(30 days)
The flexible ENT videoscopes with digital video processor and disposable sheath systems are intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages and, using additional accessories, to perform various diagnostic and therapeutic procedures.
The flexible ENT videoscope with EndoSheath® System is intended for use in flexible endoscopic examination of the upper airway, vocal cords and/or nasal passages.
The digital video processor is intended for use with the VSI flexible video scope.
The VSI flexible endoscopes are flexible endoscopes with connections to a video processor and display monitor. The 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 videoscope. The digital video processors are used with the flexible videoscopes for image visualization and capture.
The provided text describes a Special 510(k) Premarket Notification (K072073) for a modified medical device, the "Flexible ENT Scopes with Digital Video Processor and Disposable EndoSheath® Systems." This type of submission is for modifications to previously cleared devices under the FDA's "The New 510(k) Paradigm - Alternate Approaches to Demonstrating Substantial Equivalence in Premarket Notifications."
The document does not contain the detailed acceptance criteria or a specific study that quantifies device performance against those criteria in a way that typically applies to AI/ML device evaluations. Instead, it focuses on demonstrating substantial equivalence to predicate devices through design control requirements and general V&V activities.
Here's an analysis based on the provided text, addressing your points where possible, and noting where information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or report specific device performance metrics in the format of a table. For a Special 510(k) of this nature, the "acceptance criteria" are implied to be adherence to design control requirements and successful completion of verification and validation (V&V) activities to ensure the modified device remains safe and effective and substantially equivalent to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance to 21 CFR 820.30 Design Control requirements | Certification of compliance provided. |
| Risk analysis procedure adherence | Description of internal Risk Analysis procedure provided. |
| Biocompatibility | Addressed through comprehensive Design Validation and Verification. |
| Scope/sheath/processor system functional and performance | Addressed through comprehensive Design Validation and Verification. |
| Software validation | Addressed through comprehensive Design Validation and Verification. |
| Substantial equivalence to predicate device (K050972 / K040984 / K024095 / K942265) | Concluded by FDA as substantially equivalent based on indications for use, technological characteristics, and performance testing. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the document. The text refers to "comprehensive Design Validation and Verification" but does not specify the sample sizes for any testing (e.g., number of endoscopes tested, number of sheaths, duration of functional tests). The data provenance (country of origin, retrospective/prospective) is also not mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The assessment appears to be based on engineering and performance testing rather than clinical evaluation requiring expert ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of a device modification and the V&V activities described, it's unlikely that a clinical adjudication method like 2+1 or 3+1 would have been applied in this context. The V&V would likely involve objective measurements and engineering assessments.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not conducted or reported in this document. This submission is for device modification, focusing on engineering validation and substantial equivalence, not a clinical effectiveness study of human readers with vs. without AI assistance. The device in question is an endoscope system, not an AI diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This concept does not apply to the device described. This is a medical imaging and intervention device (flexible endoscope with a video processor and disposable sheaths) that is inherently used with a human-in-the-loop (a clinician). It does not involve an AI algorithm operating in a standalone capacity.
7. Type of Ground Truth Used
Based on the description of "V & V activities, including biocompatibility testing, scope/sheath/processor system functional and performance testing, and software validation," the "ground truth" would be established by:
- Engineering specifications and standards: For functional and performance testing (e.g., image resolution, light output, flexibility, durability).
- Biocompatibility standards: For material safety with patient contact.
- Software requirements specifications: For software validation.
The document does not mention the use of expert consensus, pathology, or outcomes data as "ground truth" for the device's performance, as it's not an AI diagnostic device.
8. Sample Size for the Training Set
This information is not applicable and not provided. The device is an endoscope system, not an AI/ML algorithm that requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reason as above (not an AI/ML algorithm requiring a training set).
Summary of Missing Information:
It's important to reiterate that much of the information requested (sample sizes for test sets, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) is typically associated with the evaluation of AI/ML-driven diagnostic or assistive devices. The provided document describes a "Special 510(k)" for a device modification to a flexible endoscope system, which focuses on demonstrating continued safety and effectiveness and substantial equivalence through engineering V&V rather than large-scale clinical performance trials or AI model validation.
§ 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.