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The Endo Wrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X Surgical System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS4000 and da Vinci Surgical System, Model IS4200) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use. It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The da Vinci X/Xi 8 mm monopolar scissors instrument (470179) is used in conjunction with its intended surgical robot for cutting, cauterizing, coagulation, manipulating and blunt dissue. This instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axis of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

Endo Wrist Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for greater precision in a minimally invasive environment. EndoWrist instruments, in conjunction with the applicable surgical robot, are designed to support rapid and precise suturing, dissection, and tissue manipulation in surgical procedures.

The design, materials, and intended use of the Reusable Surgical Instruments, after an additional ten (10) reuse cycles, are substantially equivalent to the predicate device in form, fit, and function. The reusable device is identical to the predicate device in that the same standard mechanicals, and size are utilized. There are no changes to the claims, intended use, clinical applications, patient population, performance specifications, or method of operation.

The provided text is a 510(k) premarket notification for a medical device: an 8mm Monopolar Curved Scissors (470179) for use with the da Vinci Xi/X Surgical System. The notification states that the device is a remanufactured/reprocessed version of an existing device, increasing its usability from 10 to 20 cycles through a refurbishment process.

The document discusses acceptance criteria and testing, but not in the context of an AI-powered diagnostic or assistive technology. Instead, the acceptance criteria and study described relate to the safety and effectiveness of the remanufactured physical surgical instrument itself.

Therefore, most of the requested information regarding AI device performance (e.g., sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, ground truth for training set) is not applicable to this submission.

Here's a breakdown of the relevant information provided:

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

2. Sample size used for the test set and the data provenance:

• Sample Size for Test Set: Not explicitly stated. The document refers to "design verification and design validation testing." This typically involves testing a representative number of units, but the specific count is not provided.
• Data Provenance: Not applicable in the context of clinical data for an AI device. The data comes from laboratory and engineering testing of the physical remanufactured surgical instruments. The country of origin of the data is not specified, but it would be from the manufacturer's testing facilities. The tests are prospective in nature, as they are conducted on the remanufactured devices to prove their performance.

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

• Not applicable. The "ground truth" here is objective physical and electrical properties, and biological safety, measured through standardized tests, not expert interpretation of medical images or data. Engineering and quality control personnel would be involved in conducting and evaluating these tests.

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

• Not applicable. Adjudication methods like 2+1 are used for expert consensus on subjective assessments. The tests described are objective and rely on measurement against predefined specifications.

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:

• No. This device is a physical surgical instrument, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not relevant.

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

• Not applicable. This is a remanufactured physical surgical tool.

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

• The "ground truth" used for this device's acceptance is based on predefined engineering specifications, material properties, electrical safety standards, and biocompatibility requirements, as well as the performance characteristics of the predicate device. It's objective, measurable criteria from a combination of regulatory standards and the original device's design.

8. The sample size for the training set:

• Not applicable. This is not an AI/machine learning device.

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

• Not applicable. This is not an AI/machine learning device.

In summary: The provided FDA submission for the 8mm Monopolar Curved Scissors focuses on demonstrating the substantial equivalence and safety/effectiveness of a remanufactured physical surgical instrument. The acceptance criteria and studies are related to the physical, electrical, and biological performance of this instrument, not to the performance of an AI algorithm.

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The EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue.

The Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral procedures restricted to benign and malignant tumors classified as Tl and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology surgical procedures). It is intended to be used by sicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The 8mm Monopolar Scissors of this submission are for use only with the Intuitive Si System (Endoscopic Instrument Control System),

The 8mm Monopolar Curved Scissors Instrument is used with the Intuitive Surgical IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument with the patient tissue. This instrument is reusable and is provided non-sterile.

8mm Monopolar Curved Scissor Instruments are designed to provide surgeons with natural dexterity and a greater range of motion than even the human hand. This allows for grecision when operating in a minimally invasive environment. EndoWrist 8mm Monopolar Curved Scissor Instruments, when used with the IS3000 system, are designed to support rapid and precise suturing, dissection and tissue manipulation in surgical procedures.

The provided text is related to the FDA 510(k) clearance for the "8mm Monopolar Curved Scissors" and discusses its substantial equivalence to predicate devices. However, it does not describe acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document focuses on the physical medical device (surgical scissors) and its continued substantial equivalence after an extended useful life (additional 10 reuse cycles). The "Performance Data" section lists various engineering and safety tests typical for a surgical instrument, such as Biocompatibility, Validation of Reprocessing, Functional Performance Testing, and Electrical Safety Testing. These are not performance metrics for an AI/ML algorithm.

Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) because the document describes the clearance of a non-AI/ML physical medical device.

To answer your request, the input document would need to be a 510(k) summary (or similar regulatory document) for an AI/ML-driven medical device, which would typically include sections on algorithm performance, clinical validation studies, and the establishment of ground truth for AI model evaluation.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci System. Model IS4000) is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes, blunt and sharp endoscopic dissectors, scissors, scalpels, forceps/pick-ups, needle holders, endoscopic retractors, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, general thoracoscopic surgical procedures and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatic use. It is intended to be used by tramed physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The EndoWrist Monopolar Curved Scissors is intended to be used with the da Vinci Xi System or the da Vinci X System for endoscopic manipulation of tissue, including: cutting, blunt and sharp dissection, electrocautery.

The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS4000 da Vinci Xi Surgical System or IS4200 da Vinci X Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

This is a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document asserts substantial equivalence to a predicate device (K131861). As such, it does not detail new clinical studies with acceptance criteria, sample sizes, expert involvement, or adjudication methods in the way a novel AI/ML device submission might. This type of submission generally focuses on demonstrating that the new device is as safe and effective as a legally marketed predicate device through engineering analysis, bench testing, and potentially some animal studies if there are significant differences.

Here's a breakdown based on the provided text, addressing your points where possible, and noting where the information is not applicable to this type of submission:

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

Since this is a submission for an electrosurgical instrument (scissors) and not a diagnostic AI/ML device, the "acceptance criteria" discussed are primarily related to engineering performance specifications and safety, not diagnostic accuracy metrics like sensitivity, specificity, or AUC. The document does not provide a table with specific numerical acceptance criteria and reported device performance for these types of metrics. Instead, it states that:

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

This information is typically not applicable to submissions for electrosurgical instruments like these scissors, which are evaluated primarily through bench and design verification/validation testing. The document does not mention "test sets" in the context of clinical data, as it describes engineering performance data rather than clinical outcomes or diagnostic accuracy.

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)

This is not applicable. Ground truth, in the context of diagnostic accuracy, is not relevant for the type of device and testing described (electrosurgical instrument performance).

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

This is not applicable for the reasons stated above.

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

This is not applicable. The device is an electrosurgical instrument, not an AI/ML diagnostic aid. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was conducted or would be relevant.

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

This is not applicable. The device is a surgical instrument and does not involve an algorithm or standalone performance in the context of AI/ML.

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

This is not applicable. The "ground truth" for the performance of an electrosurgical instrument is its ability to perform its intended mechanical and electrical functions reliably, safely, and biocompatibly, which is assessed through engineering tests, not clinical ground truth like pathology or outcomes data.

8. The sample size for the training set

This is not applicable. There is no concept of a "training set" for this type of medical device submission.

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

This is not applicable for the reasons stated above.

In summary:

The provided document describes a 510(k) submission for a surgical instrument, the 8mm Monopolar Curved Scissors, asserting substantial equivalence to an existing predicate device based on engineering and biocompatibility testing. The "acceptance criteria" and "performance" discussed relate to mechanical, electrical, and material properties, as opposed to clinical diagnostic accuracy or AI/ML performance metrics. Therefore, many of the specific questions geared towards AI/ML device evaluation are not applicable to this submission.

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The Intuitive Surgical Endoscopic Instrument Control System is intended to assist in the accurate control of Intuitive Surgical Endoscopic Instruments including rigid endoscopes. blunt and sharp endoscopic dissectors, scalpels, ultrasonic shears, forceps/pick-ups, needle holders, endoscopic retractors, stabilizers, electrocautery and accessories for endoscopic manipulation of tissue, including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, and delivery and placement of microwave and cryogenic ablation probes and accessories, during urologic surgical procedures, general laparoscopic surgical procedures, gynecologic laparoscopic surgical procedures, transoral otolaryngology robotic surgical procedures restricted to benign and malignant tumors classified as TI and T2, and for benign base of tongue resection procedures, general thoracoscopic surgical procedures, and thoracoscopically assisted cardiotomy procedures. The system can also be employed with adjunctive mediastinotomy to perform coronary anastomosis during cardiac revascularization. The system is indicated for adult and pediatric use (except for transoral otolaryngology robotic surgical procedures). It is intended to be used by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

The Intuitive Surgical EndoWrist 8mm Monopolar Curved Scissors instrument is used with the Intuitive Surgical IS2000 da Vinci S Surgical System or IS3000 da Vinci Si Surgical System for cutting, cauterizing, coagulation, manipulating and blunt dissection of tissue. The instrument consists of the housing, shaft, wrist, and tip. The shaft and wrist allow for different axes of rotation, and the instrument tip is used to interact with the patient tissue. This instrument is reusable and is provided non-sterile. The instrument is used with a single use tip cover accessory.

The provided text describes a 510(k) premarket notification for the Intuitive Surgical 8mm Monopolar Curved Scissors. The document focuses on establishing substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics in the format requested.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes, expert involvement, and ground truth establishment cannot be found in the provided document.

However, I can extract information related to the device description, testing methods, and the general statement of equivalence.

Here's a breakdown of what can be inferred and what is missing:

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

The document does not provide a table with quantitative acceptance criteria and specific numerical performance results. Instead, it lists the types of tests performed to ensure the device meets design requirements.

Inferred "Acceptance Criteria" (based on tests performed):

2. Sample sized used for the test set and the data provenance

• Sample size used for the test set: Not explicitly stated. The document mentions "Design verification and design validation testing were conducted on the subject device." It does not specify the number of units tested.
• Data provenance: The tests were conducted internally by Intuitive Surgical, Inc. on a "porcine model" for design validation. This suggests a prospective assessment of the device's performance in a controlled, simulated clinical environment. The country of origin is not specified but the company is based in Sunnyvale, California.

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

Not applicable. This device is a surgical instrument, not an AI/diagnostic tool requiring expert-established ground truth for its performance evaluation in this context. Its evaluation focuses on mechanical, electrical, and functional performance.

4. Adjudication method for the test set

Not applicable. See point 3.

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. This is not an AI-assisted diagnostic device, but a surgical instrument. An MRMC study is not relevant here.

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

Not applicable. This is a surgical instrument that is always used with a human-in-the-loop (a trained physician). Standalone performance of an algorithm is irrelevant.

7. The type of ground truth used

For the design validation, the "ground truth" was established by the physical and functional outcomes observed in a porcine model under "normal and expected worst case clinical use" scenarios. The evaluation aimed to confirm that "the features of the instrument meet the user needs and intended use."

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable. See point 8.

Summary of available information from the document:

The 8mm Monopolar Curved Scissors is a reusable surgical instrument used with the Intuitive Surgical da Vinci S and Si Surgical Systems. It performs cutting, cauterizing, coagulation, manipulation, and blunt dissection of tissue.

To demonstrate substantial equivalence to its predicate device, Intuitive Surgical performed:

• Design Verification: Bench testing on an IS3000 da Vinci Si Surgical System to verify mechanical and labeling requirements, including reliability, durability, leakage, range of motion, jaw positions, friction, electrical safety, labeling, and compatibility with accessories and software.
• Design Validation: Testing in representative simulated clinical settings utilizing a porcine model to evaluate functional and interaction requirements, as well as the safety and efficacy of the instrument under normal and worst-case clinical use. This ensured the instrument met user needs and intended use.

The document concludes that based on the intended use, indications for use, technological characteristics, and performance data from these tests, the device is substantially equivalent to the predicate device.

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