(23 days)
The flexible trans-nasal esophagoscope with sheath system is intended for use in endoscopic access and examination of the larynx, esophagus and gastro-esophageal junction. The device may also be used to assist intubation.
The VSI EndoSheath® Systems are sterile, single-use protective sheath systems, with or without a working channel, that are intended to cover the entire insertion tube of the flexible endoscope.
This document (K071903) is a Special 510(k) Premarket Notification for a device modification, which means it relies on changes to an already cleared device and doesn't typically include extensive de novo performance studies with new acceptance criteria or human reader studies. The primary focus is on demonstrating that the modifications do not adversely affect safety and effectiveness, often by showing compliance with design controls and risk analysis.
Therefore, many of the requested elements (like a table of acceptance criteria and performance, sample sizes for test/training sets, expert qualifications, MRMC studies, standalone performance, and detailed ground truth establishment) are not explicitly provided or applicable in the context of this specific type of submission as presented. The document states that "V & V activities, including sheath functional and performance testing, was addressed through Design Validation and Verification planning," implying that these tests were internal and likely verified against existing specifications for the predicate device, rather than new, independently established acceptance criteria for a novel device.
However, based on the provided text, I can extract what is available and indicate where information is missing or not relevant to this type of submission.
Acceptance Criteria and Device Performance Study Information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safety and effectiveness for intended use (unmodified) | "Shown to be safe and effective for their intended use." |
| Compliance with 21 CFR 820.30 Design Control requirements | "Certification of compliance to 21 CFR 820.30 Design Control requirements" |
| Adherence to internal Risk Analysis procedures | "Description of the internal Risk Analysis procedure." |
| Functional and performance integrity of the modified sheath | "Sheath functional and performance testing was addressed through Design Validation and Verification planning." |
| Substantial equivalence to predicate device (K031786) | FDA determined the device is "substantially equivalent." |
Note: The document does not provide specific quantitative acceptance criteria or detailed performance results in the public summary. The "performance testing" mentioned is framed as part of Design Validation and Verification (V&V) activities against the device's own specifications and intended use, rather than a new comparative clinical study with defined clinical endpoints.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified in the provided text. The "performance testing" refers to V&V activities.
- Data Provenance: Not specified. As a device modification, testing would likely be internal to the manufacturer.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not applicable/specified. This type of submission (Special 510(k) for device modification) focuses on engineering and functional performance, not typically on clinical ground truth established by external experts for diagnostic accuracy.
- Qualifications of Experts: Not applicable/specified.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable/specified. This is not a diagnostic device undergoing a typical clinical study requiring ground truth adjudication.
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
- MRMC Study: No. This is a medical device (protective sheath for endoscope), not an AI/diagnostic software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance: Not applicable. This is a medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not applicable in the traditional sense of diagnostic accuracy. The "ground truth" for this device's performance would be engineering specifications, functional requirements, sterility, biocompatibility, and mechanical integrity, all verified through internal testing and validation.
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This is a medical device, not an AI algorithm.
9. How the ground truth for the training set was established
- Ground Truth Establishment for Training Set: Not applicable. This is a medical device, not an AI algorithm.
Summary of the Study performed (as described in the 510(k) Summary):
The submission is a Special 510(k) Premarket Notification for a Device Modification. The study supporting this clearance was not a traditional clinical trial or an AI performance study, but rather a demonstration of continued safety and effectiveness through:
- Certification of compliance to 21 CFR 820.30 Design Control requirements: This indicates that the device's design, development, and modification processes adhere to FDA's quality system regulations.
- Description of the internal Risk Analysis procedure: This shows that potential risks associated with the modifications were identified, analyzed, and mitigated.
- Design Validation and Verification (V&V) activities including sheath functional and performance testing: This refers to internal testing conducted by Vision-Sciences, Inc., to ensure the modified EndoSheath® Systems meet their design specifications and intended use. The conclusion explicitly states that "Based on the indications for use, technological characteristics, performance testing and comparison to predicate devices, the modified VSI EndoSheath® Systems for use with the VSI flexible TNE scope have been shown to be safe and effective for their intended use."
The FDA's decision of "substantial equivalence" to the predicate device (K031786) further supports this, indicating that the modifications did not raise new questions of safety or effectiveness.
§ 874.4710 Esophagoscope (flexible or rigid) and accessories.
(a)
Identification. An esophagoscope (flexible or rigid) and accessories is a tubular endoscopic device with any of a group of accessory devices which attach to the esophagoscope and is intended to examine or treat esophageal malfunction symptoms, esophageal or mediastinal disease, or to remove foreign bodies from the esophagus. When inserted, the device extends from the area of the hypopharynx to the stomach. It is typically used with a fiberoptic light source and carrier to provide illumination. The device is made of materials such as stainless steel or flexible plastic. This generic type of device includes the flexible foreign body claw, flexible biopsy forceps, rigid biopsy curette, flexible biopsy brush, rigid biopsy forceps and flexible biopsy curette, but excludes the fiberoptic light source and carrier.(b)
Classification. Class II.