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The Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters are 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 for use during percutaneous vertebral augmentation, such as kyphoplasty.

The inflation of the balloon serves to create a cavity in the vertebral body, compressing the cancellous bone and/or move cortical bone, thereby reducing the fracture and preventing cement leakage, while still allowing for cement interdigitation.

Modified Winch Kypholplasy (15 and 20 mm) 11 Gauge balloon catheters fit through a 10 Gauge cannula allowing a minimally invasive kyhoplasty procedure. The low pre-inflation profile (low wrapping profile of folded balloon) enables their insertion into these small working cannulas.

The stiff distal end of the balloon catheter provides rigidity for smooth insertion while the flexible proximal catheter allows for easy maneuverability. The inflating component, laserbonded to the shaft, is a low-pressure elastomeric balloon of tubular shape (which is inflated by volume, not pressure). The inflation can expand the balloon several times its original size, it can be inflated to precise dimensions and retain well defined shapes and high pressures and when the pressure is released, it recovers close to its original size and shape, re-folding back to similar original profiles.

This document, a 510(k) Pre-Market Notification for the "Modified Winch Kyphoplasty (15 and 20 mm) 11 Gauge Balloon Catheters," does not contain information about an AI/ML-based medical device. Instead, it describes a conventional medical device (balloon catheters used in kyphoplasty) and its modification.

Therefore, many of the requested details regarding acceptance criteria and study design for an AI/ML device (e.g., sample size for test/training sets, ground truth establishment by experts, MRMC studies, standalone algorithm performance, effect size of human improvement with AI) are not applicable to the content provided.

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K152557) based on design verification and validation testing of the modified physical device, rather than performance of an AI algorithm against a medical condition.

Here's a breakdown of what can be extracted from the provided text, and what cannot be answered given the nature of the document:

1. A table of acceptance criteria and the reported device performance

The document states:
"Using design FMECA, G21 identified the necessary verification and validation testing to assure the new balloon met the catheters original performance specifications. All testing demonstrated that the modified catheters continues to meet all performance specifications."

While the general statement is made that "all performance specifications" were met, the document does not provide a specific table of quantitative acceptance criteria or the numerical reported device performance results for the physical properties of the balloon catheters (e.g., burst pressure, inflation/deflation times, material strength, dimensions). It refers to the use of Design FMECA (Failure Mode and Effects Criticality Analysis) to identify necessary testing.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This device is a physical medical instrument, not an AI algorithm evaluated on patient data. The "test set" would refer to the physical units undergoing engineering and performance testing. The document does not specify the number of catheters tested or the origin of any "data" in the sense of patient data.

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)

• Not applicable. "Ground truth" in this context would typically relate to clinical outcomes or definitive diagnoses for AI models. For a physical device, testing is against engineering specifications and performance metrics. There's no mention of experts establishing a clinical "ground truth" for the device's function or performance in the human body within this document, beyond standard medical device development and regulatory review processes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. This method is used for resolving discrepancies in expert labeling for AI/ML ground truth. It is not relevant to the engineering and performance testing of a physical device.

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

• Not applicable. This type of study is specific to evaluating the clinical impact of AI-assisted diagnostic or decision-making tools. The device is a surgical instrument.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. The device is a physical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. The "ground truth" for this device would be its adherence to pre-defined engineering design specifications and performance characteristics, verified through physical and mechanical testing, not clinical diagnostic accuracy.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" or corresponding ground truth establishment in the context of AI/ML.

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