(196 days)
The SeaSpine WaveForm L™ 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 L 1 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 and/or allogeneic bone graft material composed of cortical, 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 WaveForm L™ System is intended for use as an adjunct to fusion in the thoracolumbar spine from T1 to T12 and at the thoracolumbar junction (T12-L1), for the treatment of symptomatic disc degeneration (DDD) or degenerative spondylolisthesis at one or two adjacent levels, including thoracic disc hermiation (with myelopathy and/or radiculopathy with or without axial pain). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The SeaSpine WaveForm L System can also be used as an adjunct to fusion in patients diagnosed with multilevel degenerative scoliosis.
The SeaSpine WaveForm L System is intended for use with supplemental fixation.
When used as an intervertebral body fusion device, the system is intended for spinal fusion procedures at one or two contiguous levels (L2-S1) in skeletally mature patients with degenerative disc disease (DDD). DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. DDD patients may also have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). These patients may have had a previous nonfusion spinal surgery at the involved spinal level(s). These patients should have had six months of nonoperative treatment. The device is intended to be used with autogenous bone graft and/or allogeneic bone graft composed of cortical, cancellous and/or corticocancellous bone and supplemental fixation.
The Seaspine WaveForm Lumbar Systems are additively manufactured intervertebral fusion devices that feature a sodium hydroide (NaOH) surface treatment which results in a microroughened surface over the entirety of the implant. The devices include both NaOH treated and non-treated versions and have 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. WaveForm Lumbar System includes 3 different implants:
- A straight, rectangular-shaped cage, intended for lateral surgical placements, and referred to as WaveForm L
- . A straight, rectangular-shaped cage, intended for posterior and transforaminal surgical placements, and referred to as WaveForm TO, and
- . A curved, banana-shaped cage, intended for transforaminal surgical placements, and referred to as WaveForm TA
The implants are manufactured from Ti-6Al-4V ELI titanium alloy per ASTM F3001 and are provided sterile-packed. The instruments included with each 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.
The provided document is a 510(k) summary for the SeaSpine WaveForm Lumbar Systems. It describes the device, its intended use, and a summary of non-clinical testing. However, it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the context of diagnostic performance or AI effectiveness.
Specifically, the document focuses on the mechanical performance and substantial equivalence of the intervertebral body fusion device to predicate devices, as required for FDA 510(k) clearance.
Therefore, I cannot provide the requested information regarding acceptance criteria for diagnostic performance or AI, as this type of information is not present in the given text.
The closest relevant information, which pertains to device performance in a mechanical sense (not diagnostic or AI performance), is:
Non-Clinical Testing:
"The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."
The document concludes that the device performs at least as safely and effectively as the predicate based on these non-clinical mechanical tests, implying these standards serve as the "acceptance criteria" for mechanical performance and safety for this type of medical device.
To directly answer your numbered points based only on the provided text, many will be marked as "Not Applicable" or "Not Provided" due to the nature of this regulatory document:
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Table of acceptance criteria and the reported device performance:
- Acceptance Criteria (Implicit for non-clinical mechanical performance): Adherence to standards ASTM F2077, ASTM F2267, ASTM F1877, and successful Expulsion testing, demonstrating equivalent mechanical performance to the predicate device (K082310: SeaSpine Spacer System - Pacifica).
- Reported Device Performance: "The SeaSpine WaveForm Lumbar Systems have demonstrated equivalent mechanical performance to the predicate system in accordance with requirements outlined in ASTM F2077, ASTM F2267, ASTM F1877, and Expulsion."
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Sample size used for the test set and the data provenance: Not applicable. This document describes mechanical testing, not a diagnostic test with a "test set" in the sense of patient data.
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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. No ground truth or expert review process for a "test set" (related to diagnostic or AI performance) is mentioned.
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Adjudication method for the test set: Not applicable.
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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 document does not concern AI or human reader performance.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document does not concern an algorithm or AI.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to diagnostic or AI performance. For the mechanical tests, the "ground truth" would be the established testing parameters and results of the predicate device.
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The sample size for the training set: Not applicable. This document does not describe AI development or training.
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How the ground truth for the training set was established: Not applicable.
§ 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.