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The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The cage is offered in a variety of footprints to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.

The Tritanium® PL Cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® PL Cage. It outlines the device's indications for use, its characteristics, and references performance data to demonstrate substantial equivalence to a predicate device. However, this document does not describe acceptance criteria for a study proving device meets acceptance criteria, nor does it detail a clinical study with human readers or specific statistical performance metrics often associated with AI/software devices.

This document specifically focuses on a physical implant (intervertebral body fusion device) and its mechanical performance testing. The "Summary of Performance Data" refers to engineering analyses and mechanical tests, not clinical studies or AI algorithm performance.

Therefore, many of the requested fields cannot be filled from the provided text as they relate to AI/software performance evaluations.

Here's an attempt to answer based only on the information provided, highlighting what is not available:

Acceptance Criteria and Device Performance

The document states that "Verification and validation activities demonstrated that all relevant acceptance criteria were met." However, it does not explicitly list the acceptance criteria themselves, nor does it provide specific numerical results of the device's performance against those criteria. Instead, it refers to multiple mechanical tests according to ASTM standards, implying that meeting the standards' requirements was the acceptance criteria.

Study Details (as inferable from the document)

1. Sample size used for the test set and the data provenance: This refers to the mechanical tests conducted. The document does not specify the number of samples (e.g., number of implants or test specimens) used for each mechanical test. Data provenance (country of origin, retrospective/prospective) is not applicable or stated for these engineering analyses and mechanical tests.

2. 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 these mechanical tests would be the physical properties and performance metrics measured according to the ASTM standards, not expert clinical interpretations.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. This relates to clinical studies with expert reviewers, not mechanical testing.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is for an AI/imaging device, not a physical implant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is for an AI/software device, not a physical implant.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the mechanical tests, the "ground truth" is typically defined by the precise measurement outcomes of the physical tests according to established scientific and engineering principles and standards (e.g., maximum load at failure, displacement under load, wear rates).

7. The sample size for the training set: Not applicable. This is for an AI/software device. The "Engineering Analysis" mentions two FEAs (Finite Element Analyses), which are computational simulations, but there is no "training set" in the context of device performance in this document.

8. How the ground truth for the training set was established: Not applicable. This is for an AI/software device.

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The Stryker Spine Tritanium® PL Cage is an intervertebral body fusion device indicated for use with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when used as an adjunct to fusion in patients with degenerative disc disease (DDD) at one level or two contiguous levels from L2 to S1.

DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be skeletally mature and have six months of nonoperative therapy.

Additionally, the Tritanium® PL Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.

The Tritanium® PL Cage is to be implanted via a posterior approach.

The Tritanium® PL Cage is intended to be used with supplemental spinal fixation systems that have been cleared for use in the lumbosacral spine.

The Tritanium® PL Intervertebral Body Fusion Cage is intended for use as an aid in lumbar spinal fixation. The cage is a hollow, rectangular implant that consists of a unique configuration of both solid and porous structures that are simultaneously built using Laser Rapid Manufacturing (LRM) method applying Stryker's proprietary Tritanium® In-Growth Technology. The lordotic angles to adapt to a variety of patient anatomies. It has serrations on the superior and inferior porous surfaces of the implant for fixation, an ergonomically shaped anterior edge, and a flat posterior edge. The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine. The Tritanium® PL cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08) and are provided sterile.

The provided text is related to a 510(k) premarket notification for a medical device called the "Tritanium® PL Cage," an intervertebral body fusion device. The document primarily focuses on demonstrating substantial equivalence to predicate devices and does not detail a study involving AI or human reader performance. Therefore, I cannot provide information on the majority of the requested points.

However, I can extract the acceptance criteria and the summary of non-clinical testing for the device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document describes non-clinical testing performed in compliance with specific guidance and ASTM standards to demonstrate substantial equivalence. The "reported device performance" is the successful compliance with these tests, indicating that the device met the required mechanical and material properties.

The following points cannot be answered based on the provided text, as the document describes a 510(k) submission for an intervertebral body fusion device focusing on mechanical and material testing, not a study involving AI for image analysis or human reader performance.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable/Not provided. The testing described is mechanical and material testing of the device itself, not a clinical study with patients or data.
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/Not provided. Ground truth in the context of AI or diagnostic studies is not relevant to the mechanical device testing described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
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 type of study was not conducted or reported.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable/Not provided. The "ground truth" for this device would be its physical and mechanical properties as measured against established standards.
8. The sample size for the training set: Not applicable/Not provided. This is not an AI algorithm, so there is no training set.
9. How the ground truth for the training set was established: Not applicable/Not provided.

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