Search Results

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 purpose of this submission is to introduce new implant sizes to the previously cleared Tritanium® PL Cage offering. 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 lengths, heights, widths and 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.

This document is a 510(k) premarket notification for a medical device, the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and claims substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance:

   The document does not explicitly state acceptance criteria in the form of numerical thresholds for performance. Instead, the "acceptance criteria" are implied by the requirement to demonstrate "substantially equivalent performance" to predicate devices through various mechanical tests. The reported device performance is that it met the requirements of these tests.

   Acceptance Criterion (Implied)	Reported Device Performance
   Substantially equivalent performance to predicate devices (K160955, K151726) per FDA's June 12, 2007 "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device".	Testing performed on the subject Tritanium® PL Cages demonstrated substantially equivalent performance to the identified predicate devices in compliance with the FDA guidance document.
   Static and Dynamic Compression (per ASTM F2077)	Performed
   Static and Dynamic Compression Shear (per ASTM F2077)	Performed
   Static and Dynamic Torsion (per ASTM F2077)	Performed
   Expulsion (per ASTM F04-25-02-02 Draft)	Performed
   Subsidence (per ASTM F2267)	Performed
   Wear Debris Assessment	Performed
   Impaction	Performed
   Endotoxin limit of < 20EU/Device (per ANSI/AAMI ST72:2011)	Bacterial endotoxin testing (BET) was used to achieve the specified endotoxin limit.

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

   The document refers to mechanical testing rather than clinical or performance data involving human subjects. Therefore, the concept of a "test set" in the context of clinical data provenance (country of origin, retrospective/prospective) is not applicable here. The "test set" for this submission would be the physical Tritanium® PL Cages manufactured for mechanical evaluation. The specific number of devices tested for each mechanical test (e.g., how many cages were subjected to compression) is not provided in this summary but would be detailed in the full test reports.

   Data provenance: Not applicable in the context of human data. The tests are laboratory-based mechanical tests.

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

   This question is not applicable. "Ground truth" in this context typically refers to clinical diagnosis or outcome, which is not being assessed in this submission. The "truth" for mechanical testing is derived from the testing standards (ASTM, ANSI/AAMI) and the measured physical properties of the device compared to predicate devices. The expertise involved would be in engineering and materials science, not clinical diagnosis.

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

   This question is not applicable as there is no clinical "test set" involving expert review or adjudication of results. The mechanical tests adhere to standardized protocols.

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:

   This question is not applicable. The device is an intervertebral body fusion cage, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study or AI-related assessment is mentioned.

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

   This question is not applicable. The device is a physical implant, not an algorithm.

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

   The "ground truth" for the mechanical testing is based on established engineering principles, industry standards (ASTM, ANSI/AAMI), and comparison to the performance of predicate devices that have been deemed safe and effective. It's about meeting physical and material specifications, not a clinical "ground truth" derived from patient-specific data.

8. The sample size for the training set:

   This question is not applicable. There is no mention of a "training set" as this is a physical medical device, not a machine learning model.

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

   This question is not applicable, as there is no training set mentioned or implied.

Ask a specific question about this device

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 lengths, heights, widths and 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.

This document is a 510(k) premarket notification for the Stryker Spine Tritanium® PL Cage. It describes the device, its intended use, and argues for its substantial equivalence to a previously cleared predicate device.

Based on the provided text, the device in question is a medical implant (an intervertebral body fusion device), not an AI/ML-enabled medical device that would typically undergo the kind of performance studies and establish acceptance criteria outlined in your request. The document discusses mechanical properties, material, and manufacturing processes, but it does not mention any AI algorithms or software components.

Therefore, the requested information regarding acceptance criteria and a study proving device performance (including sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance) is not available in this specific document, as those types of studies are not relevant for this kind of physical medical device.

In summary, this document does not contain the information needed to answer your questions because it pertains to a traditional physical medical device, not an AI/ML-enabled medical device.

Ask a specific question about this device