Search Results

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® EndoWrist SP ™ Instruments during urologic 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.

Intuitive Surgical® EndoWrist 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 surgical procedures that are appropriate for a single port approach and transoral otolaryngology surgical procedures in the oropharynx restricted to benign tumors and malignant turnors 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, Endo Wrist SP™ Instruments, and Accessories is a software-controlled, electro-mechanical system designed for surgeons to perform minimally invasive surgery in an operating room environment. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SPTM Instruments, and Accessories.

The SP Access Port Kit is an ethylene oxide (EO)-sterilized, single-use, disposable accessory of the da Vinci SP® Surgical System. It is intended to be used in endoscopic surgery to provide access for da Vinci SP® instruments, a da Vinci SP® Camera, and assist instruments through a single port. It can be used when superficial instrument articulation is needed.

The SP Access Port Kit is available in two sizes, differing in the range of incision sizes each kit may be used with:

• SP Access Port Kit, Small Incision (2.7 cm-4 cm) .
• SP Access Port Kit, Large Incision (2.7 cm-7 cm) .

Each SP Access Port Kit has three main components: the SP Short Entry Guide, the Access Port, and the Wound Retractor.

The SP Short Entry Guide has four lumens to guide the instrument and camera shafts through the Access Port. The SP Short Entry Guide is inserted through a seal at the top of the Access Port. It can rotate within the Access Port.

The Access Port is the main body of the SP Access Port Kit. The Access Port connects to the instrument arm of the SP1098 Patient Cart. The base of the Access Port connects to the Wound Retractor. Key features of the Access Port include:

• Rotating Access Port Seal: Provides access for laparoscopic assist instruments and . allows rotation of the assist instrument around the SP Short Entry Guide.
• . Chamber: Flexible transparent chamber provides space for articulation of the EndoWrist SP™ instrument joints outside the incision while maintaining insufflation and enabling visualization of surgical site.
• Chamber Seal: Provides access for insufflation accessories and laparoscopic assist . instruments.
• Insufflation Lines: Provide connection to insufflator lines. .

The Wound Retractor is a flexible sleeve that provides incision retraction to create access for instruments and accessories.

The two SP Access Port Kits differ only in the size of the Wound Retractor and the size of the clamp at the base of the Access Port that connects to the Wound Retractor.

Here's an analysis of the acceptance criteria and supporting studies for the da Vinci SP Surgical System, focusing on the SP Access Port Kit, based on the provided document:

The document describes the da Vinci SP Surgical System, Model SP1098, EndoWrist SP Instruments, and Accessories, with a particular focus on the newly introduced SP Access Port Kit. The objective of the submission (K202571) is to demonstrate substantial equivalence to a predicate device (K182371) for the same system, but with a different port system.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with quantitative performance metrics for the SP Access Port Kit and its exact reported performance against those criteria. Instead, it describes general categories of testing and states that the device "met all the acceptance criteria" or "demonstrating that the design output meets the design input requirements" and "meets user needs and intended use."

However, based on the descriptions, we can infer the types of acceptance criteria and the positive results:

• Fulfillment of mechanical requirements (e.g., strength, durability).
• Proper equipment interfaces (e.g., secure connection to the Patient Cart).
• Reliability under expected conditions.
• Integrity of package and labeling. | "The SP Access Port Kit met all the bench testing acceptance criteria, demonstrating that that the design output meets the design input requirements." |
  | Cadaver and Animal Validations | - Ability to provide robotic and laparoscopic instrument access (e.g., to extraperitoneal space, large surgical work volume, various depths).
• Facilitation of instrument motion during fine dissection and gross movements.
• Robustness and secure installation of the SP Access Port Kit.
• Maintenance of insufflation.
• Safe and effective use in representative urologic procedures. | "met all the design validation acceptance criteria, demonstrating that it meets user needs and intended use." Specific successful procedures included retroperitoneal nephrectomy (cadaver) and transabdominal nephroureterectomy (porcine). |
  | Histological Evaluation | - No discernible pathologically significant differences in tissue trauma compared to predicate/reference devices after installation, incision retraction, and removal.
• No significant tissue trauma during surgical procedures.
• Normal and adequate healing for all tissue samples. | - "No discernible pathologically significant differences between any of the tissue tracks examined from the SP Access Port Kit, SP Cannula (predicate device) and GelPOINT (reference device) port sites as a result of installation, incision retraction, and removal of the port."
• "No discernible pathologically significant differences between the tissue tracks from the SP Access Port Kit and the SP Cannula used to perform a left nephroureterectomy."
• "No trauma to surrounding organs due to the installation, removal, incision retraction, and use of the SP Access Port Kit or SP Cannula during the surgical procedures that required further histopathological examination."
• "All the samples in this study would heal normally and adequately once appropriate tissue apposition and suture closure was performed." |
  | Human Factors Evaluation (Summative Validation Study) | - Validation of risk mitigations.
• Identification and assessment of previously unknown use-related hazards or those from implemented mitigations.
• Acceptable ease of use.
• Effectiveness of user documentation and training materials.
• Residual risk at an acceptable level. | The study identified and assessed use-related risks, ensuring residual risk is at an acceptable level. New hazardous use scenarios were assessed and updated in the usability risk analysis. |

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

• Design Verification (Bench Testing): Not specified. Likely involved multiple units of the SP Access Port Kit tested for various physical and mechanical properties.
• Cadaver and Animal Validations:
  • Cadaver Model: One (1) cadaver used for a complete retroperitoneal nephrectomy.
  • Porcine Model: One (1) porcine model used for a complete transabdominal nephroureterectomy. Also, another set of porcine models for the histological evaluation (exact number not specified for this part, but implied to be multiple to compare devices and surgical procedures).
  • Data Provenance: Not explicitly stated as "country of origin," but these are laboratory/controlled studies within the context of a medical device manufacturer, likely conducted in the US. They are prospective studies.
• Histological Evaluation:
  • Porcine Model: Used for comparison testing of port site tissue effects. Multiple porcine models were likely used to compare the SP Access Port Kit, SP Cannula (predicate), and GelPOINT (reference device), as well as to compare SP Access Port Kit and SP Cannula during a nephroureterectomy. The exact number of animals is not specified, but multiple samples/procedures were performed.
  • Data Provenance: Prospective studies in an animal model.
• Human Factors Evaluation (Summative Validation Study):
  • Sample Size: 16 surgical teams (each team consisting of a surgeon and a patient-side assistant). This means a total of 32 participants.
  • Data Provenance: Prospective study, conducted in a simulated operating room environment.

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

• Cadaver and Animal Validations: The assessment of "surgical performance and safety" was likely conducted by the study investigators, who are implied to be qualified in surgical procedures, given the nature of the testing. The document doesn't specify an independent panel for ground truth.
• Histological Evaluation:
  • Number of Experts: One (1) independent pathologist.
  • Qualifications: "independent pathologist" – presumed to have expertise in assessing tissue trauma and histology, though no specific years of experience or board certifications are mentioned.
• Human Factors Evaluation (Summative Validation Study): The evaluation involved monitoring by the research team (implied experts in human factors and device use) who observed objective performance data and conducted follow-up interviews. The "ground truth" here is the observed user behavior, use errors, and subjective feedback indicating safety/usability, as interpreted by human factors experts. No specific number for these evaluators is given, but it would involve the study personnel.

4. Adjudication Method for the Test Set

• Bench Testing, Cadaver/Animal Validations: Not explicitly stated as an adjudication method by a panel. Compliance was likely assessed against established engineering specifications and predetermined success criteria by the testing engineers/study team.
• Histological Evaluation: The "independent pathologist" made direct conclusions. There is no mention of a consensus process with multiple pathologists or an adjudication method for different interpretations.
• Human Factors Evaluation: The study collected both objective (observations of errors, task completion) and subjective data (open-ended questions, interviews). The "adjudication" of risks and usability was inherent in the human factors engineering process, where observed errors and feedback were analyzed by the HF team, culminating in updating the usability risk analysis. There is no explicit mention of an independent adjudication panel for observed events.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic devices to assess the performance of multiple readers on multiple cases, often comparing AI-assisted vs. unassisted human performance. The da Vinci SP Surgical System is a surgical tool, and its evaluation focuses on performance, safety, and usability during surgical procedures, not diagnostic interpretation.

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

This question is not applicable in the typical sense for this device. The da Vinci SP Surgical System is not an AI-driven diagnostic algorithm that performs tasks "standalone." It is a surgical system that assists human surgeons. The human factors evaluation assesses the human-in-the-loop performance, but the device itself is an instrument control system, not an autonomous algorithm.

7. The Type of Ground Truth Used

• Design Verification (Bench Testing): Engineering specifications and design input requirements.
• Cadaver and Animal Validations: Surgical performance parameters (e.g., instrument access, motion, robustness, insufflation maintenance) as evaluated by the study team, and the successful completion of specified procedures.
• Histological Evaluation: Expert pathological assessment by an independent pathologist. This is directly comparable to "pathology" as a ground truth.
• Human Factors Evaluation: Observed user performance (task completion, errors, close calls, difficulties) and subjective feedback from surgical teams, interpreted against usability and safety risk assessments.

8. The Sample Size for the Training Set

The document does not detail a "training set" in the context of an AI/ML algorithm for the core device performance. The da Vinci SP Surgical System is an electro-mechanical system controlled by software, but the submission focuses on hardware (the SP Access Port Kit) and its integration.

If "training set" refers to user training: "Prior to the evaluation, participants underwent representative self-guided training that a user would be provided for the SP Access Port Kit." This implies training materials were provided, but it's not a "training set" in the statistical sense for an algorithm.

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

As there is no "training set" for an AI/ML algorithm described for this device, this question is not applicable in that context.

If referring to the "training materials" for human users, the ground truth for those would be that they accurately reflect the proper and safe operation of the device as designed and validated, based on the device's operational specifications and the results from all the performance testing. However, the document does not elaborate on how the content of these training materials themselves were "ground truthed."

Ask a specific question about this device