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The AESCULAP Aicon® Container is a reusable rigid sterilization container 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 is compatible for use in the following sterilization modalities in the configurations listed below:

• Ethylene Oxide (EtO)
• STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
• STERIS V-PRO 60: Lumen, Non- Lumen, Flex
• STERIS V-PRO S2 Non-Lumen
• STERRAD 100NX: Standard, Express, Flex, Duo
• STERRAD NX: Standard, Advanced
• STERRAD 100S
• STERIZONE VP4
• PreVac Steam

The AESCULAP Aicon® consists of two different container styles: a solid bottom container and enhance drying system (EDS) container.

The AESCULAP Aicon® Container is compatible with accessories such as baskets, trays, instrument organizational accessories, holders, indicator cards, tamper evident locks, lid covers, faceplate holders, and tags. Prevac cycles without dry times are Immediate Use Sterilization Cycles (IUSS).

The AESCULAP Aicon® Container System is a reusable rigid container system used for the packaging, transportation, and storage of instruments prior to, during, and after sterilization. It consists of the various sizes of container bottoms, container lid, and basket options, and should only be used with designated Aesculap® filters, locks and indicator cards identified in this IFU.

The AESCULAP Aicon® Container System is provided non-sterile and will undergo sterilization by the end user. The AESCULAP Aicon® Container System can be identified by its JJ Series part number.

• The first digit of the model number designates the container length.
• The second digit designates the height.
• The last digit identifies the model and features.
  • Standard solid bottom container, designated by the "0" at the end of the product number.
  • Enhanced Drying System (EDS) solid bottom container, designated by the "1" at the end of the product number. The EDS container can also be identified by the Enhanced Drying Module, item 14 in the Product Component Diagram.

The JJ Series uses the same lids for the Standard and the EDS container bottoms.

The AESCULAP Aicon® Container System lid latches should remain in the closed position at all times except when installing on and removing the lid from the container bottom.

The JJ Series can be used with the perforated baskets and trays of both the AESCULAP Aicon® Container System and Aesculap® SterilContainer™ System. Non-Aesculap® pre-configured baskets that meet the clearance requirements, and can be properly aseptically presented may also be used. Medical device and container IFUs parameters (time and temperature) should be reconciled. Steam sterilization dry time performance may vary by facility based on water and steam quality and/or sterilization performance. Ensure you can achieve the same end result as identified in the instrument IFU. Follow facilities policies and procedures.

Notes:

• Thoroughly clean all Aesculap® container products, baskets, accessories and replacement parts prior to first use and after container repair service has been performed.
• Aesculap® baskets and accessories can be cleaned and sterilized following accepted industry guidelines and by using the same processes as Aesculap® sterile container bottoms.
• AESCULAP Aicon® Container System has ONLY been validated with Aesculap® filters, locks and indicator cards.
• Aesculap® only performed container testing with baskets and does not recommend using containers without baskets or with only mats.

Here's an analysis of the provided FDA 510(k) clearance letter for the Aesculap Aicon® Series Container System, focusing on the acceptance criteria and the studies that prove the device meets them.

It's important to note that this document is a 510(k) summary, which provides a high-level overview. Detailed study protocols, raw data, and comprehensive reports would be found in the full 510(k) submission, which is not publicly available here. The summary focuses on non-clinical performance data and does not involve AI or human readers for diagnostic interpretation, as this is a medical device for sterilization. Therefore, sections related to AI, multi-reader multi-case studies, and expert adjudication for ground truth are not applicable to this type of device and will be marked as "Not Applicable".

Acceptance Criteria and Reported Device Performance

Device: Aesculap Aicon® Series Container System (Sterilization Container Wrap)

Purpose of Studies: To demonstrate that the Aesculap Aicon® Series Container System is safe, effective, and performs as well as, or better than, the predicate device for its intended use of enclosing medical devices for sterilization and maintaining sterility.

Detailed Study Information

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

• Sample Size for Test Set: The document does not specify exact sample sizes (e.g., number of containers, number of sterilization cycles, number of biological indicators) for each test. For medical device sterilization studies, sample sizes are typically determined by relevant standards (e.g., AAMI, ISO) to achieve statistically significant results for sterility assurance. The phrasing "biological indicators must be negative for growth" implies that multiple indicators were used.
• Data Provenance: The document explicitly states "non-clinical tests" and does not mention clinical trials or human data. The tests are laboratory-based performance studies compliant with international and national standards (AAMI, ISO, EN). The country of origin of the data is not specified, but it would typically be from the manufacturer's labs or contracted testing facilities. The studies are prospective in nature, as they involve testing the device under controlled conditions to determine its performance.

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. This is a medical device for sterilization, not an AI or diagnostic device that requires expert human interpretation of data for ground truth establishment. The ground truth for these performance tests is based on objective, measurable criteria defined by international and national technical standards (e.g., presence/absence of microbial growth, weight difference, visible moisture, protein/hemoglobin levels).

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

• Not Applicable. As there are no human experts establishing ground truth for diagnostic purposes, there is no adjudication method involved. The evaluation of test results against predefined, objective acceptance criteria constitutes the assessment mechanism.

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 (sterilization container) and does not involve AI, human readers, or diagnostic interpretation.

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

• Not Applicable. This is a physical medical device (sterilization container) and does not involve an algorithm or AI.

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

• The ground truth for this device's performance studies is based on objective, measurable physical and biological outcomes as defined by recognized standards (AAMI ST-77, ISO 10993-5:2009, TIR30, TIR17, ISO 11167-1). Examples include:
  • Absence of microbial growth in biological indicators (for sterilization efficacy and sterility maintenance).
  • Specific quantitative thresholds for weight difference (for dry time).
  • Absence of visible moisture.
  • Quantitative levels of protein or hemoglobin below predetermined amounts (for cleaning validation).
  • No degradation or impact to functionality (for material compatibility).
  • Cellular reactivity levels below a certain threshold (for cytotoxicity).

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not an AI or machine learning algorithm that requires a training set. The development of such devices relies on engineering design, material science, and iterative physical testing.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, the concept of establishing ground truth for a training set does not apply here.

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The XABO Catheters are used for cerebrospinal fluid (CSF) shunting.

The XABO Catheters are manufactured using barium sulfate fillcone elastomer and are impregnated with clindamycin hydrochloride and rifampicin designed to be released over time from the exterior and inner lumen surface once implanted.

The XABO Ventricular Catheters will be offered in 18 cm in length with an inner diameter of 1.2 mm and an outer diameter of 2.5 mm. Lengths are marked in 1 cm intervals starting from the catheter tip, thus enabling the surgeon to qauge the depth of penetration of the catheter into the lateral ventricle. The proximal end of the catheter has 16 flow holes around the catheter circumference.

Components supplied with the XABO Ventricular Catheter include a pre-loaded stainless steel stylet and depending on the confiquration may contain a deflector.

The XABO Peritoneal Catheters measure 60 cm or 120 cm in length, 1.2 mm in inner diameter, and 2.5 mm in outer diameter. There are no length markers or wall slits on the tip is open ended. The catheter may be trimmed to the proper length.

The XABO Catheters are 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 miniNAV valve, and the Miethke Shunt System (DSV, connectors, and reservoirs) cleared by FDA (K192266/K190174/K161853/K141687/K110206/K030698/K011030).

The provided text focuses on the 510(k) premarket notification for the XABO Ventricular Catheter, XABO Peritoneal Catheter, and XABO Catheter Set. It primarily addresses the substantial equivalence of these devices to existing predicate devices. While it mentions performance bench testing and specific tests performed, it does not explicitly state specific acceptance criteria values or detailed study results that would allow for a complete fill of the requested table.

The document indicates that the devices were tested against "performance specifications" and that the results "confirm that the XABO Catheters meet performance specifications." However, the exact numerical or qualitative specifications themselves are not provided.

Therefore, the following information is extracted directly from the provided text, and where information is not explicitly stated, it is noted as "Not explicitly stated in the provided text."

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not explicitly stated in the provided text. The phrase "All testing was performed on the worst-case final finished device" could imply a limited number of samples, but a specific number is not given.
• Data Provenance: The studies are described as "Performance bench testing" and "Biocompatibility testing," suggesting laboratory-based testing, not human-patient data. The country of origin of the data is not specified. It is laboratory research, not retrospective or prospective patient data.

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

• Not applicable as the testing described is bench testing and biocompatibility, not studies requiring expert interpretation of clinical data for ground truth.

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

• Not applicable for the types of tests described (bench testing, biocompatibility).

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. The submission focuses on device equivalence through bench and biocompatibility testing, not AI-assisted human reading.

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

• Not applicable. This device is a physical medical device (catheter), not an algorithm or AI system.

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

• For performance bench testing, the "ground truth" would be the pre-defined engineering specifications and standards (e.g., ISO 7197) that the device must meet.
• For biocompatibility testing, the "ground truth" is compliance with international standards (ISO 1099-1) and FDA guidance, ensuring that the device's biological interactions are within acceptable limits.

8. The sample size for the training set

• Not applicable. This is not an AI/machine learning device that requires a training set.

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

• Not applicable. This is not an AI/machine learning device that requires a training set and ground truth establishment.

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The SQ.line KERRISONS (bone punches) are manually operated instruments indicated for cutting or biting bone during surgery involving the skull or spinal column.

The SQ.line KERRISON bone punches are reusable surgical instruments made out of stainless are coated with Medthin™ 42 DLC. The bone punches are available with the following features: shaft lengths 180 - 280 mm, bite sizes 1 - 6 mm, jaw openings 10 - 15 mm, cutting angles 90° and 130° up/down, standard and thin profile footplates and semi-detachable or fully detachable with an ejector.

This document describes the premarket notification (510(k)) for the SQ.line KERRISON manual rongeur. It outlines the device's indications for use, its substantial equivalence to a predicate device, and the non-clinical testing performed to demonstrate its safety and effectiveness.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

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 (number of devices or tests performed per device) for the cutting test, performance test, or mechanical performance after reprocessing.

For biocompatibility, the sample size or specific test article numbers are not provided.

The data provenance is not specified (e.g., country of origin). The studies appear to be internal non-clinical evaluations conducted by the manufacturer, Aesculap, Inc. All studies are retrospectively performed as part of the 510(k) submission process.

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

This information is not applicable as the studies described are non-clinical, mechanical, and biocompatibility tests, not studies requiring expert interpretation or ground truth establishment in the human diagnostic context.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are non-clinical tests and do not involve human adjudication.

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

This information is not applicable. The device is a manual surgical instrument (rongeur), not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study related to AI assistance is irrelevant.

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

This information is not applicable. The device is a manual surgical instrument, not an algorithm.

7. The Type of Ground Truth Used

For the cutting test, performance test, and mechanical performance after reprocessing, the "ground truth" is established by engineering specifications and predefined performance thresholds based on the device's intended function and safety requirements.

For biocompatibility, the "ground truth" is established by compliance with internationally recognized standards (ISO 10993).

8. The Sample Size for the Training Set

This information is not applicable. The device is a manual surgical instrument and does not involve AI or machine learning algorithms that require a "training set."

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

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

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The AESCULAP Aicon™ Container is a reusable rigid sterilization container 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 is compatible for use in the following sterilization modalities in the configurations listed below:

• Ethylene Oxide (EtO)
• STERIS V-PRO maX/maX 2: Lumen, Non-Lumen, Flex
• STERIS V-PRO 60: Lumen, Non- Lumen, Flex
• STERRAD 100NX: Standard, Express, Flex, Duo
• STERRAD NX: Standard, Advanced
• STERRAD 100S
• STERIZONE VP4
• PreVac Steam

The AESCULAP Aicon™ consists of two different container styles: a solid bottom container and enhanced drying system (EDS) container.

The AESCULAP Aicon Container is a reusable 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
• STERIS VPRO maX/ maX 2: Lumen, Non- Lumen, Flex,
• STERIS VPRO 60: Lumen, Non-Lumen, Flex
• STERRAD 100NX: Standard, Express, Flex, Duo
• STERRAD NX: Standard, Advanced
• STERRAD 100S
• STERIZONE VP4
• PreVac Steam

The containers are perforated and made from anodized aluminum and utilize a single-use filter.

This document describes the premarket notification (510(k)) for the Aesculap AICON™ Container, a reusable rigid sterilization container. The following information is extracted from the provided text:

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 sizes used for each specific test or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "testing conducted in accordance with applicable FDA guidance and standards." For example, for "Sterilization Efficacy" and "Sterility Maintenance," it mentions using "Biological Indicators" (BI), implying an appropriate number of BIs were used to validate the SAL.

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

This information is not provided in the document. The tests described are primarily in vitro/laboratory-based performance tests for a sterilization container, rather than clinical studies requiring expert interpretation of medical images or patient outcomes.

4. Adjudication Method for the Test Set:

This information is not applicable and therefore not provided. The tests described are objective, measurable performance tests with clear pass/fail criteria, not subjective assessments requiring adjudication.

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

No, an MRMC comparative effectiveness study was not done. Such studies are typically conducted for devices that involve human interpretation of diagnostic or screening results, which is not the function of a sterilization container. The studies performed are directed at the physical and biological effectiveness of the container in sterilization and maintaining sterility.

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

This question is not applicable to a physical medical device like a sterilization container. The performance tests are inherently "standalone" in the sense that they evaluate the device itself.

7. The Type of Ground Truth Used:

The ground truth for the performance tests is established by:

• Sterility Assurance Level (SAL) of 10^-6: This is a widely accepted standard for sterilization efficacy, and is verified using biological indicators (containing resistant bacterial spores).
• Weight difference and visible moisture: For dry time, objective measurements and visual inspection define the ground truth for adequate drying.
• Absence of microbial growth: For microbial aerosol challenge and sterility maintenance, the absence of bacterial growth from cultures of the container contents confirms sterility.
• Killing of spores in organic soil: For simulated use, the elimination of a specified number of spores in a challenging environment serves as the ground truth for effective sterilization of internal lumens.
• Functional integrity: For material compatibility, maintained functionality after multiple cycles serves as the ground truth.
• Cytotoxicity (mild reactivity): Defined by ISO 10993-5: 2009 standards, where a response not greater than 2 (mild reactivity) indicates acceptable biocompatibility.

8. The Sample Size for the Training Set:

This information is not provided and is not applicable. The device is a physical sterilization container, not an AI/ML algorithm that requires a training set.

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

This information is not provided and is not applicable, as there is no training set for this device.

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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 ELAN 4 Electro Motor System is intended for high speed cutting, sawing, and drilling of bone in the fields of Spine, ENT, Neuro, and Maxillofacial Surgery.

The ELAN 4 Software V3.00, Wireless Foot Control, Drill and Attachments are designed for use with the ELAN 4 Electro Motor System (K152960). The ELAN 4 Electro Motor System is an electrical motor system consisting of a control unit with different sizes and types of hand-pieces, each containing its own integrated motor, and attachments such as burrs, saw blades, drills, etc.

The Control Unit of the ELAN 4 Electro Motor System houses the system software. The ELAN 4 Software V3.00 provides support for the ELAN 4 Wireless Foot Control and ELAN 4 Drill. The ELAN 4 drill is a pistol type hand-piece designed specifically to accept various ELAN 4 attachments.

The provided text describes the regulatory clearance of a medical device, the ELAN 4 Electro Motor System, not an AI/ML powered device. As such, information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC) that would typically apply to AI/ML devices is not applicable or present in this document.

The document discusses "performance data" in the context of:

• Bench testing: In-house design verification to ensure mechanical and functional requirements, including design specifications, were met.
• Biocompatibility: Evaluation according to ISO-10993.
• Electrical safety and electromagnetic compatibility (EMC): Compliance with IEC 60601-1 and UL 2601-1 standards for safety and IEC 60601-1-2 for EMC.
• Software Verification and Validation Testing: Conducted in accordance with FDA guidance for software in medical devices, with the software considered a "moderate" level of concern.

Summary of available information:

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

2. Sample size used for the test set and the data provenance: Not applicable. The tests performed are primarily engineering and regulatory compliance tests, not studies involving datasets for AI/ML performance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.

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

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.

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

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable. "Ground truth" in this context refers to established engineering specifications, regulatory standards, and functional requirements for the device.

8. The sample size for the training set: Not applicable.

9. How the ground truth for the training set was established: Not applicable.

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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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Caiman Seal and Cut Technology System consists of dedicated bipolar electrosurgical instruments intended for use in general surgery and gynecologic surgical procedures where ligation and division 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 36cm and 44cm in length are indicated for laparoscopic procedures and instruments 24 cm in length are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracic, and thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectomy, adhesiolysis, bowel resection, and oophorectomy etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

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

The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, grasping, and dividing tissue enclosed within its dissection clips.

The reason for this submission is to capture modifications to the caiman 12 (24cm and 44cm) instruments.

The provided text describes a 510(k) premarket notification for the "Aesculap Caiman 12 Seal and Cut Technology System". This is a regulatory submission for a medical device rather than an AI-driven system. Therefore, most of the requested information regarding AI-specific criteria (e.g., sample size for test/training sets, data provenance, expert ground truth, MRMC study, standalone performance) is not applicable or available in this document.

However, I can extract information related to the device's acceptance criteria and the non-clinical testing conducted to demonstrate substantial equivalence to a predicate device, which is relevant to device performance and acceptance.

Here's the available information based on the provided text:

Acceptance Criteria and Reported Device Performance

Study Details (Non-Clinical Testing)

This document describes non-clinical testing verifying design changes to an electrosurgical device, not a study of an AI algorithm. Therefore, many of the AI-specific questions are not applicable.

• Sample size used for the test set and the data provenance: Not explicitly stated as this is non-clinical testing of a physical device. The testing was conducted to verify design changes.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical device's mechanical and electrical performance is established through engineering specifications and objective measurements, not expert consensus.
• Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical device testing.
• 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 document is not about AI assistance.
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This document is not about an AI algorithm.
• The type of ground truth used: Engineering specifications and objective measurements based on the device's design and intended function (e.g., measuring force, observing mechanical stability).
• The sample size for the training set: Not applicable. This is for a physical medical device, not an AI model.
• How the ground truth for the training set was established: Not applicable.

Additional context from the document:

• Purpose of Testing: "Non-clinical testing was conducted as part of demonstrating substantial equivalence to the predicate device and ensure the design changes met the predetermined acceptance criteria."
• Methodology: "A risk analysis was completed to identify the risks associated with the modifications to the Caiman Seal and Cut Technology System. Verification testing was conducted to evaluate the modification."
• Conclusion: "The conclusions drawn from the nonclinical tests demonstrate that the modifications described in this submission do not affect the intended use of the device or alter the fundamental scientific technology of the device."

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Caiman Seal and Cut Technology System 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.

The Caiman 12 Plus (44cm) and the Caiman 5 (36cm and 44cm) are indicated for laparoscopic procedures and the Caiman 12 Plus (24cm) and the Caiman 5 (24cm) are indicated for open procedures. The indications for use include general surgical procedures, (including urologic, vascular, thoracoscopic), and gynecological procedures where ligation and division of vessels is performed. These procedures include: vaginal hysterectomies, Nissen fundoplication, colectory, adhesiolysis, bowel resection, and oophorectorny etc., or any procedure where vessel ligation (seal and cut), tissue grasping, and dissection is performed. The devices can be used on vessels up to and including 7mm and bundles as large as will fit in the jaws of the instrument.

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

The Aesculap® Caiman Seal and Cut Technology System consists of sterile, single-use bipolar instruments that connect to a dedicated bipolar RF generator. The Caiman instruments are designed to grasp, seal (ligate), and mechanically divide (cut) varying lengths of tissue (for example mesentery) per device application. This is accomplished by a two electrode (side by side-top and bottom) design. The instruments are capable of vessel sealing, blunt dissection, grasping, and dividing tissue enclosed within its dissection clips. This reason for this submission is to capture modifications to the caiman blunt instruments.

The provided text is a 510(k) summary for a medical device called the Aesculap Caiman 5 Seal and Cut Technology System. This document outlines the device's technical characteristics, intended use, and the results of non-clinical performance testing conducted to demonstrate substantial equivalence to a predicate device.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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):

The document does not explicitly state the specific sample sizes for the test set used in the non-clinical performance tests (Tissue Related Performance, Burst Pressure, and Cutting Blade Activation). It refers to "testing and validation activities" and "design verification table" but does not provide details on the number of devices or trials performed for each test.

The data provenance is not mentioned. As this is a premarket notification for a medical device in the US (FDA 510(k)), the testing would typically be conducted by the manufacturer (Aesculap, Inc., based in Center Valley, Pennsylvania) or a contracted lab. The tests are non-clinical, implying laboratory or bench testing rather than human subject data.

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. The performance testing described is for a surgical instrument (electrosurgical cutting and coagulation device). The "ground truth" for this type of device is established through objective physical and functional measurements (e.g., sealing time, thermal spread, cutting force, burst pressure on vessels), not through expert interpretation of images or other subjective assessments.

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

This information is not applicable. Adjudication methods are typically used in clinical studies or studies where subjective assessments (e.g., image interpretation) are made by multiple experts and a consensus is needed for ground truth. The tests described are objective, non-clinical performance 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 is not applicable. The device is a surgical instrument, not an AI-powered diagnostic or interpretive tool that would involve human readers. Therefore, an MRMC comparative effectiveness study is not relevant to this submission.

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

This is not applicable. The device is a physical surgical instrument, not an algorithm, and it operates with a human surgeon in the loop.

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

The "ground truth" for the non-clinical tests is based on objective physical measurements and engineering specifications, primarily related to the device's ability to:

• Perform a specified number of operational cycles (Life Cycle test).
• Achieve a certain burst pressure strength on sealed vessels (Burst Pressure test).
• Operate its cutting blade within a defined force range (Cutting Blade Activation test).
• Control thermal spread within set limits.
• Cut tissue completely without tags.

These are verifiable properties of the device's mechanical and electrical function as applied to tissue models, not clinical "outcomes data" or "pathology" in the diagnostic sense.

8. The sample size for the training set:

This is not applicable. The Aesculap Caiman 5 Seal and Cut Technology System is a physical electrosurgical device, not a machine learning or AI algorithm. Therefore, there is no "training set" in the context of data-driven model development. Training for this type of device would involve design, manufacturing, and quality control processes.

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

This is not applicable as there is no training set for an AI/ML algorithm. The ground truth for the device's functional performance是在bench测试中由工程规格和测量仪器的结果建立的。

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The PAS-Port Proximal Anastomosis System is intended to create the aortic anastomosis of aortic autologous vein grafts.

The Aesculap® PAS-Port Proximal Anastomosis System is a mechanical device used to facilitate an aortic vein graft anastomosis. The connector replaces sutures to create a secure, patent, and reproducible anastomosis. The PAS-Port system consists of a connector and a delivery system and is contained in a package that is designed to facilitate attachment of the conduit to the implant, as well as to ensure that the venous conduit (after attachment to the system and before deployment) is kept moist and vital.

The information provided describes the acceptance criteria and the study conducted for the Aesculap PAS-Port Proximal Anastomosis System, focusing on non-clinical performance testing related to packaging.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

• The complete sterile barrier must be intact
• All sealed seams must be intact | Pass |
  | Seal Strength Verification | The seal strength must be within the defined range of 1.2 - 10 N/15 mm | Pass |
  | Transport Simulation | - There must be no fatal damages of the packaging which could cause product damage
• The product must remain in its intended position
• The product must function and must not have visible damages
• The sterile barrier must be intact | Pass |
  | Labeling Visual Inspection | All labeling contents must be intact and legible | Pass |
  | Scanning Verification | All codes must be read using bar code scanner | Pass |

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

• The document does not explicitly state the specific numerical sample size used for each of the performance tests. It generally refers to "All samples."
• Data Provenance: The study is non-clinical testing, conducted to meet requirements outlined in ISO 11607-1. The data provenance is internal testing performed by the manufacturer, Aesculap Inc., for regulatory submission in the United States (FDA). It is a prospective study in the sense that the tests were designed and executed to evaluate the new packaging.

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

• This information is not applicable to this type of non-clinical, performance-based testing for a medical device's packaging. Ground truth in this context is established by objective measurements and adherence to specified physical and mechanical standards (e.g., seal strength, visual inspection criteria, microbial barrier integrity). Experts typically establish ground truth in diagnostic or clinical efficacy studies where human interpretation is involved.

4. Adjudication method for the test set:

• This information is not applicable as the tests are non-clinical performance evaluations with objective pass/fail criteria, rather than subjective assessments requiring adjudication.

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 impact of AI on human diagnostic performance, typically in imaging or diagnostic fields. The submitted document pertains to the non-clinical performance and packaging of a surgical device, not a diagnostic AI system.

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

• This information is not applicable. This submission is for a physical medical device (a surgical system), not a software algorithm or AI. The tests performed are physical and functional evaluations of the device and its packaging.

7. The type of ground truth used:

• The "ground truth" for this non-clinical testing is based on objective, predefined acceptance criteria and internationally recognized standards (ISO 11607-1). For example:
  • Seal Strength: Measured objectively against a numerical range (1.2 - 10 N/15 mm).
  • Microbial Barrier/Transport Simulation: Visual inspections for damage, integrity of sterile barrier, and product position/functionality as per established test protocols.
  • Labeling/Scanning: Objective verification that content is intact/legible and codes are scannable.

8. The sample size for the training set:

• This information is not applicable as there is no "training set" in the context of this non-clinical packaging performance study. Training sets are used in machine learning and AI model development.

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

• This information is not applicable, again because there is no training set involved in this type of non-clinical device testing.

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