Search Results
Found 15 results
510(k) Data Aggregation
(211 days)
TransEnterix, Inc.
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in general laparoscopic surgical procedures and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The Senhance Surgical System is a multi-arm, console-based robotic system that allows a surgical team to perform laparoscopic surgery in the abdomen and pelvis in a manner similar to a manual laparoscopic approach. Each robotic arm can hold either a laparoscopic surgical instrument or an endoscope to facilitate a surgeon remotely operating the instrument from the cockpit. The purpose of this submission is to seek clearance for modifications to the indications for use to expand the types of surgical procedures for which the Senhance Surgical System may be used.
In this submission, the indications for use have been expanded to cover laparoscopic general surgical procedures. The new indications for use statement does not create a new intended use for the system.
The Senhance Surgical System consists of: a surgeon console (cockpit), which provides remote manipulators or handles to allow the surgeon to maneuver the surgical instruments and a video monitor to display the endoscopic signal; manipulator arms, which hold and maneuver the instruments and endoscope based on inputs from the surgeon; Intelligent Surgical Unit (ISU), which is the system communication hub, connecting the cockpit and manipulator arms; and instruments, which manipulate the tissue of interest.
In addition, force feedback provides an optional tactile sensory input to the surgeon control handles to give a sense of tissue elasticity. An eye tracking feature provides the surgeon an optional method to control the endoscope from the cockpit, rather than using the surgeon control handles. The ISU allows for three additional methods of camera control, in addition to the optional eye tracking method.
The Senhance instruments are similar in design and materials to traditional laparoscopic instrumentation.
Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria & Reported Device Performance
The FDA clearance is for expanding the indications for use of the Senhance Surgical System. The acceptance criteria, while not explicitly stated as numerical targets in a formal table, are implicitly demonstrated by showing the device performs comparably to established alternative surgical techniques for the expanded indications. The study aims to show that the Senhance Surgical System is as safe and effective as traditional laparoscopic and robotically-assisted surgery for Nissen fundoplication, a representative general surgical procedure.
| Acceptance Criterion (Implicit) | Reported Device Performance (Senhance System for Nissen Fundoplication) |
|---|---|
| Length of Hospital Stay (days) (Comparable to standard techniques) | Mean (range): 5 (3-6) for Cohort 1, 2 (1-4) for Cohort 2. |
| Intraoperative Complication Rates (Low/Comparable to standard techniques) | 0 for both Cohort 1 and Cohort 2. |
| Estimated Blood Loss (EBL) Volumes and Blood Transfusion Rates (Low/Comparable to std.) | Transfusion Rate: 0 (Cohort 1, for 16/18 patients), Estimated Blood Loss: 14 mL (Range 0-50) (Cohort 2). |
| Conversion Rates (Low/Comparable to standard techniques) | 2 (11%) for Cohort 1, 4 (25%) for Cohort 2. (Note: These were conversions to hybrid technique, not open surgery). |
| Readmission Rates (Low/Comparable to standard techniques) | 0 for Cohort 1, 2 (13%) for Cohort 2. |
| Reoperation Rates (Low/Comparable to standard techniques) | 1 (6%) for Cohort 1, 0 for Cohort 2. |
| Mortality Rates (Low/Comparable to standard techniques) | 0 for both Cohort 1 and Cohort 2. |
| Postoperative Complication Rates (Low/Comparable to standard techniques) | 5 (14.7%) for N=34 (combined cohorts), 0 for Cohort 2. |
| Operative Times (Comparable to standard techniques) | Mean (range): 111.5 (68-194) for N=34. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 34 patients.
- Cohort 1: 18 patients
- Cohort 2: 16 patients
- Data Provenance: Retrospective chart review.
- Cohort 1: Germany
- Cohort 2: Netherlands
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number of experts, nor their qualifications, used to establish the ground truth for the retrospective chart review data. The chart review itself implies that the data recorded by the medical professionals involved in those cases formed the "ground truth."
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1, none) for the retrospective chart review data. The data appears to have been extracted directly from patient charts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, an MRMC comparative effectiveness study was not done. The study compares the device's performance based on real-world evidence (retrospective chart review) to published clinical literature on alternative surgical techniques (traditional laparoscopic and robotically-assisted surgery). It does not involve human readers evaluating cases with and without AI assistance for an effect size.
6. Standalone Performance Study
Yes, in a way, a standalone performance was done for the device in the context of real-world use. The retrospective chart review of Nissen fundoplication procedures using the Senhance system provides data on the device's performance without comparison to concurrent human performance. The comparison is made against historical data from other techniques.
7. Type of Ground Truth Used
The ground truth for the Senhance System's performance in the test set (the 34 Nissen fundoplication cases) is derived from clinical outcomes data from patient charts. This includes recorded metrics like hospital stay, complications, blood loss, conversion rates, etc.
8. Sample Size for the Training Set
The document does not provide information about a training set. The Senhance Surgical System is a robotic surgical system, not an AI or imaging device that typically requires a large training dataset for a model. The clinical data presented is for proving the safety and effectiveness of the device for expanded indications, not for training a specific algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as a training set for an AI/algorithm is not described in this document. The device itself is a surgical system whose performance is being evaluated based on clinical outcomes.
Ask a specific question about this device
(60 days)
TransEnterix, Inc.
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The purpose of this submission is to seek clearance for an alternate Node component called the Smart Node (to be marketed as the Intelligent Surgical Unit (ISU)), which introduces enhanced image processing features and augments the endoscope movement capabilities of the TransEnterix® Senhance® Surgical System. The Smart Node adds three new methods of camera control for the surgeon operating at the Senhance Cockpit.
The provided text describes a 510(k) submission for the TransEnterix Senhance Surgical System with an alternate Node component called the Smart Node (marketed as the Intelligent Surgical Unit or ISU). This submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K192877).
However, the document does not contain the following information regarding acceptance criteria and a study proving the device meets those criteria:
- A table of acceptance criteria and the reported device performance: The document lists types of testing performed (Bench Testing, Electrical Safety and Compatibility, Software Verification and Validation, Pre-Clinical Design Validation, Usability Testing) and states that performance was evaluated and requirements were met, but it does not provide specific quantitative acceptance criteria or detailed reported performance values in a table.
- Sample size used for the test set and the data provenance: For the pre-clinical design validation and usability testing, it mentions "a single-center" and "users who represented the intended primary user population," but specific sample sizes for the test set are not provided. Data provenance is not explicitly mentioned beyond the type of model used (live porcine model for pre-clinical, simulated use for usability).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
- Adjudication method: This information is not provided.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned. The device is a surgical system, not an AI diagnostic tool, so an MRMC study comparing human readers with and without AI assistance is not applicable in this context.
- Standalone performance: The document focuses on the integrated performance of the "Senhance Surgical System with Smart Node" and its comparison to the predicate device. It does not describe a standalone performance study of the Smart Node component in isolation, outside of specific functional tests.
- Type of ground truth used: For the pre-clinical design validation, it states it was conducted in a live porcine model, which "most closely represents the human anatomy," implying the physiological outcomes in this model served as validation. For usability, "user level requirements were assessed and found to be met," suggesting user feedback and task completion were the ground truth.
- Sample size for the training set: The document describes performance testing to support substantial equivalence for a new component (Smart Node) of an existing surgical system. It does not mention a "training set" in the context of machine learning model development. The software verification and validation are for "software modifications to support the subject Smart Node," not the training of a new AI model with a distinct training set.
- How the ground truth for the training set was established: As no training set is described for a machine learning model, this information is not applicable.
Summary of available information related to performance testing:
- Device: TransEnterix® Senhance® Surgical System with Smart Node (Intelligent Surgical Unit (ISU))
- Purpose of Submission: Seek clearance for an alternate Node component (Smart Node) that introduces enhanced image processing features and augments endoscope movement capabilities.
- Performance Tests Conducted:
- Bench Testing: Evaluated the performance of the Smart Node and the overall system, confirming compatibility, reliability, functionality, safety, and efficacy. (Specific criteria/results not provided).
- Electrical Safety and Compatibility: Compliance with IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-18. (No specific numerical results/acceptance criteria given, just compliance statement).
- Software Verification and Validation Testing: Conducted on software modifications for the Smart Node, following FDA guidance for "major" level of concern software. (No specific test results/acceptance criteria given).
- Pre-Clinical Design Validation:
- Environment: Single-center, un-blinded, observational, simulated use design validation.
- Model: Live porcine model.
- Users: Users representing the intended primary user population.
- Ground Truth: Assessed user-level requirements; all found to be met.
- Sample Size/Provenance: Not specified beyond "single-center" and "live porcine model."
- Usability Testing:
- Modifications: Based on new Smart Node features.
- Study Type: Confirmatory summative study.
- Users: Performed by users in a simulated use environment.
- Ground Truth: Users were able to independently perform all critical tasks without use errors that would lead to harm.
- Sample Size/Provenance: Not specified.
Conclusion stated by the submitter: The performance testing supported the safety and functionality of the device and demonstrated that the device is substantially equivalent to the predicate device.
Ask a specific question about this device
(45 days)
TransEnterix, Inc.
The Senhance® Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The Senhance® 3 mm Monopolar L-Hook Electrode instrument and adapter are intended as additions to the suite of monopolar hook instruments and adapters initially cleared for use with the TransEnterix Senhance Surgical System through K171120 (October 13, 2017) and then expanded through K191482 (July 11, 2019). The subject instrument and adapter are modifications of the predicate TransEnterix Senhance 5 mm Monopolar L-Hook Electrode instrument and adapter FDA cleared through K191482. Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use. The subject and predicate instruments consist of a polymer coated stainless steel shaft with an electrode at the distal end and a ceramic collar between the two to provide monopolar insulation. In order to be used with the Senhance Surgical System, the typical manual laparoscopic handle at the proximal end of the instrument is removed and replaced by a connector that mates with an adapter. The adapter provides the mechanism which allows the instrument to interface with the robotic manipulator arm of the Senhance Surgical System. Each instrument is laser marked with a unique identification number that matches its corresponding adapter.
The provided text is a 510(k) Summary for the TransEnterix Senhance Surgical System, specifically for a new 3 mm Monopolar L-Hook Electrode instrument and adapter.
Based on the information provided, this submission is not for an AI/ML medical device that requires clinical performance criteria based on diagnostic accuracy and human reader studies. Instead, it is a submission for a surgical instrument and adapter to be used with an existing surgical system. The performance data presented focuses on mechanical, electrical, and biocompatibility testing, aiming to demonstrate substantial equivalence to previously cleared predicate devices.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI/ML device performance (like diagnostic accuracy, human reader improvement with AI, standalone algorithm performance, and ground truth establishment from expert consensus or pathology) is not applicable to this document.
The document discusses the following types of "performance data" which are relevant to this type of medical device:
- Biocompatibility testing: Conducted in accordance with ISO 10993-1, demonstrating the instrument is non-toxic, non-irritating, and does not result in adverse biological responses.
- Reprocessing, Cleaning, and Sterilization: Cleaning effectiveness was tested to confirm the overall effectiveness of prescribed cleaning procedures.
- Performance Testing (Mechanical Verification): Mechanical integrity under simulated use conditions was confirmed. ESU compatibility testing was also performed.
- Electrical Safety and Compatibility: Compliance with IEC 60601-2-2 and IEC 60601-2-18 was demonstrated.
The "acceptance criteria" for this device are implicitly tied to meeting the standards outlined in these tests to support a finding of substantial equivalence to the predicate device, K191482.
There is no information provided in this 510(k) summary regarding:
- A table of acceptance criteria and reported device performance related to AI/ML.
- Sample sizes for test sets or data provenance for AI/ML validation.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication methods.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Standalone (algorithm only) performance.
- Types of ground truth (expert consensus, pathology, outcomes data).
- Sample size for a training set (as this is not an AI/ML device in this context).
- How ground truth for a training set was established.
This document is a regulatory submission for a surgical instrument, not an AI/ML diagnostic tool.
Ask a specific question about this device
(37 days)
TransEnterix Inc.
The Senhance™ Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter are intended as additions to the suite of monopolar hook instruments and adapters previously cleared for use with the TransEnterix Senhance™ Surgical System. Three monopolar electrodes and one monopolar electrode adapter are being added. The instruments and adapter are modifications of the predicate TransEnterix® Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapters FDA cleared through K181517 (October 9, 2018). Like the predicate devices, the subject devices are multi-use surgical devices that are cleaned and steam sterilized by the end user before the first use and after each use.
This document describes the 510(k) summary for the Senhance™ 5 mm Monopolar L-Hook Electrode instruments and adapter, which are additions to the TransEnterix Senhance™ Surgical System. The purpose of this submission is to demonstrate substantial equivalence to previously cleared predicate devices (K181517).
Based on the provided information, the device is an accessory to a surgical system and thus the acceptance criteria relate to its physical and functional performance, rather than diagnostic accuracy.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 for tissue contact ( |
Ask a specific question about this device
(128 days)
TransEnterix, Inc.
The Senhance Ultrasonic System and accessories are indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. The Senhance Ultrasonic Surgical System and accessories are indicated for use with the Senhance Surgical System.
The Senhance Ultrasonic System is an energized instrument system which delivers ultrasonic energy to the tissue of interest for soft tissue incisions. It is designed to be used with the Senhance Surgical System which precisely manipulates laparoscopically based instruments in surgery. The Senhance Ultrasonic System is composed of five components: 1. The Dissector which interfaces with the tissue of interest 2. The Transducer which converts electrical energy into ultrasonic energy 3. The Senhance Adapter which physically attaches the instrument to the Senhance Surgical Robotic System manipulator arm 4. The Ultrasonic Generator which controls the energy settings to be delivered to the tissue 5. The Footswitch
This document describes the Senhance Ultrasonic System, a surgical device designed for soft tissue incisions. The system is intended for use with the Senhance Surgical System, a robotic platform. The 510(k) summary provided outlines the device's characteristics, comparison to a predicate device, and the performance data used to support its substantial equivalence.
Here's a breakdown of the requested information:
1. Acceptance Criteria and Reported Device Performance
The 510(k) summary does not explicitly present a table of "acceptance criteria" against which specific numerical performance metrics are then stated. Instead, the performance testing described aims to demonstrate the safety and effectiveness of the device by showing its compatibility and comparable performance to a predicate and reference device across various characteristics. The ultimate "acceptance criterion" for this submission appears to be demonstrating substantial equivalence, meaning the technological differences do not raise any different questions of safety or effectiveness.
| Category of Performance Test | Implied Acceptance Criteria (Demonstrated) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993-1 | All patient-contacting devices assessed; results support biocompatibility. |
| Cleaning, Disinfection (Reprocessing) & Sterilization | Validation through AAMI TIR12, TIR30, ANSI/AAMI/ISO 17665-1, ISO 14937, and EN ISO 11135-1:2014, EN ISO 10993-7:2008 with a SAL of 10-6. | Reusable components validated; disposable dissector provided sterile with SAL of 10-6. |
| Bench Testing | System compatibility, comparable ultrasonic energy delivery, and tissue effects to the reference system. | Confirmed compatibility; ultrasonic energy delivery to tissue comparable to the reference system; tests included cantilever bend stiffness, force feedback, fulcrum accuracy, jaw output force, mechanical reliability, thermal spread, and tissue effects (vessel sealing burst pressure & lesion size). |
| Electrical Safety and Compatibility | Compliance with IEC 60601-1, -1-2, -2-2, and -2-18 for non-interference with vision systems. | Complies with current versions of these IEC standards; verified no interference with the vision system signal when used concurrently. |
| Software Verification and Validation | Conformity to FDA's Guidance for Premarket Submissions for Software in Medical Devices ("major" level of concern). | Verification conducted for Senhance Surgical System software modification and Ultrasonic Generator; documentation provided. |
| Pre-Clinical Design Validation | System conformity to defined user needs and intended uses in a simulated environment; all pre-determined acceptance criteria met. | All pre-determined acceptance criteria were met by four teams (surgeon + assistant) performing various surgical tasks on a live porcine model. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Pre-Clinical Design Validation: Four teams (one surgeon and one surgical assistant per team), totaling 8 individuals. These teams performed surgical tasks on a live porcine model.
- Biological Testing, Cleaning/Sterilization, Bench Testing, Electrical Safety, Software V&V: Specific number of units/samples for these tests are not explicitly stated. The description indicates "testing" was conducted.
- Data Provenance: The pre-clinical design validation was conducted in a "single-center" environment.
- The "live porcine model" implies prospective data collection using animal subjects for performance evaluation.
- Other tests (biocompatibility, cleaning, bench, electrical safety, software) would typically involve lab-based prospective testing of the device components.
- The country of origin for the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Pre-Clinical Design Validation: Four surgeons and four surgical assistants were involved as users in the simulated use validation. These individuals "represented the intended primary user population" and were "trained subjects." Their specific years of experience or formal qualifications (e.g., board-certified) are not explicitly detailed, but their participation in surgery and assistance roles implies relevant medical expertise in gynecological and general surgery. They essentially served as experts evaluating the device's performance against user needs.
- For other tests (e.g., biocompatibility guidance, sterilization standards), the "ground truth" is established by adherence to recognized international standards and FDA guidance, meaning the experts implicit are those who draft and approve such standards and the specialists performing the tests according to those standards.
4. Adjudication Method for the Test Set
- For the pre-clinical design validation, the summary states that "All pre-determined acceptance criteria were met." This suggests a direct evaluation against predefined performance benchmarks. It does not describe an explicit "adjudication method" in the sense of multiple experts independently scoring and then resolving discrepancies (like 2+1 or 3+1). The "trained subjects" (surgeons and assistants) in this simulated environment were likely the evaluators of the system's performance and their assessment contributed to meeting the acceptance criteria.
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 explicitly mentioned or described in the provided 510(k) summary. The study described is a pre-clinical design validation with simulated use, not a study evaluating human reader performance with or without AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) Was Done
- The Senhance Ultrasonic System is an instrument system for robotic surgery, not an AI-driven diagnostic or image analysis algorithm. Therefore, the concept of "standalone (algorithm only without human-in-the-loop performance)" does not directly apply to this type of device. The system requires human intervention for its operation via the Senhance Surgical System by a surgeon and surgical assistant.
7. The Type of Ground Truth Used
- Pre-Clinical Design Validation: The ground truth for this phase was established by observing and evaluating the device's performance during surgical tasks on a live porcine model. The "pre-determined acceptance criteria" serve as the standard against which performance was measured. In this context, the "ground truth" is based on observed functional performance in a simulated biological environment, representing what is expected of the device in actual surgical use (e.g., effective soft tissue incisions, hemostasis, minimal thermal injury).
- Other Tests (Biocompatibility, Sterilization, Bench Testing, Electrical Safety, Software V&V): The ground truth is adherence to established scientific principles, international standards (ISO, AAMI, IEC), and FDA guidance documents.
8. The Sample Size for the Training Set
- The provided 510(k) summary does not describe a "training set" in the context of machine learning. The device is a surgical instrument and robotic system, not a machine learning algorithm that requires a data training set.
9. How the Ground Truth for the Training Set Was Established
- As the device is not a machine learning algorithm, there is no "training set" or corresponding ground truth establishment process for a training set described in this submission.
Ask a specific question about this device
(29 days)
TransEnterix, Inc.
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization, and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectorny, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the instructions for use.
The Senhance 3 mm bipolar surgical instruments and adapters are additions to the suite of bipolar instruments and adapters previously cleared for use with the Senhance Surgical System (K181517). The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter. All instruments and adapters are multi-use devices that are steam sterilized by the end user before the first use and after each use. The Senhance 3 mm bipolar instruments include:
- . Bipolar Maryland Dissector – diameter 3 mm / length 280 mm
- . Bipolar Grasping Forceps - diameter 3 mm / length 280 mm
This document describes the 510(k) summary for the TransEnterix Senhance Surgical System, focusing on the acceptance criteria and study proving its substantial equivalence to a predicate device. This is primarily a regulatory submission, so instead of typical "AI/ML model" performance metrics, the "acceptance criteria" here refer to meeting performance standards that demonstrate safety and effectiveness for a medical device, particularly in comparison to a previously cleared device.
Given the nature of the provided document, which is a 510(k) summary for a surgical instrument, many typical AI/ML study components (like expert consensus for ground truth, MRMC studies, training set details) are not applicable. The device is a surgical instrument system, not an AI diagnostic algorithm.
Here's an interpretation of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) for new instruments within an existing surgical system, the acceptance criteria are generally to demonstrate that the new instruments (3mm bipolar) perform as intended, are safe and effective, and do not raise new questions of safety or effectiveness compared to predicate devices. The performance is reported in terms of successful completion of various tests.
| Acceptance Criteria (General Goal) | Reported Device Performance |
|---|---|
| Mechanical Integrity / Intended Performance (Simulated Use) | Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use, including: |
| Cantilever Bending Reliability Testing | |
| Instrument Jaw Output Force Reliability Testing and Jaw Force to Failure Testing | |
| Bipolar Jaw Spreading Force | |
| Electrosurgical Unit (ESU) Compatibility | Demonstrated that all third-party ESUs compatible with the Senhance Surgical System are also compatible with the 3mm bipolar instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings. |
| Reprocessing/Cleaning Effectiveness | A cleaning effectiveness validation study confirmed the overall effectiveness of the prescribed cleaning procedures. Test results demonstrated that cleaning procedures for the 3mm bipolar adapters allow them to be effectively cleaned according to instructions. |
| Sterilization Efficacy | Validation of the steam sterilization process for the 3mm bipolar adapters demonstrated a Sterility Assurance Level (SAL) of at least 10^-6. |
| Electrical Safety Compliance | The 3mm bipolar instruments and adapters fulfilled all applicable requirements to demonstrate compliance with the current electrical safety standard, IEC 60601-2-2:2017 (Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories). |
| Software Compatibility and Reliability (with new instruments) | Software testing demonstrated that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters. |
| Design Validation (Performance in Simulated Clinical Environment) / Substantial Equivalence to Predicate | Design Validation was conducted in a porcine model (simulating key human anatomy) using production-equivalent instruments and adapters in a simulated use environment. This supported that the instruments perform as intended according to defined user needs and intended uses, and are substantially equivalent to the predicate devices (K181517), not raising any new issues of safety or effectiveness. The intended use/indications for use are identical to the predicate. |
2. Sample size used for the test set and the data provenance:
- Sample size: The document does not specify a numerical sample size for individual tests like mechanical testing or ESU compatibility, but indicates "testing" was conducted. For "Design Validation," it states "a porcine model" was used, implying more than one animal or multiple procedures within one animal, but no specific count is provided.
- Data Provenance: The origin of the data is from in-house testing conducted by TransEnterix, Inc. The studies appear to be prospective for the purpose of this 510(k) submission, specifically designed to test the new 3mm bipolar instruments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable in the context of this device and study type. The "ground truth" here is established by engineering and medical device performance standards (e.g., successful mechanical function, proper sterilization, electrical safety compliance) rather than expert interpretation of medical images or diagnoses. The "Design Validation" involved simulating use, implying evaluation by qualified personnel, but "experts" in the sense of clinical reviewers for ground truth is not relevant.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This type of adjudication method is common in studies involving human interpretation (e.g., radiology reads), not for performance testing of a surgical instrument.
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 a surgical instrument, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. The device isn't an algorithm. Its performance is inherent to its mechanical, electrical, and material properties, and its interaction with the Senhance Surgical System.
7. The type of ground truth used:
The "ground truth" is based on:
- Engineering specifications and performance standards (e.g., force measurements, voltage ratings, mechanical integrity).
- Validated regulatory standards (e.g., IEC 60601-2-2 for electrical safety, established SAL for sterilization).
- Demonstrated functionality in a simulated use environment (porcine model) comparing to the established performance of predicate devices.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML model that requires a "training set."
9. How the ground truth for the training set was established:
Not applicable. No training set for an AI/ML model.
Ask a specific question about this device
(123 days)
TransEnterix, Inc.
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
The Senhance "Additional" surgical instruments and adapters are intended as additions to the predicate suite of instruments and adapters previously cleared for use with the TransEnterix Surgical System (Model Senhance™ - K171120 and K180163). All instruments and adapters are multi-use components that are steam sterilized by the end user before the first use and after each use. The instrument designs are adaptations of standard laparoscopic instruments that are commonly used in surgery. Each instrument type has a corresponding system adapter.
The provided text describes performance testing for new instruments and adapters for the TransEnterix Senhance Surgical System to demonstrate substantial equivalence to previously cleared predicate devices. It does not contain an acceptance criteria table with reported device performance in the format requested, nor does it detail a study that proves the device meets such criteria as an AI-enabled medical device would typically require. The document focuses on demonstrating that new accessories do not raise new safety or effectiveness concerns compared to existing cleared devices.
However, I can extract the relevant information from the document that addresses some of your points. The "acceptance criteria" are implied by the summary statements of each test, confirming the devices "perform as intended", "met requirements", "demonstrated compatibility", or "fulfilled all applicable requirements".
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of acceptance criteria with numerical performance data. Instead, for each test, it provides a summary statement indicating that the device met the requirements or performed as intended.
| Test Category | Implied Acceptance Criteria (Summary from document) | Reported Device Performance (Summary from document) |
|---|---|---|
| Bench Testing | ||
| Senhance System Force Feedback Response | The Senhance system should provide force feedback by measuring forces and conveying information proportionally to the user. | "Demonstrated that the Senhance system provides force feedback by measuring the forces presented to the device and conveying the force information proportionally to the user." |
| Force Feedback Stability and Sensitivity | The force feedback feature should properly dampen haptic response signals from the instruments to the cockpit handles. | "Demonstrated that the force feedback feature of the Senhance system properly dampens the haptic response signals from the Additional instruments to the cockpit handles." |
| Manipulator Arm Fulcrum Feature | The fulcrum feature should be properly established for the Additional instruments. | "Demonstrated that the fulcrum feature of the Senhance system can be properly established for the Additional instruments." |
| ESU Compatibility | All compatible third-party electrosurgical units (ESUs) should be compatible with the Additional instruments and adapters, with rated voltages matching ESU manufacturer settings. | "Demonstrated that all third-party electrosurgical units (ESUs) that are compatible with the Senhance system are also compatible with the Additional instruments and adapters. Testing compared the rated voltage of the instruments with each ESU's manufacturer settings." |
| Mechanical Verification Testing | Devices should perform as intended when subjected to mechanical integrity tests under simulated use conditions, including Cantilever Bending Reliability, Instrument Jaw Output Force Reliability, and Force to Jaw Failure. | "Demonstrated that the devices perform as intended when subjected to tests of mechanical integrity under conditions of simulated use. Cantilever Bending Reliability Testing, Instrument Jaw Output Force Reliability Testing and Force to Jaw Failure Testing" |
| Clip Applier Ligation Performance | Burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier should not be statistically different from the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier. | "Demonstrated that the burst pressure of clips delivered by the Senhance Weck® Hem-o-lok Clip Applier when used with the Senhance system was not statistically different than the burst pressure of clips delivered by the legally marketed Teleflex Medical Hem-o-Lok® Clip Applier were not statistically different." |
| Biocompatibility | Patient-contacting portions should meet applicable safety requirements related to material toxicity and biological responsiveness (Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity) as per ISO 10993-1. | "The results demonstrated that these components met the requirements of ISO 10993-1 with regard to Cytotoxicity, Sensitization, Irritation/Inflammatory Response (IR), Acute Systemic Toxicity, and Pyrogenicity." |
| Reprocessing, Cleaning, Sterilization | ||
| Reprocessing/Cleaning | Cleaning procedures should allow the devices to be effectively cleaned according to processing instructions. | "The test results demonstrated that the cleaning procedures for the Additional instruments and adapters allow them to be effectively cleaned according to the processing instructions provided in the labeling." |
| Sterilization | A Sterility Assurance Level (SAL) of at least 10^-6 should be demonstrated. | "A validation of the steam sterilization process was conducted to demonstrate a Sterility Assurance Level (SAL) of at least 10^-6." |
| Electrical Safety and Compatibility | ||
| Electrical Safety and Electromagnetic Compatibility | The electrosurgical instruments should be compliant with IEC 60601-2-2:2017 for basic safety and essential performance of high-frequency surgical equipment and accessories. | "The Additional electrosurgical instruments fulfilled all applicable requirements to demonstrate that the instruments are compliant with the current electrical safety standard, IEC 60601-2-2:2017, Medical electrical equipment Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories." |
| Software | ||
| Software | The Senhance system software should continue to reliably operate as designed with the addition of the new instruments and adapters. | "Software testing was conducted to demonstrate that the Senhance system software continues to reliably operate as designed with the addition of the new instruments and adapters." |
| Design Validation | ||
| Design Validation | The Additional instruments and adapters should perform as intended according to defined user needs and intended uses, demonstrating substantial equivalence to predicate devices (K171120). | "Design Validation was conducted to ensure that the subject Additional instruments and adapters perform as intended according to defined user needs and intended uses, and to support substantial equivalence to the predicate devices cleared under K171120. The design validation was conducted in a porcine model, which was used to simulate key human anatomy. This validation used production-equivalent instruments and adapters in a simulated use environment." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated with a specific number of cases or samples for each test. The descriptions imply various tests were conducted on the "Additional instruments and adapters" as a group.
- Data Provenance: The design validation was conducted in a porcine model, simulating key human anatomy. This indicates animal data. The other bench tests and compatibility tests would likely be conducted in a laboratory setting. There is no mention of human clinical data or geographical origin.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not provided in the document. The tests described are primarily engineering, mechanical, electrical, software, and biological safety tests, not diagnostic performance evaluations that would typically involve human expert consensus for "ground truth". The "design validation" involved a porcine model, but the role or number of experts involved in evaluating its success is not detailed.
4. Adjudication Method for the Test Set:
- This information is not provided. The nature of the tests (bench, biocompatibility, sterilization, electrical, software) does not typically involve an adjudication method in the way a diagnostic study with human readers would.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, and effect size:
- No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Due to the similarity of the subject devices to the predicate devices, new usability and clinical testing were not necessary." The study is focused on demonstrating substantial equivalence of accessories, not evaluating the effectiveness of human readers with vs. without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This document describes physical surgical instruments and adapters for a robotic surgical system, not a standalone AI algorithm. Therefore, this question is not applicable. The "software" section refers to the existing system's software continuing to operate reliably with the new instruments, not a new algorithm's standalone performance.
7. The type of ground truth used:
- Ground Truth varies by test type:
- Bench Testing: Engineering specifications, physical measurements (e.g., force, voltage), statistical comparisons (for clip applier).
- Biocompatibility: ISO 10993-1 standards (e.g., cytotoxicity, sensitization levels).
- Reprocessing/Cleaning: Effectiveness against established microbial or soil removal standards.
- Sterilization: Sterility Assurance Level (SAL) of 10^-6.
- Electrical Safety: IEC 60601-2-2:2017 standard compliance.
- Software: Expected software behavior and functionality without errors or unexpected changes.
- Design Validation: Performance within a simulated use environment (porcine model) against defined user needs and intended uses.
8. The sample size for the training set:
- This document is about physical devices and their compatibility/safety, not an AI model that requires a training set. Therefore, this question is not applicable.
9. How the ground truth for the training set was established:
- As this document is not about an AI model with a training set, this question is not applicable.
Ask a specific question about this device
(126 days)
TransEnterix, Inc.
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization. The Senhance Surgical System is intended for use in laparoscopic gynecological surgery, colorectal surgery, cholecystectomy, and inguinal hernia repair. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
The Senhance Surgical System is a console-based, multi-arm surgical system, which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:
- . Cockpit - The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
- . Manipulator Arms - Independent mechanized support arms that interface with the endoscope and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
- Node A relay unit that connects the cockpit inputs to the manipulator arms in the system as configured, ● and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.
The provided text describes the TransEnterix Senhance Surgical System and its 510(k) submission (K180163) for expanding its indications for use to include inguinal hernia repair and cholecystectomy procedures. The document aims to demonstrate substantial equivalence to a predicate device (Senhance Surgical System, K171120) and reference devices (Intuitive Surgical da Vinci Xi Surgical System).
However, the provided document does not contain information about acceptance criteria in the form of a table or specific metrics for device performance (e.g., sensitivity, specificity, accuracy, or any quantifiable clinical endpoints with associated thresholds). Instead, it presents comparative clinical data from case series for the new indications against published literature data for predicate and reference devices, and standard laparoscopic techniques. The "acceptance criteria" appear to be implicit in the comparative study outcomes, where the Senhance System's performance is deemed "similar," "comparable," or "as safe and effective" as the comparators.
Therefore, I cannot generate a table of acceptance criteria and reported device performance as requested, because specific, quantitative acceptance criteria are not explicitly stated in the provided text for these procedures for the Senhance Surgical System.
I will, however, provide the available information regarding the studies and ground truth, addressing as many points of your request as possible based only on the provided text.
Here's a summary of the study information based on the provided text:
Study Information for TransEnterix Senhance Surgical System (K180163) - Expansion for Cholecystectomy and Inguinal Hernia Repair
1. Table of Acceptance Criteria and Reported Device Performance:
As noted above, specific quantitative acceptance criteria are not explicitly stated in the provided document. The document describes a comparative approach where the Senhance System's clinical outcomes are compared to published literature data from predicate/reference robotic systems and traditional laparoscopic techniques. The "acceptance" is implicitly based on achieving "comparable" or "similar" outcomes, indicating "as safe and effective."
Below are the outcomes reported for the Senhance System and comparators, which form the basis of the substantial equivalence claim.
| Outcome Measure | Senhance - Cholecystectomy (Imperial College, N=20) | Senhance - Cholecystectomy (Hamburg University, N=20) | Reference da Vinci System - Cholecystectomy (N=1435) | Laparoscopic arm from meta-analysis (Huang et al) - Cholecystectomy (N=921) |
|---|---|---|---|---|
| Complication Non-serious (Clavien Dindo I-II) | 6, 30% | 0 | 0-25% | Not Reported |
| Serious Complication (Clavien Dindo III) | 0 | 0 | 0-4% | 0-10% |
| Estimated Blood Loss (mL) | Minimal | Not Reported | Not Reported | 12-14 mL |
| Intra-op Adverse Events / Complications | 1 (intraop bleeding), 5% | 0 | 0-5% | 0-33.3% |
| Transfusions (%) | 0 | 0 | 0-2% | 0 |
| Mortality (%) | 0 | 0 | 0-0.5% | 0 |
| Conversion to Laparoscopy (%) | 1, 5% | 1, 5% | 0-12.5% | N/A |
| Conversion to Open (%) | 0 | 0 | unknown | 0-15.7% |
| Reoperation rates (%) | 0 | 0 | 0-4% | Not Reported |
| Readmission rates (%) | 3, 15% | 0 | 0-4% | 0-4.3% |
| Median Operative Time in min (range) | 86.5 (44-129) | 71.5 (34-197) | 91.7 (50-152) | 115.3 (65-141) |
| Hospital Length of Stay (days) | 0 (1 pt remained overnight) | 2** | 1-5 | 2.2 (range 1.0-5.1) |
| Outcome Measure | Senhance System - Inguinal Hernia Repair (N=64) | Reference da Vinci System - Inguinal Hernia Repair (N=652) | Laparoscopic Cohort - Inguinal Hernia Repair (N=3457) |
|---|---|---|---|
| Mean age, (y ± SD or range) | 54.5 ± 16.3 | 55.8 ± 15.6 | 34.91 - 62.3 |
| Female, n (%) or % range | 10 (15.6%) | 64 (9.8%) | 0 - 6.1% |
| Mean BMI, kg/m2 (± SD) or range | 25.9 ± 3.1 | 27.3 ± 5.1 | 22.4 - 26.8 |
| Length of Stay - Inpatient (days) | 1.04 ± 0.2 days† | 3.01 ± 4.65 (n=52) | 0.8 - 5 days |
| Length of Stay - Outpatient (hours) | n/a | 7.16 ± 3.01 | |
| Intraoperative Complications, n (%) | 0 (0%) | 2 (0.3%) | 0 - 8% |
| Transfusions - Intraoperative | 0 | 0 | Not Reported |
| Transfusions - Perioperative | 0 | 2 (0.3%) | |
| Postoperative Complications, n (%) | 1 (1.6%) | 15 (2.3%) | 0-36% (reported as total time period) |
| Readmission Rates, n (%) | 0 | 23 (3.5%) | Not Reported |
| Reoperation Rates, n (%) | 0 (Postop to discharge) / 0 (Post discharge to 30 days) | 3 (0.5%) (Postop to discharge) / 0 (Post discharge to 30 days) | 0-2.5% (reported as total time period) |
| Mortality, n | 0 | 0 | 0 |
| Operative Time, min, avg ± SD/range (Unilateral) | 44 ± 17.4 | 79.7 ± 31.7 | 32.6 - 110 |
| Operative Time, min, avg ± SD/range (Bilateral) | 79 ± 23.7 | ||
| All Complications, n (%) | 1 (1.6%) | 45 (6.9%) | 7.9 – 8.7% |
2. Sample Sizes and Data Provenance:
-
Cholecystectomy Test Set:
- Senhance System: 40 patients (20 from Imperial College, 20 from Hamburg University). Data provenance: Retrospective chart reviews. Country of origin for the Senhance data is not explicitly stated beyond "Imperial College" and "Hamburg University," implying data from UK and Germany, respectively.
- Reference da Vinci System: 1435 patients (data compiled from 19 papers from a PubMed literature search, years 2000-2018). Provenance: Literature.
- Laparoscopic arm (Huang et al meta-analysis): 921 patients (summarized from 13 trials). Provenance: Literature (meta-analysis).
-
Inguinal Hernia Repair Test Set:
- Senhance System: 64 patients who underwent 76 transabdominal preperitoneal (TAPP) inguinal hernia repairs. Data provenance: Retrospective chart review. Country of origin not explicitly stated.
- Reference da Vinci System: 652 patients (data from 510(k) summary K170713). Provenance: Literature (previous 510(k) submission).
- Laparoscopic Cohort: 3457 patients (data from 11 publications referenced in Bittner, et al.). Provenance: Literature.
3. Number of Experts and Qualifications for Ground Truth:
- Not Applicable. The studies are clinical case series and comparisons to published literature, not evaluations of an AI's diagnostic performance based on expert-labeled ground truth annotations on medical images. The "ground truth" here is the actual clinical outcome of surgical procedures.
4. Adjudication Method for the Test Set:
- Not Applicable explicitly. As these are retrospective chart reviews and literature comparisons of surgical outcomes (not image interpretation or diagnostic tasks), an adjudication method in the context of expert consensus for ground truth establishment is not described or relevant. For intraoperative complications or conversions, these would have been recorded by the operating room staff and surgeons at the time of the procedure and subsequently extracted from patient charts.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. This was not an MRMC study comparing human readers with and without AI assistance. This was a study comparing the clinical outcomes of a robotic surgical system (Senhance) to other surgical methods (other robotic systems, traditional laparoscopy). The Senhance System is a surgical tool, not a diagnostic AI system assisting human readers.
6. Standalone (Algorithm Only) Performance:
- Not Applicable. The Senhance System is a surgical device operated by a human surgeon; it is not a standalone algorithm without human-in-the-loop performance. Its performance is human-in-the-loop.
7. Type of Ground Truth Used:
- Clinical Outcomes Data: The ground truth for this device's performance is derived from real-world clinical outcomes of surgical procedures (e.g., complications, operative time, length of stay, conversions, reoperation, readmission), as documented in patient charts and published literature.
8. Sample Size for the Training Set:
- Not Applicable / Not Explicitly Stated. The Senhance System is a mechanical and software-controlled surgical device, not a machine learning model that undergoes "training" in the conventional sense of machine learning algorithms for diagnostic tasks. The "training" of the device (i.e., its development and refinement) would involve engineering, bench testing, and pre-clinical studies, not a "training set" of patient data for learning algorithms. The software updates mentioned (Software Compatibility Check Feature, R&D Mode, Service function for Automated Instrument Calibration) were subject to software V&V testing, not machine learning training.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As per point 8, there isn't a "training set" with established ground truth in the context of machine learning model development. The safety and effectiveness of the device's design and software were established through traditional engineering and software verification and validation methods, and then confirmed clinically through the comparative case series.
Ask a specific question about this device
(182 days)
TransEnterix, Inc.
The Senhance Surgical System is intended to assist in the accurate control of laparoscopic instruments for visualization and endoscopic manipulation of tissue including grasping, cutting, blunt and sharp dissection, approximation, ligation, electrocautery, suturing, mobilization and retraction in laparoscopic colorectal surgery and laparoscopic gynecological surgery. The system is indicated for adult use. It is intended for use by trained physicians in an operating room environment in accordance with the Instructions for Use.
The Senhance Surgical System is a console-based, multi-arm surgical system which enables a surgeon to remotely control surgical instrumentation during minimally invasive surgery in the lower abdomen and pelvis. The capital equipment is comprised of three main sub-systems as follows:
- Cockpit The station where the surgeon inputs information through hand and eye movements to direct the motion of the arms in the surgical field.
- Manipulator Arms Independent mechanized support arms that interface with the endoscope ● and surgical instruments. The manipulator arms produce output movements based on the instructions from the surgeon at the cockpit. The system is configurable with up to three arms.
- Node A relay unit which connects the cockpit inputs to the manipulator arms in the system as configured, and converts and transmits the video signals to the 2D/3D monitor on the cockpit console.
The document is a 510(k) summary for the Senhance Surgical System (K171120), comparing it to the predicate device, the Intuitive Surgical da Vinci Si Surgical System IS3000 (K081137). The device is an endoscopic instrument control system.
Here's an analysis of the acceptance criteria and the studies performed:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative manner for specific metrics like sensitivity, specificity, or AUC, as would be typical for diagnostic AI devices. Instead, the substantial equivalence is determined by comparing procedural endpoints of the Senhance System's clinical data to published literature data of the predicate device. The general acceptance criterion seems to be that the Senhance System is "as safe and effective as the predicate device for its intended use" based on these comparisons.
Here's a summary of the performance data presented, compared implicitly to the predicate device's published literature:
| Metric (Procedural Endpoints) | Senhance - Gynecological Study (150 patients) | Senhance - Colorectal Study (45 patients) | Implicit Acceptance Criteria / Comparison to Predicate (via published literature) |
|---|---|---|---|
| Safety | |||
| Intraoperative Complications | 10 conversions to manual laparoscopy (2 associated with serious adverse events), no blood transfusions. Overall: 2 (Total Hysterectomy group) | 0 (all groups) | Similar or better than predicate |
| Post-operative Complications | 6 serious adverse events (4%), including wound dehiscence, infections, suspected pleurisy, rapid onset anemia. None device-related. | 2 (4.4%) serious complications (anastomotic leak, intraluminal bleed). None device-related. | Similar or better than predicate |
| Mortality | 0% (all groups) | 0% (all groups) | Similar or better than predicate |
| Conversion Rates (to open/manual) | 5 (3.3%) for Total Hysterectomy group | 1 (2.2%) for Right Hemicolectomy, 2 (4.4%) for Left Hemicolectomy. No conversions to laparotomy. | Similar or better than predicate |
| Reoperation Rates | 2 (1.3%) for Total Hysterectomy group | 0% (all groups) | Similar or better than predicate |
| Readmission Rates | 3 (2%) for Total Hysterectomy group | 1 (2.2%) for Right Hemicolectomy, 0% for others | Similar or better than predicate |
| Estimated Blood Loss |
Ask a specific question about this device
TRANSENTERIX, INC.
The SPIDER® Surgical Instruments are intended for use in minimally invasive abdominal laparoscopic surgical procedures for grasping, mobilizing, dissecting, cutting, cauterizing, ligating, suction/irrigation and other manipulation of tissues and vessels during laparoscopic procedures.
The SPIDER® Flexible Monopolar Instruments are surgical instruments used to facilitate laparoscopic surgery. The instruments are a part of the SPIDER® Flexible Surgical Instruments family. They are intended for use with the SPIDER® Single Port Device. The instruments may be used with or without electrocautery. The flexible electrocautery instruments are pre-sterilized, single use, disposable devices. The devices have a ring handle with ratchets where applicable, a rotation knob for rotating the shaft and distal tips, an electrocautery post for cable connection to an electrosurgical generator, a flexible shaft, and distal tips to manipulate tissue. The instruments may be used without connecting to a power source. However, when connected by a standard cable to an electrosurgical generator, the instruments may be used for cutting and coagulation of tissue. The instrument set includes: Flexible graspers for grasping tissue, Flexible shears for cutting tissue, Flexible dissectors for dissecting tissue.
The provided document describes the K122299 510(k) Summary for the SPIDER® Flexible Monopolar Surgical Instruments. This submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding AI-specific studies and detailed performance metrics is not directly applicable or available in this document.
However, I can extract the relevant information from the document regarding the device's testing and acceptance.
Device: SPIDER® Flexible Monopolar Surgical Instruments (Flex Monopolar Graspers, Wavy Ratcheted; Flex Monopolar Graspers, Serrated Ratcheted; Flex Monopolar Maryland Dissectors; Flex Monopolar Shears)
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Type | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Functional Testing | Perform intended functions for laparoscopic surgical procedures and electrocautery functions; reliability. | "functionally tested and found to perform their intended functions for laparoscopic surgical procedures as well as their electrocautery functions and have been tested for reliability." |
| System Compatibility | Meet internal acceptance criteria for system compatibility with the SPIDER® platform. | "tested with the SPIDER® device and found to meet the internal acceptance criteria for system compatibility with the SPIDER® platform." |
| Sterility | Achieve a sterility assurance level (SAL) of 1x10⁻⁶; verified sterile per ISO 11137-1, -2, -3. | "Gamma sterility testing has been conducted... and has been shown to achieve a sterility assurance level of 1x10⁻⁶. The devices were verified as sterile via a dose audit study in accordance with ISO 11137-1, ISO 11137-2, and ISO 11137-3." |
| Sterile Barrier & Shelf Life | Maintain sterility during shelf life; in accordance with ISO 11607-1, 11607-2, and ASTM F1980-07. | "the sterile barrier packaging has been tested for the SPIDER® Flexible Instruments family in accordance with ISO 11607-1 and 11607-2 and ASTM F1980-07 and has been found to maintain sterility during shelf life testing. The SPIDER® Flexible Monopolar Instruments have likewise been tested for functionality over time and have been found to maintain performance in accordance with the design specifications." |
| Biocompatibility | Non-cytotoxic, non-irritating, non-sensitizing; in accordance with ISO 10993-1. | "tested for biocompatibility in accordance with ISO 10993-1 based on type and duration of contact to assure that they are non-cytotoxic, non-irritating and non-sensitizing." |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2; insulation integrity (HIPOT, dielectric withstand). | "evaluated and/or tested for compliance to the medical electrical safety standards IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 and found to be compliant. The device insulation has also been tested using high potential test (HIPOT) and dielectric withstand testing to assure that the insulation maintains its properties and does not breakdown." |
| Preclinical Performance | Perform as intended in laparoscopic procedures; no new safety/efficacy issues compared to predicates. | "The SPIDER® Flexible Monopolar Surgical Instruments have been tested in a preclinical swine study to evaluate their performance and success in laparoscopic procedures. The study found that the SPIDER® Flexible Monopolar Instruments performed as intended. When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy..." |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size:
- Functional Testing: Not specified.
- Sterility: Not specified (refers to a "dose audit study" an ISO standard, but specific counts not given).
- Sterile Barrier/Shelf Life: Not specified.
- Biocompatibility: Not specified.
- Electrical Safety: Not specified.
- Preclinical Swine Study: Not specified.
- Data Provenance:
- Preclinical Swine Study: Conducted internally ("tested... in a preclinical swine study"). This would typically be considered prospective and controlled.
- Other tests (Functional, Sterility, Biocompatibility, Electrical Safety, etc.): Performed in-house or by accredited labs as part of the device development and verification process. No geographical origin or retrospective/prospective nature is specified, but these are generally considered prospective verification tests.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This document describes a medical device (surgical instruments), not an AI/algorithm-based diagnostic or imaging device where "ground truth" is established by human experts for test sets.
- The preclinical swine study involved evaluation of performance, likely by veterinarians, surgeons, or device engineers, but the specific number or qualifications are not mentioned. Their role was to observe and confirm device performance, not to establish ground truth for a diagnostic outcome.
4. Adjudication Method for the Test Set:
- Not applicable as this is a physical surgical instrument and not a diagnostic or AI system requiring adjudication of results or classifications against a ground truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No, an MRMC comparative effectiveness study was not done as this is not an AI/imaging device. The study performed was a preclinical animal study to evaluate instrument performance.
- The document implies a comparison to predicate devices, stating "When compared to the predicate devices, the SPIDER® Flexible Monopolar Instruments do not incorporate any significant technological differences that affect safety and efficacy," justifying why clinical data was not deemed necessary. This is a functional and design comparison, not an impact on human reader performance.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study:
- Not applicable, as this is a physical surgical instrument. The device is always used with a human surgeon.
7. Type of Ground Truth Used:
- For this type of device, "ground truth" refers to the confirmed physical, mechanical, and biological properties and performance characteristics of the instrument. This was established through:
- Direct Measurement/Verification: Functional tests, dimensional checks, electrical tests (HIPOT, dielectric), biocompatibility assays.
- Standardized Protocols: Adherence to ISO standards for sterility, packaging, and biocompatibility.
- Preclinical Observation: Direct observation and assessment of performance in a live animal model (swine study) by qualified personnel (likely veterinarians/surgeons).
8. Sample Size for the Training Set:
- Not applicable. This is a physical medical device, not an AI model that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no "training set" in the context of this device. The development process would involve iterative design, prototyping, and testing against design specifications, but not data-driven training in the AI sense.
Ask a specific question about this device
Page 1 of 2