(248 days)
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.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).