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The CAS-One Liver system is indicated for open liver surgical procedures where image guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The CAS-One Liver system is indicated for open liver surgical procedures where image aujdance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia. It visualizes the position and pose of surgical instruments relative to a three-dimensional model of the patients liver in real-time.

The provided text describes the CAS-One Liver system, its indications for use, and a summary of performance data submitted for its 510(k) premarket notification. However, it does not contain specific acceptance criteria for device performance or a detailed study proving the device meets those criteria.

The document states:

• "Bench testing to show the accuracy and reproducibility was conducted and shown to meet the defined acceptance criteria for various functionality of the system (such as calibration, tracking and registration)."

This indicates that acceptance criteria were defined and testing was performed, but the document does not report what those criteria were, nor does it provide the results of the tests against those criteria.

Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes, ground truth, or details of a comparative effectiveness study.

Here's what can be extracted, based on the absence of the requested information:

1. Table of acceptance criteria and reported device performance:

   • The document states "Bench testing to show the accuracy and reproducibility was conducted and shown to meet the defined acceptance criteria for various functionality of the system (such as calibration, tracking and registration)."
   • CRITERIA NOT SPECIFIED.
   • REPORTED PERFORMANCE NOT SPECIFIED.

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

   • NOT SPECIFIED. The document only mentions "Bench testing."

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

   • NOT SPECIFIED, as details of the "Bench testing" are not provided.

4. Adjudication method for the test set:

   • NOT SPECIFIED.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size:

   • NO, an MRMC comparative effectiveness study is not mentioned. The device is a navigation system for surgical procedures, and the testing described is "Bench testing" for accuracy and reproducibility, not a study of human reader improvement with AI assistance.

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

   • The "Bench testing" for "accuracy and reproducibility" of "calibration, tracking and registration" could be considered standalone performance, as it tests the system's technical function. However, the exact details of how "human-in-the-loop" was excluded or included are NOT SPECIFIED.

7. The type of ground truth used:

   • For "Bench testing" of a navigation system, ground truth would typically be established through precise measurements from calibrated instruments, phantoms, or simulated environments. However, the specific type of ground truth used for the CAS-One Liver system's bench testing is NOT SPECIFIED.

8. The sample size for the training set:

   • The document implies a "virtual surgery planning tool" (MeVis Medical Solutions, Bremen, Germany) that processes CT/MRI scans. This tool likely uses algorithms that would have been "trained," but the details of any training set for the CAS-One Liver system's own components (if applicable for navigation algorithms) are NOT SPECIFIED. The document focuses on the end-use navigation system's performance.

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

   • NOT SPECIFIED.

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The Explorer ™ Liver --- Passive Tracking device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Explorer" Liver --- Passive Tracking is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver --- Passive Tracking system consists of eight (8) components which are listed below:

• An image-guided surgery software platform installed on a personal computer (PC) (1)
• (2) An optical position sensor --- the Polaris Spectra or Vicra that can accurately localize the tracked devices listed below in passive tracking mode
  • . A passive tracked abdominal reference (used for definition of coordinate and instrument calibration)
  • . A passive tracked Localization Pen Probe
  • . A passive tracked Laser Range Scanner (LRS)
  • Two passive tracked adapters (can be attached onto up to two rigid surgical instruments ● simultaneously and used for their localization in 3-D surgical space)
• (3) An LCD display monitor.

The provided text {0-4} discusses the K101979 submission for the Explorer™ Liver - Passive Tracking device. However, it does not contain specific acceptance criteria, detailed performance metrics, sample sizes for test or training sets, information on ground truth establishment at a granular level, expert qualifications, or adjudication methods relevant to an AI/ML device.

The document indicates that performance data involved "Validation and verification studies through bench tests" to evaluate the device's characteristics and demonstrate its capability to safely and accurately perform its intended use, showing "similar effectiveness to the Explorer™ (active tracking) [K071063 & K093494]". This suggests a comparison against a predicate device's performance, but the specifics of that performance are not detailed here.

Therefore, I cannot populate most of the requested table and information based on the provided text alone. The text focuses on regulatory submission details, device description, and substantial equivalence, rather than a detailed performance study report.

In summary, the provided text does not contain the necessary information to complete the requested table and answer the detailed questions about acceptance criteria, study specifics, sample sizes, ground truth, and expert involvement.

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The Explorer™ Liver device is indicated for open liver surgical procedures where image-guidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Explorer™ Liver system is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Explorer™ Liver system consists of six (6) components which are listed below:

• An image-guided surgery software platform installed on a personal computer (PC) (1)
• A three lens active-based optical position sensor that can accurately localize the tracked devices (2) listed below
  • A tracked adapter multi tool (used for localization of rigid surgical instruments and to (a) define 3-D surgical space)
  • A tracked laser range scanner (b)
  • A tracked Localization Probe (c)
• An LCD display monitor. (3)

The provided text is a 510(k) summary for the Explorer™ Liver system. It describes the device, its indications for use, and states that performance data from validation and verification studies demonstrate the device's safety and accuracy. However, this document does not contain explicit acceptance criteria or the details of a study that proves the device meets those criteria.

The "Performance Data" section (VII) is very brief and only states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Explorer™ Liver system. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use." It does not provide any specific metrics, thresholds, sample sizes, or methodologies for these studies.

Therefore, I cannot fulfill your request for a table of acceptance criteria, device performance, sample sizes, data provenance, expert qualifications, adjudication methods, MRMC study details, standalone study details, types of ground truth, or training set information based solely on the provided text.

The document is a high-level summary for regulatory submission, not a detailed technical report of the studies themselves. To answer your questions, one would need access to the actual validation and verification study reports mentioned.

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The Linasys device is indicated for open liver surgical procedures where imageguidance may be appropriate and where the patient can tolerate long apneic periods under general anesthesia.

The Linasys (Liver Navigation System) is an image-guided surgery medical device specifically designed to aid physicians during open liver procedures. The device is capable of mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images. These images can then be used as a guide by the physician for more accurate localization of tumors and other surrounding anatomic structures during liver surgery. The Linasys system consists of six (6) components which are listed below:

(1) An image-guided surgery software platform installed on a personal computer (PC)
(2) A three lens active-based optical position sensor that can accurately localize the tracked devices listed below
(3) A tracked localization probe
(4) A tracked fixed reference emitter used to define 3-D surgical space
(5) A tracked laser range scanner
(6) An LCD display monitor.

The provided 510(k) summary for the Linasys Image-Guided Liver Surgery System does not contain detailed information about specific acceptance criteria or a study proving the device meets those criteria in a quantitative sense.

It broadly states: "Validation and verification studies were conducted to evaluate the performance characteristics of the Linasys Image-Guided Liver Surgery System. The results of these studies demonstrate that the device is capable of safely and accurately performing the stated intended use."

Without specific performance metrics from a study, it's not possible to create the requested table or answer most of the detailed questions.

However, based on the limited information provided, here's what can be inferred or stated about the device and its assessment:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the document. For a medical device, these would typically include quantifiable metrics for accuracy, precision, reliability, and safety.
• Reported Device Performance: Not explicitly stated in terms of specific numerical outcomes or metrics. The summary only gives a general statement of capability.

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

• Sample Size: Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

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

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned.

4. Adjudication method for the test set:

• Not mentioned.

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:

• No, an MRMC comparative effectiveness study is not mentioned. The Linasys is described as an image-guided surgery system for assisting physicians, not an AI diagnostic tool for "human readers." Therefore, this type of study would not be directly applicable as described.

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

• The document implies the device is an assistance tool for physicians during surgery ("to aid physicians," "used as a guide by the physician"). It is not described as a standalone algorithm performing tasks without human interaction. Therefore, a standalone performance study in the context of an "algorithm only" would be unlikely or not explicitly mentioned here. The "performance characteristics" studies likely refer to the system's accuracy in mapping positions, not an AI's standalone diagnostic capability.

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

• Not mentioned. For a navigation system, ground truth would likely involve highly precise measurements of physical locations and their correlation with imaging data.

8. The sample size for the training set:

• Not mentioned.

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

• Not mentioned.

Summary of what is known from the provided text:

• Device Name: Linasys Image-Guided Liver Surgery System
• Intended Use: To aid physicians during open liver procedures by mapping the current surgical position of tracked instruments onto preoperative, patient-specific MRI or CT medical images, guiding localization of tumors and other structures.
• Performance Claim: "Validation and verification studies were conducted to evaluate the performance characteristics... The results... demonstrate that the device is capable of safely and accurately performing the stated intended use."
• Predicate Devices: Several other FDA-cleared frame stereotaxic systems (Medtronic Navigation StealthStation, BrainLAB VectorVision2, J&J ACUSTAR I). This implies the Linasys system's performance metrics, though not detailed, would likely be compared to or fall within the established performance ranges of these predicate devices.

To provide the requested details, additional information from the actual validation and verification study reports would be necessary. This 510(k) summary is a high-level overview.

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