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The Altaire MPS#1 Multipurpose Contact Lens Solution is indicated for cleaning, rinsing, chemical (not heat) disinfecting, daily protein removal, and storing of soft (hydrophilic) contact lenses, rigid gas permeable (fluoro silicone acrylate and silicone acrylate) contact lenses as recommended by your eye care practitioner.

Altaire MPS#1 Multipurpose Contact Lens Solution is a sterile aqueous solution containing sodium chloride, bis-tris propane, pluronic F127, cremophor RH40and preserved with edetate disodium dehydrate 0.025% and polyhexanide 0.0001%

The provided text describes the 510(k) Premarket Notification for Altaire MPS#1 Multipurpose Contact Lens Solution. The submission focuses on demonstrating substantial equivalence to a predicate device (SOLO-Care Plus Multipurpose Solution, K012731) rather than a de novo study proving efficacy against specific acceptance criteria with detailed performance metrics.

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

Acceptance Criteria and Reported Device Performance

The device's performance is not reported in terms of specific numerical values against quantitative acceptance criteria for each study type. Instead, the document states that the device "satisfies the requirements" or "met acceptance criteria" according to FDA guidance.

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 the various tests (Critical Micelle Concentration, Cytotoxicity, Microbiological studies).
The data provenance is also not specified (e.g., country of origin, retrospective or prospective). These details are typically found in the full study reports, not in the 510(k) summary.

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 to this type of device and study. The testing for a contact lens solution involves laboratory-based chemical and microbiological evaluations, not assessments requiring expert interpretation of clinical data or images.

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

This information is not applicable for the type of laboratory testing conducted for a contact lens solution. Adjudication methods are typically used in clinical studies or image-based diagnostic studies where multiple readers' opinions need to be reconciled.

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 was not performed. This type of study is relevant for diagnostic devices often involving AI assistance and human interpretation, which is not the case for a contact lens solution. The submission explicitly states: "clinical performance data was not performed, nor is it a requirement for the purpose of this premarket notification" because the device is substantially equivalent to a predicate.

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

This concept is not applicable to the device. A contact lens solution is not an algorithm, nor does it involve human-in-the-loop performance. The microbiological studies for disinfection were "standalone" in the sense that they evaluated the solution's efficacy against microbes without human intervention during the disinfection process.

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

The "ground truth" for the tests performed can be inferred as:

• Cleaning Studies: Established scientific and regulatory standards (FDA Guidance document) for micelle concentration and cleaning effectiveness.
• Cytotoxicity: Established cell viability assays and irritation assessment protocols which determine what constitutes "non-toxic" and "non-irritant."
• Microbiological Studies: Established microbiological testing standards (e.g., ISO, USP, or FDA guidelines) that define specific log reduction requirements for various microorganisms or preservative efficacy.

8. The sample size for the training set

This information is not applicable as the device is 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 as the device is not an AI/ML algorithm.

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The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.

The Hitachi Model Altaire Interventional MR Package is an optional enhancement designed for use with the Hitachi Model Altaire Magnetic Resonance Diagnostic Device (K050620). It's intended function and use is to aid to aid in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. (Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user).

The package consists of an open head coil, an open body coil and an MR compatible in room color monitor. The head and body coils are used for obtaining diagnostic images of the head and body regions, while the display monitor is used for in room review of the images during the interventional procedure(s). The head and body coils are compatible with existing Altaire hardware and software. Therefore no hardware or software modifications are needed to use these coils.

Based on the provided text, the device described is the Hitachi Model Altaire MR Interventional Package. This submission ([K053309](https://510k.innolitics.com/search/K053309)) is a 510(k) premarket notification for an optional enhancement to an existing MRI system. The text indicates that the device is substantially equivalent to a predicate device and addresses its intended use and description, but it does not contain any information about acceptance criteria or a study proving that specific performance criteria are met.

The document is a 510(k) summary and the FDA's acceptance letter. These types of documents typically focus on demonstrating substantial equivalence to a predicate device rather than detailing specific performance studies with acceptance criteria, especially for accessories or enhancements to well-established technology like an MRI system.

Therefore, I cannot provide the requested information from the given text. The text does not include:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for a test set or data provenance.
3. Number and qualifications of experts for ground truth.
4. Adjudication method for a test set.
5. Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
6. Information about a standalone performance study.
7. Type of ground truth used.
8. Sample size for a training set.
9. How ground truth for the training set was established.

The 510(k) summary indicates that the device "aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures...that may be facilitated by real-time MR guidance." It further states that "Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user." This implies that the device's functionality is to enhance existing MRI procedures by providing real-time guidance, and its performance is inherently tied to the overall MRI system (Hitachi Model Altaire Magnetic Resonance Diagnostic Device, K050620) and the user's clinical expertise and choice of MRI-compatible instrumentation.

In summary, the provided text does not contain the detailed performance study information requested.

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The Altaire MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry. The design was based on the AIRIS II Open MRI system. This system takes advantage of the imaging properties of the 0.7T magnet.

The provided 510(k) summary for the ALTAIRE Magnetic Resonance Imaging System w/V5.0 Operating System Software (K050602) does not contain any information regarding acceptance criteria, device performance metrics, or study details.

The document primarily focuses on:

• Device Identification: Submitter information, device names, and predicate device.
• Intended Use: Standard description of an MRI system's diagnostic purpose.
• Device Description: Technical details about the 0.7 Tesla MRI system, its scientific principles (MRI physics), and its physical/performance characteristics (high-quality anatomical images without ionizing radiation, various image contrasts).
• Technological Characteristics: States similarity to a predicate device with software enhancements.
• Conclusions: Declares substantial equivalence to the predicate device.
• FDA Approval Letter: Confirms substantial equivalence based on the provided information.
• Indications for Use: Reiterates the standard clinical applications for an MRI system for various anatomical regions and imaging techniques.

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

In summary, the input text does not contain the information requested in your prompt regarding acceptance criteria and performance studies.

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The Altaire MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility as compared to the AIRIS II by taking advantage of the imaging properties of the 0.7T magnet.

Here's an analysis of the provided text regarding the acceptance criteria and study information for the ALTAIRE Magnetic Resonance Imaging System, presented in the requested format.

Important Note: The provided document is a 510(k) summary for a medical device cleared in 2002. At that time, the regulatory requirements for performance studies, particularly concerning detailed acceptance criteria and standalone AI performance, were significantly different and generally less stringent than for modern AI/ML medical devices. This document primarily focuses on demonstrating substantial equivalence to predicate devices, rather than comprehensive performance studies as might be expected for novel AI tools today. Therefore, much of the requested information (like specific acceptance criteria, detailed study design for proving performance, expert adjudication, MRMC studies, or standalone algorithm performance) is not present in this type of submission.

Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size: Not applicable. The document does not describe a traditional "test set" or a performance study in the context of clinical accuracy or diagnostic performance involving a specific sample size of patients or images. The evaluation is centered on demonstrating substantial equivalence based on technical specifications and intended use.
• Data Provenance: Not applicable. No specific clinical data from a test set is referenced for the comparison.

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

• Not applicable. No ground truth establishment from experts for a dedicated test set is described. The evaluation is not based on direct clinical performance comparison of the new device's images against a ground truth dataset established by experts.

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

• Not applicable. There is no described test set or adjudication process for diagnostic interpretations.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. The device is an MRI system, not an AI interpretation tool.

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

• No, a standalone performance study in the context of an algorithm's diagnostic output was not done. The device is a diagnostic imaging system that requires human interpretation.

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

• Not applicable. No specific ground truth for diagnostic accuracy is described in relation to a performance study for this device. The "ground truth" for substantial equivalence is the demonstration that its technical characteristics and intended use are similar to predicate devices.

8. The sample size for the training set

• Not applicable. The document does not describe a "training set" in the context of machine learning. The device being submitted is an MRI system, not an AI/ML algorithm.

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

• Not applicable. As there's no described training set related to AI/ML, there's no mention of ground truth establishment for it.

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The MR system is an imaging device and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spinspin relaxation time (T2) and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The Transmit/Receive Coil is a radial type, multiple element resonator coil used to obtain diagnostic images of the body when used with the Altaire MR Imaging system.

The Altaire MR Imaging system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MRI system produces axial, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. Among the NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

The ALTAIRE is a Magnetic Resonance Imaging System that utilizes a 0.7 Tesla superconducting magnet in an open gantry design. The design was based on the AIRIS II Open MRI system. The ALTAIRE has been designed to enhance clinical utility by taking advantage of the imaging properties of the 0.7T magnet.

This 510(k) submission (K021751) describes a Magnetic Resonance Imaging (MRI) system (ALTAIRE) and an associated Transmit/Receive Coil. It is important to note that this document is for a new coil accessory for an existing MRI system, not a new AI-powered diagnostic device. Therefore, the questions related to AI device performance, sample sizes for test/training sets, expert ground truth establishment, adjudication methods, and MRMC studies are not applicable to this submission.

The acceptance criteria and "study" described are focused on demonstrating substantial equivalence to a predicate MRI device, primarily regarding the safety and basic performance of the new coil.

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

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

Since this is a submission for an MRI system and its coil, the "acceptance criteria" are related to its fundamental technical specifications and intended use, rather than a diagnostic performance metric like sensitivity/specificity for an AI algorithm. The core "performance" demonstrated is its ability to produce images and its substantial equivalence to a predicate device.

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

• Not Applicable. This submission does not describe a clinical study in the sense of a test set for diagnostic performance or AI algorithm validation. The "study" here is a technical comparison and declaration of substantial equivalence to an existing, legally marketed device. Therefore, no patient data test set or provenance is mentioned.

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

• Not Applicable. See point 2. There is no test set or ground truth establishment in this context for diagnostic performance.

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

• Not Applicable. See point 2.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. This is not an AI device.

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

• Not Applicable. As this is a submission for an MRI system and coil, the "ground truth" implicitly refers to the established safe and effective operation of the predicate device (Hitachi Altaire MRI System K002420) and the scientific principles of MRI, rather than a diagnostic ground truth for a specific condition.

8. The sample size for the training set

• Not Applicable. This is not an AI device, therefore, no training set is described.

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

• Not Applicable. See point 8.

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