Search Results
Found 1 results
510(k) Data Aggregation
(227 days)
The Intuitive Surgical Endoscopic Instrument Control System is intended for accurate control of selected endoscopic instruments including, rigid endoscopes, blunt endoscopic dissectors and endoscopic retractors during thoracoscopic and laparoscopic surgical procedures. It is intended to be used by professionals in operating room environments.
The Intuitive Surgical Endoscopic Instrument Control System is an electro-mechanical device consisting of a Surgical Console including "Master Manipulators", articulated Instrument Control Arms or "Slave Manipulators" and Limited Reuse Tools or end effectors.
The provided text describes the 510(k) summary for the Intuitive Surgical Endoscopic Instrument Control System (K965001). However, it does not contain the specific details required to complete all sections of your request, particularly regarding detailed acceptance criteria, specific reported device performance metrics against those criteria, and granular information about the study design (e.g., sample sizes for test and training sets, expert qualifications, ground truth establishment methods for training data).
Here's an analysis based on the available information and what is missing:
Acceptance Criteria and Study for Intuitive Surgical Endoscopic Instrument Control System (K965001)
The submission focuses on establishing substantial equivalence to predicate devices rather than demonstrating performance against predefined, quantitative acceptance criteria via a comprehensive clinical study as might be seen for novel devices.
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided text, specific quantitative acceptance criteria and corresponding reported device performance metrics are NOT explicitly stated. The document refers to "internal specification requirements" and "external standard requirements and predicate performance expectations" but does not detail what these are.
| Acceptance Criteria (Quantitative/Qualitative) | Reported Device Performance |
|---|---|
| Reproducibility | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Hysteresis | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Functional Adequacy | "All data fell within... internal specification requirements as well as external standard requirements and predicate performance expectations." |
| Substantial Equivalence to Predicates | Confirmed through "Design analysis and in vitro data" and comparison of intended use, basic functionality, and tissue effects. |
| Capability of precisely moving and controlling endoscopic tools | "The Intuitive system is substantially equivalent to both the Computer Motion and Andronic devices in terms of the capability of precisely moving and controlling endoscopic tools." |
| Tissue Effects | "The Intuitive system is substantially equivalent to the cited predicates in terms of the tissue effects." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not specified. The document mentions "in vitro test data" and "design analysis" but does not give a number of tests or samples.
- Data Provenance: The tests are described as "in vitro data," suggesting laboratory or bench testing. No information on country of origin or whether it was retrospective or prospective human clinical data is provided, as it appears to be primarily bench/pre-clinical testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. It's likely that internal engineers or subject matter experts evaluated the in vitro test results against specifications, but this is not detailed.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. Given the nature of "in vitro test data," it's more likely that direct measurements were taken and compared against pre-defined specifications rather than requiring expert adjudication in the traditional sense of clinical imaging studies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No. The provided information does not describe any MRMC study comparing human readers with and without AI assistance. This device is an electromechanical control system for surgical instruments, not an AI-powered diagnostic or assistive tool in the context of interpretation.
6. Standalone (Algorithm Only) Performance Study
- Standalone Performance Study: Yes, in a sense. The "in vitro test data" and "design analysis" would represent the "standalone" performance of the device's functional characteristics (reproducibility, hysteresis, functional adequacy) in a controlled environment. However, it's not an "algorithm only" study in the typical AI sense, but rather a performance study of the electromechanical system.
7. Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" for the in vitro tests would be the pre-defined engineering specifications and performance expectations for reproducibility, hysteresis, and functional adequacy. These would likely be based on established engineering principles, predicate device performance, and clinical needs for precise instrument control.
8. Sample Size for the Training Set
- Sample Size (Training Set): Not applicable in the context of machine learning. This device is an electromechanical system, not an AI/ML algorithm that requires a training set. Its design and validation rely on engineering principles, material science, and control systems, not data-driven machine learning models.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth (Training Set): Not applicable, as there is no training set for this type of device.
Ask a specific question about this device
Page 1 of 1