(154 days)
Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with Cardinal Health Radiopaque Bone Cement).
The Inflatable Bone Tamp (IBT) was designed for use in Balloon kyphoplasty. The balloon serves to create a cavity in the vertebral body, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation. The balloon catheter is the functional part of the device that creates a cavity and reduces the fracture. The balloon catheter provides a conduit through which the physician can inflate the balloon at the distal end of the catheter. The wire stiffener provides stiffness to the balloon catheter to facilitate insertion through the access cannula
This document, K090211, describes an Inflatable Bone Tamp (IBT) submitted for 510(k) clearance by Cardinal Health. The submission focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria and conducting a study to prove a specific level of performance for the device. Here's a breakdown of the requested information based on the provided text:
Key Takeaway: The provided document is a 510(k) summary, which aims to demonstrate "substantial equivalence" of a new device to existing predicate devices. It does not outline specific acceptance criteria for a new performance benchmark for the device, nor does it detail a study that proves the device meets such criteria as one might find for a novel device with new claims. Instead, it relies on demonstrating that the new device shares similar technological characteristics and performs comparably to already cleared devices.
1. A table of acceptance criteria and the reported device performance
Based on the provided text, specific acceptance criteria in the sense of quantitative performance thresholds (e.g., "Must achieve XYZ accuracy" or "Tensile strength of X MPa") are not explicitly stated. The "acceptance criteria" for this 510(k) submission are implicitly tied to demonstrating "substantial equivalence" to the predicate devices. The performance reported is that the device is substantially equivalent to its predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Materials meet biological safety standards (ISO 10993-1). | All materials used were evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices" and found acceptable. |
| Materials meet industry-recognized test methods. | Materials also were tested in accordance with industry recognized test methods and were found to be acceptable for the intended use. |
| Functional characteristics are substantially equivalent to predicate devices. | Performance testing demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics. |
| Design, materials, and manufacturing are same or similar to predicate devices. | The proposed device and the predicate devices are composed of the same or similar design, materials, and manufacturing characteristics. |
2. Sample sized used for the test set and the data provenance
The document mentions "Performance testing" and "biological qualification safety tests" but does not specify the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective). This information is typically detailed in the full 510(k) submission, not necessarily in the public summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable or not mentioned in this 510(k) summary. The context is not one of diagnostic accuracy or expert consensus on findings, but rather physical and biological performance of a medical device. "Ground truth" in this context would likely refer to established engineering and material science standards for device components, not expert interpretation of medical data.
4. Adjudication method for the test set
Not applicable or not mentioned. Adjudication methods are typically used in studies involving human interpretation or subjective assessments. The tests described (material safety, functional characteristics) are objective engineering and biological tests that wouldn't require an adjudication method in the clinical sense.
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 device is an Inflatable Bone Tamp, a physical medical device used in surgery, not an AI or imaging diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is entirely outside the scope of this device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. As stated above, this is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the non-clinical testing described:
- Material safety: The "ground truth" would be established by validated ISO 10993 standards and other industry-recognized test methods for biocompatibility and material properties.
- Functional characteristics: The "ground truth" would be the established performance characteristics of the predicate devices as measured against engineering specifications and validated test methods.
8. The sample size for the training set
Not applicable. This is not a study involving machine learning or algorithms that require a training set. The term "training set" is not relevant to the evaluation of this physical medical device.
9. How the ground truth for the training set was established
Not applicable. As there is no training set for this type of device evaluation, there is no ground truth to establish 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.”