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The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of the upper airway, vocal chords, nasal passages, esophagus and pulmonary structures,

The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quik-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end, which is preloaded on a deployment tube. Some models of the EndoMedical Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.

The provided document is a 510(k) summary for the EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with detailed acceptance criteria and standalone algorithm performance as would be expected for an AI/ML medical device.

Therefore, much of the requested information regarding acceptance criteria, study details, expert involvement, and ground truth establishment is not present in this document because it is not typically required or included in a 510(k) submission for this type of device.

However, I can extract the information that is present:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics in the way one would see for an AI/ML device. Instead, it describes non-clinical tests conducted to address safety and performance characteristics related to minor design differences compared to predicate devices. The "reported device performance" is a general statement about the success of these tests.

2. Sample size used for the test set and the data provenance

Not applicable. The document describes non-clinical material and functional testing of the device itself, not a study involving human or image data with a "test set" in the context of an AI/ML device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth as typically defined for AI/ML performance evaluation (e.g., expert consensus on medical images) is not relevant to this type of device and submission. The "ground truth" for the non-clinical tests would have been established by standard engineering and material science measurement techniques and validated against industry standards or predicate device performance.

4. Adjudication method for the test set

Not applicable. No "test set" of clinical cases requiring adjudication by human experts 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 is not an AI/ML device, and no MRMC study was conducted or is described.

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; therefore, no algorithm-only performance was assessed.

7. The type of ground truth used

The "ground truth" for the non-clinical tests would have been established through:

• Engineering specifications and standards: For mechanical tests and optical qualities.
• Microbiological testing standards: For barrier testing.
• Comparison to predicate device performance: To ensure similarity and non-inferiority.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no "training set."

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

Not applicable. This is not an AI/ML device; there is no "training set" or corresponding ground truth establishment process in the AI/ML context.

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The EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath provides a sterile, disposable protective covering for flexible endoscopes during endoscopic examination of bladder, urethra, lower gastrointestinal tract, and upper gastrointestinal structures including the esophagus.

The EndoMedical Technologies Quik-Cover Flexible Endoscope Barrier Sheath (EndoMedical Technologies Quilt-Cover™) is a sterile, single-use device that covers the entire patient contact surface of flexible endoscopes and eliminates the need for high-level disinfection of the endoscope following each procedure. The device is composed of a contiguous polymeric sheath, with an optical window at the distal end which is preloaded on a deployment tube. Some models of the EndoMedival Technologies Quik-Cover™ include a Y-connector and side port channel(s) that are intended to allow passage of air, water, suction and biopsy instruments.

The provided text describes a medical device, the EndoMedical Technologies Quik-Cover™ Flexible Endoscope Barrier Sheath, and its 510(k) summary for FDA clearance. However, the document does not contain the specific details required to fully address your request in the format you specified, particularly regarding detailed acceptance criteria, study methodologies, sample sizes for test and training sets, expert qualifications, or comparative effectiveness studies (MRMC).

The document states that "Nonclinical performance testing demonstrated that the EndoMedical Technologies Quik-Cover reliably achieves the desired affect and is safe for its intended use." This is a general statement of results, not a detailed breakdown of acceptance criteria and performance data.

Here's what can be extracted and what is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified in the provided text.
• Data Provenance: Not specified (e.g., country of origin, retrospective or prospective). The tests are described as "nonclinical," suggesting laboratory testing rather than human clinical trials with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

• Number of Experts: Not applicable/not specified. The testing was nonclinical (laboratory-based) and focused on device performance characteristics rather than medical image interpretation or clinical diagnosis requiring expert ground truth.
• Qualifications of Experts: Not applicable/not specified.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable/not specified. Given the nonclinical nature of the tests, an adjudication method for expert consensus on ground truth would not be relevant.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• MRMC Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the substantial equivalence of device properties (material, design, nonclinical performance) to predicate devices, not on the impact of the device on human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study: Yes, in a sense. The described "nonclinical tests" are standalone evaluations of the device's physical and functional properties (e.g., optical qualities, mechanical strength, barrier integrity) without human interaction during the test itself. This is not an "algorithm only" study as it's a physical device, but it represents standalone device performance.

7. Type of Ground Truth Used

• Type of Ground Truth: For the nonclinical tests mentioned (optical qualities, mechanical tests, barrier testing), the "ground truth" would be objective physical and material standards, specifications, and test methods designed to measure these properties. For example, a barrier test might have a measurable standard for microbial penetration, or a mechanical test might have a specified breaking point.

8. Sample Size for the Training Set

• Sample Size for Training Set: Not applicable. This document describes a physical medical device, not a machine learning model or algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Summary of Gaps:

The provided 510(k) summary is typical for a physical medical device seeking substantial equivalence. It focuses on demonstrating that the new device shares similar fundamental technology and performance characteristics with existing cleared devices. It does not contain the detailed clinical trial or AI model validation information you are requesting. For such a device, "acceptance criteria" are usually internal design specifications and performance standards against which the manufactured product is tested. The "study" proving it meets criteria refers to the nonclinical bench testing outlined, but the specific metrics and results are not detailed in this summary.

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The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder.

The Memcath Urology Catheter is designed as an intermittent pathway for drainage of the bladder. The device consists of a PVC catheter tube with pre-loaded, self-deploying PTFE sheath membrane to increase lubricity during insertion. This catheter system also includes a polyurethane snap ring and polycarbonate/acrylic guide ring to secure the sheath.

The Memcath Urology Catheter is intended to provide an intermittent pathway for draining fluids from the bladder. The device was found substantially equivalent to the Sherwood-Davis & Geck Argyle Rob-Nel Urological Catheter (K810216).

Here's a breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for Test Set

The document does not specify the sample sizes used for each test. The studies were conducted by Memcath Technologies LLC and submitted to the FDA in the United States. They appear to be prospective tests performed on newly manufactured devices.

3. Number of Experts and Qualifications for Ground Truth

Not applicable. The ground truth for these tests is based on established engineering and materials performance standards for medical devices and their intended use, rather than expert clinical consensus in interpreting data.

4. Adjudication Method for Test Set

Not applicable. The tests are objective measurements against defined specifications.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a physical medical catheter, not an AI/software-as-a-medical-device (SaMD) that typically undergoes MRMC studies.

6. Standalone Performance Study

Yes, standalone performance studies were conducted. The "Testing" section explicitly states that "Products were tested for" a list of attributes, and "All product testing met specifications." This indicates that the device's performance was evaluated independently against pre-defined criteria.

7. Type of Ground Truth Used

The ground truth used for these performance tests is based on engineering specifications and established regulatory standards for urological catheters, often with reference to predicate devices. For example, "Flow Rate," "Stiffness," and "Kink Resistance" have objective, measurable benchmarks that must be met. "SAL" pertains to sterility standards, and "EtO Residuals" to acceptable levels of ethylene oxide post-sterilization.

8. Sample Size for Training Set

Not applicable. This device is a physical medical device, not an AI/machine learning model, so there is no "training set."

9. How Ground Truth for Training Set Was Established

Not applicable, as there is no training set for a physical medical device.

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