(476 days)
The CYSTOGLIDE INTRODUCER SHEATH is intended to facilitate the introduction of catheters or instruments into the urethra. The CYSTOGLIDE INTRODUCER SHEATH is indicated for use as a guide for urological catheters or instruments inserted into the urethra and as a lubricious barrier between the urethral tissue and the catheter or instrument.
The CYSTOGLIDE INTRODUCER SHEATH consists of a film, a sheath, a stabilizing ring, and an obturator. The sheath is isolated from the skin microflora by the ViaShield film membrane.
This document is a 510(k) summary for the CYSTOGLIDE INTRODUCER SHEATH, a medical device. A 510(k) summary focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study data with specific acceptance criteria and performance metrics typically found in AI/ML device submissions.
Therefore, the provided text does not contain the kind of detailed information requested about acceptance criteria, study design, sample sizes, expert qualifications, adjudication methods, or ground truth establishment that would be present for an AI/ML device.
The "Performance Data" section merely states: "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices." This is a qualitative statement of equivalence, not a presentation of specific metrics against predefined acceptance criteria.
Based only on the provided text, I cannot complete the requested tables and information.
However, I can extract the relevant information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified | No significant difference in performance compared to predicate devices (PSI's UPDATED SLIP Urology Introducer Sheath, Astra Tech's LoFric catheter, Rusch's MMG/O'Neil catheter). |
Explanation: The document states that "Performance data demonstrated no significant difference in the performance of the CYSTOGLIDE INTRODUCER SHEATH and the predicate devices." This is the core 'performance' claim. However, the specific acceptance criteria (e.g., a threshold for friction, ease of insertion, durability) that would define "no significant difference" are not detailed in this 510(k) summary.
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable to this type of device submission. The device is a physical introducer sheath, not an AI/ML diagnostic tool using expert-labeled images/data.
4. Adjudication method for the test set:
- Not applicable.
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 is not an AI/ML device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
7. The type of ground truth used:
- Not applicable in the context of AI/ML ground truth. The "ground truth" for this device would be its physical properties and clinical function (e.g., lubricity, strength, biocompatibility), which are typically assessed through bench testing and potentially limited human use studies, but not in the sense of 'ground truth' for an AI model.
8. The sample size for the training set:
- Not applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.
§ 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.