(69 days)
SeaSpine Meridian System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Meridian System interbody is indicated for use as an adjunct to fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. These DDD patients may also have up to Grade 1 spondylolisthesis at the involved level(s). The interior of the device is to be used with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. The SeaSpine Meridian Interbody is intended for use with supplemental fixation. Degenerative disc disease is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of nonoperative treatment.
No-Profile Implants w/ Screws:
The SeaSpine Meridian System No-Profile Interbody, when used with Screws and a No-Profile Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine Meridian System No-Profile Interbody, when used with Inline Fixation Anchors and a No-Profile Locking Cover, is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. The SeaSpine Meridian No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Meridian System Interbody assembled with the Anterior Plate, when used with Screws and a Anterior Plate Locking Cover, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device. Hyperlordotic sizes (25 and 30 degrees) are intended for use with supplemental fixation.
SeaSpine Regatta Lateral System
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine Regatta Lateral System is indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD, defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies). It is intended for use at either one level or two contiguous levels in the lumbar spine, from L2 to S1, for the treatment of DDD with up to Grade 1 spondylolisthesis at the involved level(s). The interior of the interbody spacer component may be packed with autogenous bone graft material composed of cancellous and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of nonoperative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine Regatta Lateral System assembled with the TruProfile Lateral Plate, when used with Screws, is a standalone interbody implant indicated for use as an adjunct to fusion in skeletally mature patients with degenerative disc disease (DDD) at one 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 1 spondylolisthesis at the involved level. The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft, composed of cancellous, and/or corticocancellous bone. Patients must have undergone a regimen of at least six (6) months of non-operative treatment prior to being treated with the device.
The SeaSpine Regatta Lateral System assembled with the 1-hole TruProfile Lateral Plate, when used with Screws, is intended for use with supplemental fixation.
The Seaspine Meridian and SeaSpine Regatta Lateral Systems are intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous and/or corticocancellous bone prior to implantation. The implants are manufactured from PEEK (ASTM F2026) with tantalum (ASTM F560) or titanium alloy (ASTM F136) radiographic markers. The implants have a one-micron thick surface coat of commercially pure (CP) titanium (ASTM F67) and are sterile-packed. Both the Meridian and Regatta interbodies have the ability to accept an anterior or lateral faceplate and offer various configurations that can be used with bone screws or inline fixation, locking covers and an optional spin plate. The instruments included with the system facilitate the placement and adjustment of the interbody spacers, and removal if necessary. The instruments are placed in system-specific trays for storage, protection, and organization prior to and during the steam sterilization process.
The provided text is a 510(k) summary for the SeaSpine Meridian System and SeaSpine Regatta Lateral System, which are intervertebral body fusion devices. This type of FDA submission focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and performance, primarily through non-clinical (mechanical) testing. It does not involve AI/ML components or clinical studies with human readers or image interpretation.
Therefore, many of the specific questions regarding AI device performance criteria, human reader studies, and ground truth establishment are not applicable to this document.
However, based on the information provided, here's a description of the acceptance criteria and study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance:
The document doesn't present a table with specific quantitative acceptance criteria or detailed numerical performance results from the non-clinical tests. Instead, it broadly states that the device's mechanical performance in various tests "effectively demonstrates substantial equivalence" to the predicate devices. The implicit acceptance criterion for a 510(k) submission is that the new device performs as safely and effectively as legally marketed predicate devices.
The reported device performance is that the testing performed demonstrated the new systems are:
- "as safe, as effective, and performs at least as safely and effectively as the cited legally marketed predicate."
2. Sample size used for the test set and the data provenance:
- Sample Size: The document does not specify the number of individual devices or components tested in each mechanical test. Mechanical testing typically involves a set number of samples per test type (e.g., n=5 or n=6 per group) to ensure statistical validity, but these exact numbers are not provided.
- Data Provenance: The tests are "non-clinical testing" and are performed in a laboratory setting, not on patient data. Thus, there is no country of origin for patient data, nor is it retrospective or prospective in the clinical sense. The provenance is internal laboratory testing.
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 as the document describes mechanical testing of physical devices, not image analysis or diagnostic performance where expert ground truth would be required.
4. Adjudication method for the test set:
- This question is not applicable for the same reason as above. Mechanical tests are typically evaluated against engineering specifications, not expert adjudication.
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 device, not an AI-powered diagnostic tool. No human reader studies or AI assistance are involved.
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:
- For mechanical testing, the "ground truth" would be the engineering specifications and performance characteristics mandated by the relevant ASTM standards (e.g., F2077 for compression, F2267 for subsidence) and the established performance of the predicate devices. The goal is to show comparable or better performance against these established benchmarks.
8. The sample size for the training set:
- This question is not applicable as there is no AI algorithm being trained.
9. How the ground truth for the training set was established:
- This question is not applicable as there is no AI algorithm being trained.
Summary of Study (Non-Clinical Testing):
The study conducted to demonstrate the device meets acceptance criteria (i.e., substantial equivalence) involves a series of non-clinical, benchtop mechanical tests in accordance with established ASTM (American Society for Testing and Materials) standards.
Specifically, these tests include:
- Compression and Compression-Shear Testing: Performed per ASTM F2077.
- Subsidence Testing: Performed per ASTM F2267.
- Wear Testing: Performed per ASTM F1877.
- Expulsion Testing
- Static Screw Pushout Testing
- Packaging, Shipping, and Sterilization Tests: To validate a Sterility Assurance Level (SAL) of 10-6 and ensure maintenance of a sterile barrier.
- Bacterial Endotoxin Testing (BET): Conducted in accordance with ANSI/AAMI ST-72:2011.
The conclusion drawn from these tests is that the new systems are mechanically similar to the predicate devices and perform comparably, thereby demonstrating that they are as safe and effective. The acceptance criteria are implicitly met by demonstrating that the new devices' performance falls within acceptable ranges when compared to predicate devices and relevant industry standards.
§ 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.