(12 days)
The VSI Model ENT-2000V Flexible Nasopharyngo-Laryngoscope is intended for flexible endoscopic examination of the upper airway, vocal chords and/or nasal passages.
The device described in this 510(k) consists of modified flexible fiberoptic ENT scope. The scope has been modified to include an integral camera module and camera control unit.
This 510(k) summary (K040984) describes a Special 510(k) for a modified flexible fiberoptic ENT scope, the Vision Sciences Model ENT-2000V Flexible Nasopharyngo-Laryngoscope. A Special 510(k) is used for modifications to a manufacturer’s own legally marketed device where the modification does not alter the indications for use or the fundamental scientific technology of the device. Consequently, the focus of the submission is on design controls, risk analysis, and verification/validation testing demonstrating that the device continues to meet its performance specifications and is as safe and effective as the predicate device.
Here's an analysis of the provided text in relation to your request:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a specific table detailing "acceptance criteria" alongside "reported device performance" in a quantitative manner as one might find in a study specifically comparing device output to a clinical ground truth.
However, the "Safety and Performance" section states:
"Validation testing including scope image quality evaluation, focal length, resolution, distortion, reprocessing effects and electrical safety testing is included in Design Validation and Verification planning."
This indicates that these parameters (image quality, focal length, resolution, distortion, reprocessing effects, and electrical safety) likely served as the acceptance criteria for the device modification. The implication is that the device met these criteria, as the FDA granted clearance. Without explicit numerical targets and results, a direct table cannot be constructed.
Inferred Acceptance Criteria Example (based on device type and typical requirements):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Image Quality | Met predefined specifications for clarity, brightness, and color rendition. (Implied: as good as or better than predicate, maintaining diagnostic capability) |
| Focal Length | Maintained within specified range typical for flexible ENT scopes. (Implied: met engineering specifications) |
| Resolution | Met predefined specifications for distinguishing fine details. (Implied: as good as or better than predicate) |
| Distortion | Maintained within acceptable limits. (Implied: as good as or better than predicate) |
| Reprocessing Effects | Demonstrated continued functionality and integrity after specified reprocessing cycles. (Implied: met sterilization and durability standards) |
| Electrical Safety | Complied with relevant electrical safety standards (e.g., IEC 60601). (Implied: passed all required tests) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical data for AI or an imaging study. This is a special 510(k) focused on device modification and engineering validation. The validation testing mentioned (image quality, focal length, etc.) would typically involve the modified device itself undergoing technical assessments, not a collection of patient data.
Therefore, information on sample size for a test set or data provenance (country of origin, retrospective/prospective) is not applicable in the context of this specific 510(k).
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)
Similar to point 2, the concept of "ground truth" established by experts for a test set is not present in this submission. The validation testing likely involved engineers and quality control personnel assessing the physical and imaging characteristics of the device against established technical specifications, rather than clinical experts interpreting images for diagnostic accuracy.
Therefore, information on the number and qualifications of experts for ground truth establishment for a test set is not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no described test set involving human interpretation of clinical data in this 510(k), an adjudication method is not applicable.
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
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was performed or is mentioned. This submission is for a medical device (endoscope), not an AI diagnostic algorithm. Therefore, "human readers improve with AI vs without AI assistance" is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This submission is for a medical device (endoscope), not a standalone algorithm. Therefore, this question is not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to engineering and performance specifications. For example:
- Image Quality: Measured against objective metrics (e.g., contrast, sharpness, resolution targets) and potentially subjective assessment by trained personnel (e.g., optical engineers, quality control specialists) using pre-defined criteria.
- Focal Length, Resolution, Distortion: Measured objectively using calibrated test equipment and optical benches against manufacturing specifications.
- Reprocessing Effects: Evaluated by subjecting the scope to specified reprocessing cycles and then testing its performance and integrity (e.g., visual inspection, leak testing, functional checks).
- Electrical Safety: Tested according to recognized electrical safety standards (e.g., IEC 60601) by accredited labs/personnel.
So, the "ground truth" used was engineering and performance specifications and objective measurements.
8. The sample size for the training set
This is a physical medical device; there is no "training set" in the context of machine learning or AI. Therefore, this question is not applicable.
9. How the ground truth for the training set was established
As there is no training set, this question is not applicable.
§ 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.