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The EndoWrist Vessel Sealer is a bipolar electrosurgical instrument for use with a compatible da Vinci Surgical System and the ERBE VIO dV electrosurgical generator. It is intended for grasping and blunt dissection of tissue and for bipolar coagulation and mechanical transection of vessels up to 7 mm in diameter and tissue bundles that fit in the jaws of the instrument. The EndoWrist Vessel Sealer 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 8 mm Harmonic ACE Curved Shears is intended for soft tissue incisions when bleeding control and minimal thermal injury are desired. It is designed to be used in conjunction with a compatible da Vinci Surgical System and a compatible Ethicon Endo-Surgery Generator and Hand Piece.

The Intuitive Surgical da Vinci Single-Site Instruments and Accessories used with a compatible da Vinci Surgical System 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, suction/irrigation 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, clip appliers, 5 mm curved cannulae, 5 mm and 10 mm straight cannulae, 8 mm endoscope cannula, flexible and rigid blunt obturators, cannula seal, and the Single-Site Port.

The EndoWrist Vessel Sealer is a sterile, single-use (disposable), 8 mm instrument with an integrated cord that connects to the instrument housing and an Erbe VIO dV generator. The EndoWrist Vessel Sealer 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 IESU. 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.

The da Vinci 8 mm Harmonic ACE Curved Shears is a single-use, sterile instrument used to deliver ultrasonic energy to enable transection and coagulation of tissue. The movement and function of the da Vinci 8 mm Harmonic ACE Curved Shears are controlled by the surgeon from the Surgeon Console of a compatible da Vinci Surgical System. This instrument consists of a housing, instrument shaft, and instrument jaws comprised of a clamp arm and blade.

The da Vinci Single-Site Instruments and Accessories are a set of devices developed by Intuitive Surgical to enable single incision laparoscopic cholecystectomy, benign hysterectomy and salpingo oophorectomy using the compatible da Vinci Surgical System.

This document is a 510(k) premarket notification from the FDA, classifying the submitted devices as substantially equivalent to previously marketed devices. The purpose of this submission is to change the Indications for Use for three devices: the EndoWrist Vessel Sealer, 8 mm Harmonic ACE Curved Shears, and da Vinci Single-Site Instruments and Accessories. The document explicitly states that design verification and validation testing were not required as design inputs were not changed.

Therefore, there is no information about specific acceptance criteria, device performance, or a study that proves the device meets acceptance criteria presented in this document. The submission is focused on modifying the labeling regarding compatible systems.

Consequently, I cannot provide the requested information from the given text as it does not contain details about:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes or data provenance for a test set.
3. Number of experts or their qualifications for ground truth establishment.
4. Adjudication method.
5. MRMC comparative effectiveness study or related effect size.
6. Standalone algorithm performance.
7. Type of ground truth used (e.g., pathology, outcomes data).
8. Sample size for the training set.
9. How the ground truth for the training set was established.

The document essentially states that the devices are identical to their predicate devices and the changes are only to the wording of the Indications for Use regarding compatibility with different da Vinci Surgical System models.

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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 5 mm Single-Site Port.

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae (250 mm and 300 mm length), an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator (250 mm and 300 mm length), and a Single-Site Port (with insufflation tubing 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 grasping, cautery, cutting, clip ligation, suturing, and suction/irrigation functions. The instruments are non-wristed (similar to the predicate laparoscopic instruments). The da Vinci Single-Site Instruments and Accessories are intended to be used with the existing IS3000 da Vinci Si Surgical System.

The provided document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. This type of regulatory submission in the US is focused on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving that a device meets specific performance acceptance criteria via a comprehensive clinical study in the same way a PMA or a de novo submission might.

Therefore, the document does not contain the detailed information typically found in a study demonstrating how a device meets specific acceptance criteria with reported device performance against those criteria, sample sizes for test sets, data provenance, expert qualifications, ground truth establishment, or multi-reader multi-case studies.

However, I can extract information regarding the performance data mentioned and the type of studies conducted to support substantial equivalence.

Here's an attempt to answer your request based on the available information, noting where specific details are not provided:

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

Overview: The document states that "Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements." Additionally, "an acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table of specific acceptance criteria or quantitative reported device performance metrics. Instead, it broadly states that "design output meets the design input requirements" and that the testing "demonstrate[s] that the subject device is substantially equivalent to the predicate devices."

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

• Sample Size for Test Set: Not specified for the bench, cadaver, or animal studies.
• Data Provenance:
  • Bench and Cadaver Testing: The document does not specify the country of origin. This testing is typically conducted in a laboratory setting.
  • Acute Animal Study: The document does not specify the species or country of origin for the animal study.
  • Retrospective or Prospective: These studies would typically be considered prospective for the purpose of generating data to support the 510(k) submission.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified. For an animal study involving surgical procedures, it is implied that qualified veterinary surgeons or equivalent personnel would be involved.

4. Adjudication Method for the Test Set

Not applicable/Not specified. The document does not describe a clinical study with an adjudication process for a test set. The validation in the animal study likely involved direct observation and measurement of surgical outcomes.

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

• Existence of Study: No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this 510(k) summary. This type of study is more common for imaging or diagnostic AI devices where human reader performance is being evaluated.
• Effect Size of Human Readers with/without AI Assistance: Not applicable, as no MRMC study was performed.

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

• Existence of Study: No, a standalone algorithm-only study was not conducted or described. The device is a surgical instrument system, which inherently requires human-in-the-loop operation.

7. Type of Ground Truth Used

• The document implies that "ground truth" was established through direct observation and measurement of outcomes in the bench, cadaver, and acute animal studies. For example, in the animal study, the "quality and effectiveness of closure of suture lines" would be the ground truth being assessed, likely through pathological examination or direct surgical assessment.

8. Sample Size for the Training Set

Not applicable. This device is a surgical instrument system, not an AI/ML algorithm that requires a training set in the conventional sense.

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

Not applicable, as no training set for an AI/ML model is mentioned.

Summary of Device Performance Claims in the Document:

The performance data primarily aims to demonstrate substantial equivalence to predicate devices. The key statements are:

• "Bench, and cadaver testing demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements."
• "The differences do not raise any new issues of safety or effectiveness as compared to the predicate devices."
• An "acute animal study was performed to validate the quality and effectiveness of closure of suture lines with the Single-Site Needle Driver and to establish substantial equivalence between the curved needle driver and the SILS Port and manual single incision instruments."

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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 and electrocautery during single incision laparoscopic cholecystectomy with the da Vinci Single Site Instruments and Accessories, including graspers, dissectors, scissors, suction irrigators, monopolar cautery, 5mm curved cannulae, 5mm and 10mm straight cannulae, flexible blunt obturators, and the 5mm Single-Site Port.

The da Vinci Sinale-Site Instruments and Accessories are a new set of devices developed by Intuitive Surgical to enable single incision cholecystectorny using the IS3000 da Vinci Si Surgical System.

The da Vinci Single-Site Instruments and Accessories consist of semi-rigid shaft instruments, two fixed-shape curved cannulae, an accessory cannula for insertion of manual laparoscopic instruments, a semi-rigid blunt obturator, and a single fascial port (with insufflation tubing 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 provide arasping, cautery, cutting, clip ligation and suction/irrigation functions. The instruments are non-wristed (similar to the predicate, laparoscopic instruments).

The da Vinci Single-Site Instruments and Accessories are intended to be used with the existina IS3000 da Vinci Si Surgical System.

This document is a 510(k) summary for the Intuitive Surgical da Vinci Single-Site Instruments and Accessories. It focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria for a new performance claim. Therefore, much of the requested information about acceptance criteria and study details for meeting them is not present. This type of regulatory submission primarily relies on showing that the new device operates similarly to existing, already-approved devices, rather than proving a new, quantitative performance benchmark.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the given document. The 510(k) summary states, "Bench, animal, and clinical data demonstrate that the subject device is substantially equivalent to the predicate devices and that the design output meets the design input requirements. The results of the testing did not raise any new issues of safety or efficacy as compared to the predicate devices."

This indicates that internal design input verification and validation were performed, and a comparison to predicate devices was made, but specific quantitative acceptance criteria or detailed performance metrics against those criteria are not publicly disclosed in this summary. The focus is on substantial equivalence rather than meeting specific statistical performance targets for a novel claim.

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

This information is not provided in the given document. The document vaguely mentions "Bench, animal, and clinical data," but does not specify sample sizes for these tests or the provenance of the data (e.g., country of origin, retrospective/prospective).

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

This information is not provided in the given document. For a 510(k) demonstrating substantial equivalence, ground truth as typically understood in AI/diagnostic studies (e.g., expert consensus on image interpretation) is not a primary focus. The "bench, animal, and clinical data" would likely involve surgical outcomes, device functionality, and safety assessments, rather than expert interpretation of a test set in the conventional sense.

4. Adjudication Method for the Test Set

This information is not provided in the given document. Given the nature of the device (surgical instruments) and the regulatory pathway (510(k) for substantial equivalence), a formal adjudication method for a "test set" in the context of diagnostic interpretation is not applicable or described.

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 information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI-powered diagnostic or assistive tool for "human readers." Therefore, an MRMC study comparing human performance with/without AI assistance would not be relevant.

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

This information is not provided and is not applicable to this device. As explained above, this is a set of surgical instruments, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

This information is not explicitly detailed beyond the mention of "bench, animal, and clinical data." For surgical instruments, "ground truth" would generally relate to successful completion of surgical tasks, device functionality validation, and patient outcomes (e.g., absence of complications, effective tissue manipulation, etc.) as observed during animal and clinical trials. It would not be expert consensus on imaging or pathology reports in the context of diagnostic devices.

8. The Sample Size for the Training Set

This information is not provided and is not applicable to this device. This device is a set of surgical instruments, not an AI or machine learning model that requires a "training set."

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

This information is not provided and is not applicable to this device, as there is no "training set" for surgical instruments in this context.

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