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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.

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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).

Both the unmodified predicate and the subject modified InterV Kyphoplasty Catheter 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.

The provided FDA 510(k) summary does not describe a study involving an AI/CAD/software device, nor does it present acceptance criteria and performance for such a device.

The document is for a medical device called the "InterV Kyphoplasty Catheter and InterV Kyphoplasty Catheter (Mini)," which is a physical device used in surgical procedures. The summary focuses on comparing the modified version of this catheter to a previously cleared predicate device, demonstrating substantial equivalence based on mechanical and functional testing.

Therefore, I cannot extract information related to acceptance criteria and study details for an AI-powered device from this document. The sections you requested (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set size) are not applicable to the type of device described in this 510(k) submission.

Ask a specific question about this device

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

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.

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