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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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JoyDrops® Natural Personal Lubricant Gel is a personal lubricant, for penile and/or vaginal application, intended to moisturize and lubricate, to enhance the ease and comfort of intimate sexual activity, and supplement the body's natural lubrication. This product is compatible with natural rubber latex, polyisoprene, and polyurethane condoms.

JoyDrops® Natural Personal Lubricant Gel is a water-based personal lubricant gel that is contained in a 3.38 fluid ounces (100 mL) polymer container with a pump dispenser.

The provided document is a 510(k) premarket notification for a medical device: Joy Drops™ Natural Personal Lubricant Gel. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving the device meets acceptance criteria through clinical studies involving human readers or AI.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a diagnostic device utilizing AI is not applicable to this document.

The document primarily focuses on:

• Biocompatibility testing: To ensure the product is safe for contact with human tissue.
• Condom compatibility testing: To ensure it doesn't degrade various types of condoms.
• Comparison to a predicate device: To demonstrate substantial equivalence based on intended use, technological characteristics, and safety/performance data.

Here's an attempt to answer the questions based only on the information available for this specific product, acknowledging that many questions are not directly relevant to a lubricant's 510(k) submission:

1. Table of acceptance criteria and the reported device performance

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As stated on Label: Contact medium for ultrasonic and electrical transmission gel.

Konix® Sterile Gel is sterilized by gamma irradiation and intended for use in all diagnostic ultrasound procedures that currently use an ultrasound coupling gel or other fluid, alone or in combination with a transducer cover, where sterlility and in vivo biocompatibility are required. It can be used on the skin where the risk for infections is especially high, especially with oven tissue Doppler applications; and can be used for cystoscopic and ultrasound examinations.

Konix® Serile Gel can be used on the skin or in open tissue where there is a risk for infections, such as in open tissue Doppler applications. It can be used during surgery; for cystoscopic and vaginal ultrasound and Doppler examinations; for cardiac surgery and ultrasound procedures; and as a lubricant in biopsy applications

Konix® Sterile Gel is an in vivo biocompatible sterile couplant intended for use as a scanning gel in surgical procedures, biopsies and similar sterile applications. It is used to couple sound waves between the patient and medical imaging electronic transducers during intraoperative and intracavitary medical diagnostic ultrasound imaging procedures such as transcutaneous ultrasound image guided biopsy and aspiration, doppler examinations of organ and tissue intraoperative ultrasound imaging, intra-cavity ultrasound imaging, and gel infusion sonography.

Major characteristics include:

• No toxic effects; produced as a completely harmiess material .
• Hypoallergenic; non-irritating; no cytotoxicity .
• Water soluble, non-staining and easily cleanable
• Does not contain any lipid components .
• Free from formaldehyde and salt .
• Odorless .
• Gamma radiated to assure sterility .
• Will not damage the probe .
• Does not contain air bubbles .
• pH = 7 .

The provided document is a 510(k) Summary for the Konix® Sterile Gel, an ultrasound coupling gel. The submission is not for an AI/ML device, but for a medical device that establishes substantial equivalence to a predicate device. Therefore, many of the typical acceptance criteria and study design details for AI/ML performance evaluation (like sample size for test sets, data provenance, ground truth establishment by experts, MRMC studies, standalone performance, etc.) are not applicable here.

Instead, the submission focuses on demonstrating the physical, chemical, and biological properties of the Konix® Sterile Gel are substantially equivalent to a legally marketed predicate device (Sterile Aquasonic® 100 Ultrasound Gel).

Here's an analysis of the provided information, framed as closely as possible to your requested structure, while acknowledging the nature of this submission:

Acceptance Criteria and Device Performance for Konix® Sterile Gel

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for Konix® Sterile Gel are implicitly defined by its physical, chemical, and performance characteristics being comparable to, or within acceptable ranges relative to, the predicate device and established standards for sterile ultrasound gels.

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

• Test Set: Not applicable in the context of an AI/ML performance evaluation with a "test set" of cases. The "testing" here refers to laboratory and biocompatibility tests of the gel's properties.
• Data Provenance: The document does not specify the country of origin for the reported test results, but the submitter is from Turkey. The data appears to be from laboratory testing related to the product's physical, chemical, and biological characteristics, performed prospectively as part of product development and regulatory submission.

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

• Not applicable. The "ground truth" for this device relates to established scientific and medical standards for gel properties (e.g., pH, density, sterility) and biocompatibility testing interpretation, not expert consensus on medical image interpretations. The "ground truth" is determined by validated laboratory methods and standard toxicology protocols.

4. Adjudication Method for the Test Set

• Not applicable. This concept relates to resolving disagreements among multiple expert readers in diagnostic classification tasks, which is not relevant for evaluating the physical and biological properties of an ultrasound gel.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI vs. Without AI Assistance

• No. This is not an AI/ML device. MRMC studies are specific to evaluating human reader performance with and without AI assistance in diagnostic tasks.

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

• Not applicable. This term is specific to AI/ML algorithm performance. The Konix® Sterile Gel's "standalone" performance is its intrinsic physical, chemical, and biological properties, which were characterized through various laboratory tests as detailed in the "Performance Test," "Sterility and Shelf-Life," and "Additional Tests" sections.

7. The Type of Ground Truth Used

The ground truth used for evaluating Konix® Sterile Gel consists of:

• Laboratory Measurements: Quantifiable physical and chemical properties (pH, density, viscosity, acoustic impedance, speed of sound).
• Microbiological Standards: Demonstrated absence of microbial growth (sterility) confirmed by standard culture methods.
• Biocompatibility Protocols: Results from in vitro cytotoxicity, in vivo sensitization, irritation tests, and mouse systemic toxicity tests, which are assessed against established pass/fail criteria from standard biological evaluation frameworks (e.g., ISO 10993).
• Shelf-Life Stability: Demonstrated stability over time for specified properties.

8. The Sample Size for the Training Set

• Not applicable. There is no "training set" in the context of an AI/ML model for this device. The development of the gel involved formulation and testing, not machine learning training.

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

• Not applicable. As there is no training set for an AI/ML model, there is no ground truth establishment in that sense. The "ground truth" for the gel's formulation and development would involve standard chemical engineering and pharmaceutical development processes, ensuring ingredients meet quality standards, and the final product has the desired characteristics.

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Konix® Ultrasound Gel is intended for general use as a nonsterile transmission media for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. It is placed on the patient's skin prior to initiating an ultrasound examination. It is indicated for prescription use only.

Konix® Ultrasound Gel consists of deionized water, carbomer, triethanolamine, monopropylene glycol, 5-chloro-2-methyl-4-isothiazolin-3-one and 2-methyl-4-isothiazolin-3 one and is a type of conductive medium, i.e., scanning gel, used in ultrasound diagnostic techniques. A scanning gel acts as a couplant that provides an acoustic pathway between the transducer and the skin. In addition, the gel eliminates air (a disruptive influence) from the interface and adapts the contours of the probe to the skin.

The major characteristics of Konix® Ultrasound Gel include:

• . Hypoallergenic, non-irritating
• Water soluble, non-staining and easily cleanable .
• Does not contain oil and fatty matter .
• Free from formaldehyde and salt .
• No toxic effects .
• Produced as a completely harmless material .
• No smell ◆
• Vacuum treated production .
• Not-damageable to the probe .
• . Does not contain air bubbles
• pH level is 7 .

The Konix® Ultrasound Gel is a medical device designed for general use as a non-sterile transmission medium for acoustically coupling a transducer to a human body surface during external, diagnostic ultrasound imaging procedures. The device's acceptance criteria and studies are primarily focused on demonstrating its acoustic performance and equivalence to existing predicate devices.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria for Konix® Ultrasound Gel were based on its acoustic properties being virtually identical to human skin and other commonly used coupling gels in the United States.

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