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510(k) Data Aggregation
(81 days)
DA VINCI SINGLE-SITE PERMANENT CAUTERY HOOK
The Intuitive Surgical® da Vincio Single-Site™ Instruments and Accessories used with the da Vinci® Si Surgical System (1S3000) are indicated for use by trained physicians in an operating room environment for endoscopic manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing during single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo-oophorectomy with the da Vinci Single-Site Instruments and Accessories, including graspers, dissectors, needle drivers, scissors, suction irrigators, monopolar cautery, bipolar cautery, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, flexible blunt obturators, and the 5 mm Single-Site Port.
The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm lengths), and a Single-Site Port (with insufflation tubing and stopcock) for the placement and insertion of multiple cannulae/instruments through a single incision.
The da Vinci Single-Site Instruments and Accessories include instruments to perform manipulation of tissue, grasping, cutting, blunt and sharp dissection, approximation, clip-ligation, electrocautery and suturing. The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing da Vinci Si Surgical System (IS3000).
This submission describes a Special 510(k) for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories, specifically focusing on the addition of a Single-Site Permanent Cautery Hook. The filing asserts substantial equivalence to a predicate device, rather than providing a new study demonstrating performance against specific acceptance criteria for a new clinical indication.
Therefore, many of the requested elements (e.g., acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, MRMC study, standalone performance) are not provided in this 510(k) summary as they are not typically required for a Special 510(k) where the primary claim is substantial equivalence to a previously cleared device with minor modifications.
Here's an analysis based on the provided text, indicating where information is not applicable or not provided:
1. Table of Acceptance Criteria and Reported Device Performance
No specific numerical acceptance criteria or quantitative performance metrics are provided in this 510(k) summary. The submission relies on the concept of "substantial equivalence" to a predicate device.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined as numerical targets. The underlying acceptance criterion is "substantial equivalence" to the predicate device. | "Bench and animal testing demonstrated that the subject device is substantially equivalent to the predicate device and that the design output meets the design input requirements." |
| "The differences [between the subject and predicate devices] do not raise any different issues of safety or effectiveness as compared to the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "bench and animal testing" but does not specify the sample sizes (e.g., number of tests, number of animals) or the provenance (e.g., country of origin, retrospective/prospective) for these tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study involved bench and animal testing, not human expert evaluations for ground truth establishment in a diagnostic context.
4. Adjudication Method for the Test Set
Not applicable. This type of study does not involve expert adjudication as typically seen in image analysis or diagnostic device studies.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done; Effect Size of Human Readers Improve with AI vs Without AI Assistance
Not applicable. This is not a study involving AI or human reader performance in a diagnostic or interpretive context. It relates to a surgical instrument.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This refers to a surgical instrument, not an algorithm.
7. The Type of Ground Truth Used
The concept of "ground truth" as typically understood in diagnostic device evaluation (e.g., pathology, clinical outcome) is not directly applicable here. The "truth" or validation was established through:
- Bench testing: Likely involved mechanical, electrical, and functional tests against engineering specifications and predicate device performance.
- Animal testing: Involved surgical procedures in animals to demonstrate functionality, safety, and performance in a live tissue environment.
8. The Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this type of device.
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