(126 days)
The MEDINAUT Kyphoplasty 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. This system is to be used with cleared spinal Polymethylmethacrylate (PMMA) bone cements indicated for use during percutaneous vertebral augmentation, such as kyphoplasty.
The MEDINAUT Kyphoplasty System is designed to reduce spinal compression fracture and restore sagittal alignment. By creating a space in the vertebral body it facilitate the insertion of bone cement through the use of the cement dispensing plunger. The benefits of MEDINAUT Kyphoplasty System are the reduction in back pain and increase of patient's functional abilities, allowing a return to the previous level of activity.
It consists of Balloon Catheter, Bone Expander Syringe, Needle Pipe, Needle Pin, Wire Pin (Troca Type, Round Type), Cannula, Expander, Spacer, Cement Pusher, Cement Filler, and Guide Wire. It is supplied sterile and for single disposable use.
The MEDINAUT Kyphoplasty System is similar to other commercially available products based on the intended use, the technology used, the claims, the material composition employed and performance characteristics. The system is substantially equivalent in design, function and intended use to the predicate devices.
This device is a medical device, not an AI/ML device, so many of the requested fields are not applicable.
Here's an analysis of the provided 510(k) summary for the MEDINAUT Kyphoplasty System, focusing on acceptance criteria and performance data:
The MEDINAUT Kyphoplasty System is a physical medical device (an inflatable bone tamp system) used in kyphoplasty procedures. The "acceptance criteria" and "study" described are primarily bench tests comparing the device's physical properties and performance against a predicate device, rather than clinical studies or evaluations of an AI model's diagnostic accuracy.
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state "acceptance criteria" in the format of pass/fail thresholds for each test. Instead, it presents "Test Criteria" which are more akin to the methodology or conditions of the test, and then provides "Test Result" for both the MEDINAUT Kyphoplasty System and the predicate device (Kyphon Inflatable Bone Tamp). The implicit acceptance criterion for this 510(k) submission is substantial equivalence to the predicate device. This means the new device's performance should be comparable to or better than the predicate's, and not raise new questions of safety or effectiveness.
| Test | Test Criteria | MEDINAUT Kyphoplasty System (Reported Performance) | Kyphon Inflatable Bone Tamp (Predicate Performance) |
|---|---|---|---|
| Tensile Bond Strength | Outer shaft and Hub with 1mm/sec, Test report #; IMT-TBST12-01 | IBE-15; 20.85kgf | K13A; 14.76kgf |
| Fatigue Strength | No burst and leakage at 15 cycles of maximum pressure limit 400psi, Test report #; IMT-FST12-01 | IBE-10; Pass | |
| IBE-15; Pass | |||
| IBE-20; Pass | K13A; Pass | ||
| K09A; Pass | |||
| K08A; Pass | |||
| Balloon Deflation Time | Compare the performance (seconds), Test report:IMT-BDT12-01 | IBE-10 2ml; 0.50 sec. | |
| 3ml; 0.76 sec. | |||
| IBE-15 3ml; 0.51 sec. | |||
| 5ml; 1.16 sec. | |||
| IBE-20 3ml; 0.47 sec. | |||
| 5ml; 1.12 sec. | |||
| 7ml; 1.29 sec. | K13A 2ml; 0.27 sec. | ||
| 4ml; 0.62 sec. | |||
| K09A 2ml; 0.28 sec. | |||
| 4ml; 0.62ml | |||
| K08A 2ml; 0.31 sec. | |||
| 4ml; 0.54 sec. | |||
| 6ml; 0.69 sec. | |||
| Burst Pressure Constrained | 400 psi at the Constrained jig for 30 seconds, Test report: IMT-BPC12-08 | IBE-10; 3.5ml Pass | |
| IBE-15; 5.5ml Pass | |||
| IBE-20; 7.5ml Pass | K09A; 5.5ml Pass | ||
| K08A; 7.5ml Pass | |||
| Burst Strength Unconstrained | Measure the burst inflation pressure, Test report #: IMT-BST12-01 | IBE-10; 250psi | |
| IBE-15; 207psi | |||
| IBE-20; 183psi | K09A; 243psi | ||
| K08A; 237psi | |||
| Balloon Dimension before and after inflation | Initial balloon length (IBE-10; 10mm, IBE-15; 15mm, IBE-20; 20mm), Test report #: IMT-IDT11-02 | Balloon Diameter after inflation: | |
| IBE-10, 3ml: 14.1mm | |||
| IBE-15, 5ml: 17.1mm | |||
| IBE-20, 7ml: 19.3mm | |||
| Balloon Length after inflation: | |||
| IBE-10, 3ml: 16.3mm | |||
| IBE-15, 5ml: 22.2mm | |||
| IBE-20, 7ml: 29.4mm | Balloon Diameter after inflation: | ||
| K09A, 4ml: 15.2mm | |||
| K08A, 6ml: 16.8mm | |||
| Balloon Length after inflation: | |||
| K09A, 4ml: 20.1mm | |||
| K08A, 6ml: 29.2mm | |||
| Insertion and Withdrawal Force | Measure the insertion and withdrawal force with 0.01m/s test velocity, Test report #: IMT-IFWF12-01 | Insertion Force: | |
| IBE-10; MEAN 1.24N | |||
| IBE-15; MEAN 1.65N | |||
| IBE-20; MEAN 2.11N | |||
| Withdrawal Force: | |||
| IBE-10; MEAN 1.11N | |||
| IBE-15; MEAN 1.42N | |||
| IBE-20; MEAN 1.79N | Insertion Force: | ||
| K09A; MEAN 1.08N | |||
| K08A; MEAN 1.49N | |||
| Withdrawal Force: | |||
| K09A; MEAN 0.90N | |||
| K08A; MEAN 1.26N |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample size (e.g., number of devices tested for each parameter) for the bench tests. It refers to "IBE-10," "IBE-15," "IBE-20" for the applicant's device and "K13A," "K09A," "K08A" for the predicate, which likely correspond to different sizes or models of the devices tested. Without further detail, we cannot determine the n for each specific test.
The data provenance is from bench testing conducted by IMEDICOM Co., Ltd. (Republic of Korea) and compared against the Kyphon Inflatable Bone Tamp. This is laboratory data, not patient-derived data, and therefore the concepts of "country of origin of the data," "retrospective or prospective" (in a clinical sense) are not directly applicable.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This question is not applicable to this type of device and study. The "ground truth" for these bench tests is established by physical measurement and engineering standards, not by expert interpretation of medical images or patient outcomes. The physical properties (e.g., tensile strength, burst pressure) are objectively measurable.
4. Adjudication Method for the Test Set
This question is not applicable. Adjudication methods (like 2+1 or 3+1) are used for establishing ground truth in human-reviewed data sets, especially when there's variability in expert interpretations. Bench tests rely on standardized measurement protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI/ML diagnostic devices where the output of the AI is compared to human readers' performance, with or without AI assistance, on a set of clinical cases. The MEDINAUT Kyphoplasty System is a physical surgical tool, not a diagnostic AI.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, this is not applicable. The device is a physical, non-AI medical tool. The concept of "standalone performance" without human intervention doesn't apply to a surgical instrument that is used by a surgeon.
7. The Type of Ground Truth Used
The "ground truth" for the bench tests is based on engineering measurements and specifications of the physical properties (e.g., strength, pressure resistance, dimensions, forces). The comparison is made against the performance of a legally marketed predicate device to demonstrate substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. As a physical medical device, there is no "training set" in the context of machine learning or AI. The design of the device is based on engineering principles and iterative development, not data-driven machine learning training.
9. How the Ground Truth for the Training Set Was Established
This question is not applicable for the same reasons as #8.
§ 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.”