(238 days)
InterV Kyphoplasty Catheter is intended to be used for reduction and fixation of fractures and/or creation of a void in cancellous bone in the spine during balloon kyphoplasty (for use with cleared spinal polymethymethacrylate (PMMA) bone cements).
InterV Kyphoplasty Catheter is designed for use in balloon kyphoplasty; it comes as a single-use double lumen catheter with a low profile balloon mounted on the distal tip. The balloon is designed to compress cancellous bone and/or move cortical bone as it inflates. The balloon is designed to withstand bone resistance leading to an a internal pressure of up to 400 psi (27 ATM). The key components are the balloon, shaft, Y-connector and two radiopaque marker bands positioned on the inner tubing/lumen at the proximal and distal ends of the inflatable component
The provided text describes the InterV Kyphoplasty Catheter and its premarket notification [510(k)] submission. It outlines the device's technical characteristics and the non-clinical tests conducted to demonstrate its substantial equivalence to predicate devices.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Inflation Pressure | Exceed minimum burst pressure in a constrained environment | The balloon catheter exceeded the requirements for the minimum burst pressure in a constrained environment. |
| Inflation Volume | Exceed minimum burst volume in a constrained environment | The balloon catheter exceeded the requirements for the minimum burst volume in a constrained environment. |
| Inflated Balloon Dimensions | Substantially equivalent to predicate devices | The inflated balloon dimensions were substantially equivalent to those of the predicate devices. |
| Balloon Double Wall Thickness | Substantially equivalent to predicate devices | The double wall thickness of the balloons was substantially equivalent to those of the predicate devices. |
Note: The document does not explicitly state "acceptance criteria" values but rather reports that the device "exceeded the requirements" or was "substantially equivalent" to predicate devices, implying these as the criteria.
2. Sample size used for the test set and the data provenance
The document does not provide details on the specific sample sizes for the non-clinical tests (e.g., number of catheters tested for each characteristic). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) for these non-clinical tests. As these were non-clinical tests, the concept of "data provenance" in the context of human subjects is not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The study involved non-clinical, in-vitro testing of device characteristics, not an evaluation requiring human expert interpretation of data or images.
4. Adjudication method for the test set
This information is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers, which this submission explicitly states were not conducted ("N/A- No clinical tests were conducted for this submission"). The tests described are engineering performance tests.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "N/A- No clinical tests were conducted for this submission." This product is a physical medical device (catheter), not an AI diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
A standalone performance evaluation was done in the sense that the device's physical characteristics were tested independently. However, this is not an "algorithm only" or "AI without human-in-the-loop" study as the device is not an AI algorithm. The performance evaluation was focused on the mechanical and physical properties of the catheter itself.
7. The type of ground truth used
The ground truth for the non-clinical tests was established by direct measurement and observation against predefined engineering specifications and criteria, or by comparison to the performance of legally marketed predicate devices. For example:
- Inflation Pressure: Measured burst pressure.
- Inflation Volume: Measured burst volume.
- Inflated Balloon Dimensions: Measured dimensions compared against predicate devices.
- Balloon Double Wall Thickness: Calibrated measurement.
8. The sample size for the training set
This information is not applicable. This submission describes a physical medical device, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable as there was no training set for an AI algorithm.
§ 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.”