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510(k) Data Aggregation
(48 days)
The da Vinci Handheld Camera is intended for endoscopic viewing of internal surgery sites during minimally invasive surgery. It is designed for use with compatible da Vinci Surgical Systems.
The da Vinci Handheld Camera is a lightweight handheld 2D Camera which can be connected to any third party 5 mm to 10 mm laparoscope to view images on the da Vinci Xi Vision cart. The da Vinci Handheld Camera consists of the camera head, the light guide, camera connector and the light guide adaptor.
The da Vinci Handheld Camera leverages the illuminator, video processor, monitor and video outputs on the do Vinci Xi Vision Cart to provide common functions of a laparoscopic video tower. The da Vinci Xi Handheld Camera connects to the vision cart in the same way an endoscope does through the endoscope controller. The da Vinci Handheld Camera consists of the camera head, endocoupler, cable assembly, light guide, and an adapter. The da Vinci Handheld Camera Head Sterilization Tray is intended for use to encase and protect da Vinci Handheld Camera Head during sterilization.
Here's a breakdown of the acceptance criteria and study information for the da Vinci Handheld Camera, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Bench Testing | Physical Specifications | Met (demonstrated in testing) |
| Mechanical Requirements | Met (demonstrated in testing) | |
| Electrical Requirements | Met (demonstrated in testing) | |
| User Interface Requirements | Met (demonstrated in testing) | |
| Equipment Interface Requirements | Met (demonstrated in testing) | |
| Animal Validations | Performance in simulated clinical models | Evaluated and determined to meet requirements. |
| Human Factors Evaluation | Safety for intended users, uses, and use environments | Found to be safe and effective. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state specific sample sizes for each test set. It mentions "simulated clinical models (animal)" for animal validation and "Human factors evaluation" for usability, suggesting the use of a finite number of animals and human participants. The data provenance is not explicitly mentioned (e.g., country of origin).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. The studies mentioned (bench, animal, human factors) are likely conducted by engineers, researchers, and usability specialists, but their specific roles in establishing "ground truth" and their qualifications are not detailed.
4. Adjudication Method for the Test Set
This information is not provided in the document. The document describes various tests but doesn't mention any adjudication process for conflicting results or inter-reviewer variability.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study comparing human readers with and without AI assistance was not mentioned in the document. The device is a handheld camera for endoscopic viewing, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable as the da Vinci Handheld Camera is a physical imaging device and not an AI algorithm. Its performance is intrinsically tied to human usage and interpretation of the live video feed.
7. The Type of Ground Truth Used
The ground truth for the various tests seems to be established through:
- Engineering specifications and standards for bench testing (e.g., physical, mechanical, electrical requirements).
- Physiological and anatomical observations in animal models for performance evaluation.
- Usability metrics and safety assessments in human factors evaluation.
8. The Sample Size for the Training Set
This information is not applicable as the da Vinci Handheld Camera is a hardware device, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable for the same reason as above (not an AI model).
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