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The ambIT PCA*PIB Pump is used to infuse medicines and/or fluids into patients primarily for pain management.

The routes of administration are generally intravenous, epidural and/or regional.

The ambIT PCA*PIB Pump is not intended to supersede, augment, or replace any other medical device or drug indications for use or intended uses.

The ambIT PCA*PIB Pump is intended to be used in the home and in healthcare facilities.

The new ambIT PCA*PIB is an electro-mechanically controlled, rotary-peristaltic, infusion pump that consists of two components: (1) the reusable pump driver; and (2) the sterile, single-use cassette (tubing set).

The ambIT PCAPIB Pump has a microprocessor-controlled motor that turns the rollers in the cassette at a set frequency to provide the desired infusion rate/therapy. The ambIT PCAPIB Pump is powered by two (2) standard 1.5-volt "AA" batteries, and cannot be powered by electrical mains. The batteries are replaceable but cannot be recharged inside the pump.

The controls consist of two buttons and an OFF/ON switch. One button toggles the pump between pause and infusing. The other button (BOLUS button) is used to request a bolus. An LCD display shows the pump status, alarms, and history. The pump monitors downstream occlusions, pump malfunctions, and other pump error conditions. The materials of construction are all medical grade plastics. Specifically, the materials are ABS, polycarbonate, nylon, and glass-filled nylon.

The part of the pump that comes into indirect contact with the body is the cassette or tubing set. The medications flow through the tubing into a catheter and then into the body. The tubing set is classified to be used for less than 30 days. The length of time the pump is used is based on the therapy requirements.

The ambIT PCA*PIB product has been validated and verified to meet healthcare providers', lay users', and patients' needs for pain management infusions. The pump meets all applicable national and international consensus standards.

The provided text does not describe acceptance criteria for a medical device in terms of performance metrics or a study designed to prove the device meets those criteria. Instead, it is a 510(k) premarket notification for infusion pumps (ambIT PCAPIB, ambIT PIB, ambIT PIBPCA, ambIT PIEB, and ambIT Programmable Intermittent Pump).

The document focuses on demonstrating substantial equivalence to a previously cleared predicate device (ambIT PCA Pump, K002434) and a reference device (CADD-Solis Ambulatory Infusion Pump, K130394), rather than presenting a study against specific acceptance criteria for performance.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria, reported performance, or details about a study proving the device meets acceptance criteria, as this information is not present in the provided text.

Specifically, the document states:

• "Non-Clinical Performance Data: Both the predicate ambIT PCA Pump and the new ambIT PCAPIB Pump meet the same non-clinical performance data. The bench testing on the ambIT PCAPIB Pump demonstrates that the new pump meets the same volumetric accuracy requirements (when delivering high, low, and median flow rates and bolus volumes), the same usability requirements, and the same downstream occlusion alarm specifications. The volumetric accuracy and occlusion alarm were tested and the results show that the new pump meets the same specifications as the predicate pumps."
• "Clinical Performance Data: Clinical Performance Data was not relied on to show substantial equivalence."

This indicates that while performance testing was done (e.g., volumetric accuracy, usability, occlusion alarm), the purpose was to show the new device meets the same specifications as the predicate, not to meet pre-defined acceptance criteria for a new clinical performance study. The exact numerical specifications for these tests are not provided, nor is a detailed study report.

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CADD®- Solis Ambulatory Infusion Pump with Wireless Communication

CADD®-Solis Infusion Pump, Model 2110
The CADD®-Solis Pump is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space. The pump is intended for therapies that require a continuous rate of infermittent bolus, and/or with patientcontrolled demand doses.

PharmGuard® Administrator Medication Safety Software
The PharmGuard® Administrator Medication Safety Software allows the use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis Infusion Pump.

CADD® Administration Set
The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container.

Wireless Communication Module (CM)
The Wireless Communication Module is intended to be used as an accessory to provide wireless capability and battery power to a CADD®-Solis Infusion Pump, Model 2110

The CADD®- Solis Ambulatory Infusion Pump with Wireless Communication, which includes the CADD®-Solis Infusion Pump, Model 2110, the Wireless Communication Module (CM), and the PharmGuard® Administrator Medication Safety Software, work together to provide wireless communication between the pump and the server and are similar to currently marketed products.

The CADD®-Solis Infusion Pump, Model 2110 has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 3.0 (K130394). The user activates CADD®-Solis Infusion Pump, Model 2110 via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD® Administration Set is designed for use with the CADD® Infusion pumps (except CADD®-Micro) to allow medication delivery from a flexible container. The Flow Stop feature is a set-based free flow protection component (i.e. Flow Stop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. The Flow Stop is located on the set housing, which is attached to the pump.

The provided text is a 510(k) summary for the CADD®-Solis Ambulatory Infusion Pump with Wireless Communication. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific, novel acceptance criteria through a dedicated study with statistical endpoints. Therefore, many of the requested categories for a rigorous clinical or performance study involving AI or human readers are not applicable or cannot be extracted from this type of regulatory document.

However, I can extract information related to the performance testing and how the device's modifications are verified.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not present a formal table of specific acceptance criteria with corresponding performance metrics in a quantitative manner as one might expect from a statistically powered study. Instead, it states that "All the testing met the acceptance criteria." and "Device testing met pre-defined acceptance criteria and did not raise new or different question of safety or effectiveness." The criteria are largely described by adherence to relevant standards and a safety assurance case.

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

The document does not specify a "test set" in the context of a statistical study with a defined sample size (e.g., number of patients or cases). The testing performed is described as "non-clinical performance testing," "design verification and validation testing," and "software testing." Provenance is not applicable to this type of testing (e.g., no patient data is mentioned).

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

Not applicable. This is a 510(k) submission for an infusion pump and its accessories, not an AI/diagnostic device that relies on expert interpretation of data to establish ground truth for a test set.

4. Adjudication Method for the Test Set

Not applicable for the same reasons as #3.

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

Not applicable. This device is not an AI diagnostic tool and does not employ "human readers" in the context of interpreting medical images or data.

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

This refers to the performance of the device itself (the infusion pump system and its software/accessories) in delivering medication and communicating data. The non-clinical performance testing, design verification, and validation studies serve this purpose. The document states that these tests demonstrate "the device is substantially equivalent to the legally marketed predicate device."

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established by:

• Engineering specifications and design inputs: The device is tested against its own design requirements.
• Industry standards: Compliance with standards like IEC 60601-1, IEC 62304, ISO 10993-1, etc.
• Predicate device characteristics: The new device's performance characteristics are compared to those of the legally marketed predicate devices (K130394 and K040636) to demonstrate substantial equivalence.
• GLP (Good Laboratory Practice) pre-clinical studies: For the new intrathecal indication of the administration sets, studies were conducted to show freedom from unacceptable neurotoxicological risk.

8. The Sample Size for the Training Set

Not applicable. This device does not involve machine learning or AI models that require a "training set."

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

Not applicable for the same reason as #8.

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The LifeCare PCA™ infusion system is intended for intravenous or epidural administration of analgesic medications that are delivered by a continuous rate of infusion and/or with patient-controlled demand doses.

The Hospira LifeCare PCA™ Infusion System is a microprocessor controlled, pole mounted, electromechanical infusion pump that allows a patient to self-administer analgesic using an attached patient pendant, within physician prescribed, programmed parameters. The Hospira LifeCare PCA™ Infusion System also includes a sterile empty vial that can be pharmacy-filled with appropriate medications, and dedicated administration sets to administer the medication.
The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient.
The infuser will accept either a pre-filled drug vial manufactured by Hospira or a sterile empty vial that can be filled by a hospital's pharmacy. Administration Sets compatible for use in the LifeCare PCA™ Infuser are provided sterile (fluid path) and intended for single-use application.
The infuser is equipped with wireless (802.11 a/b/g) and wired interfaces to Hospira MedNet™ Software. Drug Libraries and Auto-Programs are transferred using these interfaces. The subject device bi-directionally communicates to the hospital information system through the Hospira MedNet™ Server, which is optional software, and the device can also be programmed and used without the Hospira MedNet™ software.

The provided document is a 510(k) summary for the Hospira LifeCare PCA™ Infusion System. It describes the device, its intended use, and a summary of performance data. However, it does not contain a detailed study proving the device meets specific acceptance criteria with reported device performance against those criteria. Instead, it states that system verification and validation activities were conducted and that all testing met the acceptance criteria.

Here's an analysis based on the information provided:

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

The document does not provide a table with specific acceptance criteria and detailed reported device performance for each criterion. It broadly states: "System verification and validation activities for LifeCare PCA™ Infusion System confirmed that the system meets user needs and design inputs. All the testing met the acceptance criteria."

It lists several standards to which the device complies, implying that meeting the requirements of these standards constitutes the acceptance criteria. These standards include:

• Basic Safety and Essential Performance: ANSI/AAMI ES60601-1:2005/(R) 2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012
• Electromagnetic Compatibility: IEC Standard 60601-1-2:2007 3rd Ed.
• Alarm Systems: IEC 60601-1-8, Edition 2.1 2012-11
• Infusion Pump Basic Safety and Essential Performance: IEC 60601-2-24 Medical Electrical Equipment – Part- Edition 2.0 2012-10
• Biocompatibility: ISO 10993-1:2009 (Corrigendum 2010) and FDA Draft Guidance for Industry and Food and Drug Administration Staff Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" issued April 2013

Without specific performance values against each standard's criteria, a table cannot be fully constructed from this document. The document only confirms that the device met these criteria.

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

The document does not specify sample sizes for any test sets used in performance testing. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The reported data relates to non-clinical performance and human factors evaluations.

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 applicable and not provided. The testing described is for an infusion pump, focusing on engineering performance, safety standards, and human factors, rather than a diagnostic device requiring expert interpretation for ground truth. "Human factors evaluations" were conducted, but details on the number or qualifications of participants/experts for establishing a "ground truth" are not mentioned.

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

This information is not applicable and not provided. The described testing refers to compliance with engineering and safety standards and human factors evaluations, not diagnostic image interpretation where adjudication methods like 2+1 or 3+1 would be 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:

This information is not applicable and not provided. The device is an infusion pump, not an AI-powered diagnostic tool used by "human readers" to interpret cases.

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

The device is an infusion pump with software, not a standalone algorithm in the context of AI performance. The document describes "System verification and validation activities" which imply testing of the integrated device. It also notes "Human factors evaluations," which specifically involve human-in-the-loop performance to validate the effectiveness of use error related mitigations. Therefore, testing was conducted on the complete system with human interaction being a component of the evaluation (for human factors).

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

For the non-clinical testing of the infusion pump, the "ground truth" is established by the requirements and specifications of the referenced international and national standards (e.g., IEC 60601 series, ISO 10993-1) and the device's own design inputs and user needs. The testing verifies if the device performs according to these engineering and safety specifications. For biocompatibility, the ground truth would be based on the biological evaluation criteria defined in ISO 10993. For human factors, the ground truth relates to the effectiveness of use-error mitigations and whether users can safely and effectively operate the device according to its design.

8. The sample size for the training set:

The concept of a "training set" is not applicable as this is a traditional medical device (infusion pump) and not an AI/machine learning model that undergoes training on data.

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

As the concept of a "training set" is not applicable, this question is not relevant to the provided document.

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The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, is indicated for intravenous, intra-arterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, and/or an intermittent bolus, and/or with patient-controlled demand doses.

The CADD™-Solis Medication Safety Software- Administrator allows use of a computer to create therapy-based protocol libraries to be used with the CADD®-Solis VIP Ambulatory Infusion Pump, CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD™-Solis Medication Safety Software- Point of Care allows use of a computer to send therapy-based protocols developed by the CADD™-Solis Medication Safety Software - Administrator to the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The CADD® -Solis Ambulatory Infusion Pump, Model 2110, Version 3.0 ("CADD"-Solis Version 3.0 Pump") has a microprocessor and linear peristaltic pumping mechanism, similar in design to the Smiths Medical ASD, Inc. CADD®-Solis Ambulatory Infusion Pump, Version 1.0 (K072144) and CADD -Solis VIP Ambulatory Infusion Pump, Version 2.0 (K111275). The user activates CADD® Solis Version 3.0 Pump via a color LCD screen and keypad user interface. Commands are issued to the microprocessor by activating the user interface. Microprocessor actions are controlled by a program, which is contained in the pump's memory.

The CADD®-Solis Version 3.0 Pump consists of components, such as the user interface, sensors, communication ports, power ports, structural (housing) components, electronics, pumping mechanism, watchdog timer, pump battery and circuitry, real time clock, onboard memory, and pump log. The CADD® Solis Version 3.0 Pump exterior surface components include the pump housing, LCD lens, labels, and keypad, and the materials of construction for these components are widely used in the medical industry. The CADD -Solis Version 3.0 Pump is designed to be used with a CADD® Infusion Disposable, such as Medication Cassette Reservoir.

The CADD™-Solis Medication Safety Software System consists of the Administrator and the Point of Care software applications. This software allows the user to create therapy-based protocol libraries to be used with the CADD®-Solis Ambulatory Infusion Pump, or CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher).

The provided text describes the CADD®-Solis Ambulatory Infusion Pump, Model 2110, Version 3.0, and the CADD™-Solis Medication Safety Software, Version 3.1. It focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study with reported performance metrics.

Here's a breakdown of the requested information based on the provided text, and where gaps exist:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" or provide "reported device performance" against those criteria in a table format. Instead, it relies on demonstrating equivalence through design verification, software validation, and human-factors engineering studies, concluding that "All testing met pre-established specifications."

Instead of a typical acceptance criteria table for a diagnostic device, the document presents a comparison table between the new device and predicate devices for various characteristics and infusion specifications. This table essentially defines the design and functional characteristics that were evaluated for equivalence.

Since direct "acceptance criteria" and "reported performance" like sensitivity/specificity for a medical device are not specified for this infusion pump and software, I cannot create that table. However, I can infer from the comparison tables that the acceptance for this 510(k) submission primarily involved demonstrating that the new device's characteristics and performance are comparable to the predicate devices.

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

The document does not specify a "test set" in the context of a clinical study or a dataset for evaluating an AI algorithm. The testing described is "design verification and software validation testing" and "human-factors engineering studies."

• Sample Size: Not applicable/not provided for a "test set" in the context of clinical performance evaluation. The testing would have involved engineering and software quality assurance methods.
• Data Provenance: Not applicable/not provided.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is typically relevant for studies validating diagnostic algorithms or interpretations. For an infusion pump and its associated software, "ground truth" would be established through engineering specifications, regulatory standards, and functional testing protocols rather than expert consensus on medical findings.

• Number of Experts: Not applicable/not provided.
• Qualifications of Experts: Not applicable/not provided.

4. Adjudication Method

This is also typically relevant for studies involving human interpretation. For design verification and software validation of an infusion pump and software, adjudication methods (like 2+1, 3+1) are not typically used. Testing outcomes are usually determined by passing or failing pre-defined engineering and functional requirements.

• Adjudication Method: Not applicable/not provided.

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

• MRMC Study Done: No. The document explicitly states: "Human clinical studies were deemed unnecessary to evaluate the safety or effectiveness of the CADD®-Solis Version 3.0 Pump. CADD™ Solis Medication Safety Software-Administrator and POC."
• Effect Size with AI vs. without AI assistance: Not applicable, as there was no MRMC study and the devices are an infusion pump and its safety software, not an AI diagnostic tool for human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

• Standalone Study Done: Yes, in a sense, as design verification and software validation would assess the device's inherent performance capabilities without direct human-in-the-loop performance measurement against a clinical outcome. However, this is not in the context of an "algorithm" in the way it's usually asked for AI diagnostic devices. The performance testing was of the "algorithm" of the pump's operating system and the software's functionality. The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended."

7. Type of Ground Truth Used

The "ground truth" for this type of device would be based on:

• Engineering Specifications: Pre-defined functional requirements and performance parameters for mechanical, electronic, and software components.
• Regulatory Standards: Compliance with relevant national and international medical device standards.
• Functional Testing Protocols: Measured outputs and behaviors of the pump and software across various operating conditions.

8. Sample Size for the Training Set

This product is not described as an AI/ML device that requires a "training set" in the conventional sense (e.g., for image classification or prediction tasks). Therefore:

• Sample Size for Training Set: Not applicable/not provided.

9. How Ground Truth for the Training Set was Established

As this is not an AI/ML device requiring a training set with medical "ground truth":

• How Ground Truth for Training Set was Established: Not applicable/not provided.

Summary of Study that Proves the Device Meets Acceptance Criteria:

The study described is a combination of:

• Design Verification and Software Validation Testing: This rigorously evaluated the CADD®-Solis Version 3.0 Pump and the CADD™-Solis Medication Safety Software-Administrator and Point of Care against pre-established engineering specifications and software requirements. This type of testing ensures that the device and software function as intended and meet all design inputs.
• Human-Factors Engineering Studies: These studies assessed the usability and user interface of the device and software, ensuring that they can be operated safely and effectively by users.
• Substantial Equivalence Comparison: The submission primarily relies on demonstrating that the new devices are substantially equivalent to previously cleared predicate devices (CADD®-Solis Ambulatory Infusion Pump, Models 2100/2110 Version 1.0, and CADD®-Solis VIP Ambulatory Infusion Pump, Model 2120 Version 2.0; and CADD™-Solis Medication Safety Software Versions 1.2 and 2.0). The detailed comparison tables (pages 4-8 and 9-10 of the original document) highlight the similarities in intended use, technological characteristics, and performance features between the new and predicate devices.

The "Testing Conclusion" states: "All testing met pre-established specifications, and successfully demonstrated that the devices performed as intended. The testing results allowed for a conclusion to be made that the CADD® -Solis Version 3.0 Pump, and CADD™ Solis Medication Safety Software-Administrator and POC were as safe and effective as the predicate devices."

This indicates that the "acceptance criteria" were essentially the fulfillment of all design and software requirements and the demonstration of substantial equivalence to predicate devices through comprehensive non-clinical testing. No clinical studies were deemed necessary.

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The Perfusor® Space Infusion Syringe Pump System is an electrical, external, syringe infusion pump system indicated for use with adults, pediatrics and neonates and is intended to provide infusions of parenteral fluids/medications, blood and blood products indicated for infusion through FDA approved routes of administration.

The Perfusor® Space Infusion Syringe Pump System includes an external transportable electronic syringe infusion pump and pump accessories. The Perfusor Space Infusion Syringe Pump System utilizes a swivel-drive pumping mechanism and is intended to provide infusions of parenteral fluids. The Perfusor® Space Infusion Syringe Pump System is intended to be used by trained healthcare professionals in healthcare facilities, home care, outpatient, and medical transport environments. A trained Biomedical Technician must perform a complete set-up of the pump prior to use in a clinical setting. The system is intended to provide intermittent or continuous flow of parenteral fluids to the patient. Parenteral fluids may include standard fluids and/or medications indicated for infusion as well as blood and blood products.

The provided text describes a 510(k) premarket notification for the B. Braun Medical Inc. Perfusor® Space Infusion Syringe Pump System. The document focuses on establishing substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and study results for device performance in the way a clinical trial for a diagnostic AI device would.

Therefore, much of the requested information (acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC study, standalone performance) is not present in the provided text.

Specifically, the document addresses new functionalities added to an existing device: barcode, out-bound wireless data transmission, and PCA (Patient-Controlled Analgesia) functionality. The primary claim is "substantial equivalence" to predicate devices, meaning it performs similarly and presents similar safety and effectiveness.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available in the provided text. The document focuses on substantial equivalence based on comparable type, indications for use, and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.

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

Not available. The document does not describe a "test set" or a study designed to measure performance metrics. It's a regulatory submission for device modification.

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

Not applicable. There is no mention of a ground truth being established by experts for a test set in this regulatory submission.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

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

No. No MRMC study is mentioned. The document primarily discusses the technical features and intended use of the infusion pump system and its new functionalities. This is a medical device, not a diagnostic AI system, so MRMC studies are not typically conducted for this type of product.

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

Not applicable. This is an infusion pump system, not an AI algorithm designed to interpret data or diagnose conditions. Its performance is inherent in its mechanical and software functions for drug delivery.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The concept of "ground truth" as used in evaluating AI or diagnostic systems does not apply to this medical device submission. The "truth" here relates to the reliable and accurate functioning of the pump in delivering fluids/medications as intended.

8. The Sample Size for the Training Set

Not applicable. There is no mention of a "training set" as this is a traditional medical device, not an AI/machine learning device that would typically involve a training phase on data.

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

Not applicable. See point 8.

Summary of the document's content relevant to evaluation:

The document establishes that the Perfusor® Space Infusion Syringe Pump System, with its added barcode, out-bound wireless data transmission, and PCA functionalities, is substantially equivalent to predicate devices:

• Predicate device for the original pump system: The Perfusor® Space Infusion Syringe Pump System (K062699).
• Predicate device for barcode and out-bound wireless data transmission: B. Braun Medical Inc. Outlook® Safety Infusion System (K011975).
• Predicate device for PCA functionality: MEDLEY™ PCA Module (K032233) by ALARIS Medical Systems Inc.

The argument for substantial equivalence is based on:

• Comparable type: All are computer-controlled electrical, external, syringe infusion pumps.
• Similar indications for use: For infusion of parenteral fluids/medications, blood, and blood products for adults, pediatrics, and neonates.
• Similar technological characteristics: Implementing advanced features (barcode, wireless, PCA) in a similar manner, using communication protocols (CAN bus) for data exchange with hospital information systems. All data transmitted uses B. Braun's proprietary information protocol to ensure data integrity.
• Similar accessories: Providing clinician flexibility, organizing the bedside, central power supply, tubing retainers, ease of transportation, and customization of menu/drug library parameters.

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The CADD -Solis ambulatory infusion pump is indicated for intravenous, intraarterial, subcutaneous, intraperitoneal, in close proximity to nerves, into an intraoperative site (soft tissue, body cavity/surgical wound site), epidural space, or subarachnoid space infusion. The pump is intended for therapies that require a continuous rate of infusion, patient-controlled demand doses, or both (such as patientcontrolled analgesia).

The CADD®-Solis Medication Safety Software consists of the Administrator and the Point of Care software applications. This software allows you to create a set of standard pump Protocols to be used with the CADD®-Solis Ambulatory Infusion Pump and CADD-Prizm® PCS II Ambulatory Infusion Pump. The Point of Care software application is used for the CADD-Prizm® PCS II Ambulatory Infusion pump (with software revision H or higher) only.

The CADD® -Solis ambulatory infusion pump ("Solis Pump") provides measured drug therapy to patients in the hospital setting. The pump can be programmed to deliver medication at a continuous rate, patient controlled analgesia (PCA), clinician bolus, continuous rate plus PCA, and continuous rate plus clinician bolus.

The Smiths Medical MD, Inc. CADD® -Solis Medication Safety Software -Administrator ("Solis Safety Software - Administrator"), a server based software program that operates on commercially available computers, is designed to establish user defined therapy based protocols for use by the Solis Pump or for use by use CADD®-Solis Medication Safety Software – Point of Care (POC) to program the CADD-Prizm® PCS II Ambulatory Infusion Pump (software revision H or higher). The Solis Safety Software - Administrator does not allow duplicative Drug, Protocol or User identification entries.

The provided text describes two devices: the CADD®-Solis Ambulatory Infusion Pump and the CADD®-Solis Medication Safety Software – Administrator. The information primarily focuses on the regulatory submission (510(k) summary) and does not contain detailed acceptance criteria and a study that proves the device meets those criteria in the typical format of clinical performance evaluation studies (e.g., with metrics like sensitivity, specificity, or accuracy).

Instead, the submission indicates that:

• For both devices: "The Solis Pump and Solis Safety Software – Administrator were subjected to verification and validation testing. The verification and validation testing performed demonstrate the devices function as intended and perform to specification."
• For the Medication Safety Software: "Human clinical studies were deemed not necessary to evaluate the safety or effectiveness of the CADD-Sentry Pro™ Medication Safety Software." (Note: The document inconsistently refers to "CADD-Sentry Pro™ Medication Safety Software" here, but the 510(k) is for "CADD®-Solis Medication Safety Software - Administrator").
• Conclusion: "Based upon the information provided, the CADD-Sentry Pro™ Medication Safety Software is safe, effective and performs to established specifications."

Given this, I cannot provide a table of acceptance criteria and reported device performance with quantitative metrics, nor can I answer many of the specific questions about clinical study design (sample size, ground truth, expert qualifications, etc.) because such a clinical study, as typically understood for AI/diagnostic devices, was explicitly deemed "not necessary."

However, I can extract the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

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

• No specific sample size for a test set is mentioned.
• Data provenance is not specified. The studies mentioned are "verification and validation testing," which typically involves engineering and functional testing rather than clinical data sets.

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

• Not applicable/Not provided. The document states clinical studies were "deemed not necessary."

4. Adjudication method for the test set

• Not applicable/Not provided. Clinical studies with adjudication methods were not conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

• No. A multi-reader multi-case study was not conducted as clinical studies were "deemed not necessary."

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

• The "verification and validation testing" performed for the CADD®-Solis Medication Safety Software – Administrator can be considered a form of standalone testing, as it evaluates the software's functional performance against its specifications. However, this is not a standalone clinical performance study.

7. The type of ground truth used

• For the "verification and validation testing," the ground truth would be based on the established engineering specifications and intended functional behavior of the infusion pump and the software. It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

• Not applicable/Not provided. As no AI/ML algorithm requiring a training set is explicitly discussed in the clinical study context, this information is not relevant to the described studies. The software is described as a "server based software program" designed to "establish user defined therapy based protocols."

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

• Not applicable/Not provided. No training set is mentioned.

Summary: The provided document is a 510(k) summary for medical devices (an infusion pump and its associated medication safety software). It describes "verification and validation testing" to show that the devices function as intended and perform to specification. Crucially, it states that "Human clinical studies were deemed not necessary" for the medication safety software. Therefore, the questions related to clinical study design, patient data, expert evaluation, and AI algorithm training sets are not addressed in this document. The "acceptance criteria" appear to be met through these internal functional and validation tests, rather than through a comparative clinical performance study.

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The intended use of the Multirate Infusor with Patient Control Module includes slow, continuous, subcutaneous or epidural administration of pain medications. It may also include the slow, continuous infusion of pain medications directly into an intraoperative site, subcutaneously for postoperative pain management or the continuous infusion of a local anesthetic near a nerve for regional anesthesia. The Patient Control Module allows for intermittent bolus doses of pain medication on patient demand.

Baxter's Multirate Infusor devices with attached PCM, are single-use disposable infusion pumps designed to deliver solution at a constant flow rate of 1-12mL/hr, depending upon the device configuration and settings, as well as allow for intermittent bolus doses of medication on patient demand.

The provided text describes a 510(k) notification for a device modification of the Baxter Healthcare Corporation Multirate Infusor with PCM. The focus of the submission is to demonstrate substantial equivalence to previously cleared devices, primarily through risk analysis and design verification testing.

Here's an analysis of the requested information:

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

The document states: "Design verification tests based on the result of risk analysis and design input were performed to verify those modifications. All test results meet the acceptance criteria, and proved that those modifications to be appropriate."

However, the specific acceptance criteria (e.g., flow rate accuracy, bolus volume precision, mechanical integrity) and the reported device performance values are not explicitly detailed in the provided text. The submission focuses on the process of verifying the modifications rather than presenting quantitative performance data.

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

The document mentions "design verification tests" were performed, but it does not specify the sample size used for these tests.

Regarding data provenance: The tests were conducted internally by Baxter Healthcare Corporation to verify the design modifications. The country of origin of the data is implicitly the United States, as Baxter Healthcare Corporation is a US-based company and the submission is to the FDA. The tests are prospective in nature, as they were performed specifically to verify the recent design modifications.

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

The concept of "experts" to establish ground truth is typically relevant for diagnostic devices that interpret signals or images. This document describes a modification to an infusion pump, which is a functional medical device. Therefore, the "ground truth" here would be objective engineering measurements and functional performance against specifications.

The document does not mention the use of external experts for establishing ground truth in this context. The verification would have been conducted by Baxter's internal engineering and quality teams.

4. Adjudication method for the test set

Given that the "ground truth" involves objective engineering measurements of device performance, an adjudication method (like 2+1 or 3+1 consensus commonly used in image analysis) is not applicable or mentioned in this context. Device performance is typically evaluated against defined engineering specifications and tolerances.

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

An MRMC comparative effectiveness study is not applicable here. This type of study is used for medical devices, particularly diagnostic aids that involve human interpretation (readers) of cases. The Multirate Infusor with PCM is an infusion pump, a therapeutic device, and does not involve "readers" in the context of diagnostic interpretation.

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

This question is not applicable to this device. An infusion pump does not contain an "algorithm only" component or involve human-in-the-loop performance in the way a diagnostic AI would. Its performance is inherent to its mechanical and electronic design.

7. The type of ground truth used

The ground truth for this device's performance would be established through:

• Engineering Specifications: Pre-defined functional requirements and tolerances for flow rates, bolus volumes, safety mechanisms, material compatibility, and structural integrity.
• Measurement Standards: Adherence to recognized industry standards for device performance and safety (e.g., ISO, ASTM, or internal Baxter standards derived from such).
• Risk Analysis (FMEA): The document explicitly states that Failure Modes and Effects Analysis (FMEA) was used to assess the impact of modifications. This process identifies potential failure modes and their effects, leading to verification tests designed to ensure these failures do not occur within acceptable limits.

8. The sample size for the training set

This question is not applicable. "Training set" refers to data used to train machine learning algorithms. The Multirate Infusor with PCM is a hardware medical device; its design and verification do not involve machine learning.

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

This question is not applicable for the same reasons as #8.

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The Medley PCA Module is intended for use in today's growing professional healthcare environment for facilities that utilize infusion devices for the delivery of medications or fluids. The Medley PCA Module is indicated for use on adults, pediatrics, and neonates for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural.

The addition of the PCA/Monitoring Protocol provides an optional and hospitalconfigurable feature that is intended to align with healthcare facilities' current protocols that require monitoring of patients while on PCA therapy. All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

The Medley PCA Module with PCA/Monitoring Protocol is intended for use with patients that are prescribed PCA pain management therapy with opioid medications, specifically: Fentanyl, Demerol, Morphine, and Hydromorphone. The Medley PCA Module with PCA/Monitoring Protocol is intended for use by healthcare professionals in clinical environments. The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care. All device programming, data entry and validation of the Medley PCA Module with PCA/Monitoring Protocol is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order.

Due to the potential for opioid-induced respiratory depression, hospitals require regular monitoring and assessment of patients prescribed opioid medications. By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response while receiving opioid infusion therapy.

This submission will utilize the current system modularity to add a new hospitalconfigured Guardrails parameter (PCA/ Monitoring Protocol) to the Medley PCA Module. This Protocol is designed to help ensure patient safety when administering opioid medications. This Protocol will be available for use when a PCA Module and monitoring module(s) are attached to the same Medley Point of Care Unit (PCU). The PCA/Monitoring Protocol will be part of the Guardrails data set and will consist of a specified list of opioid medications and hospital-specified pre-configured monitoring limits. The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected.

The provided document discusses the Medley™ PCA Module with PCA/Monitoring Protocol and its substantial equivalence to a predicate device, rather than presenting a detailed study with acceptance criteria and performance data in the typical sense for a diagnostic or AI-powered device.

This clearance is for a medical device (an infusion pump with a specific protocol feature), which undergoes different types of validation than, for example, an AI diagnostic tool. The "performance data" mentioned in the document refers to engineering and functional testing to ensure the device operates as intended and is safe, rather than clinical performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested categories (like sample size for test/training sets, number of experts for ground truth, MRMC studies, standalone performance with metrics like AUC/sensitivity/specificity) are not applicable or not detailed in this type of 510(k) summary for an infusion pump.

However, I can extract what is available from the document regarding the "acceptance criteria" (implied functional requirements) and what the document states about "performance data".

Here's an attempt to answer based on the provided text, highlighting what is available and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

• Ability to deliver continuous or intermittent medications/fluids.
• Compatibility with various routes of administration (IV, subcutaneous, epidural).
• Integration of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the Medley System platform.
• Activation of PCA/Monitoring Protocol based on hospital-specified parameters and detection of an "unsafe state of respiratory depression."
• All device programming, data entry, and validation of parameters performed by trained healthcare professionals according to protocol/physician's order.
• The Protocol acts as an "additional safety net" for clinicians without replacing assessment or decision-making.
• The device must meet specified requirements for safety and effectiveness. | The document states:
  "The Medley PCA Module is intended for use... for continuous or intermittent delivery through clinically acceptable routes of administration; such as intravenous (IV), subcutaneous, or epidural."

"By allowing for the combination of a PCA Module and monitoring module (EtCO2 Module and/or SpO2 module) on the same platform, the Medley System provides a readily available way for the clinician to continuously monitor the patient's respiratory response..."

"This Protocol is designed to help ensure patient safety when administering opioid medications... The Protocol will activate only when hospital-specified protocol indicates an unsafe state of respiratory depression is detected."

"All device programming, data entry and validation of PCA/Monitoring Protocol parameters is performed by the trained healthcare professional according to hospital-defined protocol or a physician's order."

"The Protocol does not replace clinician assessment or therapy decision making, but adds an additional safety net for the clinician at the point of care."

"The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device." |

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

• Not explicitly stated in the document. The "performance data" mentioned would typically refer to engineering and functional testing of the device's hardware and software, rather than clinical trials with patient data. This is common for a 510(k) medical device clearance where substantial equivalence to a legally marketed predicate is established.

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

• Not applicable/not explicitly stated. For a medical device like an infusion pump, "ground truth" in the diagnostic sense is not typically established by experts reviewing cases. Performance is usually assessed against engineering specifications and functional output.

4. Adjudication method for the test set

• Not applicable/not explicitly stated. Clinical adjudication, as seen in diagnostic studies, is not typically part of the clearance for an infusion pump's functional performance.

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 an infusion pump with a safety protocol (not an AI diagnostic tool for image or data interpretation by human readers). Therefore, MRMC studies are not relevant.

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

• Partially applicable, but for device function, not diagnostic performance. The "algorithm" here refers to the PCA/Monitoring Protocol. Its standalone functionality (i.e., whether it correctly detects 'unsafe states' based on its programming and triggers alerts) would have been tested as part of the "performance data." However, its "performance" is not measured in terms of diagnostic metrics like AUC, sensitivity, or specificity against a clinical ground truth, but rather its adherence to design specifications and safety requirements. The document states it is "intended to align with healthcare facilities' current protocols."

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

• Not explicitly stated/not applicable in the traditional sense. For this device, the "ground truth" for validation would be its adherence to engineering specifications, safety standards, and its ability to correctly implement the defined "PCA/Monitoring Protocol" logic (e.g., detecting specified physiological parameters (EtCO2, SpO2) and acting in accordance with pre-configured monitoring limits). These are validated through functional and performance testing, not against clinical outcomes or expert consensus on patient cases.

8. The sample size for the training set

• Not applicable. This device is not an AI/ML model that requires a training set in the conventional sense. Its "protocol" is programmed logic, not learned from data.

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

• Not applicable. See point 8.

Summary of the Study (as described in the 510(k) submission):

The document describes the Medley™ PCA Module with PCA/Monitoring Protocol and references a "performance data" section, which is typical for 510(k) submissions. This "performance data" is designed to demonstrate that the device meets its specified requirements and is substantially equivalent to its predicate device (Medley PCA Module, K032233).

The study that proves the device meets the acceptance criteria (i.e., functional requirements and safety) is implicitly described as the "Performance Data" section of the 510(k) submission. This data would have involved:

• Bench testing: Verifying the accuracy of fluid delivery, the functionality of the monitoring module integration (EtCO2, SpO2), and the correct execution of the PCA/Monitoring Protocol logic (e.g., proper activation in response to simulated "unsafe states" and adherence to pre-configured monitoring limits).
• Software validation: Ensuring the software correctly implements the protocol and user interface.
• Electrical safety and EMC testing: Adherence to relevant standards.

The primary goal of this submission was to demonstrate Substantial Equivalence to a previously cleared device (Medley PCA Module, K032233) due to the addition of a new hospital-configurable Guardrails parameter (the PCA/Monitoring Protocol). The document states, "The results of this comparison demonstrate that the Medley™ PCA Module with PCA/Monitoring Protocol is equivalent to the marketed predicate device in technological characteristics." and "The performance data indicate that the Medley™ PCA Module with PCA/Monitoring Protocol meets specified requirements, and is substantially equivalent to the predicate device."

This means the "study" involved comparing the new device's functional and safety performance against the established requirements and the predicate device's performance, ensuring the added protocol feature did not introduce new safety concerns or compromise existing functionality.

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The Hospira LifeCare® PCA3 Infusion System is intended for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System is also indicated for short-term (less than 96 hours) continuous epidural administration of analgesic drugs.

The Hospira LifeCare® PCA3 Infusion System is a microprocessor controlled, pole mounted, standalone, electromechanical infusion pump that allows a patient to self administer, analgeric usines, a patient pendant, within physician prescribed, programmed parameters. A stepper motor exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is powered from an AC power source and has an internal battery to maintain operation for short periods when an AC power source is not available. The infuser will accept a pre-filled drug vial manufactured by Haspire and includes one sterile empty vial that can be filled by a hospital's pharmacy.

The provided text is a 510(k) summary for the Hospira LifeCare® PCA3 Infusion System. It details the device, its intended use, and a comparison to predicate devices to establish substantial equivalence. However, this document does not contain information about specific acceptance criteria, a study proving the device meets those criteria, or details regarding sample sizes for testing or training sets, ground truth establishment, expert involvement, or MRMC studies.

The document states that the device "meets the functional claims and intended use as described in the product labeling" and that "The proposed modifications do not raise new issues of safety and/or effectiveness." It also makes claims of substantial equivalence based on:

1. Same intended use
2. Same indication for use
3. Same fundamental technology and operating principle
4. Same physical, operational, environmental and performance attributes
5. Same materials of construction for infuser components and administration sets

It lists "Performance Features" such as "Delivery Rates, Dose Units, Delivery Accuracy, Delivery Modes, Occlusion Pressure Limits, Alarm Types and Conditions" as being "Same" as the predicate devices, implying these are the performance criteria that were considered. However, explicit numerical acceptance criteria and the results of a study demonstrating these are not present in this summary.

Therefore, I cannot provide the requested information for the following points as they are not present in the provided text:

• A table of acceptance criteria and the reported device performance
• Sample size used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used (expert consensus, pathology, outcomes data, etc)
• The sample size for the training set
• How the ground truth for the training set was established

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The LifeCare PCA® Infusion System with Hospira MedNet™ Software is indicated for accurate, volumetric, infusion of analgesic drugs by continuous or patient-demanded (PCA) intravenous administration. The LifeCare PCA® Infusion System with Hospira MedNet™ Software is also indicated for short-term (less than 96 hours) continuous administration of analgesic drugs.

The LifeCare PCA® Infusion System with Hospira MedNet™ Software is an electromechanical infusion pump that uses a stepper motor that exerts pressure on an inserted drug vial to control the infusion of analgesic into a patient. The infuser is pole-mounted and includes an attached patient pendant that allows a patient to self-administer analgesia within physician-prescribed, programmed parameters that include delivery mode, PCA dose, lockout interval, and/or dose limits.

The LifeCare PCA® Infusion System with MedNet™ Software consists of:

• an infuser that is compliant with IEC 60601-1-2 2nd Edition requirements .
  • a bar code reader that recognizes Hospira- or Abbott-manufactured drug . vials as well as hospital pharmacy-generated bar codes
  • . a Nurse Call Port
  • networked communication capability (Ethernet wired and wireless) with . Medication Management compatible hospital information systems
  • hardware that is compatible with Hospira MedNet™ Software. .

This document is a 510(k) summary for the LifeCare PCA® Infusion System with Hospira MedNet™ Software. As such, it focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results for device performance. It does not contain the information requested in your prompt regarding acceptance criteria, specific performance studies, sample sizes, expert involvement, or ground truth establishment.

Here's why the requested information is absent:

• 510(k) Summary Purpose: A 510(k) submission primarily aims to demonstrate that a new device is as safe and effective as a legally marketed predicate device. This is often achieved by showing similar technological characteristics and intended use, rather than conducting new, elaborate performance studies with predefined acceptance criteria for the new device as if it were a novel technology.
• Focus on Substantial Equivalence: The document explicitly states: "The subject and predicate devices are similar in design, materials of construction, components, intended use, labeling and manufacturing processes. The proposed modifications do not raise new issues of safety and/or Frio proposou moome, the LifeCare PCA® Infusion System with Hospira™ MedNet Software is substantially equivalent to the predicate infusion pumps." This highlights the core of a 510(k) submission.
• Type of Device: This is an infusion pump, a well-established medical device type. Performance is typically assured through adherence to recognized standards (e.g., IEC 60601-1-2 mentioned for electrical safety) and comparison to existing, cleared devices, rather than new studies proving clinical efficacy or diagnostic accuracy with AI-like metrics.

Therefore, I cannot extract the information you requested from the provided text.

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