(97 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 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.
| Acceptance Criteria (Tests) | Reported Device Performance |
|---|---|
| Mechanical Tests (per ASTM F2077, F04-25-02-02 Draft, F2267): | Demonstrated substantially equivalent performance to identified predicate devices. |
| - Static Compression | Met requirements. |
| - Dynamic Compression | Met requirements. |
| - Static Compression Shear | Met requirements. |
| - Dynamic Compression Shear | Met requirements. |
| - Static Torsion | Met requirements. |
| - Dynamic Torsion | Met requirements. |
| - Expulsion | Met requirements. |
| - Subsidence | Met requirements. |
| - Wear Debris Assessment | Met requirements. |
| - Impaction | Met requirements. |
| Physical Properties and Chemistry of Tritanium® PL Cage material (per FDA guidance and ASTM 1472-08): | Porous surface design of the cage meets at minimum the requirements outlined in the referenced guidance documents and standard. |
| Mechanical Properties of Tritanium® PL Cage material (per ASTM F1147-05, F1044-05, F1160-05, E8/E8M, F2129-09): | Met requirements. |
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.
- 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.
- 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.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- 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.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No. This is not an AI algorithm.
- 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.
- The sample size for the training set: Not applicable/Not provided. This is not an AI algorithm, so there is no training set.
- How the ground truth for the training set was established: Not applicable/Not provided.
§ 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.