(229 days)
The DeGen Medical Impulse AM™ implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disk Disease (DDD) of the lumbar spine with up to Grade 1 Spondylolisthesis at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. The DeGen Medical Impulse AM™ System is indicated to be used with autograft and/or allograft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion and are intended to be used with supplemental fixation systems cleared for use in the lumbar spine. The device is to be used in patients who have had six months of nonoperative treatment.
DeGen Medical Impulse AM™ System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse AM™ system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse AM™ device is comprised of a single component that is additively manufactured. The superior and inferior endplates feature porous surfaces to mitigate subsidence and expulsion. The anatomic, lordotic, and neutral configurations feature a posterior face with a threaded hole and slots to rigidly connect to an instrument for surgical insertion. The hyperlordotic configuration features a posterior face with slots to rigidly connect an instrument for surgical insertion. Superior and inferior faces feature a central aperture to constrain bone graft. DeGen Medical's Impulse AM™ Spacers are additively manufactured from Puri-Ti™ titanium powder having a chemical composition conforming to ASTM B348
This FDA 510(k) summary is for a medical device, the DeGen Medical Impulse AM™ Interbody Fusion System, which is an intervertebral body fusion device. The document focuses on demonstrating substantial equivalence to predicate devices, rather than providing a study that establishes acceptance criteria for new performance claims for the device itself.
Therefore, the information requested about acceptance criteria and a study proving the device meets those criteria (especially regarding AI/algorithm performance) is not available in the provided text. This document describes the device and its intended use, and then lists non-clinical performance testing against established ASTM standards and FDA guidance for intervertebral body fusion devices, which are mechanical performance tests rather than clinical or AI algorithm performance evaluations.
Here's a breakdown of what can be extracted from the provided text, and what cannot:
Information Not Available in the Provided Text:
- Acceptance Criteria for an AI/Algorithm: The document does not describe acceptance criteria for an AI or algorithm's performance, as the device itself is a physical intervertebral body fusion system, not an AI software.
- Reported Device Performance (for AI/Algorithm): Since there's no AI/algorithm, there's no reported performance for one.
- Sample size for test set and data provenance: Not applicable.
- Number of experts used to establish ground truth & qualifications: Not applicable.
- Adjudication method: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm-only) performance: Not applicable.
- Type of ground truth (for AI/algorithm): Not applicable.
- Sample size for training set (for AI/algorithm): Not applicable.
- How ground truth for training set was established (for AI/algorithm): Not applicable.
Information Related to Device Performance (Non-Clinical/Mechanical) that is Available:
The "Performance Testing" section (on page 3 of the input) indicates that non-clinical testing was performed to demonstrate substantial equivalence to other predicate devices. This testing was conducted in accordance with "Guidance for Industry and FDA Staff, Guidance for Spinal System 510(k)s" (May 3, 2004) and "Class II Special Controls Guidance Document: Intervertebral Body Fusion Device" (June 12, 2007).
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied by Standards/Guidance) | Reported Device Performance |
|---|---|
| Static and dynamic compression testing per ASTM F2077 (Standard Specification for Intervertebral Body Fusion Devices) | The results of these studies show the device is substantially equivalent to predicate devices. |
| Static and dynamic compression shear testing per ASTM F2077 | The results of these studies show the device is substantially equivalent to predicate devices. |
| Subsidence testing via ASTM F2267 (Standard Test Method for Measuring Load Induced Subsidence of an Intervertebral Body Fusion Device Under Static Axial Compression) | The results of these studies show the device is substantially equivalent to predicate devices. |
| Expulsion Testing (likely following FDA guidance for intervertebral body fusion devices) | The results of these studies show the device is substantially equivalent to predicate devices. |
Note: The specific numerical acceptance criteria (e.g., minimum load to failure, maximum subsidence) are not provided in this summary but would be detailed in the full test reports referenced by the ASTM standards and FDA guidance documents. The summary only states that the device met these criteria, demonstrating substantial equivalence.
2. Sample sized used for the test set and the data provenance
The document does not specify the sample sizes (e.g., number of devices tested) for each of the non-clinical mechanical tests. Data provenance is implied to be from laboratory testing performed by DeGen Medical (or its contractors) specifically for the purpose of this 510(k) submission. These are in vitro tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable, as this refers to a physical device undergoing mechanical testing, not a diagnostic or AI algorithm requiring human expert ground truth.
4. Adjudication method for the test set
Not applicable.
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 is a medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device.
7. The type of ground truth used
For mechanical testing, the "ground truth" is typically defined by the physical properties of the materials and the design, measured against established engineering standards (ASTM standards in this case) using calibrated equipment.
8. The sample size for the training set
Not applicable. There is no AI algorithm with a training set described.
9. 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.