(221 days)
When used in conjunction with the icotec VADER® Pedicle System, G21 V-Fast and V-Steady Bone Cement are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time in patients with advanced stage tumors involving thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® one pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are for use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion.
When used in conjunction with G21 V-Fast or V-Steady Bone Cement and PicoMix™ V and/or V-HP Gun with the icotec Cement Cannula for mixing and injection of bone cements, the fenestrated VADER® pedicle screws 6.0 are intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the thoracic and lumbar spine in whom life expectancy, prior to oncological treatment, is of insufficient duration to permit achievement of fusion. The fenestrated VADER® pedicle screws 6.0 augmented with G21 V-Fast or V-Steady Bone Cement are limited to the use at spinal levels where the structural integrity of the spine is not severely compromised.
The VADER® Pedicle System is indicated to provide the surgeon with a minimally invasive and open approach for posterior spinal surgery.
The purpose if this Traditional 510(k) is to seek marketing clearance for the G21 Cement (V-Steady and V-Fast Bone Cements) to be used with the VADER® Pedicle System and to seek clearance for the VADER® Pedicle System.
V-Steady and V-Fast are polymethylmethacrylate (PMMA) based bone cements formulated to perform percutaneous vertebral augmentation procedures, such as vertebroplasty or kyphoplasty. Bone cements are self-curing systems consisting of liquid and powder components:
- The powder component is constituted of PMMA beads shaped particles containing the initiator benzoyl peroxide required for starting initiating the cement curing. The radiopacifier agent, zirconium dioxide, is necessary for the cement visibility under radiographs but it does not take part of the curing process (radical polymerization).
- The liquid component comprises the monomer, methylmethacrylate (MMA); dimethyl-para-toluidine (DMPT) as polymerization accelerator and hydroquinone (HQ) as stabilizer to prevent polymerization of the liquid during storage.
The specific content of PMMA and benzoyl peroxide is slightly different between the two cements conferring upon them specific properties. V-Steady bone cement has an immediate development of viscosity and thus it is a high viscosity cement that maintains its properties throughout the useful working time. The V-Fast has a low initial viscosity and a long working time allowing to work extremely carefully especially when a good time margin before polymerization is required. Both the liquid and powder components are supplied sterile. The sterile-filtered monomer component is supplied in an amber glass ampoule (10 ml) and comes in a blister pack sterilized by ethylene oxide. The polymer powder component is supplied in a double sterile packaging.
The sterilization process is ethylene oxide and it has been properly validated. Preparation and application procedures of the subject devices are detailed within the labeling as Mixing Phase, Waiting Phase, Application Phase, Setting/Hardening Phase.
The VADER® Pedicle System is a posterior pedicle system manufactured from Carbon/PEEK using a proprietary manufacturing process and comprised of polyaxial pedicle screws and curved, straight and J-rods as well as polyaxial, cannulated, fenestrated pedicle screws. The VADER® Pedicle System can be used for single or multiple level fixations in the non-cervical spine.
This document is a 510(k) Premarket Notification from the FDA, which outlines the substantial equivalence of medical devices (G21 Cement and VADER® Pedicle System) to already legally marketed devices. It primarily focuses on the device's intended use, description, and performance testing summaries for mechanical and material properties, rather than AI/algorithm-based diagnostic or prognostic performance.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" related to AI/algorithm performance (e.g., sample size for test set, expert consensus for ground truth, MRMC studies, standalone algorithm performance) is not applicable to this document.
The acceptance criteria and performance studies detailed in this 510(k) summary are for the physical and mechanical properties of the bone cement and pedicle screw system.
Here's a breakdown of the relevant information from the document that loosely relates to your request, but is specific to the mechanical device, not an AI:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a typical "table" for acceptance criteria as one would expect for an AI algorithm. Instead, it lists the types of performance testing conducted, implying that the acceptance criteria are adherence to the specific ASTM standards and demonstration of substantial equivalence to predicate devices. The reported performance is that the devices met these standards and were found substantially equivalent.
| Test Type | Acceptance Criteria (Implied) | Reported Performance |
|---|---|---|
| ASTM F543 Screw Testing | Adherence to specific strength/mechanical properties for screws | Results demonstrate substantial equivalence to legally marketed predicate devices. |
| ASTM F1717 Pedicle Screw System Testing | Adherence to specific strength/mechanical properties for the pedicle screw system | Results demonstrate substantial equivalence to legally marketed predicate devices. |
| ASTM F1798 Flexion Bending and Torsional Gripping | Adherence to specific resistance to bending/torsion | Results demonstrate substantial equivalence to legally marketed predicate devices. |
| ASTM F1877 Particle Analysis of Post-Fatigue Samples | Acceptable particle analysis post-fatigue (e.g., wear debris) | Results demonstrate substantial equivalence to legally marketed predicate devices. |
| G-21 Cement injection properties with icotec fenestrated screws | Acceptable injection characteristics and compatibility | Tested and found satisfactory for intended use. |
| Biocompatibility Assessment | Meeting biocompatibility standards for implanted materials | Assessed and found compliant. |
| Clinical Data | (Likely refers to existing clinical use, or limited clinical data if applicable to the predicate, as this is a 510(k)) | Included in the submission. specific details not provided. |
Note: The document states "The results of the performed tests demonstrate that the VADER® Pedicle System is substantially equivalent to legally marketed predicate devices." This is the reported performance against the implied acceptance criteria of meeting or exceeding the predicate device's performance based on these standards.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for each test. For mechanical testing (ASTM standards), the sample size would typically be a specific number of devices/implants per test as required by the standard. This is not "data" in the sense of patient data.
- Data Provenance: Not applicable in the context of patient data. The "data" comes from in vitro mechanical and material testing conducted by the manufacturer (icotec ag) in Switzerland. The "clinical data" mentioned is not detailed, but for a 510(k), it often refers to references to existing literature or limited clinical use data, not necessarily new prospective studies for the 510(k) itself unless specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. Ground truth as typically understood for AI-based diagnostic/prognostic devices (e.g., radiological interpretation) is not relevant here. The "ground truth" for these tests comes from objective physical measurements and adherence to engineering standards.
4. Adjudication method for the test set:
- Not applicable. This is not a human interpretation task.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- Not applicable. This is for mechanical device performance, not AI assistance for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a PMMA bone cement and pedicle screw system, not an algorithm.
7. The type of ground truth used:
- For mechanical tests: Objective physical measurements against established ASTM standard specifications.
- For biocompatibility: Adherence to relevant biocompatibility standards.
- For "Clinical Data": Details are not provided, but it likely refers to existing literature/clinical experience with similar devices or limited clinical data demonstrating safety and performance.
8. The sample size for the training set:
- Not applicable. This document is not about an AI/ML algorithm.
9. How the ground truth for the training set was established:
- Not applicable. This document is not about an AI/ML algorithm.
In summary: The provided document is a 510(k) clearance for a mechanical medical device (bone cement and pedicle screws). The "acceptance criteria" and "proof" relate to standard engineering, material, and biocompatibility testing, demonstrating substantial equivalence to predicate devices, rather than the performance metrics and study designs typically associated with AI/ML-based medical devices.
§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.
(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”