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510(k) Data Aggregation
(111 days)
The Spinelack® Expansion Kit is indicated for use in the reduction of painful osteoporotic vertebral compression fractures. It is intended to be used in combination with Stryker Vertaplex HV bone cements.
The SpineJack Expansion Kit (herein referred to as "SpineJack") is an implanted fracture reduction system, intended to reduce vertebral compression fractures. The SpineJack Expansion Kit is used with the Preparation Kit. The Expansion Kit is available in three sizes, to accommodate different vertebral body sizes, Ø4.2mm, Ø5mm, and Ø5.8mm. After the SpineJack implant is inserted, it is expanded, and PMMA bone cement is injected at a low pressure to stabilize the restored vertebral body. The bone cement and its delivery system are intended to be used with the SpineJack, but are sold separately.
This document describes the premarket notification (510(k)) clearance for the SpineJack® Expansion Kit, a medical device used to treat painful osteoporotic vertebral compression fractures. The document outlines the device's indications for use, comparison to predicate devices, and the results of performance and clinical testing to demonstrate substantial equivalence.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical study (SAKOS study) as the primary proof of meeting acceptance criteria:
1. A table of acceptance criteria and the reported device performance
The primary acceptance criteria for the SpineJack device were demonstrated through a non-inferiority study compared to Balloon Kyphoplasty (BKP). The key criteria and results were:
| Acceptance Criteria (Endpoint) | Reported Device Performance (SpineJack vs. BKP) |
|---|---|
| Primary Endpoint: 12-month Responder Rate (Non-Inferiority)Defined as clinically meaningful improvement in pain and function without pre-specified serious adverse events or reinterventions. | SpineJack: 89.8% responder rateBKP: 87.3% responder rateResult: p=0.0016. The posterior probability for the final Bayesian analysis (0.09969) successfully met the criteria for study success (posterior probability > 0.987) and demonstrated non-inferiority of the SpineJack to the predicate BKP. |
| Secondary Endpoint: Additional Composite Endpoint (Superiority)Defined as the primary endpoint components plus "absence of adjacent level fractures." | SpineJack: 79.7% responder rateBKP: 59.3% responder rateResult: p<0.0001, demonstrating superiority. |
| Secondary Endpoint: Midline Target Height Restoration (Superiority) | SpineJack: 1.31 ± 2.58 mm (median: 1.00 mm) restorationBKP: 0.10 ± 2.34 mm (median: 0.30 mm) restorationResult: p=0.0035, demonstrating superiority. |
| Safety Profile (Non-Inferiority/Comparable)Rates of cement extravasation, subsequent vertebral fractures, and adverse events. | Both treatment groups had similar rates of cement extravasation, subsequent vertebral fractures, and adverse events. The SpineJack group showed a significantly lower incidence of adjacent fractures and fewer instances of osteolysis/osteonecrosis (4 patients (5.9%) vs. 9 patients (12.5%)). The SpineJack group had no device deficiencies, while BKP had 2 cases of balloon rupture. |
| Pain and Function Improvement(Measured by VAS pain and Oswestry Disability Index (ODI) score) | SpineJack group: Mean VAS score improved to 15.7 (-62.1 change from baseline). Mean ODI score improved to 13.4 (-51.1 change from baseline). Both groups showed substantial and sustained improvement. |
2. Sample size used for the test set and the data provenance
- Test Set Sample Size: The pivotal clinical study (SAKOS study) enrolled 152 patients.
- Data Provenance: The study was conducted at 13 active sites in 5 different European countries, including France, Germany, Italy, Spain, and Switzerland. The study followed patients for 12 months after surgery, indicating a prospective study design.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not explicitly state the number or qualifications of experts used to establish the "ground truth" for the test set regarding the clinical outcomes. The clinical study evaluated patient outcomes (pain, function, adverse events, fracture incidence, height restoration) through direct patient follow-up and measurements, rather than a separate expert-driven ground truth assessment of diagnostic images. The study's design implies that the "ground truth" for the clinical endpoints was derived directly from the patients' reported outcomes, clinical measurements, and imaging results interpreted by the study's clinical staff/investigators.
4. Adjudication method for the test set
The document does not specify an explicit adjudication method (e.g., 2+1, 3+1) for establishing the ground truth or evaluating clinical outcomes. The study design involves patient enrollment, intervention, and follow-up by clinical investigators. The outcomes were presumably recorded and analyzed according to a pre-defined Statistical Analysis Plan.
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
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This document describes the clearance of a medical device (SpineJack) for a surgical procedure, not an AI-assisted diagnostic device. Therefore, the concept of human readers improving with AI assistance is not applicable to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No, this refers to a medical device (SpineJack) for interventional treatment, not a standalone algorithm. Performance was evaluated in a clinical trial with human surgeons performing the procedure.
7. The type of ground truth used
The "ground truth" for the clinical study was based on patient outcomes data, specifically:
- Patient-reported pain (VAS score)
- Patient-reported function (Oswestry Disability Index - ODI)
- Incidence of serious adverse events
- Need for reinterventions
- Incidence of adjacent level fractures
- Midline vertebral height restoration (likely from imaging measurements)
- Incidence of cement extravasation, subsequent vertebral fractures, osteolysis/osteonecrosis, and device deficiencies.
8. The sample size for the training set
This document does not describe an AI/ML model. Therefore, there is no training set used in the context of this device clearance. The "training" for this device would refer to the historical clinical experience and development process, but not in the machine learning sense. The clinical study described served as the validation/test set for the device's performance.
9. How the ground truth for the training set was established
As there is no AI/ML model and thus no "training set," this question is not applicable.
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