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FLASH EVD is a stereotactic image guidance system intended for the spatial positioning and orientation of neurosurgical instruments. The device is only indicated for cranial surgery where reference to a rigid anatomical structure can be identified, does not require rigid fixation of the patient, and does not require fixation of a navigated instrument guide to the patient.

FLASH EVD System is a stereotactic image guided surgical navigation system during cranial procedures. The FLASH EVD software assists in guiding surgeons during external ventricular drainage (EVD) catheter placement procedure, also known as a ventriculostomy, is prescribed to relieve elevated intracranial pressure when there is a disruption in the normal flow of cerebrospinal fluid (CSF) within the brain.

The provided text describes the 7D Surgical FLASH EVD System and its 510(k) submission for clearance. However, it does not contain the detailed information necessary to fully answer all aspects of your request, particularly regarding specific acceptance criteria metrics and a multi-reader, multi-case (MRMC) comparative effectiveness study.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (7D Surgical System Cranial Biopsy and Ventricular Catheter Placement Application, K192945) through non-clinical testing.

Here's a breakdown of what can be extracted and what information is missing based on your prompts:

1. Table of Acceptance Criteria and Reported Device Performance

The document specifies "System Accuracy Requirement" for the predicate device, which the FLASH EVD System also adopts as "Same as K192945." These are the closest things to acceptance criteria mentioned.

Note: The document states that "Device performance tests were performed to verify the absolute accuracy and repeatability of the accuracy of the device, and the navigation accuracy according to ASTM F2554-10." It also mentions "Target Registration Error (TRE) and Trajectory Angular Error (TAE) have been used to evaluate the clinical accuracy of the system on phantom models in a clinical simulated environment." However, the specific numerical results for these tests are not provided in the summary, only a general "All accuracy specifications have been met." conclusion.

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

• Test Set Sample Size: Not explicitly stated. The testing was described as "Non-Clinical Performance Surgical Simulations Conducted on Phantom Models."
• Data Provenance: The testing was conducted on "phantom models" in a "clinical simulated environment." The origin of data for clinical performance (i.e., human subject data) is not applicable as a clinical trial was not required. The manufacturer is 7D Surgical ULC, located in Toronto, ON, Canada, which suggests the development and non-clinical testing likely occurred there.
• Retrospective or Prospective: Not applicable, as the testing was on phantom models, not patient data in a retrospective or prospective manner.

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

• This information is not provided. The ground truth for the non-clinical accuracy testing (TRE and TAE on phantom models) would typically be established through precise physical measurements or a CAD model of the phantom, rather than expert consensus on medical images.

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

• Not applicable. Adjudication methods like 2+1 or 3+1 are primarily used for reviewing patient images by multiple experts to establish ground truth for AI model performance. Since the testing was non-clinical on phantom models, this type of adjudication is not relevant.

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 was explicitly NOT done. The document states: "A clinical trial was not required to demonstrate the safety and effectiveness of FLASH EVD. Clinical validation is unnecessary as FLASH EVD does not introduce new indications for use, and device features are equivalent to the previously cleared predicate device identified."
• Therefore, there is no information on how much human readers improve with or without AI assistance, as AI assistance in the context of improving human reader performance on imaging interpretation does not appear to be the primary function or study objective of this surgical navigation system. The system guides surgeons, but it's not described as an AI diagnostic aid for image interpretation.

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

• Yes, the "Non-Clinical Accuracy" testing (System accuracy, TRE, TAE) on phantom models represents a form of standalone performance evaluation of the device's navigation capabilities. The results concluded that "All accuracy specifications have been met."

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

• For the "Non-Clinical Accuracy" tests, the ground truth was based on:
  • Physical measurements/known phantom geometry: "TRE and TAE evaluate the error discrepancy between the position reported by the image guided surgery system and the ground truth position measured physically or otherwise."
  • ASTM F2554-10 Standard: This standard provides a method for objectively measuring positional accuracy.

8. The sample size for the training set

• Not applicable/Not provided. This device is a surgical navigation system, not an AI/ML model for image interpretation that typically requires a large training set of labeled images. While the system uses "preoperatively acquired tomographic data," this is for patient-specific registration and navigation, not for training a generalizable AI model in the typical sense of deep learning. The document describes it as "displaying the locations of tracked navigation tools relative to the patient" and linking "Position and orientation data of the tracked navigation tools to the preoperative image data."

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

• Not applicable/Not provided for the reasons stated in point 8.

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