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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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SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bone structure. They are intended to be gently packed into bony voids or gaps of the skeletal system as a bone void filler in the extremities and pelvis. These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone. These products resorb and are replaced with bone during the healing process.

The submitted devices are resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with cancellous bone powder and carboxymethylcellulose (CMC). The primary component of SurFuse™ and ExFuse™ is demineralized particle bone which is derived from human donor cortical bone. The additional bone powder in the ExFuse™ is derived from human donor cancellous bone. The CMC is added to enhance the cohesiveness of the composition. The submitted devices are provided in several volumes ranging from 0.3cc to 10 cc. The devices are supplied sterile for single patient use.

The provided text describes a 510(k) summary for medical devices (SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, ExFuse™ Putty), which are resorbable calcium salt bone void fillers. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than detailed performance comparisons against acceptance criteria for an AI/software device.

Therefore, much of the requested information (acceptance criteria, sample sizes for test/training sets, experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details) is not applicable or not present in this document, as it pertains to a different type of device evaluation (e.g., AI/ML-based diagnostic software).

However, I can extract information related to the device's performance studies that were conducted to establish its substantial equivalence.

Here's the breakdown of what can be extracted from the document:

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

This document does not specify quantitative acceptance criteria in the manner an AI study would (e.g., sensitivity, specificity thresholds). Instead, the performance is demonstrated qualitatively through in vivo studies to show osteoconductive and osteoinductive potential, indicating equivalence to predicate devices.

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

• Rabbit unicortical defect model: The text states "in vivo rabbit unicortical defect model," but does not explicitly provide the number of rabbits or defects used.
• Athymic (nude) rat muscle pouch model: The text states "in vivo in the athymic (nude) rat muscle pouch model," but does not explicitly provide the number of rats used.
• Data Provenance: The in vivo animal studies are experimental, not retrospective or prospective human clinical data. The bone material itself is derived from human donors in the United States and screened.

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

Not applicable. These are in vivo animal studies (rabbit, rat) and in vitro assays, not studies requiring expert human interpretation of medical images or clinical outcomes. The "ground truth" would be the biological outcome observed and quantified in these animal models (e.g., new bone formation assessed histologically or radiographically by researchers).

4. Adjudication method for the test set

Not applicable. This is not a study involving human readers or clinical 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 document describes bone void filler devices, not AI-powered diagnostic software.

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

Not applicable. This is a medical device, not an algorithm. The in vitro BMP-2 ELISA assay is an in vitro test, which is a standalone lab test, but not an algorithm.

7. The type of ground truth used

• For Osteoconduction and Osteoinductive Potential: The "ground truth" is established through direct observation and measurement of biological outcomes (new bone formation) in animal models. This would typically involve histological analysis, imaging (e.g., X-ray, micro-CT) and potentially biochemical markers.

8. The sample size for the training set

Not applicable. These are in vivo and in vitro performance studies for a medical device, not an AI/ML algorithm requiring a training set in the computational sense. Each lot of the device will be evaluated using the in vitro assay, implying ongoing quality control rather than a training set for an algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm described.

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