(40 days)
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.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.