(105 days)
SeaSpine Spacer System – Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene:
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 non-fusion spinal surgery at the involved spinal level(s). These patients should have had six months of non-operative treatment. The device is intended to be used with autogenous bone graft (autograft) and supplemental fixation.
Cambria NanoMetalene:
Cambria is intended to be used as an adjunct to spinal fusion procedures at one level (C3-C7) in skeletally mature patients with degenerative disc disease (defined as neck pain with discogenic origin with degeneration of the disc confirmed by history and radiographic studies) of the cervical spine. Patients should have received at least six weeks of non-operative treatment prior to treatment with the device. Devices are intended to be implanted via an open, anterior approach and used with autogenous bone and supplemental fixation, such as an anterior plating system.
Vu aPOD-L NanoMetalene:
The Integra Vu aPOD-L Intervertebral Body Fusion Device 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 device is to be packed with autogenous bone graft (i.e. autograft). The Integra Vu aPOD-L Intervertebral Body Fusion Device is intended for use with supplemental fixation that is in addition to the integrated buttress spin plate, such as a pedicle screw system or anterior plate.
Degenerative disc disease is defined as back pain of discogenic origin, with desc confirmed by history and radiographic studies. These patients should be skeletally mature and at least six (6) months of non-operative treatment.
Vu ePOD NanoMetalene:
When used as an intervertebral body fusion device the Vu ePOD Intervertebral Body Fusion Devices are 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 device is indicated for use with autograft only. The Vu ePOD Intervertebral Body Fusion Devices are intended for use with supplemental fixation such as the Coral Spinal System or the BodyForm Thoracolumbar Fixation System. Degenerative disc disease (DDD) 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 six months of non-operative treatment.
The SeaSpine Spacer System (Hollywood NanoMetalene, Pacifica NanoMetalene, Redondo NanoMetalene, Ventura NanoMetalene), Cambria NanoMetalene, Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene devices are intervertebral fusion devices made from polyetheretherketone (PEEK OPTIMA LT1 per ASTM F2026) with markers (tantalum per ASTM F560 or Ti-6Al-4V ELI per ASTM F136) for radiographic visualization. The devices have a central canal for receiving autogenous bone graft and are offered in a variety of sizes and geometries to accommodate variations in pathology and patient anatomy. The purpose of this 510(k) is to add a 1 micrometer surface of titanium (per ASTM F67) to the exterior surface of each of these devices.
This document is a 510(k) Premarket Notification from the FDA regarding the "SeaSpine Spacer System" with various models incorporating "NanoMetalene®". This document is a regulatory approval, not a scientific study that measures device performance against acceptance criteria in the way a clinical trial or AI algorithm validation would.
Therefore, most of the information requested in your prompt (e.g., acceptance criteria, test set sample size, expert qualifications, adjudication methods, MRMC study, standalone performance, training set size, etc.) is not applicable or available within this type of document.
Here's an explanation of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail thresholds for clinical performance in this document. The "acceptance criteria" here is that the device must be "substantially equivalent" to legally marketed predicate devices, meaning it has the same intended use and technological characteristics and any differences do not raise new questions of safety or effectiveness.
- Reported Device Performance: The document states that "analysis demonstrated that the titanium surface does not negatively impact mechanical performance of the NanoMetalene subject devices when compared to the predicate devices." This is a qualitative statement of engineering analysis and non-clinical testing results, not a quantifiable performance metric against specific clinical acceptance criteria.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Mechanical performance not negatively impacted compared to predicate devices; Passed non-clinical tests (ASTM F2077, ASTM F1877, ASTM F2267, expulsion testing). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. This document focuses on non-clinical testing (engineering analysis, mechanical tests). There is no "test set" in the context of clinical data or AI algorithms. The "data provenance" mentioned in the document refers to the origin of the predicate devices and the regulatory process in the USA.
3. 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. There is no "ground truth" establishment by experts for a test set in this regulatory submission. The "ground truth" concept is typically applied to clinical or diagnostic AI evaluations.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No explicit "adjudication method" is described as there is no test set of clinical cases being reviewed.
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. An MRMC study was not done. This device is an intervertebral body fusion device, not a diagnostic AI system or an imaging modality requiring human reader interpretation in the context of an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is a hardware medical device (an implant), not a software algorithm. Therefore, "standalone algorithm" performance is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not Applicable / Implied by Regulatory Framework. For this type of device submission, the "ground truth" or standard for comparison is compliance with recognized engineering standards (e.g., ASTM standards for mechanical testing) and demonstrating substantial equivalence to predicate devices that have already been deemed safe and effective by the FDA. The performance is assessed against these established non-clinical benchmarks rather than clinical "ground truth" data (like pathology or outcomes) in this specific submission.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set, this question is not relevant.
In summary: This FDA 510(k) letter and summary describe a regulatory approval process for a medical device (intervertebral body fusion device) based on proving "substantial equivalence" to existing predicate devices through engineering analysis and non-clinical testing. It is not a clinical study or AI algorithm validation with specific clinical acceptance criteria, test sets, or expert ground truth adjudication.
§ 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.