(116 days)
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are indicated for interbody fusion in patients with degenerative disc disease (DDD) at one or two contiguous levels from L2 to S1. DDD is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). These patients should be sketally mature and have completed six months of non-operative treatment. Supplemental fixation is required with SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. Additionally, the SpineEX devices are intended to be used with autogenous and/or allogenic bone graft comprised of cancellous and/or corticocancellous bone graft to facilitate fusion. These devices are intended to be used with supplemental fixation systems that have been cleared for use in the lumbosacral spine (e.g. posterior pedicle screw and rod systems, and anterior screw and rod systems). Hyperlordotic interbody devices (≥20° lordosis) must be used with at least anterior supplemental fixation.
The SpineEX Sagittae® Lateral Lumber Interbody Fusion Devices are manufactured out of medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy that conforms to ASTM F1472 and ASTM F136 respectively.
This document, K181531, is a 510(k) Premarket Notification for the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices. It focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical performance testing, rather than clinical study data involving AI or human-in-the-loop performance.
Therefore, many of the requested categories related to acceptance criteria for AI performance, clinical study design (sample size for test/training sets, ground truth establishment, expert adjudication, MRMC studies), and "how human readers improve with AI" are not applicable to this specific document as it describes a mechanical implant device, not an AI diagnostic tool.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative table for clinical performance. Instead, it outlines the types of non-clinical (mechanical) tests performed and a qualitative conclusion regarding their sufficiency and equivalence.
Non-Clinical (Mechanical) Performance Data:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Sufficient strength for intended use and substantial equivalence to predicate devices under various mechanical loads. | The devices were tested according to: |
- Static axial compression per ASTM 2077
- Static compressive shear per ASTM 2077
- Dynamic axial compression per ASTM 2077
- Dynamic compressive shear per ASTM 2077
- Subsidence per ASTM F2267
Conclusion: "The results of this non-clinical testing show that the strength of the SpineEX Sagittae® Lateral Lumbar Interbody Fusion Devices are sufficient for their intended use and is substantially equivalent to legally marketed predicate devices." |
2. Sample sizes used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of clinical images/data for AI. For mechanical testing, the specific number of devices tested is not provided in this summary, but would typically follow ASTM standards.
- Data Provenance: Not applicable in the context of clinical images/data for AI. The device itself is manufactured from medical grade Ti-6A1-4V (Grade 5) and Ti-6A-4V (ELI) alloy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This document pertains to a mechanical device, not an AI or diagnostic tool requiring expert interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable. This pertains to expert review of medical data for ground truth establishment, which is not relevant for 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 is a mechanical implant device, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Ground Truth for Mechanical Testing: The "ground truth" here is adherence to mechanical performance standards (ASTM 2077, ASTM F2267) and demonstration of "sufficient strength for intended use" and "substantial equivalence" to predicate devices based on these physical properties.
8. The sample size for the training set
- Not applicable. This device does not involve a "training set" in the machine learning sense.
9. How the ground truth for the training set was established
- Not applicable. This device does not involve a "training set" or ground truth establishment in the machine learning sense. The "ground truth" for the device's design and material selection would be established through engineering principles, material science, and regulatory standards for implantable 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.