(48 days)
The CYSTOGLIDE DILATING INTRODUCER SHEATH is intended to facilitate the dilation of urethral strictures and the introduction of catheters or instruments into the urethra. The CYSTOGLIDE DILATING INTRODUCER SHEATH is indicated for use as a urethral dilator and as a guide for urological catheters or instruments and as a lubricious barrier between the urethral tissue and the catheter or instrument.
The CYSTOGLIDE DILATING INTRODUCER SHEATH consists of a film, a sheath, a stabilizing hub and a dilator. The device can be front-loaded onto a urological guidewire.
The provided 510(k) summary for the CYSTOGLIDE DILATING INTRODUCER SHEATH does not contain specific acceptance criteria or a detailed study proving the device meets explicit performance metrics.
Instead, the submission focuses on demonstrating substantial equivalence to predicate devices based on "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." This means the device's performance was compared to existing, legally marketed devices, rather than against predefined, quantitative acceptance criteria.
Therefore, providing a table of acceptance criteria and reported device performance as requested, along with details about sample sizes, ground truth establishment, expert qualifications, and MRMC studies, is not possible based on the information given. The document does not provide these types of details because the approval pathway is substantial equivalence, not a demonstration of meeting specific performance endpoints.
However, I can extract and summarize the available information related to performance and study references:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly stated as quantitative criteria with predefined pass/fail thresholds. The basis for acceptance is "no significant difference" compared to predicate devices. | "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." |
2. Sample size(s) used for the test set and the data provenance
- Sample Size: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The document only refers to "Performance data."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not specified. The document does not describe a study involving human expert evaluation for establishing ground truth or performance.
4. Adjudication method for the test set
- Not applicable/Not specified.
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 a physical medical device (dilating introducer sheath), not an AI/software device that would involve human readers or comparative effectiveness studies with AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable/Not explicitly stated. The "performance data" likely refers to bench testing or animal model studies assessing physical properties and functionality mimicking the intended use, rather than clinical ground truth as understood in diagnostic AI/imaging studies. The comparison is to a predicate device's performance.
8. The sample size for the training set
- Not applicable. This is for a physical device, not an algorithm requiring a training set.
9. How the ground truth for the training set was established
- Not applicable.
Summary based on available information:
The 510(k) submission for the CYSTOGLIDE DILATING INTRODUCER SHEATH demonstrates substantial equivalence based on a comparison to predicate devices, specifically stating "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE DILATING INTRODUCER SHEATH and the predicate device." The document does not provide details on quantitative acceptance criteria, specific study designs (e.g., sample sizes, provenance), expert involvement, or AI-related metrics as it pertains to a physical medical device rather than a diagnostic algorithm or AI system.
§ 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.