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The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.

Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.

The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.

The provided document is a 510(k) Premarket Notification for a medical device, specifically the BD PosiFlush Heparin Lock Flush Syringe. The purpose of this document is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, rather than to establish new performance criteria for a novel device or an AI/ML algorithm.

Therefore, the concepts of "acceptance criteria," "study proving the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" as they relate to AI/ML device validation are not applicable to this document.

This document describes a change to an existing device (qualifying a new stopper material) and relies on design verification testing and biocompatibility testing to demonstrate that the modified device remains substantially equivalent to the predicate device and does not affect the safety and efficacy.

Key information provided in the document relevant to device validation (though not in the context of AI/ML performance):

1. Acceptance Criteria & Reported Performance:

   • The document states that "Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests." It lists the tests but does not provide a specific table of acceptance criteria values or the reported performance data for each test. It only states that the device "met predetermined acceptance criteria per BD's internal specification" and "results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device."
   • Tests Conducted:
     • Container Closure Integrity
     • Break Loose/Break Out/Sustaining force
     • Stopper Separation
     • Leakage
     • Pump Force
     • Ship Test
     • Dead Space
     • Syringe Induced Reflux
   • Biocompatibility testing was conducted in accordance with ISO 10993-1, including: Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Ocular irritation, Partial thromboplastin Time, Sensitization, Pvrogenicity, Genotoxicity, and Chemical extractable analysis. The document states "Biocompatibility evaluation was conducted..." and implies successful completion, but does not provide specific acceptance criteria or reported results.

2. Sample Size and Data Provenance: Not applicable in the context of an AI/ML test set. The document refers to "design verification testing" and "biocompatibility testing" which would have involved a certain number of manufactured units, but the sample sizes for these tests are not explicitly stated in this summary.

3. Ground Truth Experts/Adjudication Method/MRMC/Standalone Performance/Type of Ground Truth/Training Set Details: These concepts are entirely irrelevant to this type of device submission, which is for a physical medical device with a material change, not an AI/ML diagnostic or therapeutic algorithm. The "ground truth" for a device like this would be established through established physical and chemical testing standards, not expert consensus on medical images or outcomes data in the sense of AI/ML.

In summary, the provided document does not contain the information required to answer the questions as they are framed for an AI/ML device. It focuses on the substantial equivalence of a physical medical device after a material change.

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Flushing of IV catheters and IV tubing only. Solution is intended for maintenance of patency of intravenous injection devices. Prior to and after administration of intermittent medication, entirely flush the intravenous injection device (catheter and or tubing) with Heparin Lock Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy.

Excelsior Medical's Heparin Lock Flush, USP devices are provided as terminally sterilized, single-use, pre-filled, pre-packaged products. The products contain a solution of heparin sodium, USP and 0.9% sodium chloride, USP. The solution is delivered through the luer lock of a venous access device to maintain catheter patency (lock catheters) between treatments. Typically, the venous access device is flushed with normal saline before and after the administration of intermittent medication therapy, blood sampling, total parenteral nutrition, or hemodialysis.

This document does not contain information about acceptance criteria and device performance in the context of a study. The provided text is a 510(k) summary for the Heparin Lock Flush, USP, which primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a specific study with performance metrics against pre-defined acceptance criteria.

The 510(k) summary outlines the following:

• Device Description: The Heparin Lock Flush, USP
• Intended Use/Indications for Use: Flushing of IV catheters and IV tubing for maintaining patency.
• Technological Characteristics: A comparison table with predicate devices (K061497 and K023740) highlighting similarities in solution, concentrations, single-use nature, sterility, barrel material, plunger rod material, piston, tip cap material, tip cap colorants, and packaging.
• Purpose of Submission: To add alternate suppliers of the heparin sodium (USP) raw material.
• Non-Clinical Testing: A list of studies performed or relied upon:
  • Raw material qualification
  • Biocompatibility (ISO 10993-1)
  • Stability Studies
  • Sterilization validation (ISO 17665-1 and -2)
  • Extractables/Leachables
  • Testing of final product to Heparin Lock Flush Solution USP Monograph
• Conclusion: The change in heparin source is supported by the cited studies, and no new questions of safety and effectiveness are raised, leading to the conclusion of substantial equivalence.

The document does NOT include the following information, which would be necessary to answer the prompt:

• A table of acceptance criteria and reported device performance.
• Sample sizes used for any test set or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication method.
• Multi-reader multi-case (MRMC) comparative effectiveness study results.
• Standalone (algorithm only) performance.
• Type of ground truth used.
• Sample size for training set.
• How ground truth for the training set was established.

This is expected as 510(k) submissions for devices like a Heparin Lock Flush typically rely on demonstrating equivalence to existing devices through material characterization, manufacturing controls, and non-clinical testing rather than clinical performance studies with specific acceptance criteria as one might see for an AI/ML diagnostic device.

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The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)

10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.

The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave.

The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.

This submission (K090680) describes a medical device, the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe. It is important to note that this is a physical medical device (a pre-filled syringe with heparin solution) and not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML systems (such as sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment methods for observational data) are not applicable here.

Instead, the submission focuses on demonstrating substantial equivalence to previously approved predicate devices based on design verification tests for safety and effectiveness of the physical product, its materials, intended use, and manufacturing process.

Here's the information parsed from the provided text, adapted for a physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a physical device submission focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device and the design verification tests. The "reported device performance" refers to the results of these tests and the overall assessment of equivalence.

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

• Sample Size: The document does not specify a numerical sample size for "design verification tests." These tests are typically laboratory-based and may involve multiple units of the device to confirm manufacturing quality, material compatibility, and performance characteristics (e.g., flow rate, integrity, sterility).
• Data Provenance: The data would be derived from internal testing conducted by Becton, Dickinson and Company. It is "prospective" in the sense that the tests were performed specifically for this 510(k) submission on the newly designed/modified device. The country of origin of the data is the USA (where BD Medical Surgical is located).

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

This concept is not directly applicable to this type of device submission. The "ground truth" for a physical device like a pre-filled syringe is established through objective engineering and chemical testing standards, manufacturing processes, and regulatory requirements (e.g., USP monographs for the heparin solution, ISO standards for syringes, sterility testing protocols). Experts would be involved in designing and executing these tests, and interpreting the results against established standards, rather than establishing a "ground truth" through consensus on observational data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting subjective data (e.g., medical images). For physical device testing, the results are typically objective measurements against a defined standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

Not applicable. This is a physical device, not an AI/ML system.

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

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

7. The Type of Ground Truth Used

The ground truth used for this device would be a combination of:

• Established Standards: USP (United States Pharmacopeia) monographs for Heparin Lock Flush Solution, standards for syringe manufacturing, and sterility testing protocols.
• Predicate Device Performance: The performance characteristics and safety profile of the legally marketed predicate devices (K011967, K003553, K013556) serve as a de facto "ground truth" for what is considered safe and effective in this device class.
• Risk Analysis: A documented risk analysis would have guided the design verification tests to ensure all potential risks were mitigated and tested.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML system, so there is no "training set."

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

Not applicable.

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Excelsior Medical Heparin Lock Flush Syringes (1Unit/ml and 2 Units/ml) are indicated for use in maintaining patnecy of vascular access devices designed for intermittent or infusion therapy. Prior to and after administration of intermittent medication, entirely flush the vascular access device with Heparin Lock Flush Solution, USP. Use in accordance with any warnings or precautions appropriate to medication being administered. This device is not to be used for anticoagulant therapy

Excelsior Medical Heparin Lock Flush Syringes are polypropylene latex-free syringes which contains a labeled volume of a sterile, non-pyrogenic solution of Heparin Lock Flush Solution, USP derived from porcine intestinal mucosa in 0.9 sodium chloride USP with a pH range of 5.0 - 7.5.

This is a 510(k) summary for a medical device: Excelsior Medical Heparin Lock Flush Syringes. The document focuses on establishing substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria in the typical clinical study format.

Therefore, many of the requested sections about clinical study details (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, training data) cannot be fully answered from the provided text.

Here is an analysis based on the information available:

Acceptance Criteria and Reported Device Performance

The document states that the device was tested according to "specifications documented in Design Verification Testing Reports and independent laboratory testing." It concludes that the device "functioned as intended and met all pass criteria as expected." However, the specific acceptance criteria and the detailed performance results are not provided in this 510(k) summary. The summary focuses on comparing the new device's characteristics to its predicate devices to establish substantial equivalence.

Table of Acceptance Criteria and Reported Device Performance:

Study Information:

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

   • Sample Size: Not specified. The document refers to "Design Verification Testing Reports and independent laboratory testing" but does not provide details on sample sizes for these tests.
   • Data Provenance: Not specified, but likely from laboratory testing (e.g., sterility, chemical analysis, functional tests) rather than human clinical data.

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

   • This information is not applicable or not provided. This type of detail is typically associated with clinical studies involving interpretation (e.g., imaging devices), not physical device performance testing for a syringe and its contents. The ground truth would be established by validated analytical methods, not expert consensus.

3. Adjudication method for the test set:

   • This information is not applicable or not provided. Adjudication methods like "2+1" or "3+1" are used in clinical studies where human interpretation of results is involved (e.g., radiologists reading scans). This document describes performance testing for a physical device, where results are typically objective measurements.

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, an MRMC study was not done. This type of study is relevant for diagnostic devices, especially those using AI, that assist human readers in interpreting clinical data. This device is a pre-filled syringe, not a diagnostic tool assisted by AI.

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

   • Not applicable. This section is for AI/algorithm-based devices. The Excelsior Medical Heparin Lock Flush Syringe is a physical medical device.

6. The type of ground truth used:

   • Laboratory Testing Parameters/Specifications: The ground truth for this device's performance would be established by predefined quality and functional specifications (e.g., sterility, pH range of the solution, heparin concentration, syringe integrity, flush volume). These are determined through established scientific and manufacturing standards for medical devices and pharmaceuticals.

7. The sample size for the training set:

   • Not applicable. This pertains to AI/machine learning models. For a physical device, there isn't a "training set" in the AI sense.

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

   • Not applicable. See point 7.

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Excelsior Sterile Field Saline Flush Syringes and Heparin Lock Flush Syringes are intended for flushing IV catheters and IV tubing.

The modification which is the subject of this Special 510(k) is substitution of the current dust cover packaging with Sterile Field packaging. All other aspects of the product design remain unchanged.

The provided text describes a 510(k) submission for Excelsior Sterile Field Saline Flush and Heparin Lock Flush Syringes. However, it does not provide acceptance criteria and detailed study information as requested. The submission is for a modification involving a change in packaging (from dust cover to Sterile Field packaging), with all other aspects of the product design remaining unchanged.

The document highlights that the "technological characteristics... do not differ" from the predicate device and that "The results of testing conducted to verify the design modifications demonstrate acceptable performance of the device." This implies that the acceptance criteria would be based on demonstrating that the new packaging maintains sterility and does not compromise the device's existing performance, but specific quantified criteria and a detailed study report are not present in this document.

Therefore, I cannot populate the requested table and answer many of the questions directly from the provided text.

Here is what I can glean and what is missing:

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

Missing: Specific, quantifiable acceptance criteria (e.g., sterility assurance level, packaging integrity test results, shelf-life data with new packaging).

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

• Sample Size: Not specified.
• Data Provenance: Not specified, but likely from Excelsior Medical Corporation's internal testing. The tests are "Non-Clinical Tests," so they would not involve human participants or specific geographic data provenance in the way clinical studies do.

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

• This is a packaging/device modification submission, not a diagnostic or AI-driven device. Therefore, the concept of "experts to establish ground truth" (in the medical diagnostic sense) is not applicable to the non-clinical tests mentioned. The "ground truth" here would be established by validated test methods and passing criteria for physical and performance characteristics.

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

• Not applicable as this is not a diagnostic study requiring expert adjudication of cases.

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

• Not applicable. This is not an AI-assisted device or a diagnostic device involving human readers.

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

• Not applicable. This is not an algorithmic device.

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

• For the non-clinical tests, the "ground truth" would be objective measurements against pre-defined specifications (e.g., sterility test results, material strength tests, leak tests, etc.). The document only states "acceptable performance."

8. The sample size for the training set:

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

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

• Not applicable.

In summary: The provided 510(k) summary is for a minor device modification (packaging change) and focuses on demonstrating substantial equivalence. It does not contain the detailed study results, acceptance criteria, or specific methodologies that would be presented for a novel device or a device with clinical efficacy claims, especially those involving AI or human interpretation. The "tests conducted to verify the design modifications" are described as "non-clinical tests," implying laboratory or engineering evaluations.

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The Heparin Lock Flush Syringe, 10 and 100 units/mL, is intended for use in flushing compatible intravenous administration sets and indwelling intravenous access devices.

The proposed device is a sterile, single use, standard piston type syringe that is available in various fill volumes and syringe sizes containing either 10 or 100 USP u/ml Heparin Lock Flush Solution for anits Injection. The syringe uses a sterile, polypropylene luer lock fitting or blunt tip cannula. The piston syrings consists of a polypropylene barrel with a lucr lock adapter assembled with a polypropylene plunger and a polyisoprene seal. The dispensing end of the syringe is covered with a tip cap closure.

The provided text is a 510(k) summary for a medical device called the "Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study to prove the device meets specific acceptance criteria related to its performance in a clinical or diagnostic context.

Therefore, the requested information, which is typically found in studies for AI/diagnostic devices (e.g., acceptance criteria tables, sample sizes, ground truth establishment, expert qualifications, MRMC studies, standalone performance), is not available in this document.

Here's what the document does provide and why it doesn't fit the requested format:

• Acceptance Criteria & Reported Performance: The document states that "Performance testing indicates that the proposed device meets all functional requirements and supports its suitability for use." However, it does not list specific acceptance criteria (e.g., a certain percentage of flushing success, a specific force required for plunger depression) nor does it provide a table of reported performance against these criteria. The emphasis is on material compliance and stability, not diagnostic or predictive performance.
• Sample Size (Test Set) and Data Provenance: Not applicable. This device is a pre-filled syringe, not a diagnostic or AI device that would have a "test set" in the context of diagnostic accuracy.
• Number of Experts/Qualifications & Adjudication Method: Not applicable. These relate to establishing ground truth for diagnostic accuracy, which is not relevant for a pre-filled syringe.
• MRMC Comparative Effectiveness Study: Not applicable. This is for evaluating changes in human reader performance with AI assistance, which doesn't apply to a physical medical device like a syringe.
• Standalone Performance: Not applicable. This refers to the algorithm's performance without human intervention, which is not relevant for a physical device.
• Type of Ground Truth: Not applicable. Ground truth typically refers to a definitive diagnosis or outcome used to evaluate the accuracy of a diagnostic tool.
• Sample Size (Training Set) & Ground Truth for Training Set: Not applicable. This device does not use a "training set" in the machine learning sense.

What the document does describe as proof of meeting requirements:

The "study" or evidence presented in this 510(k) is primarily focused on demonstrating that the Heparin Lock Flush Syringe is substantially equivalent to legally marketed predicate devices. This involves:

1. Comparison of Technological Characteristics:

   • Same intended use
   • All pre-filled with heparin lock flush solution, USP
   • Single-use, disposable
   • Sterile and pyrogen-free
   • Manufactured using an aseptic process
   • Available in similar syringe sizes and fill volumes
   • Use polypropylene piston-type syringes
   • Packaged in a wrapper or polybag and sealed
   • Use manual energy

2. Non-Clinical Testing:

   • Physical properties of materials tested by suppliers to meet USP Class VI plastic test requirements or ISO 10993 Part 1 (for fluid path components). This ensures biocompatibility and material safety.
   • Materials in contact with the body found safe and effective (cleared through previous FDA submissions, e.g., EMT-Rx Syringe).
   • Test data generated for stability and container/closure suitability. (Specific results or acceptance criteria for these tests are not detailed in this summary).
   • Performance testing indicates the proposed device meets "all functional requirements" and supports its suitability for use. (Again, specific functional requirements and detailed results are not provided in this summary).

In summary, the "study" described is a non-clinical engineering and materials compliance assessment rather than a clinical or diagnostic performance study. The acceptance criteria are largely based on established material standards (USP Class VI, ISO 10993-1) and general functional suitability, for which specific quantitative data is not provided in this summary.

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The proposed device is indicated only for use in flushing compatible intravenous administration sets and indwelling intravascular access devices.

The proposed device is a sterile, single use, standard piston syringe of various sizes and fill volumes containing either 10 or 100 USP Heparin units/ml.

The provided document describes a 510(k) submission for a medical device, the "Monoject® PreFill Heparin Lock Flush Syringe." This document focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific performance acceptance criteria and a study proving the device meets those criteria.

Therefore, much of the requested information regarding acceptance criteria, specific device performance numbers, sample sizes for test and training sets, expert involvement, and ground truth establishment cannot be extracted from the provided text.

The document primarily states that the device is "substantially equivalent in intended use, function and composition" to a predicate device and that "Biocompatibility testing of the proposed device has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."

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

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

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

• Sample Size for Test Set: Not specified in the document. The testing mentioned (biocompatibility) would involve a certain number of samples, but no specific count is provided.
• Data Provenance: Not specified. Biocompatibility testing is typically performed in a laboratory setting, but the location or whether it's retrospective/prospective is not 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/Not specified. This information is typically relevant for studies involving human interpretation (e.g., medical imaging AI). Biocompatibility testing is laboratory-based and doesn't involve "experts" establishing ground truth in the same way.

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

• Not applicable/Not specified. This is relevant for studies involving human interpretation or complex data review, not for standard biocompatibility 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

• No. This document does not mention an MRMC study. The device is a syringe, not an AI-assisted diagnostic tool.

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

• Not applicable. This is not an algorithm or AI device. The testing described is for the physical and chemical properties of a medical device (syringe).

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

• For biocompatibility, the "ground truth" would be the established safety standards and chemical/biological assay results as defined by ISO 10993 and FDA guidelines. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

• Not applicable/Not specified. This document is not describing a machine learning model. If interpreted in the context of device development, "training set" might refer to early development samples, but no such details are provided.

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

• Not applicable/Not specified. As above, this is not a machine learning context.

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