(164 days)
The GUARDIAN Inflatable Bone Expander System is intended to be used for the reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine. This includes use during percutaneous vertebral augmentation. The system is to be used with cleared spinal polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebralaugmentation, such as kyphoplasty.
The GUARDIAN, Inflatable Bone Expander System (IBES), is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body to facilitate the insertion of bone cement and using cement dispensing plunger, the major benefits of GUARDIAN are the significant reduction in back pain and increase patient's functional abilities, allow a return to the previous level of activity. The GUARDIAN, Inflatable Bone Expander System components are Inflatable Bone Tamp (balloon catheter, inflation syringe) and accessories kit. And balloon catheter' main components are the shaft, hub and the inflatable balloon located at the distal tip and inflatable balloon is covered maximum 0.03g of silicone fluid to enhance lubricity when the balloon catheter is inserted in the cannula. Radiopaque markers located at the distal and proximal end of deflated working surface allow fluoroscopic visualization of the deflated balloon catheter during positioning. Accessories kit consists of GUARDIAN Bone Access Needle (starting needle cannula, starting needle trocar), GUARDIAN Osteo Introducer System (guide wire, cannula, trocar-R, trocar-S, drill), GUARDIAN Bone Filler Device (cement bar, cement infusion) and guide impactor.
The provided text describes a 510(k) summary for the GUARDIAN Inflatable Bone Expander System (IBES). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than conducting a full clinical study with specific acceptance criteria in the same way a novel device might. Therefore, many of the typical clinical study elements like expert ground truth, adjudication methods, or MRMC studies are not applicable or detailed in this document.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically related to meeting established performance standards for similar predicate devices, and demonstrating that the new device performs at least as well as the predicate device or meets defined engineering specifications.
| Acceptance Criteria (from Text) | Reported Device Performance (from Text) |
|---|---|
| Specifications and performance characteristics relevant to predicate devices | The GUARDIAN Inflatable Bone Expander System met the specifications and performance characteristics and are substantially equivalent to the predicate devices. |
| Functional testing standards | Testing included functional tests such as balloon compliance, deflation time, insertion/withdraw force, and fatigue testing. |
| Mechanical testing standards | Testing included mechanical tests such as tensile strength. |
| Substantial Equivalence Criteria | The GUARDIAN Inflatable Bone Expander System has equivalent device characteristics as the predicate device, the Kyphon and KyphX Xpander Inflatable Bone Tamps; intended use, material, design and use concept are similar. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a sample size for a clinical "test set" in the traditional sense. The testing mentioned (functional and mechanical) was likely bench testing of the device itself, not human subjects.
- Test Set Sample Size: Not applicable/not specified in the context of a clinical test set. The tests mentioned are likely bench tests performed on device prototypes or production samples.
- Data Provenance: The tests are described as being performed to show that the device "met the specifications and performance characteristics." This implies in-house engineering and laboratory testing by the manufacturer (BM Korea Co., Ltd.). There is no indication of clinical data from human subjects or country of origin for such data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Not applicable. The "ground truth" for this type of submission is the established performance and safety profile of the predicate devices and the engineering specifications for the new device. There is no mention of external experts establishing ground truth for a clinical dataset.
- Qualifications of Experts: Not applicable in this context. The "experts" involved would be the engineers and quality assurance personnel at BM KOREA Co., Ltd. who conducted the functional and mechanical testing.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. Given that this involves bench testing for mechanical and functional properties, there would be no need for clinical adjudication methods like 2+1 or 3+1. Performance is measured against predefined engineering specifications.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- MRMC Study: No. The document does not describe any clinical study, let alone an MRMC comparative effectiveness study involving human readers or AI assistance. The submission is based on demonstrating substantial equivalence through non-clinical (bench) testing.
6. If a Standalone (algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This device is a physical medical device (an inflatable bone expander system), not an AI algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this submission.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for this 510(k) submission relies on:
- Engineering Specifications: The device's functional and mechanical properties were tested against predefined engineering specifications.
- Predicate Device Performance: The underlying assumption and "truth" for substantial equivalence is that the predicate devices are safe and effective, and the new device performs comparably in terms of its characteristics and intended use.
- Material Compatibility/Safety Standards: Implied, but not explicitly detailed as "ground truth." The use of silicone fluid for lubricity would be evaluated against established material safety standards.
8. The Sample Size for the Training Set
- Training Set Sample Size: Not applicable. This is a physical medical device, not an AI model that requires a training set of data.
9. How the Ground Truth for the Training Set was Established
- Training Set Ground Truth: Not applicable, as there is no training set for a physical medical device.
§ 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.”