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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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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

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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