(253 days)
V-STRUT© Vertebral Implant is indicated for use in the treatment of vertebral fractures in the thoracic and lumbar spine from T9 to L5. It is intended to be used in combination with Teknimed F20® bone cement.
V-STRUT© Vertebral Implant is part of V-STRUT© Transpedicular Vertebral System. V-STRUT© Transpedicular Vertebral System is composed of :
- V-STRUT© Vertebral Implant,
- -V-STRUT© Guide Wire,
- -V-STRUT© Instrumentation Kit.
V-STRUT© Vertebral Implant is a medical device to be placed in the vertebrae through a minimally invasive procedure. Two devices are implanted in each vertebra to be treated. Each implant is introduced posteriorly through the pedicle up to the anterior vertebral body wall.
The implant is made of radio transparent polymer, PEEK (Polyetheretherketone as per ASTM F2026) and includes two visualizing markers made of tantalum (as per ASTM F560).
V-STRUT© Vertebral Implant exists in 2 different diameters and 5 different lengths to accommodate individual patient's anatomy of thoracic and/or lumbar vertebrae from T9 to L5.
V-STRUT© Vertebral Implant is provided sterile and is not reusable.
V-STRUT© Vertebral Implanted using specific instrumentation provided with the implant and is combined in situ with a Polymethylmethacrylate (PMMA) bone cement, F20® manufactured by Teknimed SA (K103433).
This document is a 510(k) summary for the V-STRUT© Vertebral Implant, which is a medical device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving clinical effectiveness through a complex clinical trial with specific acceptance criteria for AI performance as would be seen for an AI/ML medical device.
Therefore, the requested information about acceptance criteria and the study proving the device meets them, particularly in the context of an AI/ML device (e.g., sample size, expert ground truth, MRMC studies, standalone performance), is not applicable to this 510(k) submission.
This document describes a traditional medical device (an implant) and its substantial equivalence is demonstrated through:
- Biomechanical Performance Testing: Static and dynamic mechanical testing.
- Biocompatibility Testing: According to ISO 10993-1, 10993-5, and USP 42-NF 37.
- Sterility Testing: According to ISO 11137-1 and 11137-2.
- Shelf-Life Testing: According to ASTM F1980.
- Clinical Evaluation: Stating that "V-STRUT© Vertebral Implant has demonstrated to be substantially equivalent to its predicate device KIVA® VCF Treatment System. No additional safety or effectiveness issues as the ones expected and documented in the literature for predicates and references devices have been raised." This is not a prospective clinical trial with specific performance metrics designed to prove the device meets acceptance criteria related to a specific diagnosis or outcome as would be expected for an AI device.
To directly answer your numbered questions based on the provided document:
- A table of acceptance criteria and the reported device performance: This document does not contain such a table because it's for a physical implant, not an AI/ML diagnostic device with performance metrics like sensitivity, specificity, etc. The performance is assessed through the non-clinical tests listed above, demonstrating it functions as intended and is safe.
- Sample size used for the test set and the data provenance: Not applicable. There isn't a "test set" in the context of an AI/ML algorithm. The "testing" refers to lab-based biomechanical, biocompatibility, and sterility tests of the physical implant.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth as understood for AI/ML diagnostic interpretation (e.g., radiologist reads) is not relevant to this device.
- Adjudication method for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done: Not applicable. This type of study is for evaluating human performance with and without AI assistance for tasks like image interpretation, which is not the function of this implant.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical implant, not an algorithm.
- The type of ground truth used: For the physical device, "ground truth" relates to standardized testing conditions and material properties (e.g., biomechanical strength, non-cytotoxicity), rather than a clinical diagnosis adjudication.
- The sample size for the training set: Not applicable. There is no training set for a physical implant.
- How the ground truth for the training set was established: Not applicable.
In summary, the provided document details a 510(k) submission for a vertebral implant, focusing on its substantial equivalence to a predicate device through non-clinical performance testing and a literature-based clinical evaluation, as opposed to the clinical trial and AI/ML specific performance metrics you've inquired about.
§ 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.”