(22 days)
The 3F BackStop Catheter is indicated for use by physicians for facilitating access to the urinary tract, either through a retrograde or antegrade route, and may be used in conjunction with a guidewire or for the injection of gels, such as BackStop™, or fluid into the urinary tract.
The BackStop Catheter is a 100cm, 3 French, single lumen catheter with a radiopaque tip that facilitates access to the urinary tract. The catheter is inserted over a guidewire or through the working channel of a ureteroscope and is advanced through the urinary tract to the desired location. Once in place, fluid may be injected via the catheter.
The device is a single lumen catheter with a stainless steel braid and a standard female luer lock hub on the proximal end.
The provided document is a 510(k) summary for the "BackStop Catheter." It describes a medical device, its intended use, and the non-clinical tests performed to demonstrate its safety and effectiveness. However, this document does not contain information about acceptance criteria or a study that uses a test set, ground truth established by experts, or any of the other specific details requested in your prompt.
The document details non-clinical bench testing, which is focused on the device's physical performance and does not involve human subjects or the evaluation of an algorithm against a ground truth.
Therefore, I cannot fulfill your request for the specific information regarding acceptance criteria, device performance against a test set, expert involvement, or comparative effectiveness studies, as these data points are not present in the provided text.
The closest information available is:
- "Acceptance Criteria": Not explicitly stated in terms of performance metrics or thresholds.
- "Reported Device Performance": Stated as "Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device."
- "Study that proves the device meets the acceptance criteria": A series of non-clinical bench tests were performed to demonstrate equivalence to a predicate device.
Here's a breakdown of why I cannot populate the table or answer the specific questions based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | "Results of bench testing have established the device as safe and effective for its intended use, which is identical to that of the predicate device." |
Details of non-clinical tests performed:
- Catheter hub-to-shaft tensile strength
- Catheter pressure during gel delivery
- Catheter Burst/Leak Pressure
- Catheter Insertion Force
- Catheter Column Strength
- Shaft Tensile Strength
- Catheter Hub Testing
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 available in the provided document. The tests were non-clinical bench tests, not involving patient data or a "test set" in the context of an algorithm or clinical study. Samples were accelerated aged at T=7 months, T=13 months, and T=37 months.
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/available. There was no "ground truth" derived from experts for a test set, as this was non-clinical bench testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/available. There was no "adjudication method" for a test set, as this was non-clinical bench testing.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or mentioned. The device is a physical catheter, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
A standalone performance study of an algorithm was not performed or mentioned. The device is a physical catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
There was no "ground truth" of this nature used. The testing focused on physical and mechanical properties against pre-defined engineering specifications or comparisons to the predicate device.
8. The sample size for the training set
This information is not applicable/available. There was no "training set," as this was non-clinical bench testing of a physical device, not an algorithm.
9. How the ground truth for the training set was established
This information is not applicable/available. There was no "ground truth for a training set."
§ 876.5130 Urological catheter and accessories.
(a)
Identification. A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).(b)
Classification. (1) Class II (performance standards).(2) Class I for the ureteral stylet (guidewire), stylet for gastrourological catheter, ureteral catheter adapter, ureteral catheter connector, and ureteral catheter holder. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.