(248 days)
Mendec Spine HV / Mendec Spine HV System is indicated for the treatment of pathological fractures of the vertebral body using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
Mendec Spine HV and Mendec Spine HV System are highly viscous, radioopaque acrylic resins (PMMA based) for percutaneous vertebroplasty or kyphoplasty. These devices are made with the same raw material, but are supplied in different ways: . Mendec Spine HV is a traditional bone cement product: the liquid is contained in a vial and the powder in a sachet; these components are packaged in unitary PVC-blister with Tyvek lid, which is placed in an aluminum bag. . Mendec Spine HV System holds the powder and liquid components separately within a closed syringe-like device haa serves as a mixing chamber. The device is packaged in unitary PVC-blister with tray, sealed with Tyvek lid, which is placed in an aluminum bag. The devices are sold disposable and sterile.
The provided text describes a 510(k) summary for the Tecres Mendec Spine HV and Mendec Spine HV System, which are polymethylmethacrylate (PMMA) bone cements for vertebroplasty/kyphoplasty. This type of submission relies on demonstrating substantial equivalence to predicate devices, rather than a novel study proving a device meets specific clinical acceptance criteria in the way an AI/ML device would.
Therefore, many of the requested categories (e.g., sample size for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this type of device submission.
Here's how the available information maps to your request:
1. A table of acceptance criteria and the reported device performance
For a PMMA bone cement, acceptance criteria are typically defined by demonstrating that the device has comparable material and mechanical properties to legally marketed predicate devices.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical Properties | Tested (static and fatigue properties, viscosity) and found substantially equivalent to predicate devices. |
| Chemical-Physical Properties | Tested (setting-time, MMA release) and found substantially equivalent to predicate devices. |
| Intended Use Equivalence | The intended use is the same as the predicate devices: treatment of pathological fractures of the vertebral body using vertebroplasty or kyphoplasty. |
| Material Equivalence | Composed of the same raw material as predicate devices. |
2. Sample size used for the test set and the data provenance
Not applicable for this type of device. The "test set" here refers to the actual physical devices undergoing laboratory testing for their material and mechanical properties, not a clinical data set. The provenance of the data is from Tecres S.P.A.'s own performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of device performance, relates to laboratory measurements and conformity to recognized standards or comparison to predicate device specifications, not expert interpretation of clinical data.
4. Adjudication method for the test set
Not applicable. This is not a clinical study involving human readers or interpretations needing adjudication.
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. This is not an AI/ML device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (bone cement), not an algorithm.
7. The type of ground truth used
The "ground truth" for this device is based on established material science and engineering principles, and comparison to the specifications and performance of legally marketed predicate devices. This includes:
- Physical measurements of mechanical properties (e.g., strength, viscosity).
- Chemical analysis of material composition and properties (e.g., setting time, monomer release).
- Verification that the device meets safety and performance standards equivalent to the predicates.
8. The sample size for the training set
Not applicable. There is no AI/ML model, hence no training set.
9. How the ground truth for the training set was established
Not applicable. There is no AI/ML model, hence no training set or ground truth establishment method for it.
§ 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.”