(92 days)
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meet requirements of Static and Dynamic Compression Shear (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Static and Dynamic Torsion (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Static and Dynamic Compression (ASTM F2077-14) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Subsidence (ASTM F2267-04) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Expulsion (ASTMF04-25-02-02 (Draft)-2000) | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Wear Debris Analysis | Demonstrated through Engineering Analysis (including FEA) |
| Meet requirements of Impaction | Demonstrated through Engineering Analysis (including FEA) |
Study Details (as inferable from the document)
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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.
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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.
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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.
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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.
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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.
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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).
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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.
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How the ground truth for the training set was established: Not applicable. This is for an AI/software device.
§ 888.3080 Intervertebral body fusion device.
(a)
Identification. An intervertebral body fusion device is an implanted single or multiple component spinal device made from a variety of materials, including titanium and polymers. The device is inserted into the intervertebral body space of the cervical or lumbosacral spine, and is intended for intervertebral body fusion.(b)
Classification. (1) Class II (special controls) for intervertebral body fusion devices that contain bone grafting material. The special control is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intervertebral Body Fusion Device.” See § 888.1(e) for the availability of this guidance document.(2) Class III (premarket approval) for intervertebral body fusion devices that include any therapeutic biologic (e.g., bone morphogenic protein). Intervertebral body fusion devices that contain any therapeutic biologic require premarket approval.
(c)
Date premarket approval application (PMA) or notice of product development protocol (PDP) is required. Devices described in paragraph (b)(2) of this section shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.