Search Results

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons and urologists.

The intended use of the DEXTER ENDOSCOPE ARM is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The DEXTER ENDOSCOPE ARM is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, DEXTER ENDOSCOPE ARM is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the DEXTER ENDOSCOPE ARM are general surgeons, gynecologists, cardiac surgeons and urologists.

The intended use of the ARTip solo is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The ARTip solo is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, ARTip solo is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic, decompression fixation, wedge resection, lunq biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the ARTip solo are general surgeons, gynecologists, cardiac surgeons and urologists.

DEXTER ENDOSCOPE ARM and ARTip solo + ARTip solo voice are based on the same concept as the already cleared SOLOASSIST II + Voice Control (K200473) and differ only in minor details. All 3 robotic arm systems emulate an arm operating in multiple degrees of freedom. The intended use of the three robotic arm systems is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope. The surgeon can control the arm with either a joystick, voice control, or by pressing a button on the distal end of the arm. Movement is controlled by 3 motorized axes. The endoscopic camera is registered in the TROCAR POINT, which serves as the pivot point. Starting from this zero point, the device independently calculates the required individual movements of the axes to achieve the desired overall movement. The system offers a wide range of motion, allowing a 360° panoramic view with the endoscope tilted up to 90° from the vertical. Despite their wide range of motion, all arms are lightweight and compact and are attached directly to the operating table with a quick-release clamp. Only a STERILE COVER is required for safe use.

The ARTip solo is functionally identical to the already cleared SOLOASSIST II (K200473), but differs only in the color and inscription of the covers and the visual design of the control panel on the arm.

The ARTip solo can also be controlled with the ARTip solo voice. This is also identical to the already cleared VOICE CONTROL (K200473) except for the color and inscription. The ARTip solo is not compatible with the VOICE CONTROL (K200473).

In addition, the ARTip solo can also be controlled with a joystick. It can only be controlled with the JOYSTICK-IH-IA or JOYSTICK-RH-IIA, which are specially made for the ARTip solo and are only compatible with it.

DEXTER ENDOSCOPE ARM is the trade name of the SOLOASSIST IID, which was developed within the SOLOASSIST II. The special feature of the DEXTER ENDSCOPE ARM is that it provides an interface to a customer-specific device and can be controlled by it.

The arm can also be controlled by the JOYSTICK LH and JOYSTICK RH.

The SOLOASSIST IID has its own CANTILEVER, JOINT, PROBE PIN and ENDOSCOPE CLAMP, which in combination with a tension sleeve hold the endoscope.

I am sorry, but the provided text does not contain the detailed information necessary to complete some sections of your request. Specifically, it lacks data on:

• Specific acceptance criteria for individual performance metrics.
• Sample sizes for the test set.
• Data provenance (country of origin, retrospective/prospective).
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study, including effect size.
• Standalone algorithm performance.
• Type of ground truth for the test set.
• Sample size for the training set.
• How ground truth for the training set was established.

The provided text focuses on demonstrating substantial equivalence to a predicate device based on technological similarity and non-clinical testing. It states that new devices "can be classified as equally safe and effective as the predicate device" based on these tests, but does not provide specific performance metrics or detailed study designs for acceptance criteria.

Therefore, I cannot populate all the requested fields. However, I can provide the information that is present in the document which describes the testing and conclusions regarding the devices' safety and effectiveness.

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

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

The document does not explicitly list specific numerical acceptance criteria or quantitative performance metrics for the device. Instead, it refers to non-clinical tests carried out with predicate devices and additional tests for the new devices to "prove the safety and effectiveness with regard to the differences to the predicate device." The conclusion is that the new devices are "as safe and effective as the predicate device."

• Acceptance Criteria: Not explicitly stated with numerical values. The implicit acceptance criterion is likely to demonstrate equivalence in safety and effectiveness to the predicate device through successful completion of the listed non-clinical tests and software verification.
• Reported Device Performance: The document concludes that "The non-clinical tests have shown that the SOLOASSIST IID, ARTip solo voice and SOLOASSIST II + VOICE CONTROL are as safe and effective as the predicate device." No specific quantitative performance data (e.g., accuracy, precision, error rates) are provided.

Table of Acceptance Criteria and Reported Device Performance (Based on provided text, specific metrics are not detailed)

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

The document does not specify sample sizes for test sets, nor does it provide information on data provenance (country of origin, retrospective/prospective) as the tests described are non-clinical, likely bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The tests mentioned are non-clinical (e.g., temperature, lifetime, functional tests) and do not involve expert-established ground truth in the context of diagnostic interpretation.

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

Not applicable, as expert adjudication for ground truth is not mentioned for the non-clinical tests.

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. The device (SOLOASSIST IID / DEXTER ENDOSCOPE ARM, ARTip solo, ARTip solo voice, SOLOASSIST II, VOICE CONTROL) is described as a robotic computer-driven system to hold and position endoscopes, not an AI-assisted diagnostic or interpretative tool for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is outside the scope of this device's intended use and the provided documentation.

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

This refers to a standalone performance of the entire device system (robotic arm with its software and controls), not a standalone algorithm in the context of AI diagnostic performance. The non-clinical tests described (e.g., temperature, lifetime, functional tests for various components and control methods) represent tests of the device in its standalone (intended operational) capacity, without human intervention for evaluation of diagnostic output. The device itself is designed to be operated by a human surgeon.

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

For the non-clinical tests conducted, the "ground truth" would be established by engineering specifications, physical measurements, and functional requirements of the device and its components (e.g., a power supply providing the correct voltage, a quick-release connector functioning as designed, voice commands being correctly interpreted). It is not expert consensus, pathology, or outcomes data in the medical diagnostic sense.

8. The sample size for the training set

Not applicable, as the document describes a robotic surgical assistant system and associated controls, not an AI algorithm that requires a "training set" in the machine learning sense for diagnostic purposes. The software changes mentioned are related to bug fixes, parameter additions, and compatibility checks, not statistical model training.

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

Not applicable, for the same reason as point 8.

Ask a specific question about this device

The ENDOFIX EXO is indicated for use in interventions where a rigid endoscope is indicated for use. The device is intended to hold and position a rigid endoscope / exoscope during general and neurological diagnostic and therapeutic procedures.

The ENDOFIX EXO is a manually operated surgical device intended to hold endoscopes during general and neurological diagnostic and therapeutic procedures. It emulates an arm which is capable of guiding and positioning an endoscopic camera with several degrees of movement.

lt ensures stable and sensitive positioning of the endoscope and allows the surgeon to work one-handed and/or two-handed. The system provides surgeons with a stable and rocksteady field of vision, even in extreme endoscopic positions. The wide scope of movement provides surgeons with full visibility of the situs. The ENDOFIX exo can be used with both, an endoscope and exoscope.

An integrated DEACTIVATION PUSHBUTTON permits manual movement of the ENDOFIX EXO at the push of a button. In order to reposition a guided endoscopic camera, the ENDOFIX EXO is unlocked by a sterilizable CONTROL at the push of a button. The ENDOFIX EXO is operated by unlocking all 6 axes and subsequent manual positioning using the CONTROL. As soon as the button on the CONTROL is released, all 6 axes are locked again.

Despite its large scope of movement, the ENDOFIX EXO is light-weight and compact and is fastened directly to the OR table by means of a quick-acting clamp. Thus, repositioning with reference to the patient is not necessary even if the OR table is moved in the meantime.

On the rigid endoscope, there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the ENDOFIX EXO.

To allow the surgeon to convert to an open surgery in case of an emergency, the ENDOFIX EXO can be completely mounted or removed by a quick fastener.

During use, the ENDOFIX EXO is covered with a STERILE COVER. The ENDOFIX EXO can be removed from the OR table and stored on the TROLLEY.

The provided text is a 510(k) Summary for the medical device ENDOFIX EXO. It details the device's characteristics, comparison to a predicate device, and the non-clinical tests performed. However, it does not describe any acceptance criteria or studies involving AI / human reader performance.

Here's an analysis based on the provided text for the points that can be addressed:

The document clearly states that the ENDOFIX EXO is a manually operated surgical device. This means the device itself does not involve AI or algorithms for diagnosis or analysis, but rather for physical positioning of an endoscope. Therefore, many of the questions related to AI performance, such as acceptance criteria for algorithm performance, sample size for test/training sets, ground truth establishment for AI, MRMC studies, or standalone algorithm performance, are not applicable to this device as described.

The document discusses non-clinical performance tests to demonstrate the safety and effectiveness of the device compared to its predicate.

Here's a breakdown of the relevant information provided:

1. A table of acceptance criteria and the reported device performance
The document does not provide a formal table of acceptance criteria with reported performance values for specific metrics. Instead, it lists the types of non-clinical tests performed and broadly states that these tests were successful in demonstrating safety and effectiveness.

Non-Clinical Tests Performed:

• Lifetime test
• Lifetime test CONTROL
• Moving after fixation test
• Usability test
• Package drop test

Reported Device Performance (Implicit):
The summary states, "The non-clinical tests have shown that the ENDOFIX EXO device is as safe and effective as the predicate device." It also notes specific findings related to safety:

• Electromagnetic locks were mechanically tested according to IEC 60601-1:2005 + A1:2012, with no risks regarding safety observed.
• Displacement after fixation of the arm was tested, with no risks regarding safety observed.
• The device was tested with 5kg load, though its safe working load is specified as 1kg, and "no problems occurred."
• The absence of a battery in ENDOFIX EXO ensures continuous power operation safety. In case of power failure, the arm continues to hold position, and quick-release fasteners allow safe removal.
• Electrical safety tested according to IEC 60601-1, posing no danger to the user.
• Reprocessing and sterilization process validated, confirming no increased risk.
• Usability test with 15 American physicians did not negatively mention weight, despite the device being heavier than the predicate.

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

• Test Sample Size: Not specified for most tests (e.g., lifetime test, moving after fixation test, package drop test).
  • For the Usability Test: "15 American physicians."
• Data Provenance:
  • Country of Origin: The usability test involved "15 American physicians," suggesting US-based data. For other tests, the origin is not explicitly stated but the applicant is based in Germany.
  • Retrospective or Prospective: Not explicitly stated but implied to be prospective testing for device validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• This question is not applicable as this relates to AI/diagnostic performance where expert consensus is needed for ground truth. This device is a mechanical endoscope holder.
• However, for the Usability Test, "15 American physicians" were involved. Their specific qualifications beyond being "physicians" are not detailed.

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

• This question is not applicable as there is no diagnostic or interpretative task requiring adjudication. The tests described are mechanical, electrical, and usability in nature.

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 question is not applicable as the device is a mechanical endoscope holder and does not involve AI for diagnostic assistance or human-in-the-loop performance improvement.

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

• This question is not applicable as there is no algorithm or AI component in this device.

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

• This question is not applicable as the "ground truth" concept as typically applied to diagnostic AI is not relevant here. The "truth" for the mechanical/electrical tests would be adherence to engineering specifications and safety standards (e.g., proper functioning after a lifetime test, no displacement after fixation, meeting electrical safety standards).

8. The sample size for the training set

• This question is not applicable as there is no AI/algorithm component requiring a training set.

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

• This question is not applicable as there is no AI/algorithm component requiring ground truth for a training set.

Ask a specific question about this device

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a JOYSTICK, manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II or using the VOICE CONTROL.

The JOYSTICK or the VOICE CONTROL is linked to related connection of the SOLOASSIST II by wire. The JOYSTICK is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm.

The TENSION SLEEVE and the ENDOSCOPE CLAMP are loosely screwed together. The combination of TENSION SLEEVE and ENDOSCOPE CLAMP are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right TENSION SLEEVE for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II.

The starting point of the movement for an operation will be saved as the TROCAR POINT. The UNIVERSAL JOINT has to be mounted on the SOLOASSIST II. A mounted UNIVERSAL JOINT can be removed by using the release slider. To define the Trocar point the UNIVERSAL JOINT has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of the SOLOASSIST II.

The ENDOSCOPE CLAMP (together with TENSION SLEEVE and Endoscope) is mounted on the UNIVERSAL JOINT, so the SOLOASSIST II is ready for operation.

Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the JOYSTICK the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the JOYSTICK it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out.

Additionally it is possible to move the arm of the SOLOASSIST II without the use of the JOYSTICK. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system.

Additionally it is possible to move the arm of the SOLOASSIST II with the use of the VOICE CONTROL. Therefore the user has to put the headset on his head that is connected to the VOICE CONTROL by a Bluetooth-Donqle. The VOICE CONTROL is activated by using the hotword "SOLO". The SOLOASSIST II moves by using predefined Movement Commands.

To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.

The provided document is a 510(k) summary for the AKTORmed SOLOASSIST II, including its Voice Control accessory. It describes the device, its intended use, and the performance data submitted to demonstrate substantial equivalence to a predicate device.

However, the document does not contain the level of detail typically found in a clinical study report that would specify "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of diagnostic accuracy, sensitivity, specificity, or reader performance, as would be expected for a device relying on AI for interpretation.

The SOLOASSIST II is a robotic computer-driven system to hold and position a rigid laparoscope/endoscope. Its "performance" refers to its mechanical and software functionality, not the interpretation of medical images or data. The "acceptance criteria" discussed are largely related to safety, mechanical functionality, electrical safety, electromagnetic compatibility, software validation, and human factors.

Based on the provided text, here's what can be extracted, and where there are gaps regarding the typical understanding of a clinical study for AI-driven image interpretation devices:

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

The document lists various tests and states that the device "complies" or the test was "performed successfully," implying that the acceptance criteria for those engineering and human factors tests were met. However, it does not present this as a formal table with specific quantitative acceptance criteria or corresponding quantitative results in the way one would for diagnostic performance.

Here are some examples of implicit "acceptance criteria" and "reported performance" derived from the text, though not in the requested table format:

Ask a specific question about this device

The intended use of the SOLOASSIST II is a robotic computer driven system whose function is to hold and position a rigid laparoscope / endoscope.

The SOLOASSIST II is indicated for use in minimally invasive interventions where a rigid laparoscope / endoscope is indicated for use. Surgeries, SOLOASSIST II is used, are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic & thorascopic, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.

The users of the SOLOASSIST II are general surgeons, gynecologists, cardiac surgeon, thoracic surgeon and urologists.

The SOLOASSIST II allows the user to hold and control the movements of a rigid endoscope by using a joystick or manually by pushing the release button on the Control Panel that is located on the SOLOASSIST II.

The joystick is linked to related connection of the SOLOASSIST II by a wire. The joystick is mounted on the surgical instrument of the surgeon. The movement will be controlled by three motorized axes inside the SOLOASSIST II. The SOLOASSIST II simulates an arm working in several degrees of freedom. The Control Panel of the SOLOASSIST II has 2 buttons and 5 indications. One button is used to set the TROCAR POINT and the other button is used to move the SOLOASSIST manually by pushing the button while moving the arm.

The Tension Sleeve and the Endoscope clamp are loosely screwed together. The combination of Tension Sleeve and Endoscope clamp are slide over the endoscope and the tension sleeve is tightened so the endoscope can't move out but still can turn. It is important to use the right tension sleeve for the right diameter of the endoscope. On the rigid endoscope normally there is a camera linked that sends a video to a monitor. Endoscope and camera as well as the monitor are not part of the SOLOASSIST II.

The starting point of the movement for an operation will be saved as the TROCAR POINT. The Universal Joint has to be mounted on the SOLOASSIST II. A mounted Universal Joint can be removed by using the release slider. To define the Trocar point the Universal Joint has a small tracer pin. The tracer pin is placed near the body opening for the endoscope. The TROCAR POINT has to be saved by pushing the button on the control panel of SOLOASSIST

The Endoscope Clamp (together with Tension Sleeve and Endoscope) is mounted on the Universal Joint, so the SOLOASSIST II is ready for operation.

Based on the trocar point and the desired view of the software of the device calculates the required individual movements of the axes in order to achieve the desired total movement. For example by pushing the left button on the joystick the image on the monitor moves left, while the SOLOASSIST II is moving to produce the desired view. By pushing the buttons on the joystick it is possible to move the image on the monitor to the left, right, up, down, zoom in and zoom out.

Additionally it is possible to move the arm of the SOLOASSIST II without the use of the iovstick. Therefore the user has to hold the control panel on the SOLOASSIST II and push the unlocking button (release button) while moving the arm system.

To allow the surgeon to convert to an open surgery in case of an emergency, the SOLOASSIST II can be completely mounted or removed by a quick fastener.

The provided text describes the 510(k) summary for the SOLOASSIST II device. However, it does not contain information about acceptance criteria for particular performance metrics, nor does it detail a study proving the device meets specific performance thresholds in a clinical or human-in-the-loop setting.

The document focuses on non-clinical testing for substantial equivalence, primarily covering:

• Biocompatibility
• Electrical safety and electromagnetic compatibility (EMC)
• Software verification and validation
• Mechanical, acoustic, and bench testing (though these are more about general device robustness and function, not specific performance metrics like speed, accuracy, or image quality that would typically have acceptance criteria for an AI/robotic system controlling an endoscope for image acquisition)
• Cybersecurity risk assessment
• Sterilization
• Human Factors testing (focused on safety and usability, not quantitative performance against acceptance criteria)
• Packaging

Crucially, Section 8.2 states: "No clinical evaluation was conducted for this device." This means there would be no data from a study involving human users or patients to establish performance against acceptance criteria in a real-world or simulated clinical scenario, which is usually where such detailed acceptance criteria for AI-driven assistance systems are measured.

Therefore, I cannot fulfill the request as the necessary information regarding acceptance criteria and a study proving quantitative performance against those criteria (especially for AI assistance) is not present in the provided text. The device, SOLOASSIST II, is described as a "robotic computer driven system" that holds and positions an endoscope, but the performance data presented is entirely non-clinical and focused on safety, usability, and basic functional integrity, not AI-driven performance metrics.

If this were an AI-driven system requiring a clinical or human-in-the-loop study with specific performance acceptance criteria, the provided document would be insufficient.

In summary, based only on the provided text, there is no information to construct the requested table or answer the specific questions about acceptance criteria and performance study details related to an AI-driven component (beyond the general "software verification and validation"). The document explicitly states "No clinical evaluation was conducted for this device."

Ask a specific question about this device