(246 days)
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are intended for intervertebral body fusion with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is 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 with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). These patients should be skeletally mature and have completed six months of non-operative treatment.
Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage can be used as an adjunct to fusion in patients diagnosed with degenerative scoliosis.
The Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are always to be used with supplemental internal spinal fixation. Additionally, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage are to be used with autograft and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft when the subject device is used as an adjunct to fusion.
The purpose of this submission is to introduce an expandable posterior lumbar cage intended for use as an aid in lumbar spinal fixation.
The expandable Tritanium® X PL Expandable Posterior Lumbar Cage and the Tritanium® X TL Expandable Curved Posterior Lumbar Cage (also referred to as Tritanium X Cages) are Intervertebral Body Fusion Cages intended for use as an aid in lumbar spinal fixation. The TL cages are crescent shaped, and the PL cages are straight shaped.
These cages consist 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 surfaces designed for multidirectional fixation and to maximize surface area for endplate contact with the implant. The implants have a smooth, tapered leading edge to facilitate cage insertion into the intervertebral space. The implants have graft windows spanning endplate to endplate for graft containment and to aid in fusion throughout the interbody cage.
The implant is designed to be used with supplemental fixation cleared for use in the lumbosacral spine.
The Tritanium X cages are constructed from Titanium alloy: Ti-6Al-4V (ASTM F1472-08), Stainless Steel: 316 LVM (ASTM F138-08), and Silicone Rubber, and are provided sterile.
The provided text describes a 510(k) premarket notification for a medical device, the Tritanium® X PL Expandable Posterior Lumbar Cage and Tritanium® X TL Expandable Curved Posterior Lumbar Cage. This document is a regulatory submission to the FDA, not a study report detailing acceptance criteria and performance data for an AI-medical device.
The "Summary of the Performance Data" section does mention various mechanical tests performed on the device to demonstrate substantial equivalence to identified predicate devices, and compliance with FDA guidance documents and ASTM standards. However, these are physical and mechanical performance tests for an implantable device, not acceptance criteria or study results for an AI-powered medical device.
Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves an AI-powered device meets the acceptance criteria based on the provided text. The document is about an intervertebral body fusion device and its mechanical testing, not an AI device.
To answer your question directly based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided for an AI device. The document discusses the mechanical performance of an intervertebral body fusion device against standards like ASTM F2077, F2267-04, F1147-05, F1044-05, F1160-05, E8/E8M, and F2129-15, and compliance with various FDA guidance documents for orthopedic implants. These are physical performance metrics, not AI performance metrics.
2. Sample size used for the test set and the data provenance
- Cannot be provided for an AI device. The document does not mention test set sample sizes or data provenance relevant to an AI model's performance (e.g., number of images, patient demographics, retrospective/prospective). It refers to the number of test articles used for mechanical testing of the physical implant.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable for an AI device in this document. The ground truth discussed (implicitly) in the document is the physical and mechanical properties of the device as measured by standardized tests, not expert-labeled data for an AI model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable for an AI device in this document.
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 MRMC study was mentioned as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable; this is not an AI device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable for an AI device. The "ground truth" for this medical device's performance involved adherence to established ASTM standards and FDA guidance documents for mechanical and material properties (e.g., strength, corrosion resistance, wear debris).
8. The sample size for the training set
- Not applicable; this is not an AI device.
9. How the ground truth for the training set was established
- Not applicable; this is not an AI device.
In summary, the provided document is a 510(k) summary for a physical orthopedic implant (intervertebral body fusion cage), not an AI-powered medical device. Therefore, the information requested about AI device acceptance criteria and study data cannot be extracted from this text.
§ 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.