(96 days)
Interbody Device (IBD) Implants (i.e., interbody implants used alone):
The SeaSpine WaveForm A 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, cortical, and/or corticocancellous bone. The SeaSpine WaveForm A 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 non-operative treatment.
No-Profile Implants w/ Screws:
The SeaSpine WaveForm A 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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, cortical, 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.
No-Profile Implants w/ Inline Fixation Anchors:
The SeaSpine WaveForm A 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(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, 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 WaveForm A No-Profile Implants w/ Inline Fixation Anchors is intended for use with supplemental fixation.
TruProfile Interbody Implants:
The SeaSpine WaveForm A Interbody assembled with the Anterior Plate, when used with Screws and an 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 involved level(s). The interior of the spacer component may be packed with autogenous bone graft and/or allogeneic bone graft composed of cancellous, 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.
The Seaspine WaveForm A System are additively manufactured intervertebral fusion devices with large central graft windows which are packed with autogenous bone graft and/or allogenic bone graft, composed of cancellous, cortical, and/or corticocancellous bone prior to implantation. The implants are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The WaveForm A interbodies have the ability to accept an anterior faceplate and offer various configurations that can be used with bone screws or inline fixation anchors, 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 tray components for storage, protection, and organization prior to and during the steam sterilization process.
Please note: The provided text is a 510(k) premarket notification letter from the FDA regarding a medical device called "SeaSpine WaveForm™ A Interbody System." This type of document primarily focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing for mechanical performance, not a clinical study involving human patients or complex AI-driven diagnostic accuracy.
Therefore, the information typically found in a clinical study report regarding acceptance criteria for diagnostic accuracy, sample sizes for AI training/testing, expert adjudication, or MRMC studies for AI devices is not present in this document. The "study" referenced in this document refers to non-clinical mechanical and sterilization testing of the interbody fusion device itself.
Based on the provided text, here's an attempt to answer your questions, highlighting what information is not available in this specific document:
Description of Acceptance Criteria and Proving Device Meets Criteria (Based on Non-Clinical Testing)
The SeaSpine WaveForm™ A Interbody System is an intervertebral fusion device. Its acceptance criteria and proof of meeting them, as described in this 510(k) submission, primarily revolve around non-clinical mechanical performance and sterilization validation, demonstrating its safety and effectiveness are at least equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
| Criterion Type | Specific Test | Acceptance Criteria (Implied from equivalence claim) | Reported Device Performance |
|---|---|---|---|
| Mechanical Performance | Compression (ASTM F2077) | Equivalent to legally marketed predicate devices. | Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements. |
| Compression-Shear (ASTM F2077) | Equivalent to legally marketed predicate devices. | Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements. | |
| Subsidence (ASTM F2267) | Equivalent to legally marketed predicate devices. | Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements. | |
| Wear Testing (F1877) | Equivalent to legally marketed predicate devices. | Demonstrated equivalent mechanical performance to the predicate system in accordance with requirements. | |
| Expulsion | No unacceptable expulsion when tested. | Performed; determined to be equivalent. | |
| Static Screw Push Out | No unacceptable screw push out when tested. | Performed; determined to be equivalent. | |
| Sterilization & Packaging | Sterility Assurance Level (SAL) Validation | Achieve a SAL of 10^-6. | Validated to a SAL of 10^-6. |
| Maintenance of Sterile Barrier | Ensure barrier integrity post-packaging and shipping. | Ensured. | |
| Bacterial Endotoxin (BET) (ANSI/AAMI ST-72:2011) | Meets endotoxin limits. | Conducted in accordance with ANSI/AAMI ST-72:2011; results implied to be acceptable. | |
| Packaging & Shipping Tests | Maintain product integrity and sterility. | Conducted and results implied to be acceptable. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each non-clinical mechanical test (e.g., number of devices tested for compression, expulsion, etc.). These are typically described in detailed test reports referenced by such a submission but not usually included in the summary letter itself.
- Data Provenance: The data provenance is from non-clinical laboratory testing of the device itself. It is not patient or human data, so concepts like country of origin or retrospective/prospective do not apply in the context of this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not Applicable. For a medical device 510(k) clearance based on non-clinical mechanical testing, "ground truth" as it relates to human diagnosis or outcome is not established by medical experts for the test set. Ground truth for mechanical testing would be defined by the physical actual measurements and observations during laboratory experiments, compared against established engineering standards (e.g., ASTM standards).
4. Adjudication Method for the Test Set:
- Not Applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or patient outcomes, often with multiple human readers. This document describes non-clinical engineering and biological safety tests where "adjudication" is not a relevant concept.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study is a clinical study design used to evaluate the impact of a diagnostic device (often AI-assisted) on human reader performance. This document pertains to a structural interbody fusion device, not a diagnostic imaging or AI device. Therefore, no MRMC study was done, and there is no discussion of human readers improving with AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This device is a physical implant, not a software algorithm. Therefore, "standalone performance" in the context of an algorithm does not apply.
7. The Type of Ground Truth Used:
- Engineering Standards and Laboratory Measurements. The "ground truth" for the non-clinical tests described (mechanical performance, sterilization) is established by adherence to recognized ASTM F-series standards (e.g., ASTM F2077, F2267, F1877), ANSI/AAMI standards (e.g., ST-72:2011), and internal protocols for physical and chemical testing. These standards define the methods and expected performance characteristics for such implants.
8. The Sample Size for the Training Set:
- Not Applicable. The concept of a "training set" is relevant to machine learning/AI models. This document describes a manufactured physical medical device, not a data-driven model. The device's design and manufacturing processes are developed through engineering and materials science, not by training on a data set.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no "training set" in the context of this physical device, there is no ground truth established for it in that sense. The "truth" for the device's design and functionality is based on established biomechanical principles, material science, and regulatory requirements.
§ 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.