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The KnoxFog Anti-fogging Device is a temporary anti-fog coating and therein inhibits fogging on optical lenses. It is a laparoscopic accessory intended to facilitate intraoperative defogging of laparoscope lenses, thereby maintaining visualization of the surgical site and closed body cavity.

KnoxFog™ is intended for use as an anti-fog solution applied to rigid endoscope lenses prior to insertion into the body to maintain optical clarity during endoscopic procedures.

KnoxFog™ is a semi-sol gel anti-fog coating designed to prevent condensation on endoscopic lenses during surgical procedures. The device is supplied as a sterile solution in single-use containers for application immediately prior to endoscopic procedures. When applied to the endoscope lens, KnoxFog™ forms a transparent hydrophilic coating that prevents fog formation by maintaining optical clarity in high-humidity environments. The product is terminally sterilized using gamma radiation to ensure safety for use in surgical environments.

The provided FDA 510(k) clearance letter for the KnoxFog Anti-fogging Device focuses on the device's technical specifications and substantial equivalence to a predicate device, VitreOx™. However, it does not contain information typically associated with studies proving a device meets acceptance criteria for an AI/ML medical device, which would involve aspects like expert ground truth, multi-reader studies, or large data sets.

The document describes bench testing for an anti-fogging solution, not an AI/ML algorithm. Therefore, many of the requested points regarding AI/ML device studies (e.g., ground truth establishment, training sets, MRMC studies, standalone performance) are not applicable to the information provided.

I can, however, extract the acceptance criteria and performance data for the anti-fogging device based on the provided text.

Acceptance Criteria and Device Performance (KnoxFog Anti-fogging Device)

Based on the provided document, the "acceptance criteria" appear to be implicitly defined by the comparative performance against the predicate device, VitreOx™, specifically in terms of time-to-fog. Other tests (transportation, accelerated aging, biocompatibility) are also performance indicators but without explicit numerical acceptance thresholds provided beyond general "stability," "shelf-life claims," and "biocompatible."

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Note on "Acceptance Criteria": The document doesn't explicitly state numerical acceptance criteria for "Transportation Stability," "Accelerated Aging," or "Biocompatibility." Instead, it states that the tests verified stability, confirmed shelf-life claims, and demonstrated biocompatibility in accordance with standards. The time-to-fog analysis is the most quantitative comparative criterion mentioned.

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

• Sample Size: Not explicitly stated for any of the tests (Time-to-Fog, Transportation, Accelerated Aging, Biocompatibility). The text just mentions "comparative testing" and "studies."
• Data Provenance: Not specified (e.g., country of origin). The studies appear to be bench testing performed by the manufacturer, UV ONE Hygienics, Inc. The document does not indicate if the data was retrospective or prospective in the medical context, as it's a materials science/engineering evaluation rather than a clinical study.

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

• Not Applicable. This device is an anti-fogging solution, not an AI/ML diagnostic or image interpretation device. The "ground truth" would be objective measurements of fogging, material stability, and biological reactions, not expert consensus on medical images.

4. Adjudication Method for the Test Set

• Not Applicable. As above, this is for assessment of an anti-fogging solution, not human interpretation of data requiring adjudication.

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

• No. An MRMC study is relevant for evaluating the impact of AI on human reader performance, typically in interpreting medical images. This device is a topical anti-fogging agent. The "Performance Data" section details bench testing comparing the device's technical performance (time-to-fog, stability) to a predicate, not how it affects human readers.

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

• Not Applicable. This is not an algorithm. The performance data presented (time-to-fog, stability, biocompatibility) are inherently "standalone" in the sense that they measure the physical properties of the device itself.

7. The Type of Ground Truth Used

• Objective Measurements/Material Science:
  • For "Time-to-Fog Analysis": The ground truth is the measurable time until fog formation on the endoscope lens under specific conditions.
  • For "Transportation Testing": The ground truth relates to the physical integrity and continued functionality of the product after simulated transport.
  • For "Accelerated Aging": The ground truth is the product's stability and efficacy over time, extrapolated from accelerated conditions.
  • For "Biocompatibility Testing": The ground truth is established through standardized in vitro and in vivo biological tests (e.g., cytotoxicity, irritation) according to ISO 10993 standards.

8. The Sample Size for the Training Set

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

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

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

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The GOLFF Sterile Anti-Fog Solution is a single-use, medical device, anti-fog solution used by hospital staff to apply on lenses of endoscopic and laparoscopic cameras. The solution is provided in an easy-to-squeeze bottle and comes with an adhesive-backed sponge for secure placement.

GOLFF Sterile Anti-Fog Solution is used to prevent fogging on endoscopic lenses. It ensures clearer vision and avoids unnecessary interruptions during surgery. It also comes with an adhesive-backed sponge, for secure placement, which is also radio-opaque and not made with natural rubber latex. The product is available under reference code GOLFF-R1.

The provided document describes the GOLFF Sterile Anti-Fog Solution, a medical device intended to prevent fogging on endoscopic and laparoscopic camera lenses during surgery. The device's substantial equivalence to predicate devices is established through a series of tests and comparisons.

Here's a breakdown of the requested information:

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

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

The document does not specify exact sample sizes for each individual test. It states "A series of the tests were performed to evaluate the safety and effectiveness of GOLFF Anti-Fog Solution." The data provenance is internal testing performed by Batrik Medical Manufacturing Inc. The document does not specify the country of origin of the data, nor whether the studies were retrospective or prospective, but given they are for a premarket notification, they are by nature prospective for the device under consideration.

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

This information is not provided in the document. The tests performed are primarily benchtop, biocompatibility, and sterilization validation tests, which rely on standardized protocols and empirical measurements rather than expert human interpretation to establish a "ground truth."

4. Adjudication method for the test set

This information is not applicable and not provided. The types of tests conducted (e.g., functional, biocompatibility, sterility) typically involve objective measurements against predefined acceptance criteria, rather than subjective interpretation requiring adjudication among experts.

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 to the GOLFF Sterile Anti-Fog Solution. This device is an anti-fog solution for endoscopes, not an AI-powered diagnostic or imaging device that would involve "human readers" or AI assistance.

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

This is not applicable to the GOLFF Sterile Anti-Fog Solution. This device is a physical product (anti-fog solution), not an algorithm or software.

7. The type of ground truth used

The "ground truth" for the tests performed can be characterized as follows:

• Product Functional Testing: Defined physical and performance characteristics of the device (e.g., non-deformation, effective anti-fogging as per internal protocols).
• Biocompatibility Testing: Compliance with established international standards (ISO 10993 series) for biological responses (cytotoxicity, sensitization, irritation).
• Sterilization Validation: Achievement of sterility assurance levels as defined by international standards (ISO 11137, ISO 11737).
• Product Aging Validation: Maintenance of package integrity, seal strength, sterility, and fog resistance over a simulated shelf-life, as per relevant ASTM and ISO standards and internal protocols.

8. The sample size for the training set

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product that requires a training set.

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

This is not applicable as the GOLFF Sterile Anti-Fog Solution is a physical medical device, not an AI or software product.

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The E-Brik™ Visualization Assistant is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

The E-Brik™ Visualization Assistant is designed as an accessory to be used prior to and during procedures that utilize a laparoscope or endoscope. It is designed to warm the scope above body temperature and apply a warmed surfactant. The device is provided sterile and is intended for single use only in a healthcare facility/ hospital.

The E-Brik™ is activated by the user removing the nonconductive slip sheet from the bottom, completing the battery circuit. Once activated, internal circuitry begins the warming function of the device. The user is alerted to this activation by an LED which is illuminated below both ports. The E-Brik™ has two ports that accept endoscopes and/or laparoscopes ranging from 3mm to 10mm in diameter. Both ports can be used prior to the surgical case to warm the scope(s) before the insertion into a body cavity. The E-Brik™ can act as a scope stand as it is designed to support the main axis of the scope, allowing it to rest horizontally on a flat stable surface. A sterile surfactant solution is added to the ports prior to use, which is warmed when the device is active. The ports allow for the user to apply the warmed surfactant prior to and during the case.

The E-Brik™ is powered by alkaline batteries and has a single-use surgical life of a minimum of 4 hours.

Here's a summary of the acceptance criteria and study information for the E-Brik Visualization Assistant, based on the provided FDA 510(k) summary:

Device Name: E-Brik Visualization Assistant
Intended Use: To be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document doesn't explicitly state quantitative acceptance criteria in a table format with corresponding reported performance values for functional aspects. However, it states that "All necessary verification steps met pre-determined acceptance criteria to confirm substantial equivalence."

The following performance characteristics were tested and "passed," implying they met their respective acceptance criteria:

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KONIX Anti-Fog solution is a sterile, disposable, functional, anti-fog solution. The antifog solution is intended to be used prior to and during endoscopic and laparoscopic procedures to prevent fogging of the scope lens. KONIX Antifog Solution is used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.

Konix Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is released to the market as sterile and disposable with one polyurethane foam pad in a 6 ml polyethylene bottle. Secondary packaging is composed of PET film and Medical Kraft Sealing Paper.

Konix Anti-Fog Solution is intended to be used to prevent the lenses of the imaging device from fogging due to the difference in body temperature before and during endoscopic and laparoscopic procedures.

The mechanism of defogging or anti-fogging action of Konix Anti-Fog Solution, works by physically changing the water droplets that form on the lens surface from round droplets, to a flat transparent sheet of water, a phenomenon known as 'wetting'.

The provided text describes the Konix Anti-Fog Solution, a device intended to prevent fogging of endoscope and laparoscope lenses. The document is a 510(k) premarket notification summary submitted to the FDA. While it highlights safety and effectiveness, it does not include acceptance criteria or a "study that proves the device meets the acceptance criteria" in the way one might expect for a diagnostic AI/ML device.

Instead, the performance data presented focuses on biocompatibility, sterilization validation, shelf-life, and a general "fog resistance test." The "acceptance criteria" for these tests are implied by "Pass" results against established standards.

Here's an attempt to structure the information based on your request, acknowledging the limitations of the provided text for certain categories:

1. Table of Acceptance Criteria and Reported Device Performance

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AMD Anti-Fog Solution is a sterile and single-use laparoscopic accessory device for use prior to and during endoscopic and laparoscopic procedures. The product is intended to prevent condensation of the distal lenses of the endoscopic/ laparoscopic instruments during the surgery. The product is intended for prescription use only.

The AMD Anti-Fog Solution is a single-use, sterile, and biocompatible laparoscopic accessory device. The product is packaged by the Tyvek" Pouch which includes one clear plastic screw top dispenser bottle with the volume of 6 mL and one polyurethane (PU) foam pad with x-ray detectable radiopaque ribbon. The solution is a clear/colorless, odorless, and aqueous solution which comprises of surfactant (≤2%), isopropyl alcohol (≤2%), and water (≥96%). The polyurethane (PU) foam pad is an adhesivebacked sponge with radiopaque ribbon that can be used to introduce the solution into the surface of the lenses.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than defining explicit performance acceptance criteria with numerical targets for the AMD Anti-Fog Solution itself (beyond biocompatibility, sterility, and shelf life). However, the "Performance" row in Table 5.1 and the "Product Performance Test" section provide the core performance claim.

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VitreOx® is a temporary anti-fog coating and therein defogs devices such as a laparoscopic accessory intended to facilitate intraoperative defogging of the laparoscope lens thereby maintaining visualization of the surgical site.

The device, VitreOx®, is a biocompatible, aqueous solution, when used as indicated. In addition, the solution is alcohol-free. It functions in the same manner as the predicate device. The device is intended to be used prior and during minimal invasive surgeries, to prevent fogging of the lens of devices (laparoscope) that provide visualization during the procedure. The device accessory VitreOx®, can be removed from the lens with typical surgical cleaning methods such as scrubbing with soap and water, autoclaving, etc.

It is a sterile, single-use, disposable, long-lasting (beyond average surgery time of 90 minutes) anti-fog solution that can be applied on endoscope and laparoscope lenses, as well as endoscope sheaths. It is effective instantaneously, wet; but is even more lasting if allowed to dry, or applied prior to surgery to lenses.

The provided text describes the performance testing of the VitreOx Anti-fogging Device. However, it does not explicitly state specific acceptance criteria in a quantifiable manner, nor does it present the study results in a formal table directly comparing the device's performance against predefined acceptance metrics. Instead, it describes comparative performance against a control and a predicate device.

Here's an attempt to structure the information based on the provided text, while acknowledging the lack of explicit acceptance criteria and formal reporting:

1. Table of Acceptance Criteria and Reported Device Performance

As explicit acceptance criteria are not provided in the document, I will infer them from the reported observations and comparisons to the predicate device and control. The primary goal of an anti-fogging device is to prevent fogging and maintain visualization.

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

• Sample Size (Animal Study): 2 male Yucatan swine (from the same litter).

• Data Provenance: Prospective animal study conducted in Peoria, Arizona, USA (All Pets Animal Hospital).

• Sample Size (Bench Studies):

  • One handheld endoscope (Clarus 30000-10).
  • One electronic endoscope (generic electronic endoscope 14.55 mm, wide angle).
  • Various diameters of endoscope lenses (1, 1.2, 1.9, 2.7, 3.5, 4, 10 mm) were tested with the solution application methods.

• Data Provenance (Bench Studies): In vitro, simulated closed-body cavity surgical conditions. Location of bench study not explicitly stated but implied to be part of the manufacturer's testing.

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

• The text describes "veterinarians" monitoring and maintaining surgical conditions during the animal study. It does not explicitly state these veterinarians were establishing ground truth for fogging observation or if "experts" formally adjudicated video footage for fogging.
• Qualifications of Experts: "Veterinarians" who administered anesthesia and monitored vitals. Their specific qualifications (e.g., years of experience, board certification) are not detailed.
• Ground Truth Establishment for Fogging Observation: The text states, "Fogging is noted in the experiment: When there is a change of the light reflection on tissue, the light reflection will not be as crisp. In addition, veins on the tissue as also observed, because it will look less defined when fogging is present." This suggests direct visual observation by the study personnel (likely including the veterinarians) during the procedure. It doesn't mention a separate panel of experts for ground truth.

4. Adjudication Method for the Test Set

• Adjudication Method: Not explicitly stated as a formal adjudication process using multiple reviewers. The description implies direct observation and documentation by the study team during the animal procedure. There is no mention of 2+1, 3+1, or similar consensus methods.

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

• No, an MRMC study was NOT done. The study involved comparing the device's performance against a control and a predicate device in an animal model and bench tests. It did not involve multiple human readers assessing cases with and without AI assistance.

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

• This question is not applicable as the VitreOx® is a physical anti-fogging device (an solution/coating), not an AI algorithm. Its performance is entirely "standalone" in the sense that its anti-fogging effect is inherent to the solution itself, without requiring human real-time intervention beyond initial application.

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

• Ground Truth for Fogging: Direct visual observation of fogging characteristics (change in light reflection, clarity of tissue/veins) during live animal procedures.
• Ground Truth for Safety: Clinical observation of the animals post-procedure (for 2 weeks and then 1 year), including physical health, discharge status ("healthy"), and absence of adverse reactions or complications.

8. The Sample Size for the Training Set

• This question is not applicable. The VitreOx® is a physical device/solution, not a machine learning algorithm, so there is no "training set" in the context of AI.

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

• This question is not applicable for the same reason as above (not an AI algorithm).

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The anti-fog solution is intended to be used to prevent 'fogging'' (caused by condensation) on the lenses of endoscopic/ laparoscopic instruments which are likely to fog during use.

Not Found

This appears to be a 510(k) clearance letter from the FDA for a medical device (Medline Anti-Fog Solution). This document does not contain information about acceptance criteria, study details, or performance metrics for a device that typically involves AI or software, as the product is a chemical solution.

The document primarily focuses on:

• Confirming substantial equivalence to a predicate device.
• Outlining regulatory compliance requirements for the manufacturer.
• Stating the intended use of the anti-fog solution.

Therefore, I cannot extract the requested information regarding acceptance criteria, study details, expert involvement, or AI performance. The provided text does not contain any of these elements.

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The LLICS™ is indicated for use in laparoscopic surgeries to clean the laparoscope lens within the surgical cavity, preventing temperature changes associated with lens fogging.

The LLICS sterile system is intended for single-procedure use. Each LLICS package includes two cleaning swabs that can be introduced through an existing surgical trocar or cannula and one bottle of surfactant.

Each cleaning swab consists of a foam tip mounted on a plastic rod, an outer cannula, and an actuator handle.

The surfactant is applied to the foam tip on the cleaning swab. The tip is then retracted into the LLICS cannula before it is introduced through the surgical trocar/cannula. The LLICS cannula helps to keep the foam tip clean while it passes through the existing surgical trocar/cannula.

Once the LLICS device has passed through the surgical trocar/cannula, the surgeon visualizes the end of the LLICS cannula and uses the actuator handle to deploy the surfactant-moistened foam tip. The actuator handle remains outside the body and can be operated with one hand. The surgeon uses the foam tip to clean the endoscope lens and then retracts the tip into the LLICS cannula. The retracted device can be left in the surgical trocar/cannula for additional cleaning cycles or removed to make the trocar/cannula available for introducing other endoscope accessories.

This device is the LLICS™ Laparoscopic Lens Internal Cleaning System. The provided text is a 510(k) summary, which describes the device and its equivalence to legally marketed devices, rather than a detailed study report that establishes novel acceptance criteria and proves the device meets them through clinical or large-scale non-clinical studies for new indications.

The document primarily focuses on demonstrating substantial equivalence to existing devices (D.H.E.L.P. heated endoscope lens protector and Clear Field Sterile Wipes, and other laparoscopic accessories regarding trocar insertion). Substantial equivalence means that the device is as safe and effective as a legally marketed predicate device.

Given this context, the acceptance criteria and study information are presented differently than for a brand new, high-risk device where a comparative effectiveness study or large standalone study might be expected. The "acceptance criteria" here are largely based on the performance of the predicate devices and general safety/effectiveness principles for similar instruments.

Here's an attempt to extract and synthesize the requested information, acknowledging the limitations inherent in a 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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

• Biocompatibility: The summary does not specify the number of devices or experimental units used for each biocompatibility test (cytotoxicity, sensitization, irritation).
  • Data Provenance: Not specified, but generally performed by accredited testing laboratories as part of pre-market submissions. Retrospective in relation to the submission date, but the tests were performed specifically for this device.
• Cleaning Performance: The specific number of endoscopes, cleaning cycles, or repetitions is not specified.
  • Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
• Durability Testing: "Average of 29 cycles" for foam shedding suggests multiple devices or tests were performed, but the exact sample size is not provided.
  • Data Provenance: Bench testing, likely in a controlled laboratory setting. Retrospective.
• Usability Testing: Involved "surgical nurses, scrub technicians, and laparoscopic surgeons." The number of participants for each group is not specified.
  • Data Provenance: Simulated use testing in a surgical suite. Retrospective.
• Training Set Sample Size:
  • Biocompatibility: No specific training set for this type of test; it's a direct pass/fail assessment against established biological response criteria.
  • Cleaning/Durability/Usability: Not applicable for these non-clinical tests in the context of a "training set" as one would consider for an AI/ML algorithm. These are direct performance evaluations.

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

• The summary does not detail the use of "experts" in the traditional sense for establishing ground truth for the test set beyond the general implication that the tests simulate real-world conditions and are evaluated by technical personnel.
• For Cleaning Performance, a "standardized visual reference" was used to assess visibility, which would imply a pre-defined objective standard rather than direct expert consensus on each individual test.
• For Usability Testing, the participants (surgical nurses, scrub technicians, laparoscopic surgeons) were the "users" being observed, and their ability to perform tasks correctly indicated usability, rather than them establishing a separate "ground truth" for the device's performance. The "ground truth" for usability here would be the successful completion of tasks as defined by the study protocol.
• The document does not mention any formal "expert consensus" process or specific expert qualifications for establishing ground truth in the way one might for diagnostic accuracy studies (e.g., radiologists reviewing images).

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is described. The tests appear to be direct performance evaluations against pre-defined criteria (e.g., visual reference for cleaning, integrity for durability, successful task completion for usability, biological response for biocompatibility).

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

• No MRMC comparative effectiveness study was done or reported in this 510(k) summary. This type of study is typically conducted for diagnostic AI devices comparing human performance with and without AI assistance. The LLICS™ is a surgical tool, not a diagnostic imaging device.

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

• Not applicable in the context of this device. The LLICS™ is a mechanical cleaning system and does not involve an algorithm. Its performance is standalone in the sense that its physical function is evaluated, but it is always used by a human surgeon.

7. The Type of Ground Truth Used

• Biocompatibility: Established biological response criteria (e.g., ISO 10993 standards for cytotoxicity, sensitization, irritation).
• Cleaning Performance: "Standardized visual reference" for visibility, and objective assessment of removal of bacon fat/tissue. This is an objective measurement against a defined standard.
• Durability Testing: Objective assessment of material integrity (e.g., "insertion portion remained intact," "no foam shed").
• Usability Testing: Observational data of task completion and absence of use errors by trained medical professionals, against predefined successful completion criteria.
• No pathology, outcomes data, or expert consensus (in the diagnostic sense) was used as ground truth for proving performance. The ground truth is primarily based on objective physical performance and user interaction.

8. The Sample Size for the Training Set

• Not applicable. The LLICS™ is a mechanical device, not an AI/ML algorithm. Therefore, there is no "training set" in the computational sense. The device developers would have designed and prototyped the device, and tested various iterations, but this is part of engineering development, not algorithm training.

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

• Not applicable, as there is no training set for an algorithm.

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The Unimax Anti-Fog Solution is intended to be used to prevent "fogging" (caused by condensation) on the lenses of endoscopic/laparoscopic instruments which are likely to fog during use.

The Unimax Anti-Fog Solution is a clear / colorless, water soluble solution. The model with alcohol is comprised of DPGMME (=2%), Isopropyl alcohol (=6%), and Deionized water (=92%), while the model without alcohol is comprised of DPGMME (=2%) and Deionized water (=98%). Unimax Anti-Fog Solution functions by reducing the surface tension of water, thus preventing water droplets (fog) from forming on the lenses of endoscopic / laparoscopic instruments during use. This solution is bottled in a volume of 6cc's in a 10cc clear plastic dropper bottle. Included in the tyvek pouch packaging of this product is a 4.54.50.5 (LWH) adhesive backed, non-abrasive, x-ray detectable radiopaque/nonradiopaque, polyurethane foam pad for applying the product to endoscopic / laparoscopic lenses. This product is sold sterile to healthcare professionals only.

The provided text describes a 510(k) premarket notification for the "Unimax Anti-Fog Solution." This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving new acceptance criteria for an AI device. Therefore, the requested information about AI device acceptance criteria, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, and standalone performance is not available in the given text.

The document states that a series of safety and effectiveness tests were performed to assess the Unimax Anti-Fog Solution. The results of these tests demonstrate that the device meets its predefined acceptance criteria and intended uses.

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

The document mentions that all test results demonstrate Unimax Anti-Fog Solution meets the requirements of its pre-defined acceptance criteria and intended uses. However, it does not explicitly list the acceptance criteria or specific performance values for the fog resistance test, cleaning ability test, extractable test, or prolonged fog resistance test. It only states that the results indicate the new device is "as safe and effective as the predicate device."

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

This information is not provided in the document.

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 in the document as it refers to a medical device's physical properties, not an AI model requiring ground truth from experts.

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

This information is not provided in the document.

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

This information is not provided in the document. This is not an AI device.

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

This information is not provided in the document. This is not an AI device.

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

This information is not provided in the document. This is not an AI device. The tests performed are laboratory standard tests.

8. The sample size for the training set

This information is not provided in the document. This is not an AI device and does not involve training sets.

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

This information is not provided in the document. This is not an AI device and does not involve training sets.

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The Defogging and Cleaning Solution is a single-use laparoscopic accessory device intended to facilitate intra-operative defogging and cleaning of the laparoscope lens thereby maintaining visualization of the surgical site.

The Minimally Invasive Defogging and Cleaning Solution is a biocompatible surfactant (Docusate Sodium) when used as indicated. It functions in the same manner as the predicate devices. It is intended to be used to prevent fogging of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries. Additionally, the solution can be used to clean the end of the lens of devices (laparoscope) that provide visualization during minimally invasive surgeries (i.e. to rinse lens intra-operatively by rinsing any debris from the lens which becomes attached to the lens as a result of the procedure.)

The provided text describes the Minimally Invasive Devices Defogging and Cleaning Solution (Flo-X) and its equivalence to predicate devices. It includes a summary of performance testing, which serves as the data to prove the device meets certain criteria.

Here's an analysis based on your requested information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" with numerical targets in a formal table like sensitivity/specificity. Instead, it describes performance goals as "effectiveness" and "equivalence" to predicate devices. Since specific criteria are not quantified, I will present the test title as the implicit criterion and the summarized results as the reported performance.

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

• Sample Size: The document does not specify exact numerical sample sizes for most tests.
  • For the acute systemic toxicity test, it mentions "mice" but not the number of mice.
  • For other bench and animal (porcine peritoneal cavity) studies, the sample sizes are not explicitly stated.
• Data Provenance:
  • Country of Origin: Not specified.
  • Retrospective or Prospective: Not specified, but the descriptions of "testing performed" and "studies" imply these were prospective studies designed to evaluate the device.

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 tests seem to be primarily objective (e.g., measuring defogging, cleaning efficacy against a known contaminant like grease, stability analysis) rather than relying on expert subjective evaluation for "ground truth."

4. Adjudication Method for the Test Set:

This information is not provided. Given the nature of the tests (bench and animal, with objective metrics like clearing grease or defogging), it's unlikely that a human adjudication method in the context of clinical image assessment would be relevant or used.

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:

An MRMC study is not applicable and was not done. The device is a "Defogging and Cleaning Solution" for a laparoscope lens, not an AI or diagnostic imaging tool that would assist human readers interpreting medical images.

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 solution, not an algorithm. Its performance is inherent to its physical and chemical properties and is evaluated in its intended use environment.

7. The Type of Ground Truth Used:

The "ground truth" for the performance tests appears to be:

• Objective measures of function: E.g., the visible absence of fog, the visible removal of grease, the stability of chemical properties (pH, concentration, HPLC).
• Comparison to controls/predicates: Water, saline, and legally marketed predicate defogging devices serve as benchmarks for effectiveness and equivalence.
• Biological outcomes: For the toxicity study, "no mortality or evidence of systemic toxicity" in mice served as the outcome/ground truth for safety.

8. The Sample Size for the Training Set:

This question is not applicable. The device is a physical product, not a machine learning algorithm that requires a training set.

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

This question is not applicable for the same reason as #8.

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