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The Intuitive Surgical® da Vinci® Single-Site™ Instruments and Accessories used with the da Vinci® Si™ Surgical System (IS3000) 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 Single-Site™ Port.

The Single-Site™ Wristed Needle Driver instrument is intended to be used with the da Vinci® Si™ Surgical System (IS3000) to perform needle driving and suture tying tasks.

The da Vinci® Single-Site™ Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae sets (250 mm and 300 mm lengths), an accessory cannula for insertion of manual laparoscopic instruments, semi-rigid blunt obturators (250 mm and 300 mm lengths), a rigid 10 mm Blunt Obturator, and a Single-Site™ Port (with insufflation adapter 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).

The subject device, Single-Site™ Wristed Needle Driver (P/N 428115), is a new addition to the Single-Site™ Instruments and Accessories family. It is a resposable endoscopic instrument used in conjunction with the da Vinci® Si™ Surgical System (IS3000) to handle needles and suture during endoscopic surgical procedures. The distal end configuration of the instrument includes a straight grip and a wrist to enable articulation of the grip.

The provided text describes the regulatory submission for the Intuitive Surgical® Single-Site™ Wristed Needle Driver (K141075) and its performance data, primarily focusing on proving substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and study details based on the provided document:

Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics. Instead, it describes various tests designed to demonstrate that the device "meets the design input requirements," "operates properly throughout its intended life," and maintains "substantial equivalence" to the predicate device. The performance is reported qualitatively, stating that the device did meet these objectives.

Here's a summary derived from the text:

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Bench Verification: 5 test samples. Data provenance is internal laboratory testing ("Bench Testing").
   • Reliability (Life) Testing: 8 test samples. Data provenance is internal laboratory testing ("Bench testing").
   • Cadaver and Animal Validations (Design Validation):
     • Cadaver model: 3 samples. Data provenance is ex-vivo (cadaver).
     • Animal model: 2 samples. Data provenance is in-vivo (live animal, specifically porcine).
   • Equivalence Testing – Cadaver:
     • 5 independent surgeons evaluated 5 cadavers.
     • Full procedures: Benign hysterectomy with bilateral salpingo-oophorectomy (n=5).
     • Cadaver suturing task: Vaginal cuff closure (n=11).
     • Data provenance is ex-vivo (cadaver).
   • Equivalence Testing – Animal:
     • 5 independent surgeons evaluated 5 animals (porcine).
     • Porcine suturing task: Uterine horn hysterotomy closure (n=15, 3 per surgeon).
     • Data provenance is in-vivo (live animal, specifically porcine).

   All studies appear to be prospective, designed specifically for this regulatory submission. Data provenance indicates a mix of bench, ex-vivo, and in-vivo (animal) models. There is no mention of country of origin for the data, but it is implied to be within the company's testing facilities or affiliated research centers.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Equivalence Testing (Cadaver and Animal): 5 independent practicing surgeons participated. Their specific qualifications (e.g., years of experience, subspecialty) are not detailed beyond "independent practicing surgeons."
   • Safety Assessments: Study observers, surgeon participants, and independent reviewers conducted safety assessments. The qualifications of "independent reviewers" are not specified.

3. Adjudication method for the test set:

   • Equivalence Testing: The document mentions "Surgeons completed questionnaires that evaluated the suturing performance, suture line quality, and safety with the each needle driver; study observers recorded objective assessments of the suture lines quality." For safety, "Study observer, surgeon participant, and independent reviewer assessments" were considered. This suggests a multi-stakeholder assessment, but a formal adjudication method like "2+1" or "3+1" for discordant opinions is not explicitly stated. It seems to be a combination of subjective surgeon feedback and objective observer/reviewer assessments without a formal reconciliation process described.

4. 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, this was not an MRMC study comparing AI performance or human reader improvement with AI assistance. This submission is for a surgical instrument, not an AI-powered diagnostic device. The "multi-reader" aspect involved multiple surgeons evaluating the performance of two different surgical instruments (subject vs. predicate).

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This device is a physical surgical instrument, not an algorithm. Performance tests directly evaluated the instrument itself, often with human operators (surgeons) in simulated or live conditions.

6. The type of ground truth used:

   • Bench Tests: Design input requirements and specifications served as the ground truth.
   • Cadaver and Animal Validations: Product requirements, specifications, and user needs (as assessed by surgeons and observers) served as the ground truth.
   • Equivalence Testing: The performance and safety of the predicate device (Single-Site™ Curved Needle Driver) served as the comparative ground truth, along with evaluations of "suture line quality and effectiveness" through Likert scales and objective measurements (tissue bite, number of stitches, distance between stitches, closure completion time). The ability to complete procedures and tasks safely was also a ground truth. This is a form of expert consensus/assessment and objective measurement.

7. The sample size for the training set:

   • Not applicable. This is a physical surgical instrument, not a machine learning model that requires a training set.

8. How the ground truth for the training set was established:

   • Not applicable. (See point 7).

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