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510(k) Data Aggregation
(247 days)
Kyphoplasty Balloon Catheter
Kyphoplasty Balloon Catheter is intended to be used for the reduction of 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).
Kyphoplasty Balloon Catheter is an inflatable balloon catheter used in percutaneous kyphoplasty (PKP). The Balloon Catheter consists of an outer tube and core tube/rod, inflatable balloon located at the distal tip. The radiopaque markers located at the balloon tip to reflect the balloon position during positioning. The balloon catheter is supplied sterilized, single-use.
The provided text describes the 510(k) summary for the Kyphoplasty Balloon Catheter, focusing on its non-clinical testing to demonstrate substantial equivalence to a predicate device. It explicitly states that no clinical study was performed or included in the submission. Therefore, I cannot provide information on acceptance criteria and study proving device meets acceptance criteria related to a clinical study, human reader performance, or multi-reader multi-case studies, as there were none reported.
The information below is derived from the non-clinical (bench) testing section, which serves as the primary evidence for this device's acceptance.
Here's the breakdown based on the provided text for the non-clinical testing:
1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Bench Testing)
The document primarily lists acceptance criteria for various bench tests. It states that "The test results show pass the requirements" for the performance tests, implying the device met these criteria, but specific reported values are not provided, except for the "Balloon Inflation Behavior" which includes a target range.
| Test Performed | Acceptance Criteria | Reported Device Performance (Implied, as "passed requirements") |
|---|---|---|
| Balloon Burst Pressure | Balloon Burst Pressure (Constrained) ≥ 400psi | Met acceptance criterion (implicitly ≥ 400psi) |
| Balloon Burst Volume | Balloon Burst Volume (Constrained) ≥ 6ml | Met acceptance criterion (implicitly ≥ 6ml) |
| Balloon Inflation Behavior (Unconstrained Balloon Compliance) | Inflated with 6 ml, the balloon diameter should be 18.3±3.0 mm, and the balloon working length should be 28.0±3.0 mm. | Met acceptance criterion (within specified diameter and length range) |
| Tensile Force | Tensile force ≥ 15N. | Met acceptance criterion (implicitly ≥ 15N) |
| Balloon Repeated Inflation | The balloon should withstand 20 inflation/deflation cycles at rated filling volume without rupture or leak. | Met acceptance criterion (implicitly withstands 20 cycles) |
| Balloon Deflation Time | Deflation time ≤ 3s. | Met acceptance criterion (implicitly ≤ 3s) |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size (number of devices) used for each bench test. The studies were non-clinical (bench tests) meaning they were conducted in a lab environment using the physical device. Data provenance refers to the origin of the data. For bench testing, this would typically be from the manufacturer's internal testing facilities (Jiangsu Changmei Medtech Co., Ltd.). The data is prospective in the sense that the testing was performed specifically for this 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. For non-clinical bench testing, "ground truth" is established by engineering specifications, validated test methods, and measurement against international standards (ISO, ASTM, USP). Experts involved would be engineers and quality control personnel, not medical practitioners.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies, typically for resolving disagreements among human readers or expert reviewers of clinical data. This document describes bench testing where measurements are objective and quantitative.
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, an MRMC study was not done. The document explicitly states: "No clinical study is included in this submission." This device is a physical medical device (balloon catheter), not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
For non-clinical bench tests, the "ground truth" is based on:
- Pre-defined engineering specifications and acceptance criteria.
- Measurements against established physical properties and performance metrics.
- Compliance with recognized international standards (e.g., ISO 10993 for biocompatibility, ISO 11135 for sterilization, ASTM F1980 for shelf-life, ISTA-2A for shipping).
8. The Sample Size for the Training Set
Not applicable. "Training set" refers to data used to train machine learning algorithms. This document describes a physical medical device and its non-clinical testing.
9. How the Ground Truth for the Training Set was Established
Not applicable for the same reason as above.
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