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The device is intended to be used in medical and dental practices, hospitals, clinics, nursing homes, laboratories and other facilities to sterilize re-usable surgical instruments (including dental handpieces) and medical materials, heat and moisture resistant and compatible with steam sterilization process.

MILLENNIUM series are sophisticated equipments but of very friendly use, adaptable to the different demands thanks to the wide possibilities of configuration and choice of the cycles.

The equipments are able to treat in fast way every type of load through various patented systems and hi-tech solutions.

MILLENNIUM series sterilizers are equipped with a 5.5, 17 or 21 lites sterilization chamber and are characterized by an advanced fractionated vacuum system for the complete air removal also from hollow and porous materials as well as by an effective final vacuum drying phase able to eliminate any trace of condensation from the load.

An exclusive steam generation system, combined with the advanced control system, guarantees an high process speed and high stability of the thermodynamic parameters during the whole sterilization process and consequently full safety and perfect result.

The equipment offers sterilization programmes optimized for an effective, fast sterilization of different tools and materials used in medical environment, particularly the dental one.

The sterilization program of a MILLENNIUM series sterilizer can properly be described by a sequence of phases, each with a well defined activity.

Acceptance Criteria and Study for Mocom Millennium Series Steam Sterilizers

This submission describes the Mocom Millennium series of steam sterilizers (models B, B+, B2, Bµ) and their equivalence to predicate devices (W&H Lisa and Midmark M9 UltraClave). The acceptance criteria are implicitly defined by the parameters and performance characteristics of the various sterilization programs offered by the devices, and the study demonstrates that these devices meet those criteria by being substantially equivalent to legally marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are established by the operational parameters and load capacities of the predicate devices and the Millennium series sterilizers themselves. The reported device performance is presented as the various sterilization programs with their specific parameters.

The following table summarizes the typical performance characteristics, which serve as the acceptance criteria and the device's reported performance for various programs across the Millennium series. Since the document states "The new device is safe and effective as the predicate devices" and "MILLENNIUM series sterilizers are substantially equivalent to the W&H Lisa Steam Sterilizer and Midmark M9 UltraClave Steam Sterilizer," the acceptance criteria for the Millennium series are effectively the performance characteristics of these predicate devices as well as the demonstrated performance of the Millennium series devices as detailed in the "Table of the Available Programs" for each model.

Note: The document explicitly states that the "EXTRA and INTELLIGENT options" for drying and the "FAST option" for drying have not been validated. Also, the "134°C / 121°C CUSTOM program has not been validated." This indicates that these specific features, while present, are not part of the validated acceptance criteria for "safe and effective" claim and would require further validation if used as primary sterilization programs.

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

The document is a 510(k) premarket notification for substantial equivalence, not a clinical trial report. As such, it does not describe a "test set" in the context of an AI/ML device evaluating data. Instead, the "study" for this device involved engineering and performance testing to demonstrate that the sterilizers meet the specified operational parameters and effectively sterilize various loads.

• Sample Size for Testing: The document does not specify a quantitative "sample size" in terms of number of sterilization cycles or tests performed. It refers to various "programs" and their associated parameters (temperature, pressure, holding time, drying time, load types, and maximum masses). These parameters derive from general standards for steam sterilization and performance testing typical for such devices.
• Data Provenance: The data provenance is from engineering and performance testing conducted by the manufacturer (M.O.COM. s.r.l.) in Italy. This would be considered prospective testing to characterize the device's technical performance. The results are presented in the form of tables detailing the various sterilization cycles and their validated/specified parameters. While not explicitly stated, such testing would typically involve:
  • Physical Monitoring: Temperature and pressure sensors placed within the chamber and load.
  • Biological Indicators: Used to confirm sterility within various load configurations.
  • Chemical Indicators: Used to confirm exposure to sterilization conditions.
  • Bowie-Dick Test: Specifically mentioned in the tables to confirm air removal and steam penetration for porous loads.
  • Vacuum Test: Specifically mentioned to evaluate vacuum integrity.

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

In the context of a steam sterilizer, "ground truth" for a test set would pertain to the successful sterilization of items and the accurate measurement of physical parameters during a cycle.

• Number of Experts: The document does not specify a number of experts. The data presented (e.g., total cycle time, water/energy consumption, max load mass) would be derived from standard engineering and microbiological validation protocols.
• Qualifications of Experts: The "experts" involved in verifying the sterilizer's performance would primarily be:
  • Engineers: Responsible for designing, building, and testing the device to meet specified physical parameters (temperature accuracy, pressure control, vacuum levels, timing).
  • Microbiologists/Sterilization Scientists: Responsible for validating the sterilization efficacy using biological indicators and ensuring the device achieves a sterility assurance level (SAL) appropriate for medical devices.
  • Regulatory Affairs Personnel: To ensure compliance with relevant standards and regulations (e.g., ISO, AAMI, FDA).

These are implied roles based on the nature of the device and regulatory submission, rather than explicitly stated individuals in this document.

4. Adjudication Method for the Test Set

Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus on subjective evaluations (e.g., medical image interpretation). For a device like a steam sterilizer, "adjudication" is not directly applicable in this sense.

Instead, the "adjudication" for the performance of a steam sterilizer involves:

• Conformance to Standards: Ensuring the device operates within the parameters set by recognized national and international standards for steam sterilization (e.g., EN 13060 for small steam sterilizers).
• Successful Sterilization Endpoints: Confirming the inactivation of biological indicators, meeting specific physical parameter thresholds (temperature, pressure, time), and passing routine tests like the Bowie & Dick test and Vacuum test.
• Engineering Validation: Verification and validation activities by the manufacturer's R&D, Quality Assurance, and Engineering teams to ensure the device performs as designed and meets its specifications.

The document implies that these standard industry practices for validation were followed, leading to the reported performance characteristics for each program.

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

No, an MRMC comparative effectiveness study was not done. MRMC studies are typically performed for diagnostic or AI-assisted interpretation devices where multiple human readers evaluate multiple cases, often with and without AI assistance, to measure changes in diagnostic performance.

This document is a 510(k) submission for a medical device (steam sterilizer), which is an entirely different class of device and does not involve human interpretation of cases or AI assistance in that sense. The comparison provided in the submission is purely based on the technological characteristics and intended use of the sterilizer against predicate devices, establishing "substantial equivalence."

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

No, this question is not applicable to a steam sterilizer. The Millennium series of sterilizers are electromechanical devices that perform a physical process of sterilization. They do not involve algorithms in the sense of AI/ML interpretation where a "standalone" or "human-in-the-loop" performance would be evaluated. The sterilizer operates autonomously based on its programmed cycles, with human interaction limited to loading/unloading and program selection.

7. The Type of Ground Truth Used

The "ground truth" for a steam sterilizer is:

• Physical Parameters: Accurate measurements of temperature, pressure, and time achieved within the sterilization chamber and the load.
• Sterility Assurance: The confirmed inactivation of highly resistant microorganisms (e.g., Geobacillus stearothermophilus spores) as demonstrated by biological indicators (BIs) placed within test loads, achieving a specified sterility assurance level (SAL).
• Process Indicators: Successful change in color/state of chemical indicators (CIs) to confirm exposure to sterilization conditions.
• Test Pack Results: Successful passing of Bowie-Dick tests (for air removal and steam penetration) and Vacuum tests (for chamber integrity).

These are established through rigorous engineering and microbiological validation during the development and testing phases of the sterilizer. The tables in the document reflect the parameters of cycles that have demonstrated these ground truths.

8. The Sample Size for the Training Set

This question is not applicable. Training sets are relevant for AI/ML algorithms. The Mocom Millennium series sterilizers are not described as incorporating AI/ML, and therefore, there is no "training set." The device's operation is based on pre-programmed, validated sterilization cycles and control systems.

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

This question is not applicable, as there is no training set for an AI/ML algorithm. The "ground truth" for the device's efficacy is established through the validation of its physical and biological performance against accepted sterilization standards, as explained in point 7.

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The Varian Millennium 120 Multi-leaf Collimator (MLC) is provided to assist the radiation oncologist in the delivery of radiation to defined target volumes while sparing surrounding normal tissue and critical organs from excess radiation. In static mode, the MLC performs the same function as the customized shadow blocks. In a dynamic mode, a series of MLC leaf positions can be indexed to either Clinac dose fraction or gantry angle to create a changing beam shape while the radiation beam is on to create a three dimensional dose distribution.

Millennium Multi-Leaf Collimator (MLC) Release v7.0 is a modification of the present MLC device (K990085) to include the following:

• 1. Large Field IMRT treatments
• Smooth motion control 2.
• 3. Faster patient plan downloads via ethernet
     The Varian Millennium Multileaf Collimator (MLC) is an x-ray collimator designed to be mounted on a Varian Clinac® radiation therapy linear accelerator and is intended to shape the x-ray field perimeter. Field shape can either be static (fixed) or dynamic. Dynamic field shapes are controlled as a function of either Clinac® dose fraction or gantry angle.

The provided 510(k) summary for the Millennium Multi-leaf Collimator (K050442) outlines a modification to an existing device, primarily focusing on engineering enhancements rather than a new AI-powered diagnostic or predictive tool. Therefore, many standard acceptance criteria and study design elements typically associated with AI/ML medical devices are not explicitly detailed in this document.

Based on the information provided, here's a breakdown:

1. Table of Acceptance Criteria and Reported Device Performance:

The 510(k) summary does not contain a quantitative table of acceptance criteria and reported device performance in the way one would expect for a diagnostic AI device (e.g., sensitivity, specificity, AUC). Instead, the improvements are described qualitatively:

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

The document does not describe a "test set" in the context of data for an AI/ML algorithm. This 510(k) is for a physical device modification, not a software algorithm evaluated against a dataset of patient images or outcomes. Therefore, there is no mention of sample size for a test set or data provenance (country of origin, retrospective/prospective). The evaluations would likely involve engineering testing, performance verification, and possibly clinical use data from the previous version of the device, but these details are not provided in this summary.

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

Not applicable. This is not an AI/ML device requiring expert-established ground truth from medical images or patient data. The "ground truth" for this device would be its ability to perform its mechanical and electronic functions (e.g., accurately shaping radiation fields, smooth movement).

4. Adjudication Method:

Not applicable. There is no adjudication method described as this is not a study involving human-expert consensus on medical data.

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

Not applicable. This device is a physical component of a radiation therapy system, not an AI software intended to assist human readers in interpretation. Therefore, an MRMC study is not relevant.

6. Standalone (Algorithm Only) Performance:

Not applicable. This is a physical device, not an algorithm. Its performance is intrinsically linked to its operation within the linear accelerator system.

7. Type of Ground Truth Used:

The "ground truth" for this medical device would be based on engineering specifications, physical measurements, and performance benchmarks for radiation field shaping, motion control, and data transfer speeds. It would also implicitly rely on the established safety and efficacy of the predicate device (K990085). The document does not specify the exact methods for defining or verifying this "ground truth."

8. Sample Size for the Training Set:

Not applicable. This device is a hardware modification, not an AI/ML algorithm that requires a "training set" of data.

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

Not applicable. As there is no AI/ML training set, there's no ground truth established for it.

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The Millennium M10 Oxygen Concentrator is intended to provide supplemental oxygen to persons requiring oxygen therapy. The device is not intended to be life support nor life sustaining.

The Millennium M10 Oxygen Concentrator is a medical device that produces concentrated oxygen from room air for delivery to a patient requiring oxygen therapy. It uses molecular sieve and a pressure swing adsorption process to concentrate oxygen from air. The device is capable of providing oxygen flow up to 10 LPM and is offered with an optional Oxygen Percentage Indicator.

This submission focuses on the substantial equivalence of the Millennium M10 Oxygen Concentrator to existing predicate devices rather than providing a detailed performance study with specific acceptance criteria and ground truth analysis. Therefore, much of the requested information regarding sample sizes, expert qualifications, and specific statistical performance metrics is not available in the provided text.

Here's an analysis based on the available information:

Acceptance Criteria and Reported Device Performance

The document states that "Performance, environmental, electrical, mechanical and electromagnetic compatibility testing was performed to prove the safety and effectiveness of the Millennium M10." However, it does not explicitly list specific numerical acceptance criteria or the reported performance data against those criteria. The conclusion is a general statement of substantial equivalence.

Study Information

Due to the nature of this 510(k) summary, which focuses on substantial equivalence to predicate devices, comprehensive study details typically found in a clinical trial report are not present.

1. Sample size used for the test set and the data provenance: Not explicitly stated. The testing mentioned ("Performance, environmental, electrical, mechanical and electromagnetic compatibility testing") likely involved a series of engineering and bench tests rather than a patient-based test set with a defined sample size for performance evaluation in the context of diagnostic accuracy.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or not stated. As this is not a diagnostic device with "ground truth" established by human interpretation, there's no mention of experts for ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable or not stated.
4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is an oxygen concentrator, not an AI-assisted diagnostic device.
5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a medical device, not a standalone AI algorithm. The performance evaluation would be of the device itself.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not explicitly defined as "ground truth" in the diagnostic sense. The "ground truth" for an oxygen concentrator would be its physical output and functional parameters measured against engineering specifications and industry standards for safety and performance (e.g., oxygen concentration, flow rate, purity, noise levels, power consumption, etc.).
7. The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model requiring a training set.
8. How the ground truth for the training set was established: Not applicable.

In conclusion, the provided document is an Abbreviated 510(k) summary for an oxygen concentrator, primarily demonstrating substantial equivalence to existing devices. It outlines that various engineering and performance tests were conducted to confirm safety and effectiveness, but it does not detail specific acceptance criteria or results in the way a diagnostic device study would.

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The Millennium III 3T 8-Channel Neurovascular Coil is designed to provide magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 3T 8-Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon parameters (proton density, spin lattice relaxation time T1, and spin spin relaxation time T2) and (3) display the soft tissue structure of the body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium III 3T 8-Channel Neurovascular Coil is a multi-element phased array receive-only coil. The coil is shaped to conform to the contours of the head and spine and has been designed to maximize comfort and ease of use. The elements and associated circuitry are enclosed in a housing made of plastic materials, which are fire rated and have high impact and tensile strength.

The provided document is a 510(k) premarket notification for a medical device (Millennium III 3T 8-Channel Neurovascular Coil). It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.

This document describes a new MRI accessory and demonstrates its substantial equivalence to previously cleared predicate devices. The focus is on comparing the physical characteristics, intended use, indications for use, and safety features (like RF burn prevention and RF absorption) of the new coil to existing, cleared coils.

Therefore, I cannot provide the requested information. The document is not a study report for an AI/ML device that would establish performance metrics against acceptance criteria.

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The Bausch & Lomb (B&L) Millennium Peristaltic Pump System is intended for the introduction of Balanced Salt Solution (BSS) into the eye, as well as, the aspiration of fluid/tissue from the eye during ophthalmic anterior surgery. The Millennium Peristaltic Pump System consists of the B&L CX4100 module to be used with the B&L Millennium Microsurgical System and the B&L Peristaltic Phaco Pack, CX5310 sterile single-use accessory pack which consists of the various components/accessories necessary to enable the use of B&L Anterior Handpieces with the Millennium Microsurgical System.

The Peristaltic Pump System consists of a new module and will fit into the existing base of Millennium Microsurgical Systems. It is an anterior only module designed to be used with phacoemulsification. The module is flow based in that it will provide aspiration by means of a peristaltic pump. A peristaltic pump is a positive displacement type of pump which controls flow rate by the rotational speed of the pump head. The module will contain an interface for the disposable Peristaltic Pump Cartridge and one pneumatic output. The interface for the peristaltic pump cartridge ensures the peristaltic tubing is properly positioned for engagement by the pump head and the pressure sensor and integral pinch valves are properly aligned. The pneumatic connection delivers air pressure sufficient to drive a vitrectomy cutter. The Peristaltic Pump Cartridge will be provided as a sterile, single use product. The cartridge consists of a molded housing with pre-connected irrigation tubing which acts as a conduit for instilling balanced salt solution (BSS). The tubing interfaces with the rotating peristaltic roller pump head. In addition, the cartridge contains a pressure transducer that interfaces with the transducer PCB on the peristaltic module to measure the vacuum within the aspiration path of the cartridge.

I am sorry, but the provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for the Millennium™ Peristaltic Pump System, focusing on its description, indications for use, and a comparison to predicate devices to establish substantial equivalence.

It does not include:

• A table of acceptance criteria and reported device performance.
• Details about sample sizes, data provenance, number of experts, adjudication methods, or ground truth for a test set.
• Information regarding MRMC comparative effectiveness studies or standalone algorithm performance.
• Information about training set size or how its ground truth was established.

The 510(k) process primarily assesses substantial equivalence to legally marketed predicate devices, rather than requiring extensive de novo clinical studies with predefined acceptance criteria for novel performance claims.

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The Millennium III 4 Channel Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest in Magnetic Resonance Imaging Systems. The Millennium III 4 Channel Neurovascular Coil is designed for use with the 3.0T MRI systems manufactured by GE Medical Systems.

Indications for Use: The Millennium III 4 Channel Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck, and upper chest. The Millennium III 4 Channel Neurovascular Coil is designed for use with the GE 3.0T scanner manufactured by GE Medical Systems, Inc.

Anatomic Regions: brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest Nuclei Excited: Hydrogen

The indications for use are the same as for standard imaging:

The 3.0T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1. spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium III 4 Channel Neurovascular Coil is a multi-element phased array receive only coil. The coil has a rigid enclosure. The open, patient friendly design eases patient handling and positioning and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

The provided text is a 510(k) summary for a Magnetic Resonance Imaging Accessory, specifically the Millennium III 4 Channel Neurovascular Coil. This document focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving performance against specific acceptance criteria for a diagnostic algorithm.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, and comparative effectiveness will not be found in this document, as it pertains to a physical medical device (an MRI coil) and not a diagnostic AI algorithm.

However, I can extract the information that is present and indicate where information is not applicable or not provided.

Here's an analysis of the provided text based on your request:

Acceptance Criteria and Device Performance

Since this is a physical MRI coil, the "acceptance criteria" and "device performance" are typically related to its physical characteristics, safety, and imaging capabilities in comparison to a predicate device, rather than diagnostic accuracy metrics like sensitivity or specificity.

Study Information

As this is a 510(k) for a physical medical device (an MRI coil), the "study" demonstrating its performance is primarily based on comparative analysis of its technical specifications and intended use against a legally marketed predicate device. This is a common approach for demonstrating substantial equivalence for devices that are not "diagnostic algorithms" or "AI/ML devices" in the modern sense. Therefore, many of the questions regarding clinical study design for AI are not applicable.

1. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a "test set" in the context of an AI/ML algorithm. The equivalence is based on device features and intended use.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a diagnostic outcome is not established for this device, which is a hardware component.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI-enabled diagnostic device.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical device, not an algorithm.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established safety and performance of the predicate devices.
7. The sample size for the training set: Not applicable. There is no concept of a "training set" for this physical device.
8. How the ground truth for the training set was established: Not applicable.

In summary, the provided K032415 document serves as a 510(k) premarket notification for an MRI coil, establishing its substantial equivalence to previously cleared predicate devices based on technical characteristics, intended use, and safety features. It does not involve a clinical study for diagnostic performance in the way an AI/ML diagnostic algorithm would.

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The Millennium Series Mechanical Wheelchair provides enhanced mobility to physically challenged persons limited to a sitting position.

The Millennium Series Wheelchair is manually operated mechanical wheelchair. It is designed to be durable with folding frame. The range of sizes and configurations are available to accommodate the needs of each user. The wheelchair is suitable to provide mobility to user for both indoors and outdoors with firm surface that is free of climbing obstacles.

The Millennium Series Mechanical Wheelchair consists of typical components found on most manual wheelchair. The wheelchair consists of metal frame constructed of round steel tubing that is welded, seat and back upholsteries, removable footrests/legrests, front casters and rear wheels. The upholstery fabric meets the California Technical Bulletin CAL 117 Standard for flame retardancy.

The provided text does not contain details about acceptance criteria, device performance, or a study that uses specific performance metrics (like accuracy, sensitivity, specificity, or AUC) to prove the device meets said criteria.

Instead, this document is a 510(k) submission for a mechanical wheelchair, focusing on substantial equivalence to a predicate device. Here's a breakdown of what is present and how it relates to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not Applicable. The submission does not define specific performance metrics like accuracy, sensitivity, or other quantitative measures typically found in studies for AI/software devices. For a mechanical wheelchair, "performance" is generally defined by meeting safety and functional standards, not diagnostic accuracy.
• The document states: "Required tests for mechanical wheelchair listed in the Guidance Document for the Preparation of Premarket Notification [510(k)] Applications for Mechanical and Powered Wheelchairs, and Motorized Three Wheeled Vehicles, July 1995, were conducted and the results are included in the subject 510(k) submission." This indicates that some testing was done, but the specific acceptance criteria and results are not detailed in this summary. They would be in the full submission, but not in a format suitable for the table requested for device performance in the context of an AI/diagnostic device.

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

• Not Applicable. This is a hardware device (mechanical wheelchair). The concept of a "test set" for performance evaluation in the way it's used for AI or diagnostic devices does not apply here. There's no data (like images or patient records) being analyzed.
• Testing would likely involve physical trials on a limited number of wheelchair prototypes, but this is not a data-driven validation study for an AI algorithm.

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

• Not Applicable. This is a hardware device. There is no "ground truth" to be established by experts in the context of diagnostic accuracy.

4. Adjudication Method for the Test Set:

• Not Applicable. As there's no "test set" in the diagnostic sense, there's no adjudication method.

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

• No. The document explicitly states: "Comparative performance testing and clinical evaluations were not submitted as part of this 510(k)." This directly indicates that no MRMC study or clinical comparative effectiveness study was performed or included.

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

• Not Applicable. This is a mechanical device, not an algorithm. There is no standalone algorithm performance to evaluate.

7. The Type of Ground Truth Used:

• Not Applicable. This is a mechanical device. The concept of "ground truth" as it applies to diagnostic or AI performance (e.g., pathology, clinical outcomes, expert consensus) is not relevant. The "truth" for a wheelchair would be its structural integrity, maneuverability, safety, and compliance with standards.

8. The Sample Size for the Training Set:

• Not Applicable. This is a mechanical device. There is no AI algorithm being trained, therefore no training set.

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

• Not Applicable. As there is no training set.

Summary regarding your request:

The provided 510(k) summary for the Millennium Series Mechanical Wheelchairs is for a hardware (mechanical) device seeking market clearance based on substantial equivalence to a predicate device. It does not involve AI, diagnostics, or data-driven performance assessments in the way your questions are formulated. Therefore, most of the requested information (acceptance criteria for accuracy/performance metrics, sample sizes for test/training sets, expert ground truth, MRMC studies) is not applicable to this document. The "testing" mentioned refers to compliance with established standards for mechanical wheelchairs, not the type of performance evaluation relevant to AI or diagnostic software.

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The laser modes are intended for retinal photocoagulation and laser trabeculaplasty. Delivery devices available are the Endoprobe for intraocular endolaser surgery, and the Laser Indirect Ophthalmoscope Plus (LIO+) for transpupillary laser delivery for patients in the supine position.

The Millennium™ Laser Photocoagulator System is a Class 4 laser. The system is made up of three separate components that are required to interface with each other in order to allow laser emission, They are the Laser Module, Multifunctional Foot Control with laser switch and the junction box. In order for the Millennium™ Microsurgical System to operate the Lascr Module, the system must have laser enabled software. The software includes functions to recognize the laser module as a network node and provides the graphical user interface.

The provided text is a 510(k) summary for the Millennium™ Laser Photocoagulator System. This document focuses on establishing substantial equivalence to a predicate device (IRIS Medical® OcuLight® GL Laser System) rather than presenting a performance study with acceptance criteria in the context of AI/ML or diagnostic devices.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert qualifications, adjudication methods, and MRMC/standalone studies is not available in the provided text.

The document describes the device's components, intended use, and similarities/differences with the predicate device, ultimately receiving an FDA clearance based on substantial equivalence. This type of submission relies on demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against specific quantitative criteria through a clinical or technical study as might be done for novel diagnostic or AI-powered devices.

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The Neurovascular Coil is a receive-only phased array RF coil, used for obtaining diagnostic images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest extending to the cardiac region in Magnetic Resonance Imaging Systems. The Millennium 5000 Neurovascular Coil is designed for use with the Altaire 0.7T MRI system manufactured by Hitachi Medical Systems, Inc. The indications for use are the same as for standard MR Imaging.

The Millennium 5000 Phased Array Neurovascular Coil is designed to provide Magnetic Resonance Images of the brain, cervical spine, soft tissues and vasculature of the head, neck and upper chest. The Millennium 5000 Phased Array Neurovascular Coil is designed for use with the Altaire 0.7T scanner manufactured by Hitachi Medical Systems.

The indications for use are the same as for standard imaging:

The 0.7T MRI system is indicated for use as an NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR signal, (2) depend upon NMR parameters (proton density, spin lattice relaxation time T1, spin-spin relaxation time T2) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

The Millennium 5000 Phased Array Neurovascular Coil is a 4-element quadrature phased array, receive-only coil. The coil consists of three sections: a main coil base, an open designed head former, and a detachable chest plate. The split-top, three piece design minimizes claustrophobic effects and maximizes patient comfort. The coil elements and accessory electronics are enclosed in a rigid plastic housing, which is fire rated and has a high impact and tensile strength.

This document is a 510(k) premarket notification for a medical device called the "Millennium 5000 Phased Array Neurovascular Coil." It describes the device and claims substantial equivalence to previously cleared devices, rather than presenting a study to prove performance against specific acceptance criteria.

Therefore, the requested information elements related to a study (like sample sizes, ground truth establishment, expert adjudication, MRMC studies, standalone performance, training sets, clinical outcomes, etc.) are not available in this document.

The document primarily focuses on demonstrating that the new device has similar characteristics and intended use to existing devices, which is the basis for a 510(k) clearance, not a clinical performance study with predefined acceptance criteria.

However, I can extract information regarding the device's intended use, description, and comparison to predicate devices, which serves as the "performance" relevant to a 510(k) submission.

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

Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are implicitly met by demonstrating similarity to predicate devices, and the "reported device performance" is a description of its features and intended use, aligning with those of the predicates.

Regarding the other requested points, they are not applicable or estimable from the provided document as it is a 510(k) submission based on substantial equivalence, not a clinical performance validation study:

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

• Not applicable/Not provided. This document does not describe a test set or clinical study data. It relies on comparison to existing legally marketed devices.

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

• Not applicable/Not provided. No ground truth establishment is described for a test set.

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

• Not applicable/Not provided. No adjudication method is described.

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/Not provided. This is a hardware device (MRI coil), not an AI-assisted diagnostic product. No MRMC study was performed or described.

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

• Not applicable/Not provided. This is a hardware device, not an algorithm.

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

• Not applicable/Not provided. No ground truth is described.

8. The sample size for the training set

• Not applicable/Not provided. There is no "training set" as this is not an AI or software device that undergoes training.

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

• Not applicable/Not provided. No training set or ground truth for it is relevant to this submission.

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