(69 days)
The Octane Straight Intervertebral Fusion Device is intended for spinal fusion procedures at one or two contiguous levels in the lumbar spine from L2 to S1 in patients with Degenerative Disc Disease (DDD,) with up to Grade 1 spondylolisthesis or retrolisthesis at the involved level(s). DDD is defined as back pain of discogenic origin, with degeneration of the disc confirmed by history and radiographic studies. Patients should be skeletally mature, and have had at least 6 months of non-operative treatment. The device is intended for use with autogenous graft, and with supplemental fixation systems cleared for use in the lumbosacral spine.
Proposed Octane Straight Intervertebral Fusion Device components (Figure 1) are line extensions of the Octane interbody fusion device system cleared for US distribution per 510(k) #K082270.
The provided text is a 510(k) summary for a medical device, the Exactech® Octane® Straight Intervertebral Fusion Device. It focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical performance data and a comparison of technological characteristics. It is not an AI or diagnostic device, so many of the requested criteria are not applicable.
Here's an analysis of the provided information, noting where specific criteria cannot be met:
Acceptance Criteria and Reported Device Performance
The device is an intervertebral fusion device, and its performance is evaluated based on mechanical integrity and subsidence, not diagnostic accuracy or AI-driven metrics. The "acceptance criteria" in this context are the standards for mechanical testing, and the "reported device performance" is that it met these standards, demonstrating substantial equivalence to its predicate.
| Acceptance Criteria (Evaluations) | Reported Device Performance (Activities Performed) |
|---|---|
| Loss of mechanical integrity: fracture/breakage | Static compression testing per ASTM F2077 |
| Dynamic compression testing per ASTM F2077 | |
| Static compressive shear testing per ASTM F2077 | |
| Implant subsidence | Subsidence Yield Force per ASTM F2267 |
Note: The summary states that "Comparison analysis and results of engineering studies referenced in this 510(k) submission demonstrate proposed Octane Straight Intervertebral Fusion Device implants are substantially equivalent to cited predicate devices cleared for US distribution." This implies that the device met or exceeded the performance of the predicate device in these mechanical tests. Specific numerical thresholds for "acceptance" and detailed numerical "performance" results are not provided in this summary but would be part of the full submission.
Study Information (Not applicable for this type of device)
This is a physical implant, not a diagnostic or AI device, thus many of the requested study parameters (sample size for test set, data provenance, expert-established ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable. The "study" here refers to non-clinical, mechanical testing.
1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. The "test set" for this device refers to physical prototypes or samples of the implant undergoing mechanical testing. The document does not specify the number of samples used for each test, nor is "data provenance" (country/retrospective/prospective) relevant in the same way it would be for clinical or AI data. These were laboratory tests.
2. 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 this context refers to the defined mechanical standards (ASTM standards). The "experts" are implicitly the engineering and testing professionals who conducted and interpreted these standardized tests.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods are typically for clinical or diagnostic interpretations. For mechanical testing, adherence to established ASTM methodologies and passing predefined criteria are the "adjudication."
4. 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 or diagnostic tool, so MRMC studies are irrelevant.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Engineering Standards/Laboratory Testing Parameters: The "ground truth" for the device's performance is adherence to established ASTM (American Society for Testing and Materials) standards for orthopedic implants. These standards define the methods and acceptance criteria for evaluating mechanical properties like compression, shear, and subsidence.
7. The sample size for the training set:
- Not Applicable. There is no "training set" for this type of physical implant device.
8. How the ground truth for the training set was established:
- Not Applicable. There is no "training set" for this type of physical implant device.
§ 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.