(530 days)
The EndoSheath provides a sterile, disposable protective covering for the scope to be used during endoscopic examination of the upper airway, vocal chords, and/or nasal passages.
The VSI EndoSheath for use with the Machida Model ENT-4L, Olympus Model ENF Type 3P, Pentax Model FNL-10S and Pentax Model FNL-13S endoscopes consists of a sterile, disposable, protective sheath which covers the patient contact portion of the scope during a clinical procedure. The sheath is removed and disposed of following each procedure.
The provided text describes a 510(k) summary for the "EndoSheath" device and does not contain information about an AI/ML powered device. Therefore, it is not possible to answer the questions related to acceptance criteria, study details, sample sizes, ground truth, experts, and MRMC studies for an AI device.
The document discusses the safety and performance of the EndoSheath, a sterile, disposable protective covering for endoscopes. It outlines in vitro functional tests and biocompatibility data performed on the device to demonstrate its safety and effectiveness.
Here's an overview of the information present in the document that somewhat aligns with the requested categories, even though it's not for an AI device:
1. A table of acceptance criteria and the reported device performance:
The document lists functional tests performed on the proposed EndoSheath. However, it does not explicitly state the numerical acceptance criteria or the specific "reported device performance" in a table format. It only states that these tests "were performed."
| Acceptance Criteria Category | Reported Device Performance (as implied) |
|---|---|
| Sheath Expansion and Installation Test | Test performed, implied successful |
| Sheathed Scope Image Quality Test | Test performed, implied successful |
| Sheath Pressure/Burst Test | Test performed, implied successful |
The biocompatibility tests also fall under performance, implying successful completion.
| Acceptance Criteria Category (Biocompatibility) | Reported Device Performance (as implied) |
|---|---|
| Irritation | Data presented, implied compliant |
| Sensitization | Data presented, implied compliant |
| Cytotoxicity | Data presented, implied compliant |
| Acute Systemic Toxicity | Data presented, implied compliant |
| Hemolysis | Data presented, implied compliant |
| Implantation | Data presented, implied compliant |
| Microbial barrier testing (polio virus, Phi X 174 bacteriophage) | Data presented, implied compliant for label claims |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This information is not provided in the document. The document only states that tests were performed but does not specify the number of samples or the nature of the study (retrospective/prospective, country of origin).
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):
This is not applicable as the device is not an AI/ML powered device requiring expert-established ground truth for a test set. The tests are for the physical properties and biological compatibility of the sheath.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This is not applicable for the type of device and tests 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:
This is not applicable as the device is not an AI/ML powered device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the device is not an AI/ML powered device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the functional and biocompatibility tests, the "ground truth" would be established by scientific standards and laboratory protocols relevant to each specific test (e.g., standard physical measurements for sheath expansion, established biological assays for cytotoxicity, validated methods for microbial barrier testing). These are not expert consensus, pathology, or outcomes data in the context of an AI device.
8. The sample size for the training set:
This is not applicable as the device is not an AI/ML powered device and therefore does not have a "training set."
9. How the ground truth for the training set was established:
This is not applicable as the device is not an AI/ML powered device.
§ 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.