(116 days)
The Cure Twist® is a pre-lubricated intermittent urinary catheter that is inserted through the urethra and indicated for the purpose of bladder drainage for females. The urinary catheter comes in a variety of sizes and is packaged sterile for single-use.
The Cure Twist® Female Catheter is a ready-to-use intermittent catheter pre-lubricated with a water based gel and includes polished eyelets for smooth insertion and easy drainage. The catheters are manufactured in CH8 to CH16 sizes. They are single use devices made from polyvinyl chloride (PVC) and sterilized by ethylene oxide.
The Cure Medical Catheter Insertion Kits components are used to aid catheter insertion. The Cure Twist® Female Catheter plus insertion kit include the Cure Twist® Female Catheter, ambidextrous gloves (PVC or nitrile), a benzalkonium chloride (BZK) wipe, an under pad and a urine collection bag with a universal connector.
The Cure Twist catheters are expected to be used in professional healthcare facilities, homes, work, public bathrooms, as well as out and about.
The provided document is an FDA 510(k) clearance letter for the Cure Twist Female Catheter. It outlines the device, its indications for use, and a comparison to a predicate device, along with a summary of performance data. However, it does not contain the specifics of a study or acceptance criteria in the format requested, particularly for AI/machine learning device evaluation.
The document indicates that the device is a urological catheter, not an AI/ML device. Therefore, a study proving an AI device meets acceptance criteria, including specifics like sample sizes for test and training sets, expert consensus, MRMC studies, or ground truth establishment, would not be found in this type of clearance letter. The performance data points listed (sterilization, biocompatibility, packaging integrity, etc.) are standard for a physical medical device, not an AI algorithm.
Therefore, I cannot extract the requested information from the provided text for an AI/ML device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this document refer to the physical and mechanical properties of a catheter, validated through standard engineering and biological testing, not AI model performance.
Explanation of why the requested information cannot be provided from this document:
- Device Type: The Cure Twist Female Catheter is a physical medical device (urological catheter), not an artificial intelligence/machine learning (AI/ML) device.
- Performance Data Scope: The "Performance Data" section lists tests relevant to physical medical devices (e.g., sterilization, biocompatibility, packaging integrity, flow rate, tensile strength). These are not metrics or studies typically associated with evaluating AI/ML algorithms.
- Absence of AI/ML Specifics: There is no mention of deep learning models, algorithms, human readers, ground truth consensus for image or data interpretation, or any other elements that would be present in a study proving an AI device's performance.
If this were an AI device, the 510(k) summary would typically include details about:
- Clinical Performance Study: Often a standalone study or a multi-reader, multi-case (MRMC) study.
- Performance Metrics: Sensitivity, specificity, AUC, F1-score, accuracy, etc.
- Test Set Description: Number of cases, demographics, data provenance, and how ground truth was established.
- Training Set Description: Size and how ground truth was established.
- Human Reader Performance: If AI assistance improves human reader performance (MRMC).
Since the provided document pertains to a traditional physical medical device, those types of studies and acceptance criteria are not applicable or detailed within this clearance letter.
§ 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.