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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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The SYNSTER CERVICAL CAGE is indicated for intervertebral body fusion in skeletally mature patients with degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one disc level from the C2-C3 disc to the C7-T1 disc. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion. Patients should have at least six (6) weeks of non-operative treatment prior to treatment with an intervertebral cage.

The SYNSTER (ALIF, PLIF, PTLIF and TLIF) CAGE is indicated for intervertebral body fusion of the lumbar spine, from L2 to S1, in skeletally mature patients who have had six months of non-operative treatment. The device is intended for use at one level or two continuous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device system is designed for use with supplemental fixation and with autograft to facilitate fusion.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE will be offered in various device configurations based on surgical approach and patient anatomy, and consist of:

• 1. Cervical Interbody Fusion Device (SYNSTER® CERVICAL CAGE), which may be implanted as a single device via an anterior approach.
• 2. Lumbar Interbody Fusion Device [SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE], which may be implanted
  • As a single device via an Anterior or Anterolateral or Lateral (ALIF) approach; ।
  • Bi-laterally via a posterior (PLIF) approach; ।
  • As a single device via a posterior transforaminal (PTLIF) approach; -
  • As a single device via a transforaminal (TLIF) approach. -

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE components are made of polyether ether ketone (PEEK Optima LT1) that conforms to ASTM F2026. Additionally, the devices contain titanium makers (ASTM F136) to assist the surgeon with proper placement of the device.

The SYNSTER® (CERVICAL, ALIF, PLIF, PTLIF and TLIF) CAGE is implanted by using the (SCCI, SACI, SPCI, SPTCI and STCI) instruments manufactured from stainless steel materials that conform to ASTM F899.

This submission describes the SYNSTER® CERVICAL CAGE and SYNSTER® (ALIF, PLIF, PTLIF and TLIF) CAGE, intervertebral body fusion devices. The devices are made of PEEK Optima LT1 with titanium markers and are intended for intervertebral body fusion in skeletally mature patients with degenerative disc disease. The testing described for these devices primarily focuses on mechanical performance rather than AI/software performance. Therefore, many of the typical AI/ML-related questions are not applicable to this submission.

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 the data provenance

• Sample Size: Not explicitly stated in terms of number of devices tested, but the testing refers to "non-clinical tests" conducted in accordance with specific ASTM standards. These standards typically involve a defined number of samples for each test type. The document does not specify the exact number of units tested.
• Data Provenance: Not applicable in the context of clinical data. The data originates from benchtop mechanical testing performed according to ASTM standards. There is no information regarding country of origin or retrospective/prospective nature as it's not clinical data.

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

Not applicable. The ground truth for this type of device (mechanical performance) is established by adherence to recognized national/international standards (ASTM F2077-03, ASTM F2267-04, and ASTM Draft Standard F 04.25.02.02) and engineering principles, not by expert consensus on clinical interpretation. The "experts" would be materials scientists and mechanical engineers performing and interpreting the tests according to the standards.

4. Adjudication method for the test set

Not applicable. This is not a study requiring adjudication of human interpretations. Mechanical test results are objective measurements compared against specified criteria from standards.

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 submission is for a physical medical device (intervertebral cage), not an AI/ML software device.

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

Not applicable. This submission is for a physical medical device, not an algorithm.

7. The type of ground truth used

The "ground truth" for demonstrating the device's acceptable performance is defined by the mechanical properties and criteria stipulated in the referenced ASTM standards. These standards provide objective measures and acceptance thresholds for static and dynamic compression, shear, torsion, subsidence, and expulsion.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; therefore, there is no training set in the conventional sense.

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

Not applicable. There is no training set for this physical medical device.

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The PLIF Cage is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved levels. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had six months of non-operative treatment. These devices are intended for intervertebral body fusion, and are intended to be used with supplemental fixation instrumentation which has been cleared by the FDA for use in the lumbar spine.

PLIF Cage is a hollow, generally rectangular box made The of polyetheretherketone (PEEK) and having titanium x-ray markers. It is provided in a variety of shapes and sizes, and is intended to be filled with a bone graft material. The smallest footprint of the device is 8mm medial-lateral x 20mm anterior-posterior. The largest footprint is 12mm medial-lateral x 30mm anteriorposterior. Available heights range from 7mm to 16mm. The device is available either in a non-lordosed configuration, or with a built-in six degree lordotic angle.

The PLIF cage may be inserted via an open or minimally invasive approach. It may be placed singly or in pairs.

Bone graft volume of the device is variable depending on the device size; larger sizes have more volume for graft. The smallest graft volume, in the 20x8x7mm non-fordotic device is approximately 354.1mm² (0.4cc), while the largest in the 30x12x16 lordotic device is approximately 3,530mm3 (3.5cc).

The surface area of the device contacting the endplates ranges from 118mm² to 220mm2 for the smallest and largest footprint devices, respectively.

The PLIF cage may be made either from Zeniva PEEK (Solvav Advanced Polymers, Alpharetta, GA USA) or PEEK Optima (Invibio, Inc., West Conshohocken, PA USA). The particular grade of PEEK used is tracked via product lot numbering and is displayed on the package label.

The provided text does not describe acceptance criteria for a diagnostic device or a study validating its performance in the context of medical imaging or AI. Instead, it details the 510(k) summary for a medical device called "PLIF Cage," which is an intervertebral fusion device, and the FDA's decision regarding its substantial equivalence to predicate devices.

Therefore, I cannot extract the information requested as it is not present in the provided document. The document focuses on the mechanical testing and material equivalence of a physical implant (PLIF Cage) rather than the performance metrics of a diagnostic tool or an AI algorithm.

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