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CMRP:
The Customized Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

SMRP:
The Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone araft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation.

The subject devices include the Stryker Customized Mandible Recon Plate (CMRP) and Stryker Surgeon iD Mandible Recon Plate (SMRP). Both CMRP and SMRP are intended to be used for rigid internal fixation of primary, secondary mandibular reconstructions, and fixation of mandibular fractures; and have an indication for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction, secondary mandibular reconstruction, and mandibular fracture fixation. Subject devices have similar intended use and technical characteristics as the primary predicate device (K193136) and the reference device (K190696), and the additional language in indications for use statement is supported by the reference device (K014263).

The subject devices' plate(s) are designed and manufactured for one patient and/or surgeon specifically, and the customized patient-specific and surgeon-specific design of the plate(s) allows certain features to be configured to meet the individual needs of each patient and surgeon. The subject devices' plate has additional design configuration options (such as branches and flanges, and updated plate bar widths of 5.75-7.5mm) when compared to the primary predicate device. The subject devices' plate(s) are provided with the Design Proposal document, an Instruction for Use (IFU), and an optional Anatomical Model. Additionally, the subject device is compatible with a separately provided Surgical Guides accessory.

The provided text describes a medical device submission (K222650) for the Stryker Customized Mandible Recon Plate and Stryker Surgeon iD Mandible Recon Plate. It focuses on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets clinical acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth cannot be extracted from this document, as it pertains to clinical performance which was explicitly stated as not required.

However, the document does mention "performance testing" related to mechanical strength and "End User Validation" that met pre-defined acceptance criteria.

Here's the information that can be extracted, and where details are missing:

1. A 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)

• Test Set Sample Size: Not specified for mechanical strength testing (e.g., number of plates tested). Not specified for end-user validation.
• Data Provenance: Not specified.

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)

• Number of Experts: For End User Validation, it refers to "skilled users" and "surgeons," but the specific number is not provided.
• Qualifications of Experts: It specifies "skilled users" and "surgeons" for the end-user validation, but further details on their specific qualifications or experience are not provided.

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

• Not applicable to the mechanical bench testing or the described end-user validation.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a physical medical device (bone plate), not an AI/software device.

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

• Not applicable. This is not an algorithm/AI device.

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

• Mechanical Strength Testing: The "ground truth" or reference for evaluating mechanical strength was established by "the corresponding worst case design" and the tests performed "according to the standards ASTM F382 and ASTM STP 731."
• End User Validation: The "ground truth" was whether the "user needs / design inputs were met." This was assessed by surgeons in a simulated use scenario.

8. The sample size for the training set

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

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

• Not applicable. This device is not an AI/machine learning model.

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Craniomaxillofacial Implants: The Universal CMF System is a Craniomaxillofacial (CMF) plate and screw system intended for osteotomy, stabilization and rigid fixation of CMF fractures and reconstruction.

Mandible Implants: The Universal CMF System (mandible modules) is a mandibular plate and screw system intended for stabilization and rigid fixation of mandibular fractures and mandibular reconstruction.

The subject device (combination of Universal CMF System (K022185) and NewGen/Universal Mandibular System (K014263)) consists of multiple modules including fracture and reconstruction modules. The modules consist of straight, angled, hemi/full mandible bridging, curved, and pre-bent plates. The screws in the modules include 1.2-2.7mm self-tapping, self-drilling, and locking screws that vary from 3mm-42mm in length. The plates and screws are made of commercially pure titanium (ASTM F 67-95) and titanium alloy (ASTM F136-98).

It appears there's a misunderstanding of the provided FDA document. The document, K221855 for the "Universal CMF System," is a 510(k) premarket notification for a bone plate and screw system, which is a physical medical device used for fixing craniomaxillofacial fractures.

It is NOT an AI/ML-driven medical device. Therefore, the document does not contain information about:

• Acceptance criteria for an AI/ML algorithm's performance (e.g., sensitivity, specificity, AUC).
• A "study" proving device performance in the context of an AI/ML algorithm (e.g., clinical trials for AI diagnostic accuracy).
• Test set sample sizes, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or training set details.

The "performance data" section (VIII) refers to:

• Sterilization validation: Ensuring the device can be properly sterilized by the end-user.
• Performance bench testing: Mechanical tests to ensure the physical plates and screws meet engineering standards (e.g., biocompatibility, insertion/removal torque, failure strength). These are standard tests for physical implants, not AI algorithm performance metrics.
• Animal and Clinical Testing: Explicitly states "not required as a basis for substantial equivalence" for this physical device.

In summary, there is no AI/ML component described in this document, and therefore, it's impossible to extract the requested information about AI/ML acceptance criteria and performance studies from it.

The request asks for specific details relevant to the validation of an AI/ML device. Since this document pertains to a physical implantable device, those details simply do not exist within this filing.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental surgeon plans the surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS provides haptic feedback to the surgeon by constraining the motion of the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which for partially edentulous patients include the Chairside Patient Splint (CPS) (K173402) or the Clamped Chairside Patient Splint (CCPS) (K202100), the End Effector (EE) and the Patient Tracker (PT). The CPS or CCPS is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the splint prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the splint on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is a design change to the sleeves in our Edentulous Patient Splint (EPS) (K200805). The EPS enables use of the NGS in fully edentulous patients. It is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS and CCPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The provided text discusses the Neocis Guidance System (NGS) with Edentulous Patient Splint (EPS) and a design change to its sleeves. However, it does not contain a detailed study proving the device meets acceptance criteria for performance, especially not in the context of diagnostic accuracy (e.g., sensitivity, specificity, AUC).

Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Neocis Guidance System (NGS) with Patient Splints, K200805) after a design change to the EPS sleeves. The "Performance Testing" section lists various tests conducted, primarily related to the physical and biological aspects of the device, rather than a clinical performance study.

Therefore, many of the requested elements (like sample size for test/training sets, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, type of ground truth for training) are not available in the provided text for a clinical performance study.

Here's what can be extracted and inferred from the text, focusing on the design change and the tests mentioned:

Acceptance Criteria and Device Performance (Design Change Validation)

The document describes a design change to the sleeves within the Edentulous Patient Splint (EPS) component of the Neocis Guidance System (NGS). The acceptance criteria are implicitly related to ensuring this design change does not negatively impact the safety and effectiveness of the device, and that it remains substantially equivalent to the predicate.

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated for performance tests like "EPS Weighted Deflection Test" or "Total System Accuracy". These are typically engineering verification tests, and the "sample size" would refer to the number of units tested.
• Data Provenance: Not specified for these engineering tests. "Sawbones®" is mentioned, indicating laboratory testing on synthetic bone models. This is not clinical data.

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

• Not applicable for the reported tests. The tests are engineering verification tests, not diagnostic accuracy studies requiring expert-established ground truth.

4. Adjudication method for the test set:

• Not applicable. See point 3.

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 mentioned or conducted. The device is a surgical guidance system, not a diagnostic AI tool for human readers.

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

• Not explicitly described as a standalone algorithm performance study. The "Total System Accuracy" test would assess the device's accuracy in guiding the surgical instrument, which is its primary function (albeit with a human surgeon operating the instrument under guidance). The text focuses on the mechanical and system accuracy of the guidance mechanism itself, not a diagnostic algorithm.

7. The type of ground truth used:

• For mechanical tests: Engineering specifications, precision measurements, or established physical benchmarks are the "ground truth."
• For biological tests: Standards (e.g., ISO 10993) and established laboratory protocols define the "ground truth" for material properties and effects.

8. The sample size for the training set:

• Not applicable. The document does not describe the development or training of an AI algorithm in the context of a "training set" for diagnostic performance.

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

• Not applicable. See point 8.

Summary of Device Performance (from the document's conclusion):
The primary conclusion is that "The design changes to the EPS sleeves have been verified using well established methods. The new design is functionally the same as the predicate device. The subject device different questions of safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate." This implies that all the listed performance tests were successfully passed, ensuring that the modified device remains as safe and effective as its predecessor.

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The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides software to preoperatively plan dental implantation procedures and provides navigational guidance of the surgical instruments. The NGS is intended for use in partially edentulous and fully edentulous adult patients who qualify for dental implants.

The Neocis Guidance System (NGS) (K161399) is a dental stereotaxic instrument (Product Code PLV) and a powered surgical device for bone cutting (21 CFR 872.4120). The Neocis Guidance System (NGS) is a computerized navigational system intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery. The system provides precise and accurate navigational guidance of surgical instruments, with regard to planning in dental implantation procedures. The system allows the user to plan the surgery virtually in software using a cone beam computed tomography (CBCT) scan of the patient, and the plan is used by a guidance system to provide physical, visual, and audible feedback to the surgeon during the implant site preparation. The holds and guides a standard FDA-cleared powered bone cutting instrument.

The implant process occurs in two phases. First, the dental surgical procedure with the planning software. A virtual implant is placed at the desired location in the CT scan, allowing the dental surgeon to avoid interfering with critical anatomical structures during implant surgery. Second, when the implant plan is optimally positioned, the NGS provides accurate guidance of the dental surgical instruments according to the pre-operative plan. The NGS can be used for flapless dental implant procedures, which is a type of minimally invasive surgical approach. The NGS provides haptic feedback to the surgeon by constraining the bone cutting instrument to the plan. This allows the surgeon to feel resistance to attempts at motions that may deviate from the plan.

The patient tracking portion of the NGS is comprised of linkages from the NGS, which include the Chairside Patient Splint (CPS) (K173402), the End Effector (EE) and the Patient Tracker (PT). The Patient Splint is attached to the contralateral side of the patient's mouth over stable teeth. The CPS is placed on the patient using on-label dental materials (K182776) prior to the presurgical CBCT scan. A Fiducial Array (FA) with radio-opaque fiducial markers is placed on the CPS prior to the CBCT scan so the virtual plan can be related to the physical space of the system using the markers. The PT is an electromechanical feedback system that is connected to the CPS on the patient, which relays information to the control software in order to track patient movement. If patient movement occurs during the surgical procedure, the system will respond by altering the prescribed surgical cutting angle, position, and depth to accommodate the patient movement, which will maintain the accuracy of the osteotomy.

The subject of this submission is our Edentulous Patient Splint (EPS). The EPS is affixed to the anterior mandible or maxilla using standard bone screws. Like the CPS, the EPS serves as rigid connection to the patient for robotic tracking of the patient during the procedure. The EPS is intended for use in partially edentulous and fully edentulous adult patients.

Here's a summary of the acceptance criteria and study information for the Neocis Guidance System (NGS) with Patient Splints, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily focuses on demonstrating substantial equivalence to a predicate device (X-Guide Surgical Navigation System, K150222) rather than defining absolute acceptance criteria for novel performance claims. However, specific accuracy metrics are listed and compared.

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The Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.

The Stryker Surgeon iD Mandible Recon Plate is indicated for use in primary mandibular reconstruction with bone graft, temporary bridging until delayed secondary reconstruction and secondary mandibular reconstruction.

The Subject Device, the Stryker Surgeon iD Mandible Recon Plate is intended to be used for rigid internal fixation of primary and secondary mandibular reconstructions.

The Surgeon iD Mandible Recon Plate is a surgeon-specific plate which is designed based on an average mandible model. The plate is designed per surgeon's preference within the following design envelope. The Surgeon iD Mandible Recon Plate is offered in hemi and full shapes and three different sizes (Small, Medium, and Large). The plate can be designed with a profile height of 2.0 mm or 2.8 mm, with a number of screw holes between 4 and 50, and bar widths between 5.5 mm and 6.5 mm. The plate is made of commercially pure titanium.

The provided text describes the Stryker Surgeon iD Mandible Recon Plate and its acceptance criteria, but it primarily focuses on establishing substantial equivalence to a predicate device rather than presenting a standalone study showing device performance against specific, quantifiable acceptance criteria in the manner typically expected for AI/software devices. The acceptance criteria in this document relate more to the validation process rather than direct performance metrics against a clinical standard.

Here's an attempt to extract and interpret the requested information based on the provided text. It's important to note that many sections of your request are not directly applicable or explicitly stated in this type of 510(k) summary for a physical medical device. This summary focuses on materials, design, and comparison to a predicate, not AI performance.

1. Table of Acceptance Criteria and Reported Device Performance

Based on the provided text, the "acceptance criteria" are related to the successful completion of verification and validation (V&V) activities and the functional demonstration that the device performs as intended and is compatible with its packaging.

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

This information is not provided in the document. The text mentions "Verification and Validation activities" and "performance testing" but does not specify sample sizes for these tests or the provenance of any data beyond indicating that existing predicate device data was referenced for some aspects. Given this is a physical implantable device, the "test set" would likely refer to the number of plates or components tested, not a dataset in the AI sense.

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

This information is not applicable as presented. The concept of "ground truth" established by experts, particularly for an AI/software device, is not discussed in this 510(k) summary for a bone plate. Ground truth for a physical device like this is typically established through engineering specifications, material testing standards, and ultimately, clinical outcomes (though clinical trials were not required here).

4. Adjudication Method for the Test Set

This information is not applicable and not provided. Adjudication methods like "2+1" or "3+1" are typically used in clinical studies involving interpretation (e.g., radiology reads) to resolve discrepancies among experts. This 510(k) summary describes bench testing and equivalence to a predicate device, not expert adjudication of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI or diagnostic imaging devices comparing human reader performance with and without AI assistance. This document is for a physical medical device (a bone plate), not an AI diagnostic tool. Clinical testing was explicitly stated as "not required as a basis for substantial equivalence."

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

No, a standalone algorithm performance study was not done. This device is a physical bone plate, not an algorithm.

7. The Type of Ground Truth Used

For this physical device, the "ground truth" for the performance bench testing would be defined by engineering specifications, material science standards, and the expected mechanical behavior of such a plate. For aspects like biocompatibility and sterilization, the ground truth is established by regulatory standards and established test methods that were either performed or referenced from the predicate device. Clinical outcomes data was not a basis for this submission.

8. The Sample Size for the Training Set

This information is not applicable and not provided. The device is a physical bone plate, not an AI model that requires a training set. The design of the plate is based on an "average mandible model" and "surgeon's preference," which are design inputs, not a 'training set' in the machine learning sense.

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

This information is not applicable and not provided. As the device is not an AI algorithm, there is no "training set" or corresponding ground truth to be established in that context.

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The SternalPlate system is indicated for use in stabilization and fixation of fractures of the anterior chest wall including sternal fixation following sternotomy, sternal fracture(s), and sternal reconstructive surgical procedures to promote bony fusion.

The Subject Device System contains various plates with different shapes which allow for intraoperative contouring and cutting of the plates as well as for postoperative emergent cutting. The plates accept screws with a diameter of 2.3mm and 2.7mm. The Subject Device System consists of self-drilling locking screws and self-tapping locking screws. The selfdrilling locking screws are designed to allow for screw fixation with no pre-drilling. The self-tapping locking screws require pre-drilling before insertion. The Subject Device plates and screws are provided non-sterile and are for single use only.

This document describes the Stryker SternalPlate System, a medical device for sternal fixation. It does not provide information directly relevant to the acceptance criteria and study details for an AI/ML-enabled device as requested in the prompt. The document focuses on demonstrating substantial equivalence to a predicate device for traditional medical device clearance, detailing materials, operational principles, and bench testing for physical performance, not AI/ML model performance.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets those criteria for an AI/ML device based on the provided text. The document does not contain any information about a machine learning algorithm, its performance, or how its ground truth was established.

However, I can extract the information provided about the device's general performance testing:

VIII. CONCLUSIONS [§807.92(b)(3)]

The results of the non-clinical data demonstrate the Subject Device will perform as intended in the specified use conditions. According to the comparison based on the requirements of 21 CFR 807.92 and the information provided herein, it is concluded that the information included in this submission supports substantial equivalence.

General Performance Data Presented (Not AI/ML specific):

• Performance Bench Testing:
  • Cleaning Validation
  • Sterilization Validation
  • Biocompatibility
  • Product Design Validation
  • MR Compatibility
  • Screw Performance
  • Plate Performance

Study Findings (Non-AI/ML):

• "The Subject Device met all pre-defined acceptance criteria and standards and was found to not represent a new worst case. Overall, the results of the performance bench tests support the substantial equivalence of the Subject device."

Missing AI/ML Specific Information:

The document explicitly states:

• Animal Testing: "Animal testing was not required as a basis for substantial equivalence."
• Clinical Testing: "Clinical testing was not required as a basis for substantial equivalence."

This further confirms the absence of studies relevant to AI/ML model performance.

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The Stryker® Leibinger Universal CMF and Universal 2.0 Mini Plating Systems are Craniomaxillofacial (CMF) plate and screw systems intended for osteotomy, stabilization of CMF fractures and reconstruction.

The MP LeFort I Plates as part of the predicate subgroup Universal 2.0 Mini Plating System are implants indicated for osteotomy stabilization and rigid fixation of LeFort I fractures of the maxillofacial skeleton.

The LeFort I Plates, which were cleared as part of the overall plate system in K022185, have been modified for use with 2.0 mm screws, more flexible applications, and in-between advancements for stabilizing osteotomies. The proposed modifications to the LeFort I Plates comprise a dimensional design modification for maxillofacial use only. There have been no modifications to the screws, meshes/plates, screwdriver blades, or other accessory devices.

The provided text describes a 510(k) premarket notification for a medical device called "MP LeFort I Plates." This submission aims to demonstrate substantial equivalence to a predicate device, as opposed to providing detailed performance data against specific acceptance criteria for a novel device.

Therefore, the document does not contain the information needed to fill out the table regarding acceptance criteria and reported device performance, nor does it describe a study proving the device meets those criteria in the way one might expect for a new, AI/software-driven medical device.

Specifically, the document states:

• "Biocompatibility and sterility testing was not required as a basis for substantial equivalence."
• "The results of the performance bench tests support the proposed substantial equivalence of the subject device."
• "It is concluded that the information included in this submission supports substantial equivalence."

This indicates that the focus of this submission is on demonstrating that the modified device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel acceptance criteria for a device like an AI algorithm.

Based on the provided text, I cannot describe acceptance criteria or a study that proves the device meets them because the document focuses on demonstrating substantial equivalence through bench testing and material comparisons, not on establishing and meeting new performance thresholds for a device like an AI algorithm.

If this were a submission for an AI/software device, the "Performance Bench Testing" section (VIII) would contain details like the acceptance criteria, metrics, sample sizes, and ground truth establishment methods. However, for this physical bone plate device, it simply lists "Analysis of functional interfaces" and "Fatigue Test" to support substantial equivalence, without detailing specific thresholds or the type of study typically associated with AI performance validation.

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