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The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

The Hansen Medical Magellan Robotic System and accessory components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modification adds a mechanical joint between the Magellan Robotic System Rail and Adapter Plate to facilitate removal.

The Magellan Robotic System and accessory components are compatible with Hansen Medical robotically steerable catheters approved under previous 510(k)s.

This document describes a 510(k) premarket notification for the Hansen Medical Magellan Robotic System, which is a steerable catheter control system. The submission is for a modification to an already cleared device (K132369).

Here's the breakdown of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not detail specific sample sizes for the visual, dimensional, IEC, table compatibility, or life cycle testing. It simply states that testing was performed and all pre-determined acceptance criteria were met. The data provenance is not explicitly mentioned (e.g., country of origin or retrospective/prospective). Given that the testing categories are related to engineering and regulatory standards, it's highly likely this was internal, prospective testing performed by the manufacturer or a contracted lab.

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

Not applicable. The testing described (visual, dimensional, IEC, table compatibility, life cycle) are engineering and technical verification tests, not clinical performance tests requiring expert ground truth establishment for a test set in the traditional sense of AI/clinical studies.

4. Adjudication Method for the Test Set

Not applicable. This is not a study involving human readers or clinical adjudication. The acceptance criteria were met based on the results of the specified engineering and technical tests.

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 MRMC comparative effectiveness study was performed or described. This submission is for a robotic system for facilitating navigation in the peripheral vasculature, not an AI-assisted diagnostic or interpretative device that would typically involve human readers. The document explicitly states: "No additional clinical evaluation of the Magellan Robotic System is required as a result of these changes."

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

This is not directly applicable in the context of an algorithm's standalone performance for diagnostic or interpretive tasks. The "device" itself (the Magellan Robotic System) operates in a master/slave control system with a physician-in-the-loop for navigation. The testing performed was "Design verification testing," which focuses on the device's technical specifications and adherence to standards rather than an algorithm's standalone clinical accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the engineering and technical tests would be the established specifications, standards (e.g., IEC 606061-1), and design requirements for the device. For example, for dimensional verification, the ground truth would be the engineering drawings and specified tolerances. For IEC testing, the ground truth would be the pass/fail criteria defined by the standard.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML product developed using a training set in the typical sense. It is a robotic system with physical and operational characteristics verified through engineering tests.

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

Not applicable, as there is no training set for this type of device and submission.

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The Hansen Medical Magellan Robotic Catheter 6Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic Catheter 6Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Magellan Robotic Catheter 6Fr (MRC 6Fr) and accessories are a modification of the predicate Magellan Robotic Catheter 9Fr (MRC 9Fr) and accessories cleared under K132369. The Magellan Robotic Catheter 6Fr is a smaller size catheter comprised of a Guide (Outer Catheter) with dual bend articulating sections (distal and proximal) paired with a non-articulating Leader (Inner Catheter). The device is provided in two lengths (60cm and 95cm). Like the predicate device, the MRC 6Fr is designed to be used with Hansen Medical Magellan Robotic System and is intended to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The MRC 6Fr may also be used for delivery of diagnostic contrast agents. The device is provided sterile and is intended for single use only. The catheter is designed to expand Hansen Medical's market offering of compatible devices available for use with the Magellan Robotic System cleared under K132369.

The provided text describes a 510(k) summary for the Hansen Medical Magellan Robotic Catheter 6Fr. It is a submission for a modified device, primarily focusing on its substantial equivalence to a predicate device (Magellan Robotic Catheter 9Fr).

Therefore, the acceptance criteria and study information pertain to demonstrating this substantial equivalence through non-clinical testing.

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

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

The document states: "All of the pre-determined acceptance criteria were met." However, it does not explicitly list the quantitative acceptance criteria for each test or the specific numerical performance results. It only lists the types of tests performed.

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 the sample sizes used for any of the non-clinical tests. It also does not provide information on the country of origin of the data or whether the data was retrospective or prospective. Given these are non-clinical (bench and lab) tests, these details are typically less relevant than for clinical studies.

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 study performed consists of non-clinical, benchtop and lab-based engineering, and biocompatibility tests, not clinical studies requiring expert ground truth for interpretation.

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

This information is not applicable and not provided. As noted above, the study involved non-clinical tests, which do not typically involve adjudication methods for "ground truth" in the way clinical diagnostic image interpretation studies would. The "ground truth" for these tests would be the established scientific and engineering standards and methods.

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 MRMC comparative effectiveness study was done. The document explicitly states: "Clinical evaluation is not required for this device." This is a submission for a modified steerable catheter, demonstrating substantial equivalence through non-clinical testing.

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

This information is not applicable. The device is a robotic catheter, not an algorithm or AI system for diagnostic interpretation that would have "standalone" performance in the context of diagnostic accuracy. The performance testing described is for the physical and biological characteristics of the catheter itself.

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

The "ground truth" for the non-clinical tests described would be the established scientific and engineering principles, specifications, and regulatory standards to which the device was tested. For example, for biocompatibility, the ground truth is defined by ISO 10993-1, and for physical tests, it's defined by engineering specifications and industry standards for catheter performance (e.g., specific thresholds for tensile strength, leak rates, articulation angles, etc.). These are not "expert consensus" or "pathology" in the diagnostic sense.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physical medical device (catheter) and not an AI/ML algorithm that requires a "training set."

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

This information is not applicable and not provided for the same reasons as point 8.

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Magellan Robotic System: The Hansen Medical Magellan Robotic System and accessory components are intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic System is intended to be used with compatible Hansen Medical robotically steerable catheters.

Magellan Robotic Catheter 9Fr. The Hansen Medical Magellan Robotic Catheter 9Fr is intended to be used to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices.

The Magellan Robotic Catheter 9Fr is intended to be used with the Hansen Medical Magellan Robotic System and accessories.

The Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr and Accessory Components are designed to facilitate navigation to anatomical targets in the peripheral vasculature and subsequently provide a conduit for manual placement of therapeutic devices. The fundamental concept of the system is based on a master/slave control system that enables and visualizes positioning of a steerable catheter tip at a desired point inside the vasculature, while enabling a physician to remain seated and away from the x-ray radiation source. The modifications to the Magellan System were made to expand system-quide wire compatibility, provide alternate quide wire navigation using the Master Input Device in addition to the existing Workstation and Bedside Controllers and to provide support for future compatible Hansen vascular catheters.

This document describes a Special 510(k) submission for modifications to the Hansen Medical Magellan Robotic System and Magellan Robotic Catheter 9Fr. This type of submission focuses on demonstrating that the modified device remains substantially equivalent to the previously cleared predicate device, rather than proving new clinical effectiveness. Therefore, the information typically associated with studies proving device performance against acceptance criteria (like sample sizes, ground truth establishment, or clinical effectiveness studies) is largely absent or stated as not required.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list quantitative acceptance criteria in a table format with specific performance metrics (e.g., sensitivity, specificity, accuracy) for an AI/algorithm-based device. This is because the submission is for a robotic catheter system, not an AI diagnostic tool.

Instead, the "acceptance criteria" are implied by the comprehensive design verification and validation testing performed to ensure the modified system continues to meet design specifications and customer requirements. The reported device performance is that it successfully passed these tests and was found to be substantially equivalent to the predicate device.

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

The document does not specify a "test set" in the context of an AI algorithm with data samples. The testing described is verification and validation of a physical/software system. Therefore, details like country of origin or retrospective/prospective data are not applicable. The testing would involve a combination of simulated scenarios, bench testing, and potentially animal/cadaveric studies (though not detailed here for this specific submission).

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

This information is not applicable. The "ground truth" for a robotic catheter system's performance is typically established through engineering specifications, regulatory standards, and objective measurements during verification and validation testing, not through expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods are relevant for studies involving human interpretation or subjective assessments, which is not the primary focus of this submission for a robotic system.

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

No MRMC study was done, nor would it typically be expected for this type of device modification submission. The device is a robotic system to facilitate navigation, not a diagnostic tool that humans would use to interpret cases. The focus is on the functional equivalence of the system, not on comparing human reading performance with and without AI assistance.

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

This is not applicable. The Magellan system is a master/slave control system, inherently designed for human-in-the-loop operation. It is not an autonomous algorithm operating without human intervention for diagnostic or treatment decisions.

7. The Type of Ground Truth Used

The "ground truth" for the verification and validation tests performed for this robotic system would be based on:

• Engineering Specifications: Whether the system performs according to its design parameters (e.g., catheter tip movement, guide wire compatibility).
• Customer Requirements: Whether the system meets the functional needs for which it was designed.
• Regulatory Standards: Compliance with relevant standards like electrical safety (implied by "Electrical Safety Test") and risk management (ISO 14971).
• Performance against Predicate Device: Demonstration of substantial equivalence in intended use, technological characteristics, and safety/effectiveness.

8. The Sample Size for the Training Set

This is not applicable. The Magellan system is not an AI/machine learning model in the sense of requiring a "training set" of data samples. Its software modifications relate to system functionality, user interface, and compatibility, not learning from a dataset.

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

This is not applicable, as there is no "training set." The software modifications were likely developed and tested against established engineering requirements and functional specifications based on the device's intended use and the predicate device's performance.

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The Magellan-2200, Model-3 Anesthesia Machine is intended/indicated for spontaneous or manually assisted ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and source oxygen pressure.

The Model-3 is a gas machine for anesthesia or analgesia. The device consists of the following components: an inlet gas manifold for oxygen and air; pressure gauges for oxygen and air; a low-pressure alarm for inlet oxygen surveillance; an oxygen analyzer and monitor; an oxygen flow selector for nasal cannula or oxygen mask for pre- and post-anesthesia use; an oxygen flush button; oxygen and air flowmeters; an agent-specific vaporizer; a common gas outlet; a carbon dioxide absorber with one way valves; and a reservoir bag/pressure gauge/pressure relief/scavenger outlet arm.

This document is a 510(k) summary for a medical device (anesthesia machine) and does not contain information related to acceptance criteria, device performance metrics, or study details as one would find for an AI/ML-driven device.

Therefore, I cannot provide the requested information. The provided text describes a modification to an existing anesthesia machine and seeks to demonstrate substantial equivalence to predicate devices, rather than presenting a performance study against specific acceptance criteria for an AI model.

The document discusses:

• Device Name: Magellan-2200, Model-3 Anesthesia Machine
• Intended Use: Spontaneous or manually assisted ventilation, delivery of gases and anesthetic vapor, monitor/alarm functions for oxygen concentration, breathing pressure, and source oxygen pressure.
• Technological Characteristics: Lists components like inlet gas manifold, pressure gauges, oxygen analyzer, flowmeters, vaporizer, CO2 absorber, etc.
• Substantial Equivalence: States the Model-3 has the same intended use and similar indications, principles of operation, and technological characteristics as predicate devices.

There is no mention of:

• Acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for diagnostic functions).
• Any study performed to demonstrate meeting such criteria.
• Sample sizes, data provenance, ground truth establishment, expert adjudication, or MRMC studies.
• Standalone algorithm performance.

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The Magellan-2200 Model-2 Anesthesia Machine is intended for spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.

The Magellan-2200 Model-2 Anesthesia Machine in indicated for use with spontaneous, manually assisted or automatic ventilation of patients during anesthesia. It may be used for the delivery of gases and anesthetic vapor. It is capable of monitor/alarm functions for oxygen concentration, breathing pressure and respiratory volumes.

The Magellan-2200 Model-2 consists of the following components:

Gas Manifold with Safety Connections
Low Pressure Oxygen Alarm
Oxygen and Air Pressure Gauges
Oxygen Auxiliary Flow Selector
Oxygen and Air Flowmeters

The provided text is for a 510(k) summary for the Oceanic Medical Products, Inc. Magellan-2200 Model-2 Anesthesia Machine. The performance data section describes the testing conducted for this device.

Here's an analysis of the acceptance criteria and study information:

Description of Acceptance Criteria and Study

The Magellan-2200 Model-2 Anesthesia Machine was tested to ensure it functioned as designed, particularly with its replacement ventilator and electrically-powered air compressor source. The primary approach to demonstrating its performance was by comparing it to its predicate device, the Magellan-2200 Model-1 Anesthesia Machine.

The core of the study relies on the premise of substantial equivalence. Rather than establishing new acceptance criteria and conducting a de novo study, the device was deemed acceptable if it performed the same protocols and achieved results as expected when compared to the established performance of the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify a sample size for the test set in terms of number of devices or number of test scenarios. It mentions "All recommended mechanical and electrical testing was completed," suggesting comprehensive testing.

The data provenance is not explicitly stated. The tests were performed by "the manufacturers of the anesthesia machine and/or the ventilator," implying internal testing by Oceanic Medical Products, Inc. and/or their ventilator supplier. It can be inferred as retrospective in the sense of testing a finished product against established protocols.

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

Not Applicable. This type of study does not involve expert readers establishing ground truth in the typical sense of a diagnostic imaging or AI-driven decision support system. The "ground truth" here is the expected operational performance of an anesthesia machine, as defined by safety standards and the performance of the predicate device.

4. Adjudication Method for the Test Set

Not Applicable. As there are no human readers or interpretations being adjudicated, no adjudication method was used. The assessment appears to be based on objective measurements and comparison to predefined performance norms for the predicate device.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is not relevant for an anesthesia machine where the primary concern is the functional, electrical, and mechanical performance of the equipment itself, rather than human interpretation of data assisted by AI.

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

Not Applicable. The device is an anesthesia machine, not an algorithm or AI system. The testing focused on the standalone performance of the physical device components.

7. The Type of Ground Truth Used

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

• Predicate Device Performance: The known and accepted performance characteristics of the Magellan-2200 Model-1 Anesthesia Machine.
• Design Specifications: The intended functioning and operational parameters of the Magellan-2200 Model-2, especially concerning the new ventilator and compressor.
• Industry Standards: Implied adherence to relevant mechanical and electrical testing protocols for such medical devices.

8. The Sample Size for the Training Set

Not Applicable. This is a hardware medical device; there is no "training set" in the context of machine learning or AI models.

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

Not Applicable. As there is no training set, there is no ground truth to establish for it in this context.

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The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair.

The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1 cc legally marketed disposable piston syringe Dispenser Handle Plunger clip Dual channel tip (spray or cannula) Two medicine cups

The provided text describes a 510(k) premarket notification for the "Magellan Ratio Dispenser Kit." This document focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a detailed de novo clinical study with specific acceptance criteria and performance data.

Therefore, many of the requested categories for device performance and study design cannot be fully addressed from the provided text. The document explicitly states that the performance data is unchanged from the predicate device (K020147). This indicates that no new, independent study was conducted for this specific 510(k) submission to establish new performance criteria.

Here's a breakdown of what can and cannot be extracted:

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

• Acceptance Criteria: Not explicitly stated in the provided text. In a 510(k) for a device like this, acceptance criteria would typically revolve around demonstrating that the device performs as intended and is as safe and effective as the predicate. This would likely involve testing of material compatibility, sterility, dispensing accuracy (if applicable), and mechanical integrity. However, specific quantitative targets are not given.
• Reported Device Performance: Not reported as new data for this submission. The text states: "Performance data that supports the safety and effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission. This data is unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the performance established for the prior K020147 device is being referenced. Without access to the K020147 submission, specific performance metrics for this device cannot be outlined here.

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

• Sample Size: Not specified for this submission. Since the performance data is stated to be "unchanged from the predicate," this information would reside within the K020147 submission.
• Data Provenance: Not specified for this submission. As above, this information would be tied to the predicate device's performance data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. This type of information is typically relevant for studies involving subjective interpretation (e.g., medical imaging, pathology slides). The Magellan Ratio Dispenser Kit is a mechanical device for fluid application, not an interpretative diagnostic tool. Its performance would be evaluated through engineering and functional testing rather than expert-established ground truth.

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

• Not applicable. See explanation for #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 a mechanical fluid dispenser, not an AI-assisted diagnostic or interpretative tool. MRMC studies are used for evaluating reader performance in diagnostic accuracy tasks.

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

• Not applicable. This is a mechanical device, not an algorithm or AI system.

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

• Not applicable. For a device of this nature, "ground truth" would be objective measurements of its mechanical and functional performance (e.g., fluid volume dispensed, spray pattern consistency, material integrity, sterility).

8. The sample size for the training set

• Not applicable. This is a mechanical device, not an AI/ML model that requires a "training set."

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

• Not applicable. See explanation for #8.

Summary of what is known from the provided text:

• Device Name: Magellan Ratio Dispenser Kit
• Indications for Use: "The Magellan™ Ratio Dispenser Kit is intended for the application of fluids, as deemed necessary by the surgeon's determination of the clinical use requirements, to facilitate the preparation of soft tissue prior to repair."
• Predicate Devices:
  1. Magellan Ratio Dispenser Kit, Medtronic, Inc (K020147 - 04/03/2002)
  2. Harvest Technologies Dual Liquid Applicator, Harvest Technologies (K020252 - 04/05/2002)
• Performance Data: The submission states that performance data supports safety and effectiveness, and this data is "unchanged from the predicate, which is our currently marketed Magellan Ratio Dispenser kit (K020147)." This implies that the current submission relies on the existing performance data of the K020147 device to demonstrate substantial equivalence, rather than providing new performance studies.
• Basis for Substantial Equivalence: Product design, materials, packaging, and sterilization are considered substantially equivalent to the predicate devices.

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The Magellan™ Autologous Platelet Separator System is designed to be used in the clinical laboratory or intraoperatively at point-of-care for the safe and rapid preparation of platelet poor plasma and platelet concentrate (platelet rich plasma) from a small sample of blood. The plasma and concentrated platelets produced can be used for diagnostic tests.

Magellan Autologous Platelet Separator system consists of a microprocessor controlled table-top centrifuge and processing disposables designed to allow for safe and rapid automatic separation of plasma and platelets. The centrifuge spins at a maximum speed of 3800 rpms at the maximum g-force of approximately 1300g.

The Magellan™ Autologous Platelet Separator System is a general-purpose centrifuge for clinical use, designed for the safe and rapid preparation of platelet poor plasma and platelet concentrate from a small blood sample for diagnostic tests.

Here's an analysis of the provided information, addressing your questions:

1. Acceptance Criteria and Reported Device Performance

The provided 510(k) summary does not explicitly list numerical acceptance criteria or detailed device performance metrics (e.g., platelet yield, purity, processing time) in a table format. It states that "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." However, this data itself is not presented in the provided text excerpts.

The conclusion states: "Magellan Autologous Platelet Separator System is substantially equivalent to the noted predicate device based on the similarities of technological characteristics, the identical indications for use and the results of performance comparative testing." This implies that the device's performance was compared to the predicate SmartPREPTM Centrifuge System (K991430) and found to be substantially equivalent, meaning it meets the performance expectations set by the predicate device for its intended use.

Therefore, for this specific submission, the "acceptance criteria" appear to be meeting or demonstrating equivalence to the predicate device's performance as established in its prior clearance. Without access to the full 510(k) submission, specific quantitative acceptance criteria cannot be provided.

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

The provided document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply mentions "performance comparative testing" was conducted.

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

This information is not applicable as the device is a centrifuge for separating blood components, not an AI or diagnostic device that requires expert ground truth for interpretation of images or patient data. Its performance is assessed through laboratory metrics of separation efficiency and product quality.

4. Adjudication Method

This information is not applicable for the reasons stated above (not an AI/diagnostic device requiring expert interpretation).

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

This information is not applicable. The device is a medical instrument (centrifuge) for preparing blood components, not a medical imaging or diagnostic AI tool that would typically involve human readers for interpretation.

6. Standalone Performance Study

Yes, a standalone performance assessment was conducted for the device. The summary states: "Performance data that supports the safety and effectiveness of the use of Magellan Autologous Platelet Separator System is included in this 510(k) premarket notification." The conclusion further confirms that the device was deemed substantially equivalent based on "results of performance comparative testing." This indicates that the device's ability to separate plasma and platelets was evaluated independently. However, the details of this study (e.g., specific metrics, experimental design) are not provided in the given text.

7. Type of Ground Truth Used

The "ground truth" for this type of device would typically involve established laboratory methods for:

• Platelet count: To determine platelet yield in the concentrate and platelet removal in the plasma.
• White Blood Cell (WBC) count: To assess the purity of the platelet concentrate (i.e., minimal WBC contamination).
• Red Blood Cell (RBC) count/hematocrit: To assess red cell contamination in the plasma and platelet concentrate.
• Volume measurements: To determine recovery efficiency.

These would be measured using standard clinical laboratory analyzers and techniques. The goal is to demonstrate that the device effectively separates blood components into platelet-rich plasma and platelet-poor plasma, meeting predefined biological and physical parameters.

8. Sample Size for the Training Set

This information is not applicable. The Magellan Autologous Platelet Separator System is a physical device (centrifuge) with automated processing, not an AI/machine learning algorithm that requires a "training set" in the conventional sense.

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

This information is not applicable for the reasons stated above.

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The Medtronic Magellan™ Ratio Dispenser Kit including tip is intended to assist the user in simultaneously delivering two non-homogenous liquids to the same treatment area(s).

The Magellan Ratio Dispenser Kit consists of the following components: 12 cc legally marketed disposable piston syringe 1, 1 cc legally marketed disposable piston syringe 1, Dispenser Handle 1, Plunger clip 1, Dual channel tip (spray or cannula) 1, Two medicine cups.

The provided text is a 510(k) summary for the Medtronic Magellan™ Ratio Dispenser Kit. It explicitly states that performance data supporting the safety and effectiveness of the device is included in the submission but does not detail the acceptance criteria or the specific study that proves the device meets those criteria.

Based on the information provided, here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated in the provided text.
• Reported Device Performance: Not explicitly stated in the provided text. The document broadly states "Performance data that supports the safety and Effectiveness of the use of Magellan Ratio Dispenser Kit is included in the submission." without providing any specifics.

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

• Sample Size: Not specified.
• Data Provenance: Not specified.

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

• Number of Experts: Not applicable, as no ground truth establishment is described for a test set.
• Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set:

• Not applicable, as no test set evaluation with adjudication is described.

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

• Study Conducted: No MRMC study is mentioned.
• Effect Size: Not applicable.

6. Standalone Performance Study (Algorithm Only):

• Study Conducted: This device is a physical medical device (syringe dispenser kit), not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable. The performance data would relate to the physical and functional aspects of the dispenser.

7. Type of Ground Truth Used:

• Not applicable, as the document refers to performance data for a physical device, not an AI algorithm requiring ground truth in the typical sense (e.g., expert consensus, pathology for diagnostic tasks). Performance data for such a device would likely involve measurements of dispensing accuracy, consistency, ease of use, material compatibility, etc.

8. Sample Size for the Training Set:

• Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

• Not applicable.

Summary of Missing Information:

The provided 510(k) summary is a high-level overview. It declares that performance data exists and supports the substantial equivalence claim but does not provide any specifics regarding:

• The actual performance criteria the device was intended to meet.
• The results of any performance testing in quantitative terms.
• Details about the studies conducted (e.g., design, sample sizes, methodology, data sources).

To obtain this detailed information, one would typically need to review the full 510(k) submission document, which is generally not publicly available in its entirety but summarized in documents like this. The 510(k) summary is designed to provide just enough information to support the substantial equivalence claim without revealing proprietary details of the tests.

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