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510(k) Data Aggregation
(179 days)
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1-02: 6 months to 6 years; BCV1-C2: 6 years and older).
The Vathin® Video Bronchoscope System consists of Vathin®H-SteriScopeTM Single use flexible Video Bronchoscope (model: BCV1-02, BCV1-C2) to be introduced within the airways or tracheobronchial tree and Vathin®VisionCenterTM Digital Video Monitor (model: DVM-B1, DVM-B2) for clinical image processing.
The Vathin®H-SteriScopeTM Single-use flexible bronchoscope is inserted through the airways and tracheobronchial tree during Bronchoscopy. The Vathin®VisionCentereTM Digital Video Monitor provides power and processes the images for medical electronic endoscope.
Vathin®H-SteriScopeTM Single-use flexible Video Bronchoscope is a sterile single-use flexible bronchoscope. Vathin®H-SteriScopeTM Digital Video Monitor is a reusable monitor.
I regret to inform you that the provided FDA 510(k) clearance letter and accompanying 510(k) Summary for the Vathin® Video Bronchoscope System do not contain the specific information required to answer your detailed questions about acceptance criteria and the study proving device performance as it relates to AI/software functionality.
This document focuses on justifying Substantial Equivalence for a bronchoscope system based on its physical characteristics, safety standards (electrical, biocompatibility, sterilization), and basic performance (optical, mechanical). It mentions "Software verification and validation" in Section 7.4, citing the "FDA guidance: Content of Premarket Submissions for Device Software Functions," but does not provide any specific acceptance criteria, study data, or details about the software's functionality, especially regarding AI capabilities.
Therefore, I cannot populate the table or answer the specific questions about AI performance, test set details, ground truth establishment, or human reader studies.
Here's why the document is insufficient for your request:
- No AI/Algorithm Claims: The document describes a video bronchoscope and its display unit. It doesn't mention any AI or advanced algorithmic functions (e.g., automated lesion detection, image enhancement using AI, diagnostic support) that would necessitate performance criteria like sensitivity, specificity, or reader studies.
- Focus on Hardware/System Performance: The performance data section (7.1-7.6) primarily addresses the physical and electrical safety, biocompatibility, sterilization, and basic optical/mechanical functions of a medical device (bronchoscope). The "Software verification and validation" entry is generic and doesn't detail any specific software performance study.
- Substantial Equivalence Justification: The entire 510(k) submission aims to prove that the Vathin® Video Bronchoscope System is "substantially equivalent" to existing cleared bronchoscopes. This process typically focuses on demonstrating comparable safety and effectiveness, not necessarily advanced algorithmic performance.
To answer your questions, one would need a 510(k) that specifically addresses an AI/ML-enabled medical device. Such a submission would include detailed performance studies with metrics like sensitivity, specificity, AUC, and often include multi-reader, multi-case (MRMC) studies to demonstrate clinical impact.
If you had provided a 510(k) document for an AI-powered device, the table and answers would look something like this (conceptual example):
Conceptual Example - This section is not based on the provided document as it does not contain the necessary information.
For an AI-powered medical device, the acceptance criteria and study proving its performance would be detailed as follows:
1. Acceptance Criteria and Reported Device Performance
| Metric (for AI-enabled feature, e.g., Nodule Detection) | Acceptance Criteria (e.g., for standalone performance) | Reported Device Performance |
|---|---|---|
| Standalone Performance | ||
| Sensitivity (Recall) | ≥ 90% for nodules > 4mm | 92.5% |
| Specificity | ≥ 80% | 83.1% |
| FROC Score (Free-response ROC) | ≥ 0.85 | 0.87 |
| AI-Assisted Performance (If applicable) | ||
| Reader ROC AUC Improvement | Statistically significant improvement (p < 0.05) vs. unaided | Mean AUC improvement of 0.045 (p < 0.001) |
| Reading Time Reduction | Mean reading time reduction of ≥ 10% | 15% reduction |
2. Sample Size and Data Provenance for Test Set
- Test Set Size: 500 unique patient studies (e.g., Chest CT scans).
- Data Provenance:
- Country of Origin: Multi-centric from USA (40%), Europe (30%), Asia (30%).
- Retrospective/Prospective: Primarily retrospective, collected from hospital PACS archives. Data selection ensured diversity in pathology, image quality, and scanner types.
3. Number and Qualifications of Experts for Ground Truth
- Number of Experts: 3 independent expert readers.
- Qualifications: All were board-certified radiologists with subspecialty training in thoracic imaging and a minimum of 10 years of experience in interpreting chest CT scans for pulmonary nodules.
4. Adjudication Method for Test Set
- Method: 2+1 Adjudication.
- Initial reads by two independent expert radiologists.
- If their interpretations differed, a third, senior-most expert radiologist reviewed the case and made the final decision.
- Discrepancies were resolved through consensus or majority vote. All disagreements requiring a third read were documented.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was it done? Yes.
- Effect Size (Human Readers Improvement with AI vs. Without AI):
- The MRMC study demonstrated a statistically significant improvement in diagnostic accuracy (measured by ROC AUC) for radiologists using the AI device compared to those reading without AI assistance.
- Mean ROC AUC: 0.85 (without AI) vs. 0.895 (with AI).
- Effect Size: Mean improvement in AUC was 0.045 (absolute difference), which corresponds to a relative improvement of approximately 5.3% in diagnostic accuracy. The 95% confidence interval for this improvement did not include zero, confirming statistical significance (p < 0.001).
- Additional Finding: Average reading time per case decreased by 15% when using AI.
6. Standalone Performance Study
- Was it done? Yes.
- Details: The algorithm's performance was evaluated independently against the established ground truth for nodule detection and characterization. Standalone metrics included sensitivity, specificity, and FROC analysis, as detailed in the acceptance criteria table above.
7. Type of Ground Truth Used for Test Set
- Type: Expert Consensus, supported by available pathology reports (where biopsy was performed) and longitudinal follow-up data (e.g., 2-year stability on subsequent CT scans for benign lesions, or growth for malignant lesions). Pathology or follow-up was prioritized when available.
8. Sample Size for Training Set
- Training Set Size: 50,000 unique patient studies (e.g., Chest CT scans).
9. How Ground Truth for Training Set was Established
- Method: A combination of automated data labeling (using existing radiology reports, structured data, and keywords) followed by expert review and annotation.
- An initial pass of automated labeling identified potential regions of interest.
- These regions were then reviewed and carefully annotated by a team of trained radiology residents and fellows under the supervision of experienced radiologists.
- For ambiguous cases, a consensus reading of at least two radiologists was required.
- Pathology reports and longitudinal follow-up data (when available) were also incorporated to refine annotations and confirm ground truth.
Ask a specific question about this device
(144 days)
The Vathin® H-SteriScopeTM I Single use flexible Video Bronchoscope has been designed to be used with the Vathin® Displaying Unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree.
The Vathin® Video Bronchoscope System is for use in a hospital environment.
Not Found
I am sorry, but the provided text from the FDA 510(k) clearance letter for the Vathin® Video Bronchoscope System does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria.
The letter is a standard FDA clearance document that states the device has been found substantially equivalent to a legally marketed predicate device. It discusses regulatory aspects, such as general controls, potential additional controls for Class II/III devices, and compliance with various FDA regulations.
It does not include details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes for test or training sets, nor data provenance.
- Number of experts or their qualifications for ground truth establishment.
- Adjudication methods.
- Multi-reader multi-case (MRMC) comparative effectiveness studies.
- Standalone algorithm performance.
- Type of ground truth used (e.g., expert consensus, pathology).
- How ground truth for any set was established.
Therefore, I cannot fulfill your request for this information based on the provided text. To obtain such details, you would typically need to refer to scientific publications, clinical trial reports, or other technical documentation directly submitted to the FDA, which are not part of this clearance letter.
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