(212 days)
The Spineology Interbody Fusion System (SIFS) is indicated for use as an adjunct to fusion in an intervertebral body fusion at one level in the lumbar spine from L2 to S1 in skeletally mature patients with degenerative disc disease (DDD) with up to Grade 1 spondylolisthesis at the involved level. DDD is defined as discogenic back pain with degeneration of the disc confirmed by patient history, physical examination, and radiographic studies. Eligible patients shall have undergone six (6) months of conservative (non-operative) care. SIFS with compatible allograft and autograft is intended for use with supplemental posterior fixation systems intended for use in the lumbar spine.
The Spineology Interbody Fusion System (SIFS) is a lumber intervertebral body fusion device comprised of a PET (polyethylene terephthalate) mesh bag designed to contain compatible allograft and autograft as an adjunct to fusion for the treatment of degenerative disc disease. The device is placed into the prepared intervertebral disc space and then is packed with bone graft. The resulting SIFS implant is used with posterior supplemental fixation systems forming the completed SIFS construct.
The provided text describes the acceptance criteria and the study that proves the Spineology Interbody Fusion System (SIFS) meets these criteria. It does not describe an AI/ML device but rather a medical implant. Therefore, the questions related to AI/ML specific aspects (e.g., test set ground truth, MRMC study, standalone algorithm performance, training set) are not applicable to this document. The focus below will be on the information provided regarding the device's clinical and non-clinical performance and acceptance criteria.
Acceptance Criteria and Device Performance for Spineology Interbody Fusion System
This document outlines the evaluation of the Spineology Interbody Fusion System (SIFS), an intervertebral body graft containment device, for De Novo classification. The acceptance criteria are derived from both non-clinical/bench testing and a clinical study designed to demonstrate the device's safety and effectiveness.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are established through a combination of non-clinical performance benchmarks (where applicable) and primary clinical endpoints.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance (as stated in the document) |
|---|---|---|
| Non-Clinical Performance | ||
| Burst Test | The performance criteria was based on the Sponsor historical batch/lot records. | The PET sheets were tested to failure. The report included the bursting strength of each specimen and the average bursting strength for each. (Specific numerical result not provided, but implies meeting historical record performance). |
| Tensile & Elongation Test | The performance criteria was based on the Sponsor historical batch/lot records. | The PET tubes were tested to failure. The report included the tensile strength and elongation of each specimen and the average tensile strength and elongation for each specimen along with the standard deviation. (Specific numerical result not provided, but implies meeting historical record performance). |
| Static Axial Compression | No pre-determined performance criteria. | The tested device deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. (Results indicate characterization of deformation and mechanical properties, not a pass/fail against specific criteria). |
| Dynamic Axial Compression | No pre-determined performance criteria. | The tested device deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the cycle-displacement table. (Results indicate characterization of deformation and mechanical properties, not a pass/fail against specific criteria). |
| Static Compression-Shear | No pre-determined performance criteria. | The tested device deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. (Results indicate characterization of deformation and mechanical properties, not a pass/fail against specific criteria). |
| Dynamic Compression-Shear | No pre-determined performance criteria. | The tested device deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided. (Results indicate characterization of deformation and mechanical properties, not a pass/fail against specific criteria). |
| Subsidence (Bench) | No pre-determined performance criteria. | The tested device deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided. The stiffness and yield were reported. (Results indicate characterization of resistance to subsidence, not a pass/fail against specific criteria). |
| Expulsion (Bench) | No pre-determined performance criteria. | The report included the force required to displace the device along with the representative pre- and post-test images. (Results indicate characterization of migration potential, not a pass/fail against specific criteria). |
| Wear Particulate Analysis | No pre-determined performance criteria. | The particulates size and morphological characteristics, as well as associated elemental constituents, were reported. (Results indicate characterization of wear debris, not a pass/fail against specific criteria). |
| Simulated Fill Testing | The device is filled consistently and repeatedly across multiple users. | The mechanical properties of this group (personnel filled) were compared to the mechanical properties of the experienced group. The specimens deformed under the applied load and post-test dimensions and mass were provided under the applied load compared to the pre-test dimensions and mass. Representative pre- and post-test images were provided along with the force-displacement graphs. The linear equations used to calculate stiffness was also provided. (Implies consistency was demonstrated, but no specific metric or quantitative result for consistency is given). |
| Clinical Performance | Primary Endpoint for "Success" at 24 Months: | Overall Performance (Table 16 - "Overall Conclusion" section): |
| Pain Reduction | Improvement in low back pain score as evidenced by a "mm reduction on a (b)(4) mm Visual Analog Scale (VAS) when compared to baseline. (Missing specific mm reduction criterion, but implied in the "Overall Conclusion" as "at least 20 mm improvement in VAS"). | 85.4% (82/96) of subjects had at least a 20 mm improvement in VAS pain score. (Mean VAS Low Back Pain score at 24 months was (b)(4) compared to Baseline (b)(4)). |
| Functional Improvement | Improvement in low back function as evidenced by a "point decrease of the Oswestry Disability Index (ODI) score compared to baseline. (Missing specific point decrease criterion, but implied in the "Overall Conclusion" as "at least 15-point improvement of the ODI"). | 81.3% (78/96) of subjects had at least a 15-point improvement of the ODI score. (Mean ODI at 24 months was (b)(4) compared to Baseline (b)(4)). |
| Radiographic Fusion | Bridging bone demonstrated on CT Scan. | 99.0% (96/97) of subjects achieved a fusion. (Fusion rate for all evaluated subjects at 24 months, considering 12- and 24-month assessments). |
| Safety | Freedom from device-related Serious Adverse Events and secondary surgical interventions at the index level through the 24-month study interval. | 92.9% (91/98) of subjects demonstrated freedom from investigational device-related serious adverse events at the index level and free of surgical intervention at index level. |
| Additional Radiographic Findings (Clinical Study) | ||
| Expulsion (Clinical) | Implied criterion: Absence/low incidence of device moving outside disc space. | 0.0% (0/96) at 12-Month, 0.0% (0/4) at 24-Month, Combined 0.0% (0/97). |
| Subsidence (Clinical) | Implied criterion: Absence/low incidence of >5 mm migration of implant from original position. | 3.1% (3/96) at 12-Month, 0.0% (0/4) at 24-Month, Combined 3.0% (3/97). All 3 subjects with subsidence at 12 months had bone bridging. |
| Radiolucency (Clinical) | Implied criterion: Absence/low incidence of >50% of implant/endplate interface showing true lucency. | 2.1% (2/96) at 12-Month, 0.0% (0/4) at 24-Month, Combined 1.0% (1/97). One subject had bone bridging at 12 months, the other at 24 months. |
| Adjacent Level Degeneration | Implied criterion: Absence/low incidence of >5 mm loss of disc height; >3 mm translation on flexion/extension. | 0.0% (0/96) at 12-Month, 0.0% (0/4) at 24-Month, Combined 0.0% (0/97). |
2. Sample Sizes and Data Provenance
- Clinical Study Sample Size:
- Test Set (Clinical Study Cohort): 102 subjects were enrolled and treated across 10 clinical sites.
- Follow-up at 24 Months: 96 subjects provided complete data in-window (95.0% follow-up rate). Fusion assessment was conducted on 97 subjects (considering 12- and 24-month assessments).
- Data Provenance: The data is from a 24-month, prospective, single-arm, multi-center clinical study (G140140). The location of the clinical sites is not specified beyond "multi-center," but typically for FDA De Novo, such studies are conducted in the US or with data acceptable to the FDA. The study was based on a previously conducted prospective, randomized, multi-center study (G030106) for the same device. Given the context of a US FDA De Novo submission, it is highly likely that the centers were primarily in the United States, and the data is prospective.
3. Number of Experts and Qualifications for Ground Truth (Clinical Study)
- Ground Truth for Fusion: "Fusion was assessed by independent radiologists at the 12-month time point, and again at 24 months for those subjects who had not fused."
- Number of Experts: Not explicitly stated how many independent radiologists assessed each case, nor is their specific qualification (e.g., years of experience) mentioned. However, "independent radiologists" implies qualified medical professionals specialized in interpreting spinal imaging.
4. Adjudication Method (Clinical Study Test Set)
- The document implies that "independent radiologists" assessed fusion, but it does not specify an adjudication method (e.g., 2+1, 3+1 consensus process) for discrepancies between readers if multiple readers were used per case. It states fusion was "assessed by independent radiologists," which could mean one radiologist per case or multiple without a defined consensus process in the provided text.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No MRMC study was conducted. This was a single-arm study evaluating the device's performance, not a comparative effectiveness study involving human readers with/without AI assistance. The device is an implant, not an AI diagnostic tool.
6. Standalone (Algorithm Only) Performance
- Not Applicable. This is a medical implant, not an algorithm. Therefore, "standalone (i.e., algorithm only without human-in-the-loop performance)" is not relevant.
7. Type of Ground Truth Used (Clinical Study)
- Combination of Clinical Outcome Measures and Radiographic Assessment:
- Pain and Function: Ground truth derived from patient-reported outcomes (Visual Analog Scale for pain, Oswestry Disability Index for function).
- Fusion: Ground truth established through "bridging bone demonstrated on CT Scan," assessed by independent radiologists. This is a radiographic ground truth.
- Safety: Ground truth based on the occurrence and classification of adverse events, assessed by a Clinical Events Committee (CEC). This involves medical record review and expert medical judgment.
8. Sample Size for the Training Set
- Not Applicable. This is a human-implanted medical device, not an AI/ML algorithm. There is no concept of a "training set" in the context of device development as described here. The clinical study served as the primary evidence to demonstrate safety and effectiveness for regulatory approval.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant. The clinical study's data, as described in point 7, formed the basis of the evidence for the device's performance.
§ 888.3085 Intervertebral body graft containment device.
(a)
Identification. An intervertebral body graft containment device is a non-rigid, implanted spinal device that is designed to contain bone graft within its internal cavity. The device is inserted into the intervertebral body space of the spine and is intended as an adjunct to intervertebral body fusion.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Clinical performance testing must include an assessment of any adverse events observed during clinical use, as well as intervertebral body fusion, and compare this to a clinically acceptable fusion rate.
(2) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant, as well as the ability of the device to be inserted, deployed, and filled with bone graft consistently.
(3) Device must be demonstrated to be biocompatible.
(4) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components, and device-specific instruments.
(5) Design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(6) Labeling must bear all information required for the safe and effective use of the device, specifically including the following:
(i) A clear description of the technological features of the device including identification of device materials, compatible components in the fusion construct, and the principles of device operation;
(ii) Intended use and indications for use, including levels of fixation;
(iii) Identification of magnetic resonance (MR) compatibility status;
(iv) Cleaning and sterilization instructions for devices and instruments that are provided nonsterile to the end user; and
(v) Detailed instructions of each surgical step, including device removal.