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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 Thompson Brain Retractor Table Mounted and Skull Clamp Mounted Systems are indicated for self-retaining retraction of soft tissue during neurological procedures to provide surgical access and exposure. The Thompson Brain Retractor Systems also allow attachment for applicable accessories and function as a hand-rest for the surgeon.

Thompson Surgical Instruments Brain Retractor is a reusable manual instrument made from stainless steel and aluminum, as indicated. It is composed of materials that can be reused with steam sterilization methods. It is provided to the customer non-sterile. The Thompson Brain Retractor is a retractor system used to create adequate exposure of the cranial region to assist surgeons in accessing areas for surgery. The system is comprised of a stainless-steel frame with 1/2-inch diameter frame components, which create a plane over the access point in the skull of the patient. The system uses stainless steel flexible arms that are attached to the frame to hold blades (stainless steel), which ultimately retract the tissue for the needed exposure. The frame also acts as a rest for the surgeons' wrists/hands during the procedure, as well as an attachment point for various accessories to aid the surgeon (ex: pattie tray).

The system uses clamps, cam actuation, and screws to construct and support the frame. The flexible arms are attached to the frame via screw down mechanism and the flexible arms are tightened into a semi-rigid state also using a screw mechanism, very similar to the function of all the predicate devices.

N/A

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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 <788>), 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 Expandable Port is intended to provide access, allow visualization of the surgical field, and retraction of soft tissue during neurological cranial surgery.

The device is indicated for use in surgery during which subcortical access is required.

The MindsEye Expandable Port is a single use, minimally invasive intracranial medical device designed to provide access and allow visualization to the surgical field while retracting subcortical soft tissues during neurological cranial surgery. Its design allows the user to place the port while collapsed in its minimal form for atraumatic access to the subcortical space. After placement, the port can be expanded radially to create a working channel to the target surgical location. The user is able to expand the port to the desired working channel diameter appropriate for the surgical plan then collapse the port upon surgical completion for safe removal. The working channel diameter may be adjusted as needed by the user throughout surgery.

The MindsEye device is expected to be used in conjunction with other standard, commercially available intracranial medical devices, such as an aspirator, micro/endo/exoscope, irrigation, electrosurgical systems/tools and/or hemostatic agents. In addition, MindsEye is compatible with existing optical navigation systems for accurate target acquisition and may be attached to other commercial retraction systems according to user preference.

The MindsEye device is made of biocompatible, medical grade materials (metals and polymers) with no software or electrical components. The MindsEye device and its components are provided sterile and not reusable.

MindsEye is comprised of the following components and is available in three lengths (Table 1).

• Port with attached Sheath
• Obturator and Guide
• Optional Support System consisting of support clips, post, and legs

The provided text is a 510(k) summary for the MindsEye™ Expandable Port, a medical device. It does not include information about acceptance criteria or a study proving the device meets those criteria, as one would typically see for performance claims related to diagnostic accuracy or clinical effectiveness.

Instead, this document focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing, biocompatibility, sterility, and shelf-life performance. The device is a physical tool used by surgeons, not an AI/ML-driven diagnostic or prognostic device that would typically have performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested points are not applicable to the information contained in this 510(k) summary. I can, however, extract the information that is present regarding testing and validation.

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

The document provides a "Summary of Testing" rather than a formal table of acceptance criteria with numerical performance targets. The acceptance criterion for each test is simply "Pass," indicating that the device met the required standards for that specific test.

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 provided in the document. The tests described are non-clinical (e.g., in-vitro, material durability, packaging), not clinical studies involving human patients or complex data sets. Therefore, typical "sample sizes" for test sets of clinical images or patient data, or data provenance (country, retrospective/prospective) are not applicable or detailed here.

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 information is not applicable/provided. The ground truth for these non-clinical tests would be established by standardized testing protocols and laboratory measurements, not by expert consensus from medical professionals.

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

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are used for clinical studies involving multiple expert readers to resolve disagreements in interpretations (e.g., of medical images). The tests described are non-clinical, laboratory, and engineering tests.

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 information is not applicable/provided. An MRMC study is relevant for evaluating the impact of AI on human diagnostic performance. The MindsEye™ Expandable Port is a physical surgical retractor, not an AI/ML diagnostic or assistive tool.

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

This information is not applicable/provided. Standalone performance studies are for AI algorithms. The MindsEye™ Expandable Port is a physical surgical device.

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

For the non-clinical tests, the "ground truth" implicitly refers to established scientific and engineering standards and validated test methodologies. For example, for biocompatibility, the ground truth for "non-cytotoxic" is determined by the results of standardized cytotoxicity assays within acceptable limits. For physical properties, it would be the pre-defined engineering specifications and ASTM/ISO standards.

8. The sample size for the training set

This information is not applicable/provided. This device is a physical product, not an AI/ML model that requires a training set.

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

This information is not applicable/provided. (See response to #8).

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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):

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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The device intended for use as a specialized manual surgical instrument. It is reusable and intended to provide access to the thoracic and lumbar spinal column during minimally invasive and endoscopic surgical provides a selflocking type surgical retraction system with inflatable tissue protectors.

GEISTER Medizintechnik GmbH Self-retaining Retractors are reusable manual instruments made from stainless steel, PEEK or titanium. They are sold unsterile and can be re-processed according the instructions for use.

The provided document is a 510(k) premarket notification letter and summary for a medical device: "Geister® retractor for neuro - and spine surgery." This document is not about an AI/ML-based device, but rather a traditional surgical instrument.

Therefore, the requested information regarding acceptance criteria and studies that prove an AI/ML device meets them (including aspects like sample size for training/test sets, expert adjudication, MRMC studies, standalone performance, ground truth establishment for AI/ML, etc.) is not applicable to this document.

The document discusses the device's substantial equivalence to predicate devices based on:

• Indications for Use: The device is a specialized manual surgical instrument intended for use in thoracic and lumbar spinal column access during minimally invasive and endoscopic surgical procedures.
• Material: Titanium, Stainless Steel, PEEK.
• Technology: Self-locking type surgical retraction system.
• Design: Various dimensions for retractors and blades, different systems (Microdiscectomy, SpineControl Cervical, Self-Retaining Retractors).
• Performance Specifications: Bench testing was performed.

The testing mentioned for this device consists of:

• Biocompatibility
• Re-processing and sterilization
• Performance testing (bench)

No information related to AI/ML acceptance criteria or studies can be extracted from this document.

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To provide for access and allow for visualization of the surgical field during brain and spinal surgery. Indications may include subcortical access to diseases such as the following:

• Primary/Secondary Brain Tumors
• · Vascular Abnormalities/Malformations
  · Intraventricular Tumors/Cysts

The NICO BrainPath and accessories are designed to provide minimally invasive access to neurological tissues. The design specifically supports the creation of an atraumatic surgical corridor to access the brain. These BrainPath devices are part of what is being called the BrainPath Approach™, which integrates the expanding neurosurgical armamentarium of trajectory planning and navigation, optics, corridor resection and biopsy, and tissue preservation. To date, the BrainPath technology has been used to successfully access primary and secondary brain tumors, vascular abnormalities or malformations, and intraventricular tumors and cysts.

The BrainPath consists of multiple-sized reusable and re-sterilizable obturators with coordinating single patient use disposable sheaths. The obturator and sheath are assembled in the operating room immediately prior to use. After placement, the obturator is removed leaving behind the sheath which provides a 13.5 mm or 11 mm surgical corridor.

The provided text focuses on the 510(k) premarket notification for the NICO BrainPath device, specifically for an updated version (K172433) compared to a predicate device (K150378). This is a submission for device substantial equivalence, not a study proving the device meets acceptance criteria in terms of diagnostic performance or clinical outcomes for an AI/algorithm-based medical device.

Therefore, many of the requested criteria regarding AI/ML device performance evaluation (e.g., sample sizes for training/test sets, expert adjudication methods, MRMC studies, standalone performance, ground truth types) are not applicable to this document.

However, I can extract the acceptance criteria and "performance" findings relevant to a medical device's physical and functional properties, as presented in this 510(k) submission.

Here's a breakdown of the relevant information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical/Engineering):

The document describes non-clinical testing performed to demonstrate that modifications to the NICO BrainPath still meet applicable design and performance requirements and support substantial equivalence to the predicate device. The "acceptance criteria" can be inferred as the expected "Pass" or "Non-cytotoxic," "Non-sensitizer," "Non-irritant" results for the respective tests.

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

• Sample Size: The document does not specify exact numerical sample sizes for each non-clinical test (e.g., number of devices tested for biocompatibility, number of packaging units, etc.). It generally states "All" devices/components were subjected to relevant tests.
• Data Provenance: The data provenance is internal to NICO Corporation's testing and validation processes. The document does not mention the country of origin of "data" in a patient/clinical sense, as this is laboratory/engineering testing. It is retrospective in the sense that the testing was conducted prior to the 510(k) submission to demonstrate compliance.

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

• This question is not applicable to the data presented. The document describes laboratory and engineering tests (e.g., biocompatibility, sterilization, simulated use, packaging). "Ground truth" in the context of expert consensus (like for image interpretation in AI) is not relevant here. Compliance with established standards (e.g., ASTM, ISO standards for biocompatibility) would be the "ground truth."

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

• This question is not applicable to the data presented. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies where human interpretative variability exists. For engineering tests, results are typically objective Pass/Fail or numerical measurements against defined specifications.

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 question is not applicable. This device is a physical surgical tool (self-retaining retractor), not an AI/ML-based diagnostic or assistive software that interacts with human "readers" or interpreters.

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

• This question is not applicable. This device is a physical surgical tool, not an algorithm or software.

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

• The "ground truth" for the non-clinical tests is adherence to established engineering specifications, validated test methodologies, and recognized industry standards (e.g., for biocompatibility, sterility, packaging integrity). For example, a "Pass" for sterility validation means the device met the acceptance criteria for a Sterility Assurance Level (SAL) of 10-6.

8. The sample size for the training set:

• This question is not applicable. There is no "training set" in the context of an AI/ML device. The device is a physical product, and its design is based on engineering principles and previous versions (predicate device).

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

• This question is not applicable. As there is no training set for an AI/ML algorithm, this concept does not apply. The "ground truth" for the device's design and manufacturing is established through defined product specifications, design control processes, and compliance with quality system regulations (e.g., 21 CFR Part 820).

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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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