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da Vinci SP Surgical System, Model SP1098:

The Intuitive Surgical Endoscopic Instrument Control System (da Vinci SP Surgical System, Model SP1098) is intended to assist in the accurate control of Intuitive Surgical SP Instruments during urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the representative, specific procedures set forth in the Professional Instructions for Use.

da Vinci SP Instruments:

Intuitive Surgical da Vinci SP Instruments are controlled by the da Vinci SP Surgical System, Model SP1098, and include flexible endoscopes, blunt and sharp endoscopic dissectors, scissors, 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, and suturing through a single port. The system is indicated for urologic, colorectal, and general thoracoscopic surgical procedures that are appropriate for a single port approach; and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant tumors classified as T1 and T2. The system is indicated for adult use. It is intended for use 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 SP Surgical System, Model SP1098, is a software-controlled, electro-mechanical systems designed to enable complex surgery using a minimally invasive approach. The systems consist of a Surgeon Console, a Patient Side Cart (PSC), and a Vision Side Cart (VSC) and are used with an endoscope, instruments, and accessories.

The provided FDA 510(k) Clearance Letter for the da Vinci SP Surgical System (K251324) does not contain the information requested regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of an AI/ML device.

This document is for a robotic surgical system, not an AI/ML software device for diagnostic or analytical purposes. The clearance focuses on hardware, software for controlling the hardware, and human factors related to the physical use of the surgical system.

Therefore, I cannot extract the following information from the provided text:

1. A table of acceptance criteria and the reported device performance: This document does not describe specific performance metrics for an AI/ML algorithm or corresponding acceptance criteria.
2. Sample sizes used for the test set and the data provenance: No test set, data provenance, or sample sizes related to an AI/ML model are mentioned.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as there's no AI/ML model for which ground truth would be established by experts for performance evaluation.
4. Adjudication method for the test set: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is relevant for evaluating the impact of AI assistance on human diagnostic performance. The document describes human factors evaluation related to the usability of the surgical system, not diagnostic performance with AI assistance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as there's no standalone AI algorithm being cleared.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The document mentions "Software verification and validation have been conducted at the unit, integration, and system level to confirm that the subject devices continue to meet design requirements and user needs" and "Human Factors Evaluation including usability validation has been conducted to demonstrate safety and effectiveness." These are general statements about software and usability testing for a medical device, but they do not detail the specific performance metrics, acceptance criteria, or study designs typically used for AI/ML devices as requested in the prompt.

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The da Vinci SP Firefly Imaging System is intended to provide real-time endoscopic visible and near-infrared fluorescence imaging. The da Vinci SP Firefly Imaging System enables surgeons to perform minimally invasive surgery using standard endoscopic visible light as well as visual assessment of vessels, blood flow and related tissue perfusion, using near-infrared imaging.

The da Vinci SP Firefly Imaging System consists of a near-infrared laser light source located in the Endoscope Controller and a connected endoscope. The Firefly imaging system uses near-infrared light in conjunction with the imaging agent Indocyanine Green (ICG), to create fluorescent images of tissue. ICG is administered to the patient according to its manufacturer's labeling, and the system is switched to Firefly imaging. Two modes are available in Firefly imaging: Standard mode and Sensitive mode. When Firefly is active in Standard mode, the system displays the resulting images as a fluorescent (green) overlay on a gray-scale background image. In Sensitive mode, the gray-scale background is no longer illuminated, resulting in increased sensitivity to fluorescent signal.

This FDA 510(k) clearance letter pertains to the da Vinci SP Firefly Imaging System, focusing on a new "Sensitive Firefly" imaging mode.

Based on the provided document, here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state specific quantitative acceptance criteria for the device's performance, nor does it provide a table of reported device performance metrics against such criteria. It generally states that "Verification and validation testing on the subject device confirmed that no issues of safety or effectiveness, analogous to the results of the predicate device verification and validation testing." This implies that the new mode performs comparably to the predicate device, but specific metrics are not detailed.

2. Sample Size Used for the Test Set and Data Provenance

The document states "clinical validation testing with an animal model" was performed.

• Sample Size: Not specified.
• Data Provenance: Animal model; implies prospective (testing performed specifically for this submission). The country of origin is not specified.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not specified in the document.

4. Adjudication Method for the Test Set

Not specified in the document.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention a Multi-Reader Multi-Case (MRMC) comparative effectiveness study, nor does it quantify any improvement for human readers with AI assistance. The device description is for an imaging system, not an AI-assisted diagnostic tool in the typical sense that would involve human reader performance comparisons.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

The device is an imaging system designed for surgeons to visualize tissues in real-time. It's not an "algorithm only" device in a standalone diagnostic capacity. The testing described (bench and animal model) supports its functionality as an imaging tool to be used by a surgeon.

7. Type of Ground Truth Used

The document mentions "clinical validation testing with an animal model" to confirm "no issues of safety or effectiveness." This suggests the ground truth was likely based on observed physiological responses in the animal model, evaluating whether the system accurately visualized vessels, blood flow, and tissue perfusion using ICG, as intended. However, the specific method for establishing this ground truth (e.g., direct observation, histopathology) is not detailed.

8. Sample Size for the Training Set

The document does not explicitly mention a "training set" or its sample size. Given the description, the device appears to be an imaging hardware system with a new mode, rather than a machine learning model that would typically have a distinct training phase with a labeled dataset. The verification and validation testing focus on confirming the functionality of the imaging system itself.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned for an algorithm, the method for establishing its ground truth is not applicable or described in this document.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Surgical System Model IS5000 (also referred to as dV5) is a software-controlled, electromechanical system designed for surgeons to perform minimally invasive surgery. It consists of a Surgeon Side Console (Console), a Patient Side Cart (Robot), and a Vision System Cart (Tower) and is used with an Endoscope, EndoWrist Instruments, and Accessories.

This submission is based on the software and labeling modification to the da Vinci Surgical System, Model IS5000, previously cleared under K232610. The IS5000 system software has been modified to enable features including Focused Mode, 3D Model Viewer, and Video Review. The Device Labeling of the da Vinci Surgical System, Model IS5000, is also modified to reflect the additional features.

Focused Mode is a new menu mode within the da Vinci Surgical System IS5000 Graphical User Interface (GUI) that allows users to access and interact with 3D Model Viewer and Video Review.

3D Model Viewer (3DMV) is a software feature that enables the da Vinci Surgical System IS5000 system to display and manipulate 3D Models and 2D image files directly on the da Vinci Surgeon Console graphical user interface.

Video Review is a software feature that allows the surgeon to record surgical case video on the da Vinci Surgical System IS5000, create bookmarks, and review the video and bookmarks intraoperatively.

The provided FDA 510(k) clearance letter for the da Vinci Surgical System, IS5000 (K250442) describes modifications to an existing device, focusing on software and labeling updates for new features: Focused Mode, 3D Model Viewer, and Video Review. As such, the study described is primarily focused on demonstrating that these new features do not raise new questions of safety or effectiveness and that the modified device remains substantially equivalent to its predicate.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with specific quantitative thresholds. Instead, it states that "All testing performed met its predetermined acceptance criteria and supports the subject device changes." The acceptance criteria are broadly described by the types of testing conducted and the regulatory guidance followed. The reported device performance is that these tests were met.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a sample size for any of the testing conducted. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The testing appears to be primarily focused on internal verification and validation of the software and human-device interaction rather than a clinical study involving patients or patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used or their qualifications for establishing ground truth associated with the test set. For "Human Factors Information," it mentions that "human factors validation testing was performed for impacted critical tasks," which would typically involve user testing with representative users (e.g., surgeons). However, details about the number or qualifications of these users/experts are not provided.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set. Given the nature of the testing described (software V&V, human factors, cybersecurity), a formal adjudication process akin to clinical trial endpoint determination is generally not applicable or described in this type of submission summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

An MRMC comparative effectiveness study was not conducted. The submission focuses on modifications to an existing surgical system and primarily addresses safety and effectiveness through software, human factors, and cybersecurity testing, rather than comparative clinical outcomes with human readers or AI assistance. The new features (Focused Mode, 3D Model Viewer, Video Review) are enhancements to the user interface and functionality, not diagnostic aids or AI-driven decision support tools that would typically warrant an MRMC study.

6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study

A standalone performance study of an algorithm without human-in-the-loop performance was not conducted or described. The da Vinci Surgical System is, by definition, a human-in-the-loop system controlled by a surgeon. The new features described are intended to assist the surgeon (e.g., displaying 3D models, reviewing video) rather than operate autonomously.

7. Type of Ground Truth Used

The type of "ground truth" used is not explicitly specified in terms of clinical outcomes, pathology, or expert consensus on a test set. Instead, the "ground truth" for the testing performed likely refers to:

• Design Requirements: For software V&V, the "ground truth" is that the software performs according to its specified requirements and user needs.
• Usability Objectives: For human factors testing, the "ground truth" is that critical tasks can be performed safely and effectively by intended users without unacceptable use errors.
• Security Standards: For cybersecurity testing, the "ground truth" is adherence to established cybersecurity best practices and the mitigation of identified vulnerabilities.

8. Sample Size for the Training Set

The document does not specify a sample size for any training set. As the modifications described are for software features (Focused Mode, 3D Model Viewer, Video Review) that enhance the control system but do not appear to involve machine learning models that require a "training set" in the traditional sense, this information is not applicable or provided.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set in the document, information on how its ground truth was established is not provided. The system enhancements are described as software functionalities rather than machine learning algorithms that would typically rely on labeled training data and an associated ground truth establishment process.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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.

Contraindication:
Use of the force feedback needle driver is contraindicated in hysterectomy and myomectomy due to the risk of vaginal bleeding requiring hospital readmission and/or the need for additional procedures. The use of non-force feedback needle drivers is recommended for suturing in these procedures.

The da Vinci Surgical System, Model IS5000 (da Vinci 5) is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console, Robot, and Tower and is used with an endoscope, instruments, and accessories.

The basis for this submission is a modification to the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software has been modified to include a new "force gauge" graphical user interface element, which provides a visual representation of forces applied while completing tasks with the da Vinci Force Feedback instruments.¹ The modification also includes changes to the device labeling.

The provided FDA 510(k) clearance letter and summary for the Da Vinci Surgical System (IS5000) focuses on a software modification, specifically the addition of a "force gauge" graphical user interface (GUI) element. The document does not provide detailed information about clinical performance studies with acceptance criteria in the sense of diagnostic accuracy or clinical outcomes directly tied to the new GUI feature.

Instead, the performance data presented is related to software verification and validation and human factors. This is typical for device modifications where the core functionality of the device remains unchanged, and the modification primarily affects the user interface or internal software operations.

Here's a breakdown of the requested information based only on the provided text, recognizing the limitations of this type of submission:

1. Table of Acceptance Criteria and Reported Device Performance

Since the primary modification is a software change and the addition of a GUI element, the acceptance criteria are not clinical performance metrics but relate to the software's adherence to design specifications and usability.

2. Sample Size Used for the Test Set and Data Provenance

• Software Verification & Validation: The document states "unit, subsystem integration, and system level" testing. This typically involves internal testing by engineers. It does not specify a "sample size" in terms of patient data or clinical cases. The provenance is internal development and testing.
• Human Factors Validation: While a "human factors validation" was conducted, the document does not specify the number of users (the "test set" in this context) involved in these studies. The provenance would be from internal usability testing.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts

Not applicable in the context of this software modification submission. The "ground truth" for software verification is adherence to design specifications and functional requirements. For human factors, it relates to usability and safety of interaction, which is assessed through user testing and expert review of the interface. The document does not specify the number or qualifications of "experts" involved in establishing this ground truth.

4. Adjudication Method for the Test Set

Not applicable for the types of testing described. Adjudication methods like "2+1" typically apply to diagnostic studies where multiple readers interpret cases and a consensus or tie-breaker is needed to establish ground truth.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not explicitly mentioned or implied to be done for this submission. The submission focuses on verification of the software change and human factors, not on comparing clinical effectiveness with and without the AI assistance (which the force gauge isn't explicitly defined as, but rather a new GUI element for an existing force feedback instrument).

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

Not applicable. The force gauge is a graphical user interface element that provides visual feedback to the human operator using the Da Vinci Surgical System. It inherently functions "with human-in-the-loop."

7. The Type of Ground Truth Used

• Software Verification & Validation: The "ground truth" is the design specifications and functional requirements of the software. The tests verify that the software performs as designed.
• Human Factors Validation: The "ground truth" is adherence to usability principles and mitigation of use-related risks, assessed through task analysis and user studies against established human factors engineering principles.

8. The Sample Size for the Training Set

Not applicable. This submission concerns a modification to an existing surgical system's software GUI. It does not describe an AI/ML algorithm that requires a "training set" in the conventional sense for model development. The "force gauge" is a visual representation of existing force feedback data, not a new predictive or analytical algorithm trained on data.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no mention of a "training set" for an AI/ML model.

Summary of Device and Study Context:

The Da Vinci Surgical System (IS5000) submission (K251213) is a Traditional 510(k) for a software modification to an already cleared device (K232610). The modification adds a "force gauge" graphical user interface (GUI) element that visually represents forces applied by existing Da Vinci Force Feedback instruments.

The study described is not a clinical effectiveness trial but rather a set of engineering verification and validation activities to ensure the software modification is safe and functions as intended, and that the new GUI element does not introduce new use-related risks. The FDA's clearance is based on the determination that the modified device is substantially equivalent to its predicate device, and the performance data provided (software V&V, human factors) supports this equivalence for the specific modification.

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The Intuitive Surgical Endoscopic Instrument Control System (da Vinci Surgical System, Model IS5000) shall 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 and general thoracoscopic surgical procedures. The system is indicated for adult 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 Surgical System, Model IS5000, is a software-controlled, electro-mechanical system designed to enable complex surgery using a minimally invasive approach. The system consists of a Console (Surgeon Console or SSC), a Robot (Patient Side Cart or PSC), and a Tower (Vision Side Cart or VSC) and is used with an endoscope, instruments, and accessories.

The basis for this submission is the modification of the da Vinci Surgical System, Model IS5000, cleared under K232610. The device software is being modified to include a new feature called "Networked Central Configuration Management" which enables Intuitive technical support to remotely push configuration data to a system connected to the network for user to update the system. The configuration data includes customer site preference settings and system feature enabling or disabling. The modification also includes changes to the device labeling.

The provided FDA 510(k) clearance letter for the da Vinci Surgical System (IS5000), K251202, describes a submission for a modification to an already cleared medical device, not a completely novel device. The core of this submission revolves around software changes, specifically the addition of a "Networked Central Configuration Management" feature and associated cybersecurity updates.

As such, the detailed information typically found for a new device's performance study (MRMC, expert ground truth, extensive sample sizes for training/test sets, etc.) is not present in this type of 510(k) submission. The FDA clearance is based on demonstrating that the modifications do not adversely affect the device's safety and effectiveness and that the new features function as intended without introducing new risks.

Therefore, the response below will focus on what can be inferred or reasonably assumed from the provided document regarding performance criteria and how the device meets them in the context of this specific modification.

Acceptance Criteria and Device Performance for da Vinci Surgical System (IS5000) K251202

Given that this 510(k) submission (K251202) is for a modification to an already cleared device (K232610), the performance data provided focuses on verifying the safety and functionality of the changes rather than re-establishing the fundamental efficacy of the surgical system itself. The core acceptance criteria revolve around ensuring that the new software feature ("Networked Central Configuration Management") and associated cybersecurity updates do not introduce new risks or degrade the existing performance of the device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Test Set Sample Size: The document does not specify a quantitative "sample size" in terms of patient cases or surgical procedures for the performance testing of these software modifications. This is typical for software-only changes. Instead, testing would involve a comprehensive set of software validation tests, unit tests, integration tests, and system-level tests for the new functionalities and cybersecurity.
• Data Provenance: Not specified in terms of country of origin. The testing would have been performed by the manufacturer (Intuitive Surgical, Inc.) in a controlled development and testing environment. The data is retrospective in the sense that it's derived from internal validation activities, not a prospective clinical trial for these specific changes.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• Number of Experts: Not explicitly stated. For software and cybersecurity validation, "experts" would likely be:
  • Software engineers and quality assurance (QA) testers experienced in medical device software.
  • Cybersecurity experts (e.g., ethical hackers, penetration testers, network security specialists).
  • Clinical subject matter experts (e.g., surgeons, clinical engineers) might be involved in reviewing use cases and validating clinical workflows impacted by the new features, but this is not detailed.
• Qualifications of Experts: Not specified. It's assumed they would possess relevant engineering, software development, cybersecurity, and potentially clinical experience for their respective roles in the verification and validation process.

4. Adjudication Method for the Test Set

• Adjudication Method: Not applicable or specified. For software and cybersecurity testing, "adjudication" typically refers to the process of resolving discrepancies in expert interpretations of data (e.g., image reads). In software testing, the "ground truth" is adherence to design specifications and user requirements, as well as absence of bugs and security vulnerabilities. Test results are compared against expected outcomes, not expert consensus.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• MRMC Study: No, an MRMC study was not performed. MRMC studies are typically conducted to evaluate the impact of a new diagnostic imaging AI algorithm on human reader performance (e.g., radiologists improving detection rates). This 510(k) is for a surgical system's software modification, not a diagnostic AI.

6. If a Standalone (Algorithm Only) Performance Study Was Done

• Standalone Performance Study: Not in the traditional sense of an AI algorithm's diagnostic performance (e.g., sensitivity/specificity for a disease). However, the "Software Testing" and "Cybersecurity Testing" sections represent the standalone performance evaluation of the new software feature and its security aspects in isolation from the full clinical context. This involves testing the software's ability to correctly manage configurations, push updates, and maintain data integrity and security, independent of a specific surgical procedure.

7. The Type of Ground Truth Used

• Type of Ground Truth: For this type of submission, the ground truth is established by:
  • Design Specifications and User Requirements: The software is tested against whether it correctly implements the defined functionalities (e.g., "Networked Central Configuration Management" remotely pushes data, updates settings as specified).
  • Cybersecurity Threat Models: The security measures are validated against identified threats and vulnerabilities to ensure they provide adequate protection.
  • Existing Validated Performance: The ground truth for the core surgical system's performance is assumed from its prior clearance (K232610), and the current testing aims to ensure this performance is not degraded.

8. The Sample Size for the Training Set

• Training Set Sample Size: Not applicable. The "Networked Central Configuration Management" feature is a conventional software function, not a machine learning or AI algorithm that requires a "training set."

9. How the Ground Truth for the Training Set Was Established

• Ground Truth for Training Set Establishment: Not applicable, as there is no training set for a machine learning model in this submission.

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The cannulas, obturators, seals, and related accessories are intended to establish a port of entry for instruments, endoscopes, or accessories. They are intended to be used only in a medical facility by trained medical professionals in accordance with its associated user manual.

The subject device 8 mm and 12 mm Assist Cannulas are used as part of a trocar system to establish a port of entry into the surgical site. The 8 mm and 12 mm Assist Cannulas are intended to be used laparoscopically (independently of the da Vinci Systems), but may be used in conjunction with da Vinci systems to assist robotic procedures.
The cannula is a stainless steel hollow tube that serves as a port of entry for endoscopic instruments. A seal is attached to a cannula and an obturator is placed through the seal. The seal attaches to the top of the cannula to create an air-tight system that allows an insufflated body cavity to be maintained. The seal has an insufflation port with a universal luer fitting and stopcock which connects to the da Vinci Insufflator Tube Set with Smoke Evacuation.

This FDA 510(k) clearance letter pertains to medical devices (8 mm and 12 mm Assist Cannulas), not AI/ML software. Therefore, the information typically found for AI/ML device studies (such as acceptance criteria for algorithm performance, sample sizes for test sets, expert consensus, MRMC studies, or training set details) is not present in this document.

Instead, the document focuses on demonstrating substantial equivalence to a predicate device through engineering and performance testing relevant to surgical cannulas, such as dimensional measurements, mechanical and functional verification, biocompatibility, and sterilization.

Here's a breakdown of the available information related to performance and testing, framed to align with your request where applicable, but noting the absence of AI/ML-specific details:

Device: 8 mm Assist Cannula; 12 mm Assist Cannula

1. Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated numerically. The performance data section vaguely mentions "bench and animal" testing. The human factors evaluation refers to "post-market data and the MAUDE database" and "formative usability evaluations." Specific numbers for test units or subjects are not provided.
• Data Provenance:
  • Bench and Animal Testing: Implied to be conducted internally or by a testing facility, but no specific country of origin is mentioned. These are typically prospective tests.
  • Human Factors Evaluation: "Post-market data and the MAUDE database" is retrospective data from device adverse event reporting. Formative usability evaluations are prospective. No country of origin is specified for these studies.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable and not provided in the document as this is a traditional medical device (surgical cannula) clearance, not an AI/ML device that requires expert-established ground truth for diagnostic accuracy.

4. Adjudication Method for the Test Set

Not applicable. This concept is typically relevant to the establishment of ground truth in AI/ML diagnostic studies through expert review.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is specific to evaluating human reader performance with and without AI assistance for diagnostic tasks, which is not relevant for a surgical cannula.

6. If a Standalone (i.e. algorithm only, without human-in-the-loop performance) Was Done

No, this is not applicable. The device is a physical surgical tool and does not involve an algorithm.

7. The Type of Ground Truth Used

For the physical device, "ground truth" would correspond to engineering specifications and safe/effective performance. This was established through:

• Design Input Requirements: The pre-defined criteria for the device's function and performance.
• Bench Testing: Direct physical measurements and functional tests against specifications.
• Animal and Cadaver Models: Simulated use to confirm performance in a biological context.
• Biocompatibility Standards: Adherence to ISO 10993-1.
• Sterilization Standards: Confirmation of steam sterilization methods.
• Human Factors Analysis: Identification and mitigation of use-related risks through analysis of historical data and usability assessments.

8. The Sample Size for the Training Set

Not applicable. "Training set" refers to data used to train AI/ML algorithms. This device does not use an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no AI/ML training set for this device.

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The Vessel Sealer Curved is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and a compatible electrosurgical generator. It is intended for grasping and blunt dissection of tissue, and for bipolar coagulation and mechanical transection of blood vessels (veins and arteries) up to 7 mm in diameter, lymphatic vessels, and tissue bundles that fit in the jaws of the instrument. The Vessel Sealer Curved has not been shown to be effective for tubal sterilization or tubal coagulation for sterilization procedures, and should not be used for these procedures.

The Vessel Sealer Curved is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing. The Vessel Sealer Curved device consists of a distal wristed end effector and a proximal housing connected by a tubular shaft. The housing contains mechanisms to actuate the end effector when attached to a compatible da Vinci Surgical System. An integrated cord attached to the housing is connected to a receptacle in the Intuitive Electrosurgical generator, E-200. An electrode sealing surface and a cutting blade within the jaws of the instrument enable sealing of vessels and cutting of sealed vessels and other tissues. The sealing and cutting functions are controlled using the compatible da Vinci Surgical System foot pedals.

Based on the provided FDA 510(k) clearance letter and summary for the "Vessel Sealer Curved" device, it is important to note that this document pertains to a surgical instrument (hardware), not a medical device with an AI/software component that would involve "acceptance criteria" and "studies" as typically understood for AI-based diagnostic or prognostic devices.

The information requested in the prompt (acceptance criteria for AI, sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this type of device submission. The 510(k) summary clearly outlines the types of testing performed: mechanical, reliability, software (presumably related to the electrosurgical generator and da Vinci system, not AI), biocompatibility, shelf-life, transit, and animal studies focusing on functional performance like burst pressure and thermal spread.

Therefore, I cannot extract the information requested in the format provided because the device and its clearance process do not involve AI performance evaluation. The "study that proves the device meets the acceptance criteria" in this context refers to the engineering and preclinical validation tests detailed in Section VI "Performance Data" (Design Verification, Shelf-Life, Transit, Biocompatibility, Design Validation via animal testing).

Here's how to address the prompt given the nature of the device:

Acknowledgement of Device Type:
The Vessel Sealer Curved is a physical surgical instrument (bipolar electrosurgical instrument) used with a compatible da Vinci Surgical System and an electrosurgical generator. It is not an AI/software-based diagnostic or imaging device.

Why the Requested Information is Not Applicable:
The majority of the questions in the prompt (e.g., acceptance criteria for AI, sample sizes for test/training sets for AI, expert ground truth, MRMC studies, standalone AI performance) are relevant to the regulatory pathway for AI/Machine Learning-enabled medical devices. Since the Vessel Sealer Curved is a hardware device focused on mechanical and electrosurgical performance, these metrics are not part of its 510(k) submission.

Information that is relevant and can be inferred from the document:

The acceptance criteria for a device like this would be tied to its functional performance, safety, and substantial equivalence to a predicate device.

• Overall Goal: To demonstrate substantial equivalence to the predicate device (Vessel Sealer Extend K183107) in terms of intended use, technological characteristics, safety, and performance.

• Key Performance Indicators (Acceptance Criteria): While not explicitly stated in a table format with specific percentages for AI performance, the document implies the following types of performance criteria based on the tests conducted:

  • Mechanical Integrity: The device must withstand expected forces and remain functional (e.g., ability to grasp, dissect, and transect tissue).
  • Reliability: Consistent performance over its intended lifespan/usage.
  • Sealing Effectiveness: Ability to seal vessels up to 7mm effectively, preventing burst at a certain pressure (Burst Pressure Testing).
  • Controlled Thermal Spread: Minimizing unintended thermal damage to surrounding tissue (Thermal Spread on Vessels).
  • Compatibility: Seamless function with the da Vinci Surgical System and E-200 electrosurgical generator.
  • Biocompatibility: No adverse biological reactions when in contact with tissues.
  • Shelf-Life and Transit Stability: Maintaining sterility and functional integrity throughout its shelf-life and during shipping.

Study Proving Device Meets Criteria (Based on Document):

The performance data listed in Section VI outlines the studies conducted:

• Design Verification:
  • Mechanical bench testing
  • Reliability Testing
  • Force to Jaw Failure
  • Software Verification (likely for the control system, not AI)
  • Testing in accordance with IEC60601-1 and IEC60601-1-2 (electrical safety)
  • Usability Testing
• Shelf-Life Verification: In accordance with ASTM F1980.
• Transit Verification: In accordance with ASTM D4169-16.
• Biocompatibility: In accordance with ISO 10993-1 and FDA guidance.
• Design Validation (Animal Testing):
  • Burst Pressure Testing
  • Thermal Spread on Vessels
  • Chronic Animal Study

Addressing Specific Prompt Questions (as far as applicable):

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

   • As explained, specific quantitative acceptance criteria for AI performance are not relevant here. The acceptance criteria would be successful completion of the listed engineering and preclinical tests, demonstrating that the device's functional outputs meet design inputs and that it performs safely and effectively comparable to the predicate. The document states, "The successful completion of testing demonstrated that the Vessel Sealer subject design outputs meets design inputs."

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

   • Test Set Sample Size: Not explicitly stated for bench or animal testing in this summary and would vary by test (e.g., number of units tested mechanically, number of animals in the design validation study, number of vessels sealed).
   • Data Provenance: Not specified regarding country of origin. The studies are described as engineering bench tests and animal studies. These are prospective experiments conducted to validate the device.

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

   • Not applicable in the AI sense. Ground truth for a surgical instrument would be established through direct measurement of physical performance (e.g., pressure at which a seal bursts, precise measurements of thermal spread, visual inspection for mechanical integrity), and observation of physiological effects in animal models by veterinary or surgical experts. These wouldn't be "experts establishing ground truth for an AI assessment."

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

   • Not applicable as it's not an AI-based diagnostic assessment. Performance is measured objectively.

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 for evaluating AI assistance in diagnostic tasks, which is not the function of this device.

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

   • Not applicable. This device is a surgical instrument operated by a human surgeon via the da Vinci system. Its "performance" is inherently tied to human use.

7. The type of ground truth used:

   • The "ground truth" for this device's performance is based on direct physical measurements (e.g., force, pressure, temperature, electrical parameters), observational data from preclinical animal studies (e.g., successful vessel sealing, lack of adverse tissue reactions, long-term tissue response in chronic studies), and adherence to established engineering and biocompatibility standards.

8. The sample size for the training set:

   • Not applicable. This device is not an AI model that undergoes "training."

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

   • Not applicable.

In summary, the provided document details the regulatory clearance for a conventional surgical instrument, not an AI-enabled device. Therefore, the performance criteria and validation methods are entirely different from those required for AI software.

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