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Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are personal lubricants 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. The products are compatible with natural rubber latex and polyisoprene condoms. These products are not compatible with polyurethane condoms.

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are non-sterile, water-based personal lubricants that are compatible with natural rubber latex and polyisoprene condoms. They are not compatible with polyurethane condoms.

Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant are sold as over-the-counter (OTC) products in tube packaging made of low-density polythethylene (outer layer), ethylene vinyl alcohol copolymer (middle layer) and low-density polyethylene (inner layer), ranging from 0.34 fl oz to 8 fl oz, depending on formulation.

These products are composed of purified water, propanediol, oat beta glucan, hyaluronic acid, gluconolactone, sodium benzoate, steviol glycosides, and Nelumbo Nucifera (Lotus) Root water. Depending on the formulation, the flavored formulations contain natural vanilla 1.5X flavor extract, organic coconut flavor concentrate, or organic mint flavor concentrate.

This FDA 510(k) summary provides information for a personal lubricant and as such, it does not involve an AI/ML device. Therefore, many of the requested sections regarding AI/ML device evaluation criteria, such as "Sample sized used for the test set and the data provenance," "Number of experts used to establish the ground truth," "Adjudication method," "Multi reader multi case (MRMC) comparative effectiveness study," "Standalone (i.e. algorithm only without human-in-the loop performance)," "Type of ground truth," "Sample size for the training set," and "How the ground truth for the training set was established," are not applicable to this document.

However, I can provide the acceptance criteria and the study that proves the device meets those criteria, based on the provided text.

Acceptance Criteria and Device Performance for Sutil Luxe Personal Lubricants

The Sutil Luxe Personal Lubricant devices (Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Luxe Coconut Personal Lubricant, and Sutil Luxe Mint Personal Lubricant) were evaluated against several performance parameters to demonstrate their safety and effectiveness.

1. Table of Acceptance Criteria and the Reported Device Performance

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

The document does not explicitly state the sample sizes used for each specific test (e.g., how many units were tested for viscosity, pH, etc.). However, it refers to "testing on samples" for shelf-life, and general "testing" for other parameters. The data provenance (country of origin, retrospective/prospective) is not specified, but the testing would have been conducted as part of a prospective evaluation 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. This is a physical/chemical product, not an AI/ML device requiring expert ground truth for image or data interpretation. Performance is measured using standardized laboratory test methods.

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

Not applicable. This is a physical/chemical product, and performance is determined by meeting objective industrial/pharmacopoeial standards, not by human adjudication of interpretations.

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

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

The "ground truth" for this device is established by meeting predefined, objective specifications and standards set by pharmacopoeias (USP) and international standards organizations (ISO, ASTM). These are laboratory-derived measurements and tests, not human-interpreted ground truth.

8. The sample size for the training set

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

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

Not applicable. This is a physical/chemical product, not an AI/ML device.

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Profisil® Fluoride Varnish is a 5 % sodium fluoride varnish which produces mechanical occlusion of the dentinal tubules in the treatment of tooth hypersensitivity.

Profisil® Fluoride Varnish is designed to securely adhere to the tooth surface for several hours while releasing fluoride ions. The varnish contains 5 % sodium fluoride suspended in a mucosa-friendly, pleasantly flavored dimethicone gel. The varnish is available in following versions: mint, berry and unflavored.

The provided document describes a 510(k) premarket notification for a dental device, "Profisil Fluoride Varnish." This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than conducting new clinical trials for effectiveness. Therefore, the information typically requested about acceptance criteria and studies proving a device meets them for new effectiveness claims, especially those involving AI or comparative effectiveness with human readers, is not directly applicable to this specific submission.

However, the document does detail how the new device demonstrates equivalence to its predicate, focusing on non-clinical performance and biocompatibility. Here's a breakdown of the relevant information provided:

1. Table of Acceptance Criteria and Reported Device Performance

For "Profisil® Fluoride Varnish," the acceptance criteria for non-clinical performance are based on the international standard EN ISO 17730:2020 "Dentistry - fluoride varnishes."

Biocompatibility Acceptance Criteria:

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

• Test set sample size: Not explicitly stated as this is a non-clinical device evaluation. The "test set" would refer to the samples of the Profisil® Fluoride Varnish subjected to the various physical and chemical tests (e.g., specific batches for pH, viscosity, fluoride release tests) and biocompatibility studies (e.g., cell cultures for cytotoxicity, animal models for sensitization/irritation). The exact number of samples tested for each property is not detailed in the summary.
• Data provenance: The standard EN ISO 17730:2020 is an international standard. Biocompatibility standards like ISO 10993 series are also international. The summary indicates these tests were performed to demonstrate compliance with these standards, suggesting laboratory testing specifically for the Profisil® product. There is no information on country of origin of data beyond the manufacturer being based in Germany. The data is prospective as it was generated to support the current submission.

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

This information is not applicable. The "ground truth" for this type of device comparison is based on established scientific and engineering principles codified in international standards (EN ISO 17730:2020 for dental fluoride varnishes) and biocompatibility standards (ISO 10993 series). The results are objectively measured physical and chemical properties and biological responses, not subjective interpretations by human experts in the sense of medical image analysis.

4. Adjudication Method for the Test Set

Not applicable, as the "test set" involves objective laboratory measurements against predefined standard requirements rather than subjective assessments requiring 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

Not applicable. This device is a dental fluoride varnish, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies are irrelevant to this submission.

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

Not applicable for the same reason as above; this is a physical dental material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the current device's performance evaluation is based on International Standards:

• EN ISO 17730:2020 "Dentistry - fluoride varnishes" for physical and chemical properties (pH, dynamic viscosity, fluoride release, SEM).
• ISO 10993 series for biocompatibility studies (cytotoxicity, sensitization, irritation, pyrogenicity, systemic toxicity).

These standards define the acceptable range or nature of results for these properties, which serve as the objective "ground truth" for evaluation.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI algorithm and therefore does not have a "training set."

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

Not applicable.

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MINT Product Family (Including MINT Lift, and MINT-I Sutures) are comprised of PDO and are indicated for use in soft tissue approximation where use of a barbed absorbable suture is appropriate.

These sutures are also indicated for use in face suspension surgery to temporarily fixate the cheek sub dermis in an elevated position.

MINT Product Family Sutures are synthetic, absorbable, sterile, surgical sutures comprised of polydioxanone. These sutures are available in a range of lengths and thicknesses and have bi-directional barbs which hold the suture in position and exert tension throughout the length of the suture. These sutures are provided sterile. They degrade and reabsorb over time.

The provided text is a 510(k) summary for the MINT Product Family of absorbable polydioxanone surgical sutures. It describes the device, its intended use, and argues for substantial equivalence to a predicate device. However, it does not contain the type of AI/ML device performance data, acceptance criteria, or study details (sample sizes, expert consensus, MRMC studies, etc.) that would typically be found for an AI/ML powered medical device.

The document is for surgical sutures, a physical medical device, not an AI/ML software device. Therefore, the requested information about acceptance criteria for an AI/ML device, details of diagnostic performance studies, expert involvement in ground truth, etc., are not present in this document.

The document discusses "non-clinical performance data" and "clinical performance data" related to the physical sutures, but these are for the material properties and safety/effectiveness of the suture itself, not for an AI/ML algorithm's diagnostic performance.

Therefore, I cannot provide the requested information because the provided text is about a physical surgical suture device, not an AI/ML software device.

The document does not describe:

• Acceptance criteria related to AI/ML performance (e.g., sensitivity, specificity, AUC)
• A test set size for an AI/ML model
• Data provenance for AI/ML training/testing
• Number/qualifications of experts for AI/ML ground truth
• Adjudication methods for AI/ML ground truth
• MRMC studies for AI/ML assistance
• Standalone AI algorithm performance
• Type of ground truth for an AI/ML model
• Training set size for an AI/ML model
• How ground truth for a training set was established for an AI/ML model.

What the document does discuss (related to the physical suture device):

• Non-Clinical Performance Data: Bench testing confirming compliance with USP standards for tensile strength, barb holding strength, suture-needle attachment strength, needle corrosion resistance, needle flexural stress, cannula pull testing, and needle penetration testing. Biocompatibility testing per ISO 10993.
• Clinical Performance Data: A review of published clinical literature (10 relevant articles) from regions where the product is available. This literature involved over 500 patients with a minimum of 3 months follow-up (some 22+ months) supporting the safety and effectiveness of the sutures for face suspension surgery. The literature addressed complications associated with the sutures and procedure, not an AI algorithm.

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MINT™ is indicated for use in mid-face suspension surgery to temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.

The MINT™ device is a sterile synthetic absorbable surgical suture comprised of polydioxanone, (GHoOJ)n. Polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment of the violet dye is D&C Violet No.2 (21CFR §74.3602). MINT™ is available in a range of gauge sizes and lengths. Each suture has bi-directional barbs along the long axis of the suture monofilament. The MINT™ Synthetic Absorbable PDO suture approximates tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues. Barbed suture lifting is a minimally invasive surgical technique for facial rejuvenation. The MINT™ Product Family includes models which are supplied with needles. For those models supplied with a needle, designated as "Lifting Thread Combined with needle" in the MINT™ Product Family instructions for use, the needle is used to make the insertion point and for threading of the suture in the patient's dermis.

Here's an analysis of the provided text to extract the requested information about device acceptance criteria and the supporting study:

Device: MINT™ Product Family (Absorbable Polydioxanone Surgical Suture) for mid-face suspension surgery.
Indication: Temporarily fixate the cheek subcutaneous fat layer and SMAS layer in an elevated position for the treatment of moderate to severe nasolabial folds.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a "table of acceptance criteria" with quantifiable targets for the clinical study. However, the primary effectiveness endpoint and several secondary effectiveness evaluations serve as the de-facto acceptance criteria for clinical efficacy. The reported performance for these criteria is extracted below.

2. Sample Size for the Test Set and Data Provenance

• Sample Size (Clinical Study): 62 male and female subjects (referred to as "FA set" in results, with 61 subjects for some analyses).
• Data Provenance: Prospective clinical study. The country of origin of the data is not explicitly stated, but the sponsor, Hans Biomed Corporation, is located in the Republic of Korea, suggesting the study may have been conducted there.

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

• Number of Experts: Unspecified, but referred to as "independent, blinded assessors" and "blinded evaluators." Also, "testers" (who may or may not be the same as independent evaluators) were involved.
• Qualifications of Experts: Not specified. They are generally referred to as "evaluators" or "assessors."

4. Adjudication Method for the Test Set

The document mentions "Independent, blinded assessors" and that the analysis was based on "blinded evaluator Global Aesthetic Improvement Scale (GAIS) ratings" and "comparing the photos... by blinded evaluators." It also refers to "evaluation of independent evaluators" and "evaluation of testers."

However, no specific adjudication method (e.g., 2+1, 3+1, majority vote, etc.) for resolving disagreements between multiple evaluators is described. It implies individual independent ratings were collected and analyzed (e.g., averaging or using individual scores).

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

• No, a MRMC comparative effectiveness study was not done in the sense of comparing human readers' performance with and without AI assistance, as this is a medical device (suture) and not an AI/CADe system for image analysis.
• The clinical study evaluates the device's effectiveness through expert assessment of clinical outcomes (WSRS, GAIS) performed directly on subjects or their photos, not through a reader-AI interaction for diagnosis or interpretation.

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

• Yes, a standalone performance was done for the device in the context of its mechanical and biological properties.
• The "non-clinical performance data" (USP compliance, barb holding strength) and "animal performance data" (absorption, mechanical strength in vivo) represent standalone performance assessments of the physical characteristics of the suture itself, without human intervention in the device's inherent function.
• The clinical study then assessed its performance in vivo in human subjects, which is the ultimate "standalone" performance for a medical implant like a suture.

7. The Type of Ground Truth Used (Clinical Study)

• Expert Consensus and Subjective Scales: The primary ground truth for the clinical study was established using validated subjective rating scales like the 5-grade Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). These were applied by:
  • Independent, blinded assessors/evaluators.
  • Testers (likely clinicians involved in the study).
  • The subjects themselves (for GAIS).
• This represents a form of expert assessment/consensus based on observable clinical outcomes, rather than objective pathology or hard outcomes data like mortality.

8. The Sample Size for the Training Set

• Not Applicable. This document describes a medical device (surgical suture), not an AI/Machine Learning model. Therefore, there is no "training set" in the context of machine learning. The clinical study served as the primary evidence for the expanded indication.

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

• Not Applicable, as there is no training set for an AI/ML model.

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Intended 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. These products are compatible with natural rubber latex condoms and polyisoprene male condoms. These products are not compatible with polyurethane condoms.

Exsens Personal Lubricants are non-sterile, water-based personal lubricants that provide personal lubrication during intimate sexual activity. They are made up of Glycerin, Water, Propylene Glycol, Aroma (Flavor), Aloe Barbadensis (aloe vera) leaf juice, Hydroxyethylcellulose, Sodium Benzoate, Potassium Sorbate, Sodium Saccharin and citric acid. The product is packaged in a 70ml polyethylene white tube with a flip-top cap and protective sleeve. It is for over-the-counter (OTC) use.

The document describes the acceptance criteria and performance data for Exsens Personal Lubricants. This information is presented in the context of a 510(k) premarket notification to the FDA, where the device is compared to a predicate device (K-Y Marilyn Pleasure Gel, K151884) to demonstrate substantial equivalence.

Here's an organized breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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Mint Lesion is a software solution intended to be used for viewing, manipulation, storage, 3Dvisualization and comparison of medical images from multiple imaging multiple time-points. Mint Lesion is a software only medical device which will be delivered on CDROM / DVD to be installed by trained service personnel.

Mint Lesion is a medical diagnostic application for viewing, manipulation and comparison of medical images from multiple imaging modalities and/or multiple time-points. The application supports functional data, such as PET or SPECT as well as anatomical datasets, such as CT or MR. The images can be viewed in a number of output formats including MPR, MIP and volume rendering.

Mint Lesion enables visualization of information that would otherwise have to be visually compared disjointedly. Mint Lesion provides analytical tools to help the user assess, and document the stage of a disease and/or the response to therapy in accordance with user selected standards. Mint Lesion supports the interpretation and evaluation of examinations and follow up documentation of findings within healthcare institutions, for example, in Radiology, Oncology, and Nuclear Medicine environments.

Note: The clinician retains the ultimate responsibility for making the pertinent diagnosis based on their standard practices and visual comparison of the separate unregistered images. Mint Lesion is a complement to these standard procedures. Mint Lesion is not to be used in mammography.

mint Lesion™ is a software based Picture Archiving and Communication System (PACS) used with general purpose computing hardware for the display and visualization of medical image data. It runs on either a native or a virtualized Microsoft Windows platform.

mint Lesion™ functionality provides for communication, storage, processing, rendering, and display of DICOM compliant image data derived from various sources including anatomical datasets (e.g. CT, MRI) and functional datasets (e.g. PET), lesion measurement, tabulation and summation of measurements, lesion categorization and standard evaluation in accordance with radiological staging and response criteria, and generation of a structured report. The user controls these functions with a system of interactive menus and tools.

I am sorry, but the provided text does not contain the specific details about acceptance criteria, the study proving the device meets those criteria, or the detailed information regarding sample sizes, ground truth establishment, or multi-reader multi-case studies.

The document is a 510(k) premarket notification acceptance letter and a summary of the device mint Lesion. It focuses on:

• Substantial Equivalence: Comparing mint Lesion to predicate devices (OncoTrac and Syngo.via MI Workflows) to demonstrate that it is as safe and effective.
• Intended Use: Describing the device's purpose for viewing, manipulating, storing, 3D-visualizing, and comparing medical images for assessment, staging, and documenting disease and therapy response.
• General Information: Manufacturer details, classifications, and regulatory compliance.

While it mentions that "The mint Lesion™ software has been extensively tested on Windows 64 bit systems by members of the development and quality control teams" and that "Verification and Validation activities have been successfully performed," it does not provide any quantitative data, specific acceptance criteria, or details of any clinical or performance studies.

Therefore, I cannot populate the table or provide answers to the specific questions you've asked based on the provided text.

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The MINT™ comprised of PDO is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.

The MINT™ synthetic absorbable PDO suture is made of polydioxanone has been found to be nonantigenic and to elicit only a slight tissue reaction during absorption. The pigment for the violet dye is D&C Violet No.2. The MINT™ is available sterile after ethylene oxide (EO) gas sterilization and degrades or dissolves over time in tissue.

Each dyed (violet) suture has bi-directional barbs along the long axis of the suture monofilament without needle attachment. The MINTM Synthetic Absorbable PDO suture approximate tissues, without the need to tie surgical knots, by using the opposing barbs on the suture surface to embed in the tissues after the surgeon precisely places the suture within the tissues.

While the formation of barbs in the MINT™ reduces the tensile strength relative to non-barbed suture material of the same size, tying of knots in non-barbed suture materials also reduce their effective strength. For this reason, the strength of the MINT™ can be compared with USP knot strength of non-barbed sutures and the USP size of MINT™ is 1 while its tensile strength is equivalent to that of USP 2-0.

The provided text for the MINT™ 510(k) submission (K130191) describes the device, its intended use, and its substantial equivalence to predicate devices, but does not include a study proving device performance against acceptance criteria in the way a clinical trial or algorithm performance study would.

Instead, the document focuses on demonstrating substantial equivalence to a legally marketed predicate device (Quill™ Self-Retaining System) based on similar materials, design features (bi-directional barbs), and intended use. The "Safety and performance" section mentions types of testing performed but does not provide specific performance data or acceptance criteria for those tests.

Therefore, for many of the requested points, the information is not available in the provided text, as this document is a summary for a 510(k) submission, not a detailed study report.

Here's a breakdown of the available and unavailable information based on your request:

Acceptance Criteria and Device Performance Study (K130191 - MINT™ Suture)

1. Table of Acceptance Criteria and Reported Device Performance

• USP monograph for absorbable sutures
• In vitro and in vivo resorption testing
• Biocompatibility testing per ISO 10993
• Barb holding strength evaluation | Document states these tests were performed but does not provide specific numerical acceptance criteria or performance results. The conclusion is that it is "substantially equivalent" to predicate devices, implying it met the necessary performance standards to demonstrate this equivalence. |

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

• Not available: The document does not describe a "test set" in the context of a clinical performance study with a distinct sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission refers to a series of physical and biological tests for the device itself rather than patient data.

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

• Not applicable/Not available: Ground truth is not established in the context of a "test set" for diagnostic performance. The document describes product characteristic testing, not a study requiring expert-derived ground truth.

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

• Not applicable/Not available: No adjudication method is mentioned as there is no "test set" requiring it.

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/Not available: This device is an absorbable surgical suture, not an AI-powered diagnostic or decision support tool. An MRMC study is not relevant to its type of evaluation.

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

• Not applicable/Not available: This is not an algorithm.

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

• Not applicable/Not available: As this is a medical device (suture) and not an AI/diagnostic tool, the concept of "ground truth" as typically defined for such studies is not directly applicable. The "truth" in this context is adherence to physical, chemical, and biological standards (e.g., USP monographs, ISO 10993).

8. The sample size for the training set

• Not applicable/Not available: There is no "training set" as this is not an AI/machine learning device.

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

• Not applicable/Not available: No training set exists.

Summary of Study (as described in the 510(k) Summary):

The "study" described in the provided text is primarily a demonstration of substantial equivalence to existing predicate devices (Quill™ Self-Retaining System and Quill™ Synthetic Absorbable Barbed Suture). This is a regulatory pathway for medical devices where a new device can be marketed if it is shown to be as safe and effective as a legally marketed device that does not require premarket approval (PMA).

The evidence for this substantial equivalence included:

• Material Comparison: The MINT™ is made of the same material (Polydioxanone, PDO) as the predicate.
• Design Comparison: Both the MINT™ and the predicate have bi-directional barbs. The submission notes a difference in barb size and spacing but implies this does not alter substantial equivalence.
• Intended Use Comparison: Both devices share the same indication for use: "soft tissue approximation where use of an absorbable suture is appropriate."
• Safety and Performance Testing: The submission states that various tests were performed in accordance with FDA guidance and USP monographs, including:
  • USP monograph for absorbable sutures (physical properties like tensile strength).
  • In vitro and in vivo resorption testing (how it degrades).
  • Biocompatibility testing as per ISO 10993 (tissue reaction, toxicity).
  • Barb holding strength evaluation.

The conclusion of the submission is that "the MINT™ is substantially equivalent to predicate device as described herein" based on these comparisons and the implied successful completion of the performance tests. The document does not provide the detailed results or specific acceptance criteria for each of these performance tests, as is common in a 510(k) summary which focuses on the overall conclusion of equivalence.

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The Minta Radiofrequency Thermocouple Electrodes are indicated for use in the lesioning of peripheral nerve tissue.

The Minta Ryan RF Thermocouple Electrodes are used in conjunction with the commercially available Neurotherm (K011387), RF Lesion Generators and Pajunk RF disposable cannula (K060397) to create radiofrequency (RF) lesioning of peripheral nerve tissue. The Minta Ryan RF Thermocouple Electrode is a temperature sensor (thermocouple) which is used to deliver RF energy to the tissue. The RF energy is then transferred from the electrode which heats the surrounding tissue to create a lesion. The thermocouple also measures the temperature at the tip of the electrode. The Minta Ryan RF Thermocouple Electrodes are provided as non-sterile re-usable devices (re-processed single use). The Minta Ryan RF Thermocouple Electrode will be available in a variety of lengths and gauges. The Minta Ryan RF Thermocouple Electrode consists of a stainless steel shaft, a PET (polyethylene terephthalate) hub; a non-latex silicone rubber insulated electrical lead and a plug connector.

The provided document is a 510(k) summary for the Minta Ryan RF Thermocouple Electrode. It states that this device is the same device that was previously cleared under K011387, with only a name change. Therefore, the acceptance criteria and the study that proves the device meets them refer to the original submission, K011387, and not to a new study conducted for K090608.

Based on the provided text, here's a breakdown of the requested information:

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

The document does not explicitly state acceptance criteria in a table format with specific quantitative targets. Instead, it refers to the performance established with the predicate device (K011387). The core claim is that the device is the predicate device.

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

The document states that "All non-clinical data for the Minta Ryan RF Thermocouple Electrode was submitted under K011387 to confirm the performance characteristics." It also mentions "functional performance testing" and "compatibility testing" but does not specify the sample size or data provenance beyond asserting the device's long-standing use in the UK, other countries, and the USA since 2001. No specific test set sample size is provided for K090608, as the justification relies on the predicate.

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)

The document does not describe a study involving expert review for establishing ground truth, as it is a submission for a non-clinical device based on equivalence to a predicate. The testing mentioned is for functional performance and compatibility, not diagnostic accuracy requiring expert interpretation.

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

No adjudication method is described, as the evaluation is based on non-clinical performance and compatibility testing, not diagnostic accuracy.

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 done, as this device is a physical electrode, not a diagnostic AI or imaging system. Therefore, there's no mention of human reader improvement or AI assistance.

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

A standalone performance evaluation was implicitly done, as the document refers to "functional performance" and "compatibility testing" of the device itself. However, this is for a physical medical device, not an algorithm.

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

The "ground truth" for this device would be its demonstrated functional performance in generating radiofrequency lesions and its compatibility with specified RF generators and cannulas, established through engineering and performance testing. There's no mention of expert consensus, pathology, or outcomes data as "ground truth" for this type of device submission.

8. The sample size for the training set

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

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

This is not applicable, as there is no training set mentioned for this device.

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The TROJAN® MINT TINGLE™ Latex Condom is used for contraception and for prophylactic purposes (to help reduce the risk of pregnancy and the transmission of sexually transmitted diseases, STDs).

The TROJAN® MINT TINGLE™ Brand Latex Condom is a male condom consisting of a sheath of natural rubber latex with a colored pigment and a flavored water-based lubricant. The condom is a straight-walled, nipple-end condom with a nominal length of 180 mm and an approximate width of 52 mm.

This document is a 510(k) summary for a TROJAN® MINT TINGLE™ Brand Latex Condom, seeking clearance from the FDA. It does not include acceptance criteria or the study details you've requested. The 510(k) process is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific performance criteria through new studies in the same way a PMA (Premarket Approval) might require.

Therefore, I cannot provide the information you asked for based on the provided text, as it is not present in this 510(k) summary. I can only confirm that this document pertains to a condom and its intended uses for contraception and STD prevention, and that it was deemed substantially equivalent to a predicate device.

To give you the information you're looking for, the document would need to include details about:

1. Specific performance tests conducted (e.g., burst strength, leak test, freedom from holes, dimensions).
2. Quantitative acceptance criteria for these tests (e.g., "99.9% freedom from holes").
3. The actual results from testing the TROJAN® MINT TINGLE™ condom against these criteria.
4. Sample sizes used for these performance tests.
5. Ground truth establishment, expert qualifications, adjudication methods, and details about MRMC or standalone studies are generally not relevant for 510(k) submissions of devices like condoms, as they typically don't involve algorithms or image analysis. Their performance is assessed through physical and mechanical property testing and adherence to standards like ASTM D-3492-97.

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Mint Flavour, Blue Colour Powder Free BarrierPro™ Copolymer Rubber Examination Glove is a single use device intended for medical purposes that is worn on the hand of healthcare and similar personnel to prevent contamination between the healthcare personnel and the patient.

Cleantexx TM Mint Flavour, Blue Colour Powder Free Barrier
Pro TM Polybutadiene Copolymer Examination Gloves
meets all the current specifications listed under the ASTM
Specification D 6319-00a, Standard Specification for Nitrile
Examination Gloves for Medical Application. They are
made from BarrierPro TM synthetic copolymer rubber latex, a
polybutadiene based copolymer. They are mint flavour,
blue in colour, are powder free.

The provided text describes the regulatory clearance of "CLEANTEXX™ MINT FLAVOUR, BLUE COLOUR POWDER FREE BARRIER PRO™ POLYBUTADIENE COPOLYMER EXAMINATION GLOVES". This is a medical device, specifically an examination glove, and the submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a new medical diagnosis or treatment through extensive clinical studies like those for AI/ML-based diagnostic devices.

Therefore, many of the requested points are not applicable to this type of device and submission. I will address the relevant points and indicate when information is not provided or applicable.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the acceptance criteria is a series of non-clinical tests performed according to recognized standards and methods.

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

• Sample Size for Test Set: The submission does not specify the exact sample sizes used for each test (e.g., for physical properties, irritation, or sensitization). ASTM standards typically prescribe minimum sample sizes for specific tests.
• Data Provenance: The tests were performed by the manufacturer, LATEXX MANUFACTURING SDN. BHD., located in Malaysia. The tests are non-clinical (laboratory/animal-based) as opposed to human subject data.

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. For this type of device (examination gloves), ground truth is established through objective, standardized physical, chemical, and biological tests, not through expert human interpretation or consensus like in diagnostic imaging. Biocompatibility testing (irritation/sensitization) involves animal models and laboratory analysis.

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

Not applicable. Adjudication methods are typically employed in studies where human expert disagreement on interpretation of data is possible and needs resolution (e.g., in medical image reading). The nature of the tests for examination gloves (physical, chemical, animal-based) does not require such 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

Not applicable. This is not an AI/ML diagnostic device, and therefore, MRMC studies are not relevant.

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

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 for this device is based on objective measurements and observations derived from:

• Standardized test methods (e.g., breaking strength, elongation, dimensions) as specified in ASTM D 6319-00a.
• Laboratory analysis (e.g., USP iodine test for starch).
• Animal test results for biocompatibility (primary skin irritation in rabbits, delayed contact sensitization in guinea pigs).

8. The sample size for the training set

Not applicable. This is not an AI/ML device requiring a training set.

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

Not applicable. This is not an AI/ML device requiring a training set.

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