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Actreen® Hi-Lite Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by adult and pediatric patients with chronic urine retention or voiding dysfunction.

The proposed B. Braun Actreen® Hi-Lite Intermittent Urinary Catheter devices are flexible tubular devices that are inserted through the urethra and used to pass fluids from the urinary tract. These Actreen® Hi-Lite Intermittent Urinary Catheters are offered in a 7.5 inch length with a variety of French gauge sizes ranging from 6-16 with a straight tip. The outer packaging was designed to facilitate easier, no touch access for those with limited dexterity, while the hydrophilic lubrication makes this single use catheter ready to use.

The provided text is a 510(k) Pre-market Notification for a medical device, the Actreen® Hi-Lite Intermittent Urinary Catheters. This document details the process for obtaining FDA clearance for a device by demonstrating its "substantial equivalence" to a predicate device already on the market.

It's important to understand that a 510(k) summary does not contain the detailed clinical study results or statistical analyses that would typically be required to answer your specific questions about acceptance criteria for an AI/ML medical device, especially regarding aspects like MRMC studies, human-in-the-loop performance, or the nuances of ground truth establishment for complex image analysis.

The "studies" described in this document are primarily non-clinical performance tests demonstrating the physical, chemical, and biological safety and functionality of a physical medical device (a catheter) compared to an existing, similar catheter.

Therefore, many of your questions are not applicable to the information provided in this 510(k) summary. I can, however, extract the relevant "acceptance criteria" and "performance data" as presented for this specific type of device.

Here's an attempt to answer your questions based on the provided document, acknowledging the limitations for an AI/ML context:

Acceptance Criteria and Device Performance (for a physical medical device, not AI/ML)

The "acceptance criteria" for this device are implicitly tied to demonstrating substantial equivalence to its predicate device (K180801) through various non-clinical tests. The "performance" is the successful outcome of these tests, confirming that the new device performs similarly and safely to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria here are for a physical urinary catheter, not an AI/ML device. They relate to material compatibility, physical properties, and sterility, as outlined in the referenced standards. The "performance" is the successful meeting of these standards, which is stated as a conclusion rather than detailed results.

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Actreen Mini Intermittent Urinary Catheters are indicated for intermittent urinary catheterization by female patients with chronic urine retention or voiding dysfunction.

The Actreen Mini Intermittent Urinary Catheters include the Actreen Mini Cath and the Actreen Mini Set. The Actreen Mini Set is identical to the Actreen Mini Cath, except that the Actreen Mini Set includes a urine collection bag which is pre-attached to the catheter. The proposed devices are available in one length of 3.5 in with a straight tip, and offered in gauges 10 FR, 12 FR, 14 FR.

This document is a 510(k) Premarket Notification from the FDA regarding the Actreen® Mini Intermittent Urinary Catheters. It does not describe a study that uses AI or machine learning algorithms, nor does it provide detailed acceptance criteria and performance data in the context of such studies.

Therefore, I cannot provide a description of acceptance criteria and a study proving device performance as requested, because the provided text does not contain information about an AI/ML powered device, acceptance criteria or performance studies of the type requested in the prompt.

The document states that biocompatibility and performance testing were performed in accordance with ISO 10993-1 and EN 1616 to support substantial equivalence to predicate devices, but it does not specify the details of these tests, acceptance criteria, or the results.

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Hi-Slip, Hi-Slip Plus and Hi-Slip Kit are launched for Clean Intermittent Catheterization-CIC treatment and is indicated for use by patients with chronic urine retention. The catheter is inserted into the bladder through the urethra for emptying the bladder.

The Hi-Slip Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable polyvinyl chloride catheter (medical grade PVC) coated with hydrophilic polymer. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The catheter is provided in a variety of sizes and lengths.

The Hi-Slip Plus Hydrophilic Urinary Catheter is a single use urinary catheter designed for Clean Intermittent Catheterization, drainage of bladder. The device consists of disposable PVC (medical grade) catheter coated with hydrophilic polymer and water sachet (sterile water). Coating is activated by the water of integrated water sachet. Water is let down by squeezing the water sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. The PLUS is provided in a variety of sizes and lengths.

Hi-Slip Kit includes a single use coated PVC (medical arade) catheter, urine bag (medical grade PVC urine bag), water sachet (sterile water) and povidone iodine swab for cleaning urethra outlet prior to catheterization. The catheter is coated with a hydrophilic polymer (polyvynil pyrolidone, PVP) which makes the catheter surface slipperv when dipped into the water. Patient clean the urethra outlet by using povidone iodine swab and lets the water fill the catheter place in the urine bag by squeezing the sachet. When the catheter is immersed in water for 30 seconds, it becomes slippery and ready to use. Patient disposes the urine directly into urine bag. The KIT is provided in a variety of sizes and lenaths.

The provided text describes a 510(k) summary for Hi-Slip, Hi-Slip Plus, and Hi-Slip Kit urinary catheters, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving the device meets specific performance criteria. Instead, it focuses on demonstrating substantial equivalence to already marketed devices based on technological characteristics and intended use.

Therefore, most of the requested information cannot be extracted from the provided text.

Here's an attempt to answer the questions based only on the provided text, noting its limitations:

1. Table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria or a table of reported device performance in the context of comparative effectiveness or specific performance metrics for the Hi-Slip products. It primarily focuses on demonstrating substantial equivalence to predicate devices through comparisons of device composition, sizes, function, indications for use, features, sterility, and packaging. The "Summary of Safety Testing" section (Table 3.7) provides results for biocompatibility tests, but these are pass/fail criteria against ISO standards, not performance metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not mention any specific "test set" in the context of a clinical performance study. The safety tests listed in Table 3.7 would have involved samples of the device material, but the sample sizes (e.g., number of animals or cell cultures) are not specified. Data provenance (country of origin, retrospective/prospective) is not provided for these safety tests.

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)

Not applicable. The document does not describe a study involving expert-established ground truth for a test set. The safety tests typically rely on standardized laboratory protocols and measurements, not expert consensus on clinical cases.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical test set or adjudication method is described.

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 medical catheter, not an AI diagnostic tool involving human readers or AI assistance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical medical catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the safety tests (biocompatibility), the "ground truth" or reference is adherence to the specified ISO/DIN standards and observed biological responses (e.g., absence of toxicity, sensitization, genotoxicity, irritation, or critical cell damage).

8. The sample size for the training set

Not applicable. This device is a physical medical catheter, not an AI or algorithm that requires a training set.

9. How the ground truth for the training set was established

Not applicable. No training set is involved.

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