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• The system may be used to store, retrieve, edit and report records of biologic origin such as ECG, exercise stress and Holter tests.
• The system can receive tests from a variety of devices. Data is then available through . onscreen display, printer, email, fax, HIS (Hospital Information System) results reporting interface or via customized database queries.
• . Users may view and edit interpretative statements and measurements through the onscreen display.
• The system can calculate multiple QTc metrics based upon acquired ECG data. ●
• The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data.
• . The system is designed to provide information for qualified clinicians responsible for the diagnosis and treatment of patients (adult and pediatric) with heart disease.
• The system is designed for use in a clinical setting by physicians, nurses, clinical . technicians, medical records personnel and medical record transcriptionists.

The Pyramis system is a personal computer based, comprehensive data management tool, with multi-tasking capabilities for receiving, editing, retrieving, and printing of ECG, Stress and Holter reports. The Pyramis system uses a transactional client/server database model with database transactional backup logging. User interface tools include bar coding, batch processing, on-screen diagnostic quality waveform viewing, customized header format, dynamic record retrieval and automated Quality Assurance reports on demand. Records can be accessed upon demand and transmitted remotely. The Pyramis system also uses industry standard protocols for communication so it can interface with the hospital's information system.

The Pyramis system can be comprised of two functional components; the client application (user interface), and a suite of server applications that serve to acquire the ECG, Stress and Holter records, store them in a database and print/fax/email and export (distribute) those selected records.

The provided text is a 510(k) Summary for the Pyramis ECG Management System. It outlines the device's description, intended use, and technological comparison to a predicate device, but it does not contain information about acceptance criteria or a study proving the device meets those criteria.

This document is a regulatory submission for premarket notification, aiming to demonstrate substantial equivalence to an already legally marketed device (the predicate device). It focuses on comparing the new device's features and safety/efficacy to the predicate, rather than detailing specific performance acceptance criteria and a study to meet them.

Therefore, I cannot provide the requested information from this input. The sections of your request that cannot be answered are:

1. A table of acceptance criteria and the reported device performance: Not available.
2. Sample size used for the test set and the data provenance: Not available.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
4. Adjudication method for the test set: Not available.
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 available.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this device is a data management system, not an AI algorithm performing interpretations.
7. The type of ground truth used: Not available.
8. The sample size for the training set: Not available.
9. How the ground truth for the training set was established: Not available.

The document states: "Neither device modifies the original waveform as provided by the ECG recording device." and "The system does not modify the original ECG waveform information, nor does it provide an automated ECG interpretive analysis of the data." This indicates that the device's primary function is data management, storage, viewing, and transmission, not diagnostic interpretation or modification of raw data. Therefore, the types of performance studies typically associated with AI-driven diagnostic devices (like those requiring ground truth, expert consensus, MRMC studies, etc.) would not be applicable to this specific device description.

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The device is intended to monitor, analyze, document, and report hemodynamic data acquired during a cardiac catherization procedure.
The system contains an acquisition subsystem and an analysis subsystem.
The system acquires non-invasive and invasive data parameters. The data is received, displayed, stored, and analyzed in the Q-Cath.
The device is to be used on adult and pediatric patients while undergoing a cardiac catherization procedure.
Patient demographics, registration, patient assessment, procedure log notes, collected physiological and other Q-Cath data can be exported to an information management system.
A Q-Cath remote workstation may be used to access patient files off-line or for the entering of additional patient information or editing of existing patient files. Additionally, the workstation may be used as a means of recording non-invasive vital signs data through the use of qualified third party peripheral monitoring devices.
Multiple Q-Cath systems and workstations may be used and connected to a local area network.
The Q-Cath system is not intended to be the sole means for monitoring a patient's status.

The Q-Cath system is a monitoring and analysis system that is used by Physicians, nurses, technicians and administrators associated with the cardiac catherization (cath) lab. The Q-Cath is a Microsoft Windows® based system with 32-bit architecture. The system contains an acquisition subsystem and an analysis subsystem. The O-Cath organizes patient signals (invasive & non-invasive), and non-physiological signals from external devices. The Signal Conditioning System (SCS) acquisition subsystem contains connectors for the 12 lead surface ECG, four pressure inputs, three HIS inputs, two DC inputs, two types of synchronization waveform outputs and ECG simulator outputs. The optional Vital Statistical System (VSS) acquisition system contains module connections for the non-invasive blood pressure, the SPO2 and two auxiliary modules. The analysis system generates data based upon pressure site locations, ECG data and the entry of information such as cardiac output, oximetry results, and the patient physiological condition. The system stores Full Disclosure data of all waveform data to the O-Cath local computer or can be stored off-line to a file server.

The provided document, a 510(k) summary for the Quinton Q-Cath System, does not contain information regarding acceptance criteria, a specific study proving device performance against such criteria, or details typically found in performance evaluation sections for AI/ML-driven devices.

The document describes a medical device for monitoring and analyzing hemodynamic data during cardiac catheterization procedures. Its purpose is to demonstrate substantial equivalence to a predicate device (Quinton Q-Cath, K862740), focusing on technological comparison, intended use, and safety/effectiveness aspects. The improvements mentioned are primarily related to system architecture (Windows-based, co-resident image analysis, integration of external data) and workflow efficiency, rather than a new analytical algorithm requiring rigorous performance metric evaluation against defined acceptance criteria.

Therefore, I cannot provide the requested information from the provided text. The document does not include details on:

1. Acceptance criteria table and reported device performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision for an analytical task) or acceptance thresholds are mentioned.
2. Sample size for the test set and data provenance: No test set is described.
3. Number of experts and qualifications for ground truth: No ground truth establishment is described as there's no analytical model being evaluated.
4. Adjudication method: Not applicable.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone (algorithm only) performance: Not applicable.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable.
9. How ground truth for the training set was established: Not applicable.

The 510(k) summary focuses on demonstrating that the Q-Cath System is "substantially equivalent in safety and effectiveness" to its predicate device through a comparison of technological characteristics, intended use, and compliance with general safety standards (like IEC 60601-1 and electromagnetic compatibility). It states, "Both devices perform equivalently," and "Generated data is identical," implying that the core functionality related to data generation and initial analysis remains the same as the predicate device, with enhancements primarily in user experience, data integration, and system architecture.

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The intended use of the Q-Tel® Telemetry System v. 6.0 (ST) is the acquisition and transmission of ECG data by means of a radio-frequency transmitter worn by individual patients in a hospital or clinical setting to a central monitor where it is received, displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change. The intended population are ambulatory adults where cardiac monitoring is prescribed while undergoing exercise rehabilitation.

The Q-Tel® Telemetry System v. 6.0 (ST) consists of a central receiver, transmitter, viewing monitor, keyboard, and accessories. ECG data is received via the transmitter to the central receiver and is displayed, stored, and analyzed, with alarms for heart rate, arrhythmia, and ST change.

The provided text describes the Q-Tel® Telemetry System v. 6.0 (ST) and its performance testing. However, it does not explicitly state acceptance criteria in a quantitative table or the specific results to demonstrate direct adherence to such criteria. The document mentions that "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" but does not provide these detailed results or a comparison against predefined numeric thresholds.

Therefore, much of the requested information cannot be definitively extracted from the provided text.

Here's an attempt to answer based on the available information:

Acceptance Criteria and Study Details for Q-Tel® Telemetry System v. 6.0 (ST)

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of explicit, quantitative acceptance criteria with corresponding performance metrics. It generally states that the "Conclusion shows tape-by-tape results that indicate the algorithm's ability to detect events of clinical importance" for both arrhythmia detection and ST algorithm testing.

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

• Sample Size: Not explicitly stated. The document refers to "tape-by-tape results," suggesting individual recordings were used, but the total number of tapes or patients is not provided.
• Data Provenance:
  • Arrhythmia Detection: Data was tested "in accordance with AAMI recommended practice, Testing and Reporting Performance Results of Ventricular Arrhythmia Detection Algorithms." This typically implies standardized arrhythmia databases, which often consist of retrospective recordings. However, the exact source or country of origin is not specified.
  • ST Algorithm: Data was "using a test protocol from the European ST-T Database sponsored by the European Society of Cardiology." This indicates the data is from Europe and is likely retrospective.

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

This information is not provided in the text. The document refers to testing against "AAMI recommended practice" and the "European ST-T Database," but it does not detail how the ground truth within these sources was established or the qualifications of the experts involved.

4. Adjudication method for the test set:

This information is not provided in the text.

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:

A multi-reader multi-case (MRMC) comparative effectiveness study focusing on human reader improvement with AI assistance was not mentioned or described in the provided text. The testing described is focused on the standalone algorithm performance against established industry practices and databases.

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

Yes, a standalone algorithm performance study was done. The description focuses entirely on the "arrhythmia detection" and "ST algorithm" functions being tested against established protocols and databases, implying evaluation of the algorithm's performance independent of human-in-the-loop interaction.

7. The type of ground truth used:

• Arrhythmia Detection: The ground truth would have been established within the "AAMI recommended practice" ventricular arrhythmia detection algorithms. This typically involves expert-annotated ECG recordings of various arrhythmias.
• ST Algorithm: The ground truth would have been established within the "European ST-T Database." This database contains expert-annotated ECG recordings with ST segment changes.

8. The sample size for the training set:

The sample size for the training set is not provided in the text. The document focuses on performance testing of the device, not its development or training process.

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

This information is not provided in the text. The document does not describe the training phase of the algorithm.

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The Quinton MedTrack CR Plus Treadmill is intended to be used as a rehabilitation device for cardiovascular conditioning. The intended population are ambulatory patients undergoing exercise rehabilitation.

Not Found

The provided document is a 510(k) premarket notification letter from the FDA for a treadmill (Quinton MedTrack CR Plus Treadmill). This type of document declares substantial equivalence to a predicate device but does not contain any information regarding acceptance criteria or a study proving device performance against such criteria.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on regulatory approval based on substantial equivalence, not on a detailed performance study with acceptance criteria.

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The ViewCath™ Catheter Pullback is a device used for motorized pullback of medical Ultrasound intravascular imaging catheters to assist in consistent, selectable speed, 2-D image acquisition for use by medical imaging software for longitudinal view display or 3-D reconstruction and rendering and volumetric presentation of 3-D images for diagnostic review.

The ViewCath™ Catheter Pullback is a medical Ultrasound Intravascular transducer catheter pullback device used in conjunction with Intravascular Ultrasound system devices. The ViewCath™ Catheter has a cradle that firmly holds various catheter transducer drive motors. Upon actuation, the device pulls the motor cradle at one of two selected speeds. A medical Intravascular Ultrasound catheter attached to the drive motor is pulled back at a consistent speed to obtain multiple 2-D ultrasound images. It is similar in design to other such catheter pullback devices. It has a motor driven mechanical screw mechanism, Intravascular Ultrasound catheter motor drive cradle, control switch and travel readout scale.

This document is a 510(k) summary for the ViewCath™ Catheter Pullback device, submitted to the FDA in 1997. It describes the device, its intended use, and states its substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

The document states: "Performance tests were conducted by testing the system to the requirements of the design specifications and comparison to the predicate devices." and "The performance evaluations indicated that the system consistently performed within its design parameters, and equivalently to the predicate devices."

However, specific numerical acceptance criteria (e.g., maximum speed variation, accuracy of travel readout) and their corresponding reported device performance values are not explicitly provided in the provided text. The submission focuses on demonstrating substantial equivalence rather than detailed performance metrics.

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

The document does not specify a "test set" in the context of typical AI device testing with a distinct dataset of images or cases. The performance evaluation appears to be based on engineering tests of the device's mechanical and electrical functions and comparison to the predicate device.

• No information on data provenance (country of origin, retrospective/prospective) is provided, as no clinical data or image-based test set is mentioned.

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

Not applicable. The "ground truth" for this device would be its mechanical and functional specifications (e.g., the actual speed it pulls the catheter, the accuracy of its travel readout). This is assessed through engineering tests, not expert interpretation of medical data.

4. Adjudication Method for the Test Set:

Not applicable. There is no mention of adjudication, as no expert review of cases or images is described.

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

No, an MRMC comparative effectiveness study was not done. This device is a mechanical catheter pullback system, not an AI software intended to assist human readers in interpreting medical images. Therefore, the concept of human readers improving with or without AI assistance is not applicable.

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

Not applicable in the context of AI algorithms. The device itself operates "standalone" in performing its mechanical function (pulling the catheter), but this is not analogous to an AI algorithm's standalone diagnostic performance. The document describes the device's operational performance, stating it "consistently performed within its design parameters."

7. Type of Ground Truth Used:

The ground truth used for this device's performance evaluation would be its engineering design specifications (e.g., specified pullback speeds, travel readout accuracy, mechanical stability). The performance tests would have verified that the device's output (actual speed, actual travel distance) matched these specified parameters.

8. Sample Size for the Training Set:

Not applicable. This device is a mechanical medical instrument, not an AI model that requires a training set.

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

Not applicable, as there is no training set for this device. Its design and operation are based on mechanical and electrical engineering principles, not machine learning from data.

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The intended use of the Quinton Synergy Cardiology Information System (CIS) is the acquisition, storage, and display of electrical signals of biological origin, as ECG data, that are obtained from other devices connected directly to the patient. This display on the CIS would only occur at the cessation of data acquisition by the patient connected equipment. (Hence, the CIS would only operate as non-real time system.) Additionally, the CIS may acquire, store, and display administrative data, as patient demographic information.

Acquired information may be reviewed, edited, abridged, or re-formatted and distributed electronically or printed.

The CIS is a cardiology data management system that encompasses and integrates proprietary software and third party software on a single workstation or networked workstations. The workstation may include ancillary devices as a server, bar cod system, and printer.

The CIS provides a means to establish, maintain, access, review, and edit cardiology patient records that are typically generated from ECG procedures.

The Quinton Synergy Cardiology Information System (CIS) is a cardiology data management system that acquires, stores, and displays electrical signals of biological origin (ECG data) obtained from other connected devices, as well as patient demographic information.

1. Acceptance Criteria and Reported Device Performance:

The acceptance criteria for the Quinton Synergy Cardiology Information System (CIS) were implicitly demonstrated through performance testing comparing data integrity and visual assessment of ECG and textual information. The reported device performance met these criteria.

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

The document does not explicitly state the numerical sample size for the test set (number of ECG waveforms or textual data transmissions). However, it mentions "randomized ECG waveforms and textual data."

The data provenance is from existing devices for which the CIS is receiving data: the Quinton Model Q710 Exercise and Resting Electrocardiograph and the HP PageWriter XLi. The study appears to be retrospective in the sense that it uses pre-existing data from these devices for transmission testing, rather than prospectively generating new patient data for the purpose of the study. The country of origin of the data is not specified.

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

One expert was used to establish the ground truth for the visual comparison of printed ECG and textual data. This expert was identified as a cardiologist. Specific qualifications (e.g., years of experience) were not provided.

4. Adjudication Method for the Test Set:

For the digital comparisons, the adjudication method was software-based comparison to determine the integrity of the digital transfer. This implies an automated, objective comparison without human adjudication.

For the visual comparisons of printed data, the adjudication method was single expert review, where a cardiologist compared the pre- and post-transmission print-outs. No multi-reader adjudication method (like 2+1 or 3+1) was used.

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

No, an MRMC comparative effectiveness study was not done. This study focuses on the data transfer and display capabilities of the CIS, not on the interpretative accuracy of an AI or human readers, or how AI might assist human readers.

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

Yes, a form of standalone performance was implicitly done for the digital comparison aspects. Software was used to determine the integrity of the digital transfer, meaning the algorithm (CIS's data handling) was evaluated independently of human interpretation of the raw digital data. However, for the visual integrity of printed reports, a human (cardiologist) was in the loop.

7. The Type of Ground Truth Used:

Two types of ground truth were used:

• Original Digital Data: For the digital transmission integrity tests, the "pre-transmitted information" was considered the ground truth against which the received and stored information at the CIS was compared.
• Original Printed Reports and Expert Visual Comparison: For the visual integrity tests, the "pre-transmission print-outs" from the source devices served as the visual ground truth. The "cardiologist compared the pre- and post-transmissions for significant differences," indicating that expert visual assessment established the ground truth for acceptability.

8. The Sample Size for the Training Set:

The document does not mention a training set. This device is a data management system, not an AI/ML-driven diagnostic algorithm that typically requires a training set. The performance testing described relates to data transfer and display integrity.

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

As no training set was mentioned or implied, this question is not applicable.

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The intended use of the Quinton Vital Statistics System (Q-Cath Accessory) is the acquisition, calculation, and transmission of physiological parameters as diastolic and systolic blood pressure, blood oxygen saturation levels, and heart rate to the Quinton Q-Cath during cardiac cath procedures.

The Vital Statistics System (VSS) is an accessory to the Quinton Q-Cath catheterization analysis system. The purpose of the VSS is to acquire, calculate, and transmit physiological data as blood pressure (acquired noninvasively), blood oxygen saturation data, and heart rate to the Q-Cath during cardiac cath procedures. Additionally, the VSS has 'pass-through' input and output connections for the purposes of acquiring and transmitting low voltage signal data to the Q-Cath from external devices and from the Q-Cath Signal Conditioning System component. Set-up of the VSS modules occurs at the Q-Cath via software controls.

The VSS is made up of a 3" x 20" x 12" metal enclosure that has compartments for insertion of the non-invasive blood pressure module, SP02 module, and two pass-through modules. A power supply within the device is capable of converting line voltage to regulated low voltage needed by the modules. The VSS weighs 35 Ibs when all modules are in place within the VSS.

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

Acceptance Criteria and Device Performance

Study Details

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

   • Sample Size: The document states "The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached." and "The number of randomized blood pressure, heart rate samples chosen were such that a meaningful statistical analysis and conclusion could be reached." This indicates statistical power was considered, but an exact numerical sample size is not specified in the provided text for either NIBP or SP02 testing.
   • Data Provenance: The data was generated using "Randomized simulated oscillometric NIBP and HR outputs" from an "NIBP simulator" and "Randomized simulated SP02 and HR outputs" from an "SP02 simulator." This implies simulated, laboratory-based data. The document does not specify a country of origin, but given the submitter's address is in Washington, USA, it is likely US-based. The study appears to be prospective in its design, as measurements were taken specifically for this comparison.

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

   • Not applicable. The ground truth in this study was not established by human experts but by the outputs of simulators, which are considered objective, controlled inputs for device testing.

3. Adjudication Method for the Test Set:

   • Not applicable. Since the ground truth was based on simulator outputs, there was no need for human adjudication of results. The comparison was directly between device measurements and simulator outputs, or between the candidate device and the predicate device's measurements of the simulator outputs.

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

   • No. An MRMC study was not conducted as this device is a physiological monitor, not an interpretive diagnostic tool requiring human readers. The study focused on the accuracy and equivalence of measurements between devices.

5. Standalone (Algorithm Only Without Human-in-the-Loop) Performance:

   • Yes. The performance testing described is inherently standalone as it compares the measurements produced by the VSS modules directly against those from the predicate devices, both operating on simulator outputs. There is no mention of a human operator influencing the measurement or calculation process in the performance test.

6. Type of Ground Truth Used:

   • The ground truth was established by simulator outputs. Specifically, "Randomized simulated oscillometric NIBP and HR outputs" were obtained from an "NIBP simulator," and "Randomized simulated SP02 and HR outputs" were obtained from an "SP02 simulator."

7. Sample Size for the Training Set:

   • Not applicable. This device is a physiological monitoring system, not an AI or machine learning algorithm that typically requires a training set. The performance testing involves direct comparison of measurements from the device against a known reference (simulator) or a predicate device.

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

   • Not applicable. As a physiological monitoring device without AI/ML components, there's no concept of a "training set" or ground truth establishment for such a set in the context of this 510(k) submission.

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The Mahurkar 8 Fr Catheter is intended to be used as a short-term central venous access device for hemodialysis, apheresis, and infusion.

The Mahurkar 8 Fr Catheter, a radiopaque polyurethane tube with two D-shaped lumina, is coated with silicone fluid. The lumina can be distinguished by the colorcoded luer-lock adapters on the clear silicone rubber extensions: the red adapter indicates the proximal lumen, and the blue adapter indicates the distal lumen. During hemodialysis and apheresis, the proximal lumen provides "arterial" outflow from the patient and the distal lumen provides "venous" return.

The Mahurkar 8 Fr Catheter is available in four (4) implantable lengths (9 cm, 12 cm, 15 cm, and 19.5 cm), with straight extensions or curved extensions, and is packaged in catheter kit and catheter tray configurations.

The provided text is a 510(k) summary for the Mahurkar 8 Fr Dual Lumen Catheter. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, as typically found in comprehensive performance testing reports. Instead, it focuses on demonstrating substantial equivalence to predicate devices.

Therefore, I cannot extract the requested information. The text does not provide:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets, data provenance, number of experts, their qualifications, or adjudication methods for establishing ground truth.
• Information about multi-reader multi-case (MRMC) comparative effectiveness studies.
• Details on standalone algorithm performance.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
• Sample size for the training set or how its ground truth was established.

The document states that "Performance data for the Mahurkar 8 Fr Catheter, including biocompatibility, mechanical characteristics, dynamic flow performance, infusion flow performance, and in vitro hemolysis testing, were compared to that of the predicate devices identified in paragraph (3) of this Summary." However, it does not provide the specific acceptance criteria for these tests or the detailed results demonstrating the device met them. It only concludes that "These test results demonstrate that the device is substantially equivalent to predicate devices commercially distributed for hemodialysis, apheresis, and infusion."

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