(248 days)
The SIRION Lateral Lumbar Interbody System Spacer, either used individually or assembled to the SIRION plate, is indicated for intervertebral body fusion procedures in skeletally mature patients with degenerative disc disease (DDD) of the lumbar spine at one or two contiguous levels from L1-L2 to L5-S1. DDD is defined as discogenic pain with degeneration of the disc confirmed by history and radiographic studies. These DDD patients may also have up to Grade I spondylolisthesis or retrolisthesis at the involved level(s). SIRION Spacers are to be used with autogenous bone graft and supplemental fixation. Approved supplemental fixation includes the Olympic Posterior Spinal Fixation System. Patients should have at least six (6) months of non-operative treatment prior to treatment with an intervertebral cage.
The SIRION Lateral Lumbar Interbody System Plate, in 2-hole and 4-hole configurations, is indicated for use via a lateral or anterolateral surgical approach above the bifurcation of the great vessels in the treatment of thoracic and thoracolumbar (T1-L5) spine instability or via the anterior surgical approach, below the bifurcation of the great vessels in the treatment of lumbar and lumbosacral (L1-S1) spine instability as a result of: fracture (including dislocation and subluxation), tumor, degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by patient history and radiographic studies), scoliosis, kyphosis, lordosis, spinal stenosis, or a failed previous spine surgery.
The SIRION Lateral Lumbar Interbody System Plate, 1-hole buttress configuration is intended for use in conjunction with traditional supplemental fixation to maintain the relative position of interbody spacers during spinal fusion. The 1-hole plate is not intended for use in load-bearing applications
The Sirion Lateral Lumbar Interbody devices are implants developed for the substitution of the classical autogenous bone graft blocks. The cages assist to avoid complications related to the bone graft donation site (chronic pain, hematoma, infection, bone removal from the donor site making it impossible to remove bone again, quality of the iliac bone, accessing a healthy donor site that may become an unhealthy site, hernias by the incision). They are available in a range of footprints and heights to suit the individual pathology and anatomical conditions of the patient. The implants have a hollow center to allow placement of autogenous bone graft. The superior and inferior surfaces are open to promote contact of the bone graft with the vertebral end plates, allowing bone growth (arthrodesis). The Sirion spacer may also be used with an integrated plate component. The Sirion cages are designed to be used in conjunction with supplemental spinal fixation instrumentation.
This document is focused on the regulatory clearance of a medical device, the SIRION Lateral Lumbar Interbody Fusion System, based on substantial equivalence to predicate devices. It does not contain information about a clinical study designed to test the device's performance against specific acceptance criteria for metrics like sensitivity, specificity, accuracy, or other performance characteristics typically associated with AI/software devices.
Therefore, many of the questions related to acceptance criteria, device performance tables, sample sizes for test and training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to the provided text.
Based on the provided text, here's what can be answered:
1. A table of acceptance criteria and the reported device performance
This document does not define acceptance criteria in terms of clinical performance metrics (like sensitivity, specificity, accuracy) for the device itself. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical testing. The "performance" reported pertains to structural and mechanical integrity, rather than diagnostic or treatment efficacy metrics typically found in AI/software medical devices.
| Acceptance Criteria (Implied) | Reported Device Performance (Non-Clinical Test Summary) |
|---|---|
| Mechanical Safety | FEA conducted |
| Structural Integrity | Static Compression Bending (ASTM F1717) passed |
| Endurance | Dynamic Compression Bending (ASTM F1717) passed |
| Torsional Stability | Static Torsion (ASTM F1717) passed |
| Cantilever Strength | Static Cantilever Bending Testing passed |
| Component Interconnection | Spacer and Plate Dissociation Testing passed |
Note: The document states "The results of these evaluations indicate that the Sirion implants are equivalent to predicate devices," implying that passing these tests to a level comparable to predicate devices served as the acceptance criteria for these specific performance aspects.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data is mentioned for performance evaluation in the context of an AI/software device. The tests mentioned are non-clinical (mechanical and structural).
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. No ground truth establishment by experts for a test set is discussed in this document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No adjudication method is discussed.
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. No MRMC study was performed or discussed, as this is a physical medical device (interbody fusion system), 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 is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The clearance is based on substantial equivalence to predicate devices and non-clinical mechanical testing, not on a ground truth related to clinical outcomes or expert labels.
8. The sample size for the training set
Not applicable. No training set is mentioned as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. No training set is mentioned.
§ 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.