(143 days)
The SPACE 360 Delivery System is intended for percutaneous delivery of SPACE CpsXL Bone Cement in vertebroplasty or kyphoplasty procedures in the treatment of pathological fractures of the vertebrae. Painful vertebral compression fractures may result from osteoporosis, benign lesions (hemangioma), and malignant lesions (metastatic cancers, myeloma).
The SPACE 360 Delivery System consists of a reusable controller and disposable, single-use components, including a delivery cannula and stylet, a hydraulic assembly and bone cement syringe, and control cables.
This document is a 510(k) Premarket Notification summary for the SPACE 360 Delivery System, a device for delivering bone cement in vertebroplasty and kyphoplasty procedures.
Based on the provided text, a detailed breakdown of acceptance criteria and a study proving the device meets them cannot be fully generated as the information is not present in this document. This document pertains to regulatory approval and focuses on substantial equivalence to predicate devices rather than a detailed performance study with specific acceptance criteria.
Here's what can be extracted and what is missing:
1. A table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "...meets its performance requirements to support its use as a bone cement delivery system." (Specific criteria and reported numerical performance are not provided.) |
| Not specified | "...demonstrates that the SPACE 360 Delivery System meets its performance requirements..." (Specific criteria and numerical performance are not provided.) |
Explanation: The document states that the device "meets its performance requirements," but it does not list those performance requirements as specific acceptance criteria (e.g., flow rate must be X, burst pressure must be Y) nor does it provide the numerical results from the tests against such criteria.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not specified. The document mentions "Mechanical performance and safety testing" but does not detail the number of units tested.
- Data Provenance: Not specified.
- Retrospective or Prospective: Not specified.
3. 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 / Not Specified. This device is a bone cement delivery system, not an AI diagnostic or clinical decision support tool that would require expert-established ground truth for performance evaluation in the way a diagnostic algorithm does. The testing likely focused on mechanical and safety aspects.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable / Not Specified. As above, this is not relevant for a mechanical device's performance testing described here.
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. This is a mechanical bone cement delivery system, not an AI or computational imaging device that would typically undergo an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Specified. For mechanical testing, the "ground truth" would be engineering specifications and standards, not clinical ground truth in the diagnostic sense.
8. The sample size for the training set:
- Not Applicable. This is a physical device, not an AI model. Therefore, there is no "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set exists for this type of device.
Study Summarized in the Document:
The document refers to a study as:
- "Mechanical performance and safety testing demonstrates that the SPACE 360 Delivery System meets its performance requirements to support its use as a bone cement delivery system."
This statement confirms that testing was performed to substantiate the device's claims for its intended use, focusing on its mechanical function and safety. However, the details of these tests (e.g., specific parameters measured, test methods, sample sizes, numerical results, and the acceptance thresholds) are not detailed in this 510(k) summary. The purpose of this summary is to demonstrate "substantial equivalence" to predicate devices, not to provide a full scientific report of all validation testing.
§ 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.”