(118 days)
The Gyrus ACMI Variable Length Access Sheath is intended to be used to permit direct passage of catheters or other devices for the purpose of performing diagnostic and surgical procedures (e.g.,nephrostomy, cystoscopy, ureteroscopy, etc.) in the urinary tract.
Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath is a single use, sterile disposable product. The device consists of a sheath (manufactured from PTFE with BiOs) and dilator (manufactured from HDPE with BaS02) to facilitate the passage of catheters and other urological devices in the urinary tract. The sheath length is adjustable to the size necessary for the procedure. The dilator is attached to the sheath via a locking leur. The leur connector also allows for injection or irrigation or contrast fluid. For ease of visualization, the dilator and sheath are radiopaque.
The provided text describes a Special 510(k) Notification for the Gyrus ACMI Vari-Pass™ Adjustable Length Access Sheath and primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance data in the traditional sense of a clinical or analytical performance study.
Therefore, many of the requested elements for a study showing device performance against acceptance criteria are not directly available in the provided text.
Here's an attempt to extract and infer information based on the given text:
1. A table of acceptance criteria and the reported device performance
The submission primarily relies on demonstrating substantial equivalence through non-clinical testing comparing the modified device to predicate devices. The "acceptance criteria" are implicitly that the modified device performs no worse than the predicate devices across relevant performance characteristics.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Materials are biocompatible. | Biocompatibility testing performed in compliance with ISO-10993. |
| No significant difference in technological features. | Incorporates the same technological features (peel away sheath, tapered dilator and locking mechanism with port) as previously cleared devices. |
| No significant difference in intended use. | Has the same Indications for Use as previously cleared devices. |
| Similar materials with established history of successful clinical application. | Uses similar materials (PTFE for sheath, HDPE for dilator - same as predicate but from different supplier). Materials have an established history in Urology. |
| Performance demonstrated to be substantially equivalent to predicate devices. | Nonclinical testing conducted, demonstrating no significant difference in performance compared to predicate devices. |
| No new issues of safety and effectiveness raised by modifications. | Non-clinical testing confirms that no new issues of safety and effectiveness have been raised by the proposed device modifications. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "nonclinical testing" but does not specify sample sizes for these tests. It's also not a clinical study, so terms like "test set" in the context of clinical data are not directly applicable. The testing is likely laboratory-based. No country of origin or retrospective/prospective nature is mentioned, consistent with non-clinical, in-vitro testing.
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)
This is not applicable as the submission describes non-clinical testing for substantial equivalence, not a study requiring expert-established ground truth on clinical cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as it's a non-clinical submission for substantial equivalence.
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 device is an access sheath for urological procedures, 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 device is an access sheath, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical testing, the "ground truth" would likely be the established performance characteristics and safety profile of the predicate devices, against which the new device's performance was compared. This comparison would be based on engineering specifications and material science, not clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable.
§ 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.