(39 days)
SpeediCath Compact is indicated for use by patients with chronic urine retention and patients with a post void residual volume (PVR) due to neurogenic and non-neurogenic voiding dysfunction. The catheter is inserted into the urethra to reach the bladder allowing urine to drain.
The catheter is for female patients only.
SpeediCath Compact is a sterile, single use, disposable polyurethane catheter for females. The catheter is pre-lubricated with a hydrophilic coating and immersed in saline solution. The packaging of SpeediCath Compact is an integrated part of the product functioning partly as an insertion handle. In use, the inner tube is extended and removed from the handle as the catheter is locked in place with the handle. The catheter is then ready to use allowing easy handling and urine to flow through the catheter and handle.
The provided text describes a 510(k) summary for the SpeediCath Compact device, a urinary catheter. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.
Key takeaway regarding your request: The provided text does not contain information about acceptance criteria or a study proving device performance against such criteria in the manner typically associated with clinical trials for AI/ML medical devices (e.g., performance metrics like sensitivity, specificity, F1-score, AUC).*
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Coloplast's SpeediCath) through:
- Material and functional similarity: Both are ready-to-use intermittent catheters with hydrophilic coatings, made of the same material, immersed in the same saline solution, sterile, and single-use.
- Minor differences in packaging and intended user group: SpeediCath Compact has a modified packaging for ease of use and is specifically for female use, while the predicate is for both males and females.
- Compliance with relevant standards: The device has been tested against ASTM 623, ASTM D1894, EN 1616, EN 1618, and relevant sections of ISO 10993 (Biological Evaluation of Medical Devices). These standards generally relate to physical properties, biocompatibility, and intended use characteristics of catheters, not diagnostic performance of an AI/ML algorithm.
Therefore, I cannot populate the table or answer most of your specific questions related to AI/ML device performance criteria, sample sizes for test/training sets, expert ground truth, or MRMC studies, as this information is not present in the provided 510(k) summary for this device.
Below is a table reflecting the type of "acceptance criteria" (compliance with standards) and "reported performance" (compliance achieved) as derived from the document, but it's crucial to understand this is not the typical performance evaluation for AI/ML.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria (Compliance with Standards) | Reported Device Performance (Status) |
|---|---|
| ASTM 623 (relevant sections) | Complies |
| ASTM D1894 (relevant sections) | Complies |
| EN 1616 (relevant sections) | Complies |
| EN 1618 (relevant sections) | Complies |
| ISO 10993 (relevant sections - Biological Evaluation of Medical Devices) | Complies |
| Functional Equivalence to Predicate (SpeediCath) | Substantially Equivalent |
Regarding the study that proves the device meets the acceptance criteria:
The study that proves the device meets these "acceptance criteria" is a series of tests demonstrating compliance with the relevant sections of the listed national and international standards (ASTM, EN, ISO). These tests would typically assess physical properties, sterility, biocompatibility, and other performance characteristics specific to urinary catheters. The document states, "SpeediCath Compact has been tested and complies with relevant sections..." which serves as the "proof" within this regulatory submission. The specifics of these tests (e.g., sample sizes, methodology) are not detailed in this summary.
The following information is NOT available in the provided text as it pertains to AI/ML device evaluation, which this document does not cover:
- Sample sizes used for the test set and the data provenance: Not applicable/Not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided.
- Adjudication method for the test set: Not applicable/Not provided.
- 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/Not provided.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/Not provided.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable/Not provided.
- The sample size for the training set: Not applicable/Not provided.
- How the ground truth for the training set was established: Not applicable/Not provided.
§ 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.