(61 days)
8G InterV Kyphoplasty Catheter, 11G InterV Kyphoplasty Catheter (Mini), 13G InterV Kyphoplasty Catheter (Micro) and 11G InterV Kyphoplasty Catheter (Flex) are 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).
Both the predicate and the subject InterV Kyphoplasty Catheters are designed for use in balloon kyphoplasty; they come 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 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.
This document is a 510(k) premarket notification for a medical device called the "InterV Kyphoplasty Catheter." As such, it focuses on demonstrating substantial equivalence to existing devices rather than proving performance against specific acceptance criteria through a clinical study for a novel device. The information provided is for a modified/new size device, not an AI/ML powered medical device, therefore many of the standard questions about acceptance criteria for AI/ML devices do not apply.
Here's an analysis based on the provided text, addressing the points where applicable and noting where the information is not relevant to this type of submission:
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria and reported device performance in the context of an AI/ML device. Instead, it describes "predetermined acceptance criteria were met" for non-clinical tests without detailing the specific criteria or exact results for each.
The summary of non-clinical tests states:
"Verification activities including mechanical and functional testing as required by the risk analysis for the line extension were performed to confirm that the subject device functions as intended and does not raise any new issues of safety or effectiveness. The results from the testing demonstrated that the predetermined acceptance criteria were met and the device does not raise any new issues of safety or effectiveness."
It also mentions:
"Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate (LAL) test conducted on the subject device confirmed that the device met the pyrogen limit specification of 20 EU/device."
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable. The device is a physical medical device (kyphoplasty catheter), not an AI/ML algorithm that processes data. The testing mentioned refers to mechanical, functional, and sterility tests performed on physical samples of the device.
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)
This information is not applicable. Ground truth and expert consensus are concepts relevant to AI/ML model validation, not to the verification of mechanical and functional performance of a physical medical device.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable as it pertains to establishing ground truth for AI/ML models.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human interpretation, which is not applicable to a physical medical device like a kyphoplasty catheter.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable as there is no AI algorithm involved in this device submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. For a physical device, testing verifies that the device meets its design specifications and functional requirements (e.g., burst pressure, inflation volume, material compatibility, sterility), rather than comparing its output to a "ground truth" derived from patient data.
8. The sample size for the training set
This information is not applicable as there is no AI/ML algorithm with a training set.
9. How the ground truth for the training set was established
This information is not applicable as there is no AI/ML algorithm with a training set.
Summary of Device and Study Type:
This document is for a Special 510(k) submission for modifications (new sizes) to an existing InterV Kyphoplasty Catheter. The core of a 510(k) is to demonstrate that the new device is substantially equivalent to a legally marketed predicate device.
Acceptance Criteria and Proof of Meeting Them (as described in the document):
- Overall Goal: To confirm the subject device functions as intended and does not raise any new issues of safety or effectiveness compared to the predicate devices.
- Method: "Verification activities including mechanical and functional testing as required by the risk analysis for the line extension were performed."
- Acceptance Criteria for Non-Clinical Tests: "predetermined acceptance criteria were met." (Specific criteria and quantitative results are not detailed in this summary, but would be present in the full submission).
- Specific Example of Acceptance Criteria and Performance:
- Test: Bacterial Endotoxin Test (BET)/ Limulus Amebocyte Lysate (LAL) test.
- Acceptance Criteria: Pyrogen limit specification of 20 EU/device.
- Reported Performance: "confirmed that the device met the pyrogen limit specification of 20 EU/device."
Clinical Studies:
- "N/A - No clinical tests were conducted for this submission." This is common for 510(k) submissions, especially for modifications or line extensions where substantial equivalence can be demonstrated through non-clinical testing.
Conclusion of the Submission:
The conclusion states that based on the same indications for use, similar materials (with a minor stylet change noted and justified as not affecting safety/effectiveness), same operating principle, same shelf life, and same packaging/sterilization, along with the results from risk analysis and associated verification testing, the new devices are substantially equivalent to the currently marketed predicate devices.
§ 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.”