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Intuitive Surgical® Endoscopic Instruments including scissors, scalpels, forceps/pick-ups, needle drivers and electrocautery are intended for endoscopic manipulation of tissue, including: grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery and suturing.

The subject device(s) consist of a family of endoscopic instruments with either grasping or cutting end effectors to be used with the Intuitive Surgical® da Vinci™ Endoscopic Instrument Control System. These instruments attach to the two instrument manipulator arms on the Intuitive Surgical® Endoscopic Instrument Control System. The instruments are re-usable (for a limited number of uses), are provided non-sterile, and must be cleaned and sterilized before use (pre-vacuum autoclave). Single-use scalpel blades are packaged sterile and provided separately. The instruments are programmed for a limited number of uses to ensure reliability and consistent performance, and have non-volatile "add-only" memory that the Instrument Control System decrements after each use.

The instruments attach to a re-usable, sterilizable adapter on the manipulator arm of the Endoscopic Instrument Control System to provide a barrier between the (sterile) instrument and the (non-sterile) manipulator arm. A mounting surface on the adapter provides a means to secure a sterile drape that covers the arm assembly. This allows instruments to be interchangeable during a procedure, without compromising the sterile barrier. When attached to the manipulator, the instrument is inserted through a cannula mounted to the manipulator.

All instruments have articulations at the distal end that are controlled by the surgeon. The instrument is the "wrist" of the system and provides four (4) degrees of freedom (wrist pitch, wrist yaw, roll and grip) and the manipulator arm provides an additional three (3) degrees of freedom (insertion, arm pitch, arm yaw) for a total of seven (7) degrees of freedom. The instruments described herein share similar architecture, materials, and manufacturing processes. The primary difference between the instruments is the tip end effector also known as a "grip". The device and accessories are essentially identical in size and shape to the referenced predicate device, and represent standard embodiments of surgical tools modified for use with the Intuitive Surgical® Endoscopic Instrument Control System.

The provided document is a 510(k) summary for the Intuitive Surgical EndoWrist™ Endoscopic Instruments, dated January 10, 2002. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing extensive de novo clinical study results for novel AI-powered devices.

Therefore, the requested information pertaining to AI/algorithm performance (e.g., acceptance criteria for AI, MRMC studies, standalone algorithm performance, AI training/test set details) is not applicable to this submission. The device described here is a set of surgical instruments, not an AI or software as a medical device.

The "Performance Data" section explicitly states: "Design analysis and comparison as well as in vitro testing confirm that basic functional characteristics are substantially equivalent to the predicate device cited." This indicates that the validation occurred through engineering analysis and bench testing, not through human-in-the-loop studies or AI performance metrics.

Here's what can be extracted based on the provided document:

1. A table of acceptance criteria and the reported device performance

The document does not specify quantitative acceptance criteria or detailed reported performance metrics in a table format as would be typical for a new AI device or a novel functional device. Instead, it relies on demonstrating substantial equivalence to a predicate device through:

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable, as this is not a study involving human data or a test set in the context of AI performance. The "test set" would refer to the instruments themselves undergoing engineering and in vitro (bench) testing. The document does not specify sample sizes for these tests, which is common for 510(k) summaries of traditional devices unless a specific performance claim requires it. Data provenance beyond "in vitro testing" is not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. Ground truth in this context would refer to engineering specifications and performance expectations for surgical instruments, not expert interpretation of medical images or patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are relevant for subjective interpretations, typically in clinical studies or expert review of data, which is not the case here.

5. 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

Not applicable. No AI component is described in this device submission.

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

Not applicable. No AI component is described in this device submission.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for these surgical instruments would be established through engineering specifications, design requirements, and in vitro performance testing confirming material properties, mechanical integrity, functional movement, and compatibility with the da Vinci™ system.

8. The sample size for the training set

Not applicable. There is no AI training set as this is not an AI device.

9. How the ground truth for the training set was established

Not applicable. There is no AI training set.

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