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Koala Intrauterine Pressure Catheter is indicated for use on patients requiring intrapartum intrauterine pressure monitoring.

The Koala Intrauterine Pressure Catheter is a disposable, sterile, single patient use intrauterine pressure monitoring catheter, designed for measurement of intrauterine contraction pressures. The catheter is designed with a pressure-sensing membrane cavity at the tip (mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. The Koala Intrauterine Pressure Catheters utilizes a reusable cable with a reusable pressure transducer which is connected at the other end of the device. The sensor, located on the tip of the catheter is a 360° sensor that registers pressure in all directions. The tip is made of soft, malleable urethane. There are no electronics in the catheter. Clinicians can disconnect the catheter while it is in the uterus and zero the monitor while the transducer is exposed to atmospheric pressure, providing a true zero reading. The Koala Intrauterine Pressure Catheter has two different, clear lumens, one for the amnioinfusion, to confirm proper placement via amniotic fluid flashback, and another channel for sensor-charging. The amnioinfusion port has a hydrophobic and a tethered replacement cap.

The FDA Clearance Letter for the Koala Intrauterine Pressure Catheter (IPC-5000E) indicates that the device has met the requirements for substantial equivalence to a predicate device. However, the provided document does not contain information about clinical studies with specific acceptance criteria, sample sizes for test/training sets, or expert involvement for ground truth adjudication, particularly in the context of AI/ML performance. This is because the device is a physical medical device (catheter) for measuring intrauterine pressure, not an AI/ML-driven software device.

Therefore, many of the requested points related to AI/ML performance evaluation (e.g., sample sizes for test/training sets, expert ground truth establishment, MRMC studies, standalone performance) are not applicable to this specific device as described in the provided clearance letter.

The document focuses on demonstrating substantial equivalence through:

• Comparison of intended use and technological characteristics with a predicate device.
• Non-clinical performance tests, including biocompatibility, sterility, shelf-life, and functional testing.

Below is a table summarizing the functional acceptance criteria that were met by the device during non-clinical testing, as described in the document.

1. Table of Acceptance Criteria and Reported Device Performance

While the document doesn't explicitly list a "table of acceptance criteria" with numerical values alongside "reported device performance" in the typical AI/ML sense (e.g., sensitivity/specificity targets), it states that "All device samples met their acceptance criteria" for various functional tests. These functional tests are the "performance" demonstrated.

• Package Integrity (ASTM F1929-15, ASTM F88/F88M-21, ASTM F1886/F1886M-16) | Maintained package integrity and functional performance for proposed 6-month shelf-life. All samples met acceptance criteria. |
  | Functional Testing | Simulated Use (Balloon Pressure, Tip Pull-off force, Monofilament removal) | Functions as intended. All samples met acceptance criteria. |
  | | Pressure Accuracy | Functions as intended. All samples met acceptance criteria. |
  | | Leak Rate/Membrane Integrity | Functions as intended. All samples met acceptance criteria. |
  | | T-connector Bond Strength | Functions as intended. All samples met acceptance criteria. |
  | | Tip Bond Strength | Functions as intended. All samples met acceptance criteria. |
  | | Catheter Flexibility | Functions as intended. All samples met acceptance criteria. |
  | | Introducer Peel-force | Functions as intended. All samples met acceptance criteria. |
  | Performance Specifications | Operation Pressure Range | -50 to +150mmHg (Same as predicate) |
  | (with reusable cable) | Over-pressure Protection | -400 to +1200 mmHg (Same as predicate) |
  | | Operating Temperature | 15º C to 40º C (Same as predicate) |
  | | Amnio Lumen Flow | Min. 20 cc/min at a pressure of 65 mmHg (Same as predicate) |

Note: The phrase "All device samples met their acceptance criteria" is used consistently, indicating successful performance against predetermined thresholds, even if numerical specifics for each functional test aren't detailed in this summary.

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

• The document mentions "All device samples" for functional and shelf-life testing without specifying exact numerical sample sizes per test. These were non-clinical bench and material tests, not human patient data or a clinical test set in the AI/ML context.
• Data Provenance: Not applicable in the context of clinical data for AI/ML. The tests conducted are laboratory-based, demonstrating physical and material properties of the device.

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

• Not applicable. The ground truth for this medical device (a catheter) is established through engineering specifications, material science, and established international standards (e.g., ISO, ASTM). It does not involve expert readers adjudicating clinical "ground truth" to evaluate an algorithm's performance on patient data.

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

• Not applicable. This applies to expert review of clinical cases, which was not part of this device's non-clinical testing.

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 device is a physical medical instrument, not an AI-assisted diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are irrelevant.

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

• Not applicable. This device is not an algorithm; it is a physical catheter designed for direct measurement.

7. The type of ground truth used:

• The "ground truth" for this device's performance is based on engineering specifications, material properties, and adherence to established international and national standards (e.g., ISO 10993 for biocompatibility, ISO 11737 for sterility, ASTM standards for package integrity and material testing). It's a "known" physical and chemical standard, not derived from expert consensus or patient outcomes data in a diagnostic sense.

8. The sample size for the training set:

• Not applicable. This is a physical device, not an AI/ML model that requires a training set. The device's design is based on engineering principles and previous iterations (as indicated by the predicate device K974389).

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

• Not applicable. See point 8.

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IB Lab KOALA is a radiological fully-automated image processing software computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedics, physicians and medical technicians.

The Knee OsteoArthritis Labeling Assistant (KOALA) software provides metric measurements of the ioint space width and indicators for presence of radiographic features of osteoarthritis (OA) on posterior-anterior-posterior (PA/AP) knee X-ray images. The outputs aid clinical professionals who are interested in the analysis of knee OA in adult patients, either suffering from knee OA or having an elevated risk of developing the disease.

Outputs are summarized in a KOALA report that can be viewed on any FDA approved DICOM viewer workstation. KOALA operates in a Linux environment and can be deployed to be compatible with any operating system supporting the third-party software Docker. The integration environment has to support KOALA data input and output requirements. The device does not interact with the patient directly, nor does it control any life-sustaining devices.

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Note: The document states that the "analysis supports good agreement between the two sets of measurements" for JSW, indicating these values meet the unstated acceptance criteria for agreement. The sensitivity and specificity values are direct reported performance against implied thresholds for clinical utility.

Study Details

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

   • Sample Size: 6597 radiographs.
   • Data Provenance: From a large longitudinal US study, the Osteoarthritis Initiative (OAI) study. The data is retrospective.

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

   • Number of Experts: Three physicians.
   • Qualifications: The document does not specify their exact qualifications (e.g., number of years of experience, specific specialty like "radiologist"), only that they are "physicians."

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

   • The ground truth was established by three physicians "following adjudication procedures for discrepancies." This implies a form of consensus-based adjudication, likely majority rule or discussion to resolve disagreements. The specific method (e.g., 2+1 meaning if two agree, that's the truth, otherwise a third arbitrates) is not explicitly detailed.

4. 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 comparing human readers with AI assistance versus without AI assistance was not reported in this section. The study described is a standalone performance validation of the AI system.

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

   • Yes, a standalone clinical performance validation was done. The reported sensitivities, specificities, and JSW measurements are for the KOALA algorithm's performance alone.

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

   • Expert Consensus: The ground truth was established by three physicians based on Kellgren-Lawrence grades and OARSI guidelines for osteophyte, sclerosis, and joint space narrowing grades, following adjudication procedures. This is a form of expert consensus derived from image interpretation.

7. The sample size for the training set:

   • The document does not specify the sample size for the training set. It only mentions that the machine-learning algorithms were "trained on medical images."

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

   • The document does not specify how the ground truth for the training set was established. It only implies that the algorithms were "trained on medical images" with sufficient ground truth to achieve high accuracy.

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The single-use disposable, non-sterile Koala TOCO is intended for use in conjunction with standard fetal monitors for the evaluation of relative external uterine activity during antepartum and intrapartum periods in a clinical setting.

The Koala IUP/TOCO Reusable Cable is also for use with the Koala Intrauterine Pressure Catheter for intrapartum, intrauterine pressure monitoring.

The Koala TOCO and Koala IUP/TOCO Reusable Cable are not intended for home monitoring of pre-term labor.

The Koala TOCO is a single-use tocodynamometer that is a transducer pressure-sensing device that can detect the changes in a mother's abdomen as her uterus tightens during a contraction. The device detects how often contractions occur and the length of each.

The Koala TOCO device is a pneumatic tocodynamometer that comprises a guard-ring with a thin elastic membrane stretched across a shallow depression in the center of the guard-ring. The elastic membrane traps a small volume of air in the depression. The air volume beneath the membrane of the Koala TOCO is connected via a low volume air channel to a pressure transducer in the Koala IUP/TOCO Reusable Cable. The operational response of the Koala TOCO is substantially equivalent to that of the standard guard-ring TOCO. This requires that the Koala TOCO have essentially the same physical shape, guard-ring area and pressure sensing area of the predicate devices. The pressure sensing area will present resistance to applied pressure. In other words, the displacement of air in the elastic membrane mimics the compression of the strain gauge of the guard-ring TOCO.

The Koala IUP/TOCO Reusable Cable can be used for intrauterine pressure monitoring with the Koala Intrauterine Pressure Catheter. The Koala TOCO and the Koala IUP/TOCO Reusable Cable are compatible with Philips and Corometrics monitors.

The provided text describes a 510(k) summary for the Koala TOCO and Koala IUP/TOCO Reusable Cable. This submission focuses on establishing substantial equivalence to a predicate device through non-clinical testing. Crucially, it explicitly states "Not Applicable" for clinical testing. Therefore, the document does not contain information about acceptance criteria or a study proving the device meets those criteria from a clinical perspective.

Here's a breakdown of what can be extracted based on the provided text, and what cannot:

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

• Not Available. The provided document does not specify quantitative acceptance criteria or performance metrics for the device in a clinical context. The non-clinical testing focused on establishing substantial equivalence in terms of design, materials, and specific physical/electrical characteristics compared to the predicate device.

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

• Not Available. Since no clinical study was performed, there is no test set or data provenance from a clinical perspective. The non-clinical tests would have involved specific test samples (e.g., of materials, components), but the sample sizes for these are not detailed in this summary.

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. No clinical test set or ground truth established by experts is mentioned, as no clinical study was conducted.

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

• Not Applicable. No clinical test set was used.

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 device is a physical medical device (tocodynamometer and cable), not an AI-powered diagnostic system. No MRMC study or AI-related effectiveness is discussed.

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)

• Not Applicable for clinical ground truth. The substantial equivalence claim is based on non-clinical testing, comparing technological characteristics (e.g., physical dimensions, materials, sensing technology) to a predicate device. The "ground truth" for these tests would be established engineering standards, material specifications, and performance against defined test parameters for the device itself, rather than clinical outcomes or expert consensus on patient data.

8. The sample size for the training set

• Not Applicable. This is a physical medical device, not a machine learning model requiring a training set.

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

• Not Applicable.

Summary of available information:

The 510(k) summary explicitly states "Not Applicable" for clinical testing. The device's acceptance is based on demonstrating substantial equivalence to an existing predicate device (FeatherLite™ Tocodynamometer - K013477) through non-clinical performance testing.

The non-clinical testing included:

• Predicate comparison testing
• Simulated use testing
• Hardware testing
• Electrical performance testing
• Biocompatibility testing according to ISO 10993-1
• Intrauterine pressure catheter (IUPC) compatibility testing

The conclusion is that the differences between the proposed device and the predicate device (minor differences in visual appearance, weight, sensing technology, and transducer location) are minor and do not impact safety and effectiveness, thus supporting substantial equivalence.

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The indications for use of the Koala Clamp & Cutter are to simultaneously clamp and cut the umbilical cord.

Not Found

This is a medical device 510(k) premarket notification for the Koala Clamp & Cutter, an umbilical cord clamp and cutter device. The submission aims to demonstrate substantial equivalence to a predicate device, the ClampCut by PriceInvena APS (510(k) No. 982464).

Given the nature of this submission, which is for a physical medical device (an umbilical cord clamp and cutter) and not an AI/ML-driven diagnostic or prognostic device, the concepts of "acceptance criteria," "device performance" in the context of AI metrics (like sensitivity, specificity), "sample size for test/training sets," "ground truth establishment by experts/pathology," "MRMC studies," or "standalone algorithm performance" are not applicable.

The document focuses on comparing the physical characteristics, materials, intended use, and general performance attributes (like sterility) of the Koala Clamp & Cutter to its predicate device. This is a common approach for 510(k) submissions for non-software/AI devices, where substantial equivalence is demonstrated through engineering and material comparisons, and potentially performance testing related to its mechanical function.

Therefore, I cannot provide the information requested in your prompt as it pertains to AI/ML device evaluation. The document does not contain data or studies related to AI/ML performance.

However, I can extract the comparison chart provided, which highlights the device's technical specifications:

1. Table of Acceptance Criteria and Reported Device Performance
(Note: "Acceptance Criteria" here refers to the comparison points for substantial equivalence, not AI performance metrics. "Device Performance" refers to the characteristics of the Koala Clamp.)

The remaining requested information (2-9) is not applicable to this 510(k) submission as it is for a physical medical device, not an AI/ML-driven diagnostic/prognostic tool. There are no AI algorithms, test sets, training sets, ground truth derived from expert consensus, or MRMC studies described in this document. The "study" proving the device meets criteria is implicitly the declaration of substantial equivalence based on the comparison of physical and performance characteristics to a legally marketed predicate device.

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The Koala Vascular Clamps and Inserts are reusable, ring-handled stainless steel clamps for clamping delicate vessels during surgery. They are radiopaque, visualized under fluoroscopy. Designed for tip-first closure to prevent vessel roll-out. Applications include pulmonary, gastrointestinal procedures, peripheral clamping, thoracic procedures such as occlusion of the aorta and vena cave, cross-clamping of the aorta and aortic aneurysms, etc.

The Boss Instrument Koala Vascular Clamps and inserts are reusable, ring-handled stainless steel instruments which have inserts which reduce trauma to the tissue being clamped.

The provided text describes a 510(k) submission for the "Koala Vascular Clamps and Inserts," demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and a detailed performance evaluation of the device itself.

Therefore, many of the requested details, such as specific acceptance criteria and a study proving those criteria were met, are not available in the provided document. The document focuses on comparing the new device to an existing predicate device to establish substantial equivalence for regulatory approval.

Here's a breakdown based on the available information:

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

This information is not present in the provided document. The document asserts substantial equivalence to a predicate device based on attributes such as indicated use, design, packaging, and materials.

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

This information is not present in the provided document. The document describes a comparison to a predicate device, not a performance study of the Koala Vascular Clamps and Inserts with a test set.

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 information is not present in the provided document.

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

This information is not present in the provided document.

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 information is not present in the provided document. This type of study is more relevant for diagnostic AI devices, not for surgical instruments like vascular clamps.

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

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

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

This information is not present in the provided document. The basis for comparison is the characteristics and intended use of the legally marketed predicate device.

8. The sample size for the training set

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

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

This information is not present in the provided document. This is not applicable to a physical surgical instrument.

Summary of what is available:

The document is a "Non-Confidential Summary of Safety and Effectiveness" for a 510(k) premarket notification. It aims to demonstrate that the "Koala Vascular Clamps and Inserts" are substantially equivalent to a legally marketed predicate device.

Predicate Device: Baxter V. Mueller - Fogarty Hydragrip Clamps and Inserts - K951413

Comparison to Predicate Devices (which serves as the "study" for substantial equivalence):

Differences between Other Legally Marketed Predicate Devices:
"The clamps are manufactured and supplied by the same manufacturer. The inserts are manufactured by different companies, but the base material is exactly the same. Therefore there are no significant differences between the intended device and the predicate - Baxter - V. Mueller - Fogarty -Hydragrip Vascular Clamps and inserts approved under K951413."

Conclusion of the FDA:
The FDA reviewed the 510(k) and determined that "the device is substantially equivalent... to legally marketed predicate devices."

This document does not provide a study with acceptance criteria for the Koala Vascular Clamps and Inserts themselves, but rather provides evidence for substantial equivalence to a known device, which is the basis for its regulatory clearance.

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This catheter is for use on patients requiring intrapartum, intrauterine pressure monitoring.

An intrauterine pressure catheter with a pressure-sensing membrane cavity at the tip (either inside the catheter or mounted externally), a port for amnioinfusion and amniotic fluid sampling, and an introducer which is removed after placement. This product is a sterile, single patient use catheter. The system includes a reusable cable with a reusable pressure transducer.

The provided 510(k) summary for the Koala Intrauterine Pressure Catheter focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria through a specific performance study against defined metrics. Therefore, the information requested for a detailed acceptance criteria study is largely not present in the provided text.

However, based on what is available, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Disclaimer: The document states that effectiveness is "the same as the predicate devices." This implies that the performance of the Koala IPC is expected to meet the established performance levels of the legally marketed predicate devices, but these specific levels are not quantified in this summary.

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

• Sample Size: Not specified. The document mentions "clinical testing" but does not provide details on the number of patients or samples.
• Data Provenance: Not specified, but "clinical testing" generally implies prospective data collected from patients. The country of origin is not mentioned.

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

• Number of Experts: Not specified.
• Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

• Not specified. The document only generically mentions "clinical testing."

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

• No, an MRMC comparative effectiveness study is not indicated or described in the provided text. This device is a measurement catheter, not an imaging interpretation or diagnostic aid system that typically involves human readers. The clinical testing mentioned would likely involve comparing pressure readings against a reference standard or assessing clinical outcomes, rather than human reader performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

• Yes, in a sense. The document states "The laboratory testing verified the performance in terms of sensor accuracy, mechanical integrity, and overall performance." This "laboratory testing" would represent a standalone evaluation of the device's technical specifications and function without direct human interpretation in the loop (beyond operating the equipment). However, it's not an "algorithm" in the typical sense of AI/software.

7. The Type of Ground Truth Used

• The ground truth for sensor accuracy would typically be established against a highly accurate reference pressure measurement system in a laboratory setting.
• For mechanical integrity, ground truth would be against engineering specifications and failure criteria.
• For the "clinical testing" mentioned, the ground truth would likely be physiologic pressure measurements and/or clinical outcomes. Specific details are not provided.

8. The Sample Size for the Training Set

• Not applicable. This device is a medical catheter with a pressure sensor; it is not described as having an AI algorithm that requires a "training set" in the machine learning sense. The "training set" concept is therefore irrelevant to the reported evaluations.

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

• Not applicable, as there is no "training set" for this device.

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This accessory is used with a Koala Intrauterine Pressure System and is used in priming the catheter.

The pre-filled Syringe is 10 cc syringe filled with 0.9% isotonic saline and is an accessory to the Koala Intrauterine Pressure System used in priming the catheter. This product is a sterile, single-use device.

This submission is for a medical device (pre-filled syringe) and does not involve AI/ML. Acceptance criteria and study details as requested for AI/ML devices are not applicable.

Here's a summary of the information provided in the document:

Device: Pre-filled Syringe for Koala Intrauterine Pressure Catheter

Intended Use: To prime the catheter in an intrauterine pressure monitoring system.

Predicate Devices: Pre-filled syringes used with the Medex MX 4042 Series Intrauterine Pressure Catheter and the Quest (formerly Healthdyne Cardiovascular) ISOFLO Intrauterine Pressure Monitoring & Amnio.

Basis for Substantial Equivalence:

• Same intended uses: Priming catheters in intrauterine pressure monitoring.
• Same basic technological characteristics: A syringe pre-filled with saline.
• Same or similar materials: All materials are biocompatible and function well in the intended application.

Safety and Effectiveness Documentation:

• Safety and effectiveness are similar to existing devices as demonstrated in the laboratory.
• Biocompatibility testing shows that the materials used in the pre-filled syringe are safe for this application.
• Effectiveness is stated to be the same as the predicate devices.

Regulatory Classification: Class II, 21 CFR §884.2700, Product code: 85 HFN.

Note: The document is a 510(k) summary for a relatively simple medical device (a pre-filled syringe). It primarily focuses on demonstrating substantial equivalence to predicate devices based on intended use, technological characteristics, and materials, rather than detailed performance metrics or clinical study data typically associated with more complex or AI-driven devices. Therefore, many of the specific questions regarding acceptance criteria and studies (e.g., sample size for test/training sets, expert consensus, MRMC studies, standalone performance for AI) are not applicable to this type of submission.

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