(93 days)
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.
§ 874.4760 Nasopharyngoscope (flexible or rigid) and accessories.
(a)
Identification. A nasopharyngoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the nasopharyngoscope and is intended to examine or treat the nasal cavity and nasal pharynx. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel and flexible plastic. This generic type of device includes the antroscope, nasopharyngolaryngoscope, nasosinuscope, nasoscope, postrhinoscope, rhinoscope, salpingoscope, flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biospy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.