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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 K7 Lumbar Spacers are 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 either one level or two contiguous levels for the treatment of degenerative disc disease (DDD) with up to Grade I spondylolisthesis or retrolisthesis. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The device is intended for use with supplemental fixation and with autograft to facilitate fusion.

The K7 Lumbar Spacers are a collection of radiolucent interbody devices having variously shaped cross-sections. The superior and inferior surfaces are open with parallel serrations to facilitate implant stability. The implants are available in an assortment of height, length, width and anteroposterior angulation combinations to accommodate a variety of anatomic requirements.

The provided text describes the K7 Lumbar Spacers, a medical device for intervertebral body fusion. The study presented focuses on demonstrating substantial equivalence to predicate devices through mechanical testing, rather than a clinical study evaluating the device's performance in a human population.

Therefore, many of the requested categories related to clinical performance metrics, ground truth establishment, expert involvement, and reader studies are not applicable or cannot be extracted from this document, as the FDA 510(k) submission for this device type typically relies on demonstrating engineering and material equivalence for clearance.

Here's a breakdown of the information that can be extracted, and where the requested information is not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

• Static Compression (according to ASTM F2077)
• Dynamic Compression (according to ASTM F2077) | Performance shown to be substantially equivalent to predicate devices. |
  | Subsidence Properties:
• Evaluated according to ASTM F2267 | Performance shown to be substantially equivalent to predicate devices. |
  | Technological Characteristics:
• Intended Use
• Basic Design (hollow column)
• Material (PEEK polymer and tantalum)
• Sizes (widths, lengths, heights within predicate range) | Same as predicate devices. |

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

• Sample Size: Not explicitly stated as a "test set" in the context of clinical data. The mechanical testing was likely performed on a representative sample of K7 Lumbar Spacers of the "worst case" configuration. The specific number of units tested for static, dynamic compression, and subsidence is not provided.
• Data Provenance: The data is from mechanical testing of the device itself (K7 Lumbar Spacers) in a laboratory setting, not from human subjects. Therefore, country of origin or retrospective/prospective clinical data is not applicable.

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

• This is not applicable. The "ground truth" for this device's regulatory clearance is established by engineering standards (ASTM F2077, ASTM F2267) and comparison to predicate device characteristics, not by expert clinical consensus on a "test set" of patient data.

4. Adjudication Method for the Test Set

• This is not applicable, as there was no clinical "test set" involving human interpretation or adjudication.

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

• No, an MRMC comparative effectiveness study was not done. This device is a spinal implant, and its regulatory clearance here is based on mechanical performance and material equivalence, not on the interpretative performance of a diagnostic algorithm or image analysis by human readers.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

• No, a standalone study in the context of AI algorithm performance was not done. This device is a physical implant, not an AI algorithm.

7. Type of Ground Truth Used

• For the mechanical performance, the "ground truth" is defined by engineering standards (ASTM F2077 for compression, ASTM F2267 for subsidence) and the established performance/characteristics of legally marketed predicate devices. The goal was to demonstrate that the K7 Lumbar Spacers met or were equivalent to these benchmarks.

8. Sample Size for the Training Set

• This is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

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

• This is not applicable. See point 8.

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PATRIOT® TransContinental™ Spacers are interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain with deqeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s).

The PATRIOT® TransContinental® Spacers are to be filled with autogenous bone graft material. These devices are intended to be used with supplemental fixation, such as the PROTEX® or REVERE® Stabilization System.

The PATRIOT® TransContinental® Spacers are lumbar interbody fusion devices used to provide structural stability in skeletally mature individuals following discectomy. The spacers are inserted using an anterior or lateral approach to the lumbar spine. The devices are available in various heights and geometric options to fit the anatomical needs of a wide variety of patients. These spacers are to be filled with autogenous bone graft material. Protrusions on the superior and inferior surfaces of each device grip the endplates of the adjacent vertebrae to resist expulsion.

PATRIOT® Spacers are made from radiolucent polymer, with titanium alloy or tantalum markers, as specified in F2026, F136, F1295, and F560.

This document is a 510(k) premarket notification for the PATRIOT® TransContinental® Spacer, an intervertebral body fusion device. It describes the device and its intended use, but it does NOT contain a study or data proving the device meets acceptance criteria.

The 510(k) process is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. It does not typically require new clinical studies with acceptance criteria in the same way a PMA (Premarket Approval) submission would.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets them because this document does not contain that information. It primarily focuses on demonstrating substantial equivalence to predicate devices, which is a different regulatory pathway.

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