(129 days)
The HD Lumbar Interbody System is indicated for use in skeletally mature patients with Degenerative Disc Disease (DDD) at one or two contiguous levels from L2-S1. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have received 6 months of non-operative treatment prior to treatment with the devices. The device must be used with supplemental fixation. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). It is indicated to be used with autograft bone and allograft bone comprised of cancellous and/or corticocancellous bone.
The HD Lumbar Interbody System consists of interbody fusion cages made from Ti-6Al-4V implant-grade titanium using additive manufacturing technology. The implants of the HD Lumbar Interbody System are offered in a variety of lengths, widths and cross sectional geometries to accommodate patient anatomy and surgical approach. The implants of the HD Lumbar Interbody System are also offered in various lordotic configurations to ensure proper stability and alignment of the spine for differing patient anatomy. The implants are provided sterile.
The provided text describes a 510(k) premarket notification for the "HD Lumbar Interbody System," a medical device used in spinal fusion. The document focuses on demonstrating substantial equivalence to predicate devices rather than proving independent effectiveness through clinical studies with acceptance criteria for device performance in terms of accuracy or efficacy in diagnosing/treating disease.
Therefore, many of the requested items related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software as a medical device (SaMD) are not applicable to this submission. This is a traditional hardware medical device.
However, I can extract information related to the performance testing that was done to demonstrate substantial equivalence.
Here's a breakdown of what is and is not applicable based on the provided text:
1. A table of acceptance criteria and the reported device performance
- Applicable, but not in the context of clinical accuracy: The acceptance criteria for this device relate to mechanical performance (strength, stability, etc.) rather than clinical outcomes or diagnostic accuracy.
- Reported Device Performance: The document states: "The results of this non-clinical testing show that the strength of the Lumbar Interbody System is sufficient for its intended use and is substantially equivalent to legally marketed predicate devices." Specific numerical results or direct comparisons to numerical acceptance criteria are not provided in this summary, but the conclusion of meeting these criteria is given.
| Acceptance Criteria (Type of Test) | Reported Device Performance (Summary) |
|---|---|
| Static axial compression (ASTM F2077-14) | Sufficient for intended use and substantially equivalent to predicates |
| Static compressive shear (ASTM F2077-14) | Sufficient for intended use and substantially equivalent to predicates |
| Dynamic axial compression (ASTM F2077-14) | Sufficient for intended use and substantially equivalent to predicates |
| Dynamic compressive shear (ASTM F2077-14) | Sufficient for intended use and substantially equivalent to predicates |
| Static expulsion (ASTM Draft F-04.25.02.02) | Sufficient for intended use and substantially equivalent to predicates |
| Static subsidence (ASTM F2267-04) | Sufficient for intended use and substantially equivalent to predicates |
| Bacterial endotoxins (ANSI/AAMI ST72:2011, USP , USP , EP 2.6.14, JP 4.01) | Sufficient for intended use and substantially equivalent to predicates |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Not applicable for clinical data: This information is not provided as the submission relies on mechanical testing rather than clinical data from human subjects. The "sample size" would refer to the number of devices tested in the lab, which is not specified in this summary.
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: Ground truth in the context of expert review is relevant for diagnostic or AI-based devices. This device is an implant, and its "ground truth" for performance is based on standardized mechanical testing rather than expert clinical assessment of patient data.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable: Adjudication methods are used to resolve discrepancies in expert labeling or diagnoses. This is not relevant for the mechanical testing performed on this device.
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 type of study is specific to AI-assisted diagnostic devices. The HD Lumbar Interbody System is a physical implant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable: This refers to the standalone performance of an AI algorithm, which is not relevant for this device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Applicable, but different context: The "ground truth" for this device's performance is defined by adherence to established ASTM (American Society for Testing and Materials) and other recognized standards for mechanical and biocompatibility testing. These standards define the acceptable range for forces, loads, and biological responses.
8. The sample size for the training set
- Not applicable: There is no "training set" in the context of an implant device relying on mechanical testing for 510(k) clearance based on substantial equivalence. This concept is relevant for machine learning/AI models.
9. How the ground truth for the training set was established
- Not applicable: As there's no training set, this question is not relevant.
In summary: The provided document is for a traditional medical device (an interbody fusion cage) seeking 510(k) clearance based on "substantial equivalence" to existing predicate devices. The primary evidence presented relates to non-clinical (mechanical and biological) performance testing against recognized industry standards, rather than clinical efficacy studies, diagnostic accuracy, or AI model performance benchmarks. Therefore, most of the questions relating to AI/SaMD acceptance criteria and study design are 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.