(115 days)
The Bipore Balloon Dilatation Catheter is indicated for Transluminal Percutaneous Angioplasty (PTA) of the iliac, femoral, and renal arteries, and for the treatment of obstructive lesions of autologous or synthetic arteriovenous dialysis fistulae.
The Bipore Balloon Dilatation Catheter is a double lumen balloon catheter for percutaneous transluminal angioplasty in peripheral vessels. One lumen is for inflation and deflation of the balloon; the other lumen is used to pass the catheter over a guidewire to locate the balloon at the site of stenosis.
The Bipore Balloon Dilatation Catheter will be offered in three balloon sizes and one shaft length, as follows:
Inflated Balloon Diameter (mm): 6, 8, 10
Balloon Length (cm): 4, 4, 4
Catheter Size (Fr): 5, 5, 5
Usable Length (cm): 100, 100, 100
The provided text is a summary of a 510(k) premarket notification for the "Bipore Balloon Dilatation Catheter" from 1996. It describes the device, its intended use, and lists some in vitro functional tests and biocompatibility tests performed.
However, the document does not contain the detailed information necessary to answer all the questions regarding acceptance criteria and a study proving those criteria. Specifically, it lacks:
- Quantitative acceptance criteria values. It lists the types of tests performed (e.g., "Balloon Burst"), but not the specific thresholds for passing those tests (e.g., "Balloon Burst pressure > X atm").
- Reported device performance values. While it mentions tests were performed, it doesn't provide the results of these tests (e.g., "Balloon Burst pressure was Y atm").
- Information about a specific study to prove device performance against acceptance criteria. The document states "The following in vitro functional tests were performed..." and "The following biocompatibility tests were performed...", implying tests happened, but it doesn't describe these as a formal "study" with the characteristics you've requested (e.g., sample size, ground truth establishment, expert involvement, MRMC study, etc.). This is a medical device, not an AI/ML-driven diagnostic, so many of your questions, particularly those about experts, ground truth, and AI-assistance, are not applicable in this context.
Below is an attempt to answer the questions based on the limited information provided, acknowledging the significant gaps.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Evaluation | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Functional Performance | Balloon Burst | Device withstands burst pressure (specific pressure not stated) | Performed, but specific performance data not provided. |
| Balloon Multiple Inflation | Device maintains integrity after multiple inflations (number of inflations not stated) | Performed, but specific performance data not provided. | |
| Balloon Compliance | Balloon expands according to specifications (specific compliance not stated) | Performed, but specific performance data not provided. | |
| Balloon Inflation/Deflation Time | Balloon inflates/deflates within acceptable time (specific time not stated) | Performed, but specific performance data not provided. | |
| Biocompatibility | Systemic Toxicity | Absence of systemic toxic effects | Performed, deemed acceptable. |
| Intracutaneous Toxicity | Absence of intracutaneous irritation/toxicity | Performed, deemed acceptable. | |
| Implantation | Absence of adverse tissue reaction upon implantation | Performed, deemed acceptable. | |
| Hemolysis | Minimizes damage to red blood cells | Performed, deemed acceptable. | |
| Cytotoxicity | Absence of cell toxicity | Performed, deemed acceptable. |
Note: The document concludes the device is "safe and effective for its intended use" based on these tests, implying all criteria were met, but specific numerical values for criteria and performance are not given.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the in vitro or biocompatibility tests. It also does not discuss "data provenance" in the context of geographical origin or retrospective/prospective nature, as these tests are laboratory-based device characterization.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to the type of device and testing described. The tests are in vitro functional and biocompatibility tests, which rely on established laboratory protocols and measurements, not human expert interpretation of data points to establish a "ground truth."
4. Adjudication method for the test set
This question is not applicable. Adjudication methods like "2+1" or "3+1" are used in studies involving human interpretation or subjective assessment where consensus is needed. For in vitro and biocompatibility testing, results are typically objective measurements or observations against predetermined criteria.
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
This question is not applicable. The device is a physical medical device (balloon catheter) and does not involve AI or human readers for its operation or performance evaluation as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable. The device is a physical medical device (balloon catheter) and does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the in vitro functional tests, the "ground truth" would be established physical measurements and engineering specifications. For biocompatibility tests, the "ground truth" would be established biological and toxicological standards and observations. These are objective measures, not expert consensus, pathology, or outcomes data in the way these terms are typically used for diagnostic or predictive devices.
8. The sample size for the training set
This question is not applicable. There is no "training set" for physical device testing in the context of machine learning or AI.
9. How the ground truth for the training set was established
This question is not applicable for the reasons stated above.
§ 870.1250 Percutaneous catheter.
(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).