(52 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 Pluromed 3F BackStop™ Catheter is a 100 cm, 3F, single lumen, radiopaque catheter that facilitates access to the urinary tract. The catheter may be inserted over a guidewire or through the working channel of an ureteroscope and is advanced through the urinary tract to the desired location in the ureter. Once in place fluid or gels, such as BackStop™, 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.
This document is a 510(k) summary for the Pluromed 3F BackStop™ Catheter, a urological catheter. It asserts substantial equivalence to a predicate device and outlines performance standards met. However, it does not contain the kind of detailed information about acceptance criteria, specific device performance against those criteria, or the methodology of a study with sample sizes, expert qualifications, or ground truth establishment that would be expected for an AI/ML medical device.
Therefore, many of your requested points cannot be answered from the provided text. This document is a regulatory submission for a physical medical device, not a software or AI/ML device, and thus the type of studies and data provenance you're asking for are not applicable or present here.
Here's what can be extracted based on the provided text, with notes indicating where information is absent for an AI/ML context:
Acceptance Criteria and Device Performance (Not applicable for physical device, but can list standards met)
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| AAMI / ANSI / ISO 11607-1:2006 (Packaging for terminally sterilized medical devices) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 10993-1:2009(E) (Biological evaluation of medical devices) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 11137-1:2006 (Sterilization of health care products - Radiation - Part 1) | Complies (Implied by 510(k) clearance) |
| AAMI / ANSI / ISO 11137-2:2006 (Sterilization of health care products - Radiation - Part 2) | Complies (Implied by 510(k) clearance) |
Note: For an AI/ML device, this table would typically contain specific performance metrics (e.g., sensitivity, specificity, AUC) and the thresholds for acceptance for those metrics. The provided document details compliance with general medical device standards, not AI-specific performance metrics.
Study Details (Information Not Provided for AI/ML context)
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Information not provided. This document is for a physical medical device, not an AI/ML product. The 510(k) focuses on substantial equivalence to a predicate device based on design, materials, and intended use, and compliance with general device standards, not a clinical study to evaluate AI performance on a test set.
-
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):
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device.
-
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:
- Information not provided. This is not an AI/ML device; therefore, an MRMC study related to AI assistance would not have been conducted or reported here.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Information not provided. This is not an AI/ML device, so standalone algorithm performance is not relevant.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Information not provided. This concept is not applicable to the 510(k) submission for this physical device. The "truth" for this device would relate to its physical properties, biocompatibility, and functionality as a catheter, which are assessed against engineering standards and bench testing, not against medical ground truth for diagnosis/prognosis.
-
The sample size for the training set:
- Information not provided. This is not an AI/ML device; a "training set" doesn't apply.
-
How the ground truth for the training set was established:
- Information not provided. This is not an AI/ML device; "ground truth for training" doesn't apply.
In summary, the provided document is a 510(k) premarket notification for a physical medical device (a urological catheter). It outlines standard compliance and claims substantial equivalence to a predicate device (K090270). The questions you've asked are specifically tailored for AI/ML-driven medical devices, and the nature of the traditional medical device submission provided here does not contain such information.
§ 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.