(84 days)
The SteriSpine™LC device is indicated for intervertebral body fusion procedures at one or two contiguous levels from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade I spondylolisthesis at the involved level(s). DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history and radiographic studies. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage. This device is to be used with autogenous bone graft to facilitate fusion and is intended for use with SteriSpine™ PS, a supplemental fixation system cleared by the FDA for use in the lumbar spine.
The SteriSpine™LC cages are intervertebral body fusion devices with a central cavity that is filled with bone graft (autograft) to facilitate fusion. The SteriSpine™LC is available either in straight rectangular shape for transforaminal (TLIF) or posterior (PLIF) approach and in curved shape for transforaminal (TLIF) approach. The SteriSpine™LC is made of (Zeniva ZA-500) conforming to ASTM F2026 with Tantalum markers conforming ASTM F560 to visualize the position of the implant in the disc space. The SteriSpine™LC cages are available in several sizes to adapt to anatomical variations.
The provided text describes a 510(k) premarket notification for a medical device (SteriSpine™LC Lumbar Cage), which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. This type of submission does not typically involve clinical studies with human participants to establish the device's performance against detailed acceptance criteria in the way that, for example, an AI diagnostic tool would be evaluated. Instead, it relies on non-clinical (bench) testing to show that the new device performs similarly to existing, cleared devices.
Therefore, many of the requested categories in your prompt are not applicable or would be misleading if forced into the context of this 510(k) submission. I will address the relevant information provided and explain why other sections are not present.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on predicate device performance) | Reported Device Performance (SteriSpine™LC) |
|---|---|
| Static axial compression performance comparable to predicates (K122021, K094025, P960025) | Performs as safely and effectively as previously cleared devices |
| Dynamic axial compression performance comparable to predicates | Performs as safely and effectively as previously cleared devices |
| Static compression shear testing performance comparable to predicates | Performs as safely and effectively as previously cleared devices |
| Dynamic compression shear testing performance comparable to predicates | Performs as safely and effectively as previously cleared devices |
| Subsidence testing (according to ASTM F2267) performance comparable to predicates | Performs as safely and effectively as previously cleared devices |
| Expulsion testing (according to in-house protocol) performance comparable to predicates | Performs as safely and effectively as previously cleared devices |
2. Sample size used for the test set and the data provenance: Not applicable. This submission focuses on non-clinical, bench testing of the device's mechanical properties, not on a "test set" of patient data or clinical outcomes.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized test methods (e.g., ASTM standards) and engineering principles, not expert consensus on clinical data.
4. Adjudication method for the test set: Not applicable.
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 physical intervertebral fusion device, not an AI diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: For the non-clinical tests, the "ground truth" is defined by the performance characteristics of the legally marketed predicate devices and established ASTM standards for intervertebral body fusion devices. The goal is to demonstrate "substantial equivalence" in mechanical performance.
8. The sample size for the training set: Not applicable. This refers to a "training set" in the context of machine learning or AI. For a physical medical device, there is typically a design and development process that involves iterative testing and refinement, but not a "training set" in this sense.
9. How the ground truth for the training set was established: Not applicable.
Summary of the Study and Device Performance:
The study referenced in the 510(k) submission (K133893) for the SteriSpine™LC Lumbar Cage is a non-clinical performance testing study. The purpose of this study was to demonstrate that the SteriSpine™LC device is substantially equivalent to previously cleared predicate devices in terms of safety and effectiveness.
The testing involved:
- Static axial compression
- Dynamic axial compression
- Static compression shear testing
- Dynamic compression shear testing (according to ASTM F2077)
- Subsidence testing (according to ASTM F2267)
- Expulsion testing (according to an in-house protocol)
Result: The results of these tests demonstrated that the SteriSpine™LC performs as safely and effectively as previously cleared devices. The conclusion states that the device is substantially equivalent to its predicate devices in terms of intended use, material, design, mechanical properties, and function, with minor differences not raising new safety or effectiveness issues.
Data Provenance: The data provenance for this non-clinical testing is the internal laboratory testing conducted by SafeOrthopaedics to meet regulatory requirements and demonstrate substantial equivalence to the selected predicate devices (K122021, K094025, and P960025). The data is from mechanical bench testing, not from any clinical data set or country of origin in that sense.
§ 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.