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510(k) Data Aggregation
(93 days)
RTC INC.-MEMCATH TECHNOLOGIES LLC
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.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Optical qualities of sheath window | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Sheath mechanical tests | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Finished device barrier testing | Demonstrated satisfactory performance (implied by "reliably achieves the desired affect") |
| Overall safety for intended use | "reliably achieves the desired affect and is safe for its intended use." |
| No new questions of safety or effectiveness for endoscope barrier sheaths | "No new questions of safety or effectiveness for endoscope barrier sheaths were raised during the testing." |
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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(40 days)
RTC INC.-MEMCATH TECHNOLOGIES LLC
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
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Optical Qualities of Sheath Window | Not explicitly stated in terms of specific metrics or thresholds. The study mentions this as a nonclinical test performed. |
| Sheath Mechanical Tests | Not explicitly stated in terms of specific metrics or thresholds (e.g., tensile strength, tear resistance, puncture resistance). The study mentions this as a nonclinical test performed. |
| Finished Device Barrier Testing | Not explicitly stated in terms of specific metrics or thresholds (e.g., microbial barrier effectiveness, fluid impermeability). The study mentions this as a nonclinical test performed. |
| Overall Safety and Effectiveness | "Nonclinical performance testing demonstrated that the EndoMedical Technologies Quik-Cover reliably achieves the desired affect and is safe for its intended use." |
| "No new questions of safety or effectiveness for endoscope barrier sheaths were raised during the testing." |
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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