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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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Cervical System Indications:
The Tyber Medical PT Interbody Spacer System is indicated for use as an intervertebral body fusion device in sketally 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 faciliate fusion in the cervical spine (C2-T1) and are placed via an anterior approach using autogenous bone and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as an interbody fusion device, supplemental fixation must be used.

Lumbar System Indications:
The Tyber Medical PT Interbody Spacer 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). DDD patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved levels. These patients may also have had a previous non-fusion spinal surgery at the involved spinal level(s). Additionally, the Tyber Medical PT Interbody System can be used in patients diagnosed with spinal deformities as an adjunct to fusion. Patients should have six weeks of nonoperative 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 autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft. When used as interbody fusion devices these implants are intended for use with supplemental fixation systems cleared for use in the thoracolumbar spine.

This submission is to update language in the Indications for Use, and update language in the package insert in reference to MR testing.

There is no change with this submission from the primary predicate.

This submission does not change or add any new instruments.

The Tyber Medical PT Interbody System, manufactured from PEEK-Optima® LT1, with a plasma-sprayed integrated commercially pure titanium. The system consists 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 provided text is a 510(k) summary for the Tyber Medical PT Interbody Spacer System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, rather than proving that an AI/ML powered device meets acceptance criteria through a specific study.

Therefore, the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, multi-reader multi-case studies, and standalone performance studies for an AI/ML device is not present in this document.

The document states:

• "No new mechanical testing was performed, because there is no change to the device."
• "MR testing was performed per ASTM F2052-15, ASTM F2119-07, ASTM F2213-06, ASTM F2503-13 & ASTM F2182-11a." (This refers to MRI compatibility testing, not AI performance.)
• "Clinical data and conclusions were not needed for this device."

This indicates that the submission relies on the prior clearance of the predicate device and standard non-clinical testing (like MR compatibility and mechanical testing) to establish substantial equivalence for a physical implant, not the performance of an AI/ML algorithm.

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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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