(99 days)
E3D™-A Static Interbody Devices are thoraco-lumbar interbody fusion devices indicated at one or more levels of the thoracic spine (T1-T12), thoracolumbar junction (T12- L1), or lumbosacral spine (L1-S1) as an adjunct to fusion in patients with the following indications: degenerative disc disease (DDD), disc herniation (with myelopathy and/or radiculopathy), spondvlolisthesis, deformity (degenerative scoliosis or kyphosis), spinal stenosis, and failed previous fusion (pseudarthrosis). DDD is defined as discogenic back pain with degeneration of the disc as confirmed by history and radiographic studies. These patients should be skeletally mature and have had at least six (6) months of non-operative treatment. Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems). Hyperlordotic interbody devices (>20° lordosis) must be used with at least anterior supplemental fixation.
E3D™-A Integrated Interbody Devices are integrated lumbar interbody fusion devices intended for use in patients with degenerative disc disease (DDD) at one or two contiguous levels of the lumbosacral spine (L2-S1). DDD is defined as discogenic back pain 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. In addition, these patients may have up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). Devices are to be filled with autograft bone and/or allogenic bone graft composed of cancellous and/or corticocancellous bone. These devices are intended to be used with three screws or anchors which accompany the implants. When used with screws, these devices are stand-alone interbody fusion devices. When used with anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). Hyperlordotic implants (>20° lordosis) are intended for use with supplemental fixation (e.g., facet screws or posterior fixation). When used without screws or anchors, these devices are intended for use with supplemental fixation (e.g., facet screws or posterior fixation).
When used for multilevel degenerative scoliosis or sagittal deformity, supplemental fixation that have been cleared for use in the thoracolumbosacral spine (e.g., posterior pedicle screw and rod systems, anterior plate systems, and anterior screw and rod systems) must be used.
The E3D™ -A Interbody System provides interbody fusion devices designed to provide structural stability during spinal fusion. The E3D™-A Interbody System consists of Interbodies offered in various sizes to accommodate surgical needs and anatomic requirements. The E3D™-A Interbodies were designed to be placed via an anterior approach. All Interbodies in the system are additively manufactured from titanium alloy powder, per ASTM F3001. The System offers both Static and Integrated Interbodies. The Integrated version is to be used in conjunction with three (3) screws that are subtractively manufactured from titanium alloy, per ASTM F136; or three (3) Anchors that are additively manufactured from titanium alloy per ASTM F3001.
The E3D™-A Interbody System's implants are available with and without HAnano Surface®, a 20-40 nanometer thin hydroxyapatite (HA) surface treatment. The surface treatment presents nano-scale topography on the entirety of the implant surface.
The purpose of this submission is to add larger footprints and Anchors.
This document is a 510(k) summary for the E3D™-A Interbody System, a medical device used for spinal fusion. The information provided heavily focuses on regulatory aspects and comparisons to predicate devices, rather than a detailed study proving the device meets specific acceptance criteria based on clinical performance. Therefore, I cannot provide a table of acceptance criteria and reported device performance directly from this text, as specific quantitative performance metrics and acceptance thresholds for clinical efficacy are not detailed.
However, I can extract information related to performance testing that supports the device's substantial equivalence.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As noted above, the document does not contain a typical table of clinical acceptance criteria (e.g., sensitivity, specificity, accuracy) and reported device performance. It instead describes mechanical performance testing against predicate devices and standards.
| Acceptance Criteria Type | Acceptance Standard/Predicate Performance | Reported Device Performance |
|---|---|---|
| Mechanical Testing | Performed equal to or better than predicate devices in static and dynamic testing per ASTM F2077. | "The worst-case implants for the E3D™-A Interbody System were tested and performed equal to or better than the predicate devices in static and dynamic testing per ASTM F2077." |
| HAnano Surface® Performance | Previously conducted per Promimic's protocols, as accepted by FDA for clearance of reference device K232432. | Performance tested as accepted for K232432. |
| Substantial Equivalence | Demonstrated through comparison of design, intended use, material composition, function, and range of sizes against predicate devices. | The E3D™-A Interbody System was shown to have "substantially equivalent technological characteristics" and "substantially equivalent to legally marketed predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "worst-case implants" for mechanical testing, but does not specify the sample size (number of implants tested) for the test set. It does not mention clinical data or studies with human subjects, so there is no information on data provenance (country of origin, retrospective/prospective). This submission is for substantial equivalence based on technological characteristics and mechanical testing, not clinical performance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The document does not describe a clinical study or expert review for establishing ground truth, as the submission focuses on mechanical and design equivalence.
4. Adjudication Method for the Test Set
Not applicable. There is no mention of adjudication, as no clinical ground truth assessment or expert review is described.
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
Not applicable. This device is a physical intervertebral body fusion device, not an AI or software-based diagnostic tool, so an MRMC study is not relevant.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical implant, not an algorithm.
7. The type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the mechanical testing, the "ground truth" would be the established performance standards of ASTM F2077 and the performance of the predicate devices. For the HAnano Surface®, the "ground truth" was established by Promimic's protocols accepted by FDA (reference K232432).
8. The Sample Size for the Training Set
Not applicable. This document describes a physical medical device and its regulatory submission, not a machine learning model, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no training set mentioned, this question is not relevant.
§ 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.