(112 days)
Intended for the reduction and fixation of fractures in cancellous bone in the spine for kyphoplasty (for use with CareFusion 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
The provided text is a 510(k) summary for the CareFusion Inflatable Bone Tamp. It describes the device, its intended use, and states that performance testing demonstrated substantial equivalence to predicate devices. However, the document does not contain the detailed information necessary to answer the specific questions about acceptance criteria, a comprehensive study design, or specific performance metrics.
Here's what can be extracted and what is missing based on your template:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated as quantifiable metrics. The document broadly states that the device was evaluated through biological qualification safety tests as outlined in ISO 10993 Part-1 and in accordance with industry-recognized test methods, and "were found to be acceptable for the intended use." Performance testing "demonstrated that the proposed device is substantially equivalent to the currently marketed predicate devices with regard to functional characteristics."
- Reported Device Performance: No specific performance metrics (e.g., success rates, precision, accuracy, sensitivity, specificity, etc.) are provided. The only "performance" reported is meeting the safety standards and achieving substantial equivalence to predicates.
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 for Test Set: Not specified.
- Data Provenance: 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 as no human-expert-reviewed test sets are mentioned. The testing described focuses on material and functional characteristics, not diagnostic or interpretive tasks.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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 a medical device for a surgical procedure (Inflatable Bone Tamp), not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the biological and functional testing, the "ground truth" would be established by the ISO standards and industry-recognized test methods themselves (e.g., material property specifications, inflation/pressure limits, leakage tests against defined benchmarks).
8. The sample size for the training set
- Not applicable. This is not a machine learning or AI device.
9. How the ground truth for the training set was established
- Not applicable.
Summary of Study Information Available in the Document:
The study described in this 510(k) pertains to the non-clinical testing of the Inflatable Bone Tamp.
- Type of Study: Non-clinical (bench testing) to assess material safety and functional characteristics.
- Objective: To demonstrate substantial equivalence of the proposed device to predicate devices.
- Methods:
- Biological Qualification Safety Tests: As outlined in ISO 10993 Part-1 "Biological Evaluation of Medical Devices."
- Other Performance Testing: Evaluated in accordance with industry-recognized test methods. These tests focused on ensuring the device shares similar design, materials, and manufacturing characteristics, and functional performance, with legally marketed predicate devices.
- Results: All materials and performance testing were found to be acceptable for the intended use and demonstrated substantial equivalence to the predicate devices.
- Predicates: Cardinal Health Inflatable Bone Tamp (K090211), Kyphx Inflatable Bone Tamp (K041454, K981251), and Radiopaque Bone Cement (K043518).
In conclusion, this document primarily serves as a regulatory submission demonstrating substantial equivalence for a physical medical device, not an AI/software device. Therefore, many of the requested details related to clinical studies, AI performance metrics, and human reader-contributed data are not present nor relevant to this type of device submission.
§ 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.”