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The Medical Video Endoscope is designed to be used with endo-therapy accessories such as a biopsy forceps and other ancillary equipment for endoscopy and endoscopic surgery within urinary tract and interior of the kidney.

The image processor is used with the specified endoscope designed by SEPLOU during minimally invasive surgery.

The image processor provides power and processes the images for medical electronic endoscope.

The Medical Video Endoscope system is designed to provide image solution for endoscopy and endoscopic surgery, and perform procedures in the urinary tract and interior of the kidney using appropriate accessory devices (e.g. laser fibers, forceps baskets).

The Medical Video Endoscope is a sterile Medical Video Endoscope. The Image Processor for Endoscopy is a reusable monitor.

The Medical Video Endoscope is comprised of a control body with articulation controls and accessory access ports, and a flexible insertion tube with an on-tip camera module and LED lighting source. The Image Processor processes the images from the Endoscope and outputs video signals to a display.

This document describes the FDA 510(k) clearance for the Seplou (ZHUHAI) Co., Ltd. Medical Video Endoscope System. It is important to note that this is a medical device clearance, not an AI/ML device clearance. Therefore, the information regarding AI-specific criteria like training sets, expert ground truth, and MRMC studies will not be present in this document. The provided text does not describe an AI/ML device.

Here's an analysis based on the provided document for the Medical Video Endoscope System:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a medical device and not an AI/ML system, the "acceptance criteria" discussed are related to physical, electrical, and performance standards rather than metrics like sensitivity or specificity. The "reported device performance" refers to the device's adherence to these standards.

2. Sample Sizes Used for Test Set and Data Provenance

This is not applicable as the clearance is for a physical medical device (endoscope system) and not an AI/ML algorithm that processes data. The "test set" in this context refers to the physical units and their components undergoing various engineering and performance tests, not a dataset of medical images. The data provenance would be laboratory testing data generated during the device's development and validation.

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

This is not applicable for a non-AI medical device clearance. Ground truth, in the context of AI/ML, refers to definitively labeled data. For this device, "ground truth" would be established through adherence to engineering standards, validated measurement techniques, and industry best practices by qualified engineers and technicians.

4. Adjudication Method for the Test Set

Not applicable for a non-AI medical device clearance. Adjudication methods like 2+1 or 3+1 are used for reconciling expert disagreements in AI ground truth labeling. For a physical device, testing outcomes are typically definitive measurements against established standards.

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

Not applicable. An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an endoscope system, not an AI diagnostic tool.

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

Not applicable. This device is a physical endoscope system, not a standalone algorithm.

7. Type of Ground Truth Used

The "ground truth" for this medical device's performance is established by:

• International Standards: Adherence to ISO, ASTM, and IEC standards for biocompatibility, sterilization, electrical safety, EMC, optical performance, and packaging.
• Engineering Specifications: The device's measurable physical and optical properties meeting predefined design specifications.
• Comparison to Predicate Device: Demonstrating substantial equivalence to a legally marketed predicate device, implying similar performance characteristics.

8. Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set."

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

Not applicable for the same reason as above.

Summary of Device and Performance:

The Seplou (ZHUHAI) Medical Video Endoscope System aims to provide an image solution for endoscopy and endoscopic surgery within the urinary tract and interior of the kidney. It consists of multiple models of flexible endoscopes and an image processor.

The device's performance has been demonstrated through a series of non-clinical tests to meet established regulatory and industry standards. This includes:

• Biocompatibility: Evaluated according to ISO 10993-1, covering cytotoxicity, sensitization, irritation, acute systemic toxicity, and material-mediated pyrogens.
• Sterilization and Shelf Life: Validated via ISO 11135:2014 for sterilization, ISO 10993-7:2008 for EO/ECH residuals, and ASTM F1980-21 for accelerated aging to support a 3-year shelf life. Package validation was also done per ISO and ASTM standards.
• Electrical Safety and EMC: Complies with IEC 60601-1 (general medical electrical equipment safety), IEC 60601-2-18 (endoscopic equipment specific safety), and IEC 60601-1-2 (electromagnetic compatibility).
• Software Verification and Validation: Conducted and documented as per FDA guidance.
• Bench Performance Testing: Included optical performance (according to ISO 8600 series, color reproduction, geometric distortion, resolution, depth of field, image intensity uniformity, noise, dynamic range compared to the predicate device) and mechanical tests (use-life of bending section, control knob, connection strength, tensile force, and corrosion resistance).

The conclusion states that these performance tests and compliance with voluntary standards confirm the substantial equivalence of the proposed Medical Video Endoscope system to its predicate device (K172098). No clinical studies were deemed necessary for this clearance.

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The SPROTTE® STANDARD (LUER/ NRFit®) lumbar puncture needles are intended to gain entry into or puncture the spinal cavity permitting injection/ withdrawal of fluids for purposes of diagnostic lumbar puncture, myelography/ discography.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the spinal space.

The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

This document, an FDA 510(k) clearance letter and associated summary, pertains to a lumbar puncture needle – a physical medical device. The information provided heavily details the material composition, dimensions, and manufacturing processes (including sterilization and packaging) of the needle, and compares these characteristics to previously cleared predicate and reference devices.

Crucially, this document does NOT describe the acceptance criteria and study that proves a software algorithm or AI/ML device meets those criteria. It is about a physical medical device, not a digital health product that uses algorithms to process data or make predictions.

Therefore, I cannot extract the information required by your prompt, as it is designed for a different type of medical device (software/AI/ML).

To directly answer your numbered points based on the provided text:

• 1. A table of acceptance criteria and the reported device performance: Not applicable for an AI/ML device. The document lists performance testing against physical standards (ISO 7864, ISO 9626, ISO 80369-6, ISO 80369-7) for the needle's physical properties (e.g., cleanliness, dimensions, bond strength, fluid/air leakage, stress cracking), with all sections reported as "Passed."
• 2. Sample sizes used for the test set and the data provenance: Not applicable for an AI/ML device. For the physical device, testing appears to be based on compliance with ISO standards, implying a certain number of units were tested to demonstrate conformity. Data provenance specific to an AI/ML context (e.g., country of origin, retrospective/prospective) is not present.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for an AI/ML device. This document does not describe a process of establishing "ground truth" by experts reviewing medical images or data.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for an AI/ML device.
• 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 for an AI/ML device. This type of study is for evaluating AI assistance to human interpretation, which is not relevant for a physical needle.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for an AI/ML device.
• 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for an AI/ML device. The "ground truth" for a physical needle's performance is its adherence to mechanical, material, and sterility standards.
• 8. The sample size for the training set: Not applicable for an AI/ML device. There is no AI model being trained.
• 9. How the ground truth for the training set was established: Not applicable for an AI/ML device.

In summary: The provided text describes the regulatory clearance for a traditional, physical medical device (a lumbar puncture needle) based on its material properties, manufacturing processes, and adherence to established physical performance standards. It does not contain any information relevant to the testing and validation of an AI/ML-based medical device.

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aScope 5 Cysto HD is a sterile, single-use, flexible cysto-nephroscope intended to be used for endoscopic access to and examination of the lower urinary tract and kidney.

The cysto-nephroscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The Ambu® aScope™ 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract and kidney via antegrade (percutaneous) access. The cysto-nephroscope is intended to be used with a compatible and reusable Ambu displaying unit (the Ambu® aBox™ 2 or the Ambu® aView™ 2 Advance) to visualise the urethra and the bladder as well as the kidney.

The cysto-nephroscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, for instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu® aScope 5 Cysto HD shall be disposed of as infected medical device with electronic components.

Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cysto-nephroscope are available: aScope 5 Cysto HD - Reverse Deflection and aScope 5 Cysto HD - Standard Deflection. Apart from the mode of deflection, the cysto-nephroscopes share the same design.

The provided FDA 510(k) Clearance Letter for the Ambu® aScope™ 5 Cysto HD (K250269) does not describe acceptance criteria or a study that proves the device meets specific acceptance criteria in the context of AI/ML performance.

This device is a physical endoscope, and the provided document focuses on its mechanical, optical, and safety characteristics following standard medical device testing procedures. There is no mention of an AI/ML component or associated performance metrics like sensitivity, specificity, or AUC.

Therefore, I cannot provide the requested information regarding acceptance criteria and studies for AI/ML performance. The document only lists verification and optical performance tests for the physical device, and states that these tests were met.

Here's an analysis based on the information that is present in the document, acknowledging that it's not related to AI/ML performance:

1. Table of Acceptance Criteria and Reported Device Performance

The document broadly states that the device "met the test specifications set" and "passed the predefined acceptance criteria" for various tests. However, it does not provide specific numerical acceptance criteria or detailed reported performance values for most of these tests. For instance, for "Resolution," it doesn't state "Resolution shall be X lines per mm, and was Y lines per mm."

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

Since this is not an AI/ML clinical study, but rather engineering and bench testing of a physical device:

• Sample Size: Not specified for most tests. For physical device verification and optical performance tests, the "sample size" would typically refer to the number of physical devices or components tested. The document does not provide these numbers.
• Data Provenance: Not applicable in the context of clinical data provenance (e.g., country of origin, retrospective/prospective). The data comes from internal testing and validation activities by the manufacturer.

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

This information is not applicable. For physical device performance, "ground truth" is defined by engineering specifications, validated test methods, and industry standards (e.g., ISO, ASTM, IEC). It does not involve expert readers establishing a medical diagnosis "ground truth."

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like "2+1" or "3+1" are used in clinical studies, particularly for AI/ML, to resolve discrepancies among human readers or validate AI outputs against human consensus. This device's testing involves objective measurements against engineering specifications.

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

No. This document pertains to the clearance of a medical device (endoscope), not an AI/ML diagnostic software. There is no mention of human readers, AI assistance, or an MRMC study.

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

No. The device is a physical endoscope. There is no AI/ML algorithm described that would have standalone performance.

7. The Type of Ground Truth Used

The "ground truth" for the tests described is based on:

• Engineering Specifications: Internal design requirements for the device.
• International Standards: e.g., ISO 8600-3 (for field of view, direction of view), IEC 62471 (photobiological safety), ASTM D4169 (transportation), ISO 11135 (sterilization), ASTM F1980 (stability/shelf life), ISO 10993-1 (biocompatibility), IEC 60601-1/60601-2-18 (electrical safety), IEC 60601-1-2 (EMC).
• Validated Test Methods: Procedures designed to objectively measure specific performance characteristics.

8. The Sample Size for the Training Set

Not applicable. There is no AI/ML component mentioned that would require a training set.

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

Not applicable, as there is no AI/ML component or training set.

In summary: The provided FDA 510(k) clearance letter details the regulatory approval of a physical endoscope (Ambu® aScope™ 5 Cysto HD). It successfully underwent a series of non-clinical (bench) tests to demonstrate its safety and performance in line with established engineering specifications and international standards, thereby proving substantial equivalence to a predicate device. However, it does not involve any AI/ML components or studies that would address acceptance criteria related to AI/ML performance, such as diagnostic accuracy, human reader improvement, or training/validation data characteristics.

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Rota-Trach Disposable Standard Tracheostomy Tube is indicated for airway maintenance of tracheostomized patients.

Rota-Trach Disposable Standard Tracheostomy Tube is a respiratory device inserted into the patient's trachea through a stoma, making direct contact with the tracheal mucosal membrane tissue. It may be with or without a cuff attaching around the tube of the device. The design of the cuff could seal the space between the tube and the patient's trachea from inhaling undesired or foreign matters and for assistance of positive pressure ventilation.

The provided document is a 510(k) clearance letter and summary for a physical medical device (tracheostomy tube), not a software-based AI/ML device. Therefore, the document does not contain information about acceptance criteria or studies proving performance for an AI/ML device.

The questions asked pertain specifically to the validation of AI/ML models in medical devices, which typically involve metrics like accuracy, sensitivity, specificity, and detailed study designs (test sets, ground truth, expert adjudication, MRMC studies, etc.).

Since the document describes a Class II physical medical device (Tracheostomy Tube and Tube Cuff), the information regarding acceptance criteria and performance data is related to its physical and biological safety and efficacy, not AI/ML performance.

Therefore, I cannot provide the requested information because the provided input does not describe an AI/ML device or its validation.

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The ETHICON™ 4000 and ETHICON™ 3D Reloads are intended for transection, resection and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials. The instruments may also be used for transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, single-patient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

Based on the provided FDA 510(k) clearance letter for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads (K250835), here's an analysis of the acceptance criteria and the study proving the device meets them:

Important Note: The provided document is a 510(k) clearance letter, which summarizes the FDA's decision based on the applicant's submission. It does not contain the full details of the studies conducted. Therefore, some information requested (e.g., specific acceptance criteria values, sample sizes for training sets, adjudication methods, details of expert qualifications, and MRMC study effect sizes) is not explicitly stated in this public document. The answers below are derived directly from the content provided and identify where information is not present.

Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria

The primary purpose of this 510(k) submission was to expand the indications for use of an already cleared device to include transection and resection of liver parenchyma (hepatic vasculature and biliary structures), pancreas, kidney, and spleen. The acceptance criteria would therefore revolve around demonstrating safe and effective performance of the stapling system in these specific organ tissues.

Based on the document, the general "acceptance criteria" can be inferred from the types of performance tests conducted and the conclusion statement that the "subject devices passed the functional requirements of the device features" and "have been demonstrated to be safe and effective for the expanded indications for use."

1. Table of Acceptance Criteria and Reported Device Performance

As specific quantitative acceptance criteria (e.g., minimum burst pressure, maximum staple height deviation) are not provided in this summary document, we can only infer the categories of performance that were evaluated and determined to be acceptable.

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

• Sample Size for Test Set: Not explicitly stated in the document. The general descriptions refer to "nonclinical (bench) tests" and "pre-clinical (animal) testing," implying a test set was used, but no specific numbers of samples, instances, or animal subjects are provided.
• Data Provenance:
  • Country of Origin: Not specified. Standard practice for such studies would likely involve labs in the US or collaborating international facilities, but the document does not state this.
  • Retrospective or Prospective: These were prospective studies, as they were conducted specifically to gather data for this 510(k) submission to support the expanded indications for use.

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

This information is not applicable as this submission is for a mechanical surgical stapler and reload system, not an AI or image-based diagnostic device where "ground truth" would be established by human experts in image interpretation. The "truth" in this context is the physical performance and biological outcome (e.g., successful staple formation, hemostasis) confirmed through engineered testing and animal models.

4. Adjudication Method for the Test Set

This information is not applicable as this submission is for a mechanical device. Adjudication methods are typically used in studies involving human interpretation or clinical outcomes where there might be inter-reader variability. The "adjudication" in this context would be the rigorous adherence to testing protocols and criteria, verified by engineers and potentially DVMs for animal models.

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

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI or CAD (Computer-Aied Detection/Diagnosis) systems where the performance of human readers (e.g., radiologists) is compared with and without AI assistance. This submission is for a mechanical surgical stapler.

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

This question is not applicable as this is not an AI/algorithm-based device. The "standalone performance" of the device is its mechanical function (stapling, cutting) which was assessed through bench and animal testing.

7. The Type of Ground Truth Used

The "ground truth" for this medical device's performance was established through:

• Bench Test Results: Direct measurement and evaluation of physical characteristics and functional performance (e.g., formed staple height, staple form quality, vessel sealing, staple line integrity) under controlled laboratory conditions. These are objective engineering measurements.
• Animal Model Outcomes: Direct observation and measurement of biological outcomes in live animal tissues (porcine model for liver, spleen, pancreas, isolated vessels, lung, uterine tissues). "Hemostasis performance" implies direct assessment of whether the stapling achieved effective cessation of bleeding. These are physiological and anatomical "truths."

8. The Sample Size for the Training Set

This information is not applicable as this is a mechanical device, not an AI/machine learning algorithm that requires a "training set."

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

This information is not applicable for the same reason as above (not an AI/ML device).

In summary, the 510(k) clearance for the ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads for expanded indications was based on a combination of rigorous nonclinical (bench) testing to verify mechanical performance and engineering specifications, and pre-clinical (animal) testing to demonstrate in vivo safety and effectiveness, particularly hemostasis performance in the newly indicated solid organs (liver, pancreas, kidney, spleen) and associated vasculature. The acceptance criteria were implicitly met by the successful completion and positive outcomes of these tests, demonstrating substantial equivalence to predicates and no new questions of safety and effectiveness for the expanded uses.

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The ATMOS C 051 Thorax is indicated for aspiration and removal of surgical fluids, tissue, gases, bodily fluids, or infectious material from a patient's respiratory system after surgery. The general indication of the ATMOS C 051 Thorax is thoracic drainage.

The ATMOS C 051 Thorax (317.0200.0) drainage system is a device for mobile, digital thoracic drainage. It is portable, mains-independent and has an electronic monitoring system with optical and acoustic display. The device takes medical effect as a system in combination with a secretion canister and a hose system. The system creates the (natural) vacuum in the pleural cavity by draining off air and secretion. The ATMOS C 051 Thorax is equipped with a rechargeable battery. A charging unit which is located within the suction device guarantees the secure charging of the battery. The hose system is rinsed with air at regular intervals to prevent the collection of debris in the hose. Bacterial and viral filters in the secretion canister and measuring hose prevent contaminated secretions from entering the device. The device is equipped with a disposable strap and a carrying handle. These enable mobility. A universal bracket or the standard rail bracket can be ordered separately as accessories. The ATMOS C 051 Thorax is a reusable device delivered in non-sterile state. The secretion canister and hose systems are single-use devices and delivered sterile. All other accessories subject to this submission are reusable and delivered non-sterile.

The provided document is a 510(k) clearance letter from the FDA for a medical device called "ATMOS C 051 Thorax," a powered suction pump for thoracic drainage. While it discusses performance tests and adherence to various standards, it does not contain the detailed clinical study data typically found in a clinical trial report or a comprehensive technical submission.

Therefore, I cannot extract answers for many of your specific questions related to acceptance criteria, ground truth, expert qualifications, adjudication methods, MRMC studies, or training set details from this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance bench testing, software validation, biocompatibility testing, human factors validation, and risk management.

However, I can provide information on what is explicitly stated or can be inferred from the document regarding the acceptance criteria and the nature of the study.

Here's what can be extracted:

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

The document mentions that "Performance tests were carried out to ensure that the subject device functions as intended and meet design specifications." and "Risk analysis was carried out based on acceptance criteria established in accordance with ISO 14971." However, the specific numerical acceptance criteria or the direct reported performance values for each criterion are NOT provided in this summary.

The document lists the following categories of performance tests conducted with "no unexpected results or significant deviations":

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

The document primarily describes bench testing and validation activities rather than a typical clinical study with a "test set" of patient data. Therefore, the concept of sample size as it applies to patient data is not relevant here. The "tests" refer to engineering and quality assurance activities. No country of origin for data or retrospective/prospective nature is mentioned as it's not a clinical data study.

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 provided as there is no mention of clinical "ground truth" derived from expert interpretation in this document. The tests performed are technical and engineering-focused (e.g., flow rates, vacuum levels, battery performance), with human factors validation likely involving usability experts or human factors engineers, but their specific qualifications and number are not detailed.

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

This information is not provided as it's relevant for clinical adjudication of medical images or diagnoses, not for the technical bench testing described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC study was conducted or mentioned. This device is a powered suction pump, not an AI-assisted diagnostic tool.

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

This question is not applicable. The device is a physical medical device (suction pump), not a software algorithm or AI.

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

The "ground truth" for the tests mentioned are engineering specifications, international standards (IEC, ISO), and regulatory guidance documents (FDA guidance). For example, for flow rate, the "ground truth" would be the measured flow rate compared against the predefined design specification. For human factors, it would be the assessment of safety and effectiveness of use against defined usability goals and risk analysis.

8. The sample size for the training set

This question is not applicable. This is not an AI/machine learning device, so there is no "training set."

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

This question is not applicable for the reason stated above.

In summary, the provided document details a 510(k) submission for a non-AI medical device (powered suction pump). The "studies" proving it meets acceptance criteria are predominantly non-clinical bench tests and validation activities against established engineering specifications, international standards, and regulatory guidelines, rather than clinical trials that generate patient data and require expert ground truth establishment.

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The SPROTTE® STANDARD (LUER/ NRFit®) needles are anesthesia conduction needles which are used to administer anesthetic agent to the subarachnoid space.

The subject device, the SPROTTE® STANDARD (LUER/ NRFit®) anaesthesia conduction needle is a single-use anaesthesia conducting intended for administer anesthetic agent to the subarachnoid space. The SPROTTE® cannulas are equipped with a stylet as well as optional with an Introducer. It is available with a LUER respectively with a NRFit® hub. The LUER is either a standard hub, a magnifying hub or a 2.G hub. The cannula tube is straight. The distal connection of the hub is either equipped with a LUER Connector according to ISO 80369-7 or a NRFit-Connector according to ISO 80369-6.

The provided text describes a 510(k) premarket notification for a medical device, specifically SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology needles. The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (SPROTTE NRFit™, Quincke NRFit™) by validating the addition of an alternative sterilization service provider and an alternative packaging material.

The document does not detail acceptance criteria or study results for AI performance or diagnostic accuracy. Instead, it focuses on the physical and biological characteristics of the needle itself, and the validation of manufacturing processes (sterilization and packaging) to ensure sterility and shelf life.

Therefore, many of the requested items (e.g., AI performance, expert ground truth, MRMC studies, training set details) are not applicable to this type of device submission. This is a traditional medical device submission, not an AI/ML-based device.

However, based on the provided text, we can address the applicable criteria:

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

The acceptance criteria are generally implied by adherence to relevant ISO standards and maintaining the same performance characteristics as the predicate device. The "reported device performance" is essentially a "Pass/Fail" determination against these standards.

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: The document indicates that for ISO 9626, "5.7 Sample size" was "Passed", implying a specific sample size was used as per the standard, but the exact number is not provided. For sterility and shelf-life testing, "process most challenging worst case devices" were used, but specific numbers are not given.
• Data Provenance: The manufacturing and testing are stated to occur at PAJUNK GmbH Medizintechnologie in Geisingen, Germany, and the contract sterilizers are in Wiesbaden, Germany (Sterigenics) and Halberstadt, Germany (HA2 Medizintechnik). The data is derived from prospective testing conducted to validate the manufacturing and sterilization processes.

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

This is not applicable. This submission concerns the physical and biological characteristics of a medical device (anesthesia needle) and the validation of its manufacturing and sterilization processes, not the performance of an AI/ML algorithm or diagnostic accuracy involving expert review.

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

This is not applicable. No adjudication method for expert reviews or ground truth establishment is mentioned as this is not an AI/ML or diagnostic performance study. Performance is measured against specific ISO standards and validated processes.

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. This is not an AI-assisted device; it is a physical medical device.

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

This is not applicable. This is not an AI/ML algorithm.

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

The "ground truth" in this context is the adherence to established international standards (ISO series) for medical device design, manufacturing, sterilization, and biocompatibility. For instance, sterility is validated to an SAL of 10^-6 (a defined standard), and material properties are tested against specified values in the ISO standards. The performance characteristics of the new device are directly compared to existing predicate devices and their proven specifications, and confirmed by testing against the same engineering and safety standards.

8. The sample size for the training set:

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

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

This is not applicable.

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The Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, has applications throughout the alimentary tract for the creation of end-to-side, and side-to-side anastomoses in both open and laparoscopic surgeries.

The Signia™ circular adapters are reusable instruments that connect with the assembled Signia™ power handle and Signia™ power shell to make up the Signia™ stapler. The Signia™ circular adapters are composed of motor-mating connectors, sensor gauges and device communication interfaces to provide functionality and communication between compatible reloads and the Signia™ circular adapters are available in two shaft lengths, standard (25 cm) and extra-long (30 cm).

The Signia™ Circular Adapter are for use with the Signia™ stapler, when used with the Signia™ circular adapters and Tri-Staple™ 2.0 circular single use reloads, is a battery powered microprocessor controlled surgical stapler that provides push-button powered operations and firing of compatible reloads. The Signia™ stapler is intended to be used by medical professionals qualified in the transportation, preparation, cleaning, sterilization, and use of surgical devices. The Signia™ stapler is intended for use in a sterile operating room environment in surgical procedures where surgical stapling is indicated. Signia™ Stapler can be used for both linear and circular stapling application depending on the software version installed in the Signia™ power handle.

This FDA 510(k) summary for the Signia™ Circular Adapter (K240881) does not contain information about acceptance criteria or a study proving that an AI/Software as a Medical Device (SaMD) meets such criteria.

The device in question, the Signia™ Circular Adapter, is a surgical stapler component. The document describes its physical and functional characteristics, and the non-clinical testing performed to establish its substantial equivalence to a predicate device. This testing primarily focuses on device performance, safety, and manufacturing quality, not on the performance of a diagnostic or therapeutic AI/software.

Therefore, I cannot provide a response to your request, as the provided input does not include the details regarding acceptance criteria for an AI/SaMD or a study to demonstrate its performance.

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The ETHICON™ 4000 Staplers and ETHICON™ 3D Reloads are intended for transection, resection, and/or creation of anastomoses. The instruments have applications in multiple open or minimally invasive general, urologic, thoracic, and pediatric surgical procedures. They can be used with staple line or tissue reinforcement materials.

The ETHICON™ 4000 Stapler and ETHICON™ 3D Reloads are sterile, singlepatient-use instruments that simultaneously cut and staple tissue. There are six staggered rows of staples, three on either side of the cut line. Together, the ETHICON™ 4000 60 mm Staplers and ETHICONTM 3D Reloads deliver 3D staples in the first, second, fifth and sixth rows of staples. The third and fourth rows (nearest the knife) maintain the traditional 2D B-formed staples.

ETHICON™ 4000 60 mm Staplers have a staple line that is approximately 60 mm long and a cut line that is approximately 57 mm long. The Subject stapler device is available in three different shaft lengths - Compact, Standard and Long. The shaft can rotate freely in both directions and an articulation mechanism enables the distal portion of the shaft to pivot to facilitate lateral access to the operative site. The device is packaged with a primary lithium Battery Pack that must be installed prior to use. There is embedded software to articulate and initiate firing of the device.

The instruments are packaged without a reload and must be loaded prior to use. The instrument may be reloaded for a maximum of 12 firings during a single procedure. A Staple Retaining Cap on the reload protects the staple leg points during shipping and transportation. The instruments' lockout feature is designed to prevent a used or improperly installed reload from being re-fired or an instrument from being fired without a reload.

The staples are permanent implants that provide tissue closure and apposition from the time of implant through the critical phases of healing. The staples remain in place for the patient's lifetime, unless in the opinion of the treating physician, they require removal.

The Subject stapler and reloads will not be compatible with previous ECHELON™ staplers and reloads. This is a new platform that will work with 3D reloads only.

This 510(k) summary is for the ETHICON™ 4000 60mm Staplers and ETHICON™ 3D 60mm Reloads. It focuses on non-clinical testing to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list a table of acceptance criteria with corresponding performance metrics for the reasons stated below. Instead, it indicates that the devices either met or improved upon the predicate devices' performance, or passed functional requirements.

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

The document does not provide specific sample sizes for the test sets used in the non-clinical studies (e.g., staple performance, functional performance, staple line strength, hemostasis, tissue healing).

The data provenance is from non-clinical studies, which implies laboratory or animal testing rather than human subject data. Pre-clinical data for hemostasis and tissue healing response were conducted in "Abdominal and Thoracic procedures," indicating animal models.

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

This information is not applicable as the evaluation relies on non-clinical (bench and pre-clinical animal) testing and not on expert interpretation of human clinical data or images. Ground truth, in this context, would be established by objective measurements and scientific protocols.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation relies on non-clinical testing, not subjective assessments that would require 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

An MRMC study was not done. This device is a surgical stapler and reload system, not an AI-assisted diagnostic or interpretive device that would involve human readers.

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 surgical stapler, which is a physical medical instrument, not an algorithm or software-only device.

7. The type of ground truth used

The ground truth for the non-clinical tests would be established through:

• Objective Measurements: For staple performance, functional performance, and staple line strength, measurements of physical properties (e.g., staple formation, closure force, staple line integrity, burst pressure) would serve as ground truth, compared against pre-defined engineering specifications or predicate performance.
• Histopathology/Pathology and Physiological Measurements: For hemostasis and tissue healing response in pre-clinical animal studies, ground truth would be established through direct observation, macroscopic assessment, histological examination (pathology), and physiological measurements relevant to bleeding control and tissue repair.
• Compliance with Standards: For biocompatibility, ground truth is compliance with the requirements of ISO 10993-1.

8. The sample size for the training set

This information is not applicable. The device is a physical surgical instrument, not an AI/ML algorithm that requires a "training set." The development process would involve extensive engineering design, prototyping, and iterative testing, but not a "training set" in the context of machine learning.

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

This information is not applicable for the reasons stated in point 8.

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aScope 5 Cysto HD is a sterile, single-use, flexible cystoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The cystoscope is intended to provide visualization via a compatible Ambu displaying unit and can be used with endoscopic accessories and instruments.

The aBox™ 2 is intended to display live imaging data from compatible Ambu visualization devices.

The Ambu® aScope™ 5 Cysto HD System is a combination of an endoscope, Ambu® aScope™ 5 Cysto HD, and a compatible displaying unit, Ambu® aBox™ 2.

Ambu aScope 5 Cysto HD is a sterile single-use and flexible endoscope for use within the lower urinary tract. The cystoscope is intended to be used with a compatible and reusable Ambu displaying unit to visualise the urethra and the bladder.

The cystoscope is powered by connecting to the displaying unit. Ambu® aScope 5 Cysto HD can be used with endoscopic instruments and accessories, instillation of fluids (e.g. saline for expanding the bladder) and suctioning of fluids. Ambu ° a Scope 5 Cysto HD shall be disposed of as infected medical device with electronic components.

Ambu® aScope 5 Cysto HD is available in one size and can be operated by either the left or right hand. Two variants of the cystoscope are available: aScope 5 Cysto HD – Reverse Deflection and aScope 5 Cysto HD – Standard Deflection. Apart from the mode of deflection, the cystoscopes share the same design.

The Ambu® aBox™ 2, also referred to as displaying unit, is a non-sterile, reusable digital monitor intended to display live imaging data from Ambu visualization devices. The product consists of a base unit with a 12.8″ LCD screen mounted on the top. The device is powered by an integrated power supply and comes with country specific power cables.

The Ambu® aBox™ 2 has the following physical and performance characteristics:

• Can process and display live imaging data from Ambu® aScope™ 5 Cysto HD to a monitor
• Can record, store and transport image data from Ambu® aScope™ 5 Cysto HD
• Is a portable device with an integrated monitor, and the possibility to connect to an external monitor

The provided text is a 510(k) Premarket Notification summary from the FDA for a medical device called the Ambu® aScope™ 5 Cysto HD System. It describes the device, its intended use, and the testing performed to demonstrate substantial equivalence to legally marketed predicate devices.

However, the document does not contain the detailed acceptance criteria and the study results in the format requested (e.g., a table of acceptance criteria vs. device performance, sample sizes for test/training sets, expert qualifications, clear details on MRMC studies, or specific ground truth methodologies for image-based AI studies).

This 510(k) summary primarily lists the types of tests performed (e.g., bending performance, optical performance tests, biocompatibility, electrical safety) and states that the device "performed as expected and met the test specifications set" or "passed the predefined acceptance criteria." It does not provide the specific numerical acceptance criteria or the actual measured performance values for these tests. Also, there is no mention of AI/ML or image-based diagnostic assistance, so no specific information on AI model training, ground truth establishment through expert consensus, or MRMC studies is present in this document.

Therefore,Based on the provided text, I cannot provide the specific details regarding acceptance criteria and study results in the format requested. The document does not contain this level of detail.

The document states: "In all instances, the Ambu® aScope™ 5 Cysto HD System performed as expected and met the test specifications set. N/A All included bench tests, which have been designed to evaluate substantial equivalence as well as the product's conformity to established quality and performance measures, have been successfully conducted, and have passed the predefined acceptance criteria." This is a general statement of compliance, not a detailed breakdown of criteria and performance.

1. A table of acceptance criteria and the reported device performance: Not provided in the document. The document only lists types of tests (e.g., Bending performance, Irrigation performance, Optical performance tests like Field of view, Sharpness and Depth of field, Resolution, Color performance, Noise performance, Dynamic range) and states they "met the test specifications set" or "passed the predefined acceptance criteria" without giving the specifics.

2. Sample sizes used for the test set and the data provenance: Not provided. The tests mentioned are primarily bench tests, electrical safety, biocompatibility, and stability tests rather than clinical study data from patient cases.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable based on the provided document. This document describes the safety and performance validation of an endoscope and its display unit, not an AI-enabled diagnostic device that would require expert-established ground truth for image interpretation.

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. The device is not an AI-assisted diagnostic tool.

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. For the physical and optical performance tests, the "ground truth" would be established by validated measurement standards and engineering specifications rather than clinical ground truth as understood for diagnostic AI.

8. The sample size for the training set: Not applicable. The device is not an AI/ML model that requires training data.

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

In summary, the provided FDA 510(k) Premarket Notification summary confirms that various non-clinical performance and safety tests were conducted and successfully met predefined acceptance criteria. However, it does not offer the detailed breakdown of the acceptance criteria or reported performance values, nor does it describe AI-specific testing methodologies (like MRMC studies, training/test set details for AI, or expert ground truth). This is likely because the device cleared (endoscope and display unit) is a hardware device where the focus of the submission is on physical, optical, electrical, and biocompatibility performance, not on AI/ML diagnostic capabilities.

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