(30 days)
The SPACE CpsXL bone cement is indicated for the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
The SPACE CpsXL bone cement is a self-curing polymethyl-methacrylate (PMMA) bone cement intended for use in the treatment of pathological fractures of the vertebrae using a vertebroplasty or kyphoplasty procedure. SPACE CpsXL bone cement is provided as a two-component system. The powder component of both devices consists of a PMMA polymer with a barium sulphate as a radiopacifier and benzoyl peroxide as an initiator. The liquid component consists of methylmethacrylate monomer with the addition of hydroquinone as a stabilizer and N.N-dimethyl-p-toluidine as a promoter.
The provided text is a 510(k) Premarket Notification Summary for the SPACE CpsXL bone cement. This document describes a medical device and its substantial equivalence to a predicate device, rather than a study evaluating an AI-powered diagnostic or assistive tool against specific acceptance criteria.
Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details are not present in this document.
Here's what can be extracted and a clear statement about what is not available based on the request:
Acceptance Criteria and Device Performance:
The document implicitly defines "acceptance" as demonstrating substantial equivalence to a predicate device. This is a regulatory standard for medical devices. The performance criteria are therefore primarily related to the physical, chemical, and mechanical properties of the bone cement, ensuring they are comparable to the predicate.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Substantial Equivalence to predicate device (SPACE CpsXL bone cement, K061531) | "Documentation is provided which demonstrated the SPACE CpsXL bone cement to be substantially equivalent to other legally cleared devices." |
| Similar chemical composition to predicate device | "Both the SPACE CpsXL bone cement and the predicate are bone cements intended for use in vertebroplasty, and are similar with respect to chemical composition..." |
| Similar fundamental scientific technology to predicate device | "...and fundamental scientific technology." |
| Differences do not significantly affect safety and effectiveness | "Any differences do not significantly affect the safety and effectiveness of the device." |
| Performs as intended for vertebroplasty/kyphoplasty procedures for pathological fractures of vertebrae | "Based upon the testing and comparison to the predicate device and commercially available bone cements, the SPACE CpsXL bone cement, performs as intended..." |
| Meets physical, chemical, and mechanical testing standards | "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted." |
Information NOT available in the provided text, as it pertains to AI/diagnostic studies:
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for this type of device submission.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable. "Ground truth" in this context would likely refer to material science standards, not clinical interpretations.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 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, as this is not an AI-assisted diagnostic device.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): The "ground truth" for this device would be established through established engineering and biomaterial standards and testing, not clinical consensus or pathology.
- The sample size for the training set: Not applicable for this type of device submission.
- How the ground truth for the training set was established: Not applicable.
Study Details (as per the provided document):
The "study" or evaluation described is a series of physical, chemical, and mechanical tests conducted on the SPACE CpsXL bone cement. The purpose of these tests was to demonstrate its performance and substantial equivalence to a legally marketed predicate device (SPACE CpsXL bone cement, cleared under 510(k) K061531).
The document states:
- "Physical, chemical and mechanical testing of the SPACE CpsXL bone cement has been conducted."
- This testing, along with comparison to the predicate device and commercially available bone cements, formed the basis for the conclusion that the device "performs as intended and is substantially equivalent to the predicate device."
Without the actual detailed testing reports, the specific parameters, methodologies, or quantitative results of these "physical, chemical, and mechanical tests" are not available in this summary.
§ 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.”