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The Extracorporeal Shock Wave Lithotripter, model: U200, is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Extracorporeal Shock Wave Lithotripter, U200, is intended to treat urinary tract stones using ESWL. The Extracorporeal Shock Wave Lithotripter generates high-energy shock waves using a shock wave generator that is focused to produce a highly concentrated stress area at the focal point. These pressure pulses are focused on a specific point in the body where the Urinary calculi are located using assisted movement and manual localization through B-ultrasound. The pressure generated by the shock wave causes the human urinary tract stones to produce physical effects to achieve the therapeutic purpose of crushing stones.

The Extracorporeal Shock Wave Lithotripter, U200, is composed of main unit, control console, patient table, electrical cabinet, power supply unit, and computer.

Control platform is integrated control of electric cabinet, main engine and treatment bed.

Electrical cabinet is used to provide power control of the whole machine, and shock wave source function control.

Main Unit contains the L-shape arm and the support matrix of the impact wave source, and realize the movement of L-shape arm up and down, rotation and oscillation of the impact wave source inside and outside.

Power box is power supply of the whole machine, power supply input voltage 120 V, 60 Hz, 3000VA.

Treatment bed is used for patient support and treatment position, and provides three-dimensional movement to allow easy positioning of the stone in the shock wave focus for lithotripsy and urological procedures.

PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling.

Principle of operation:

The extracorporeal shock wave lithotripter generates pressure pulses using an electromagnetic shock wave generator, with water serving as the transmission medium. These high energy shock waves with peak acoustic pressure up to 35MPa are focused on a specific point using a lens. In addition, the lithotripter often incorporates an ultrasound-based assisted movement system which locates and aligns the shock wave focus with the urinary tract stone. The shock waves create a stress effect on the stone. After several hundred to around two thousand discharges, the stones are fragmented into smaller pieces which can be excreted from the body.

This document is a 510(k) clearance letter for an Extracorporeal Shock Wave Lithotripter (U200). It describes the device, its intended use, and the studies conducted to demonstrate its safety and effectiveness.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as quantitative thresholds for the clinical study's primary effectiveness endpoint. Instead, the clinical study aims to demonstrate that the device has a "safety and effectiveness profile that is similar to the predicate device." The reported device performance is presented as successful outcomes in various subgroups. The key performance metrics are "effective rate" for stone fragmentation.

• FAS (Full Analysis Set): 79.2%
• PPS (Per-Protocol Set): 86.4% |
  | Localization Accuracy: Auxiliary positioning target error, number of auxiliary positioning operations, and total time of auxiliary positioning operations should demonstrate relative speed, accuracy, and convenience. | Localization Performance:
• Auxiliary positioning target error: within 3mm
• Number of auxiliary positioning operations: within 3 times
• Total time of auxiliary positioning operations: within 15min
  (Stated as "relatively fast, accurate, and convenient, and the system ergonomics performance is good.") |
  | Safety: Device should be safe with no device malfunctions reported in the clinical investigations. | Safety: "The incidence of device malfunction does not happen in these clinical investigations." "patients treated by the Extracorporeal Shock Wave Lithotripter (model: U200) are safe." |
  | Subgroup Effectiveness (Inferred, as results are presented): Demonstrate effectiveness across different stone sizes, locations, and densities. | Stone Size:
• Stones 5-10mm (FAS): 92.9% effective rate
• Stones 10-15mm (FAS): 60.0% effective rate
• Stones 5-10mm (PPS): 100% effective rate
• Stones 10-15mm (PPS): 66.7% effective rate |
  | | Stone Location:
• Kidney stones (FAS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (FAS): 78.6% effective rate (Upper ureteral: 70.0%, Middle ureteral: 100%, Lower ureteral: 100%)
• Kidney stones (PPS): 80.0% effective rate (Renal calyx: 75.0%, Renal pelvis: 100%)
• Ureteral stones (PPS): 91.7% effective rate (Upper ureteral: 87.5%, Middle ureteral: 100%, Lower ureteral: 100%) |
  | | Stone Density:
• Density 1000HU (FAS): 81.8% effective rate
• Density 1000HU (PPS): 81.8% effective rate |

Study Details from the Provided Text:

1. Sample Size Used for the Test Set and Data Provenance:

   • Clinical Test Set Sample Size: 25 subjects enrolled, 22 subjects completed the study. (4 subjects failed screening, 3 dropped out). The study used both a Full Analysis Set (FAS) and a Per-Protocol Set (PPS) for effectiveness calculation, implying some missing data handled by intent-to-treat (FAS) and per-protocol (PPS).
   • Data Provenance: The clinical investigation was a "multicenter, open-label clinical design." The specific countries of origin for the clinical data are not mentioned, but the manufacturer and correspondent are based in China. The retrospective or prospective nature is not explicitly stated, but "clinical investigations" with "subjects screened," "enrolled," and "followed for a period of follow-up" strongly suggest a prospective study design.

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

   • The document does not explicitly state the number of experts or their qualifications used to establish "ground truth" for stone fragmentation. The primary effectiveness endpoint, "effective rate," is defined based on the outcome of the ESWL treatment, likely assessed clinically (e.g., successful fragmentation and clearance/passage of stones). This assessment would typically be done by treating physicians (urologists) or through imaging (e.g., ultrasound, X-ray) reviewed by radiologists, but the document does not specify.

3. Adjudication Method for the Test Set:

   • The document does not describe any specific adjudication method (e.g., 2+1, 3+1 consensus) for assessing the "effective rate" or other clinical outcomes. It suggests that the clinical outcomes were observed and reported as part of the study.

4. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

   • No. This device is an Extracorporeal Shock Wave Lithotripter, which is a physical medical device for breaking up stones, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and was not performed.

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

   • Not applicable in the AI sense. The device's primary function is a physical therapy. However, the document does mention "PC(OptiPlex 7000 Tower) is used for installation of Extracorporeal Shock Wave Lithotripter Computer Control System, and to realize the Movement Control Support Function and the calibration of shock wave target, and image handling." It also states "Software Verification and Validation was performed, and it was demonstrated that the software performs as intended." This implies a standalone software performance assessment, but not a standalone diagnostic algorithm performance assessment. The device's "localization/stone targeting system" appears to be an integral part of its operation, not a separate diagnostic algorithm.

6. The Type of Ground Truth Used:

   • For the clinical effectiveness endpoint ("effective rate"), the ground truth is based on clinical outcomes (successful stone fragmentation and presumed clearance) observed in patients after receiving ESWL treatment. This would typically be assessed by follow-up imaging and clinical evaluation.
   • For Localization Accuracy, the ground truth was likely established by physical measurements comparing the "target location" to the "shock wave focus."

7. The Sample Size for the Training Set:

   • The document does not mention a separate training set or its sample size for the clinical study. This is a medical device clearance, not an AI model development project where explicit training sets are typically discussed. If any software component used machine learning, details of its training would be relevant, but those are not provided. The clinical study described appears to be a validation/test set for the entire system's clinical performance.

8. How the Ground Truth for the Training Set Was Established:

   • Since no explicit training set for a machine learning model is mentioned, the method for establishing ground truth for a training set is not applicable based on the provided text.

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CS-2012A-3 is intended for use by attending physician in the treatment of all kinds of calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

ESWL, model CS-2012A-3, is an mobile electromagnetic lithotripter with a focal zone to treat patients, the shock wave generator has a high voltage power supply, a closed circuit water supply system with a tank, an spherical concave electromagnetic coil, a membrane and a water cushion (rubber membrane) for the acoustic conductivity of the shock waves to the patient.

It is intended to be used properly by trained and qualified medical personnel for use in noninvasive fragmentation of urinary calculi in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The shock waves are generated by the high voltage discharge through the electromagnetic coil which repels the membrane creating a shockwave. The shockwave is then focused to the focal point. The stones to be fragmented are positioned at this focal point by moving the motorized patient table in 3 axis. The localization is performed with a separate and commercially available mobile fluoroscopic x-ray unit and/or US equipment.

The device includes following parts:

1. ESWL device
   The ESWL device contains therapy head, main switch, control panel, target indicator and foot pedal. It also provides patient with treatment, controls functions of CS-2012A-3.
2. Therapy table
   Therapy table consists of table (For personal hygiene, the table should be covered by disposable medical nonwoven fabrics in treatment), table supporter and 3-dimension movement.

Patient is positioned on therapy table. Table cutout area allows positioning of therapy table near patient, table can be moved as required. Table motion is completely independent of ESWL device. It has its own 3 dimension movement, not to link CS-2012A-3.

The provided document describes the acceptance criteria and study data for the Extracorporeal Shock Wave Lithotripter, model CS-2012A-3.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the device are implicitly demonstrated through its compliance with various standards and the outcome of the clinical study, particularly the success rate. The specific "acceptance criteria" for the clinical study's success rate are not explicitly stated as a numerical threshold in isolation but are presented as the achieved performance which is deemed satisfactory for substantial equivalence.

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

• Sample Size (Clinical Test Set): 144 patients (105 male, 39 female).
• Data Provenance: The document states that "clinical investigations were performed at 2 sites." The country of origin is not explicitly stated for these clinical sites, but the manufacturer is Suzhou Xixin Medical Instruments Co., Ltd. from China, suggesting the studies likely took place in China. The studies were prospective in nature, described as "clinical investigations were performed... to support this application."

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

The document does not specify the "number of experts" or their "qualifications" involved in establishing the ground truth for the clinical test set. It mentions that the device is "intended for use by attending physician" and that "experiences of physicians have shown that patients treated by the CS-2012A-3 are safe and having high evaluations". This suggests that the clinical outcomes (e.g., stone fragmentation, removal) assessed by the attending physicians served as the ground truth, but the details of their roles in data adjudication are not provided.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "overall success rate" was measured, implying a clinical assessment of treatment efficacy by the medical professionals involved in the study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The clinical study focused on the performance of the CS-2012A-3 device itself, not on comparing human readers with and without AI assistance.

6. Standalone (Algorithm Only) Performance

This device is an Extracorporeal Shock Wave Lithotripter, a physical medical device, not an AI algorithm. Therefore, a standalone (algorithm only) performance study is not applicable and was not performed.

7. Type of Ground Truth Used (Clinical Test Set)

The ground truth for the clinical test set was based on clinical outcomes. Specifically, the "overall success rate" of the treatment was measured, with success presumably defined by the fragmentation and/or removal of kidney and ureteral calculi. The document mentions "patients with stones were treated" and the evaluation of the "device function."

8. Sample Size for the Training Set

The document does not refer to a "training set" as this device is a physical medical instrument, not a machine learning or AI model that requires a data training set. The development and validation of the device would have involved engineering tests and potentially pre-clinical studies, but not a data training set in the context of AI.

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

As there is no "training set" in the context of an AI/machine learning device, the concept of establishing ground truth for a training set is not applicable to this device.

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The GEMSS UROCAMP ASADAL-M1, Extracorporcal Shockwave Lithotripter is indicated for fragmentation of kidney stones such as renal calyx stones and renal pelvic stones and for upper, middle, and lower ureteral stones.

The GEMSS UROCAMP Medical Systems Co., Ltd., ASADAL-M1 is an Electromagnetic Extracorporeal Shock Wave Lithotripter that effectively treats urinary calculi. It is routinely used for the fragmentation of kidney and ureteral stones and offers a good combination of clinical performance, and flexibility. The ASADAL-M1 device consists of a Shockwave Generator, an operator interface panel, and a water circulation subsystem. Shock waves are generated on the basis of a principle similar to that used in loudspeakers. An electrical impulse is sent through an inductance soil, generating a magnetic field which repulses a metallic membrane. The acoustic impulse created by this repulsion is focused by an acoustic lens to form a shock wave. A water circulation subsystem is used to provide transmission of shock waves and cooling of the generator. For the ESWL operation to be fully functional, two or three subsystems are provided. The first is a special treatment table. The second and third are a C-arm X-ray fluoroscope and an ultrasound imaging unit. The treatment table is a motorized floating table which can be moved in all three axes.

The GEMSS UROCAMP ASADAL-M1 Extracorporeal Shock Wave Lithotripter is indicated for fragmentation of kidney stones and ureteral stones. The provided text details a clinical study to support its safety and effectiveness, but it does not explicitly state specific acceptance criteria (e.g., stone-free rate, complication rate thresholds) with numerical targets. Instead, the clinical study aims to demonstrate that the device is "safe and without follow-up complications."

Here's an analysis of the provided information:

1. Table of Acceptance Criteria and Reported Device Performance:

As noted, the submission does not explicitly define numerical acceptance criteria for clinical performance (e.g., target stone-free rates or complication rates). It focuses on safety and comparison to predicate devices. The "reported device performance" from the clinical study is qualitative in terms of safety.

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

• Sample Size: 200 patients (142 male and 58 female).
• Data Provenance: The studies were performed at "two sites." The country of origin is not explicitly stated for the clinical sites, but the company is based in Korea. The study appears to be prospective as it describes "clinical investigations were performed... with one and two week follow-ups."

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

• The text mentions "The experiences of physicians have shown that patients treated by the ASADAL-M1 are safe and without follow-up complications."
• The number and specific qualifications of the physicians/experts are not detailed. It refers to "physicians" generally, implying the clinicians who performed the treatments and follow-ups.

4. Adjudication Method for the Test Set:

• The document does not describe any explicit adjudication method (e.g., 2+1, 3+1). The safety and lack of complications appear to be assessed by the treating physicians.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was NOT done. The study described focuses on the device's safety and effectiveness in a standalone clinical investigation demonstrating its performance post-treatment. There is no mention of comparing human readers' performance with and without AI assistance. This device is a lithotripter, not an AI-powered diagnostic tool.

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

• This question is not applicable as the device is a medical device for therapeutic intervention (lithotripsy), not an algorithm for diagnosis or image interpretation. The clinical study described evaluates the device's performance directly on patients.

7. The Type of Ground Truth Used:

• The "ground truth" for the clinical study was based on clinical outcomes and physician assessment of safety and absence of complications among treated patients, observed during follow-up visits. This is an outcomes data approach, specifically focusing on the absence of adverse events and perceived safety/effectiveness by clinicians.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device (lithotripter), not an AI algorithm that requires a training set of data.

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

• Not applicable. As the device is not an AI algorithm, there is no training set or ground truth establishment relevant to an AI model's training.

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The Genestone Exel (XL) Extracorporeal Shock Wave Lithotripter is indicated for use in the non-invasive disintegration of kidney (renal pelvis and renal calyceal) and upper ureteral stones between 5 and 20 mm in size.

Not Found

This document is a 510(k) clearance letter for the Genestone Exel (XL) Extracorporeal Shockwave Lithotripter. It acknowledges that the device is substantially equivalent to legally marketed predicate devices. However, this letter does not contain any information about acceptance criteria or a study proving the device meets those criteria.

A 510(k) clearance evaluates substantial equivalence to a predicate device, not necessarily new performance data against specific acceptance criteria. To find the information you requested, one would typically need to review the original 510(k) submission document itself, which is not provided here.

Therefore, I cannot provide the requested information based on the provided text.

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The Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Twinheads® TH-103 ESWL is a spark gap dual head shock wave lithotripter for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-103 delivers a pair of shock wayes, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing legally marketed C-arm fluoroscopy system via two orientations. Also included is an accurate motorized table with carbon fiber top.

The provided document does not contain information about the acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML device. The document describes a traditional medical device, a lithotripter, and its clearance process through a 510(k) submission.

Here's a breakdown of why the requested information is absent and what the document does say:

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

• Not applicable to this document. This document is for a physical medical device (Twinheads® TH-103 Extracorporeal Shock Wave Lithotripter), not an AI/ML device. Acceptance criteria for such a device would typically involve mechanical specifications, safety features, energy delivery parameters, and clinical efficacy (e.g., stone-free rates, re-treatment rates), which are not explicitly detailed as acceptance criteria in this summary. The "reported device performance" would typically be derived from clinical studies or non-clinical tests, neither of which are extensively detailed or used to establish "acceptance criteria" in this 510k summary.

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

• Not applicable to this document. No test set in the context of AI/ML validation is mentioned.

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 to this document. No ground truth for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No adjudication method for an AI/ML test set is mentioned.

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 to this document. No MRMC study or AI assistance is mentioned.

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

• Not applicable to this document. The device is a physical lithotripter, not an algorithm.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

8. The sample size for the training set

• Not applicable to this document. No training set for an AI/ML algorithm is mentioned.

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

• Not applicable to this document. No ground truth for an AI/ML algorithm is mentioned.

What the document does state regarding acceptance criteria and studies:

The document explicitly states:

• "No clinical studies were performed."
• The premise for clearance is substantial equivalence to a predicate device (Twinheads® TH-101 ESWL, K030346).
• The Twinheads® TH-103 ESWL is described as a "modification" of the predicate device, having the "same fundamental scientific technology and intended use."

Therefore, the "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context are interpreted as the FDA's "substantial equivalence" determination, based on the device having similar technological characteristics and intended use to a previously cleared device, without the need for new clinical data. The "proof" is the comparison to the predicate device and the claim that the modifications do not change the fundamental scientific technology.

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The Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter is intended to fragment urinary stones in the kidney (renal pelvis and renal calyces) and ureter (upper, middle, and lower ureter).

The Twinheads® TH-101 ESWL is a spark gap dual head shock wave lithotripter with an integrated fluoroscopy system for the fragmentation of kidney and ureteral calculi. The Twinheads® TH-101 delivers a pair of shock waves, which are separated from each other by a certain delay time, with perpendicular trajectories and overlapping focal zones. The pulse pairs or twin shocks are aligned with the calculi or stone utilizing the fluoroscopy system via two orientations. A rapid current pulse discharges through a small gap in each of the two heads. The pulse discharge creates a shock wave, which radiates outward. Two identical ellipsoid reflectors serve to reflect and focus the shock waves, which are transmitted into the patient by a water cushion through a membrane and contact gel. There are two shockwave sources and two cushions in the Twinheads® TH-101 ESWL. Also included are an accurate motorized table and U-arm movements, high resolution fluoroscopy, and efficient shock wave energy sources.

The provided document describes a 510(k) premarket notification for the Twinheads® TH-101 Extracorporeal Shock Wave Lithotripter. The acceptance criteria and the study proving the device meets them are outlined in section 7, "Clinical study."

1. Table of Acceptance Criteria and Reported Device Performance:

The document implicitly refers to the special controls guidance for ESWL devices as the acceptance criteria. The specific performance metrics assessed in human clinical trials for a new ESWL device would typically include:

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 20 patients.
• Data Provenance: The study was conducted at "two sites." The document does not specify the country of origin, but given the 510(k) submission to the FDA, it is highly probable the data was collected in the United States.
• Retrospective or Prospective: Prospective, as it states "20 patients were treated" indicating a clinical trial was performed.

3. Number of Experts and Qualifications for Ground Truth:

The document does not explicitly state the number of experts used to establish the ground truth or their specific qualifications (e.g., radiologist with 10 years of experience). In a clinical study for a lithotripsy device, the success of "stone fragmentation" would typically be assessed by the treating urologists or other medical specialists involved in post-procedure imaging and patient follow-up.

4. Adjudication Method for the Test Set:

The document does not specify an adjudication method (e.g., 2+1, 3+1) for assessing the outcomes of the clinical study.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or indicated in this summary. The study described is a confirmatory clinical study to demonstrate the device's functionality, safety, and effectiveness, not a comparison of human reader performance with and without AI assistance.

6. Standalone (Algorithm Only) Performance:

No, a standalone (algorithm only) performance study was not conducted. This device is a physical medical device (Extracorporeal Shock Wave Lithotripter), not an AI algorithm. The study described assesses the device's ability to fragment stones in patients.

7. Type of Ground Truth Used:

The ground truth used was based on clinical outcomes (successful stone fragmentation) and safety assessments (absence of unanticipated adverse effects) in treated patients. While not explicitly detailed, these assessments would involve post-treatment imaging and clinical evaluation by medical professionals.

8. Sample Size for the Training Set:

The document does not mention a "training set" in the context of an AI/ML algorithm. This device is a physical lithotripsy machine; therefore, the concept of a training set for an algorithm is not applicable here. The "clinical study" described serves as the primary evidence for its intended use, rather than a separate training and test set distinction typically associated with AI.

9. How Ground Truth for Training Set Was Established:

As there is no training set for an AI algorithm, this question is not applicable. The device's fundamental design and technological characteristics (Section 6) are based on established physics and engineering principles, and its performance is validated through the clinical study.

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