(81 days)
The Opticage Interbody Fusion Device is a posterior lumbar intervertebral body fusion device and is indicated for use with autogenous bone graft in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2-S1. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). The Opticage Interbody Fusion Device can be implanted via posterior or transforaminal approach.
DDD is defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies. Candidates for surgery should be skeletally mature and have had six months of conservative treatment. These patients may have had primary or secondary surgery, but no previous fusion at the involved levels.
The device is not intended to be used as a stand-alone device. It must be used with supplemental internal spinal fixation systems that have been cleared for use in the lumbar spine (i.e. facet screw fixation systems, facet compression devices and posterior pedicle screw and rod systems).
The Opticage™ Expandable Interbody Fusion Device, Model Series 9070 is composed of lumbar intervertebral body fusion implants manufactured from implant grade titanium alloy and ranging in widths from 9 mm x 12 mm and lengths from 21 x 30 mm. Each implant consists of an upper and lower titanium plate and two titanium wedges that interact to change the height of the construct from a minimum of 9 mm to a maximum of 14 mm. The top and bottom plates are fenestrated and contain a window to enhance bony in-growth. A cavity internal to the device is intended to hold autogenous bone graft.
Here's an analysis of the provided text regarding the Opticage™ Expandable Interbody Fusion Device, Model Series 9070, focusing on acceptance criteria and supporting studies.
Based on the provided 510(k) summary, the device is being cleared for additional sizes of an already cleared product. Therefore, the "study" described is a demonstration of substantial equivalence for these new sizes, rather than a clinical trial for a novel device.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Mechanical Performance for New Sizes (Equivalency to Predicate Devices) | A Finite Element Analysis (FEA) model was developed and validated. This FEA model demonstrated that the additional sizes perform at least equivalently to the previously cleared devices (K113527 and K132479). |
| Material Composition | Manufactured from implant grade titanium alloy. |
| Indications for Use (for new sizes) | Consistent with predicate devices: Posterior lumbar intervertebral body fusion with autogenous bone graft for DDD (up to Grade I spondylolisthesis/retrolisthesis) at 1-2 contiguous levels from L2-S1. Must be used with supplemental internal spinal fixation. |
| Technological Characteristics | The "additional sizes" maintain the same technology as the predicate: designed to hold bone graft, expand after implantation, and allow bony ingrowth. Expansion by rotating a central shaft. |
Study Details
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test Set Sample Size: Not applicable in the traditional sense of a clinical trial with patient data. The "test set" here refers to the parameters and simulations run within the Finite Element Analysis (FEA) model. The specific number of simulations or variations tested within the FEA is not disclosed.
- Data Provenance: The FEA model itself is a computational model, not based on human patient data for this submission. The validation of the FEA model would ideally refer to correlations with physical testing data of the predicate devices, but the details of this validation are not provided. There is no mention of country of origin as no patient data was used for this part of the submission. It is a prospective analytical study using computational modeling.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. Ground truth, in this context, would relate to the accuracy and validity of the FEA model. This would typically be established by engineers and biomechanics experts, but no specific number or qualifications are mentioned for the development or validation of the FEA model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are relevant for human interpretation of data, like radiology reads. For an FEA, the "adjudication" would be in the rigorous validation of the model's assumptions and results against established engineering principles and possibly physical test data, but no specific 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
- Not applicable. This device is an implant, not an AI diagnostic or assistive tool. Therefore, an MRMC study is irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The FEA model can be considered a "standalone" computational analysis, but it's not an algorithm in the AI sense, nor does it have human-in-the-loop performance implications described here.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The "ground truth" for the FEA model would be its ability to accurately predict the mechanical behavior of the physical device. This would typically be established by comparing FEA predictions against:
- Physical bench testing data (e.g., compression, torsion, fatigue testing) of the predicate devices.
- Established engineering principles and material properties.
The document states the FEA model was "developed and validated," implying such comparisons were made, but specific details of this validation are not provided.
8. The sample size for the training set
- Not applicable in the context of machine learning. If "training set" refers to the data used to validate the FEA model, it would be the data from physical mechanical tests of the predicate devices. The size of this dataset is not specified.
9. How the ground truth for the training set was established
- Not applicable for a "training set" in the machine learning sense. For the validation of the FEA model, the ground truth would have been established through physical mechanical testing of the previously cleared Opticage devices (K113527 and K132479) and adherence to recognized engineering standards for medical devices.
§ 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.