-17 Annex A2.
• Clinical Test Summary: Explicitly states "n/a" (not applicable), confirming no clinical studies were performed or required for this submission.

Therefore, I cannot populate the table or answer the specific questions about AI/ML device performance, ground truth, expert opinions, or MRMC studies from the provided text.

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Cervical System Indications:

The Tyber Medical PT Cervical Interbody Spacers are interbody fusion devices indicated at one or more levels of the cervical spine C2-T1 in patients with cervical disc disease, instability, trauma including fractures, deformity defined as kyphosis, lordosis, or scoliosis, cervical spondylotic myelopathy, spinal stenosis, and failed previous fusion. Cervical disc disease is defined as intractable radiculopathy and/or myelopathy with herniated disc and/or osteophyte formation on posterior vertebral endplates producing symptomatic nerve root and/or spinal cord compression confirmed by radiographic studies. These patients should be skeletally mature and have had at least six (6) weeks of non-operative treatment.

Tyber Medical PT Cervical Interbody spacers are to be filled with autograft bone and/or allogenic bone graft composed of cancellous, cortical, and/or corticocancellous bone. These devices are intended to be used with supplemental fixation.

This submission is to add additional ACIF configurations to the Tyber Medical PT Interbody System and corresponding trials. Additionally, the Indications for Use are being revised.

The new configurations will be manufactured from PEEK – Optima® and plasma sprayed with commercially pure titanium coating, identical to the existing devices in the system. The new ACIF configurations have superior and inferior surfaces that are inclined at larger angles than the existing configurations. In addition, a new extra-large configuration for these sizes will be included. Other geometries, such as the open lumen area and teeth geometry on the superior and inferior surfaces remain identical to the devices within the Tyber Medical PT Interbody System.

The trials will be manufactured from stainless steel and will incorporate trial geometries that match the corresponding implant.

The provided document is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device. This document does NOT contain information about an AI/ML device or any study involving human readers and AI assistance. Therefore, I cannot generate a response that includes information related to acceptance criteria for an AI device, sample sizes for test sets, expert ground truth, MRMC studies, or standalone algorithm performance.

The document details the substantial equivalence of new configurations of an intervertebral body fusion device to previously cleared predicate devices. The performance data presented are for non-clinical mechanical tests (static, dynamic compression, shear, torsion, and expulsion testing) and pyrogenicity testing, which are standard for this type of medical implant. Clinical data was explicitly stated as "not needed for this device."

To reiterate, the provided text does not describe an AI/ML device, its acceptance criteria, or studies related to its performance in the context of human-AI interaction or standalone AI performance.

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Lumbar System Indications
The Tyber Medical PT Interbody System is indicated for use as intervertebral body fusion devices in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one or two contiguous levels of the lumbar spine (L2-S1). Patients should have six months of non-operative treatment prior to surgery. These implants are used to facilitate fusion in the lumbar spine and are placed via either a posterior, transforaminal, lateral or anterior approach using autogenous bone. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.
Cervical System Indications
The Tyber Medical PT Interbody System is indicated for use as an intervertebral body fusion device in skeletally mature patients with degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies) at one level of the cervical spine with accompanying radicular symptoms. Patients should have six weeks of non-operative treatment prior to surgery. Cervical implants are used to facilitate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone. When used as an interbody fusion device, supplemental fixation must be used.

This submission is to add additional shape configurations, with an optional optimized coating process, to the previously cleared interbody system.
This submission does not include any new instruments. However, part of the changes to implants, were made to interface with instruments that were cleared with previous submissions.
The Tyber Medical PT Interbody System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights, and lordotic configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces to help prevent the device from migrating once it is surgically positioned. The device comes in PEEK with a plasma-sprayed commercially pure titanium coating.

The provided document is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device for spinal fusion. This specific document outlines the product's regulatory submission to the FDA, demonstrating its substantial equivalence to previously cleared predicate devices.

Critical Analysis of the Document:

It is crucial to understand that a 510(k) submission, like the one presented, does not involve a clinical study in the way one might typically think of an "AI clinical trial" or a "diagnostic device performance study." Instead, it focuses on demonstrating substantial equivalence to an already legally marketed device. This means the manufacturer is showing that the new device is as safe and effective as a device that is already on the market, usually by comparing mechanical properties, materials, design, and intended use.

Therefore, the specific questions regarding acceptance criteria, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance of an AI algorithm, and training sets are not applicable in the context of this 510(k) submission. This document pertains to a physical implantable device, not an AI software/algorithm.

Addressing the Prompts Based on the Provided Document:

Given the nature of the document (a 510(k) for a physical medical implant), the requested information as it relates to AI/software performance is not present. However, I can extract the relevant information about the device's performance testing as detailed in the document, which primarily focuses on non-clinical (mechanical) testing.

Response to the Request:

The provided document describes a 510(k) premarket notification for a physical medical device, the "Tyber Medical PT Interbody Spacer System," which is an implant used for intervertebral body fusion. This type of regulatory submission aims to demonstrate "substantial equivalence" to a legally marketed predicate device, rather than proving performance through a clinical study involving human patients in the way an AI or diagnostic device would. Therefore, many of the questions asked, particularly those related to AI algorithm performance, human-in-the-loop studies, and the specifics of clinical ground truth establishment, are not applicable to this document.

The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the mechanical and biological testing performed to demonstrate that the new device is as safe and effective as its predicate.

Here's an breakdown based on the information available in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly defines "acceptance criteria" for substantial equivalence based on mechanical testing compared to the predicate device. The performance results are framed as successfully meeting these comparative standards.

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

• Sample Size: Not explicitly stated for each mechanical test. Mechanical testing typically involves a small, statistically justified number of physical samples (e.g., 5-10 per test condition) rather than a large "dataset" of patient cases.
• Data Provenance: The data comes from non-clinical performance testing of the device itself (physical samples), not from patients or clinical studies. No geographical or temporal provenance for "data" in the sense of patient records is applicable. The tests were conducted according to specified ASTM and ST standards.

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

• Not applicable. This relates to physical device testing, not the establishment of ground truth by clinical experts for a diagnostic or AI algorithm.

4. Adjudication Method for the Test Set:

• Not applicable. Adjudication is relevant for interpreting patient data, such as images or clinical outcomes, often in the context of diagnostic performance or clinical trials. This document describes mechanical device testing.

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

• No, not performed. This type of study is relevant for evaluating the impact of AI or diagnostic tools on human reader performance, which is not the subject of this 510(k) submission for a physical implant.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

• Not applicable. This refers to the evaluation of AI algorithms. The Tyber Medical PT Interbody Spacer System is a physical medical device, not an algorithm.

7. Type of Ground Truth Used:

• Engineering/Mechanical Test Standards: The "ground truth" for the device's performance is established by the well-defined, standardized test methods (e.g., ASTM F2077, ASTM F1877, ST72:2011) and the comparison of results against predetermined acceptance criteria derived from the predicate device's performance.

8. Sample Size for the Training Set:

• Not applicable. This concept pertains to machine learning algorithms. The device undergoes manufacturing and quality control processes, but there isn't a "training set" in the AI sense.

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

• Not applicable. See point 8.

Summary of Device and its Proof of Meeting Criteria (from document's perspective):

The Tyber Medical PT Interbody Spacer System is an intervertebral body fusion device made from PEEK-Optima® with an optional titanium coating. It is intended to facilitate spinal fusion in skeletally mature patients with degenerative disc disease. The device comes in various shapes and sizes to accommodate lumbar (L2-S1) and cervical (C2-T1) spine applications.

Proof of Meeting Criteria (Substantial Equivalence):

The manufacturer demonstrated that the new device meets the criteria for "substantial equivalence" to its previously cleared predicate device (Tyber Medical Interbody Spacer System K130573) and other additional predicates (Synthes ACIS, DePuy Spine Concorde Curve, DePuy Spine Lateral System, Aesculap ASpace, CESpace, Prospace, T-Space). This was established through non-clinical performance data (mechanical and biocompatibility testing).

The key argument for substantial equivalence is that:

• The indications for use are the same.
• The design, materials, application, and anatomic mechanical properties are considered identical or have been shown to be equivalent through testing.
• The mechanical tests (Static and Dynamic Compression, Compression Shear, Wear Debris, Static Torsion per ASTM F2077, F1877) and pyrogenicity testing (per ST72:2011) demonstrate that the new device's performance is comparable to the predicate and that the new configurations do not introduce a "new worst-case" scenario for mechanical performance.
• The material, tooth profile, worst-case construct, smallest cross-sectional area, and manufacturing process are unchanged from the predicate, further supporting equivalence.

The FDA's determination of substantial equivalence indicates that, based on the provided non-clinical data, the device is considered as safe and effective as a legally marketed device and can be marketed without requiring a premarket approval application (PMA) which typically involves more extensive clinical trial data.

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PEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges

• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform of Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cunciform arthrodesis (TMT os Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

TyPEEK System Indications

The Tyber Medical Wedge System is intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle and foot such as:

Cotton and Evans Wedges

• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• · Opening wedge of Medial Cuneiform of Cotton osteotomies
• · Lateral Column Lengthening (Evans Lengthening Osteotomy or Calcaneal Z Osteotomy) Midfoot Wedges
• · Opening wedge osteotomies of the bones of the foot including osteotomies for Hallux Valgus
• · Nonunion of arthrodesis of the Midfoot including Metatarsal/Cuneiform arthrodesis (TMT of Lapidus)

The device is intended for use with ancillary fixation The Tyber Medical Wedge System is not intended for use in the spine

This submission is to add additional footprints to the system.

The Tyber Medical Wedge System, manufactured from PEEK-Optima®, consist of implants available in various foot prints, heights and indication configurations with an open architecture to accept packing of bone graft materials. The exterior of the device has "teeth" or other generally sharp engagement members on the superior and inferior surfaces. The device comes in a PEEK or PEEK with a plasma-sprayed commercially pure titanium coating on the superior and inferior surfaces.

This document is a 510(k) premarket notification for a medical device called the "Tyber Medical Wedge System," specifically for adding new footprints (configurations) to an already cleared system. This type of submission relies on demonstrating "substantial equivalence" to a predicate device, rather than proving efficacy or performance through extensive clinical trials as would be the case for a novel device.

Therefore, the typical metrics and study designs used for evaluating AI/ML-based medical devices (like MRMC studies, sensitivity/specificity, AUC, etc.) are not applicable to this document. The document explicitly states:

• "Performance Data (Clinical) Clinical data and conclusions were not needed for this device" (Page 5)
• "The worst-case device has not changed from the prior submission and so no new testing has been completed." (Page 5)

The acceptance criteria here concern demonstrating the device functions comparably to a predicate device, without introducing new safety or effectiveness concerns, particularly for the new configurations.

Here's an interpretation based on the provided document, addressing the prompt's questions where applicable, and noting where the information is not present or relevant due to the nature of a 510(k) for an updated existing device:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence for a 510(k) Modification)

Detailed Answers to Specific Questions (as per this 510(k) document):

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

   • See table above. The acceptance criteria for this 510(k) are based on demonstrating substantial equivalence, meaning the device's modifications do not introduce new safety or effectiveness concerns compared to the predicate. The performance is assessed by confirming the new configurations do not alter the existing, accepted performance envelope.

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

   • N/A. This document is for a 510(k) submission adding new configurations to an existing device. It explicitly states, "The worst-case device has not changed from the prior submission and so no new testing has been completed." (Page 5) and "Clinical data and conclusions were not needed for this device" (Page 5). Therefore, there is no "test set" in the context of clinical or performance data for new configurations, nor is there provenance data in the sense of patient-based studies. Pyrogenicity testing was mentioned, but no sample sizes for that are provided.

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

   • N/A. As no clinical "test set" was generated, no experts were used in this context. The "ground truth" for a 510(k) is typically established by the predicate device's existing clearance and the established safety and performance of its design and materials.

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

   • N/A. No clinical test set.

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:

   • N/A. This device is a physical implant (a bone wedge/fastener), not an AI/ML diagnostic or assistive software. Therefore, MRMC studies and AI assistance are irrelevant.

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

   • N/A. This is a physical implant, not an algorithm.

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

   • For this 510(k) and its claims of substantial equivalence, the "ground truth" rests on the established safety and effectiveness profile of the predicate device (Tyber Medical Wedge System (K150394)) and the demonstration that the new configurations do not introduce new safety or performance risks. This often involves engineering analysis, material properties, and comparison to existing biomechanical data of the cleared predicate.

8. The sample size for the training set:

   • N/A. There is no "training set" in the context of AI/ML or a traditional clinical study for this device type.

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

   • N/A. No training set exists.

In summary: This FDA document is a 510(k) clearance based on "substantial equivalence" of a modified device (adding new sizes/footprints). It is not a document describing the rigorous clinical testing typically associated with demonstrating efficacy or diagnostic performance for novel or high-risk devices, nor is it related to AI/ML software validation. The "acceptance criteria" revolve around demonstrating that the modified device remains as safe and effective as its predicate.

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The Tyber Medical BioTy® Nanotopography Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. The screw is intended for single use only.

A trauma screw with BioTy® Nanotopography Surface Treatment is designed to apply compression and fixation between two adjacent segments of cortical and/or cancellous bone.

This FDA document is for a medical device called the "Tyber Medical BioTy® Nanotopography Trauma Screw." It's a 510(k) premarket notification, meaning it's seeking to demonstrate substantial equivalence to previously marketed devices, rather than proving novel effectiveness. Therefore, the information provided focuses on non-clinical testing and comparison to predicates, not on clinical trials or AI performance.

Based on the provided text, I cannot answer the questions regarding acceptance criteria and study design for AI devices because:

• This is not an AI/ML device. The document describes a trauma screw with a specific surface treatment (BioTy® Nanotopography), which is a physical medical device, not a software algorithm or an AI system.
• No clinical study to prove AI performance is mentioned. The "Clinical Test Summary" explicitly states "n/a" (not applicable), indicating that no clinical trials were conducted or reported for this submission to evaluate the device's performance in humans. The testing performed was non-clinical (mechanical, invitro, pyrogenicity) to evaluate the physical characteristics and safety of the screw itself and its surface treatment.
• Acceptance criteria for AI performance are not relevant here. The acceptance criteria discussed in the document relate to the physical properties, safety, and substantial equivalence of the trauma screw to predicate devices, not to metrics like sensitivity, specificity, F1-score, or human reader improvement with AI assistance.

Therefore, since the input document does not pertain to an AI device or a clinical study for an AI device, I cannot provide the requested information.

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The Tyber Medical Trauma Screw is indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

General trauma screw for compression and fixation of bone. This submission adds a headed screw and snap off option as well as an optional washer to the previously cleared headless trauma screw with and without previously cleared modified surface treatment. The screws will be provided sterile and non-sterile in both solid and cannulated form, made of from titanium (with and without Modified Surface treatment) and

The provided document is a 510(k) summary for the Tyber Medical Trauma Screw. It describes the device's characteristics, intended use, and substantial equivalence to a predicate device, but it does not contain information about the acceptance criteria or a study proving that a device meets those criteria in the context of an AI/ML medical device.

The document pertains to a physical medical device (trauma screw) and primarily focuses on demonstrating substantial equivalence through non-clinical testing of mechanical properties, specifically static torsion. There is no mention of an algorithm, AI, or machine learning model.

Therefore, I cannot fulfill the request for information regarding acceptance criteria and studies proving an AI/ML device meets them based on the provided text. The questions posed (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are highly specific to AI/ML device evaluations and are not applicable to the content of this 510(k) summary for a trauma screw.

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