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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

This document pertains to the 510(k) premarket notification for the "Laparoscope Lens Shield Device (LENS)" by Medeon Biodesign, Inc., designated K200902. The focus of the information provided within this document is on establishing substantial equivalence to a predicate device (K192891) for a slightly modified version of the device, specifically to accommodate a 5mm/30°/30cm standard laparoscope.

Therefore, the acceptance criteria and study proving the device meets these criteria are primarily comparative and based on demonstrating that the modifications do not negatively impact the safety or effectiveness already established for the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Since this submission is based on demonstrating substantial equivalence for a modified device to a predicate device, the "acceptance criteria" here are implicitly related to ensuring the modified device performs comparably and safely to the predicate. The performance testing focuses on verifying that the changes do not introduce new risks or reduce performance.

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

The document does not explicitly state the sample size (number of devices) used for the mechanical performance tests. It mentions "The following mechanical tests have been successfully performed," implying that a sufficient number of samples were tested to demonstrate compliance.

• Sample Size: Not explicitly stated, but implies a sufficient number of devices were tested to validate mechanical performance.
• Data Provenance: The tests were conducted internally by Medeon Biodesign, Inc. ("The mechanical function and structure integrity of modified device were tested..."). The document does not specify the country of origin of the data beyond Taiwan, where the submitter is located. The tests appear to be prospective as they were performed specifically for this 510(k) submission to demonstrate substantial equivalence of the modified device.

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

Not applicable in this context. This is a medical device (laparoscope lens shield) that operates on physical principles (shielding debris, maintaining view). The "ground truth" for its performance is directly measurable through engineering and mechanical tests (e.g., light reflection, field of view). It is not a diagnostic device that requires expert interpretation of outputs to establish ground truth (e.g., radiologists interpreting images).

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is established through direct physical/mechanical testing, not through expert consensus or interpretation requiring adjudication.

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

No, an MRMC study was not done. This device is a physical accessory designed to maintain a clear surgical view, not a diagnostic imaging AI algorithm. Therefore, human reader performance (with or without AI assistance) is not a relevant metric for this device.

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

Not applicable. This is a physical medical device, not an algorithm or AI.

7. The Type of Ground Truth Used

The ground truth for this device's performance is established through direct engineering and mechanical measurements against pre-defined specifications (design input). For example, "Field of view test" and "Light reflection test" would have clear, measurable pass/fail criteria.

8. The Sample Size for the Training Set

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

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

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

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The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose™ - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures, facilitating standard suture closure techniques.

The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by folding the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

This document describes the AbClose - Port Site Closure Device, which is a sterile, single-use device used in laparoscopic procedures for tissue approximation and percutaneous suturing to close incision sites.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly define "acceptance criteria" for performance in a quantitative table. Instead, it states that various tests were performed and "all the results were passed," indicating that the device met the internal design specifications and requirements. The core acceptance is framed around demonstrating substantial equivalence to the predicate device (K160117).

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

• The document does not specify the sample sizes used for each of the mechanical tests or the animal study. It only states that the tests were "successfully performed" with "all the results were passed."
• Data Provenance: The animal study was mentioned, implying prospective data collection for the functional testing. The biocompatibility and mechanical tests are typically lab-based studies. The country of origin for the data is implied to be related to the manufacturer, Medeon Biodesign, Inc., which is based in Taipei, Taiwan.

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

• This information is not provided in the document. The studies described are primarily engineering/laboratory tests and an animal model, not studies requiring human expert adjudication for ground truth (e.g., image interpretation).

4. Adjudication Method for the Test Set:

• This information is not applicable/provided as the studies described do not involve human expert adjudication in the context of diagnostic accuracy or similar tasks.

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 performed. The device described is a surgical instrument (port site closure device), not an AI-assisted diagnostic or interpretive tool.

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

• A standalone performance study in the context of an algorithm or AI was not performed, as the device is a physical surgical tool. The functional animal study could be considered a "standalone" performance test of the device itself.

7. The Type of Ground Truth Used:

• Biocompatibility: Ground truth is established by the well-defined scientific standards and recognized guidance (ISO 10993 series, USP Chapter ) which describe the expected biological responses to materials.
• Mechanical Testing: Ground truth is established by the engineering design specifications and predefined pass/fail criteria for each test (e.g., minimum force, number of cycles, dimensional tolerances).
• Functional Testing (Animal Model): Ground truth is established by the successful execution of the intended surgical function (approximating tissues, closing incision sites) in the animal model, as defined by appropriate veterinary/surgical endpoints. This typically involves observation of successful closure, absence of complications related to the device, and potentially histological examination of the tissue if relevant.

8. The Sample Size for the Training Set:

• This is not applicable as the device is a mechanical surgical instrument, not an AI/ML algorithm that requires a training set.

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

• This is not applicable for the reason stated in point 8.

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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

This document is a 510(k) Premarket Notification for a Laparoscope Lens Shield Device (LENS) for which the device is a laparoscopic accessory lens shield device to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The document describes modifications to a previously cleared predicate device (K170103) to accommodate laparoscopes with a 5mm outer diameter (the previous model accommodated 10mm). The submission is a "Special 510(k) Notification," indicating that the modifications do not raise new questions of safety or effectiveness. As such, the performance testing focuses on demonstrating that these modifications maintain substantial equivalence to the predicate device.

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

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of numerical acceptance criteria with corresponding performance metrics for the modified device in the manner typically seen for diagnostic AI/ML devices (e.g., sensitivity, specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating that the modified device performs similarly to the predicate device and meets established medical device standards.

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

• Sample Size for Test Set: Not specified in terms of number of cases or specific specimens.
• Data Provenance:
  • Biocompatibility: Tested materials (implicitly, the materials used in the modified device). No geographic provenance for materials is given.
  • Mechanical Testing: Performed on the modified device itself.
  • Functional Testing: Performed in an animal model. No specific details on the animal model (e.g., species, number of subjects) or geographic origin are provided.

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

• Not Applicable. This device is a physical medical device (a lens shield), not a diagnostic AI/ML algorithm that requires expert-established ground truth for its performance evaluation (e.g., for image interpretation). The evaluation focuses on physical, chemical, and biological performance characteristics, verified through established testing protocols and animal studies.

4. Adjudication Method for the Test Set

• Not Applicable. As noted above, this is a physical device, and its performance evaluation does not involve diagnostic interpretation or adjudication typically associated with AI/ML systems where ground truth is derived from human expert consensus.

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

• No such study was done. This is a physical accessory device, not a diagnostic AI/ML algorithm that assists human readers in interpreting medical images. Therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant to this device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Not Applicable. This is a physical medical device, not an algorithm. Its function is to physically shield a laparoscope lens, not to perform a standalone diagnostic interpretation.

7. Type of Ground Truth Used

• Biocompatibility: Ground truth is established by meeting the specific pass/fail criteria outlined in the referenced ISO and USP standards (e.g., no cytotoxicity, no irritation, no systemic toxicity above thresholds).
• Mechanical Testing: Ground truth is established by verifying that the device meets its design specifications and maintains structural integrity under tested conditions.
• Functional Testing: Ground truth is established by observing that the device fulfills its intended use (maintaining the intra-operative view by shielding the lens) in the animal model. This is an observational functional assessment rather than a diagnostic "ground truth."

8. Sample Size for the Training Set

• Not Applicable. This is a physical medical device. It does not involve machine learning or AI, and therefore does not have a "training set" in the computational sense.

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

• Not Applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, for various sizes of laparoscopes including standard and bariatric laparoscope, intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS) is a laparoscopic accessory lens shielding device designed to maintain the intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids. The device was deemed substantially equivalent to a previously cleared predicate device (K160172).

Here's an analysis of the acceptance criteria and supporting studies, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary provided does not explicitly define quantitative acceptance criteria for device performance as would be expected for an AI/ML device. Instead, it focuses on demonstrating substantial equivalence to a predicate device by comparing intended use, technological characteristics, and showing that design modifications do not negatively impact safety or effectiveness.

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

The document describes performance testing which can be likened to a "test set" for evaluation.

• Biocompatibility Testing: The sample size for biocompatibility testing is not explicitly stated in terms of number of devices or test repetitions. The provenance is implied to be laboratory testing conducted according to recognized international standards (ISO 10993).
• Mechanical Testing: The sample size for mechanical testing is not explicitly stated. This would involve specific numbers of devices or components undergoing various mechanical stresses. The provenance is implied to be laboratory testing.
• Functional Testing: "Device functionality was tested in the animal model." The document does not specify the number of animals used, the species, or other details of the animal model. The provenance is an animal study.

Given the nature of the device (a physical accessory, not an AI/ML system), the concept of "country of origin of the data" and "retrospective or prospective" as typically applied to clinical data or AI training/test sets is not directly applicable here. The testing described is primarily in-vitro (biocompatibility, mechanical) and pre-clinical (animal model functional).

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

This question is not applicable in the context of this device and the provided document. The ground truth for biocompatibility is established by the results of standardized assays against ISO 10993 criteria, not expert consensus. The "ground truth" for mechanical integrity is adherence to design specifications verified through engineering tests. The "ground truth" for functional testing in the animal model would be the observable ability of the device to shield the lens and maintain the intra-operative view, likely assessed by the surgical team performing the animal procedure, but explicit expert involvement and qualifications for establishing this "ground truth" are not detailed.

4. Adjudication Method for the Test Set

This question is not applicable. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies for AI/ML devices to resolve discrepancies in expert interpretation of medical images or data. The testing described for this physical device does not involve such expert review or adjudication processes for its performance metrics.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance

This question is not applicable. The device is a physical laparoscopic accessory, not an AI/ML system, and therefore does not involve "human readers" or "AI assistance" in the sense of an MRMC study for diagnostic or prognostic AI.

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 laparoscopic accessory, not an algorithm or AI system.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" in this context is implicitly derived from:

• Biocompatibility: Adherence to established biological safety standards (ISO 10993) based on laboratory assays.
• Mechanical Integrity: Compliance with engineering design specifications validated through mechanical testing.
• Functional Performance: Observable effectiveness in maintaining intra-operative view in an animal model. This would likely be clinical observation by the surgical team in the animal study.

8. The Sample Size for the Training Set

This question is not applicable. The device is a physical product, not an AI/ML system, and therefore does not have a "training set."

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

This question is not applicable, as it relates to AI/ML systems which this device is not.

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The AbClose - Port Site Closure Device has application in laparoscopic procedures for approximation of tissues and percutaneous suturing for closing incision sites.

The AbClose - Port Site Closure Device is a sterile, single-use device including 2 major components, Suture Guide and Suture Passer. The device is used with a commercially cleared suture, and is used as a manual instrument to pass needles with suture through soft tissues for suturing. The device is designed with a suture retrieval system for unassisted fascial closures. facilitating standard suture closure techniques. The Suture Guide is structured by a Handle and a Suture Catcher. The pyramid-shape Suture Catcher is controlled by a Push Button to fold the Suture Catcher into cylinder shape for insertion into the trocar wound. Once the Suture Guide is in position, Suture Catcher is expanded back to a pyramid shape to stabilize the device on the trocar wound site. The Suture Passer is a handheld suture grasping device designed to pass sutures through soft tissue. It features a Handle and a stainless steel Needle assembled with a Suture Shaft that grasps a suture. The Suture Passer is designed to work with the Suture Guide to penetrate through soft tissues and deploy suture ends into the Suture Catcher. Withdraw Suture Guide by fold the Suture Catcher into cylinder shape, the two suture ends are securely captured and are ready for user to type knots to close the trocar wound site.

The provided document indicates that the AbClose - Port Site Closure Device has undergone performance testing to demonstrate that it meets performance specifications for its intended use. However, it does not explicitly state acceptance criteria in a quantifiable manner (e.g., specific thresholds for success/failure rates, mechanical strength, etc.) or provide detailed device performance data in a table format.

Instead, the document broadly describes the types of studies conducted and their general conclusions regarding device functionality and safety.

Here's an attempt to structure the information based on your request, with missing information clearly noted:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific, quantifiable acceptance criteria for mechanical tests (e.g., force thresholds, cycles to failure).
• Specific, quantifiable acceptance criteria for animal tests (e.g., success rate of closure, absence of complications).
• Detailed performance results (e.g., numerical data, statistical analysis) from any of these tests.

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

• Sterilization Validation: The document states "Sterilization validation was conducted." It does not specify the sample size (e.g., number of devices tested).
• Mechanical Testing: The document states "Abclose - Port Site Closure Device's mechanical function and structure integrity were tested." It does not specify the sample size (e.g., number of devices tested).
• Animal Test: The document states "The intended use has been conducted by animal test." It does not specify the sample size (number of animals, number of procedures).
• Data Provenance: The document does not explicitly state the country of origin for the data or whether the studies were retrospective or prospective. Given the submitter is in Taipei, Taiwan, it's plausible the studies were conducted there, but this is not confirmed. The context implies these were prospective studies designed to evaluate the device.

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 studies described (sterilization, mechanical, animal) do not typically involve human experts establishing "ground truth" in the same way, for instance, a clinical trial with diagnostic image interpretation would. For animal models, the "ground truth" would be established by the observed physiological and anatomical outcomes/observations by veterinary professionals/researchers, but their specific number and qualifications are not detailed.

4. Adjudication Method for the Test Set

• This information is not provided and is generally not applicable to the types of studies (sterilization, mechanical, animal) described in the document. Adjudication is typically used in studies involving subjective assessments or different interpretations (e.g., clinical trials, image reading).

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

• No, an MRMC comparative effectiveness study was not done. The document describes sterilization validation, mechanical testing, and an animal test. These are not MRMC studies.

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

• This question is not applicable as the AbClose - Port Site Closure Device is a manual medical instrument, not an AI algorithm or a device with an automated "algorithm only" component. Performance is inherent to its mechanical function and interaction within an anatomical context.

7. The Type of Ground Truth Used

• Sterilization Validation: The "ground truth" is measured against industry standards (ISO 11135:2014) for sterility, achieving a specified SAL.
• Mechanical Testing: The "ground truth" is based on the device's design input specifications and the requirement for structural integrity and safety.
• Animal Test: The "ground truth" is the successful physical approximation of tissues and percutaneous suturing for closing incision sites, assessed through direct observation and potentially histological examination in an animal model.

8. The Sample Size for the Training Set

• This information is not applicable as the document describes a mechanical medical device, not a device that utilizes machine learning and therefore does not have 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; there is no training set for this type of device.

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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscope accessory lens shielding device consisting of multi-lumen sheath that slides over the laparoscope. The sheath assembling consists of 2 concentric sheaths: one outer and one end-to-end connected inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The document describes the Medeon Biodesign, Inc. Laparoscope Lens Shield Device (LENS). However, it does not contain a detailed study report that proves the device meets specific acceptance criteria for its performance (e.g., maintaining intra-operative view consistently), nor does it provide a table of acceptance criteria with reported device performance metrics like sensitivity, specificity, accuracy, or effect sizes for human readers.

The provided information primarily focuses on establishing substantial equivalence to a predicate device (K151117) for a modified version of the LENS device, and lists types of tests conducted (biocompatibility, mechanical, functional).

Here's an analysis of what information is available and what is missing based on your specific questions:

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

• Missing. The document confirms that functional testing was performed ("Device functionality was tested in the animal model to demonstrate that the intended use is fulfilled."). However, it does not provide a table of quantitative acceptance criteria for this functional performance (e.g., a specific percentage reduction in lens soiling, or a duration for which the view is maintained without cleaning) nor the reported performance against such criteria. It only states qualitatively that "design modifications do not alter the device function and intended use."

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

• Sample Size: The document mentions "animal model" for functional testing but does not specify the sample size (e.g., number of animals, number of trials).
• Data Provenance: The document does not specify the country of origin for the animal model data. It is implied to be prospective testing carried out for regulatory submission.

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 / Not specified. For a device like a lens shield, ground truth would likely be established based on direct observation of the lens cleanliness or image clarity during the functional tests, not typically through expert consensus on interpretations of output. The document does not mention experts or their qualifications being used to establish ground truth for the functional testing.

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

• Not applicable / Not specified. Adjudication methods are typically relevant for studies where subjective interpretation or classification is involved, often in diagnostic imaging. For a functional device like this, the assessment of "device function and intended use" would likely be based on objective observations (e.g., visual clarity, presence of debris) rather than an adjudication process among multiple reviewers.

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

• Not applicable. This device is a physical laparoscopic accessory, not an AI-powered diagnostic or assistive tool for human readers. Therefore, an MRMC study or AI-related metrics are not relevant to this product.

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

• Not applicable. This device is a physical shield, not an algorithm.

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

• For the functional testing, the ground truth would likely be based on:
  • Direct observation of the laparoscopic view: Assessment of image clarity, presence or absence of debris on the lens.
  • Measurement of physical parameters: Potentially measuring the time before the lens requires cleaning, or the number of cleanings prevented.
• The document states testing was done "to demonstrate that the intended use is fulfilled," which implies a ground truth defined by the successful maintenance of the intra-operative view. However, the specific criteria for this "ground truth" are not detailed.

8. The sample size for the training set

• Not applicable. Historical data or previous versions of the device might implicitly "train" the design process, but for a physical device, there isn't a "training set" in the sense of a machine learning algorithm.

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

• Not applicable. See point 8.

Summary Table of Available Information vs. Missing Information:

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Laparoscope Lens Shield Device (LENS), a sterile, single-use and disposable laparoscopic accessory lens shield device, is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.

The Laparoscope Lens Shield Device (LENS) is a laparoscope accessory lens shielding device consisted of multi-lumen sheath that slides over the laparoscope. The sheaths assembly consists of 3 concentric sheaths: one outer and two inner sheaths. The outer sheath provides protection and cover for the inner sheath and shielding film. It is intended to maintain the intra-operative view of the surgical site during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids The Laparoscope Lens Shield Device (LENS) is intended to be used by clinicians through prescription use only.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria in the context of AI/ML device performance. The document is a 510(k) premarket notification from the FDA regarding a "Laparoscope Lens Shield Device (LENS)."

It outlines:

• Device Description and Intended Use: The device is a sterile, single-use, disposable accessory lens shield intended to maintain intra-operative view during minimally invasive surgery by physically shielding the laparoscope lens from debris, grease, blood, and bodily fluids.
• Substantial Equivalence: The document asserts substantial equivalence to a predicate device (Clear-Vu System) based on similar intended use, target patient/user population, anatomical site, use location, performance, and biocompatibility.
• Differences: Differences from the predicate device are noted in sterilization method (Ethylene Oxide vs. Radiation), energy source (None vs. CO2 Gas), and physical barrier material (PET film vs. CO2 Gas).
• Performance Testing: General categories of performance testing are listed:
  • Biocompatibility testing (in accordance with ISO standards)
  • Sterilization validation (in accordance with ISO 11135)
  • Mechanical testing (to demonstrate design specification fulfillment and structural integrity)
  • Image quality test: "Laparoscope Lens Shield Device (LENS) had been tested for view quality during laparoscopic procedures regarding the resolution, distortion, field of view, depth of view, and color, to demonstrate that adequate view quality of laparoscopy is maintained to a safe and effective clinical use."

However, the document does not provide any specific acceptance criteria (metrics or thresholds) or detailed results from these tests. It merely states that the tests were performed and that the device meets performance specifications or demonstrates adequate view quality.

Therefore, I cannot populate the requested table and information points as there is no data on acceptance criteria, reported device performance, sample sizes, expert involvement, adjudication, MRMC studies, standalone performance, or ground truth details.

The device described is a physical medical device, not an AI/ML diagnostic tool, which the detailed questions about "test set," "training set," "ground truth," "MRMC," and "effect size" typically pertain to.

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