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The Aurora Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference.

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• The LEDs provide illumination to the surgical field by directing light down the sheath, along . the instrument channel.
• The camera captures video image of the surgical field. ●

The proximal end of the sheath also contains a tab, which may be used to manually hold the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the sheath, and the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed. Two sterile, single use accessories optional for use are provided with the Aurora Surgiscope System: an Irrigation Device and 12 French Suction Device.

The ICB is a non-sterile device that provides three main functions in the Aurora Surgiscope System:

• To power the Surgiscope LEDs and camera
• . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
• . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.

The provided FDA 510(k) clearance letter and summary for the Aurora Surgiscope System do not contain information typically found in a clinical study report or performance evaluation for an AI/software device. The document focuses on demonstrating substantial equivalence to a predicate device, which means proving that the new device is as safe and effective as a legally marketed device, rather than rigorously quantifying performance against defined acceptance criteria in a study setting.

Specifically, the document does not include:

• A table of acceptance criteria and reported device performance related to a diagnostic or AI function.
• Sample sizes for test sets or data provenance for AI model validation.
• Details about expert readers, ground truth establishment, or adjudication methods for AI performance.
• Information on multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance data.
• Training set details for an AI model.

The "testing" mentioned in the document pertains to traditional medical device testing for hardware, biocompatibility, electrical safety, and mechanical aspects. While it states "Software verification and validation testing" was conducted and "documentation provided as recommended by the FDA Guidance Content of Premarket Submissions for Device Software Functions," it does not provide any specific performance metrics or acceptance criteria for software functionality that would typically be associated with an AI/ML-driven device's diagnostic performance. The "Image Control Box" software mentioned focuses on image adjustment and display, not diagnostic interpretation.

Therefore, based solely on the provided text, it is not possible to describe the acceptance criteria and the study proving the device meets those criteria from an AI/ML perspective. The device, as described, appears to be a neurological endoscope system for visualization, diagnostic, and therapeutic procedures, with software for image display and adjustment, not an AI-powered diagnostic tool.

If this were an AI-powered device, the information requested would be crucial for its evaluation. Without it, I cannot fulfill the request for AI-related performance criteria.

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The Vycor Viewsite Brain Access System (VBAS) is intended to provide for access and allow for visualization of the surgical field during brain and spine surgery.

The Vycor Medical Surgical Access System (VBAS) includes a family of retractor devices of varying shapes and sizes designed for providing diagnostic and surgical access to various portions of the brain and spinal region. The subject device is comprised of the modified version of the predicate device cleared under #K060973 together with the optional Alignment clip (A)C component.

The models designated with post characters "AC" includes the Alignment Clip ("AC") included separately in the packaging. This is available for all models other than the 6mm size. The AC may be optionally attached to aid in centering third party navigational and image guided system ("IGS") pointers or probes ("pointer").

Like the predicate, the subject device consists of an introducer and port. The port and introducer are packaged assembled and ready for use. Upon insertion of the device, the introducer is removed and the port is left in place. The introducer has a length greater than the port. The smooth and soft tapered introducer works to spread apart the brain or other portions of delicate tissue. Upon removal of the introducer, the port provides a hollow working channel allowing the surgeon access to the target tissues.

The AC optional component was designed to make the VBAS easier to use with IGS by enabling the IGS pointer to be centered and held in place:

• . Designed to accommodate a range of commonly-used pointers
• . Securely clips onto the VBAS device when used
• Provides insertion direction to center the pointer in the device and ensure vertical alignment
• Provides locking mechanism to securely hold the pointer in place and therefore enable the pointer and VBAS to be one integrated unit freeing up one of the surgeon's hands

The provided text is a 510(k) premarket notification summary for the Vycor Medical Viewsite Brain Access System (VBAS) and VBAS with Alignment Clip (VBAS AC). It describes the device, its indications for use, technological comparison to a predicate device, and non-clinical tests performed to demonstrate substantial equivalence.

However, the document does not describe a study that proves a device meets acceptance criteria related to AI/Machine Learning performance, such as those that would typically involve:

• A table of acceptance criteria and reported device performance (e.g., sensitivity, specificity, AUC) for an AI model.
• Sample sizes for test sets in the context of AI models.
• Number of experts and their qualifications for establishing ground truth for AI model test sets.
• Adjudication methods for AI model ground truth.
• Multi-reader multi-case (MRMC) comparative effectiveness studies comparing human readers with and without AI assistance, or effect sizes for such studies.
• Standalone performance (algorithm only) of an AI model.
• Types of ground truth for AI models (e.g., pathology, outcomes data).
• Sample size for training sets of AI models.
• How ground truth for training AI models was established.

Instead, this document details the testing performed for a physical medical device (a self-retaining retractor for neurosurgery) to demonstrate its safety and effectiveness and substantial equivalence to a predicate device. The tests are typical for physical devices and include:

• Shelf Life Testing / Functional Testing
• Packaging Validation
• Human Factors / Usability Testing
• Sterilization Validation
• Biocompatibility (not performed, as identical materials to predicate were used)

Therefore, I cannot extract the requested information regarding AI/Machine Learning criteria and studies from this document. The document explicitly states "Discussion of Non-Clinical Tests Performed" and "Discussion of Clinical Tests Performed: Not applicable." This indicates that the device's clearance was based on engineering and usability testing, not performance metrics related to an AI algorithm.

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The AURORA Surgiscope System is intended for use in neurosurgery and endoscopic neurosurgery and pure neuroendoscopy (i.e. ventriculoscopy) for visualization, diagnostic and/or therapeutic procedures such as ventriculostomies, biopsies and removal of cysts, tumors and other obstructions.

The Aurora Surgiscope System consists of two components: (1) a sterile, single use, sheath with integrated illumination LEDs and camera, with an obturator, and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The sheath is intended to provide access to the surgical site by acting as the insertable portion of the device, as well as the instrument channel to accommodate other surgical tools. Depth markers are present along the length of the sheath for user reference.

At the proximal end of the sheath is the imager, which comprises the following components: LEDs (light emitting diodes), camera (and optical components), and focus knob.

• . The LEDs provide illumination to the surgical field by directing light down the sheath, along the instrument channel.
• The camera captures video image of the surgical field.

The proximal end of the sheath also contains a tab, which serves as the location for the fixation arm to hold/fix the device. To facilitate insertion of the surgical site, an obturator is provided with the device. During insertion, the obturator is fully inserted into the entire unit is advanced to the desired location. The distal end of the obturator is conical in shape to minimize tissue damage. In addition, the proximal handle of the obturator is designed to accommodate various stereotactic instruments for neuronavigation. Once inserted, the obturator is removed.

The ICB is a non-sterile device that provides three main functions in the AURORA Surgiscope System:

• . To power the Surgiscope LEDs and camera
• . To relay the video feed captured by the Surgiscope camera to a display monitor for real-time image visualization
• . To allow the user to make adjustments to the displayed video feed (e.g., contrast, brightness), as well as vary the LED light output.

The user interface is a membrane keypad with buttons located on the ICB that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The ICB is supplied with two cables: A power cable for connection to an AC wall outlet, and a display cable for connection to a high definition surgical monitor.

The provided text describes the AURORA Surgiscope System, a neurological endoscope. However, it does not contain specific acceptance criteria in terms of diagnostic performance metrics (e.g., sensitivity, specificity, accuracy) or details of a study designed to demonstrate them.

The document discusses various non-clinical tests performed to demonstrate the device's safety and substantial equivalence to a predicate device. These tests fall under general medical device regulatory requirements rather than specific performance outcomes for an AI/algorithm-driven device.

Therefore, for almost all of the requested information, the answer is that the data is not available in the provided text.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document describes non-clinical testing for the device (biocompatibility, electrical safety, software V&V, mechanical testing), but does not mention a "test set" in the context of diagnostic performance or AI model evaluation.

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

N/A. The document does not describe a study involving expert review for establishing ground truth related to diagnostic performance.

4. Adjudication method for the test set

N/A. No test set for diagnostic performance is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance

No. The document does not describe an MRMC study or any study evaluating human reader improvement with AI assistance. The device is a surgical endoscope, not an AI diagnostic tool.

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

No. The document does not describe a standalone algorithm performance study.

7. The type of ground truth used

N/A. The concept of "ground truth" in the context of diagnostic or AI performance is not relevant to the non-clinical testing described. The "truth" in these tests relates to engineering specifications, material properties, safety standards, and software functionality.

8. The sample size for the training set

N/A. No training set for an AI/algorithm is described. The software validation mentioned (point 4 in "SUMMARY OF NON-CLINICAL TESTING") refers to the software controlling the endoscope's functions, not an AI algorithm for diagnostic purposes.

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

N/A. No training set is described.

Summary of what the document DOES describe regarding "studies" and "performance":

The document outlines a series of non-clinical tests that demonstrate the device's safety and functional performance in accordance with regulatory standards for a medical device (neurological endoscope). These include:

• Biocompatibility testing: MEM Elution (cytotoxicity), Sensitization (Kligman Maximization), Irritation (Intracutaneous Injection), Systemic Toxicity (Systemic Injection), Hemolysis (Indirect), Materials Mediated Pyrogenicity. The device sheath with LEDs and camera is considered tissue-contacting for less than 24 hours. The ICB (Image Control Box) has no patient contact.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1-1, IEC 60601-1-2, and IEC 60601-2-18.
• Software verification and validation testing: Conducted as per FDA Guidance for "major level of concern" software (meaning failure could cause serious injury or death). This ensures the software controlling the device functions correctly.
• Mechanical and other testing: Dimensional, imaging (visualization, resolution), illumination, tensile strength, simulated use (clinician evaluation), instrument compatibility, particulate testing (USP ), sterilization (ISO 11135-1 for SAL of 10-6), packaging and shelf-life (ISTA 2A and ASTM F1980).

These tests are designed to show the device is safe and performs its intended function (visualization, diagnostic/therapeutic procedures using an endoscope), and that it is substantially equivalent to a predicate device based on its technical characteristics. It does not involve AI or diagnostic performance metrics typically requested for such systems.

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The MEDICON Spinal Spreading Systems are used to spread soft tissue and maintain surgical access in spine surgery and may only be used by surgeons with proper training and adequate experience in spine surgery.

The MEDICON Spinal Spreading System is made up of multiple reusable manual spreader systems. The spreaders include components for all approaches in spine surgery, including those specifically for cervical spine surgery, as well as inter-laminar, trans-laminar, extra-foraminal and dorsolateral approaches. The multiple components support classic and minimally invasive procedures. The components are made from a radiolucent x-ray compatible material, from titanium, some from stainless steel, and some from anodized aluminum.

This document describes the MEDICON Spinal Spreading Systems, a set of reusable manual retractor systems used in spine surgery. The information provided is for regulatory clearance (510(k)) and focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance characteristics of an AI/ML device. Therefore, many of the requested details concerning AI/ML device acceptance criteria and study designs are not applicable or cannot be extracted from this medical device submission.

Here's an analysis based on the information provided, highlighting the differences due to the nature of the device:

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

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

This information is not applicable as this is not an AI/ML device, but a physical medical instrument. The "test set" here refers to the physical devices undergoing non-clinical technical testing. Specific sample sizes for each test (e.g., number of blade supports tested) are not provided, only the qualitative outcome. The data provenance is internal testing performed by the manufacturer, MEDICON eG, which is based in Germany.

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 is not applicable. "Ground truth" in the context of expert consensus is relevant for diagnostic or AI/ML devices where interpretation is involved. For a physical surgical instrument, the acceptance criteria are based on objective engineering and sterilization standards.

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

This is not applicable. Adjudication methods like 2+1 or 3+1 refer to how discrepancies in expert interpretations (e.g., in reading medical images) are resolved to establish a ground truth. For the physical testing of surgical instruments, results are objective and measured against established standards, not subject to expert interpretation discrepancies in the same way.

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 is not applicable. An MRMC study is designed to evaluate the performance of diagnostic systems or AI assistance in a clinical setting with human readers. This device is a surgical instrument, not a diagnostic or AI-assisted system. No clinical studies (including MRMC) were performed.

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

This is not applicable. There is no algorithm or AI component in this medical device.

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

The "ground truth" for this device's performance is established by adherence to recognized engineering standards for mechanical strength, biocompatibility standards, and sterilization validation standards. This is not an expert consensus or pathology-based ground truth typical for AI/ML or diagnostic devices.

8. The sample size for the training set

This is not applicable. This is a physical medical device, not an AI/ML system, so there is no training set.

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

This is not applicable. No training set exists for this device.

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