(41 days)
The Spider System Kolibri Cement Needle is intended to be used as a system for the creation of a cavity in cancellous bone in the spine, in order to treat pathological compression fractures that may result from osteoporosis, benign lesions, and/or malignant lesions. This system is to be used with an already FDA cleared PMMA bone cement.
The needle has the following characteristics:
- . entirely cannulated needle;
- threaded proximal end to screw the needle into the pedicle to temporarily link the . needle to the pedicle during the cement injection; .
- . luer-lock to allow the easy connection with standard syringes and with other system of injection of the cement;
- . windows in the distal end that allow the outflow of cement and its optimal distribution around the needle.
The device is supplied in an appropriately labeled sterile packaging.
The provided text is a 510(k) summary for the Sintea Plustek's Spider System KOLIBRI Cement Needle. This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study with acceptance criteria for device performance in the way a clinical trial for a complex diagnostic or therapeutic device might.
Therefore, many of the requested elements regarding acceptance criteria, performance studies, expert involvement, and ground truth are not applicable or not provided in this type of submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Testing Requirements | "No mechanical testing is required." | The submission asserts that no mechanical testing is necessary to demonstrate substantial equivalence for this device. |
| Biocompatibility | "All materials used in fabrication of the Spider System KOLIBRI Cement Needle were evaluated through functional testing and appropriate quality system requirements." | The evaluation of materials is mentioned, but specific acceptance criteria or performance results are not detailed. It likely refers to standard material biocompatibility testing as part of quality systems, rather than a specific performance study in the context of this 510(k). |
| Sterility | "The device is supplied in an appropriately labeled sterile packaging." | Implies the device meets sterility requirements, but specific acceptance criteria or testing results are not provided. |
| Substantial Equivalence to Predicate Devices (Key Characteristics) | - Indications for Use: Substantially equivalent | The primary "performance" criterion for a 510(k) is demonstrating substantial equivalence to a legally marketed predicate device. This is met for all listed characteristics. |
| - Materials: Substantially equivalent | ||
| - Dimensions: Substantially equivalent | ||
| - Function: Substantially equivalent | ||
| Technological Characteristics | "There are no significant differences in technological characteristics compared to the predicate device." | This is a key statement of equivalence. |
Study Details
The provided document describes a 510(k) Pre-Market Notification, which aims to demonstrate that a new device is as safe and effective as an already legally marketed device (predicate device). It is not a clinical study or a performance study in the sense of establishing new performance metrics or efficacy. Instead, it relies on demonstrating equivalence through comparison of design, materials, and intended use.
Therefore, the following information is not applicable or not provided in this 510(k) summary:
- Sample size used for the test set and the data provenance: Not applicable. No "test set" of patient data or samples was used for a performance study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth was established from expert review for a performance test set.
- 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. This device is a cement needle, not an AI-powered diagnostic tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical instrument, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. There was no "ground truth" used in the context of a performance study. The "truth" here is the prior FDA clearance of predicate devices and the demonstration that the new device is sufficiently similar.
- The sample size for the training set: Not applicable. This device is a physical medical instrument, not a machine learning model requiring a training set.
- How the ground truth for the training set was established: Not applicable.
§ 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.”