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The slim clip applier is used to open, close and apply permanent/temporary Aesculap YASARGIL titanium aneurysm clips.

The Aesculap Slim Clip Appliers are manufactured from stainless steel and are available in various lengths, jaw angulations, with or without latches. This submission intends to add a coating to the previously cleared clip appliers. Each clip applier is individually laser marked with the type of clip designated for use. In addition, at least one identification plug is located within one of the handles to aid in identifying the aneurysm clip designation.

Here's an analysis of the provided text regarding the acceptance criteria and study for the Aesculap Slim Clip Applier, formatted as requested:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the mechanical "Verification test for clip opening." It merely states "Pass" for the test.

For biocompatibility testing, the sample sizes are implied by the test descriptions:

• Cytotoxicity: "Test articles were extracted for 24 hours per ISO 10993-5." (Specific number of test articles not given).
• Sensitization: "in the guinea pig." (Specific number of guinea pigs not given).
• Pyrogenicity: "following intravenous injection in rabbits." (Specific number of rabbits not given).
• Irritation: "All animals appeared normal throughout the study." (Specific number of animals not given).
• Systemic Toxicity: "extracts injected into mice." (Specific number of mice not given).
• Hemolysis: "The test article extract was tested in vitro." (Specific number of test articles or replicates not given).

The data provenance is not explicitly stated regarding country of origin or whether it's retrospective/prospective. However, given that these are bench and biocompatibility tests conducted for a 510(k) submission, they are typically conducted prospectively in a controlled laboratory setting by the manufacturer or a contract research organization.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable for this type of device and testing. The ground truth for mechanical performance is based on engineering specifications and physical measurements. The ground truth for biocompatibility is based on established ISO standards and observed biological reactions in animal models or in vitro tests, rather than expert consensus on medical images or clinical outcomes.

4. Adjudication Method for the Test Set

Not applicable. This document describes bench testing and biocompatibility testing against defined physical and biological parameters, not subjective assessments requiring adjudication by multiple experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is evaluated. The Aesculap Slim Clip Applier is a surgical instrument, and its evaluation focuses on mechanical performance and biocompatibility.

6. Standalone Performance (i.e., algorithm only without human-in-the-loop performance)

Yes, the studies described are essentially "standalone" in the sense that they evaluate the device's intrinsic mechanical properties and biocompatibility without a human operator's performance being the primary subject of the test (beyond the execution of the test itself). The "Verification test for clip opening" directly assesses the applier's mechanical function, and the biocompatibility tests evaluate the material's interaction with biological systems. There isn't an "algorithm" per se, but the device's performance is tested independently.

7. Type of Ground Truth Used

• For Clip Opening Verification: Engineering specifications and physical measurements of the clip's opening width.
• For Biocompatibility Tests: Established biological endpoints and standards (e.g., ISO 10993 series) for cytotoxicity, sensitization, pyrogenicity, irritation, systemic toxicity, and hemolysis.

8. Sample Size for the Training Set

Not applicable. The Aesculap Slim Clip Applier is a mechanical surgical instrument, not an AI/machine learning device that requires a training set of data. The "training" in manufacturing would relate to process validation and quality control, not a data-driven model.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this device.

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The DIR 800 is an accessory for the Aesculap Aeos and is used in viewing intra-operative blood flow in the cerebral vascular area including, but not limited to, assessing cerebral aneurysm and vessel branch occlusion, as well as patency in neurosurgery. It also aids in the visual assessment of intraoperative blood flow and vessel patency in bypass surgical procedures in neurosurgery.

The DIR 800 is an accessory to the Aeos Digital Surgical Microscope Class I 510(k) exempt surgical operating microscope. The DIR 800 allows the Aeos to produce excitation light to illuminate the fluorescence properties of the Indocyanine Green (ICG). The generated fluorescence signal depicts the distribution of the infrared dye in the patient's blood vessels during surgery.

The provided text describes a 510(k) premarket notification for the DIR 800 device. This type of FDA submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving direct safety and effectiveness through extensive clinical trials with strict acceptance criteria often seen for novel devices.

Therefore, the information available in this document is primarily related to proving substantial equivalence, not a standalone "performance study" in the sense of a clinical trial with specific diagnostic accuracy metrics. The "performance data" section largely covers verification and validation (V&V) testing to ensure the device performs as intended and is comparable to the predicate.

Here's an attempt to extract the requested information based on the provided text, while acknowledging the limitations of a 510(k) submission in terms of detailed performance criteria and study design:

Device Name: DIR 800
Predicate Device: Carl Zeiss Surgical GmbH, INFRARED 800 with FLOW Option (K100468)
Intended Use: Accessory for viewing intra-operative blood flow in the cerebral vascular area (e.g., assessing cerebral aneurysm, vessel branch occlusion, patency in neurosurgery, bypass procedures).

1. Table of Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence and the device performing as intended through verification and validation. There are no explicit quantitative performance metrics like sensitivity/specificity thresholds mentioned for clinical utility in this document.

2. Sample Sizes Used for the Test Set and Data Provenance

• Test Set (Animal Study):

  • Sample Size: A porcine model and a rabbit elastase model. The exact number of animals is not specified beyond "a" model for each.
  • Data Provenance: The study was conducted specifically to support this submission. The text doesn't specify country of origin for the animals, but the submission is to the US FDA. It was a prospective animal study.

• Test Set (Bench Testing): Not applicable for "sample size" in the traditional sense of patient data. Bench tests would involve specific units of the device or test setups according to a protocol.

3. Number of Experts Used to Establish Ground Truth and Qualifications

• Animal Study Experts: "Neurosurgeons" were used for independent scoring assessments.
  • Number of Experts: Not specified.
  • Qualifications: "Neurosurgeons." No further details on years of experience or board certification are provided in this document.

4. Adjudication Method for the Test Set

The text states that in the animal study, "independent scoring assessments which were predefined in the protocol" were performed. It does not specify a formal adjudication method like 2+1 or 3+1. It implies individual assessments were carried out and then likely compared against pre-established criteria or against the DSA gold standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No.

• The study described is an animal study comparing the DIR 800 visualization to Digital Subtraction Angiography (DSA), not a human MRMC study to compare human reader performance with and without AI assistance.
• The DIR 800 is an imaging accessory that allows visualization, not an AI algorithm that assists in interpretation or diagnosis. Therefore, an MRMC study related to AI assistance for human readers is not relevant to this device's function as described.

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

Yes, in essence, as much as applicable for an imaging accessory.

• The "performance data" largely describes the standalone technical performance of the imaging system (DIR 800) in visualizing blood flow when ICG is introduced.
• The animal study assessed the device's capability to visualize structures and blood flow independently (compared to DSA) and confirmed it met its pre-established acceptance criteria for visualization, image quality, etc. This is inherently a standalone performance assessment of the device's imaging capabilities.

7. The Type of Ground Truth Used

• Animal Study: Digital Subtraction Angiography (DSA) data was collected and used as a comparative "ground truth" to evaluate the DIR 800's visualization of blood flow, vascular structures, and aneurysms in the animal models. DSA is a widely accepted method for visualizing vasculature.

8. The Sample Size for the Training Set

Not applicable.

• The DIR 800 is described as an optical imaging accessory that enables visualization of fluorescence. There is no indication in the document that it incorporates a machine learning/AI algorithm that would require a separate "training set" of data in the typical sense for an AI-powered diagnostic device.
• The "software" mentioned underwent standard software verification and validation, but not training on a dataset.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a training set or AI model in the provided description of the DIR 800 device.

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The catheter is used for cerebrospinal fluid (CSF) shunting.

The ventricular catheter is part of the Miethke Shunt System. It is used to gain access to the cavities of the brain for shunting of excessive CSF.

The ventricular catheter will be offered in lengths of 18 cm or 25 cm with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. The ventricular catheter contains five stripe depth markers at 3, 5, 7, 10 and 13 cm from the catheter tip. The ventricular catheter is manufactured using barium sulfate filled silicone elastomer.

The purpose of this submission is to seek clearance for modifications to the ventricular catheter which is part of the Miethke Shunt System (K020728). This submission proposes the following modification:

• adding stripe depth markers at 4, 6, 8, 9, 11 and 12 cm and point markers at 1 cm intervals on both sides of the tubing starting at 3.5 cm to 12.5 cm from the catheter tip.

The ventricular catheter is designed to articulate with existing Miethke Shunt Systems, such as the M.blue Adjustable Shunt System, Miethke Shunt System GAV 2.0 and SA 2.0 Valves, proGAV 2.0 Adjustable Shunt System, proSA Progammable Shunt System, Miethke Shunt System miniNAV valve, Miethke Shunt System Gravity Assisted Valve (GAV), and the Miethke Shunt System (DSV, ShuntAssistant, paedi-GAV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K120559/K110206/K103003/K062009/K031303/ K030698/K011030).

The provided text is a 510(k) summary for the Miethke Ventricular Catheter, which addresses a modification to an existing device rather than a new AI-powered diagnostic tool. Therefore, much of the requested information regarding AI study design, such as MRMC comparative effectiveness, standalone performance, training set details, and expert ground truth establishment, is not applicable to this document.

However, I can extract information related to the acceptance criteria and the study performed for this specific device, as it pertains to the physical catheter modification.

Here's the relevant information:

1. Table of acceptance criteria and the reported device performance:

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

• Sample Size: Not explicitly stated. The document mentions "All samples" in relation to meeting acceptance criteria, implying a test set was used, but the exact number is not provided.
• Data Provenance: Not explicitly stated, but it is implied to be from non-clinical laboratory performance testing.

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

• Not Applicable. This device is a physical medical device (catheter) and the testing performed relates to its physical properties (radiopacity) rather than diagnostic accuracy requiring expert interpretation for ground truth.

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

• Not Applicable. As mentioned above, this testing does not involve human interpretation or adjudication in the context of diagnostic accuracy.

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 Applicable. This is a physical medical device, not an AI-powered diagnostic tool.

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

• Not Applicable. This is a physical medical device, not an AI-powered diagnostic tool.

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

• For the radiopacity testing, the "ground truth" would be established by the physical measurements and standards defined in the ASTM F 640-12 standard test methods. This is an objective measurement rather than a subjective interpretation requiring expert consensus or pathology.

8. The sample size for the training set:

• Not Applicable. This is a physical medical device; there is no "training set" in the context of an AI algorithm.

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

• Not Applicable. There is no training set for this type of device.

Study Details:

• Study performed: Non-clinical laboratory performance testing.
• Standard used: ASTM F 640-12 standard test methods for determining radiopacity for Medical Use.
• Purpose: To demonstrate that the modification (additional depth markers) to the ventricular catheter maintains its intended performance, particularly regarding radiopacity, and is substantially equivalent to the predicate device.

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The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device during transport and until used. This container system is compatible for use in steam sterilization according to the configurations listed in the tables below.

The JJ Series Container System container styles: a solid bottom container and enhanced drying system (EDS) container.

The Aesculap JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.

The attached tables identifies the load configurations.

The Aesculap JJ Series Container System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in Prevac steam with and without dry time.

The JJ Series Container System consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

The containers are made from anodized aluminum and utilize a single-use filter. The JJ Series Container System includes accessories such as baskets, trays, silicone mats, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags.

The provided text is a 510(k) Summary for the Aesculap JJ Series Container System. This document focuses on demonstrating substantial equivalence to a predicate device based on nonclinical performance data, rather than on a comparative effectiveness study with human readers (MRMC) or a standalone AI algorithm. Therefore, many of the requested categories (2, 3, 4, 5, 6, 7, 8, 9) are not applicable or cannot be extracted from this document as they are specific to studies involving AI or human interpretation of data, which is not the nature of this device (a sterilization container system).

However, I can provide the acceptance criteria and reported device performance from the nonclinical testing, as well as general information about the device and its testing.

Here's the information that can be extracted:

1. 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 provided in the document. The document describes the acceptance criteria for various performance tests, but does not specify the sample sizes used for these tests or the data provenance. It states "Testing was conducted in accordance with applicable FDA guidance and standards," which implies a prospective testing approach conducted by the manufacturer to meet regulatory requirements.

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 device is a sterilization container. The "ground truth" for the performance tests listed (e.g., sterility, dry time, material compatibility) is established through standardized laboratory testing protocols and objective measurements, not by expert consensus or interpretation of medical images.

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 typically used in studies where human judgment is involved in establishing ground truth (e.g., reading medical images) and disagreements need to be resolved. This is not relevant for the type of objective performance testing described for a sterilization container.

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. An MRMC study is relevant for evaluating the performance of AI-assisted diagnostic tools with human readers. The Aesculap JJ Series Container System is a physical medical device (sterilization container), not an AI diagnostic tool, so such a study was not conducted.

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

This information is not applicable. This question pertains to the performance of an AI algorithm in isolation. The Aesculap JJ Series Container System is a physical product and does not involve an AI algorithm.

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

The "ground truth" for the tests performed on the Aesculap JJ Series Container System is established through objective, standardized laboratory measurements and scientific principles as defined by recognized standards (e.g., AAMI ST-77, EN868-8, EN 285, ISO 11167-1, TIR17, ISO 10993-5:2009, TIR30). For example:

• Sterilization Efficacy: Achieved Sterility Assurance Level (SAL) of 10-6, confirmed by negative biological indicators.
• Dry Time: Measured weight difference and absence of visible moisture.
• Microbial Aerosol Challenge: Absence of microbial growth after exposure.
• Sterility Maintenance: Absence of microbial growth in stored test articles.
• Material Compatibility: Absence of degradation or impact on functionality.
• Cytotoxicity: Response to article not greater than 2 (mild reactivity) via ISO Elution Method.
• Cleaning Validation: Absence of visible soil and protein/hemoglobin levels below predetermined amounts.

8. The sample size for the training set

This information is not applicable/provided. A "training set" refers to data used to train machine learning models. This device is a physical product, not an AI algorithm, so there is no training set in this context.

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

This information is not applicable/provided for the same reason as point 8.

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The Aesculap SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities:

• Ethylene Oxide
• STERRAD 100NX DUO cycle
• . STERIZONE VP4

The Aesculap SterilContainer S2 System includes accessories such as silicone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

The Aesculap SterilContainer S2 System is a reusable rigid container system intended for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:

• Ethylene Oxide ●
• STERRAD 100NX DUO cycle
• STERIZONE VP4 ●

The containers are perforated and made from anodized aluminum and utilize a single-use filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.

The provided document is a 510(k) summary for a medical device (sterilization container system), not for an AI/ML powered device. As such, the concept of a "test set," "training set," "experts to establish ground truth," "adjudication method," or "MRMC comparative effectiveness study" does not apply to this type of device submission. The performance testing outlined is for sterilization efficacy, simulated use, material compatibility, and cytotoxicity, which are standard for sterilization container systems and do not involve AI/ML components.

Therefore, I cannot extract the information required by your prompt regarding AI/ML device acceptance criteria and study details from this document. The document describes the acceptance criteria and study that proves the device meets those criteria, but these are for a physical sterilization device, not an AI/ML algorithm.

If you are interested in the acceptance criteria and study for the sterilization container itself, I can provide that information based on the document.

However, assuming you are looking for the outlined AI/ML specific information, I must state that the document does not contain it.

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The M.blue Adjustable Shunt System is used for cerebrospinal fluid (CSF) shunting.

M.blue is an adjustable valve that combines an adjustable gravitational unit and a fixed differential pressure unit. The M.blue valve can be set for a range of pressures and is offered in four pressure level settings. The M.blue valve is comprised of a titanium housing enclosed by a thin titanium membrane with a curved wave profile design. The gravitational unit of the M.blue valve contains a tantalum weight, leaf spring and ball mechanically controlled by internal magnets. The differential pressure unit (ball-in-cone) of the M.blue valve contains a sapphire ball and titanium spring.

Manual devices are available to locate, verify the pressure setting and to set or change the pressure pre and postoperatively. These manual accessories are for external use by the Healthcare provider.

The M.blue valve will be distributed by itself or in combination with the proGAV 2.0 valve. The M.blue valve includes the same legally marketed accessories that are available with the Miethke Shunt Systems.

The provided document describes the K192266 submission for the M.blue Adjustable Shunt System. This document focuses on the device's performance criteria and its substantial equivalence to a predicate device, rather than the performance of an AI/ML device or a medical imaging device. Therefore, many of the requested categories for AI/ML study descriptions are not applicable.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the M.blue Adjustable Shunt System are based on various performance tests demonstrating its safety and efficacy, often by showing it performs substantially equivalent to the predicate device.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state numerical sample sizes for each test listed. It generally refers to "samples" passing the acceptance criteria. The data provenance (country of origin, retrospective/prospective) is not mentioned, but these are likely laboratory or bench tests conducted by the manufacturer.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. This is a device performance and biocompatibility study, not an AI/ML study requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is objective physical or chemical measurement against established standards.

4. Adjudication Method for the Test Set

Not applicable. There's no subjective assessment requiring adjudication in these device performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This device is a medical implant, not an AI-assisted diagnostic tool.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a physical medical device, not an algorithm. The performance tests are for the physical device itself.

7. The Type of Ground Truth Used

The ground truth used for these tests are:

• Established engineering standards and physical properties: e.g., pressure-flow characteristics, mechanical strength, resistance to leakage, bursting pressure, radiopacity.
• Biological and chemical standards: e.g., cytotoxicity assays against ISO standards (ISO-10993).
• MRI safety standards: as per ASTM guidelines.
• Manufacturer's declarations: for certain performance characteristics mentioned in the Instructions for Use.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML product.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no "training set."

Summary of Device and Study:

The K192266 submission describes the M.blue Adjustable Shunt System, a medical device for cerebrospinal fluid shunting. The core of the submission is to demonstrate its substantial equivalence to a legally marketed predicate device (Aesculap Miethke proSA Adjustable Shunt System K161853) and a reference device (Miethke Shunt System miniNAV Valve K110206).

The acceptance criteria are based on various physical and biological performance tests, as detailed in the table above. These tests cover aspects like radiopacity, resistance to leakage, pressure-flow performance, mechanical integrity (dynamic break strength, bursting pressure), long-term stability, and MRI compatibility. The device's components were also subjected to biocompatibility testing, specifically cytotoxicity, demonstrating the absence of cytotoxic potential.

The studies conducted are primarily bench testing (in vitro) and biocompatibility assessments. The document states that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities," concluding that the device "performs as intended and is substantially equivalent to the predicate device." The "performance data is provided in support of the substantial equivalence determination." This implies that the 'study' is a series of verification and validation tests aligned with relevant standards (e.g., EN ISO 7197:2009 for shunt safety and performance, and ISO-10993 for biocompatibility).

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Aesculap ELAN 4 Tools are intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery

The ELAN 4 Tools are cutting devices designed for use with the ELAN 4 Electro Motor System. The ELAN 4 Tools are designed for cutting, sawing and drilling of bone. The ELAN 4 Tools have an attachment mechanism designed specifically for the type of motors and attachments with which they will be used. The ELAN 4 Tools are manufactured from stainless steel with some tools containing a coated layer of diamond chips. The ELAN 4 Tools are components of the ELAN 4 Electro Motor System (K152960).

Based on the provided text, the device in question is Aesculap ELAN 4 Tools, which are instruments for high-speed cutting, sawing, and drilling of bone. This document is an FDA 510(k) summary, which focuses on demonstrating substantial equivalence to previously cleared predicate devices, rather than establishing de novo clinical efficacy or performance of a novel AI/software medical device.

Therefore, the information required for explaining acceptance criteria and a study proving device performance, particularly related to AI performance metrics, clinical studies, reader studies, and large datasets for training/testing, is not present in this document. The document details testing related to the physical device's characteristics and safety.

Here's what can be extracted and why other sections cannot be completed:

1. Table of Acceptance Criteria and Reported Device Performance & 2. Sample Size and Data Provenance (for test set):

Since this is a physical medical device (drills, burrs, trephines) and not an AI/software device, the "acceptance criteria" and "reported device performance" in an AI context (e.g., AUC, sensitivity, specificity, F1-score) are not applicable. The performance evaluated here relates to the mechanical function and biocompatibility of the tools.

Sample Size and Data Provenance:

• For Rotating performance test and Measurement of temperature: The document does not specify the sample size used for these bench tests (e.g., how many tools were tested). The data provenance is implied to be from the manufacturer's internal testing.
• For Biocompatibility, Sterilization, Packaging, and Shelf-life testing: These typically involve standardized protocols where the "sample size" refers to the number of units tested to achieve statistical confidence for validation. Specific numbers are not provided in this summary but are part of the underlying validation reports. The data provenance is internal lab testing by the manufacturer or their contractors.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is not applicable as the studies described are bench tests and biocompatibility tests for a physical device, not a diagnostic or AI-driven system requiring expert ground truth for interpretation (e.g., radiologist reads).

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable for the same reason as above.

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 applicable. This device is a surgical tool, not an AI diagnostic or assistance system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the physical device testing:

• Bench Testing (Rotating performance, Temperature Measurement): Ground truth is based on engineering specifications and physical measurements, demonstrating the device performs as designed under specified conditions.
• Biocompatibility, Sterilization, Packaging, Shelf-life: Ground truth is established by adherence to recognized international standards (ISO, ASTM) and achieving specified pass/fail criteria (e.g., no cytotoxicity, acceptable endotoxin levels, sterility assurance level).

8. The sample size for the training set & 9. How the ground truth for the training set was established:
Not applicable. This device does not involve a "training set" in the context of machine learning or AI. The development process would involve iterative design and testing, but not in the same sense as an AI model's training phase.

In summary: The provided document is a 510(k) clearance letter and summary for a conventional surgical instrument. The "acceptance criteria" and "study" described pertain to the manufacturing, material science, and mechanical performance of the physical tools, and their biological safety (biocompatibility and sterilization). It does not involve any AI, software, or diagnostic imaging components, thus many of the requested fields are not relevant to this specific submission.

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The Miethke Shunt System GAV 2.0 and SA 2.0 are used for cerebrospinal fluid (CSF) shunting.

The Aesculap Miethke Shunt System is used in the treatment of hydrocephalus. Components of the Miethke Shunt System can include the GAV (Gravity Assisted Valve) 2.0 valve and SA (SHUNTASSISTANT) 2.0 valve.

The GAV 2.0 is a posture dependent, fixed gravitational valve that combines a differential pressure unit and gravitational unit. This combination allows an automatic adjustment of the opening pressure according to the patient's different body position and is used to control overdrainage. The housing of the GAV 2.0 valve is manufactured from titanium. The GAV 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The GAV 2.0 valve is available as a single device as well as with various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

The SA 2.0 valve is a posture dependent gravitational valve and is used to control overdrainage. The SA 2.0 is designed for use in combination with an adjustable or non-adjustable differential pressure valve to add increased resistance to the shunt system as a patient changes position. housing of the SA 2.0 valve is manufactured from titanium. The SA 2.0 valve is available in three models, each model is offered in six pressure level settings in various accessory configurations. The SA 2.0 valve is available as a single device as well as with the proGAV 2.0 valve and various Miethke shunt system accessories such as catheters, connectors, deflectors and reservoirs.

This document is a 510(k) summary for the Miethke Shunt System GAV 2.0 and SA 2.0 Valves, which is a cerebrospinal fluid (CSF) shunting device. This type of device regulates the flow of CSF to treat hydrocephalus.

Based on the provided information, the device is a shunt system, not an AI/ML powered device. As such, concepts like "acceptance criteria for an AI/ML powered device," "sample sized used for the test set," "number of experts used to establish the ground truth," "adjudication method," "multi reader multi case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for the training set," and "how the ground truth for the training set was established" are not applicable in this context.

The acceptance criteria and study that proves the device meets the acceptance criteria are related to the physical performance and safety of the shunt system.

Here's the information extracted from the document regarding the acceptance criteria and performance of the device:

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

The document summarizes that "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." It does not provide a specific table of quantitative acceptance criteria values for each test, but rather lists the types of tests performed and attests to a "Pass" result for all of them.

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

The document states, "All samples met predefined acceptance criteria and the proposed devices passed design verification test activities." However, it does not specify the sample size used for these performance tests. The data provenance (e.g., country of origin, retrospective or prospective) is not stated, but given it's a device manufactured by Aesculap, Inc. in Center Valley, Pennsylvania, the testing was likely conducted in a controlled lab environment, not on patient data directly.

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

This concept is not applicable for a physical device performance test. The "ground truth" for a medical device like a shunt is its compliance with established engineering standards and its physical performance characteristics, measured in controlled laboratory settings, not established by human experts in the way an AI algorithm's output might be.

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

Not applicable. This is a term used in validating expert assessments for AI/ML models. For a physical device, the "adjudication" is typically adherence to predefined test protocols and measurement verification.

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 applicable. This is relevant to AI/ML software. This document is for a physical medical device.

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

Not applicable. This is a physical device, not an algorithm. Its performance is inherently "standalone" in mechanical terms, meaning it functions without human intervention once implanted, but its pre-market testing is bench testing.

7. The type of ground truth used:

The ground truth for the device's performance is established by physical measurements and adherence to international and national standards for medical device safety and performance, specifically ISO 7197:2006 and various ASTM F standards for MRI compatibility.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The Aesculap(R) SterilContainer™ S2 System is a reusable rigid sterilization container system intended to be used to enclose another medical device that is to be sterilized by a healthcare provider. It is intended to allow sterilization of the enclosed device and also maintain sterility of the enclosed device until used. This container system is compatible for use in the following sterilization modalities:

• Dynamic-air removal steam (PreVac) (Exposure: 270°F for 4 minutes with 15 minute dry time)
• Gravity Steam (Exposure: 250°F for 30-60 minutes with 15 minute dry time)
• STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD 100NX Standard, STERRAD 100NX Flex Cycles
• STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX Lumen, V-PRO maX Non-Lumen, and V-PRO maX Flex Cycles.

The Aesculap SterilContainer S2 System includes accessories such as sillcone mats and organizers, stainless steel baskets, trays, holders, sterilization indicator cards and tamper proof locks.

The attached table identifies the validated load configurations for each of the modalities.

The Aesculap SterilContainer S2 System is a reusable rigid container system that will allow for sterilization and storage of other medical devices. This container system is compatible for use in the following sterilization modalities:

• Dynamic-air removal steam (PreVac) (270°F for 4 minutes with 15 minute dry time)
• Gravity Steam (250°F for 30-60 minutes with 15 minute dry time)
• STERRAD 100S, STERRAD NX Standard, STERRAD NX Advanced, STERRAD ● 100NX Standard, STERRAD 100NX Flex Cycles
• STERIS V-PRO 60 Lumen, V-PRO 60 Non-Lumen, V-PRO 60 Flex, V-PRO maX . Lumen, V-PRO maX Non-Lumen, V-PRO maX Flex cycles

The containers are perforated and made from anodized aluminum and utilize a single-use or reusable filter. The SterilContainer S2 System includes accessories such as mats, baskets, trays, instrument holders, organizers, filters, indicator cards and tamper proof locks.

The document provided is a 510(k) premarket notification for a medical device, the Aesculap® SterilContainer™ S2 System. It details the device's intended use, compatibility with various sterilization modalities, and comparisons to predicate devices. Crucially, it includes a "Summary of Non-Clinical Testing" which outlines performance tests, acceptance criteria, and results.

Here's the breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

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

The document does not explicitly state the specific sample sizes (e.g., number of container units, number of test cycles) for each non-clinical test. It indicates that "Non-clinical testing was conducted to verify the performance of the subject device," implying that these tests were performed experimentally. The data provenance is implied to be from laboratory testing as part of the device's premarket submission, likely conducted by the manufacturer (Aesculap, Inc.) or a contracted testing facility. The nature of these tests suggests they are prospective, designed specifically to validate the device's performance. There is no information regarding the country of origin of the data beyond the manufacturer's location in Pennsylvania, USA.

For tests like "Sterilization Efficacy," "Simulated Use," and "Reusable Filter," the acceptance criteria mention specific biological indicator (BI) outcomes (e.g., "Biological indicators must be negative for growth") and log reductions, which imply a certain number of biological indicators and test cycles would have been used to statistically ensure the SAL. However, the concrete numbers are not provided in this summary.

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

This document describes technical performance testing of a sterilization container, not a diagnostic or AI-driven device that requires human expert interpretation of images or other data. Therefore, the concept of "experts establishing ground truth" as it would apply to, for example, a medical imaging AI, is not relevant here. The ground truth for these tests (e.g., "sterility," "no degradation," "no cytotoxicity") is established through objective, quantifiable laboratory methods and established standards (like SAL of 10⁻⁶, ISO 10993-5: 2009).

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

As this is not a study involving human reader interpretation or subjective assessments, there is no mention of an adjudication method. The test results are based on objective, measured outcomes and pass/fail criteria.

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 study was not done. This device is a physical medical device (sterilization container), not an AI-driven diagnostic tool or imaging software that would involve human readers or AI assistance.

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

This question is not applicable to the device described. The device is a sterilization container, not an algorithm. The tests performed are "standalone" in the sense that they assess the device's inherent physical and functional properties.

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

The ground truth used for these performance tests is based on:

• Microbiological Standards: Demonstrated sterility (e.g., SAL of 10⁻⁶) measured by the absence of biological indicator growth.
• Physical/Functional Integrity: Observation of no degradation, impact on functionality, or maintenance of barrier properties after challenging conditions.
• Biocompatibility Standards: Adherence to ISO standards for cytotoxicity, measured by the reactivity level.

These are objective, empirical measures defined by scientific and regulatory standards for medical device sterilization and material safety.

8. The sample size for the training set:

This question is not applicable. The device is a physical product and does not involve AI or machine learning models that require training sets. All tests described are performance validation tests.

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

This question is not applicable, as there is no training set for this type of device.

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Caiman Seal and Cut Technology consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation of vessels is desired. The instruments create a seal by the application of bipolar electrosurgical RF energy (coagulation) to vascular structure (vessels) interposed between the jaws of the device. A cutting blade is actuated for the division of tissue.

Instruments 12.5 cm, 17 cm, and 24 cm in length are indicated for open procedures and instruments 36 cm and 44 cm in length are indicated for laparoscopic procedures. The include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

Caiman Seal and Cut Technology has not be effective for tubal sterilization or tubal coagulation for sterilization procedures. Do not use the system for these procedures.

The Caiman® 5 Maryland instruments are seal and cut devices which are provided as sterile, single use devices. These devices are capable of vessel sealing, blunt dissection, grasping and dividing tissue enclosed within its jaws during open and laparoscopic procedures. The devices are designed to be used with the dedicated Lektrafuse RF Generator and create vessel ligation by the application of bipolar electrical RF energy and tissue division with a cutting blade.

The provided document is a 510(k) premarket notification for a medical device, the Caiman® 5 Maryland, an electrosurgical cutting and coagulation device. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials. Therefore, the document primarily details performance testing related to the device's technical specifications and safety, not a study evaluating human reader performance with or without AI assistance, or the performance of an AI algorithm.

Based on the provided text, here's an analysis of the acceptance criteria and the "study" (which are more accurately described as performance tests and verification activities) that proves the device meets them:

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

The document does not present explicit "acceptance criteria" in a quantitative, target-based manner (e.g., "burst pressure must be > X mmHg for Y% of samples"). Instead, it lists various performance tests and their outcomes, indicating a "Pass" result for each. The acceptance criteria are implicitly met by achieving a "Pass" in these design verification tests, which are presumably designed to demonstrate equivalence to the predicate and ensure safety and effectiveness.

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

The document does not specify the sample sizes used for the design verification tests (e.g., how many arteries/veins were tested, how many instruments were used for stress testing). The data provenance (country of origin, retrospective/prospective) is also not stated. These tests are typically conducted in a laboratory setting as part of product development and verification.

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

The document does not involve a study where "ground truth" is established by experts in the context of medical image interpretation or clinical diagnosis. The performance tests described (tissue-related performance, burst pressure, jaw stress) are objective engineering and material science tests. For the "Validation of usability" test, a "user survey" was conducted, implying involvement of potential users (likely surgeons or healthcare professionals), but the number and qualifications of these users are not specified.

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

Adjudication methods like "2+1" or "3+1" are relevant to studies where human interpretation of data (e.g., medical images) is being assessed, often to establish a consensus ground truth. This document describes performance tests for a surgical instrument, not an AI algorithm or diagnostic tool involving human interpretation of complex medical data. Therefore, an adjudication method is not applicable here.

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 MRMC comparative effectiveness study was done. This document describes the 510(k) submission for a surgical instrument, not an AI-powered diagnostic or assistive tool. Thus, there is no mention of human readers, AI assistance, or effect sizes related to such a study.

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

No standalone algorithm performance study was done. As mentioned, this submission is for a physical surgical device, not an algorithm.

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

For the mechanical and electrical performance tests, the "ground truth" is based on established engineering principles, material science properties, and adherence to relevant international standards (e.g., IEC, ISO). For the "Usability" test, the ground truth is based on user feedback collected via a survey, indicating whether the device meets user needs for usability. There is no biological or diagnostic ground truth (like pathology or outcomes data) in the context of this submission.

8. The sample size for the training set

There is no mention of a training set or machine learning algorithms in this document. Therefore, no sample size for a training set is applicable.

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

As there is no training set for an AI algorithm, there is no ground truth establishment process for it described in this document.

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