(222 days)
The DeGen Medical Impulse implant is an intervertebral body fusion device intended for use in skeletally mature patients with Degenerative Disc 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 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 System is a lumbar interbody fusion device for posterior and transforaminal lumbar fusion procedures. The Impulse system includes various lengths, widths, heights, and endplate shapes (curvatures include neutral, lordotic, and anatomic). The DeGen Medical Impulse device is comprised of a single component that is traditionally machined. The superior and inferior endplates are coated with a porous coating to facilitate bony ingrowth and 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 Impulse System is made from Titanium (ASTM F67) and Titanium alloy (Ti-6Al-4V ELI) per ASTM F136.
The provided text describes the DeGen Medical Impulse Interbody Fusion System and its FDA 510(k) clearance. However, it does not contain the specific information requested in your prompt regarding acceptance criteria, device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.
This document is a 510(k) summary, which is a regulatory filing demonstrating substantial equivalence to a legally marketed predicate device, as opposed to a full clinical study report demonstrating new safety and effectiveness. The performance testing mentioned is primarily non-clinical (mechanical testing) and is conducted to show that the device performs similarly to predicate devices, not to establish specific clinical performance metrics against defined acceptance criteria in the way you might see for an AI/ML device or a novel therapeutic.
Here's a breakdown of what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as pass/fail metrics. The "acceptance" for this type of device is demonstrating substantial equivalence to predicate devices through a battery of non-clinical tests.
- Reported Device Performance:
- Non-clinical testing performed:
- Static and dynamic compression testing per ASTM F2077
- Static and dynamic compression shear testing per ASTM F2077
- Subsidence testing via ASTM F2267
- Expulsion Testing
- Wear debris analysis via ASTM F1877
- Results: "The results of these studies show the subject DeGen Medical Impulse System is substantially equivalent to the other predicate devices."
- Non-clinical testing performed:
What is missing: Specific numerical results of these tests and their direct comparison to pre-defined numerical acceptance criteria for a "device performance" table as typically seen for AI/ML or diagnostic devices. The acceptance is implied by the comparison to predicates and relevant ASTM standards.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: This information is not present. The document focuses on non-clinical (mechanical) testing, not clinical data sets, and therefore doesn't discuss test sets in the context of patient data or data provenance.
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)
- Missing: This information is not present. No clinical ground truth or expert review is described for the evaluation of this medical device in this summary.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: This information is not present. No clinical adjudication method 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
- Missing: This information is not present. This device is an intervertebral body fusion system, not an AI/ML diagnostic or assistive device, so MRMC studies in this context are not applicable.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Missing: This information is not present. This device is an implantable surgical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Ground Truth (for mechanical testing): The "ground truth" for the mechanical performance of this device is established by adherence to recognized ASTM standards (e.g., F2077, F2267, F1877) and demonstrating performance equivalent to legally marketed predicate devices. This is a non-clinical "ground truth."
- Missing: Clinical ground truth, pathology, or outcomes data related to device performance in patients is not detailed in this 510(k) summary.
8. The sample size for the training set
- Missing: This information is not present. No training set is involved in the evaluation described.
9. How the ground truth for the training set was established
- Missing: This information is not present as there is no training set mentioned.
Summary of what the document does provide:
- Device Name: Impulse Interbody Fusion System
- Indications for Use: Skeletally mature patients with Degenerative Disc Disease (DDD) of the lumbar spine (L2-S1) with up to Grade 1 Spondylolisthesis at one or two contiguous levels. Used with autograft/allograft and supplemental fixation systems, after 6 months of nonoperative treatment.
- Technological Characteristics Comparison: Compared to predicates in intended use, indications for use, design, function, and technology.
- Performance Testing: Static/dynamic compression, compression shear, subsidence, expulsion, and wear debris analysis (all per specific ASTM standards).
- Conclusion: Substantially equivalent to predicate devices based on indications for use, technological characteristics, and performance testing.
§ 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.