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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 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 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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The Phantom™ Fukushima and Mastability Neurological Holding Systems are intended to provide access and allow visualization of the surgical field, and to retract soft tissue during neurological cranial procedures.

Not Found

This is a 510(k) clearance letter for the Phantom Fukushima Neurological Holding Systems and Phantom Mastability Neurological Holding Systems. The document states that the devices are substantially equivalent to legally marketed predicate devices and outlines the general controls provisions of the Act that apply.

However, the provided text does not contain any information regarding acceptance criteria or a study proving the device meets acceptance criteria in the context of device performance metrics like sensitivity, specificity, or accuracy. It is a regulatory clearance document, not a performance study report.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This information is not present.
2. Sample size used for the test set and the data provenance: Not present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not present.
4. Adjudication method for the test set: Not present.
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: Not relevant, as this is a surgical holding system, not an AI diagnostic device, and no such study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
7. The type of ground truth used: Not present.
8. The sample size for the training set: Not relevant, as this is a surgical holding system, not an AI diagnostic device.
9. How the ground truth for the training set was established: Not relevant, as this is a surgical holding system, not an AI diagnostic device.

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Fetzer Medical Self-Retaining Retractors are intended to hold the edges of a wound open during spinal surgery.

Fetzer Medical Self-retaining Retractors are reusable manual instruments made from stainless steel, aluminum or titanium. They are sold unsterile and can be reprocessed (cleaned and sterilized) according the instructions for use. Devices are available with the following features: frame type retractors, Ring handle retractors, MIS Port retractor.

The document describes the submission for a medical device called "Fetzer Medical Self-Retaining Retractors" for 510(k) clearance. The device is a self-retaining retractor for neurosurgery.

Here's an analysis of the acceptance criteria and the study used to prove the device meets these criteria:

1. Table of Acceptance Criteria and Reported Device Performance

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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 most areas of the brain. The BrainPath also facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy. 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 surgical corridor to the lesion or abnormality.

The BrainPath Accessories include a "manipulation tool," which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. The accessories also include "shepherd's hooks" for attaching to various commercially available retractors, and a sterilization tray for the reusable components (i.e., obturators and manipulation tools).

This document is a 510(k) premarket notification for the NICO® BrainPath® and Accessories, a medical device for neurosurgery. It does not describe a study that proves the device meets specific acceptance criteria related to its clinical efficacy in the context of an AI/ML powered device. Instead, it focuses on demonstrating substantial equivalence to a predicate device (NICO Brain Port, K120691) through non-clinical testing.

Therefore, many of the requested elements for an AI/ML powered medical device study are not applicable or cannot be extracted from this document, as this is a traditional medical device submission.

Here's a breakdown of the available information based on your request, with an emphasis on what is present in the document and what is not:

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

The document provides a table of "Non-Clinical Testing" with "Result/Conclusion". These are the acceptance criteria and performance for a traditional medical device, not an AI/ML powered one.

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

• Not Applicable. This document describes non-clinical engineering and biocompatibility testing for a surgical device, not a study involving patient data or test sets in the context of AI/ML.

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)

• Not Applicable. Ground truth, in the context of diagnostic accuracy, is not established in this type of submission. The "ground truth" for the non-clinical tests is based on established engineering standards and validated methods (e.g., ISO standards for biocompatibility, cleaning validation protocols).

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

• Not Applicable. No adjudication method is described as this is not a study assessing diagnostic performance.

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 not done. This device is a surgical instrument, not an AI-powered diagnostic tool. The document states that the BrainPath "facilitates the expanding neurosurgical armamentarium of trajectory planning software (e.g., Synaptive® Medical Inc. BrightMatter® Planning Software, K140337), navigation (e.g., Synaptive BrightMatter Navigation System, K142024), optics, corridor resection (e.g., NICO Myriad), and biopsy." This indicates it can be used with other technologies, some of which may be software-based, but BrainPath itself is not an AI/ML device, and no MRMC study on its comparative effectiveness with AI assistance is mentioned.

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

• No. A standalone algorithm performance study was not done. The device is a physical surgical tool and does not operate as an algorithm.

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

• The "ground truth" for the non-clinical tests is based on established scientific and engineering principles, such as:
  • Biocompatibility standards: (e.g., ISO 10993 for Cytotoxicity, Sensitization, Irritation).
  • Sterilization validation methods: (e.g., for steam autoclaving, gas plasma, gamma irradiation).
  • Mechanical and functional specifications: (e.g., ability to interface with other instruments, packaging integrity).
  • These are not "expert consensus" or "pathology" in the clinical sense, but rather adherence to predefined and validated test methodologies and acceptance limits.

8. The sample size for the training set

• Not Applicable. There is no training set mentioned as this is not an AI/ML device.

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

• Not Applicable. As there is no training set, there is no ground truth establishment for it.

In summary: This document is a 510(k) submission for a physical surgical device, the NICO® BrainPath®, demonstrating substantial equivalence to a predicate device through non-clinical testing. It does not pertain to the development or validation of an AI/ML powered medical device, and thus, most of the requested information regarding AI/ML study design and criteria is not present.

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To provide for access and allow for visualization of the surgical field during brain and spinal surgery.

The NICO Brain Port is a family of products that consists of multiple sized reusable and re-sterilizable obturators with coordinating single patient use, disposable sheaths. The obturator and sheath are assembled in the OR immediately prior to use. These two components are held together by an interference fit. The device when used as intended is designed to provide access to neurological tissues. The Brain Port system also includes a "manipulation tool", which is similar to a dental probe and is used for manipulating the position of the sheath after it has been placed. Finally, the Brain Port includes a custom sterilization tray which houses all reusable components (obturators and manipulation tools).

The provided document is a 510(k) Summary for the NICO Brain Port device, which is a medical device for neurosurgery. It describes the device, its intended use, comparison to a predicate device, and a summary of non-clinical testing.

However, this document does not contain information about a study that establishes acceptance criteria for device performance or proves the device meets those criteria in a clinical setting. Instead, it focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Therefore, I cannot provide the detailed information requested in the prompt (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, training set details) because such clinical study information is not present in the provided text.

The closest information related to testing and validation is found under the "Summary of Non-Clinical Testing/Statement of Equivalence" section:

Summary of Non-Clinical Testing (as described in the document):

The document states that "Multiple tests concerning product functionality, biocompatibility, packaging and sterilization have been performed to ensure that the Brain Port device is as safe and as effective as the predicate device."

Specific tests included:

• Radiation sterilization validation on sterile components.
• Cleaning method and sterilization validation of reusable components.
• Packaging drop testing.
• Simulated shipping, aging, and environmental stress testing.
• In Vitro Cytotoxicity testing.
• Irritation and Delayed-Type Hypersensitivity biocompatibility testing.
• General functional, mechanical, dimensional, and performance testing against pre-determined specifications.
• Simulated use testing consisting of inserting the Brain Port into a medium representative of brain tissue.

Ground Truth Used: The ground truth for this non-clinical testing would be the pre-determined specifications for the device's functionality, mechanical properties, dimensions, and performance, as well as established standards for biocompatibility, sterility, and packaging integrity. For simulated use, the "medium representative of brain tissue" served as the test environment.

Sample Sizes: The document does not specify sample sizes for any of these non-clinical tests.

Data Provenance: This is non-clinical, in-vitro, and simulated data, not human patient data. Therefore, country of origin or retrospective/prospective distinctions are not applicable in the typical sense for clinical studies.

Expert Involvement: The document does not mention the number or qualifications of experts used to establish ground truth or conduct these non-clinical tests, beyond the general statement of "pre-determined specifications."

Adjudication Method: Not applicable to the described non-clinical testing.

MRMC Comparative Effectiveness Study: Not performed or mentioned in the document.

Standalone Performance (algorithm only without human-in-the-loop performance): Not applicable, as this is a physical medical device, not an AI algorithm. Its performance is inherent to its design and how it is used by a human surgeon.

Training Set: Not applicable to a physical medical device. The "training" for such a device comes from engineering design, material science, and prior knowledge of similar predicate devices.

In summary, the provided text details a 510(k) submission focused on demonstrating substantial equivalence through non-clinical testing, rather than a clinical study with acceptance criteria for device performance in human subjects.

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