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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 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 Aurora Surgiscope System is intended for use in 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, neurological endoscope and (2) a non-sterile, reusable control unit, Image Control Box (ICB).

The Aurora Surgiscope includes the following components:

• Sheath
• Camera
• LED (Light Emitting Diodes)
• Sheath Cable
• Obturator

The Sheath is fabricated from ABS plastic and is cylindrically shaped. It acts as both the insertion portion and instrument channel of the endoscope. Depth markers are located on both sides of the Sheath in 1 cm increments to aid with device insertion. LEDs are embedded into the interior wall of the Sheath that provide illumination of the surgical field. A larger diameter plastic ring, Camera mount (or Fixation ring), is located at the proximal end of the Sheath and may be used with fixation arm(s) to hold/fix the device.

The Camera assembly is rigidly attached to the Camera Mount and positioned to produce a forward view (0° direction) of the surgical site. An optical lens and prism are also incorporated for imaging.

The Surgiscope electronics are connected to the ICB by a flexible shielded Sheath Cable. The cable exits from the rear of the Camera housing and is connected to the ICB during system set-up.

The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped to minimize injury to tissue during insertion. At the proximal end, a plastic handle is used for removal of the Obturator from the Sheath and has an attachment on the handle to secure stereotactic instruments for neuronavigation. A stainless steel tube connects the Obturator tip and handle.

The Image Control Box (ICB) controls the real-time video image that it receives from the camera on the Surgiscope. It also delivers the real-time video to an external Display Monitor and provides isolated power to the Surgiscope LEDs and camera. The ICB is supplied with two cables: an isolated 110V power cable to be connected to an AC electrical outlet and a cable which is to be connected to the Display Monitor in the operating room.

The user interface is a membrane keypad with buttons that can be depressed for image adjustment, such as zoom, contrast, brightness, and orientation. The connections to the Surgiscope, Display Monitor and Power are the side of the ICB as well as the ON/OFF switch.

The provided text is a 510(k) summary for the Aurora Surgiscope System. It describes the device, its intended use, and a comparison to a predicate device to establish substantial equivalence. However, it does not contain information about the acceptance criteria or a study that proves the device meets specific performance criteria through a clinical or non-clinical validation study in the format requested.

The document primarily focuses on:

• Device Description: What the Aurora Surgiscope System is composed of (single-use endoscope, reusable control unit, etc.).
• Indications for Use: Its purpose in endoscopic neurosurgery for visualization, diagnostic, and therapeutic procedures.
• Non-Clinical Testing: A list of conducted or adopted tests for safety and effectiveness (Biocompatibility, Electrical Safety, EMC, Particulate Testing, Sterilization, Packaging/Shelf-life, Design Verification, Software/System V&V).
• Comparison to Predicate Device: A detailed table comparing the subject device to a previously cleared Aurora Surgiscope System (K182211) across various characteristics like indications, materials, endoscope specifications, light source, camera, control unit, and use.

The document uses the predicate device as a basis for demonstrating substantial equivalence, meaning that the new device operates similarly and has similar technological characteristics, and therefore, does not raise new questions of safety or effectiveness. The non-clinical tests listed are typically used to show that the device performs as intended in a controlled environment and meets relevant safety standards, but they are not presented as a "study that proves the device meets acceptance criteria" in terms of clinical performance metrics like sensitivity, specificity, accuracy, or human reader improvement with AI assistance.

Therefore, I cannot populate the requested table or answer most of the specific questions about acceptance criteria, study design (sample size, data provenance, expert ground truth, MRMC study, standalone performance), or training set information, as this information is not present in the provided 510(k) summary.

The only information that can be extracted is:

• Type of Ground Truth Used (for non-clinical testing): Standards-based testing (e.g., ISO, IEC, USP, ASTM) and design verification. This is not clinical ground truth.
• Study Design (implicitly, non-clinical): Design verification and various safety and performance tests. This is not a clinical study to assess performance against a specific clinical acceptance criterion.

To directly answer your request based on the provided text, many fields would be "Not Applicable" or "Information Not Provided."

Here's a table based on the information provided (or the lack thereof):

• Biocompatibility per ISO 10993-1
• Electrical Safety & Enclosure Protection per IEC 60601-1 & IEC 60529-1
• Emissions & Immunity per IEC 60601-1-2
• Particulate Testing per USP
• Sterilization per ISO 11135-1 (SAL of 10-6)
• Packaging & Shelf-life per ISTA 2A & ASTM F1980
• Design Verification testing
• Software and System Verification and Validation |
  | 2. Sample Size (Test Set) & Data Provenance | Not Applicable / Information Not Provided. This document describes non-clinical testing for substantial equivalence, not a clinical trial with a "test set" of patient data for performance evaluation in the context of diagnostic accuracy. |
  | 3. Number of Experts & Qualifications (Ground Truth for Test Set) | Not Applicable / Information Not Provided. No clinical ground truth establishment described. |
  | 4. Adjudication Method (Test Set) | Not Applicable / Information Not Provided. No clinical test set described. |
  | 5. MRMC Comparative Effectiveness Study & Effect Size (Human Readers w/wo AI) | Not Applicable / No AI component or MRMC study described. The device is a physical endoscope and control system, not an AI/software. |
  | 6. Standalone Performance Study (Algorithm only without Human-in-the-loop) | Not Applicable / No AI algorithm described. The "Image acquisition" and "Image processing" refer to the camera and control unit’s standard functions, not a diagnostic algorithm. |
  | 7. Type of Ground Truth Used | Primarily Engineering Standards and Design Specifications. For instance, a sterile SAL of 10-6 is a defined standard to meet. The ground truth for biocompatibility is whether the device materials meet the specified ISO standards for various toxicities. |
  | 8. Sample Size for Training Set | Not Applicable / No training set for an AI/algorithm described. Testing refers to device verification and validation against specified requirements. |
  | 9. How Ground Truth for Training Set was Established | Not Applicable / No training set for an AI/algorithm described. |

In summary, the provided document is a 510(k) summary demonstrating substantial equivalence for a medical device (an endoscope system) based on non-clinical testing and comparison to a predicate, not a clinical study report proving performance against specific clinical acceptance criteria for diagnostic or therapeutic accuracy in the way an AI/software device might be evaluated.

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The Aurora Surgiscope System is intended for use in 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: A sterile, single use, neurological endoscope called the Aurora Surgiscope and a non-sterile, reusable control unit called the Image Control Box (ICB).

The Aurora Surgiscope includes the following parts:

• Sheath
• Camera
• LED (Light Emitting Diodes)
• Sheath Cable
• Obturator

The Sheath is fabricated from plastic and shaped like a hollow cylinder. It acts as both the insertion portion and instrument channel of the endoscope. LEDs are embedded into the Sheath's distal end for illumination. The Sheath's proximal end incorporates a larger diameter plastic ring with a fixation tab. The Camera is rigidly attached to the plastic ring and positioned to produce a forward view of the surgical site. The Sheath's electronics are connected to the ICB by a flexible shielded cable. The cable exits from the rear of the Camera housing and connects to the ICB during system set-up. The Obturator is pre-loaded into the Sheath. Its distal tip is fabricated from clear plastic and is conical shaped. It has a plastic handle at the proximal end to facilitate removal. A cannulated steel post connects the Obturator tip and handle.

The Image Control Box is supplied with two cables; one for power and the other for connection to a 3rd party external HD Monitor. The ICB delivers power to the LEDs and Camera, transfers the video image to the HD Monitor, and allows a user to turn knobs that digitally adjust image quality and orientation.

I am sorry, but the provided text focuses on the FDA clearance document (K182211) for the Aurora Surgiscope System. This document details the device description, indications for use, comparison to predicate devices, and a summary of non-clinical testing conducted to establish substantial equivalence.

However, the document does not contain the specific information required to answer your questions regarding acceptance criteria, the detailed study design (sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance), or training set information.

The document states that "The following testing was conducted to demonstrate the safe and effective use of the Aurora Surgiscope System and its' substantial equivalence to the primary predicate," and then lists several types of non-clinical testing such as:

• Biocompatibility Testing
• Electrical Safety and Enclosure Protection
• Emissions and Immunity
• Particulate testing
• Sterilization
• Packaging and Shelf-life
• Simulated use testing
• Design verification testing
• Software and System Verification and Validation

While these tests demonstrate performance against certain standards, the document does not specify acceptance criteria in a quantifiable manner (e.g., specific metrics and thresholds for accuracy, sensitivity, specificity, resolution) that would typically be found in a clinical study report for an AI/CADe device. It also does not describe a "study that proves the device meets the acceptance criteria" in the context of an algorithm's diagnostic performance for the criteria you've outlined.

Therefore, I cannot populate the table or answer the specific questions about the study design with the information provided.

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