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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 Aesculap Implant Systems® activL® Next Generation Instrumentation are indicated for the successful implantation of the Aesculap activL® device. These instruments are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of the activL® device.

The activl ® Next Generation Instrumentation would allow successful implantation of the Aesculap activL® device. These are manual surgical instruments which aid in selecting, placing, and revising the activL® device. These activL® instruments device comprises of trial, trial holders, single and double chisels, implant inserter, depth stop, depth stop driver, and impaction caps.

This document is a 510(k) Premarket Notification from the FDA regarding the activL® Next Generation Instrumentation. It focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study proving a device meets specific acceptance criteria based on metrics like sensitivity, specificity, or AUC for an AI/CADe device.

Therefore, the requested information regarding acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment cannot be found or inferred from the provided text. The document pertains to manual surgical instrumentation, not an AI or diagnostic device that would typically undergo such rigorous performance evaluation.

The "Performance Testing Summary" section (Page 4, {4}) briefly mentions:

• Simulated use/Functional testing
• Transit testing
• Sterilization/Cleaning validation

These are standard engineering and manufacturing performance tests for reusable surgical instruments, not clinical performance studies with human subjects or AI algorithm evaluations. The conclusion explicitly states the device is substantially equivalent based on "indication, design, materials, function, and performance" relative to predicate devices, and that performance testing demonstrated it "do not introduce any new question of safety or effectiveness."

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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 Aesculap Ennovate Cervical Spinal and Occiput System is intended to provide immobilization of spinal segments as an adjunct to following acute and chronic instabilities of the craniocervical junction, the cervical spine (Cl to C7) and the thoracic spine (Tl-T3): traumatic spinal fractures and/or traumatic dislocations; instability or deformity; failed previous (e.g. pseudoarthrosis); tumors involving the cervical/thoracic spine; and degenerative disease, including intractable radior myelopathy, neck and/or arm pain of discogenic origin as confirmed by radiographic studies, and degenerative disease of the facets with instability. The Aesculap Ennovate Cervical Spinal and Occiput System is also intended to restore the integrity of the spinal column even in the absence of fusion for a limited time period in patients with advanced stage tumors involving the cervical spine in whom life expectancy is of insufficient duration to permit achievement of fusion.

In order to achieve additional levels of fixation, the Aesculap Ennovate Lumbar System may be connected to the Aesculap Ennovate Cervical Spinal and Occiput System using connectors and rods.

The Aesculap ENNOVATE Cervical Spinal and Occiput System is implant systems used to facilitate the biological process of spinal fusion. This system is intended to promote fusion of the cervical and thoracic spine (C1-T3) and occipito-cervico-thoracic junction (occiput-T3). The Aesculap ENNOVATE Cervical Spinal and Occiput System consist of various plates, screws, rods, hooks, and connectors.

The provided text is a 510(k) Summary for the Aesculap ENNOVATE Cervical Spinal and Occiput System, which is a medical device. This document focuses on demonstrating substantial equivalence to a predicate device, primarily through bench testing (performance data).

The request asks for information about the acceptance criteria and the study that proves the device meets the acceptance criteria, specifically in the context of an AI/algorithm-based device. The original document does not describe an AI/algorithm-based device. It describes a physical implant system (screws, rods, plates, etc.) for spinal stabilization. Therefore, the questions related to AI/algorithm performance studies (such as MRMC studies, standalone algorithm performance, ground truth establishment for training/test sets, training set sample size, expert consensus, etc.) are not applicable to this submission.

The "Performance Data" section solely lists ASTM standards that the physical device was tested against. These standards evaluate the mechanical properties of the implant system (e.g., strength, fatigue, static properties) to ensure it performs as safely and effectively as the predicate device.

Given that the request is for an AI/algorithm device study and the provided document is for a physical orthopedic implant, I can only address the "acceptance criteria" and "device performance" in the context of the mechanical and material testing described for this specific physical device.

Acceptance Criteria and Device Performance (Based on the provided document for a physical implant):

The acceptance criteria for this physical device are implicitly tied to the successful completion of the listed ASTM standard tests, demonstrating equivalence in mechanical performance to the predicate device. The performance is stated to be "as safely and effectively" as the predicate device based on these tests.

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

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

• Sample Size: Not specified in the document. For physical device testing, this typically refers to the number of implants or components tested according to the ASTM standards.
• Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). However, since it's bench testing, the "data" originates from the physical tests performed on the device samples in a laboratory setting.

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

• Not Applicable. This is a physical device, and its performance is evaluated against engineering standards, not by expert interpretation of images or data. Ground truth here is based on the objective measurements from the mechanical testing.

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

• Not Applicable. Adjudication methods are relevant for human interpretation or complex data analysis, not for direct physical property measurements against engineering standards.

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 not an AI/algorithm-based device. An MRMC study would not be performed for a physical implant.

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

• Not Applicable. This is not an AI/algorithm-based device.

7. The type of ground truth used:

• Mechanical Performance Standards: The ground truth for this physical device is the set of mechanical and material properties defined by the ASTM standards (e.g., tensile strength, fatigue life, torque limits) which are universally accepted engineering benchmarks for such implants. Compliance with these quantitative standards serves as the "ground truth."

8. The sample size for the training set:

• Not Applicable. This is a physical device, not an algorithm that requires a training set.

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

• Not Applicable. As above, no training set for an algorithm is involved.

In summary, the provided document describes a 510(k) submission for a physical medical device. The "acceptance criteria" and "study proving device meets criteria" are based on a series of bench tests against pre-defined ASTM engineering standards to demonstrate substantial equivalence to an existing predicate device, primarily in terms of mechanical and material performance. The questions related to AI/algorithm studies are not relevant to this specific premarket notification.

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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 ENNOVATE® Spinal System is intended for anterior/anterolateral and posterior, non-cervical pedicle and nonpedicle fixation. Fixation is limited to skeletally mature patients and is intended to be used as an adjunct to fusion using autograft or allograft. The ENNOVATE System can be used in both an Open and Minimally Invasive Surgery (MIS). The device is indicated for treatment of the following acute and chronic instabilities or deformities:

1. Degenerative disc disease (defined as discogenic back pain with degeneration of the disc confirmed by history and radiographic studies).
2. Spondylolisthesis,
3. Trauma (i.e., fracture or dislocation)
4. Spinal Stenosis,
5. Deformities or Curvatures (i.e., scoliosis, kyphosis, and/or lordosis),
6. Tumor.
7. Pseudoarthrosis, and
8. Failed previous fusion

The ENNOVATE Spinal System is an implant system used to correct spinal deformity and facilitate the biological process of spinal fusion. This system is intended for posterior use in the thoracic, lumbar and sacral areas of the spine. This system includes screws of varying types, diameters and lengths, hooks, rods, rod-to-rod connectors, lateral offset and cross connectors of various styles and lengths. All implant components are top loading and top tightening. The implants in this system are manufactured from titanium alloy (Ti-6Al-4V) conforming to ISO 5832-3 as well as CoCr alloy conforming to ISO 5832-12.
The ENNOVATE Spinal System is a spinal rod and screw system. This system's screws can be rigidly locked into a wide range of configurations, therefore allowing each construct to be formed to the needs of an individual patient. All screws within this system are not intended for use with bone cement. Rods of this system may be shaped intraoperatively to correct or maintain proper spinal curvature. The hooks have curved blades underneath the head portion of the implant that wrap around posterior anatomy of the spine to provide an alternative method of anchoring the rod to the spine.

The provided text does not contain information about an AI/ML-powered medical device or its performance criteria. The document is an FDA 510(k) clearance letter and a 510(k) summary for the ENNOVATE® Spinal System, which is a physical medical device (a thoracolumbosacral pedicle screw system) used for spinal fusion.

Therefore, I cannot answer the questions related to acceptance criteria for an AI device, sample sizes for test sets, expert ground truth establishment, MRMC studies, or training set details, as this information is not present in the provided context for this specific device.

The "Performance Data" section in the document refers to biomechanical testing of the physical spinal implant system (e.g., dynamic/static compression, torsion tests per ASTM standards, endotoxin testing), not the performance of a software algorithm.

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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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