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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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MaxiGen™ is an implant intended to fill bony voids or gaps of the skeletal system i.e., posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. MaxiGen™ resorbs and is replaced with bone during the healing process

MaxiGen™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with calcium sulfate and carboxymethylcellulose (CMC). MaxiGen™ comes in the form of a kit with a premeasured and premixed DBM, calcium sulfate, and CMC powder, premeasured mixing solution, the tools for mixing the components, and a 5cc syringe. After the powder is hydrated using all the mixing solution supplied in the kit, the resultant putty can then be handled and placed in the appropriate bone voids, or it can be injected using the syringe supplied in the kit. This product is supplied sterile for permanent resorbable device, implanted in bone tissue.

The provided text does not contain information about acceptance criteria or a study proving that an AI device meets acceptance criteria. The document is an FDA 510(k) clearance letter for a medical device called "MaxiGen™," which is a resorbable calcium salt bone void filler. It describes the device's indications for use, materials, testing for biocompatibility and performance (osteoconduction and osteoinduction), and comparison to predicate devices, but it does not involve any AI technology or related performance metrics.

Therefore, I cannot provide the requested information.

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The BellaFuse™ is an implant intended to fill bony voids or gaps of the skeletal system, i.e. posterolateral spine. These osseous defects are surgically created or the result of traumatic injury to the bone and are not intrinsic to the stability of the bony structure. Bellafuse™ resorbs and is replaced with bone during the healing process.

Device Identification and Materials of Use:
BellaFuse™ is a resorbable bone void filler, combining Human Demineralized Bone Matrix (DBM) with gelatin. The primary component of this BVF product is demineralized particle bone, which is derived from human donor cortical bone. The additional porcine gelatin is a biocompatible component which maintains the shape and enhances flexibility.
Device Characteristics:
This product is provided in several flexible sheet sizes ranging from 10x10x2.5mm to 50x100x5.0mm. It is supplied sterile for single patient use.
Body Contact:
BellaFuse™ is a permanent resorbable device, implanted in bone tissue.

I am sorry, but the provided text does not contain the detailed information necessary to complete the table and answer the questions regarding acceptance criteria, device performance, and study specifics as outlined in your request.

The document is a 510(k) premarket notification summary for a medical device called BellaFuse™. It discusses the device's intended use, description, mechanism of action, and a summary of testing for serological, biocompatibility, osteoconduction, and osteoinductive potential. However, it does not provide:

• Specific numerical acceptance criteria for performance. It states the device "was tested successfully to fully assess the performance to grow bone" and "was shown to have osteoinductive potential," but doesn't quantify these successes with specific metrics or thresholds.
• Detailed reported device performance outcomes. While it mentions new bone growth, it doesn't provide statistical results like sensitivity, specificity, accuracy, or quantitative measures of bone growth in the context of specific acceptance criteria.
• Sample sizes for test sets, training sets, or data provenance. Only a sample size of "nude rat muscle pouch model" (n=?) is mentioned for osteoinductive potential, and no other sample sizes are given.
• Information about experts, ground truth establishment, adjudication methods, or MRMC studies.
• Specifics on how the ground truth for training or test sets was established.

Therefore, I cannot populate the table or answer most of the questions based on the provided text.

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The SurFuse ™ II Putty and ExFuse ™ II Putty are bone filling materials indicated for dental intraosseous, oral and maxillofacial defects, including periodontal/infrabony defects; alveolar ridge augmentation; dental extraction sites; sinus lifts; cystic defects.

The SurFuse ™ II Putty and ExFuse ™ II Putty are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty-like consistency. The ExFuse ™ II Putty also contains cancellous bone powder. They are provided sterile for single patient use. The products are provided sterile for single patient use.

The provided text describes the 510(k) summary for the SurFuse™ II Putty and ExFuse™ II Putty, which are bone grafting materials. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study with specific acceptance criteria and performance metrics in the way a diagnostic device submission might. Therefore, many of the requested elements for acceptance criteria and study design are not explicitly present in the provided text.

Based on the information given, here's what can be extracted and what cannot:

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

The document does not specify quantitative acceptance criteria with numerical targets. Instead, it focuses on demonstrating equivalence through:

• Donor Suitability: Compliance with FDA regulations (21 CFR Part 1270 and Part 1271) and AATB-certified tissue banks for donor bone.
• Viral Inactivation: Validation assessment for potency against HIV-1, BHV, BVDV, HAV, and PPV.
• Biocompatibility: Demonstrated as non-toxic and biocompatible according to ISO 10993.
• Osteoconductivity: Ability to grow bone in vivo in the dog alveolar bone model.
• Osteoinductivity: Osteoinductive potential shown in vivo in the athymic (nude) rat muscle pouch model and correlated with an in vitro BMP-2 ELISA assay.

Since specific quantitative "performance" metrics for these criteria are not given (e.g., "X% reduction in viral load," "Y units of new bone growth"), a direct table with numerical acceptance criteria and reported values cannot be constructed from the provided text. The reported "performance" is qualitative, stating that the devices met these assessments.

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

• Osteoconductivity Study: "dog alveolar bone model." The sample size (number of dogs) is not specified.
• Osteoinductivity Study: "athymic (nude) rat muscle pouch model." The sample size (number of rats) is not specified.
• Data Provenance: The studies are described as in vivo animal models. The country of origin for the studies is not specified, though the submitter is HansBiomed Corp. from Korea, and donor bone is sourced from AATB-certified tissue banks in the United States.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This type of information is not applicable and not provided. The studies involve animal models and in vitro assays, not human clinical evaluations requiring expert interpretation of primary data (like images). The "ground truth" for osteoconductivity and osteoinductivity would be determined by histological analysis and quantitative measures in the animal models and biophysical/biochemical assays, typically assessed by pathologists or laboratory scientists, but the number and qualifications of such individuals are not detailed.

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

This is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used for human reader studies where there's a need to resolve discrepancies in expert interpretations (e.g., radiology case readings). These methods are not relevant to the in vivo animal model or in vitro assay studies described.

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

This is not applicable and not provided. MRMC studies are for evaluating the impact of AI assistance on human diagnostic performance, typically in imaging. This device is a bone grafting material, and its evaluation does not involve AI or human readers for diagnostic purposes.

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

This is not applicable and not provided. This device is a physical material, not an algorithm.

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

• Osteoconductivity and Osteoinductivity: The ground truth appears to be based on pathology/histology and biochemical assays (BMP-2 ELISA) from in vivo animal models. The formation of new bone in the different animal models is the objective ground truth.
• Biocompatibility: The ground truth is established by adherence to ISO 10993 standards for non-toxicity and biocompatibility, likely through in vitro and in vivo tests described in those standards.
• Viral Inactivation: The ground truth is based on the effectiveness of the manufacturing and sterilization processes in inactivating specified viruses, assessed by validation studies.

8. The sample size for the training set

This is not applicable and not provided. The assessment described here involves characterization of the material's biological properties, not machine learning or AI, so there is no concept of a "training set."

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

This is not applicable for the same reason as point 8.

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The SurFuse™ Gel, SurFuse™ Putty, ExFuse™ Gel, and ExFuse™ Putty products are indicated for bony voids or gaps that are not intrinsic to the stability of the bony structure. They are intended to be gently packed into bony voids or gaps of the skeletal system (posterolateral spine). These defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone.

The SurFuse™ and ExFuse™ family of products are derived from human allograft bone tissue that is processed into a powder and demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a resorbable carrier, carboxymethylcellulose (CMC) and formulated into a putty or gel-like consistency. The ExFuse™ products also contain cancellous bone powder. The products are provided sterile for single patient use.

The provided text is a 510(k) summary for the HansBiomed Corp. SurFuse™ and ExFuse™ devices. This type of submission is for medical devices and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with detailed acceptance criteria and performance metrics typically seen for AI/ML-driven software as a medical device.

Therefore, the requested information specifically related to acceptance criteria, sample sizes for test and training sets, expert qualifications, adjudication methods, multi-reader multi-case studies, and ground truth types are not available in the provided document, as these are primarily associated with the validation of AI/ML diagnostic or prognostic algorithms.

The document discusses safety and performance in a more general sense for a bone void filler product, focusing on biocompatibility, osteoinductivity, and osteoconductivity, rather than an AI/ML algorithm's analytical or clinical performance.

Here's a breakdown of what can be extracted and what is missing:

The device is a physical medical device (resorbable bone void filler), not an AI/ML software. Therefore, the parameters typically used to describe AI/ML studies are not relevant or present.

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

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for quantitative metrics in an AI context. Instead, the acceptance is based on demonstrating safety (biocompatibility, viral inactivation) and performance (osteoinductivity, osteoconductivity) through established biological and in vivo models.
• Reported Device Performance:
  • Safety:
    • Donor bone obtained from AATB-certified tissue banks, screened for infectious viruses.
    • Manufacturing and sterilization processes validated to inactivate HIV-1, Bovine Herpes Virus (BHV), Bovine Viral Diarrhea Virus (BVDV), Hepatitis A Virus (HAV), and Porcine Parvovirus (PPV).
    • Biocompatibility testing (according to ISO 10993) performed, demonstrating devices are safe, nontoxic, and biocompatible.
  • Performance:
    • Osteoconductive ability: Successfully grown bone in the in vivo rabbit spinal model.
    • Osteoinductive potential:
      • Demonstrated new bone growth within muscle tissue in the athymic (nude) rat muscle pouch model.
      • Evaluated with a surrogate, in vitro BMP-2 ELISA assay, with results correlated with successful bone formation in the athymic rat for the same lots.
      • Each lot will be evaluated for osteoinductive potential using the in vitro assay.

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

• Sample Size (Test Set): Not specified for human data. For preclinical studies:
  • Rabbit spinal model: Sample size not specified.
  • Athymic (nude) rat muscle pouch model: Sample size not specified.
• Data Provenance: Preclinical animal models (rabbit and rat). Human data (if any for testing) is not described. Donor bone is sourced from AATB-certified tissue banks in the United States.

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. The ground truth for this type of device relies on biological outcomes in animal models (e.g., bone formation observed histologically) and in vitro assays, not on expert human interpretation of medical images or clinical cases.

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

• Not applicable. This is not an AI/ML diagnostic device requiring adjudication of human expert 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 not an AI/ML device that assists human readers.

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

• Not applicable. This is a physical medical device, not an algorithm.

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

• Ground Truth (for performance):
  • Observation of bone formation in vivo (rabbit spinal model, athymic rat muscle pouch model).
  • Results of in vitro BMP-2 ELISA assay correlated with in vivo bone formation.
• Ground Truth (for safety/biocompatibility):
  • Viral inactivation validation studies.
  • ISO 10993 biocompatibility testing results.

8. The sample size for the training set

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

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

• Not applicable. There is no training set for this physical device.

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